Regulating the ‘Brave New World:’ Ethico-Legal Implications of the Quest for Partial Ectogenesis
A thesis submitted to the University of Manchester for the degree of Doctor of Philosophy in the Faculty of Humanities School of Social Sciences
2020 Elizabeth Chloe Romanis Department of Law
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SHORT TABLE OF CONTENTS
INTRODUCTION ...... 19 Chapter One – Key Context ...... 25 Chapter Two – Approach ...... 48 Chapter Three – Outline of Papers...... 64 PART I – UNDERSTANDING PARTIAL ECTOGENESIS ...... 69 Paper One – Artificial Womb Technology and the frontiers of human reproduction: conceptual differences and potential implications ...... 70 Paper Two – Challenging the ‘Born Alive’ Threshold: Foetal Surgery, Artificial Wombs and the English Approach to Legal Personhood...... 84 Paper Three – Artificial Womb Technology and the Significance of Birth: Why Gestatelings are not Newborns (or Fetuses) ...... 122 PART II – REALISING PARTIAL ECTOGENESIS ...... 129 Paper Four – Artificial Womb Technology and Clinical Translation: Innovative Treatment or Medical Research? ...... 130 PART III – IMPLICATIONS OF PARTIAL ECTOGENESIS ...... 153 Paper Five – Artificial Womb Technology and the Choice to Gestate Ex Utero: Is Partial Ectogenesis the Business of the Criminal Law? ...... 154 Paper Six – Partial Ectogenesis: Freedom, Equality and Political Perspective ...... 194 CONCLUSION ...... 200 BIBLIOGRAPHY ...... 234 APPENDIX ...... 250
Word Count (including footnotes, excluding front and end matter): 88,507
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COMPLETE TABLE OF CONTENTS
ABSTRACT ...... 7 DECLARATION ...... 8 COPYRIGHT STATEMENT ...... 8 ACKNOWLEDGEMENTS ...... 9 THE AUTHOR ...... 11 LIST OF ABBREVIATIONS ...... 14 TABLE OF CASES ...... 15 TABLE OF LEGISLATION ...... 17 INTRODUCTION ...... 19 CHAPTER ONE – KEY CONTEXT ...... 25 Aims and Objectives ...... 25 On Speculation ...... 25 Scope ...... 28 Partial ectogenesis ...... 28 The subject of the artificial womb ...... 35 Moral Status ...... 36 CHAPTER TWO - APPROACH...... 48 Thesis Structure ...... 48 Method and Methodology ...... 49 Bioethics, the Law and Science ...... 49 Critical Doctrinal Analysis ...... 55 Feminist Perspective ...... 58 Notes on Terminology ...... 61 Pregnant People ...... 61 Human Entities ...... 62 Maternal-Foetal Surgery ...... 63 CHAPTER THREE – OUTLINE OF PAPERS ...... 64 PART I – UNDERSTANDING PARTIAL ECTOGENESIS ...... 64 PAPER ONE: Artificial Womb Technology and the frontiers of human reproduction: conceptual differences and potential implications (2018) 44 Journal of Medical Ethics 751 ...... 64
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PAPER TWO: Challenging the ‘Born Alive’ Threshold: Foetal Surgery, Artificial Wombs and the English Approach to Legal Personhood (2020) 28 Medical Law Review 93 ...... 65 PAPER THREE: Artificial Womb Technology and the Significance of Birth: Why Gestatelings are not Newborns (or Fetuses) (2019) 45 Journal of Medical Ethics 727 ... 65 PART II – REALISING PARTIAL ECTOGENESIS ...... 66 PAPER FOUR: Artificial Womb Technology and Clinical Translation: Innovative Treatment or Medical Research? (2020) 34 Bioethics 392 ...... 66 PART III – IMPLICATIONS OF PARTIAL ECTOGENESIS ...... 67 PAPER FIVE: Artificial Womb Technology and the Choice to Gestate Ex Utero: Is Partial Ectogenesis the Business of the Criminal Law? (2020) 28 Medical Law Review 342 ...... 67 PAPER SIX: ‘Partial Ectogenesis: Freedom, Equality and Political Perspective (2020) 46 Journal of Medical Ethics 89 ...... 67 PART I - UNDERSTANDING PARTIAL ECTOGENESIS ...... 69 PAPER ONE: Artificial Womb Technology and the frontiers of human reproduction: conceptual differences and potential implications ...... 70 Artificial Wombs – Where are we? ...... 71 Limitations of Neonatal Intensive Care ...... 72 The Biobag ...... 73 Subjects in the Biobag ...... 75 Beyond just another form of Neonatal Intensive Care ...... 77 The innate features of AWT ...... 78 The subject of partial ectogenesis ...... 80 Potential uses of partial ectogenesis ...... 81 Conclusion ...... 82 PAPER TWO: Challenging the ‘Born Alive’ Threshold: Fetal Surgery, Artificial Wombs and the English Approach to Legal Personhood...... 84 Artificial Wombs and Maternal-Foetal Surgery: The Future of Obstetrics ...... 87 The Test for Legal Personality ...... 91 Maternal-Foetal Surgery: Born or Not Born ...... 93 Is Birth Just a Matter of ‘In vs. Ex Utero?’ ...... 94 Artificial Wombs: Born Alive or Inactively Alive...... 102 Breathing after birth ...... 104 Signs of Life ...... 106 Gestatelings are not ‘dead’? ...... 108 The Intersection between ‘Born Alive’ and Viability ...... 110
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Moving Forward: Being Clearer about Birth and Being Alive ...... 114 How much should location feature in the law? ...... 115 What about the process of birth is significant? ...... 116 Should the developing human entity’s capacities feature in the law? ...... 116 What does it mean to be ex utero and lack personality? ...... 117 Could there be a ‘Third Status:’ legal existence before legal personality? ...... 117 Conclusion ...... 119 PAPER THREE: Artificial Womb Technology and the Significance of Birth: Why Gestatelings are not Newborns (or Fetuses) ...... 122 Birth ...... 123 The Exercise of Independent Life ...... 125 Moral Status ...... 126 PART II - REALISING PARTIAL ECTOGENESIS ...... 129 PAPER FOUR: Artificial Womb Technology and Clinical Translation: Innovative Treatment or Medical Research? ...... 130 The Prospects for Artificial Womb Technology ...... 132 Experimental AWT is medical research...... 136 Clinical Trials and AWT ...... 142 Conclusion ...... 151 PART III - IMPLICATIONS OF PARTIAL ECTOGENESIS ...... 153 PAPER FIVE: Artificial Womb Technology and the Choice to Gestate Ex Utero: Is Partial Ectogenesis the Business of the Criminal Law? ...... 154 The Prospects for Artificial Womb Technology ...... 158 Changing Choices in Obstetrics ...... 160 The Legal Permissibility of Pregnancy Termination ...... 168 Is All ‘Foetal Extraction’ Unlawful Procurement of Miscarriage? ...... 171 All deliberate endings to a pregnancy are prima facie criminal? ...... 172 Only terminations intending foetal death are criminal? ...... 173 Are there available Defences to Unlawfully Procuring Miscarriage? ...... 182 Risk to life ...... 184 Risk of grave, permanent injury to physical or mental health ...... 186 Doctors’ Discretion? ...... 189 Conclusion ...... 192 PAPER SIX: Partial Ectogenesis: Freedom, Equality and Political Perspective...... 194 Freedom ...... 194 Equality ...... 196
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Political Perspective ...... 197 CONCLUSION ...... 200 Key Findings ...... 202 Research Questions Revisited ...... 203 Additional Findings ...... 214 Contribution to Literature...... 219 Re-orienting Towards Partial Ectogenesis ...... 219 Important Conceptual Distinctions and the Formulation of Appropriate Ethical and Legal Questions ...... 220 Practical Inquiry about the Ethico-Legal Conditions for AW Human Trials / Clinical Translation ...... 222 Ending Pregnancy ‘Beyond Abortion’ and the Law ...... 223 Future Research ...... 225 Understanding Gestation and Birth ...... 226 Regulating Assisted Gestative Technologies (AGTs) ...... 228 Ethical Experimentation ...... 232 BIBLIOGRAPHY ...... 234 APPENDIX ...... 250 Thesis Papers in Published Form ...... 250 Appendix 1 – Artificial Womb Technology and the frontiers of human reproduction: conceptual differences and potential implications (2018) 44 Journal of Medical Ethics 751 ...... 250 Appendix 2 – Challenging the ‘Born Alive’ Threshold: Fetal Surgery, Artificial Wombs and the English Approach to Legal Personhood (2020) 28 Medical Law Review 93 ... 256 Appendix 3 – Artificial Womb Technology and the significance of birth: why gestatelings are not newborns (or fetuses) (2019) 45 Journal of Medical Ethics 727 .... 288 Appendix 4 – Artificial Womb Technology and Clinical Translation: Innovative Treatment or Medical Research? (2020) 34 Bioethics 392 ...... 292 Appendix 5 – Artificial Womb Technology and the Choice to Gestate Ex Utero: is Partial Ectogenesis the Business of the Criminal Law? (2020) 28 Medical Law Review 342 ...... 304 Appendix 6 – Partial Ectogenesis: Freedom, Equality and Political Perspective (2020) 46 Journal of Medical Ethics 89 ...... 338 Additional Relevant Publications ...... 341 Appendix 7 - Re-viewing the Womb (2020) Journal of Medical Ethics (forthcoming) . 341 Appendix 8 – Is ‘Viability’ Viable? Abortion, Conceptual Confusion and the Law in England and Wales and the United States (2020) Journal of Law and the Biosciences (forthcoming) ...... 352
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ABSTRACT
This PhD thesis considers legal and ethical questions surrounding the development of artificial womb technologies. In 2017, scientists based in Philadelphia and in Western Australia / Japan announced the development of ‘artificial womb prototypes’ that had been successfully able to partially gestate lamb foetuses delivered prematurely. While this technology has not yet been tested on human preterm neonates, scientists have continued to report positive results from animal testing, and it is hoped that their devices might soon revolutionise care for human preterm neonates. Conventional neonatal intensive care has proved to be one of the miracles of modern medicine; being able to aid the survival of neonates born increasingly premature. However, these technologies have limitations; neonatal intensive care often has serious short- and long-term health implications for those preterms that survive. Moreover, because neonatal intensive care is dependent on the neonate being able to withstand gas-based ventilation, neonates who are born without sufficiently formed lungs (usually <22 weeks) cannot be aided. The ‘artificial womb’ however, in being able to continue the process of gestation ex utero, would not be subject to the same constraints of gestational maturity, and might reduce the incidence of morbidities associated with neonatal intensive care.
While artificial womb technologies are to be welcomed as a potential future alternative to neonatal intensive care, the technologies also bring unique ethical and legal challenges that have not been previously addressed in the literature. This thesis is comprised of a series of six published papers all of which highlight and address some of these issues, organised into three parts. Part I considers conceptual questions about artificial womb technologies and the legal and moral significance of birth. In these papers, I argue that the subject of the artificial womb is a unique entity; ‘the gestateling,’ and I consider the potential legal implications of this entity remaining the subject of gestation but ex utero. Part II considers practical ethico-legal questions about the introduction of artificial womb technologies as experimental neonatal intensive care. I argue that clinical trials of these technologies would only be ethically justifiable in a narrow set of circumstances. Part III considers the potential implications of technologies that could provide pregnant people with an alternative to gestation. I posit that, were such technology available, they might present pregnant people with a greater range of choices about what burdens and risks they are willing to endure in gestation as part of reproducing. I demonstrate, however, that the current legal framework does not necessarily enable a pregnant person to opt for gestation ex utero. I argue that the availability of artificial womb technologies bolsters the case for the decriminalisation of termination of pregnancy; inclusive of the choice to end a pregnancy in order to continue gestation artificially ex utero.
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DECLARATION
No portion of the work referred to in the thesis has been submitted in support of an application for another degree or qualification of this or any other university or other institute of learning.
COPYRIGHT STATEMENT
i. The author of this thesis (including any appendices and/or schedules to this thesis) owns certain copyright or related rights in it (the “Copyright”) and she has given The University of Manchester certain rights to use such Copyright, including for administrative purposes.
ii. Copies of this thesis, either in full or in extracts and whether in hard or electronic copy, may be made only in accordance with the Copyright, Designs and Patents Act 1988 (as amended) and regulations issued under it or, where appropriate, in accordance Presentation of Theses Policy You are required to submit your thesis electronically Page 11 of 25 with licensing agreements which the University has from time to time. This page must form part of any such copies made.
iii. The ownership of certain Copyright, patents, designs, trademarks and other intellectual property (the “Intellectual Property”) and any reproductions of copyright works in the thesis, for example graphs and tables (“Reproductions”), which may be described in this thesis, may not be owned by the author and may be owned by third parties. Such Intellectual Property and Reproductions cannot and must not be made available for use without the prior written permission of the owner(s) of the relevant Intellectual Property and/or Reproductions.
iv. Further information on the conditions under which disclosure, publication and commercialisation of this thesis, the Copyright and any Intellectual Property and/or Reproductions described in it may take place is available in the University IP Policy (see http://documents.manchester.ac.uk/DocuInfo.aspx?DocID=2442 0), in any relevant Thesis restriction declarations deposited in the University Library, The University Library’s regulations (see http://www.library.manchester.ac.uk/about/regulations/) and in The University’s policy on Presentation of Theses
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ACKNOWLEDGEMENTS
I am incredibly grateful to have had such dedicated advisors throughout this project. I am indebted to my primary supervisor Alex Mullock who has supported me since my very first year as an undergraduate law student at Manchester through to the final word of this project (and beyond). Alex, I could not be more grateful for your kindness, encouragement, support, feedback, generosity of time and every opportunity you afforded me beyond the confines of this PhD. I consider myself extra lucky that you have become such a wonderful friend to me and that has helped me throughout this process just as much as all of your advice. This PhD really would never have been the same without Becki Bennett asking me what the question is. Becki, I genuinely hear your voice in my head asking exactly that whenever I sit down to start writing. I am grateful that you always knew how to inspire confidence, and when to tell me to take a break. Bernard Dickens’s work was such an influence on my thinking and ideas as they evolved in this thesis even before we met. Bernard, I am thankful that you generously took the time to supervise me on a summer research visit in Toronto, reading and commenting on so much of my work. I am incredibly appreciative that you became and continued to be a third supervisor to this project all the way through to its completion, and a mentor to me, long after I returned to the UK. Finally, I am indebted to Margot Brazier who supervised me during my masters’ degree fostering my love for the subject of this thesis, encouraging me to progress onto this programme and for continuing to support me by reading and commenting on some of my research papers.
I am extremely fortunate to have been surrounded by so many wonderful people in the Centre for Social Ethics and Policy and on the BMJ programme at Manchester. I am particularly grateful to Dunja Begović and Richard Gibson. Thanks for always being willing to go for coffee / wine / cider when necessary (back when that was possible). I’m also thankful that you were both willing to read drafts of almost everything in our first few years at this. Dunja I am endlessly thankful for our chats on Zoom/Facebook Messenger/ WhatsApp while we were confined to our homes in spring/summer 2020. I am also grateful to Anna Nelson for proof-reading a full draft of this thesis. Thanks also must go to Vicki Hooton and Jordan Parsons for being wonderful cheerleaders, and extra thanks to Jordan for effectively being full-time IT support. I am very fortunate to have received a Studentship from the Wellcome Trust (Grant reference: 208245/Z/17/Z) that enabled me to complete this PhD, and additional funding from the Institute of Medical Ethics and Manchester PGR mobility fund to support other research activities. I am also thankful for the patience and kindness of Jackie Boardman who has been incredibly helpful, even as I bothered her with endless administrative questions on the technicalities of everything imaginable.
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My time at Manchester has been about much more than what is contained in these pages because I was lucky enough to teach some wonderful undergraduate students in contract law, criminal law and medical law, whose enthusiasm for the law was infectious. Thank you for teaching me how to teach.
I owe my deepest gratitude to my wonderful family. Thanks must go to my grandad Bill Romanis who is truly my number one fan: reading every published word with such excitement and curiosity. I am incredibly lucky to have had such supportive parents, Juliet and Adam Romanis, who have taught me (by example) the value of hard work, being enthusiastic and kindness above all. I also must thank my little sister Charlotte for pointing me in the direction of medical textbooks (and disagreeing with me about most things). I am most grateful to my incredible fiancé, Nathan Chalk, who really deserves a medal for tolerating me for the last three years - especially for sharing a home office with me during the COVID-19 pandemic as I was formatting this document (and for politely describing my enthusiastic typing as an ‘occupational hazard’). Your endless support and belief in my abilities and ideas throughout every meltdown was everything I needed. And, of course, I am indebted to you for your help in brainstorming the name for the subject of the artificial womb when excess coffee and staring at my laptop alone was not doing it. The gestateling is for you.
***
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THE AUTHOR
Education The University of Manchester September 2017 – present PhD in Bioethics and Medical Jurisprudence
The University of Manchester September 2015 – September 2016 LLM Healthcare Ethics and Law (Distinction)
The University of Manchester September 2012 – June 2015 LLB (Hons) Law (First Class)
Publications Peer-reviewed publications
1. E C Romanis, ‘Is ‘Viability’ Viable? Abortion, Conceptual Confusion and the Law in England and Wales and the United States,’ (2020) Journal of Law and the Biosciences (forthcoming).
2. E C Romanis & C Horn, ‘Artificial Wombs and the Ectogenesis Conversation: A Misplaced Focus? Technology, Abortion and Reproductive Freedom’ (2020) International Journal of Feminist Approaches to Bioethics (forthcoming).
3. E C Romanis, D Begović, M Brazier & A Mullock, ‘Re-Viewing the Womb,’ (2020) Journal of Medical Ethics online first doi:10.1136/medethics-2020-106160.
4. E C Romanis, J A Parsons, & N Hodson, ‘COVID-19 and Reproductive Justice in Great Britain and the United States: Ensuring Access to Abortion Care during a Global Pandemic,’ (2020) Journal of Law and the Biosciences online first doi.org/10.1093/jlb/lsaa027.
5. E C Romanis, ‘Addressing Rising Caesarean Rates: Maternal Request Caesareans, Defensive Practice and the Power of Choice in Childbirth’ (2020) 13 International Journal of Feminist Approaches to Bioethics 1.
6. E C Romanis, ‘Partial Ectogenesis, Equality, Freedom and Political Perspective,’ (2020) 46 Journal of Medical Ethics 89.
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7. E C Romanis, ‘Artificial Womb Technology and the Choice to Gestate Ex Utero: Is Partial Ectogenesis the Business of the Criminal Law?’ (2020) 28 Medical Law Review 342.
8. E C Romanis, ‘Artificial Womb Technology and Clinical Translation: Innovative Treatment or Medical Research?’ (2020) 34 Bioethics 392.
9. E C Romanis, ‘Challenging the ‘Born Alive’ Threshold: Foetal Surgery, Artificial Wombs and the English Approach to Legal Personhood,’ (2020) 28 Medical Law Review 93.
10. E C Romanis, ‘Artificial Womb Technology and the Significance of Birth: Why Gestatelings are not Newborns (or Fetuses)’ (2019) 45 Journal of Medical Ethics 727.
11. E C Romanis, ‘Why the Elective Caesarean Lottery is Ethically Impermissible,’ (2019) 27 Health Care Analysis 249.
12. E C Romanis, ‘Artificial Womb Technology and the frontiers of human reproduction: conceptual differences and potential implications,’ (2018) 44 Journal of Medical Ethics 751.
13. E C Romanis, ‘Pregnant women may have moral obligations to foetuses they have chosen to carry to term, but the law should never intervene in a woman’s choices during pregnancy,’ (2017) 6 Manchester Review of Law Crime and Ethics 69.
Book chapters
1. C Horn & E C Romanis, ‘Establishing Boundaries for Speculation about Artificial Wombs, Ectogenesis, Gender and the Gestating Body,’ in Chris Dietz and others (eds), A Jurisprudence of the Body, Palgrave 2020.
Awards University of Manchester Distinguished Achievement Medal Humanities Postgraduate Research Student of the Year 2020/2021
Successful Funding Bids Brocher Foundation Symposia Funding Co-applicant with Elselijn Kingma and Joanne Verweij - £5,000 (awarded March 2020) Project Title: ‘Realistic Ethical, Legal and Social Implications of LiFE-S (Liquid Fetal Extracorporeal Support, or ‘Artificial Womb’) Technology’
Faculty of Humanities Strategic Investment Fund Postgraduate Research Student Mobility Grant (University of Manchester) £2,550 (July 2019 – September 2019) Project Title: ‘Artificial Womb Technology, Viability and the Law in the US, UK and Canada.’
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Institute of Medical Ethics Seminar Series Funding Lead applicant, with Dr Alexandra Mullock, Professor Margaret Brazier, Professor Rebecca Bennett and Dunja Begović - £1,760 (awarded May 2019) Project Title: ‘Reconceiving the Womb in Medicine, Law and Society’
Wellcome Trust Doctoral Studentship in Society & Ethics (WT208245/Z/17/Z) £82,000 (September 2017 – September 2020) Project Title: ‘Regulating the ‘Brave New World:’ Ethico-Legal Implications of the Quest for Partial Ectogenesis’
Destination From 1 September 2020 I will be working as an Assistant Professor in Biolaw in the Centre for Ethics and Law in the Life Sciences at Durham Law School, Durham University.
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LIST OF ABBREVIATIONS
AA 1967 – Abortion Act 1967 ACT – Assisted conception technology AGT – Assisted gestative technology AAPT – Artificial amnion and placenta technology AW – Artificial womb AWT – Artificial womb technology BDRA 1953 – Births and Deaths Registration Act 1953 CE – Complete ectogenesis ILPA 1929 – Infant Life (Preservation) Act 1929 NIC – Neonatal Intensive Care OAPA 1861 – Offences Against the Person Act 1861 PE – Partial ectogenesis UTx – Uterus transplantation
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TABLE OF CASES
Airedale NHS Trust v Bland [1993] AC 789 Ampthill Peerage Case [1977] AC 547 Attorney-General’s Reference (No. 3 of 1994) [1997] 3 W.L.R 421 Burton v Islington Health Authority [1993] QB 204 C v S [1987] 1 All ER 1230 Collins v Wilcock [1984] 1 WLR 1172 CP (A Child) v Criminal Injuries Compensation Authority [2015] QB 459 Great Ormond Street Hospital NHS Foundation Trust v Yates and Others [2017] EWHC 1909 (Fam) Heydon’s Case (1584) EWHC Exch J36 J v C [2006] EWCA Civ 551 Leeds Teaching Hospital NHS Trust v A [2003] EWHC 259 Montgomery v Lanarkshire Health Board [2015] UKSC 11 Parkinson v St James and Seacroft NHS Hospital Trust [2001] Lloyd Rep Med 309, CA Paton v British Pregnancy Advisory Service Trustees [1979] WB 276 Pepper v Hart [1993] AC 593 Planned Parenthood v Casey 112 US 2791 (1992) (United States Supreme Court) R (Burke) v General Medical Council [2005] EWCA Civ 1003 R (on the application of McConnell) v Registrar General for England and Wales [2020] EWCA Civ 559 R (on the application of Smeaton) v Secretary of State for Health [2002] EWHC 610 (admin) R (on the application of T) v HM Coroner for West Yorkshire [2018] 2 WLR 211 R (on the application of TT) [2019] EWHC 2384 R (on the application of Williamson) v Secretary of State for Education and Employment [2005] 1 FCR 498 R v Bourne [1939] 1 KB 687 R v Brain (1834) 6 Car & P 350 R v Crutchely (1837) 7 Car & P 814 R v Enoch (1833) 5 Car & P 539 R v Handley (1874) 14 Cox 79
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R v Human Fertilisation and Embryology Authority, ex parte Blood [1997] 2 All ER 687 R v Hutty [1953] VLR 228 (Supreme Court of Victoria Australia) R v Iby [2005] 63 NSWLR 278 (Australia New South Wales Court of Appeal) R v Ireland [1998] AC 147 R v Misra and Srivastava [2005] 1 Cr App R 328 R v Poulton (1832) 5 Car & P 328 R v Reeves (1839) 9 Car & P 25 R v Sellis (1837) 7 Car & P 350 R v Smith (John) [1973] 1 WLR 1510 R v Trilloe (1842) Car & M 650. Rance and Another v Mid-Downs Health Authority and Another [1991] 1 QB 587 Re A [1992] 3 Med LR 303 Re A (Children) (Conjoined Twins: Surgical Separation) [2001] Fam 147 Re AA (Compulsorily Detained Patient: Elective Caesarean) [2012] EWHC 4378 Re B (A Minor) (Wardship: Medical Treatment) [1981] 1 WLR 1421 Re C (Adult: Refusal of Treatment) [1994] 1 WLR 290 Re F (In Utero) [1988] Fam 122 Re G (Residence: Same Sex Partner) [2006] UKHL 43 Re MB [1997] 8 Med LR 217 Re McCready [1909] 2 Sask LR 46 (Supreme Court of Saskatchewan Canada) Re T (Adult: Refusal of Medical Treatment) [1993] Fam 95 Roe v Wade 410 U.S. 113 (1973) (United States Supreme Court) Royal Free NHS Foundation Trust v AB [2014] EWCOP 50 Simms v Simms [2003] 1 Fam 83 St George’s Healthcare NHS Trust v S [1998] 3 WLR 936 Winnipeg Child and Family Services (Northwest Area) v G (D.F) [1997] 3 SCR 925 (Canadian Supreme Court) X, Y, Z v UK [1997] ECHR 20 (European Court of Human Rights)
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TABLE OF LEGISLATION
Statutes Abortion Act 1967 Animal Welfare Act 2006 Births and Deaths Registration Act 1953 Congenital Disabilities (Civil Liability) Act 1976
Criminal Code of Canada 1985 (Canada) Criminal Code of Canada 1892 (Canada)
Federal Food, Drug and Cosmetic Act 21 USC 1976 (United States)
Food and Drugs Regulations 21 CFR 1 (2018) (United States)
Gender Recognition Act 2004 Human Fertilisation and Embryology Act 1990 Human Fertilisation and Embryology Act 2008 Human Rights Act 1998 Infant Life (Preservation) Act 1929 Northern Ireland (Executive Formation etc) Act 2019 Offences Against the Person Act 1861 Stillbirth Definition Act 1992
Therapeutic Goods Act 1989 (Australia)
US Department for Health and Human Services Regulations 45 CFR 46 (2018)
European Material Council Directive 93/42/EEC of 14 June 1993 concerning medical devices Secondary Legislation 17
Medical Devices Regulations 2002, SI 2002/618 The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019, SI 2019/791
Therapeutic Goods Regulations 2002, SR 2002/236 (Australia)
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INTRODUCTION
Technology that can sustain the artificial gestation of human entities will revolutionise reproduction, by challenging the most fundamental and immutable fact of human reproduction that has prevailed since the beginning of time: that ‘a foetus must gestate in a woman’s body.’1 It is for this reason that the artificial womb (AW) has occupied scientists and fascinated ethicists and lawyers alike. Fascination with the AW and resulting legal imaginaries has intensified during the writing of this thesis following recent and high-profile scientific developments. Two research teams based in the United States and Western Australia/Japan published promising results from animal testing of artificial womb prototypes, attracting significant media attention, in both 2017 and 2019;2 and more recently a third research team based in the Netherlands announced that they had received a substantial grant to develop an AW prototype.3 The ongoing work of these scientists and medical practitioners is making substantial progress towards the development of an AW device capable of partially facilitating the process of ectogenesis (the gestation of a human entity extra uterum supported artificially) in the not too distant future. These working groups have all made confident statements about the likelihood of testing an AW on human subjects almost imminently.4 This claim has, of course, generated lively debate about the ethics and legalities of AW technology to which this thesis has contributed.
Academic debate about the ethics of ectogenesis has been primarily focused on complete ectogenesis (also known as full ectogenesis). Complete ectogenesis (CE) is the creation of an embryo using in vitro fertilisation techniques which is then gestated entirely artificially in an AW. There is no ‘pregnancy’ that is carried by a ‘pregnant person.’ Partial ectogenesis (PE), in contrast, is the development of a foetus in an AW for part of the gestational period following transfer from the womb in which it was initially conceived or implanted and
1 Jennifer Bard, ‘Immaculate Conception? How will Ectogenesis Change Current Paradigms of Social Relationships and Values?’ in Scott Gelfand and John Shook (eds), Ectogenesis: Artificial Womb Technology and the Future of Human Reproduction, (Rodopi 2006), 149. 2 Emily Partridge and others, ‘An Extrauterine System to Physiologically Support the Extreme Premature Lamb,’ (2017) Nature Communications 8; Haruo Usuda and others, ‘Successful use of an artificial placenta to support extremely preterm ovine fetuses at the border of viability,’ (2019) 221 American Journal of Obstetrics and Gynecology 69.e1. 3 Nicola Davies, ‘Artificial Womb: Dutch researchers given €2.9m to develop prototype,’ (The Guardian, 8 October 2019)
19 partially gestated. This process, utilising the AW for PE, is the motivation behind the current scientific developments because it is sought after as an advanced alternative to neonatal intensive care.5 Prematurity remains the leading cause of death in neonates worldwide.6 The development of incubators, other equipment and pharmaceuticals in neonatal intensive care is undoubtedly a modern medical success story, because of rapid improvements towards the end of the 20th century. However, the prospect of preterm survival, particularly with good7 long- term outcomes, has not meaningfully changed since the 1990s.8 Thus, it is hoped that the development of more sophisticated technology (AWs facilitating continued gestation) might be better able to improve preterm mortality rates and reduce incidences of morbidity in preterm neonates.
PE ‘carries the obvious benefit of saving the lives of babies born prematurely and reducing the suffering of women whose wanted pregnancies spontaneously abort by providing a means of continuing gestation artificially.’9 Alghrani explains that ‘arguably very few would dispute the use of such technology to rescue the lives of babies born too early [and] the potential to treat such neonates provides an incentive for continued research.’10
The development of PE would also be of considerable benefit for pregnant people experiencing dangerous but wanted pregnancies which are, sadly, not uncommon.11 For example, where a pregnant person develops pre-eclampsia or gestational diabetes, or a form of cancer in need of treatment that would harm the foetus. With the advent of the AW, such a pregnant person (carrying a wanted pregnancy) would no longer have to make a decision between continuing to carry their pregnancy at severe risk to themselves, delivering and risking their foetus facing bleak outcomes in neonatal intensive care or having an unwanted
5 ibid. 6 Kishwar Azad and Jiji Matthews, 'Preventing newborn deaths due to prematurity,' (2016) 36 Best Practice & Research Clinical Obstetrics and Gynecology 131, 132. 7 I appreciate that ‘good outcomes’ is a relative term; here I mean absent severe long-term health problems. 8 Kate Costeloe and others, ‘Short term outcomes after extreme preterm birth in England: comparison of two birth cohorts in 1995 and 2006 (the EPICure Studies),’ (2012) 345 British Medical Journal.e7976. 9 Evie Kendal, Equal Opportunity and the Case for State Sponsored Ectogenesis, (Palgrave 2015), 19. These sentiments are echoed all over the literature: Amel Alghrani, ‘The Legal and Ethical Ramifications of Ectogenesis' (2007) 2 Asian Journal of WTO & International Health Law and Policy 189, 191; Emily Jackson, ‘Degendering Reproduction?’ (2008) 16 Medical Law Review 346, 357; Jennifer Hendricks, ‘Not of Woman Born: A Scientific Fantasy,’ (2012) 62 Case Western Law Review 399, 408; Natasha Hammond-Browning, 'A New Dawn? Ectogenesis, Future Children and Reproductive Choice' (2018) 14 Contemporary Issues in Law 349, 351; Peter Singer and Deanne Wells, ‘Ectogenesis’ in (eds), Ectogenesis: Artificial Womb Technology and the Future of Human Reproduction, (Rodopi 2006), 11. 10 Amel Alghrani, Regulating Assisted Reproductive Technologies, (CUP 2018), 131. 11 This is demonstrated in paper five of this thesis: Elizabeth Chloe Romanis, ‘Artificial Womb Technology and the Choice to Gestate Ex Utero: Is Partial Ectogenesis the Business of the Criminal Law?’ (2020) 28 Medical Law Review 342.
20 abortion. PE would provide a third option: gestation extra uterum. PE is thus also sought after as a tool in the emancipation of the female body and of maximising choices for females about how to use their body to reproduce by minimising the potential burdens of pregnancy. This argument is usually made in the context of complete ectogenesis;12 but it is important to note that PE might also offer pregnant people the opportunity to minimise the burdens they experience in gestation by offering an alternative to later-term pregnancy. Hendricks explains that AWs could, in theory, end the real health risks associated with pregnancy evident for many people.13 However, there are two significant problems located within these normative justifications for the development of PE as an aid to pregnant people and preterm neonates.
Firstly, there is a pervasive mischaracterisation of PE in the bioethical and legal literature. It has been routinely assumed, presumably on the basis that PE could drastically improve outcomes for neonates born preterm, that PE is already a ‘partial reality’14 evidenced by neonatal intensive care already capable of ‘saving’ preterm neonates. Alghrani asserts that ‘partial ectogenesis already exists in the form of incubators in the neonatal intensive care unit;’15 because ‘the incubators that help to treat premature babies are in essence ectogenic incubators mimicking the functions of the maternal womb in the later stages of pregnancy.’16 In other work, she uses the terms incubator and artificial womb interchangeably.17 Bard speaks of ectogenesis as the ‘logical end of a continuum that has already been developing into a full panoply of incubators and equipment already in use to support premature infants.’18 Cannold refers to the ‘gestation of premature babies in incubators.’19 Singer and Wells make the same assumptions,20 falling into the same trap of conflating gestation and incubation. This failure to examine any potential conceptual differences between gestation extra uterum facilitated by an AW and incubation is concerning because the assumed
12 Smajdor claims that ‘pregnancy is a condition that causes pain and suffering and only affects women:’ Anna Smajdor, ‘In Defence of Ectogenesis,’ (2012) 21 Cambridge Quarterly of Healthcare Ethics 90, 90. Firestone describes pregnancy as ‘barbaric:’ Shulamith Firestone, The Dialetic of Sex: The Case for a Feminist Revolution, (William Morrow and Company 1970), 188. Kendal claims that ectogenesis is a ‘much-needed option for those women who wish to have children without submitting to the physical burdens of gestation…:’ Kendal (n9) 8. 13 Henricks (n9). 14 Singer and Wells (n9) 11; Leslie Cannold, ‘Women, Ectogenesis and Ethical Theory,’ (1995) 12 Journal of Applied Philosophy 55, 55; Amel Alghrani, ‘Regulating the Reproductive Revolution: Ectogenesis - A Regulatory Minefield?’ in Michael Freeman (ed), Law and Bioethics: Current Legal Issues Volume 11, (OUP 2008), 307. 15 Alghrani (n10) 130. 16 ibid. 17 Alghrani (n9) 190. 18 Bard (n1) 150. 19 Cannold (n14) 55. 20 Singer and Wells (n9) 11. 21 similarity between technology that already exists and PE has resulted in a failure to formulate the appropriate ethico-legal questions about PE, in particular about the subject of the AW and the experimental use of the technology.
Secondly, arguments about the potential for PE to have an emancipatory benefit for pregnant people by reducing some burdens that are necessarily experienced in pregnancy have been routinely produced without accompanying examination of the legal context in England and Wales. The vast majority of legal literature concerning the permissibility of ectogenesis has focused on complete ectogenesis and focused on the law in the United States.21 This body of literature is also generally focused on the issue of the permissibility of a conventional abortion in the advent of technology capable of sustaining an unborn entity at any point in gestation.22 It is generally assumed in this discourse that the choice to opt for artificial gestation in place of continuing a pregnancy would be lawful, but there may be good reasons, when an examination of the law surrounding gestation and birth is undertaken, to question whether that is a sound presumption. Although the law has been constructed around viability,23 the foetus attaining the label of ‘viable’ has never been considered legal justification for a pregnant person to prematurely deliver (even if the foetus is capable of surviving post-birth); precisely the opposite is true. The viability threshold is explicitly
21 Kevin Abel, ‘The Legal Implications of Ectogenetic Research,' (1974) 10 Tulsa Law Review 243; Mark Goldstein, ‘Choice, Rights and Abortion: The Begetting Choice Right and State Obstacles to Choice in Light of Artificial Womb Technology,’ (1978) 51 Southern California Law Review 877; Robert Favole, ‘Artificial Gestation: New Morning for the Right to Terminate Pregnancy,’ (1979) 21 Arizona Law Review 755; Kelly Frey, ‘New Reproductive Technologies: The Legal Problem and a Solution (1982) 49 Tennessee Law Review 303; Laurence Tribe, Abortion: The Clash of the Absolutes, (Norton & co 1990); Lisa Hemphill, ‘American Abortion Law Applied to New Reproductive Technology,’ (1992) 32 Jurimetrics 361; Hyun Jee Son, ‘Artificial Wombs: Frozen Embryos, and Abortion: Reconciling Viability’s Doctrinal Ambiguity (2005) 14 UCLA Women’s Law Journal 213; Vernellia Randall and Tshaka Randall, ‘Built in Obsolescence: The Coming End to the Abortion Debate,’ (2008) 4 Journal of Health and Biomedical Law 291; Eric Steiger, ‘Not of Woman Born: How Ectogenesis Will Change the Way we View Viability, Birth and the Status of the Unborn,’ (2010) 23 Journal of Law and Health 143; Jessica Schultz, ‘Development of Ectogenesis: How Will Artificial Wombs Affect the Legal Status of a Foetus or Embryo?’ (2010) 84 Chicago-Kent Law Review 877; Stephen Gilles, ‘Does the Right to Elective Abortion Include the Right to Ensure the Death of the Fetus?’ (2015) 49 University of Richmond Law Review 1009; Marion Abecassis, ‘Artificial Wombs: The Third Era of Human Reproduction and the Likely Impact on French and U.S. Law,’ (2016) 27 Hasting’s Women’s Law Journal 3; I Glenn Cohen, ‘Artificial Wombs and Abortion Rights,’ (2017) 4 The Hastings Center Report; Julia Dalzell, ‘The Impact of Artificial Womb Technology on Abortion Jurisprudence,’ (2019) 25 William & Mary Journal of Race, Gender and Social Justice 327; Elvira Razzano, ‘Artificial Rights: Potential Implications of Compelled Fetal Extraction and Artificial Gestation for Reproductive Autonomy in the Wake of Whole Women’s Health v. Hellerstedt,’ (2019) 28 Southern California Review of Law and Social Justice 379. 22 Kendal (n9); Alghrani (n9); Anna Smajdor, ‘The Moral Imperative for Ectogenesis,’ (2007) 16 Cambridge Quarterly of Healthcare Ethics 336; Cohen (n21); Scott Gelfand, ‘Ectogenesis and the Ethics of Care,’ in Scott Gelfand and John Shook (eds), Ectogenesis: Artificial Womb Technology and the Future of Human Reproduction, (Rodopi 2006); Amel Alghrani, ‘Viability and Abortion: Lessons from Ectogenesis,’ (2009) 4 Expert Review of Obstetrics and Gynecology 303; Evie Kendal, ‘The Perfect Womb: Promoting Equality of (Fetal ) Opportunity,’ (2017) 14 Journal of Bioethical Inquiry 182. 23 Explicitly so in the United States following the logic of Roe v Wade 1973 410 U.S. 113 (United States Supreme Court) and implicitly in the construction of the Abortion Act 1967: this will be discussed in paper five of this thesis see Romanis (n11).
22 constructed to prevent people from opting out of pregnancy; it is unlawful for labour to be induced before full-term outside of emergency circumstances.24 Of the literature that has examined PE in the English legal framework it has been predominantly focused on foetal welfare and the law,25 as opposed to the legalities of a decision to opt-out of pregnancy in order for gestation to be continued extra uterum. Even amongst those few legal scholars that have acknowledged the potential complexities of this scenario they tend to make this commentary based on social, rather than legal, limitations,26 or they pose questions about the legal framework and lawfulness of PE but do not examine or answer them in detail.27
It is widely acknowledged amongst academics that ‘if this technology becomes a reality, its regulation will raise an exceptionally complex web of questions for which our legal system is currently unequipped.’28 Despite recognition of the legal complexities, these issues have been underexplored. A thorough doctrinal analysis of key legal instruments concerning gestation and birth, including, but not limited to, the Offences Against the Person Act 1861, Abortion Act 1967, Infant Life (Preservation) Act 1929, and the Births and Deaths Registration Act 1953 was missing from this body of work. It is difficult to make conclusions about the potential of a technology to aid preterms or to emancipate pregnant people of some of the difficulties in pregnancy without an analysis of the current legal framework to determine the permissibility or accessibility of technology during gestation. Even if science and medicine can offer opportunities, these can only come to fruition if the law presents no barriers to those opportunities. Given that the historical context in England and Wales is of excessive legal and medical interference into gestation, pregnancy and childbirth29 and given the age of the English legal framework concerning aspects of reproductive health (including abortion)30 it is unwise to presume the compatibility of the current legal framework with reproductive technologies capable of increasing choice for pregnant people. Thus, it is crucial to consider
24 See paper five: Romanis (n11). 25 Hammond-Browning (n9); Amel Alghrani and Margaret Brazier, ‘What is it? Whose it? Re-positioning the fetus in the context of research,' (2011) 70 Cambridge Law Journal 51. 26 Jackson (n9). 27 Alghrani and Brazier (n25); Margaret Brazier and John Harris, ‘‘Fetal Infants’: At the Edge of Life’ in Pamela Ferguson and Graeme Laurie (eds), Inspiring a Medico-Legal Revolution; Essays in Honour of Sheila McLean, (Ashgate 2015); Alghrani (n10; n14); Jackson (n9). 28 Jackson (n9) 365. 29 Elizabeth Chloe Romanis and others, ‘Re-Viewing the Womb,’ (2020) Journal of Medical Ethics doi:10.1136/medethics- 2020-106160. 30 At the time of writing the Offences Against the Person Act 1861 had been regulating termination of pregnancy for 159 years; and the Abortion Act 1967 regulating the reach of those provisions had been in operation for 53 years and was last amended 30 years ago. 23 and establish the legal framework surrounding PE to determine what reform would be necessary to better encapsulate the emancipatory aims of the technology for pregnant people and female people.
These problems, the conflation of gestation and incubation in the literature and the absence of a thorough doctrinal analysis of key legal instruments relating to gestation and birth, are demonstrated in further detail and addressed in the six papers that make up this thesis. These papers challenge the pervasive mischaracterisation of AW devices using relevant medical and scientific literature to demonstrate why current prototypes are, in substance, form and design, distinct from conventional neonatal intensive care technologies. At the time of their publication these papers were the first to address the metaphysical properties of contemporary artificial womb designs in the ethico-legal literature. The papers in this thesis also demonstrate the practical implications of the conceptual distinction between AW devices and conventional care by considering the unique ethico-legal issues they raise. I focus on the nature and meaning of birth in fact and in law and the status of the subject gestating ex utero, ethical issues in testing artificial womb devices on human entities and the availability of the choice to gestate ex utero rather than continuing a pregnancy. These papers were the first to consider the implications of extra uterum gestation for the functionality of the ‘born alive’ rule in detail, to address ethical issues in clinical translation of contemporary artificial womb designs and to thoroughly consider the legalities of the choice to opt out of pregnancy in favour of an AW later in gestation. Before presenting these papers, the next two chapters of this thesis provide the background to these investigations.
24
CHAPTER ONE – KEY CONTEXT
Aims and Objectives
The object of this thesis is to address a gap in the bioethical and legal literature pertaining to practical problems surrounding PE. This thesis seeks to address a conceptual concern surrounding PE to ensure the formulation of the appropriate ethico-legal questions and subsequently highlight and explore some of these questions, in particular:
Is artificial womb technology to facilitate partial ectogenesis conceptually different from neonatal intensive care? What does the artificial womb, used to facilitate partial ectogenesis, illustrate about the meaning and significance of birth in the law? Can experimental partial ectogenesis be justified in the best interests of the ‘foetus?’ How does/how might partial ectogenesis present liberating choices for female people/ pregnant people? To what extent does the current legal framework support any potential choices about alternatives to gestation resulting from partial ectogenesis?
On Speculation
The identified research questions are, of course, shrouded in speculation about how a functional AW might operate and when it might be used. I might also be charged with assuming the inevitability of technology that does not yet exist. While a functional AW has yet to be developed, the ongoing scientific research makes the consideration of its potential ramifications increasingly topical. With the active pursuit of the technology seemingly escalating, I agree with Alghrani that it would be ‘imprudent to dismiss ectogenesis as being confined to the realms of science fiction. Both directly and indirectly, scientific endeavours continue to slowly make progress into what is needed for this advance.’31 There is, thus, a need for a speculative body of literature that examines the potential development of this technology and its implications. The law famously struggles to keep up with advances in
31 Alghrani (n10) 142. 25 science and technology, and this can render some stakeholders vulnerable to uncertainty. Examples of the law failing individuals because of this gap between the law and technological possibility are not difficult to find in the context of assisted reproduction; Louise Brown the first IVF baby, Diane Blood and posthumous conception32 and the looming development of uterus transplantation33 are just a few. In each of these cases, it is easy to see how scientific possibility can offer life-altering opportunities for those involved, and thus uncertainty about the lawfulness of different courses of action can cause severe distress and in some instances, such as Blood,34 necessitate a long, costly and emotionally laborious legal process. Because of the potential implications of PE for pregnant people, female people more broadly and preterm neonates, there should be an active attempt to prevent any potential uncertainty about where and when it might be lawful to use this technology both when it is experimental and if it were to become routinely available.
There are, of course, places in this thesis in which facts are unavoidably presumptive because the exact trajectory of technological development, and also the social response to that development, is impossible to exactly predict.35 There remains value in such speculation, however, because it allows for the formulation of scenarios that illuminate potential ethico- legal problems. This thesis has intended to highlight and pose questions that must be asked about AWs as much as it has attempted to provide potential answers to these lines of enquiry. It is only with the consideration of events or processes that are not yet possible that potential problems with and in our contemporary ethical and legal frameworks become evident. Considering the development of PE and how the pregnant people and the medical profession might want to utilise this technology is an important means of highlighting possible reproductive futures and considering problems with contemporary legal frameworks and approaches. Travis explains that considering speculative technological futures (he makes this case as discussing science fiction) enables law to consider ‘different strategies for dealing with new events and scenarios.’36 As Travis explains, ‘by considering science fiction’s representations of the different approaches that could be taken to possible legal problems of
32 R v Human Fertilisation and Embryology Authority, ex parte Blood [1997] 2 All ER 687 33 A Sifferlin, ‘Exclusive: First U.S. Baby Born After a Uterus Transplant,’ (Time, 1 December 2017)
26 the future, the law will be better equipped to deal with these problems when they eventually arise.’37 The ethical questions that technology capable of partially emulating gestation raises, and the problems with the English legal framework that it potentially exposes (that this thesis highlights), are both intricate and wide-ranging. The ethical, legal, political and social implications are numerous and complex. We can only have reasoned discussions about these issues, absent visceral reactions whether motivated by fear or dangerous over-enthusiasm,38 and with adequate space for all relevant voices, if these issues are approached while the technology remains somewhat speculative as opposed to waiting until AWs, as a potential replacement or alternative to conventional neonatal intensive care, have materialised.
Schick explains that speculative discourse in bioethics ‘has become a framework in which technological visions are transformed into sets of probable facts demanding proactive ethical scrutiny.’39 He warns, however, that ‘much of what is now written on the biotechnological future reflects a regulatory orientation that tends to collapse the distance between present and future.’40 For this reason, in this thesis I have been mindful of technological realities. Moreover, Schick encourages (using the work of J.B.S Haldane) that ‘envisioned futures [and technologies] should be understood in terms of their effect on the present…. [this prevents] an excessive fixation on possible futures themselves – as is often the case in bioethics – and orients us towards a more constructive focus on the present as it is shaped by such [possibilities].’41 The consideration of speculative technologies like PE in the existing legal framework surrounding pregnancy and gestation can expose flaws in the conceptual formulation of the law or its practical implementation. The consideration of such technologies can provide space for new insights and new readings of the law. Thinking about how rules might be applied to new technologies can illuminate a great deal about the aspiration of that law. These discussions can contribute meaningfully to contemporary discussion. In this thesis, I have addressed problems that contribute to broader discussions of conceptual and practical failings of the legal framework in England and Wales from a
37 ibid 242. 38 Scott Gelfand and John Shook (eds), Ectogenesis: Artificial Womb Technology and the Future of Human Reproduction, (Rodopi 2006), 1. 39 Schick (n35) 225. 40 ibid 228. 41 ibid 225.
27 contemporary feminist perspective (regarding termination of pregnancy),42 and contemporary concerns about the law in relation to legal personality and its boundaries from a trans- humanist perspective.43 The questions I ask of PE in this thesis are thus important now, as well as for the future.
Scope
In this section I explain how and why I have made some express limitations on the scope of this thesis; in particular why I examine PE as opposed to complete ectogenesis; why I evade questions of the moral status of the subject of the AW and why I only refer to use of AWs on human entities between 18 – 28 weeks in the gestational period.
Partial ectogenesis There has been a predominant focus in both the bioethical and legal literature on the implications of complete ectogenesis.44 This thesis, in marked contrast, focuses solely on the implications of partial ectogenesis for three principal reasons.
Legal and scientific limitations Firstly, PE is likely to become a reality long before technologies capable of facilitating the gestation of entities from conception to full term. In 2016, two teams of scientists, at the University of Cambridge and Rockefeller University New York, were the first to succeed in growing embryos in laboratory conditions beyond the point embryos need to implant in the
42 These calls are prevalent in the academic literature: Emily Jackson, ‘Abortion, Autonomy and Prenatal Diagnosis,’ (2000) 9 Social & Legal Studies 467; Sally Sheldon, ‘The Decriminalisation of Abortion: An Argument for Modernisation,’ (2015) 36 Oxford Journal of Legal Studies 334. For the current political campaign for decriminalisation of abortion in the UK see We Trust Women, ‘5 Reasons to Decriminalise Abortion,’
28 womb lining to survive.45 The researchers were able to chemically stimulate embryo implantation in-vitro in the absence of ‘maternal tissue.’ This technique has provided the first opportunity to observe embryonic development after implantation; uncovering previously unobserved biological events.46 The discovery could prove ground-breaking in unearthing the causes of and reducing the occurrence of miscarriages and congenital abnormalities, and illuminating potential clinical applications of stem-cell research.47 Moreover, the ability to ‘chemically mimic the womb’ is often cited as marking the first step on the path to complete ectogenesis.48
In England and Wales, however, restrictive legislative provisions prohibit research on embryos beyond fourteen days gestation.49 This fourteen-day rule has been widely adopted internationally in the law and scientific guidelines in many jurisdictions,50 such that it has been described as ‘one of the most internationally agreed rules in reproductive science and medicine to date.’51 Both teams from Cambridge and Rockefeller,52 had to desist their research activity before the formation of each embryo’s primitive streak53 (an observable indication of early vertebrate formation).54 This point, occurring at around fifteen days, is thought to be biologically significant because it confirms an embryo’s individuation.55 While previously there had been some consensus in the scientific community that the fourteen-day rule was a fair limitation on research activity, the cessation of these experiments has led to vociferous criticism of the fourteen-day rule and subsequent calls to repeal it because it is obstructing scientific advance.56 The legislative provisions in question in England and Wales,
45 Marta Shahbazi and others, 'Self-organization of the human embryo in the absence of maternal tissues.' (2016) 18 Nature Cell Biology 700; Alessia Deglincerti and others, 'Self-organization of the in vitro attached human embryo,' (2016) 533 Nature 251. 46 Shahbazi and others (n45) 706. 47 Deglincerti et al (n45) 251. 48 Giulia Cavaliere, ‘Gestation, Equality and Freedom: Ectogenesis as a Political Perspective,’ (2019) 46 Journal of Medical Ethics 76; Alghrani (n10). 49 Human Fertilisation and Embryology Act 1990, as amended by Human Fertilisation and Embryology Act 2008, s 3(3)(a). 50 Insoo Hyun and others, 'Embryology Policy: Revisit the 14-day Rule,' (2016) 533 Nature 169. 51 John Appleby and Annelien Bredenoord, ‘Should the 14-day rule for embryo research become the 28-day rule?’ (2018) 10 EMBO Molecular Medicine e9437. 52 Scientific guidelines in the US also prohibit embryo research after fourteen days development; Hyun and others (n50). 53 Shahbazi and others (n45) 706. 54 Eleanor Lawrence (ed), Henderson’s Dictionary of Biology, (Pearson 2008), 538. 55 This was certainly the opinion of the Warnock Committee: Department of Health and Social Security, Report of the Committee of Inquiry into Human Fertilisation and Embryology, (TSO 1984). 56 John Harris, 'It's time to extend the 14-day limit for embryo research,' (The Guardian, 6 May 2016)
29 contained in the Human Fertilisation and Embryology Act 1990 (HFEA 1990) are now over twenty-five years old. There is concern that these provisions are outdated because today’s scientific context is very different from that in which the law was formulated. Before these studies it was not scientifically possible to sustain embryos beyond what the law permits. It is only really, therefore, since 2016 that the fourteen-day rule has, in actuality, been placing any barrier on research activity.
Considering these developments, and associated commentary, The Nuffield Council on Bioethics hosted a workshop to facilitate critical discussion of the fourteen-day statutory time limit on embryo research.57 In 2017, a report was published summarising the discussions. The report makes no conclusions as to whether a review of or change in the law is warranted.58 It does observe, however, that there is not presently,
‘a clear case for change of the sort that would persuade legislators of the need for action, either in relation to the prospect of scientific benefit or in relation to the availability of a satisfactory alternative regulatory tool.’59
Reform of the law governing embryo research does not appear to be a public policy priority because there is limited political capital (or parliamentary time) at present to mount such an upheaval of the law. The fourteen-day rule is often described as a compromise,60 designed to navigate conflicting moral stances regarding the treatment of the embryo, as well as to balance scientific progress and the maintenance of public trust.61 The regulation of embryo research requires the law to navigate a path between two opposing normative ethical positions. The first is that life begins at conception meaning embryo research is always morally wrong, and the second is that the human embryo ought to be afforded no special status and so research can be justifiable. The moral status of an embryo is an ethical
57 Nuffield Council on Bioethics, ‘Council Publishes a Collection of Views on Legal Limit for Embryo Research, 25 years after UK’s first fertility legislation came into force,’ (Nuffield Council on Bioethics, 4 August 2017)
30 conundrum that is impossible to resolve unilaterally.62 Moreover, the mutually exclusive positions described, and commonly advanced, are impossible to reconcile.63 The fourteen-day rule was recommended to Parliament by the Warnock Committee64 and presented as the middle ground between reaping scientific benefits and perceived public ‘moral repugnance.’ There was supplementary justification for the specific time restriction recommended: at fifteen days the formation of the primitive streak begins, which marks the beginning of individuation.65 Other possible time limits and their justifications were discussed but discarded. Reanimating these discussions based on moral justifications that appear to have already been tossed aside in the mid-80s would be politically difficult, though of course not impossible.
The argument for amending the Human Fertilisation and Embryology Act 199066 is based entirely on the claim that there would be considerable scientific and therapeutic progress were the restriction removed. It is hard, however, to articulate imminent scientific grounds67 with sufficient gravitas at this time to justify removing the restriction. There is still knowledge to be gained from studying the newly uncovered stages of embryonic development and the technique of artificial implantation. The benefits of studying embryos for the purpose of CE beyond fourteen days are entirely speculative (or at least there is reason to believe there would not be rapid progress)68 until there is a greater understanding of the recent findings. Serious political debate is even less likely without compelling arguments that nothing else at all can be done to generate knowledge and attain progress (on more contemporary matters of scientific interest) other than experiment on embryos beyond fourteen days.
The demand from the scientific community is also not that all restrictions on embryo research be removed. There are very few advocates of such a position. Any restriction, even if it is more liberal than the status quo, will always limit the development of CE because it will
62 This will be discussed in detail later in this chapter. 63 ibid. 64 Warnock Report (n55). 65 Appleby and Bredenoord (n51). 66 As amended by Human Fertilisation and Embryology Act 2008. 67 Nuffield Council on Bioethics (n58) 7. 68 ibid 9.
31 prevent the complete gestation of foetuses in artificial conditions. Even if all time-period restrictions were removed, CE remains a distant possibility. It seems unlikely to be a research priority. Those calling for a change in the law cite more immediate applications of research such as understanding more about the causes of miscarriage or the development of clinical applications for stem cells.69 Moreover, it has taken almost three decades for pioneering research to finally get to a stage where laboratory conditions can be manipulated to stimulate embryo implantation. There is far more to be done to establish how this state can be maintained in later stages of development as well as how the embryo’s development would be supported. As Jackson explains, ‘whether it will ever be possible to gestate a foetus entirely outside a woman’s body remains to be seen; controlling the process of organ development, which takes place during the first trimester, would be much more complex than controlling the delivery of nutrients necessary for growth earlier on in pregnancy.’70 It is thus inevitable that observing the still unknown events in embryogenesis (embryonic development) and developing methods of sustaining the embryo-foetus in artificial conditions would be a slow process. How life might be entirely artificially sustained beyond thirteen days conception through to the current understanding of a viable neonate remains uncharted territory, and, at least for now, that territory remains cordoned off.
While there is no imminent prospect of babies grown from scratch entirely in the laboratory, other scientific developments related to neonatal intensive care that will be discussed in this thesis give us reason to suspect that some form of ectogenesis might be within our grasp. As there are fewer absolute legal barriers and gaps in knowledge slowing the development of PE it is more likely to be developed first, and thus, the ethical and legal implications of PE are more deserving of immediate attention.
Grounded analysis Secondly, PE provides a means of examining the implications of gestation extra uterum that is better situated in being attentive to the embodied nature of pregnancy. Some of the material facts of PE (namely the continued involvement of a pregnant person) mean that it cannot be
69 Deglincerti et al (n45) 251. 70 Jackson (n9) 328.
32 entirely divorced from contemporary legal and social realities.71 While I have briefly defended the need for speculation about potential futures in order to examine the law in advance of technological developments, it is also clear there should be some limitations on that speculation.72 A world in which CE is possible is so far removed from our own, that it seems almost impossible to imagine the application of the current legal framework in those circumstances. In the literature ectogenesis is simultaneously imagined as existing in but also as the primary creator of that world; AWs are discussed as having themselves removed harmful social, legal and cultural paradigms of the present day (for example, gender inequality).73 I question the utility of imagining a future in which a technology has created that future in itself without examination of how such a change could come to fruition starting from present-day socio-legal conditions. The approach that is generally taken when examining CE does not adequately perform any normative work in establishing how we can achieve a particular set of advantageous social benefits from technology, because ectogenesis is envisaged and advocated as a ‘technological solution’ in itself. The literature thus ‘reflects a curious paradox: in order to escape “current and social paradigms”… [in which it] tends to leap to a future in which these paradigms have been erased… [and thus] fails to address the contemporary limitations that make this future ungraspable.’74 Considering the ethico-legal implications surrounding PE first can better ensure that discussion about AWs is grounded and mindful of impacted parties.
If complete ectogenesis is to ever come to fruition it is likely to be because PE has demonstrated the success of the AW in facilitating gestation extra uterum with outcomes somehow comparable to pregnancy.75 It is only in this circumstance (that is the successful proof of concept for the AW) that the necessary experimentation on embryos might be deemed ethical and made permissible for the reasons explored above. Thus, the focus on complete ectogenesis neglects essential and more immediate questions that are
71 Claire Horn and Elizabeth Chloe Romanis, ‘Establishing Boundaries for Speculation about Artificial Wombs, Ectogenesis, Gender and the Gestating Body,’ in Chris Dietz and others (eds), A Jurisprudence of the Body, (Palgrave 2020). 72 ibid. 73 ibid. 74 ibid. It is important to note that since the drafting of this thesis and the publication of the papers within it there has been an emergence of literature considering the limitations of reproductive technologies in promoting the equality and freedom of women as a result of contemporary social circumstances: see Cavaliere (n48). 75 It is, of course, doubtful that man-made artificial device could be as good as or superior to natural gestation: Elselijn Kingma and Suki Finn ‘Neonatal Incubator or Artificial Womb? Distinguishing Ectogestation and Ectogenesis using the Metaphysics of Pregnancy,’ (2020) 34 Bioethics 354, 360 – in reality, an artificial womb device would at best be a superior alternative to neonatal intensive care.
33 underexplored. This thesis sought to provide a more robust account of the development of ectogenetic technology, that might usefully aid the heavily speculative discussion76 that is more prevalent. Furthermore, exploring the ethico-legal issues concerning PE is a necessary building block in the process of examining these same issues in the context of CE.
In this thesis I sought to avoid assuming technology can achieve certain ends whilst failing to account for current social and legal conditions, as is often the case in the literature concerning CE.77 The approach specifically taken in this thesis with regards to PE is to take this technology as an alternative to something already considered routine – neonatal intensive care, which is the primary purpose for which the AW is currently sought. This approach, considering AWT as an alternative to neonatal intensive care as opposed to all pregnancy, is important for the formulation of ethical and legal questions and argument that does not de- centre impacted parties by the negation of particular facts. In particular; the fact that the development of ectogenesis will necessarily involve experimentation on and with pregnant people, that even if there are technological alternatives to gestation there will still be pregnant people, that present social conditions are not always kind to persons of female biology who want to opt for (or against) technological alternatives in pregnancy and childbirth,78 and that there are embedded and operational ethical and legal frameworks that prevent pregnant people from having complete control over or ending their pregnancy. Considering PE necessitates engagement with these material facts because it considers ‘the use of AWs as a process that inevitably still involves pregnant people’s bodies (because a process of extraction is necessary) [and this] ensures that issues relating to bodily integrity and autonomy are not as easily disregarded’79 as they can be when imaging away the necessity of pregnancy.
76 Romanis and Horn (n44). 77 For a more in depth examination of this claim and examples of how this is often assumed in the literature surrounding AWT see Horn and Romanis (n71). In this chapter, we note that ‘our concern with the trajectory of speculation in the literature on artificial wombs reflects a curious paradox: in order to escape “current cultural and social paradigms,” the literature tends to leap to a future in which these paradigms have been erased. In so doing, it fails to address the contemporary limitations that make this future ungraspable.’ 78 Elizabeth Chloe Romanis, ‘Why the Elective Caesarean Lottery is Ethically Impermissible,’ (2019) 27 Health Care Analysis 249. 79 Romanis and Horn (n44).
34
Thirdly, at the time of writing each of the papers that make up this thesis, PE went relatively unexplored in the literature despite the strong case that it is a more likely and realistic technology and a part of the natural evolution of any ectogenetic technologies capable of more in the future. There has been repeated occurrence of literature considering the implications of ectogenesis since the 1920s, but this has consistently focused on the complete gestation of human entities ex utero.80 Following the recent scientific advances, despite the clear evidence and insistence of the researchers themselves81 that such technology would only be capable of facilitating PE, there has emerged a similar body of literature considering the implications of technology capable of gestating from conception to full-term.82 In this thesis it was necessary to focus, therefore, on the more essential and neglected questions relating to the use of AWs to facilitate partial gestation. Because there has been little academic consideration of PE83 there has been limited understanding of the nature of the process, and even less about the potential legal barriers to development. Neglecting to adequately consider some of the mechanics of prematurity, the limitations of conventional care and the difference between incubation and gestation has led to some conceptual confusion in the literature. Furthermore, the law related to gestation is complicated and I believed that a lot of the benefits that were claimed for (partial) ectogenesis might not even be legally permissible without reform.
The subject of the artificial womb Because CE is beyond the scope of this thesis, there is no consideration of the early stages of human development after conception and thus embryos (the developing human organism before 8 weeks gestation).84 It is possible in the future, however, that AWs may be used beyond the boundaries of what is currently scientifically and legally recognised as viability – as will be discussed in this thesis. Consequently, I do consider the implications for the developing human entity at stages of gestation beyond the embryonic product of conception
80 ibid; John BS Haldane, Daedalus or science and the future: a paper read to the heretics, Cambridge on February 4th 1923, (E Dutton 1924); Abel (n21); Michael Lupton, ‘Artificial Wombs: Medical Miracle, Legal Nightmare,’ (1997) 16 Medicine and Law 621; Kendal (n9); Abecassis (n21); Smajdor (n22). 81 Partridge and others (n2) 11; Usuda and others (n2) e2. 82 Romanis and Horn (n44); Cohen (n21); Jason Blahuta, ‘Liability for Harms Caused in Utero: New Technologies, New Problems,’ (2017) 21 The International Journal of Human Rights 758; Joona Räsänen, ‘Ectogenesis, abortion and a right to the death of the fetus,’ (2017) 31 Bioethics 697; Christopher Kaczor, ‘Ectogenesis and a Right to the Death of the Prenatal Human Being: A Reply to Räsänen,’ (2018) 32 Bioethics 634; Dalzell (n21). 83 There are, of course, a few notable exceptions: Alghrani (n10) and Alghrani and Brazier (n25) in particular. 84 Jock Findlay and others, ‘Human Embryo: A Biological Definition,’ (2007) 22 Human Reproduction 905, 910.
35 but before viability (before 24 weeks).85 From 12 weeks the foetus begins to possess some recognisably human features, and the chance of miscarriage is, at this point, substantially reduced.86 However, I will consider foetuses of 18 weeks or beyond because their physiology is more developed. This point has also been identified and referenced by other scholars.87 I will make little reference in this thesis to the foetus beyond 28 weeks gestation, because the vast majority of these developing human entities would not be deemed ‘extremely premature’88 if delivered and can survive with a decent long-term prognosis.89 Throughout this thesis I have provided, when necessary, specific reference to the exact gestational age or age-range of the developing human entity I am discussing.
Moral Status There are all sorts of different moral, religious, societal, and cultural perspectives on and intuitions about the human organism developing from conception. What is it? Does it matter morally? What can and should be done to it? These perspectives often determine the terminology employed to describe the human organism between conception and full-term gestation. This makes the ethico-legal discussion of the growing human entity challenging to navigate. PE further complicates this problem by introducing the possibility of a gestating human entity outside of the pregnant person’s body (in an AW). In this thesis, I will not dwell on the moral status of the gestating human entity; the literature on moral status is vast and therefore it is beyond the scope of this thesis to attempt to resolve this issue. This thesis makes no arguments by appealing to the moral status – or lack thereof – of the developing entity. As I explain in this rest of this section, I will instead focus on externalities and the extrinsic value of a gestating entity; paying close attention to material facts about such an entity’s existence in an AW and the experiences of pregnant people.
85 In English law 24 weeks is the point at which viability is presumed in the Abortion Act 1967, s.1 (1) (a). In the medical literature there is some consensus that a realistic chance of survival after premature delivery – when treatment is provided - can be placed at 24 weeks: Hannah Glass and others, ‘Outcomes for Extremely Premature Infants,’ (2015) 120 Anesthesia & Analgesia 1337, 1338. This is confirmed in a 2019 systematic review that found that the survival rate at 24 weeks is around 59.7% (when calculated as a proportion of those who are transferred to neonatal intensive care), but this falls drastically when neonates are delivered before this 24-week point. See Hilde Myrhaug and others, ‘Survival and Impairment of Extremely Premature Infants: A Meta-analysis,’ (2019) 143 Pediatrics e2018093. 86 Joanne Topping and Roy Farquarson, ‘Spontaneous Miscarriage,’ in Keith Edmonds (ed), Dewhurst’s Textbook of Obstetrics and Gynaecology, (Blackwell Publishing 2007), 95. 87 Alghrani and Brazier (n25). 88 Philip Bennett, ‘Preterm Labour’ in Keith Edmonds (ed), Dewhurst’s Textbook of Obstetrics and Gynaecology, (Blackwell Publishing 2007), 177. 89 ibid 178.
36
The notion of moral status is traditionally deployed to conceptualise the intrinsic value of a being, weigh its value against that of others, and then use this normative judgement to determine how the being should be treated.90 Ultimately, the concept of moral status is a label applied to beings that we use to rationalise whether or not we have obligations to them (and thus whether they have ‘rights’ that enable them to demand the realisation of those obligations). If we describe a foetus as having moral status, this implies that we have some moral obligations towards it and that some of its interests may deserve protection. Few debates in medical ethics and moral philosophy are as controversial, divisive, and complex as the moral status of developing human entities (the embryo/foetus). There are two extreme opposing views to this debate. At one end are those who argue that human life begins at conception or shortly after conception and should be afforded (at least some) protection from that point.91 At the other end are those that would argue that the foetus is not a person morally speaking92 and thus it has no right to life before birth93 or even beyond.94 In the middle are a number of positions that attempt to straddle the gap between these two polarised views. In this space there are claims that the foetus has moral status as a result of its potential,95 or that
90 Mary Anne Warren, Moral Status: obligations to persons and other living things, (OUP 1997), 13. 91 Such an account advocates that human life begins at conception (or shortly after), that all human life is valuable and that any action that interferes with the development of human life is wrong. Therefore, a foetus has moral value denoting a right not to be killed because it is a human being with a valuable life. Werner, for example, argues that it is difficult to isolate a particular stage of gestational development that is substantially different from the previous successive stage to explain a change in the organism’s moral status; thus, a human life must be morally significant from the point of conception because the same moral status must always be afforded to a growing human entity. See Richard Werner ‘Abortion and the Moral Status of the Unborn,’ (1974) 3 Social Theory and Practice 201, 202. 92 There is some disagreement over the psychological qualities sufficient for moral personhood, although there is some broad consensus around qualities such as sentience and self-awareness. See Michael Tooley, Abortion and Infanticide, (Clarendon Press 1983); Warren (n90); Mary Anne Warren, ‘On the Moral and Legal Status of Abortion,’ (1973) 57 Monist 43; Peter Singer, Practical Ethics, (CUP 1993); Bonnie Steinbock, Life Before Birth: The Moral and Legal Status of Embryos and Foetuses, (OUP 1992). 93 This account posits that there is a difference between the biological concept of human life (encompassing only membership of the species homo sapiens) and the psychological concept of personhood (that involves possessing characteristics like self-awareness and consciousness). A foetus is a human being but is not a person. Being a person is what makes life matter morally (whether an organism is human is morally irrelevant), therefore the foetus has no intrinsic moral worth affording it a right not to be killed. It is not inherently wrong to destroy it. See ibid. 94 E.g. Alberto Giubilini and Francesca Minerva, ‘After-birth abortion: why should the baby live?’ (2013) 39 Journal of Medical Ethics 261. 95 Marquis, for example, argues that while a foetus is not a person, it is a potential person. If there is no interference with the process of its development, a fertilised ovum will eventually become a fully developed adult human being with the characteristics associated with moral personhood. Thus, he posits that, even though a foetus cannot apprehend the value of its life at this point in its development, destroying it deprives it of all of the possibilities associated with a future that will become valuable to it and so there is moral value in the foetus such that it has a right not to be killed. See Don Marquis, ‘Why Abortion is Immoral,’ (1989), 86 The Journal of Philosophy 183, 198. Such an approach has been widely criticised in the philosophical literature, because although we may adopt some differential attitudes to things based on what they might become, we do not treat individuals based on what they might be, but on what they are. Significant changes must take place before a foetus develops personhood and drawing attention to potential only serves to highlight that it is actualising of the potential that is morally significant. See John Harris, Enhancing Evolution: The Ethical Case for Making Better People, (Princeton University Press 2007), 166; John Harris, ‘Embryos and Hedgehogs’ in Anthony Dyson and John Harris (eds),
37 it gains moral status during gestation; this is understood as either a gradual increase in moral status throughout gestation96 or the attainment of moral status at a particular developmental threshold in gestation.97 The debate surrounding the foetus’s moral status is marked by complexity and a lack of consensus. It has also become somewhat stagnant and polarised; largely because the two extreme positions begin from different axiomatic premises regarding what morally matters and why. The premise that all human life (at any stage) is valuable is irreconcilable with the premise that it is only the lives of persons that have intrinsic value. There is little hope of unilaterally resolving the question of the moral status of a developing human entity in a way that can universally convince.98 Simply put, ‘there never will be consensus about the moral status of a fetus.’99 In any event, to attempt to contribute meaningfully to this debate, at the very least, would require an entire thesis dedicated to the enterprise.
The majority of discourse on the moral status of the foetus has centred on the question of the morality of abortion and, specifically, on the notion of personhood.100 It has been suggested that PE changes the landscape of the moral status question such that it necessitates a re- examination of when the foetus begins to matter, morally speaking; first because it changes
Experiments on Embryos, (Routledge 1991), 70; Jonathan Glover, Causing Death and Saving Lives, (Penguin Books 1990), 124; Singer (n92), 153-154. 96 Aristotle theorised that that the moral significance of a foetus increased throughout gestation. He posited that the foetus attains more sentience, and thus more intrinsic value, as it attains a human shape see Aristotle, De Anima (On the Soul), (Penguin Books 1986). 97 While several points have been advocated as the relevant developmental threshold, viability is the point most often identified. Viability is the point at which it is deemed that there is a reasonable probability that the foetus has developed to the point that, if delivered, it could survive ex utero with care. This threshold is adopted explicitly in the law in the United States and implicitly in the law in England and Wales. It is, however, widely criticised in the bioethics literature equally by those who believe that all humans (from conception) matter morally and those who believe that only persons matter morally, for being both geography- and technology-dependent. It is thought that where an entity is located – whether it is within or external to a womb – does not determine its moral status. Feinberg stresses that there is nothing inherent in the ability to exist outside the womb that makes a life morally significant because there is no evidence that it is constitutive of personhood or the possession of morally significant qualities. See Joel Feinberg, ‘Abortion,’ in Tom Regan (ed), Matters of Life and Death: New Introductory Essays in Moral Philosophy, (Random House 1980), 185. A believer in the intrinsic value of life from conception would agree that it is not the ability to survive independent of the mother that is morally significant but the fact that the growing foetus is human, which is equally valid before and after viability. It is also often argued that the viability standard is entirely arbitrary because it continues to change as technology advances. Developments in neonatal care are constantly pushing further and further back the point at which a foetus has a chance of survival if born premature. Singer questions whether it is right that a foetus born at 22 weeks today can be considered morally significant, when a foetus born at this point a decade ago would not have given that they are ontologically identical. See Singer (n92) 140. I have argued elsewhere that viability is an incoherent legal standard: Elizabeth Chloe Romanis, ‘Is ‘Viability’ Viable? Abortion, Conceptual Confusion and the Law in England and Wales and the United States,’ (forthcoming) Journal of Law and the Biosciences. 98 See Ruth Macklin, ‘Personhood in the Bioethics Literature,’ (1983) 61 The Milbank Memorial Fund Quarterly 35. 99 Emily Jackson, Regulating Reproduction: Law, Technology and Autonomy, (Hart 2001), 1. 100 Macklin (n98).
38 the nature of the abortion debate,101 and second because we will need to determine the moral value of the subject gestating ex utero.102
It might be thought, therefore, that any conclusions about the moral status of foetuses might shape the ethical approach to the research questions that this thesis will address. However, to investigate and address this matter to a satisfactory degree, in light of the complexity of existing debate, would have distracted to the extent of precluding the examination of many of the unique ethico-legal issues raised by PE that I chose to direct my attention to. Identifying the intrinsic moral worth (or absence of) of the foetus/subject of the AW is not crucial to identifying, or even resolving, some of these practical ethico-legal issues that are raised by PE – especially those raised in this thesis. This is because to focus on the moral status of a developing human entity is to situate the discussion of AWT and the human entity in the abstract, whereas I am interested in the factual circumstances and their ethical consequences. In what follows I demonstrate that there are ethically significant factual circumstances surrounding foetuses and potential subjects of the AW that are both relevant and more determinative in establishing the obligations that we may (not) have towards it than making conclusions about moral status.
The moral status of the foetus It is often posited that PE severs the presently inextricable link between abortion103 and foetal death.104 Two questions that are frequently posed in relation to this are; if a pregnant person can have an abortion to secure freedom from pregnancy without it necessarily resulting in foetal death105 are they still entitled to insist on foetal death?106 Would it be justifiable for the pregnant person to insist on abortion by conventional methods (meaning that the foetus dies)
101 Singer and Wells (n9) 12; Eric Mathison and Jeremy Davis, ‘Is there a right to the death of the foetus?’ (2017) 31 Bioethics 313; Bruce Blackshaw and Daniel Rodger, ‘Ectogenesis and the case against the right to the death of the foetus,’ (2019) 33 Bioethics 76; Christopher Kaczor, ‘The Edge of Life: Human Dignity and Contemporary Bioethics,’ (Springer 2005), 107; William Simkulet, ‘Abortion and Ectogenesis: Moral Compromise,’ (2020) 46 Journal of Medical Ethics 93. 102 Gelfand (n22) 104; Joyce Raskin and Nadav Mazor, ‘The Artificial Womb and Human Subject Research,’ in Scott Gelfand and John Shook (eds), Ectogenesis: Artificial Womb Technology and the Future of Human Reproduction, (Rodopi 2006), 180. 103 Or any early termination of pregnancy where it is virtually certain that so doing will result in foetal death or that is not undertaken as a ‘premature delivery’ - that is a termination of pregnancy undertaken in order to save the life or health of a pregnant person and a subsequent attempt to keep the very premature neonate alive. 104 Singer and Wells (n9) 12. 105 Sheila McLean, ‘Abortion Law: Is Consensual Reform Possible?’ (1990) 17 Journal of Law and Society 106, 117. 106 Kaczor (n101), 107; Räsänen (n82), Alghrani (n22).
39 even though the foetus they are sustaining could be transferred to an artificial womb?107 These questions are presented as distinct from those raised in the contemporary context of abortion – in which it is often argued (or accepted) that regardless of the moral status of the foetus externalities can determine the moral permissibility of abortion.108 In the accounts of those who imagine ectogenesis as changing the nature of the abortion debate, some of these externalities (such as the pregnant person’s right to be free from pregnancy) are posited to be no longer applicable, because a pregnant person can be free of pregnancy without ‘killing’ the foetus.109 Thus, such accounts suggest that we must first determine the moral status of the foetus to ascertain if it has, or does not have, intrinsic moral worth denoting a right to life in order to answer the ‘abortion question.’
This focus on the permissibility of ‘conventional’ abortion,110 and claims that certain externalities (namely the engagement of a pregnant person’s bodily autonomy in the abortion decision) are ‘no longer applicable’111 if this technology comes to fruition, should be approached with caution. This is because questions about the permissibility of abortion remain – even if AWT were readily available – questions about a pregnant person’s body and their autonomy. PE begins with a pregnant person’s body and necessarily involves the body of a pregnant person; this is unfortunately an often-neglected fact in the debate about ectogenesis.112 We must be alert to the danger in such discourse; that it dislocates enquiry from these key facts that we must pay close attention to in ethical analysis. Focus on the intrinsic moral worth of the foetus – or on any obligations we might have toward the foetus – risks obscuring the material involvement and importance of the pregnant person. This thesis
107 Singer and Wells (n9) 12; Mathison and Davis (n101); Bruce Blackshaw and Daniel Rodger, ‘Ectogenesis and the case against the right to the death of the foetus,’ (2019) 33 Bioethics 76; Christine Overall, ‘Rethinking abortion, ectogenesis, and fetal death,’ (2015) 46 Journal of Social Philosophy 126. 108 E.g. Judith Jarvis Thomson, ‘A Defence of Abortion,’ (1971) 1 Philosophy and Public Affairs 47; Peter Alward, ‘Abortion Rights and Paternal Obligations,’ (2012) 26 Public Affairs Quarterly 273; David Boonin, A Defense of Abortion, (CUP 2002). 109 Singer and Wells (n9) 12; Mathison and Davis (n101); Blackshaw and Rodger (n101); Simkulet (n101); Hendricks (n665). 110 That is abortion resulting in foetal death. 111 For example, Blackshaw and Rodger argue that ‘ectogenesis severs the link between termination of pregnancy and the death of the foetus. Provided ectogenesis is safe, which we have assumed, and affordable, the mother can withdraw the life support she is providing without harming the foetus, and without a ‘Good Samaritan’ sacrifice being required of her.’ They submit that this argument works where the process of transfer to an AW is ‘significantly worse than abortion [for the pregnant person], but not substantially worse.’ See Blackshaw and Rodger (n101), 78. 112 This is also the case when individuals talk about abortion in the advent of complete ectogenesis – in asking questions about abortion the matter is inevitably asking questions about pregnancy – for there to be a debate about conventional abortion vs. transfer to an artificial womb there must be a pregnancy carried by a pregnant person, and thus the pregnant person’s right to bodily autonomy will always be relevant to the discussion of abortion.
40 does not address questions about the permissibility of abortion in the event of this technology, because I do not believe that PE is an ‘alternative’ to abortion.113 As a result, I do not think that PE necessitates a re-examination of the moral status of the foetus as a part of a conversation about the permissibility of abortion.
As already alluded to, I take that it there are important material facts about pregnancy (that is gestation facilitated by the body of a pregnant person)114 – that remain unchanged by the potential advent of PE - that frame the ethical approach in this thesis. Pregnancy is facilitated by a pregnant person who clearly has intrinsic moral worth that must always be afforded more value than a foetus (irrespective of any conclusions that might be made about its intrinsic moral worth). The pregnant person is a fully developed human being with subjective preferences, goals, desires, and beliefs formed as a result of subjective experiences, relationships, and interaction with their social context. Respect for these aspects of a pregnant person’s individuality means respecting that their body remains their own and respecting their ability to make choices about that body, and what may be done to it based on their ideals. There can be no doubt about the status of a pregnant person as a person deserving of respect, and thus I am of the belief that their rights and preferences must be prioritised over any potential claims based on any perceived interests of the human organism being gestated.
The approach that I take here is not unique; many scholars have before argued that the rights of pregnant people must always take precedence over the foetus irrespective of its moral value.115 Even some scholars who argue that there is some intrinsic value to human life from conception, or some point before birth, accept that the rights of pregnant people must take precedence over this value.116 There are, however, some who maintain that abortion is permissible only because the foetus lacks moral personhood; Greasley, for example, while being firmly pro-choice, takes the position that addressing the question of whether the foetus
113 I will briefly explain some of the reasons for this conclusion in paper five in this thesis, but I have co-authored a full account of why PE (or complete ectogenesis) is not an alternative to abortion elsewhere see Romanis and Horn (n44). 114 Romanis and others (n29). 115 Warren (n90) 202; Thomson (n108); Boonin (n108); Alward (n108); Maggie Little, ‘Abortion, Intimacy and the Duty to Gestate,’ (1999) 2 Ethical Theory and Moral Practice 295. 116 E.g. Dworkin argues that there is sacredness to all human life, including foetuses (as a result of the complex creative investment it represents) that affords it some intrinsic value. However, he argues that this does not allow a State to limit a pregnant person’s right to choose without a compelling reason. Ronald Dworkin, Life’s Dominion: An Argument about Abortion, Euthanasia, and Individual Freedom, (Alfred A. Knopf 1993).
41 is a person is necessary; because it changes how abortion is/must be justified.117 Greasley argues that if the foetus is a person, abortion would potentially only be permissible if it is shown to be an instance of ‘justifiable homicide.’ She explains that this could be difficult to establish because there are ethico-legal requirements that limit the permissibility of killing in ‘self-defence,’ namely that it must be necessary and proportionate.118 However, I am in agreement with Little that ‘in wondering whether abortion is murder, then, the issue is not just a matter of deciding whether or when the foetus is a person; it is a matter of determining the contours of the right to life in the rather distinctive circumstance of being gestated.’119 There is the danger that in centring the debate on the question of moral status – of personhood – that
‘we can end up thinking of fetuses, not just as persons, but as persons atomistically situated, as physically individuated and separate – as though the bundle of specified rights at issue for the fetus are the same bundle we commonly face walking down the street in everyday life.’120
I take a view similar to that famously articulated by Thomson, which is that whatever the moral value of a foetus,121 there is no right to use the pregnant person’s body to sustain its life,122 nor is there any justification for interfering with the pregnant person’s bodily autonomy in the name of any articulated foetal interests.123 This is also the approach of the
117 Kate Greasley, Arguments about Abortion: Personhood, Morality and Law, (OUP 2017), 86. 118 ibid 61. While I am not addressing the issue of abortion, I note here that I believe Greasley has underestimated the degree of proportionality in the abortion decision. She suggests that ‘it still seems that a pregnant person who aborts will struggle to meet [the proportionality condition] in any scenario where her life is not put at risk by the pregnancy;’ and that although ‘the physical burdens to pregnancy and childbirth that arise in perfectly typical pregnancies are by no means trivial…. They are, I think, less serious in the respect that they do not entail the permanent loss of any function or lasting, debilitating damage… the question, remember is whether they are comparable to the sorts of threats which legitimate defensive killing, the most extreme self-defensive measure’ at 60-61. I contest the extent to which it is appropriate to make such claims in the current climate of rising maternal mortality in childbirth in high-income economies, particularly amongst women from ethnic minorities and individuals with limited socio-economic resources (see Horn and Romanis (n71)). Moreover, focusing on only the physical and medical risks in pregnancy and childbirth to justify the proportionality of the abortion decision negates both the realities and seriousness of pregnancy. In Little’s words, ‘to be pregnant is to be inhabited. It is to be occupied. It is to be in a state of physical intimacy of a particularly thorough-going nature... whatever medical risks one faces or avoids, the brute fact remains that the fetus shifts and alters the very physical boundaries of the woman’s self… To mandate that the woman remain pregnant is to mandate that she remain in a state of physical intertwinement against her consent:’ (n115) 301. We accept a shift in proportionality in considering reasonable response to threats in instances of home invasion in English law in s.76 of the Criminal Justice and Immigration Act 2008, I see no reason why we would also not – if we accepted a foetus was a person and that abortion was a case of killing a person – accept that abortion is a proportionate response to being trespassed in this way. 119 Little (n115) 229. 120 ibid 229. 121 To be clear, I am not stating (or conceding) that the foetus does have intrinsic moral value. 122 Thomson (n108) 56. There are some who disagree with this account because there are instances in which they imagine there could be a moral obligation to continue to gestate, however I will not engage in this debate for reasons of space. 123 Romanis and others (n29).
42 law in England and Wales, which is clear in its assertation that the foetus is ‘not nothing,’124 but whatever value it has is subordinate to a pregnant person’s rights125 and health.126 Preventing pregnant people from making decisions about their body, gestation, and their pregnancy has concrete harms in preventing individuals from determining the direction of their own lives and bodies, and in reducing female bodies to ‘fetal containers;’127 ‘incubators;’ ‘baby-making machines;’ effectively treating female people as means to an end.
The moral status of the subject of the artificial womb Many of those speculating about ectogenesis have posited that this technology demands a re- examination of the gestating entity and its moral status.128 As this thesis will demonstrate, PE introduces a whole new ‘class of entity’ (the subjects of the artificial womb) that needs to be understood. Entities in this class are physiologically similar to foetuses sustained by pregnant persons;129 but are not located within a pregnant person’s body. The question then arises of how these entities should be treated;130 like the foetuses to which they are physically and physiologically more similar131 or like newborn neonates that are also ex utero (though distinguishable because newborns are not still undergoing the process of gestation)? It is true that once a subject is in the AW the bodily autonomy of a pregnant person is not engaged in the same way because what is done to it does not direct physically impact on another person’s body (though, for emphasis I note again that the bodily autonomy of the pregnant person will have been engaged in the process that resulted in the entity coming to be in the AW). Thus, asking whether developing human entities matter morally and why might seem prima facie crucial in dealing with these issues. The question is harder to avoid absent the context of pregnancy because the same externalities (that are deemed more determinative) cannot be
124 Jackson makes this observation about the embryo (n99) 145, but the same can be said of the foetus as it is afforded some legal protections. 125 E.g. a pregnant person is entitled to refuse medical treatment even if it necessary to save the foetus; Re MB (An adult: medical treatment) [1997] 8 Med LR 217. 126 In s.1 of the Abortion Act 1969, the defences that are available to a doctor to avoid criminal sanction in providing abortion services after 24 weeks are much narrower and framed in terms of greater severity. Effectively the legislation effectively seems to grant the ‘foetus’ limited recognition in terms of a ‘right to be gestated,’ but subordinate to pregnant people’s life and health because the law distinguishes between the justifications for abortion before and after this point. See Elizabeth Chloe Romanis, ‘Pregnant Women May Have Moral Obligations to Foetuses They Have Chosen to Carry to Term, But the Law Should Never Intervene in a Woman’s Choices during Pregnancy,’ (2017) 6 Manchester Review of Law, Crime and Ethics 69, 72. 127 Laura Purdy, ‘Are Pregnant Women Fetal Containers?’ (1990) 4 Bioethics 273, 273. 128 Gelfand (n22) 104; Raskin and Mazor (n102) 180. 129 This is established in papers one, two and three of this thesis. 130 Several academics have asked this question of the status of the subject of the artificial womb, though they have not investigated the conceptual difference between gestation and incubation to demonstrate the uniqueness of the subject as I have in this thesis: Jackson (n9); Bernard Dickens, ‘The Ectogenetic Human Being: A Problem Child of Our Time,’ (1979) 18 University of Western Ontario Law Review 241; Alghrani and Brazier (n25). 131 This is established in papers one, two and three of this thesis. 43 used to avoid the question of moral status, and the moral value we assign to the subject of the artificial womb may more directly, therefore, affect beliefs about how it ought to be treated.
I do not deny that the question of the intrinsic value of a gestating entity located ex utero will be an interesting question for many moral philosophers, however, in the context of the issues examined in this thesis the matter is not crucial. As already noted earlier in this section, I will not appeal to the moral status – or lack of – to make any of my arguments. I believe that little is achieved by making determinations about the abstract intrinsic moral value of different developing entities in themselves. Assigning a moral status to the subject of the AW, while directing towards an abstract discussion about moral value, is of limited utility in the broader regulatory context which I focus on in this thesis. Even if the moral worth of a gestating entity is possible to objectively and universally determine, how that moral worth is (or ought to be) translated into protections or the imposition of obligations onto others, both ethically and legally,132 would remain in need of an answer. Here I note that even amongst those who are in agreement about the possession or absence of moral status of developing human entities, there is subsequent disagreement about what that means in terms of the obligations that are owed by others towards that entity.133 Taking the position that we must identify the moral status of a human entity assumes that this is necessary in order to afford any particular protections or to make determinations about how it ought to be treated. However, it is not clear that this is the case. Debate continues to rage about the moral status of animals and embryos and yet determinations can be made in the law, and in ethical discourse, about some boundaries of their appropriate treatment. Jackson notes that, therefore, ‘in deciding the legal priority to fetal interests… moral judgments about the status of the fetus seem to be much less
132 Naffine observes that ‘the legal concept of the person can be metaphysically neutral. It is not necessarily tied to any particular philosophical, religious or scientific understanding of what we really are and therefore it can be used in any which way, to endow and deny rights; to impose and remove duties.’ Ngaire Naffine, Law’s Meaning of Life: Philosophy, Religion, Darwin and the Legal Person, (Hart Publishing 2009), 166. 133 For example, those who argue that morally significant life begins at conception do not necessarily agree on whether or not this means that abortion is immoral or should be illegal; some believe that the protection that should be afforded to foetuses from conception does not outweigh a pregnant person’s right to choice about their pregnancy, and in other choices during pregnancy. The same disagreement about what obligations are owed to gestating entities is evident amongst those who believe that the foetus is not a moral person; for example, many argue that just because there is no morally significant life before birth does not mean that no protection ought to be afforded at all to gestating entities. Even those who believe that a newborn neonate is not morally significant in its own right as it lacks moral personhood still advocate that there are certain protections that need to be afforded to it. Advocates of personhood often concede that whilst it is not wrong to kill a biological human for its own sake there may be, in some circumstances, external ethical considerations that determine the permissibility of its treatment. Singer argues that foetuses that experience pain are morally equivalent to other non-human animals that possess similar capacities, but equally are not self-aware or rational: Singer (n92) 151.
44 important than normative decisions about the practical consequences of recognising different sorts of obligations.’134
Since the law ‘is not capable of divining any absolute truths about the moral status of the embryo,’135 foetus or gestating entities ex utero, in navigating complex ethico-legal questions about life and birth focusing on the extrinsic value that might be afforded to gestating entities by others surrounding it is of more importance.136 This extrinsic value will more often directly influence our perceptions about the gestating entity and the obligations that we may have towards it. There are concrete harms that materialise to surrounding persons as a result of how the entity gestating ex utero is treated. That is to say that, even if an entity exists ex utero it does not exist in a vacuum; it remains embedded in a particular set of complex circumstances, particularly in relation to the genetic progenitors of that entity. This thesis recognises that ultimately, ‘moral problems are problems of human relations’137 and that whatever its intrinsic moral value, the human entity gestating ex utero exists in ‘a moral community and thereby [is] situated in a complex web of relationships will provide the most fruitful framework when responding to ethical issues such as those generated by the abortion dialogue’138 or, in the case of this thesis, determining ethical treatment of the subject of an AW. The subject of an AW is a human entity that will be (often) meaningful to actors around it. It is still undergoing the process of gestation, though facilitated by artificial conditions. What is done, or not done, to this developing entity will impact on those around it, for example, those responsible for its conception and/or the former pregnant person, whether these are individuals who want to parent it or not.
While I will not address abortion in this thesis, as I have already made clear, I think it important to make the observation that the question of abortion in the event of complete ectogenesis becoming available would be broader than a matter of the pregnant person’s
134 Jackson (n99) 145 (emphasis added). 135 ibid 229. 136 By extrinsic value I mean the value that might be afforded to the entity by those around it, for example, those who might value it as the embodiment of the chance to parent, as opposed to the inherent or ‘real’ intrinsic value of the entity. 137 Carol Gilligan, In a Different Voice: Psychological Theory and Women’s Development, (Harvard University Press 2009), 19. 138 Elizabeth Mackintosh, ‘Abortion and Moral Context: Human Beings in a Moral Community,’ (PhD thesis, Durham University, 2015), 51.
45 bodily autonomy, for reasons related to the extrinsic value of ‘unborn’ human entities. Jackson observes that ‘very few women seek abortion solely to avoid the physical processes of pregnancy and labour.’139 This position is echoed across the feminist literature that recognises and emphasises ‘the multiple individual, social and structural factors which may lead a woman to seek an abortion, and affirm that abortion is not reducible to a physical desire not to be pregnant.’140 This is a result of the extrinsic value of the existence of a particular gestating entity, as I have argued elsewhere, ‘termination of pregnancy provides closure; it affords pregnant people the opportunity to conclusively reject biological parenthood and/or social motherhood as this is still strongly associated with biological parenthood in women. This conclusive rejection is simply not possible by other means.’141 This matter, however, is beyond my scope as I consider the use of AWT primarily as an alternative to neonatal intensive care.
In the context of the issues I identify and explore; metaphysical questions about the distinction between incubation and gestation, ethical conditions for experimental PE and the choice to gestate ex utero in place of later-term pregnancy, the perspectives of those surrounding the gestating entity will be central to the way that it is treated. This is largely because the extrinsic value invested in these entities will be the very motivation for the use of AWT in the first place;142 potentially because a pregnant person experiencing a dangerous pregnancy and/or the genetic progenitors want to access PE for reasons of wanting to become a parent. While it is debatable whether the gestating entity has an intrinsic value because, for example, it lacks moral personhood, the extrinsic value it will embody for potential parent(s) is of undeniable ethical significance.
Moving away from moral status, therefore, this thesis endeavours instead to focus on what I believe are more material facts that will influence how the subject of the artificial womb is or could be perceived by those around it. This approach is helpful to highlight practical ethico- legal implications or issues in the development of, or following the introduction of, PE that cannot be resolved by making conclusions about the intrinsic value of entities, and to allow
139 Jackson (n9) 362 (emphasis added). 140 Romanis and Horn (n44). 141 ibid. 142 I will not be considering instances of PE being used to ‘rescue’ otherwise unwanted foetuses in this thesis, because as explained I do not believe PE to be an ‘alternative’ to abortion. 46 for the consideration of the impact of the technology on other parties, primarily the pregnant person.
47
CHAPTER TWO - APPROACH
Thesis Structure
This thesis is presented in three parts. In Part I, understanding partial ectogenesis, I consider conceptual questions about the AW and PE. This examination is undertaken on the premise that it would be impossible to make any normative evaluations about PE, about ethical experimentation with PE, or to consider its legal implications if it is not correctly understood and conceptualised. This part consists of three papers. The first paper outlines the scientific landscape of AWs and advances the premise that there is a conceptual distinction between gestation and incubation obvious in the context of PE. The second paper considers the legal significance of this distinction by examining the extent to which the law recognises such a distinction and whether, in the context of PE and maternal-foetal surgery, unique subjects of reproductive technologies would be recognised as birthed neonates or not. This second paper also considers the practical implications of such a determination, thus demonstrating the practical implications of the conceptual distinction particularly for pregnant people. The third paper (a short response paper) further defends this conceptual distinction between gestateling and newborn neonate.
In Part II, realising partial ectogenesis, I consider practical questions about the regulatory background and necessary ethical considerations for clinical trials of AW devices used to facilitate PE. This part consists of one paper that considers the justifications that might be offered for experimental PE, potential clinical translation strategies and regulatory and ethical requirements before this research could be undertaken. The conceptual distinction in Part I was crucial to the formulation of the ethical questions addressed in this paper. It is necessary to address these questions about experimental AWT before considering potential implications of the technology to ensure that normative conclusions about the acceptability of experimental treatment are not assumed.
Finally, in Part III, implications of partial ectogenesis, I consider the legal framework surrounding choices about gestation to question whether PE will have, in the absence of legal and social reform, the emancipatory consequences that is often claimed. This part consists of
48 two papers. The first paper considers the mechanisms by which PE could liberate pregnant people from some of the burdens of gestation and considers the extent to which the decision to opt out of gestation in favour of an AW is lawful under the current legal framework in England and Wales. The second paper (a short commentary) helpfully places the concerns I have about the excessive medical and legal regulation of gestation, especially regarding PE, into social and ethical context.
In chapter three I provide full outlines of each of these papers. Before this, however, I briefly explain aspects of method and methodology that were central to the writing of this thesis.
Method and Methodology
Bioethics, the Law and Science Ethics is widely understood as the process of adopting moral reasoning to understand and examine life.143 Bioethics is the area of study144 that seeks to bring ethics to the biological and medical sciences. It is the ‘systematic study of the moral dimensions – including moral vision, decisions, conduct and policies – of the life sciences and healthcare….’145 and, as a form of applied ethics, it considers and attempts to implement moral norms and theories in context.146 At the crux of bioethics is an attempt to address the relationship between life sciences and values in society. Thus, both a good grasp of science and the law, I believe, are crucial to good bioethics.
143 Thomas Beauchamp and James Childress, Principles of Biomedical Ethics, (OUP 2001), 1. 144 There is ongoing debate about whether bioethics is a discipline, a field of inquiry or neither. See Gabriele Irrazabal, ‘On the emergence and consolidation of bioethics as a discipline, as seen from a sociological perspective,’ (2015) 22 História, Ciências, Saúde-Manguinhos 1. In this thesis I chose to describe bioethics as an area of study to reflect that there are a wide variety of approaches to the formation of research questions, method, methodology and in the value placed on different sources and evidence. 145 Warren Reich, Encyclopedia of Bioethics, (Macmillan 1995), 21. 146 Chan explains this need not always be the case because ‘an argument does not always have to translate directly into policy or have an immediate and measurable real world outcome in order to be of some practical value’ and thus constitute good bioethics: Sarah Chan, ‘A Bioethics for all Seasons,’ (2015) 41 Journal of Medical Ethics 17, 18. 49
The importance of accurate scientific understanding
I have always found biological and medical sciences fascinating147 for what scientific facts can illuminate about life, life’s fundamental questions and life’s language. Greely explains this in words that I find difficult to improve on; biology is fascinating in ‘its breadth, its combination of deep unities and myriad complexities, its many rules – each with exceptions and every exception with provisos – and its infinite surprises.’148 I started this thesis by surveying and engaging with the scientific literature concerning the limitations of conventional neonatal intensive care technologies, of obstetrics and of AW prototypes. While this was partly the result of my personal interest, I believe the close attention I have paid to sources from the medical sciences was necessary and is an important methodological feature of good bioethics scholarship. Understanding the scientific concepts and realities underlying reproductive technologies does not simply enrich bioethical discussion and argument, it is a prerequisite to that discussion. As Holm highlights, biological knowledge is essential in bioethics as ‘straightforward empirical premises when a particular ethical argument needs an empirical premise of a particular kind.’149
Moreover, accurate understanding of scientific fact is necessary to formulate the correct ethical questions. The bioethical and legal literature surrounding AWs has generally suffered from a failure to demonstrate sufficient comprehension of the AW. It is for this reason that, as this thesis demonstrates, there has been a failure to appreciate the conceptual distinction between incubation and gestation, and thus important ethical questions have gone ignored. This lack of attention to scientific fact has permeated far beyond metaphysical matters into the vast majority of applied argumentation about AWs, abortion (where attention has been primarily directed) and female liberation. As just one example, there is an underappreciation of the stark difference between an extraction procedure to move a foetus from a pregnant person’s uterus to an AW and methods of conventional abortion (whether medical or
147 A statement that might come as a surprise to my A level science teachers. 148 Henry Greely, The End of Sex and the Future of Human Reproduction, (Harvard University Press 2018), 7. Greely also explains that there are a lot of similarities between biological facts and legal method, which is perhaps why I found the transition from studying A level sciences to an undergraduate in law to be so comfortable. 149 Soren Holm, ‘Bioethics and Biological Knowledge: A Conflicted Relationship,’ (2020) Fra Forskningsfronten 62, 62.
50 surgical), and the difference between a routine caesarean extraction and the experimental and likely more invasive process necessary for foetal extraction.150
In grounding my discussion in scientific realities as I have, this thesis has sought to reinforce the notion that appreciating the life sciences is an important foundation to good bioethics.
The symbiotic relationship between law and bioethics
Most scholars engaged in bioethics ‘have wandered into the field from somewhere else, more or less inventing it as they go.’151 I am no exception; coming to bioethics during my study of the law. I am therefore inevitably influenced by a predisposition towards legal sources based on a firm belief (contrary to many philosophers in this area of study) in the importance of law in ethical inquiry.
The age-old jurisprudential debate concerning the relationship between law and morality need not be repeated here. It is enough to note that I am generally of the persuasion that there is no innate or necessary connection between the law (a system of rules created by a society) and morality. The law is not a source of moral content, ideals or authority; it is often, though not always, devoid of moral function152 and is intended to serve purely regulatory ends. Gray observes that;
‘the law of a state or other organised body is not an ideal, but something which actually exists. It is not that which is in accordance with religion, or nature, or morality; it is not that which ought to be, but that which is.’153
In response to a practical problem, there could be different conclusions reached by bioethical and legal reasoning. Despite this, and the different limitations on each area of thinking,154
150 I am grateful to Joanne Verweij for discussions about experimental obstetrics in this context. 151 Daniel Callahan, ‘Bioethics as a Discipline,’ (1973) 1 Hasting Center Studies 66, 68. 152 Jerry Menikoff, Law and Bioethics, (Georgetown University Press 2001), 2. 153 John Gray, The Nature and Sources of the Law, (Columbia University Press, 1909), 213. 154 The law is subject to the constraints of having to perform real-world functions, to provide definitive answers to regulatory problems, and is subject to the constraints of legal reasoning – for example, the rules of precedent.
51 there has developed a comfortable symbiotic relationship between law and bioethics. Drane observes that the propensity ‘to look for legal solutions to problems led to an immediate involvement of bioethics with the law.’155 Brassington similarly describes how the law has invited ethics into the conversation in situations where there is legal uncertainty and the path to resolution is unclear.156 He explains that there are ‘any number of examples of judges appealing to moral principles as a way of settling legal disputes.’157 There are examples littered across the landscape of English healthcare law, as it remained for some time an under-legislated area of the law even as an array of practical medico-ethical problems arose. Some of the most famous examples include Re A158 in which the House of Lords were charged with determining the lawfulness of separating conjoined twins with the certainty that one would not survive; Re C159 in which the High Court was tasked with determining the limits of individual choice as a delusional man refused a necessary leg amputation; and Bland160 in which the House of Lords considered whether the sanctity of life prevented a patient’s medical team, with the family’s support, from turning off a life support machine when the patient was in a permanent vegetative state. One does not envy judges making these decisions, especially when making such a decision in the absence of any existing precedent. Bioethics thus has come to influence solutions to legal problems and provide substance to legal concepts. For example, personhood originated as a moral concept but has come to feature greatly in legal thinking about the parameters of life.
Bioethics has come to be particularly important in legal thinking surrounding reproductive technologies. This is because ‘the relationship between law and human reproduction is a complex and a fascinating one’161 that is constantly evolving and expanding. There are significant, lengthy and comprehensive pieces of legislation governing assisted human reproduction,162 and regulatory practices, but there are plenty of places in which these statutes
155 James Drane, ‘What is Bioethics? A History,’ in Fernando Lolas and Lorenzo Agar (eds), Interfaces between bioethics and the empirical social sciences [Regional program on bioethics OPS/OMS publication series 2002], (Pan American Health Organisation and WHO, 2001), 22. 156 Iain Brassington, ‘On the Relationship between Medical Ethics and the Law,’ (2018) 26 Medical Law Review 225, 239. 157 ibid 240. 158 Re A (Children) (Conjoined Twins: Surgical Separation) [2001] Fam 147. 159 Re C (Adult: Refusal of Treatment) [1994] 1 WLR 290. 160 Airedale NHS Trust v Bland [1993] A.C. 789. 161 Jackson (n99) 1. 162 The Human Fertilisation and Embryology Act 1990; The Human Fertilisation and Embryology Act 2008.
52 leave room for moral judgements163 and inevitably advances in technology mean that this law continues to lag behind scientific development. The major pieces of legislation in this area are over a decade old. In this decade we have seen the advent of a multitude of technologies related to conception (in vitro maturation, mitochondrial replacement therapy, germline genome editing as just as a few) and in relation to gestation (uterus transplantation). Shapiro describes bioethics as the important bridge between scientific and legal inquiry.164 I have discussed the value of speculation earlier in this chapter but here it is important to note that bioethics as an area is more open to speculative discourse165 and thus can remind lawyers to be proactive. If appropriately approached, bioethical conversations continue to inform legal solutions by encouraging proactive conversation.
Capron and Michel argue that the law has informed bioethical thinking as much as bioethics has informed the law. They observe that certain legal concepts, such as autonomy,166 have permeated into the consciousness of bioethics. Furthermore, it is my belief that the law makes for a convenient place to begin an ethical inquiry because it gives us a statement of the status quo for evaluation. That the law is X, for example, allows us then to ask whether X, or the outcome generated by X, is moral. The formulation of ethical questions in this way is particularly helpful if the objective of inquiry is to examine practical questions in need of assessment tied to the emergence and implications of new health technologies. The law is, in its nature, orientated towards a practical purpose or outcome. Specifically, the law has a direct and formative influence on the behaviour of professionals providing medical services, on how professionals and patients perceive of those services, and the relationship between patients and healthcare providers. Therefore, questions about the law can force bioethical inquiry to be pragmatically orientated. In the midst of rapid developments in biomedical
163 Human Fertilisation and Embryology Act 1990, s 13 (5) stipulates that licensed fertility clinics must, before providing any treatment to a person or couple, consider the ‘welfare’ of any child who might be born as a result of fertility treatment and of any other child who might be affected by the birth of the child. This provision effectively allows fertility clinics to make moral judgements about family. Jackson argues that the welfare requirement is unjust, incoherent, and disingenuous: Emily Jackson, ‘Conception and the Irrelevance of the Welfare Principle,’ (2002) 65 The Modern Law Review 176. 164 Zachary Shapiro, ‘Bioethics in the Law,’ (2017) 47 The Hasting’s Center Report. 165 Schick (n35); Silvia Camporesi, ‘Bioethics and Biopolitics: Presents and Futures of Reproduction,’ (2017) 14 Journal of Bioethical Inquiry 177; Sarah Chan, ‘More than cautionary tales: the role of fiction in bioethics,’ (2009) 35 Journal of Medical Ethics 398. 166 Alexander Capron and Vicki Michel, ‘Law and Bioethics,’ (1993) 27 Loyola of Los Angeles Law Review 25, 32
53 technology ‘a central task of law and bioethics scholarship [is equally] to anticipate needed social responses…’167 Thus, I believe that they can work together closely to this end.
Law in Context While the law cannot be appealed to as a source of moral authority in bioethical argument, it can be a valuable empirical168 data source of social facts and social values crucial to, or at least a useful aid to, bioethical discussion. The social acceptability of certain practices in reproduction has historically played a crucial role in the formulation and enforcement of169 legal rules. The law plays an important role in the social regulation of relationships (including pregnancy and gestation) because of the recognition it affords in specific instances and because of the restraints or obligations it places on individuals and social institutions in relationships. Thus, exploration of the law as the starting point of, and featured as a part of, bioethical inquiry can illuminate social conditions and assist in understanding the context in which any normative conclusions (with any tangible impact) must be able to comfortably sit. For example, it often takes considerable time for new technologies (that might assist with family building) to become accessible to marginalised groups. Section 13 (5) of the Human Fertilisation and Embryology Act 1990 contains a welfare clause requiring fertility clinics to consider the future welfare of any child born as a result of treatment, including the need for ‘supportive parenting.’170 Before 2008 amendments, s.14 referenced a child’s need for a ‘father’ (rather than the need for a supportive parent) which restricted single women and lesbian couples from accessing IVF because this provision effectively translated ‘into a statutory obligation to take into account the undesirability of single or lesbian motherhood.’171 It was only in 2019/20 that France began debating lifting its longstanding
167 ibid 33. 168 There is some disagreement as to whether the law should be seen as an ‘empirical data source,’ McCrudden stipulates that ‘[l]aw is not a datum; it is in constant evolution, developing in ways that are sometimes startling and endlessly inventive:’ Christopher McCrudden, ‘Legal Research and the Social Sciences’ (2006) 122 Law Quarterly Review 632, 648. However, it is my belief that primary sources of law (all of which can tell us something about social conditions because of the very fact of what the regulation sought to address and how to resolve practical problems) should be considered valuable sources of information, but that need to be made sense of and interpreted. 169 John Griffiths, ‘The Social Working of Legal Rules,’ (2003) 8 Journal of Legal Pluralism and Unofficial Law 1, 6. 170 Human Fertilisation and Embryology Act 1990, s 13(5) as amended by Human Fertilisation and Embryology Act 2008, s 14. 171 Jackson (n99) 179.
54 ban on lesbian couples and single women accessing IVF.172 It is often the case that even as reproductive technologies with the capacity to help a diverse range of persons build their families are developed, these are kept inaccessible to those who need or want them the most.
Socio-legal thinking (the core nexus of which is the consideration of the relationship between the law and wider society)173 is often thought of as ‘in opposition’ to doctrinal methods of law because it offers an alternative way of construing and understanding the law,174 and because it considers the law as empirical phenomenon used to understand social forces. Bradney claims that in paying ‘the upmost attention to textual contexts’ doctrinal method effectively ‘forbids the making of connections with the wider questions which lie at the roots of human inquiry.’175 It is not clear that this is the case. Wheeler and Thomas advocate that socio-legal study involves ‘interface with a context within which the law exists.’176 Law is not, nor has it ever been, a subject in isolation. Contextual issues, influenced by wider questions of broader socio-political importance, are a salient part of the process of interpretation in doctrinal method. Moreover, I believe it possible to be both concerned with doctrine (recognising that it is pivotal first and foremost to understand the law) and placing that doctrine in social context (in order to determine the social consequences of the implementation of doctrine). In this thesis I was clear that the implications of the legal framework as it is and as it might be applied to PE are of cause for concern.
Critical Doctrinal Analysis In this thesis I conduct a critical doctrinal analysis of important legal sources (predominantly primary statute and case law) in relation to birth and gestation in order to address my identified research questions. There is an assumption that the doctrinal method is ‘so implicit
172 Elizabeth Pineau, ‘French Senate approves bill allowing IVF for single women, lesbians,’ (Reuters, 22 January 2020)
55 and so tacit that many working within the legal paradigm consider that it is unnecessary to verbalise the process.’177 However, I believe it is useful here for me to provide a brief account of the doctrinal process that was deployed in my research.
Doctrinal method is a ‘critical conceptual analysis of all relevant legislation and case law to reveal a statement of the law relevant to the matter under investigation.’178 It is thus, ‘research which provides a systematic exposition of the rules governing a particular legal category, analyses of the relationship between rules, explains area of difficulty, and perhaps, predicts future developments.’179 As summarised by Hutchinson and Duncan, this is essentially a two part process; first, locating legal sources and second, the interpretation and integration of those sources.180 Identifying relevant law is a process of assembling relevant facts and then scrutinising potential issues with a view to searching for the law, identifying the legal issues and then locating the primary material (sources of law).181 The relevant facts to this project were those identified in the previous chapter considering scope, and legal sources were ascertained accordingly.
The interpretation of the law is an exercise in synthesising and elucidating legal sources in context in order to deploy a tentative statement of the law. The legal reasoning involved in synthesis and interpretation is a creative yet ‘subtle and sophisticated jurisprudential concept… [best described as] a unique blend of deduction and induction’182 based on a close textual analysis (that is an examination of legal text in detail). This rigorous analysis is underpinned by a sound understanding of the English legal system and common law, for example, the rules of precedent and of statutory interpretation. This project should be described as ‘critical’ in nature, because the intention of synthesis and interpretation of legal sources in relation to birth and gestation was to ‘expose unstated assumptions, patterns or
177 Terry Hutchinson and Nigel Duncan, ‘Defining and Describing What We Do: Doctrinal Legal Research,’ (2012) 17 Deakin Law Review 83, 99. 178 Terry Hutchinson, ‘Valé Bunny Watson? Law Librarians, Law Libraries and Legal Research in the Post-Internet Era’, (2014) 106 Law Library Journal 579, 584. 179 Dennis Pearce, Enid Campbell and Don Harding, Australian Law Schools: A Discipline Assessment for the Commonwealth Tertiary Education Commission (Australian Government Publishing Service, 1987). 180 Hutchinson and Duncan (n177) 106. 181 ibid. 182 Council of Australian Law Deans, ‘CALD Statement on the Nature of Research (May and October 2005),’ (2005)
56 results, internally inconsistent structures, or other tensions within… [this] body of law’183 and to explore how these problems relate to the ethical issues apparent in PE.
While aspects of doctrinal method appear scientific, the analysis is inevitably somewhat subjective. Even the identification of legal sources is not an objective matter given the variety of subtly different approaches that might be taken to any given set of circumstances to identify potential legal issues. In ‘deciding which facts are relevant, or which legal precedents should be applied, for example… [the decision-maker is left with] a wide range of acceptable substantive results.’184 More obviously, synthesis and interpretation will always be influenced by the researcher’s perspective. There is much room for manoeuvre in interpreting the law, despite the conventional rules of statutory interpretation seeming straight forward when drilled into us as undergraduate law students, based on the personal, political and ethical opinions and experiences of the researcher. Interpretation is a delicate art and the meaning that is afforded to different words, phrases or the omission of others or the focus that is placed on some aspects of the text rather than others will be unique to the researcher. It is important to acknowledge the potential that different tentative conclusions about the law of birth and of gestation might have been reached were this project to have been undertaken by a different researcher. This is not to belittle my conclusions (I believe I have provided a persuasive account of the current legal framework); but is to recognise the idiosyncrasies inevitable in understanding law. Here, I also note the influence of socio-legal thinking in my approach to interpretation. I take it that the law is one of a series of instruments in the socio- political regulation of public activity; thus, it is only feasible to generate legal scholarship of practical/ political significance if the function and implications of the law are considered in context.185 There are places in this thesis, in particular paper two and paper five, in which the meanings of terms as they were deployed in ordinary, social contexts was considered important in the process of interpreting vague legal concepts.
The primary purpose of critical doctrinal method is to establish what the law is, and consider any internal inconsistences, rather than to make any determination about what the law should be. It is difficult (or impossible) to make any claims about what the law should be, or where
183 Martha Minow, ‘Archetypal Legal Scholarship – A Field Guide,’ (2013) 63 Journal of Legal Education 65, 68. 184 Katharine Bartlett, ‘Feminist Legal Methods,’ (1990) 103 Harvard Law Review 829, 845. 185 Griffiths (n169) 6. 57 reform is necessary, without first understanding the legal framework itself. This is an important exercise in the context of novel reproductive technologies, and in particular technology so far removed from the circumstances in which the law was formulated, because the rules related to them are not always easy to ascertain. This is evident in the papers that make up this thesis, and thus doctrinal analysis constituted an important foundation for further discussion. Doctrinal method is sometimes criticised for preferencing the status quo186 and leaving little room for the articulation of new rights and standards. In this thesis I did not perform a textual analysis in a vacuum, rather I carefully examined doctrinal text within identified social context – and made specific deductions about testing that law or how that law might be tested. In this thesis I do not advocate that existing legal paradigms and structures are appropriate (in fact readers will see that the opposite is true my papers), but I believe that understanding existing law is important in the discussion of how we get from our current legal structures to what might be considered ideal or preferable. Ultimately existing rules represent ‘accumulated past wisdom, which must be reconciled with the contingencies and practicalities presented by fresh facts.’187 In this thesis, after establishing what the law is surrounding PE I did reach some normative conclusions about how that law should be reformed.
Feminist Perspective The primary objective of analysing the complex ethico-legal problems raised by PE was to ensure that the legal framework surrounding PE is or could be consistent with the pragmatic aim of the feminist agenda; ‘maximising the liberty of women [and female people] living their lives in a currently less than egalitarian world.’188 It is necessary to consider the implications of PE in the context of the legal framework and conditions, as the law is consistently identified as a source of entrenched inequality. Frug writes that legal rules ‘permit and sometimes mandate the maternalization of the female body’ with provisions
186 Douglas Vick, ‘Interdisciplinarity and the Discipline of Law,’ (2004) 31 Journal of Law and Society 164, 181; Terry Hutchinson, ‘Doctrinal Research: Researching the Jury,’ in Dawn Watkins and Mandy Burton, Research Methods in Law, (Routledge 2018) 23. 187 Bartlett (n184) 852. 188 Vanessa Munro, ‘Surrogacy and the Construction of the Maternal-Foetal Relationship: The Feminist Dilemma Examined,’ (2001) 7 Res Publica 13, 15.
58 rewarding women and female people who become mothers and penalising those who do not, and in restricting abortion.189 Dickens highlights that the:
‘historical assumption regarding reproduction… [is that] decisions on whether and when individuals and families had children were social, legal and religious matters, to be determined by social, legal and religious authorities and leaders who were almost exclusively men. A woman’s childbearing was her husband’s right and responsibility.’190
We cannot answer questions about how PE might benefit female people and pregnant people without engaging with social conditions created by existing legal frameworks.
Cook explains that ‘feminist legal approaches start with the conviction of women’s unjust subordination and they evaluate law in terms of how much it contributes to the dismantling of such injustice.’191 Bartlett suggests that ‘a question becomes a method when it is regularly asked’ and summarises that feminist method in law is, simply put, ‘the woman question;’ that is, the examination of ‘how the law fails to take into account the experiences and values that seem more typical of women… or how existing legal standards and concepts might disadvantage women.’192 The purpose, she explains, is ‘to expose these features and how they operate, and to suggest how they might be corrected.’193 The object of this strategy is thus to ensure that in considering the implications of the law, women are placed at the centre of inquiry so that their interests are not ignored, and that focus is placed on whether the legal framework has contributed to the formation of or can assist in the dismantling of the unjust treatment of women. It is important to note that to make claims about what is ‘feminist’ generally is to ‘assume a definition of “woman” or a standard for “women’s experiences” that is fixed, generalising, homogenizing and oppositional…’194 It is crucial to note that not all women and female people will perceive their interests, or feel the impact of unjust laws, in the same way. This is particularly the case during pregnancy, in which pregnant people from disadvantaged backgrounds often experience the interference of the law to a much greater
189 Mary Joe Frug, ‘A Postmodern Feminist Legal Manifesto (An Unfinished Draft),’ (1992) 105 Harvard Law Review 1045, 1050. 190 Bernard Dickens, ‘Value systems and healthcare ethics,’ in S. William Gunn and others (eds), Understanding the Global Dimensions of Health, (Springer 2005), 63. 191 Rebecca Cook, ‘International Human Rights and Women’s Reproductive Health,’ (1993) 24 Studies in Family Planning 73, 75. 192 Bartlett (n184) 837. 193 ibid 194 ibid 834.
59 degree.195 The overwhelming majority of the forced caesarean cases, for example, concern pregnant people who are undoubtedly experiencing substantial discrimination on the grounds of their mental health.196 Re F (in utero),197 the case in which social services famously sought wardship over an unborn foetus, concerned a pregnant woman with addiction issues. Interventions into pregnancy thus ‘disproportionately punishes those already ostracised from society by factors often beyond their control, such as addiction, [mental health] and poverty’198 and among them black people and people of colour in particular.199
Furthermore, not all pregnant people conceptualise of their pregnancy in the same way. Some pregnant people will subscribe effectively to the ‘foetal parthood’ view that the foetus is a part of them until born;200 others will see their foetus as their child and believe that they are already a parent.201 Some pregnant people will not want a pregnancy to result in parenting responsibilities, others will see that as the very objective in getting and remaining pregnant. Ultimately how an individual pregnant person chooses to understand their pregnancy is a matter of personal perspective (dependent on many factors) and we must try and find a way to respect the multitude of personal perspectives here. The law must respect the choices of pregnant people and protect access to health services (everything from abortion to prenatal care).
I approached my arguments about the implications of the legal framework by asking ‘the woman question’202 in a slightly adapted form. That is, ‘the female body question.’ I did this to ensure that due attention was paid to determining the effect that PE could have on female
195 Horn and Romanis (n71). 196 The vast majority (though not all) of caesarean cases that come before courts on the grounds of a pregnant person’s mental capacity concern patients who have mental health diagnoses: St George's Healthcare NHS Trust v S [ 1998] 3 WLR 936; Re AA (Compulsorily Detained Patient: Elective Caesarean) [2012] EWHC 4378; Royal Free NHS Foundation Trust v AB [2014] EWCOP 50. 197 Re F (in utero) [1988] Fam. 122. 198 Romanis (n126) 74. 199 See Michelle Goodwin, Policing the Womb: Invisible Women and the Criminalization of Motherhood, (CUP 2020). 200 The parthood ‘view’ of pregnancy (that the foetus is a part of the pregnant person just as much as any other aspect of their physiology e.g. internal organs or hair) is advocated Kingma in opposition to the ‘containment’ view of pregnancy (which she explains is the commonly adopted starting point in philosophical literature) in which the foetus is a separate entity (not a part of the pregnant person) but residing inside the pregnant person: Elselijn Kingma, ‘Were you a part of your mother? The Metaphysics of Pregnancy,’ (2019) 128 Mind 609, 609. 201 The containment model of pregnancy is not something to be defended, since it is in its essence degrading to describe a pregnant person as a ‘container’ for a foetus; but there is room to doubt the utility of the parthood view (not in a metaphysical sense) but when creating the law because it is important to account for the perspectives of real people, and a lot of pregnant people will not see their foetus as simply a ‘part’ of them. 202 Bartlett (n184) 837; Dickens (n190) 63. 60 people (being those people that would usually have the physiology to get pregnant) and pregnant people as a result of the enforcement of the current legal framework. My reasoning was, as a result of the approach taken, contextualised with close attention paid to the specific role of the pregnant person and the female body generally in discussion about the emergence of this technology and the construction of the law. In doing this, I tried to be mindful of making sweeping assumptions of what female people and pregnant people want by not assuming they all want the same thing and being careful to be specific about which groups of pregnant or female people I am referring to. In paper five, for example, in considering the potential advantage of PE as an alternative to neonatal intensive care for pregnant people, I am careful to refer only to pregnant people who want to become biological parents.
Notes on Terminology
I have learnt a lot during this thesis and my thinking has certainly evolved during the process. Since some aspects of this thesis were published in my first year (paper one, paper two) some of the terminology I used then is not necessarily that which I would use now. I want to draw attention to some of the terms used, the reasons for so doing and why I use different language now.
Pregnant People At various points in the published works in this thesis I have referred to ‘women’ and ‘pregnant women.’ It is a biological fact that only female physiology is able to sustain a pregnancy, however it is of course the case that not all people with female physiology who might carry a pregnancy or worry about becoming pregnant will identify as women. Ross and Solinger note that ‘woman’ is too broad in the context of pregnancy because many people identify as women who do not have female physiology and therefore cannot get pregnant. Moreover, it is too narrow because ‘woman’ excludes those people who have female physiology, and so worry about getting or become pregnant, but who do not identify as women. For these reasons, it has become increasingly common in the literature to refer to ‘pregnant people’ in order to prevent the routine exclusion of pregnant people who identify as non-binary or as men from discussion. This is important because this group of persons are
61 marginalised in a multitude of different ways as a result of discrimination related to their gender identity as well as specific experiences that should be noted about trans-pregnancies. I regret that earlier in this project I did not consider as well as I should have how my language could be in some ways exclusionary to this group of pregnant and potentially pregnant people.203
However, there are places in which the use of ‘pregnant women’ remains important. It is important to acknowledge that the vast majority of pregnant people identify as women; I believe that the routine socialised association between female biology and the gender identity of ‘woman’ (‘pregnancy is a women’s issue’) historically is one of the reasons why the interests of women and female people have been structurally disregarded.204 Furthermore, that most pregnant people identify as women has a huge impact on the social experience of pregnant people and the social and medical response to pregnant people. Later in the writing of this project I became more explicit about my language and why I adopted particular terms in each of my papers (see the published version of paper five in the appendix). However, in formatting this thesis I chose to use non-gendered language throughout in order to prevent the erasure of some people who might benefit from the development of AWs. Moreover, using this language highlighted better some of the arguments I wanted to make about the conceptualisation of the female body in the law.
Human Entities In paper one and paper two of this thesis I refer repeatedly to the fact that the subject of the AW is a ‘human being’ ontologically (meaning physiologically and behaviourally) similar to a foetus except that the process of gestation is facilitated artificially and extra uterum. I used the term ‘human being’ simply to mean that the entity was genetically human in line with the discussions in the philosophical literature205 and because in the legal framework of England and Wales the term ‘human being’ is of little legal significance. This law affords legal personality only to ‘human persons.’206 However, in studying the law of other jurisdictions during a research visit in Toronto later in the process of this research I realised the
203 Loretta Ross and Rickie Solinger, Reproductive Justice: an Introduction, (University of California Press 2017), 7. 204 Romanis and others (n29). 205 See the distinction between genetic human beings and persons that are commonly drawn in the philosophical literature: Tooley (n92); Singer (n92). 206 Paton v British Pregnancy Advisory Service Trustees and Another [1979] QB 276 62 significance of using such a term in the context of other jurisdictions. For example, the Canadian Criminal Code concerning homicide protects ‘human beings’ defined as a child that has ‘completely proceeded, in a living state, from the body of its mother, whether or not (a) it has breathed; (b) it has independent circulation; or (c) the naval string is severed.’207 This definition of an entity that is protected under homicide law is different from England and Wales (most notably in that there is an express reference that it is not necessary that there is breathing). However, the language used I thought was interesting; and thus, in my work that followed (paper three, paper four, paper five and paper six) I sought to use the term human entity instead of ‘human being’208 when referring to the subject of the AW, to be clear that I was not necessarily ascribing legal personality to the subject of gestation ex utero. I have amended my language in the formatted version of this thesis for clarity and consistency.
Maternal-Foetal Surgery In paper two of this thesis, I considered maternal-foetal surgery as an example of another technology (aside from PE) that casts some doubt on the way the current legal framework conceptualises and defines ‘birth.’ I had used the term foetal surgery (in the published version) to describe this technique (partial extraction of a foetus from the uterus for a medical intervention before it is subsequently returned to the uterus for the remaining duration of pregnancy). This was mostly because at the time of writing, and in the (predominantly legal and scientific) literature I referred to this was the term used. However, I believe that, in line with the movement in terminology in ethical and legal discussion, the term ‘maternal-foetal surgery’209 would have been more appropriate. This term is important to emphasise that the pregnant person is the primary patient in such a procedure.210 In formatting this thesis I changed the terminology appropriately in the main body of work.
207 Canadian Criminal Code, s 223. 208 I am grateful to Bernard Dickens for discussions about the substantive meaning of ‘human being.’ 209 Frank Chervenak and Laurence McCullough, ‘The ethics of maternal-fetal surgery,’ (2018) 23 Seminars in Fetal and Neonatal Medicine 64, 64. 210 Anne Drapkin Lyerly, ‘Maternal-Fetal Surgery: The Fallacy of Abstraction and the Problem of Equipoise,’ (2001) 9 Health Care Analysis 151, 154. 63
CHAPTER THREE – OUTLINE OF PAPERS
The substance of this thesis is comprised of a series of six published papers. The abstracts for each of these papers are detailed below.
PART I – UNDERSTANDING PARTIAL ECTOGENESIS
PAPER ONE: Artificial Womb Technology and the frontiers of human reproduction: conceptual differences and potential implications (2018) 44 Journal of Medical Ethics 751 In 2017 a Philadelphia research team revealed the closest thing to an artificial womb (AW) the world had ever seen. The ‘biobag,’ if as successful as early animal testing suggests, will change the face of neonatal intensive care. At present, premature neonates born earlier than 22 weeks have no hope of survival. For some time, there have been no significant improvements in mortality rates or incidences of long-term complications for preterms at the viability threshold. Artificial womb technology (AWT), that might change these odds, is eagerly anticipated for clinical application. We need to understand whether AWT is an extension of current intensive care or something entirely new. This question is central to determining when and how the biobag should be used on human subjects.
This paper examines the science behind AWT and advances two principal claims. Firstly, AWT is conceptually different from conventional intensive care. Identifying why AWT should be understood as distinct demonstrates how it raises different ethico-legal questions. Secondly, these questions should be formulated without the ‘human entity growing in the AW’ being described with inherently value laden terminology. The ‘human entity in an AW’ is neither a foetus nor a baby, and the ethical tethers associated with these terms could perpetuate misunderstanding and confusion. Thus, the term ‘gestateling’ should be adopted to refer to this new product of human reproduction: a developing human entity gestating ex utero. While this paper does not attempt to solve all the ethical problems associated with AWT, it makes important clarifications that will enable better formulation of relevant ethical questions for future exploration.
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PAPER TWO: Challenging the ‘Born Alive’ Threshold: Foetal Surgery, Artificial Wombs and the English Approach to Legal Personhood (2020) 28 Medical Law Review 93 English law is unambiguous that legal personality, and with it all legal rights and protections, is assigned at birth. This rule is regarded as a bright line that is easily and consistently applied. The time has come, however, for the rule to be revisited. This article demonstrates that advances in maternal-foetal surgery and (anticipated) artificial wombs do not marry with traditional conceptions of birth and being alive in law. These technologies introduce the possibility of ex utero gestation, and/or temporary existence ex utero, and consequently developing human entities that are novel to the law. Importantly, therefore, the concepts of birth and born alive no longer distinguish between human entities deserving of legal protection in the way originally intended. Thus, there is a need for reform; for a new approach to determining the legal significance of birth and what being legally alive actually encompasses. Investigating the law of birth is of crucial importance, because of the implications of affording or denying the subjects of new reproductive technologies rights and protections. A determination of the legal status of the subject of maternal-foetal surgery or an artificial womb will determine what can and cannot be done to each entity. Moreover, the status afforded to these entities will drastically impact on the freedoms of pregnant people.
PAPER THREE: Artificial Womb Technology and the Significance of Birth: Why Gestatelings are not Newborns (or Fetuses) (2019) 45 Journal of Medical Ethics 727 In a recent publication, I argued that there is a conceptual difference between artificial womb (AW) technology, capable of facilitating gestation ex utero, and neonatal intensive care, providing incubation to neonates born prematurely. One of the reasons I provided for this distinction was that the subjects of each process are different entities. The subject of the process of gestation ex utero is a unique human entity: a ‘gestateling,’ rather than a foetus or a newborn preterm neonate. Nick Colgrove wrote a response to my paper, claiming that my distinction between the subject of an AW and a newborn (in intensive care) was false. He claims that I have not accounted for the proper definition of ‘birth’ and that gestatelings are not a distinct product of human reproduction. Further, Colgrove posits that even if I can successfully distinguish gestatelings from preterms, such a distinction is morally irrelevant because the entities would have the same moral status. In this paper, I address the three
65 challenges raised and defend the claim that gestatelings are unique entities. Moreover, I argue that moral status should not be considered ipso facto determinative in the debate about AWs.
PART II – REALISING PARTIAL ECTOGENESIS
PAPER FOUR: Artificial Womb Technology and Clinical Translation: Innovative Treatment or Medical Research? (2020) 34 Bioethics 392
In 2017 and 2019 two research teams claimed ‘proof of principle’ for artificial womb technology (AWT). AWT has long been a subject of speculation in bioethical literature, with broad consensus that it is a welcome development. Despite this, little attention is afforded to more immediate ethical problems in the development of AWT, particularly as an alternative to neonatal intensive care. To start this conversation, I consider whether experimental AWT is innovative treatment or medical research. The research-treatment distinction, pervasive in regulation worldwide, is intended to isolate research activities and subject them to a greater degree of oversight. I argue there is a tendency in the literature to conceptualise AWT for partial ectogenesis as innovative treatment. However, there are sufficiently serious ethical concerns with experimental AWT that mean it must not be first used on humans on the basis that it is a ‘beneficial treatment.’ First, I outline the prospects for translation of AWT animal studies into treatment for human preterms. Second, I challenge the conceptualisations of experimental AWT as innovative treatment. AWT must be considered medical research to reflect the investigatory nature of the process and guarantee sufficient protections for subjects. Identifying that AWT is research is crucial in formulating further ethico-legal questions regarding the experimental use of AWT. Third, I demonstrate that clinical trials will be a necessary part of the clinical translation of AWT because of requirements laid out by regulators. I consider the justification for clinical trials and highlight some of the crucial ethical questions about the conditions under they should proceed.
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PART III – IMPLICATIONS OF PARTIAL ECTOGENESIS
PAPER FIVE: Artificial Womb Technology and the Choice to Gestate Ex Utero: Is Partial Ectogenesis the Business of the Criminal Law? (2020) 28 Medical Law Review 342 It is frequently claimed that artificial wombs could alleviate the burdens placed exclusively on female people in reproduction. In this paper, I demonstrate how artificial wombs used for the partial gestation of preterm neonates could introduce new choices for pregnant people by changing perceptions of tolerable risks in gestation. In light of advancing medical technology, it is necessary to consider whether the current legal framework in England and Wales would support increased choice for pregnant people about alternative forms of gestation. I examine the ill-defined offence of ‘unlawfully procuring miscarriage’ in the Offences Against the Person Act 1861 and demonstrate that different conclusions about the legal significance of ending a pregnancy are evident, depending on the analytical lens adopted in interpreting ambiguities. Furthermore, I demonstrate that the defences available to pregnancy termination under the Abortion Act 1967 are too narrow to support choices about alternative forms of gestation, even if they become physically and medically possible. Therefore, we should decriminalise termination of pregnancy, or, if it is assumed that gestation is the business of the criminal law, specific reforms to the legal framework are necessary. The offence of unlawfully procuring miscarriage is too uncertain and broad, and the defences available are too restrictive.
PAPER SIX: Partial Ectogenesis: Freedom, Equality and Political Perspective (2020) 46 Journal of Medical Ethics 89 In this commentary, I consider how Giulia Cavaliere’s arguments about the limited reach of the current justifications offered for complete ectogenesis in the bioethical literature apply in the context of partial ectogenesis. I suggest that considering the extent to which partial ectogenesis is freedom- or equality promoting is more urgent because of the more realistic prospect of artificial womb technology being utilised to facilitate partial gestation extra uterum as opposed to facilitating complete gestation from conception to term. I highlight concerns about potentially harmful social narratives surrounding pregnancy and about the current legal framework surrounding gestation limiting access to technology in the advent of partial ectogenesis. I do not advocate that these concerns mean that we ought not develop
67 artificial wombs, but like Cavaliere I suggest that we must be mindful of these concerns, and I posit that legal reform must accompany technological developments. Ectogenesis as a political perspective, through which we consider the value in social reproduction and the experiences of pregnant people, is useful to prevent political capture of this technology for regressive policies. Using this perspective to examine the law is also a useful tool to expose just how restrictive the law is in relation to gestation and female reproductive health.
***
Before the main body of this work, it is important to note that the papers contained in this thesis are a snapshot in time. The law, science and other factual circumstances as described were correct at the time of their publication. However, because these papers were published between 2018 and early 2020, there are some places where there might have been some updates to factual circumstances since publication. For example, I refer to the decriminalisation of abortion in Northern Ireland and consultation regarding a new legal framework in paper five. This legal framework has since come into force in the Abortion (Northern Ireland) Regulations 2020.
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PART I - UNDERSTANDING PARTIAL ECTOGENESIS
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PAPER ONE: Artificial Womb Technology and the frontiers of human reproduction: conceptual differences and potential implications
In early 2017, news broke of the closest thing to an artificial womb (AW) the world had ever seen. The prototype ‘biobag’ successfully supported lamb foetuses on the current viability threshold. All emerged from the biobag healthy, having seemingly evaded the common complications associated with preterm birth.211 The biobag facilitates the process of partial ectogenesis: the development of a foetus in an AW during part of the gestational period following transfer from the maternal womb.212 It shows real promise of a future in which more sophisticated technology could secure better long-term prognoses for premature neonates.
Singer and Wells argued that technologies enabling the artificial gestation of human entities would come about ‘by accident’ as developments in neonatal intensive care (NIC).213 Others argue that partial ectogenesis is already a partial reality.214 NIC is one of modern medicine’s clearest success stories. Constantly improving technology has supported increasingly premature neonates.215 I argue, however, that the biobag is not another improvement in conventional NIC, but an entirely novel approach. The distinctiveness of artificial womb technology (AWT) must be recognised in discussion regarding future clinical applications to prevent harmful decision-making for and by affected parties. Highlighting this distinction is important, as clinicians may easily overlook it because their use of AWT will have the same clinical objective as NIC.
First, I explore the current limitations restricting NIC and prospects for AWT to provide important context for ethical discussion. Second, I argue that AWT will challenge perceptions of viability, a concept referring to the ability of a developing human entity to survive ex
211 Partridge and others (n2); Usuda and others (n2). 212 Gelfand and Shook (n38) 1. 213 Singer and Wells (n9) 10. 214 Cannold (n14) 55. 215 Frida Simonstein, ‘Artificial reproduction technologies (RTs) – all the way to the artificial womb?’ (2006) 9 Medicine Health Care Philosophy 359, 360.
70 utero.216 AWT, I argue, will most likely be used beyond the current recognised viability threshold (24 weeks from conception) to facilitate partial ectogenesis. During partial ectogenesis a foetus already developing in utero is transferred to an AW to continue gestating ex utero. This process is distinct from complete ectogenesis (the creation of an embryo using IVF that is gestated entirely in an AW).217 The possibility of biobags being utilised for complete ectogenesis is a more remote possibility and encompasses some distinct ethical issues. Therefore, it is not discussed in this paper. Partial ectogenesis exposes a problem of terminology that will be examined. New terminology should be used to describe the subject of the AW to evade the ethical tethers that existing terms imply, which cloud discussion. The term ‘gestateling’ is introduced to refer to a developing human entity in the process of ex utero gestation. Finally, I argue that AWT should be treated as conceptually distinct from conventional rescue technologies. I provide three reasons for the distinction: innate differences between the features of AWT and NIC, differences between the subjects of each technology and further potential uses for AWT beyond newborn rescue. While this paper does not attempt to solve all the ethical problems associated with AWT and its experimental use, the crucial clarifications it provides are necessary to consider when formulating relevant ethical questions for future discussion.
Artificial Wombs – Where are we?
Preterm birth, before 37 weeks gestation, is the leading cause of death amongst newborns globally.218 The swift advancement of NIC, however, was an example of medicine overcoming some of the biological body’s inherent vulnerabilities. The survival prospects for preterms in developed countries had been steadily improving over the last few decades. So much so that the survival of extremely premature neonates, born at 28 weeks or less,219 is no longer wholly irregular. ‘Infant incubators,’ have sustained preterms born as early as 21 weeks and 6 days.220 However, survival this premature is not the norm. A recent study
216 Glover (n95) 122. 217 Gelfand and Shook (n38) 1. 218 Azad and Matthews (n6) 132. 219 ibid 132. 220 Alghrani (n14) 307.
71 reported a survival rate of only 0.7% amongst preterms born at 22-23 weeks.221 There is no hope of survival before this point. Preterms on the viability threshold that survive birth often develop complications, resulting in severe disability or death.222 In the last 20 years, there has been a 44% increase in preterms born at 22-25 weeks surviving long enough to receive NIC,223 but the pattern of mortality and proportion with severe long-term health problems has not meaningfully changed for some time.224
Limitations of Neonatal Intensive Care The occurrence and severity of complications associated with preterm birth decline markedly with increased gestation.225 Neonates born before 26 weeks gestation remain unlikely to survive common complications.226 Around 50% of surviving preterms born at 26 weeks have a severe long-term impairment. This increases to 75% amongst those born at 23 weeks.227 The biggest issues plaguing preterms include: underdeveloped lungs and respiratory problems, circulatory problems causing low blood pressure and oxygen deprivation and an underdeveloped ability to swallow or suck.228 These complications are almost inevitable before 26 weeks. They can be managed by providing mechanical ventilation, administering oxygen, using external pumps to aid circulation, and nasogastric feeding.229 These functions are all interventions facilitated in infant incubators, and they each carry risks and limitations. Mechanical ventilation and the administration of oxygen can hinder further lung development or damage the lungs.230 External aids for circulation can cause heart failure by effecting
221 Véronique Pierrat and others, ‘Neurodevelopmental Outcome at 2 years for preterm children born at 22 to 34 weeks’ gestation in France in 2011: EPIPAGE-2 cohort study,’ (2017) 358 British Medical Journal j3448. 222 Alghrani (n14) 307. 223 Tamanna Moore and others, ‘Neurological and developmental outcome in extremely preterm children born in England in 1995 and 2006: the EPICure Studies,’ (2012) 345 British Medical Journal e7961. 224 Costeloe and others (n8). 225 Tom Lissauer and Graham Clayden (eds), Illustrated Textbook of Pediatrics, (Elsevier 2012), 159. 226 ibid 159. 227 Moore and others (n223). 228 Lissauer and Clayden (n225) 159. 229 ibid 167. 230 Jennifer Couzin-Frankel ‘Fluid-filled 'biobag' allows premature lambs to develop outside the womb,’ (Science, 25 April 2017)
72 imbalances in blood flow.231 Nasogastric feeding carries a high risk of necrotising enterocolitis (death and leakage of intestinal tissue)232 and infection.233
Due to the risks and limitations of interventions, some scientists believe the clinical possibilities of NIC have been exhausted.234 There is only so much medicine can do for a neonate born without the capacity for an independent life. This is why between 60% and 80% of NIC deaths occur after withdrawal of interventions.235 Conventional NIC also raises ethical concerns. When treatment is withdrawn, as is often the case, all the treatment achieved was the prolonging of the neonate’s physical suffering and the emotional distress of its parent/s. Possible alternative forms of intervention to those used routinely will still harbour risks and similar barriers to success. With this in mind, researchers are seeking an alternative physiological approach to sustaining underdeveloped human entities by better mimicking the uterine environment to effectively prolong gestation.236 This encompasses a support system closer to an AW, facilitating continuing development as if the neonate had never been born, as opposed to infant incubators assisting preterms with bodily functions they cannot perform adequately for themselves.
The Biobag In early testing, the newly designed AW was able to sufficiently mimic the uterine environment to sustain preterm lamb ‘foetuses’ for 4 weeks.237 These lambs were developmentally equivalent to human preterms at the recognised viability threshold: 24
231 ibid. 232 Great Ormond Street Hospital for Children NHS Foundation Trust, ‘Necrotising enterocolitis,’ (16 July 2016)
73 weeks. After the incubation period all subjects were ‘delivered’ and survived. News of the Philadelphia-based team’s success made global headlines.238
The biobag consists of a sealed bag to contain the subject, a ‘pump-less oxygenator circuit’ and umbilical cord access. The sealed system prevents outside exposure, minimising the risk of infection. The bag enables constant exchange of amniotic fluid, providing all necessary water and nutrients. Cannulae act as an ‘umbilical cord’ carrying required nutrients and oxygen into the subject’s bloodstream. Circulation is dependent on the subject’s heart working with an oxygenator. This mimics normal placental circulation, ensuring sufficient oxygen and a safe blood pressure.239 The biobag effectively simulates natural gestation in utero. All biobag test subjects had continued normal lung development and circulation without any infection.240 The three most common complications (lung development, circulation, infection) experienced in NIC appear to have been sidestepped. Another research team based in Australia has also developed an AW system with comparable success in animal studies.241 The AW this team has developed, however, is not the focus of this paper because the team are more tentative about the potential clinical application of their technology in humans.242 The enormity of these findings, and their capacity to reduce morbidity amongst preterms, is hard to overstate.
Further refinement of the biobag, as well as scientific and safety validation, is necessary before clinical use can be anticipated.243 It seems probable, however, that we are only several years away from testing on human subjects.244 If the results of this animal study are repeated with similar success there will soon be calls for its use from parents trying to overcome troubled pregnancies245 or aid preterm children. The biobag study authors identify their ‘clinical target population’ as preterms between 23 and 25 weeks gestation.246 The
238 Michelle Roberts, ‘Premature lambs kept alive in ‘plastic bag’ womb,’ (BBC News, 25 April 2017)
74 researchers comment that if animal testing continues to yield positive results the morbidity rate amongst human preterms alone justifies use of the technology.247 They are already foreseeing the clinical application of the biobag.248 The team’s brief mention of a justification for experimental use implies they see no meaningful difference between the AW they have designed and NIC relevant to decision-making about its use. It could be argued there is no difference for now, because the objective of the technology’s use will be similar to NIC. However, because of the implications that will be explored, the assumption that there is little difference between AWT and current NIC must be critiqued.
Subjects in the Biobag
In this section, I demonstrate how the biobag is likely to be used beyond the current viability threshold, and why this means we need new terminology to describe the subject of an AW. The authors of the biobag study are explicit that their research aims only to reduce incidences of death and disability amongst ‘just-viable’ preterms. Their objective is not to ‘push back’ the viability threshold,249 and they have identified their future clinical target population accordingly. Though the authors do not explain why, narrowing their scope at this stage of experimentation is understandable. Viability is, in many countries, the point at which the foetus is afforded some legal protections limiting abortion access250 because, in providing a medicalised model for abortion, viability provides a politically expedient compromise between the anti-abortion lobby and pro-choice activists. The researchers may wish to avoid their work becoming embroiled in discussions of broader ethical implications relating to abortion. However, if the biobag is as successful for human preterms as it has been for animals, it will eventually have the effect of changing, at least, perceptions about where the viability threshold lies.
247 ibid 11. 248 It should be noted that whilst the technology has shown significant promise the experiments were conducted on living beings with a different physiology to human beings. The success of the project does not necessarily mean that the biobag will be as successful when used to attempt to save human preterm neonates. The researchers, however, do imply there is enough reason to believe the technology might successfully be used on human subjects to justify experimental application on human beings in future. 249 Partridge and others (n2) 11. 250 Roe v Wade (n23).
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Even with conventional NIC, and its evident limitations, there has been a huge shift in perception regarding when technology should be used to support preterms. Despite the current recognised viability threshold of 24 weeks, and high probability of complications before 26 weeks, rescue is frequently attempted on preterms as young as 22 weeks. Only attempts to resuscitate before 22 weeks are deemed experimental.251 There is much societal conditioning encouraging intervention to save preterm babies often regardless of the likely outcome.252 The willingness to attempt rescues is the result of clinicians trying their upmost to aid the patient in front of them at the request of the parent(s). When the neonate is only fractionally less developed than preterms routinely sustained, this increases the pressure to attempt rescue. Parents are often willing to challenge clinicians to ensure their premature infant is provided with treatment offering it a chance at life. Challenges sometimes develop into high-profile legal disputes.253
Once AWs can ensure the consistent and healthy survival of preterms on the viability threshold, there will be immediate calls, from medical practitioners and parents alike, to use AWT to aid preterms not far behind the current threshold. Similar trends with conventional NIC are how we arrived at the current viability standard. If the biobag works as designed, its subjects will be less likely to suffer complications than if they are supported using conventional NIC. Clinicians will see more value in treatment for younger preterms when AWs are available because outcomes will be better. This willingness to try something different to aid ‘almost surviving’ preterms was ultimately the motivation behind the biobag study. It is unlikely that placing younger subjects in AWs would be seen as controversial, with little opposition to attempts, if AWT is successful for older neonates.
The potential use of AWs, which challenges our understanding of viability, exposes a terminology problem. The human entity growing in the AW is in the process of artificially induced gestation. It will, in some cases, be incapable of exercising any independent capacity for life and be more ontologically similar to the pre-viability foetus in utero, than to what is thought of as a ‘newborn baby.’ The terminology used to describe preterms is similar to that
251 Nuffield Council on Bioethics, Critical Care Decisions in Fetal and Neonatal Medicine: Ethical Issues, (Latimer Trend & Company 2006). 252 Simonstein (n215) 360. 253 Great Ormond Street Hospital NHS Foundation Trust v Yates and others (No 2) [2017] EWHC 1909 (Fam). 76 for newborns at full-term. Calling the human entity gestating ex utero a ‘preterm’ or ‘newborn’ is arguably misleading as to its behaviour and the extent of its development. This will be explored further when comparing AWT and NIC. Notably, the biobag team refer to their subjects as foetuses. Describing the human entity gestating ex utero in the AW as a foetus, in an attempt to distinguish it from a neonate receiving NIC, is also confusing and misleading. Most medical definitions of the foetus imply it is located inside a human gestator by describing it as ‘unborn.’254
The terms used to describe preterms and foetuses are inappropriate in this context and so a different term, which avoids the connotations of using either ‘newborn’ or ‘foetus,’ is needed. I will, therefore, refer to the human entity in the AW as the ‘gestateling.’ This terminology provides useful clarity and an accurate descriptor for the AW subject. A gestateling is a human entity in the process of ex utero gestation exercising, whether or not it is capable of doing so, no independent capacity for life. The gestateling might soon, through experimental treatment, become a medical reality complicating ethico-legal discussion in obstetrics and neonatology.
Beyond just another form of Neonatal Intensive Care
In this section, I advance three justifications for treating AWT as distinct from NIC. There is noticeably a paucity of academic commentary on this matter. However, this investigation is necessary to determine how biobag trials with human subjects can begin in an ethical manner Singer and Wells argued AWT would be just an extension of conventional NIC. Therefore, experimentation would be inherently ethical. By only extending existing interventions it would not be reckless with human life, but consist of connected medical treatments undertaken to aid a particular patient.255 However, AWT is potentially emerging as the only feasible technology to erode the current viability threshold, despite intentions to the contrary. Many scientists believe conventional NIC has ‘hit a wall’ that will seemingly always hinder its ability to support younger preterms.256 AWs, having different innate features, are more radical in approach. The three reasons for treating AWT as distinct I defend are relevant in
254 Elizabeth Martin (ed), Concise Medical Dictionary, (OUP 2015), 275. 255 Singer and Wells (n9) 22. 256 Hendricks (n234) 8. 77 considering future clinical applications of AWT and how we might treat affected parties. Harmful decision-making by or on behalf of parties involved is likely if conceptual differences are ignored.
The innate features of AWT When two medical technologies provide the same function, they can be treated as interchangeable, unless the process of each markedly distinguishes them. Medical and surgical remedies, for example, are distinguished by comparative invasiveness. AWT and conventional NIC both support underdeveloped humans. Hendricks observes, however, that AWT is different in nature because it provides more comprehensive support.257 Current care is dependent on the preterm ‘tolerating artificial ventilation,’ which is limited by a natural threshold of lung development. This threshold does not limit the AW because it better resembles natural gestation,258 and thus does not rely on the lungs for gas exchange. There appears to be no natural limit, at least related to lung development, restricting the AW.
The inherent difference between AWT and NIC is more nuanced than its effect on one aspect of development. AWT has the capacity to entirely replace a human function: it works by replicating and replacing a biological process, rather than attempting a rescue. This makes it, in effect, a move into the realm of automation. The purpose of AWT is to treat a gestateling as if it had never been born, and thus requires the gestateling to exercise, regardless of its capabilities, no independent capacity for life. The traditional infant incubator, in contrast, has the purpose of only supporting what capacity for life the newborn is already exercising or beginning to exercise. Therefore, the neonate shoulders some of the burden of sustaining itself. The gestateling, however, has no such pressure incumbent on them during partial ectogenesis. AWT requires of its subject no exercise of any independent capacity for life. If the AW were switched off or malfunctioned, an underdeveloped gestateling would die just as a foetus would in utero during a severe placental abruption. The underdeveloped premature neonate in an infant incubator that is then switched off, however, might survive a short time before life functions dwindled. AWT is closer to technologies sustaining individuals with brain stem death, than to forms of artificial support provided to comatose patients with
257 Hendricks (n9) 405. 258 ibid 404. 78 working nervous systems still coordinating some important bodily functions. The latter is more comparable to NIC.
Rieder argues that when physicians, at present and with only current technologies available, engage in the resuscitation and treatment of extremely premature infants they effectively take over the process of creating them.259 He argues that conventional NIC does not rescue when used to aid extremely premature infants, but attempts to uptake the creative process and ‘artificially continue gestation.’ He posits this observation needs little defence.260 It is my contention, however, that his observations work when applied to technologies like the biobag, but are misplaced when applied to conventional NIC. Rieder conflates a human entity continuing to develop with gestation (the creative process). Gestation, whether in or ex utero, is distinct from ‘continuing to develop after being born.’ Human entities continue to develop long after the gestational process is complete, for example as part of development continuing into childhood.261 Gestation, however, is different in that it is a process of formation, which if not completed adequately the human entity has no capacity for life independent. The limitations of conventional NIC demonstrate it is not capable of anything other than providing assistance with life functions a preterm is struggling to perform itself. Conventional NIC is not a ‘creative process,’ AWT, however, is.
A further distinction between AWT and conventional NIC is in environment. Intensive assistance with life functions is wholly invasive, and yet also leaves the preterm exposed and within an environment where some human interaction (skin-to-skin contact) is possible. The gestateling in the biobag, however, is encased and support is almost entirely non-invasive. Support mechanisms surround rather than aggressively invade the gestateling. One imagines the process of AWT would be less stressful and painful for the developing human. Less is required of, and there is less to disturb, the gestateling. Notably, AWT is so unique in method that outcomes will be different and, outside of animal studies, are unknown. There is no way of knowing now, or anytime soon, what the long-term implications of artificial gestation might be. Gestatelings may be subjects of a research trial long after removal from the biobag.
259 Travis Rieder, ‘Saving or Creating: Which Are We Doing When We Resuscitate Extremely Preterm Infants?’ (2017) 17 American Journal of Bioethics 4, 7. 260 ibid 9. 261 Dean Hayden and Dominic Wilkinson, ‘Asymmetrical Reasons, Newborn Infants and Resource Allocation,’ (2017) 17 American Journal of Bioethics 13, 13. 79
For some time, the biobag will remain a new experimental treatment, while conventional NIC is business as usual. The unknown implications should encourage some caution.
The subject of partial ectogenesis AWT could in theory, and possibly in practice, support a gestateling unable to exercise any independent life functions ex utero at all. The marked difference in terms of gestational age, and consequent abilities, of the subject potentially sustained by each support mechanism is striking. Hendricks argues the status of the subject would, therefore, be an important distinguishing factor. We may be inclined to accept that AWT is different because it can sustain something that ‘does not look like a baby.’262 Whether there is any difference in moral status between the gestateling and the premature neonate is beyond the scope of this paper. There is, however, based on their dissimilarities in development and appearance, a huge difference in their capacities. This difference is meaningful in terms of the function technology must serve to sustain them.
Let us assume AWT does not confuse the viability threshold further and it has the same natural limitations as NIC in terms of the subjects it could support.263 There remains a distinction in the way the subjects behave. The significance of the subjects’ contributing, or not, to their own survival has already been highlighted. Additionally, the premature neonate is available for social interaction, can experience the benefits of connection with other human entities and become embedded in social networks. Other individuals can interact directly and physically with it. The gestateling is shut off from the outside world and does not touch, smell or interact with anything other than its artificial gestator. This isolation will influence the perception of and, on occasion, the feeling attached to each entity. These perceptions will impact, in various meaningful ways, on the decision-making of those surrounding the gestateling.
262 Hendricks (n9) 405. 263 It is worth emphasising, given the reasoning advanced elsewhere in this paper, that this is a big and unwarranted assumption to make. 80
Potential uses of partial ectogenesis Finally, AWT introduces opportunities beyond more efficacious care for preterms. Partial ectogenesis, once AWs are available, could become a distinct course of action in obstetrics to manage dangerous pregnancies. A dangerous, but wanted, pregnancy is not wholly uncommon and the choices at present seem painfully bleak. When (earlier) pregnancy threatens a person’s life, the pregnant person is usually advised to have an abortion. The alternative is that they continue the pregnancy hoping they survive long enough to deliver a healthy child, but taking the risk that neither they, nor their foetus, will survive. In 2016, Heidi Loughlin faced this decision after being diagnosed with a cancer un-treatable during pregnancy. Loughlin refused to accept there was no alternative to choosing between her life and her foetus. She elected for a third choice: remaining pregnant until 28 weeks and opting for premature delivery. Unfortunately, the premature neonate did not survive long after delivery.264 This decision was (an attempt at) ‘partial ectogenesis’ in action, but before AWT was available. An AW, were it accessible, may have changed the odds. AWT might encourage more people experiencing dangerous pregnancies to make Loughlin’s choice. It might even be that, in future, pregnant people may wish to opt for AWT over continuing pregnancy in situations of less concern, for example to avoid unpleasant symptoms like morning sickness. AWT is, therefore, distinct from rescue technologies because it introduces the possibility of the extraction of gestatelings that would never have existed ex utero otherwise. AWT in these situations performs the function of reliably sustaining gestatelings removed from pregnant people and unable to sustain themselves. However, AWT is then functionally not just about ‘rescuing a foetus/gestateling,’ but also enabling pregnant people to choose an alternative to pregnancy without risking the loss of the product of reproduction. NIC, because of its risks and limitations, will never be considered a reliable enough alternative to gestation to enable this choice.
If AWT is chosen as an alternative to the ‘dangerous pregnancy-abortion’ dichotomy, an extraction procedure will be part of the therapeutic process and is also experimental. A safe method of extraction, potentially a ‘more complex and intricate’ C-Section must be
264 Peter Walker, ‘Baby Delivered Early to Allow Mother’s Cancer Treatment Dies,’ (The Guardian, 20 December 2015)
81 developed265 inevitably involving trial and error. We are not only considering experimenting on gestatelings: we are also potentially considering experimenting on the pregnant people who carried them.
Conclusion
The possibility of gestation ex utero begins with technology initially used as an alternative to conventional NIC before inevitably challenging the viability threshold. The biobag, however, is more than a mere extension of conventional preterm care. It marks a shift in physiological approach for three reasons.
First, AWT replaces a natural function rather than facilitating a newborn rescue. Instead of assisting a premature neonate with functions it is struggling to perform alone AWT treats its subject as if had not been born. Unlike a preterm in intensive care, the gestateling does not have to exercise any independent capacity for life. AWT also places the gestateling in a different environment; the consequences of which are still unknown. Second, if testing on human ‘just-viable’ preterms is successful, the technology is likely to be used beyond the current viability threshold. Clinicians and parents have incentives to try AWT to sustain preterms only slightly below the threshold, shifting perceptions of viability. Thus, AWT could sustain subjects with very different capacities. These subjects cannot be appropriately described as either babies or foetuses because they are unique in behaviour, location, and the process they are undergoing. The term ‘gestateling’ should be used to identify the developing human entity in the AW. Third, AWs have potential clinical uses beyond conventional rescue technologies. AWT might appear just a better alternative to NIC, but its development is more significant and will enable the birth of partial ectogenesis as a therapeutic process in itself.
Identifying these distinctions is crucial to inform ethico-legal discussion and ensure better protection for affected parties. Recognising the difference in subject, and terminology that might helpfully be deployed to describe it, will also prevent the interference of value laden
265 Julien Murphy, ‘Is Pregnancy Necessary? Feminist Concerns about Ectogenesis,’ in Scott Gelfand and John Shook (eds), Ectogenesis: Artificial Womb Technology and the Future of Human Reproduction, (Rodopi 2006), 34; Schultz (n21) 880. 82 terms and bring clarity to this discussion. Being mindful of these differences allows us to consider what, if any, additional regulation is appropriate to ensure AWT research and its potential clinical applications are ethical.
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PAPER TWO: Challenging the ‘Born Alive’ Threshold: Fetal Surgery, Artificial Wombs and the English Approach to Legal Personhood
The law of England and Wales is clear that legal personality is afforded to all persons born alive.266 The law does, and seemingly always has, unambiguously distinguished between a child before and just after birth. Before birth, a foetus has no legal personality, whereas after it has been born it is afforded all the rights and protections of a child.267 There is not, however, much further clarification about the meaning of birth or what it means to be born alive. The law makes its distinction at birth, despite apparent biological similarities between human entities just before and just after birth,268 because ‘for legal purposes there are great differences…[before and after birth] that raise a whole host of complexities.’269 This article argues that these complexities are no longer limited to the unborn/born dichotomy. The legal principles determining what constitutes being (born) alive will be examined, further developing the debate about how the law manages difficult questions on the cusp of life and death. Emerging medical advances in the treatment of foetuses in utero and premature infants give cause to question whether the legal concepts of birth and born alive provide a sound legal and ethical approach to assigning personhood.
In 2017, a Philadelphia team of scientists and foetal surgeons announced the development of the ‘biobag.’270 This was an artificial womb prototype (AW) that had, in clinical trials, successfully supported lamb foetuses on the viability threshold for four weeks.271 The biobag is significant for three reasons. First, all test subjects survived the experiment without experiencing any of the common complications associated with (lamb) preterm birth.272 It is hoped that this technology will also have the capacity to overcome the present limitations of neonatal intensive care and improve patterns of morbidity and poor prognoses in human
266 Paton (n206). 267 Alghrani and Brazier (n25) 52. 268 Singer (n92) 126. 269 Ngaire Naffine, ‘Who are Law’s Persons? From Cheshire Cats to Responsible Subjects,’ (2003) 66 Modern Law Review 346, 359. 270 Partridge and others (n2) 8. 271 ibid. 272 ibid 2; 6.
84 preterms.273 AWs could have an immediate clinical application as an alternative to neonatal intensive care.274 Second, the biobag marks a shift in physiological approach to intensive care for developing human entities. It treats the subject as if it had not been born (removed from the uterus) by closely mimicking uterine conditions to effectively prolong gestation.275 Third, the subject of an AW is distinct from both a foetus in utero and a premature neonate treated by traditional intensive care.276 The subject is an underdeveloped human entity ontologically identical to, and undergoing the same processes as, a foetus in utero, but without the support of a human gestator. This developing human entity is neither in utero nor existing independently ex utero. Because the AW continues gestation as if its subject had not been born it does not resemble the traditional image of life ex utero.
AWs are not the sole reason to reconsider the born/not born dichotomy. Maternal-foetal surgeries have been undertaken for some time,277 and ever-advancing techniques bring new possibilities. In 2016 Texas-born Baby Boemer made headlines as ‘the baby born twice.’278 During Margaret Boemer’s pregnancy it was discovered that her unborn fetus had an aggressive and life-threatening tumour. An innovative surgical team succeeded in extracting the pre-viability foetus almost entirely279 from the uterine environment, removing the tumour, and placing the foetus back into the uterus to continue gestating. Lynlee Boemer was then delivered healthy at the end of the normal gestational period.280 The advent of both AWs and innovative maternal-foetal surgeries give rise to questions about the workability of birth as the point of affording legal personality. Should the law consider a mechanism of affording legal personality involving a more nuanced approach than asking if the human entity is in or ex utero?
273 Costeloe and others (n8). 274 Elizabeth Chloe Romanis, ‘Artificial Womb Technology and the frontiers of human reproduction: conceptual differences and potential implications,’ (2018) 44 Journal of Medical Ethics 751, 752. 275 For a more in-depth discussion and justification of the conceptual differences between artificial wombs and other forms of neonatal intensive care see ibid. 276 ibid 753. 277 Anna Smajdor, ‘Ethical challenges in fetal surgery,’ (2010) 37 Journal of Medical Ethics 88, 88. 278 Susan Scutti, ‘Meet the baby who was born twice,’ (CNN 20 October 2017)
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There has been considerable academic commentary concerning the significance of birth. This discussion, however, has focused on the protection that should be afforded to foetuses gestating in utero.281 Brazier and Alghrani raised, but did not attempt to answer, the question of whether the subject of an AW was born alive.282 There has been little further consideration of how birth might not always be the significant marker in a human’s development (as it was thought to be) because of the development of technologies enabling gestation ex utero. Current academic discussion has not provided in depth investigation of the legal fine print detailing what birth encompasses from a legal perspective. This article attempts to fill this gap and demonstrate that clarification and greater nuance in the law is necessary.
Investigating the law of birth is of crucial significance. Legal personhood signals the extent to which the interests of an entity are worthy of legal recognition. Personhood is the mechanism that affords entities with the rights and protections underlying the entirety of criminal and civil law. Legal personhood also determines the nature of the relationships an entity can have with others. It is notable, for its implication in legal discourse, that granting legal personality to an entity changes the way it is discussed ‘as it turns something… into someone.’283 Personhood, or the absence of it, affects what may legally be done to, and perceptions about, the developing human entity. Understanding how the subject of the AW should be treated is thus important for establishing the legality of clinical trials of AWs on humans. Recent success with animals284 gives reason to believe human trials are on the horizon. The legal status the gestational subject ex utero is afforded will also have broader ramifications. For example, it will impact ongoing debates about the definition of stillbirth.285 This will in turn influence abortion jurisprudence and legal discussion of embryo research, because of the normative and political impact of affording or denying the gestating human entity access to certain rights and entitlements.
281 E.g. Elizabeth Wicks, ‘Terminating Life and Human Rights: The Fetus and the Neonate’ in Charles Erin and Suzanne Ost (eds), The Criminal Justice System and Health Care, (OUP 2007), 202. 282 Alghrani and Brazier (n25) 68. 283 Saru Matambanadzo, ‘Embodying Vulnerability: A Feminist Theory of the Person,’ (2012) 40 Duke Journal of Gender, Law and Policy 45, 68. 284 Couzin-Frankel (n230). 285 BBC News, ‘Parents of Nottingham stillborn baby call for legal change,’ (5 October 2017)
This article argues that the current test for legal personality fails to adequately address the legal prospects for the subject of an AW or maternal-foetal surgery. Thus, it is important to explore an alternative concept. This article first outlines the prospect of artificial womb technology (AWT) and maternal-foetal surgery, demonstrating how they dramatically impact on our understanding of birth. Second, this article explores how the law currently affords personality to illustrate that the concepts of birth and born alive need clarification. Further, it demonstrates that new technologies demonstrate that birth and born alive do not distinguish between human entities deserving of legal protection in a satisfactory or ethically sound way. Finally, this article highlights some important questions that should be addressed in future to afford clarity to the legal concepts of birth and born alive.
Artificial Wombs and Maternal-Foetal Surgery: The Future of Obstetrics
AWT offers the ability to gestate human entities ex utero. The technology, if perfected, will mimic the uterine environment and support a developing human entity throughout the gestational period. In the distant future AWT might eliminate the need for pregnancy at all. Human entities could be created in laboratories by in vitro fertilisation and grown in an AW until 37 weeks from conception. However, this process, known as complete ectogenesis, remains a remote possibility. English legislative provisions currently prevent experimentation on embryos after 14 days from development,286 hindering potentially illuminating research about how embryo development in artificial conditions might be achieved.287 Partridge et al’s recent publication of the biobag study, however, revealed a prototype AW with potential. In the study lambs were removed from the uteri of ewes and placed into the biobag when developmentally equivalent to the human preterm neonate on the recognised viability threshold: 23-25 weeks.288 All test subjects were successfully ‘delivered’ from the biobag after a 4-week period and survived. All subjects also avoided developing the most common, and often fatal, complications that plague (lamb) preterms.289 These same complications have
286 Human Fertilisation and Embryology Act 1990, s.3 (3) (a). 287 In this article, I make no comment on the 14-day rule. It is worth noting, however, that there have been recent calls from the scientific community to lift this restriction following some recent successful experiments at the boundaries of the law. This resulted in a Nuffield Council on Bioethics Workshop to facilitate critical discussion of the time limit. For a report summarising the findings see Nuffield Council on Bioethics (n58) 4. 288 Partridge and others (n2). 289 ibid 2; 6; Biobag technology has at least demonstrated that this is true in respect of preterm lambs. The success of the project in preterm lambs does not necessarily mean that the biobag will be as successful at addressing these complications that result from being preterm in human preterm neonates. There are also limitations to these studies in respect of sample
87 seemingly prevented meaningful change in mortality rates and long-term prognoses in human preterm-neonates for some time.290 The biobag study was so successful that, subject to further animal testing, the authors suggest testing on humans is on the horizon.291 They identify their clinical target population as prematurely born neonates.292 We are seemingly on the verge of AWT not as an alternative to all pregnancy, but as a viable alternative to neonatal intensive care. Whilst complete ectogenesis is not in our immediate future, partial ectogenesis (the development of a human entity in an AW for part of the typical gestational period)293 may well be.294
It is a mistake to presume newly designed AWs should be treated just like all other neonatal intensive care. Firstly, the subject of this technology will have, at some point, been gestated in utero. The process still involves the pregnant person because subjects of the technology will be either delivered prematurely or extracted by C-section295 with the pregnant person’s consent. Secondly, AWT treats its subject as if it had not been born. During the incubation period, the subject of the AW is not exercising any capacity for life, whether it is capable of exercising any independent life functions or not.296 AWT is able to mimic the uterine environment almost entirely, and thus continues the process of gestation. In contrast, conventional care for preterms provides interventions and assistance to perform life functions the preterm is attempting or beginning to attempt alone.297 Thirdly, AWT has the capacity to support much younger subjects than conventional neonatal intensive care, and it is likely that it will be used to support these less developed preterms.298 Conventional support for preterms, such as mechanical ventilation, has proved inadequate beyond the viability threshold because they cannot support developing human entities without any capacity for independent life.299 Traditional intervention can assist the inherent vulnerabilities of an size etc. The researchers, however, do imply in their paper that the results give enough reason to believe the biobag might be as successful in humans (experiencing similar complications) so as to justify the experimental application of the technology on human entities in the future. 290 Costeloe and others (n8). 291 Partridge and others (n2) 11. 292 ibid 11. 293 Partial ectogenesis is the development of a human entity in an AW for part of the typical gestational period following transfer from a pregnant person’s womb. Kaczor (n101) 113. 294 Gelfand and Shook (n38) 1. 295 Until this technology becomes more commonplace, it is probable that the subjects of AWT are likely to be preterm neonates, which would have otherwise been treated with conventional neonatal intensive care. 296 Romanis (n274) 753. 297 ibid 753. 298 ibid 753. 299 ibid 752.
88 underdeveloped human body, but it cannot aid the further development of the human entity if that human does not have the capacity to develop. For example, mechanical ventilation cannot support lungs that are before a certain threshold of development300 (around 22 weeks).301 The AW prototype, however, does not appear to have this limitation.302 The subject of the AW does not need semi-functional lungs: it is reliant on gas exchange through cannulae and amniotic fluid, 303 just as the foetus in utero is reliant on amniotic fluid and the umbilical cord. The AW thus can and will challenge current conceptions of viability.304
Finally, the subject of AWT could have different capacities to, will behave differently to, and will be treated differently to, a newborn baby.305 Adopting the terminology applied to newborn babies and premature neonates is inappropriate, because this fails to account for the differences in behaviour and location between the AW subject and the baby in intensive care. The subject is more ontologically similar to, and is undergoing the same processes as, a foetus in utero. However, its ex utero location makes it inappropriate to label as a foetus because most medical definitions (and lay conceptions) of the foetus refer to it being ‘unborn,’306 implying it remains located in a pregnant person’s uterus.307 Because all terminology used to describe the product of reproduction at various different points in development is inappropriate for the being in the AW, a different term should be adopted.308 The term ‘gestateling,’ that I first coined elsewhere, refers to the ‘human… [entity] in the process of ex utero gestation in an AW exercising… [regardless of whether] it is capable of doing so, no independent capacity for life.’309 We must be mindful of the conceptual differences between AWT and neonatal intensive care to ensure that the implications of AWT, such as the impact on the law of birth, are fully investigated.
A second important development profoundly changing our understanding of birth is advanced maternal-foetal surgery, most famously performed on LynLee Boemer in 2016. The advent of
300 Couzin-Frankel (n230). 301 This point is identified because it is the age of the youngest premature neonate that has ever survived. It is notable, however, that lung development will occur at a slightly different rate for different foetuses and so this is not a fixed point. 302 Hendricks (n9) 405. 303 See Partridge and others (n2) 2-4 for a detailed description of how the biobag functions. 304 Romanis (n274) 753. 305 ibid 753-754. 306 E.g. Martin (n254) 275. 307 Romanis (n274) 753. 308 ibid 753. 309 ibid 753. For further conceptual differences between artificial wombs and conventional neonatal intensive care discussed in more detail see ibid.
89 different techniques for surgical procedures on the in utero foetus bring much needed aid to foetuses with conditions that would otherwise prevent them surviving long enough to be born alive.310 Lenow describes how ‘the ultimate achievement in foetal surgery was the partial removal of the foetus from its mother’s uterus and onto an operation field.’311 Surgeries involving the foetus’s removal partially resemble a caesarean because the same incision is made into the uterus. The patient of the surgery is the pregnant person, who must consent to the procedure. The foetus is then removed from the incision and operated upon. Baby Boemer’s surgeon described his procedure in a press interview, explaining the foetus was ‘hanging out in the air… the foetus is outside, like completely out, all the amniotic fluid falls out, it’s actually fairly dramatic.’312 During surgery, the foetus remains dependent on the placenta (attached by umbilical cord), and is returned to the uterus on completion of the procedure.313 In utero, the foetus continues undergoing natural gestation for the remaining period.
What terminology should be used to describe the subject of a maternal-foetal surgery while ex utero? The subject of a maternal-foetal surgery differs from a foetus because it is ex utero. Thus, a distinct term for this unique entity will ensure clarity in the discussion and potentially avoid attaching misleading moral connotations to the subject of a maternal-foetal surgery. In some ways the subject of a maternal-foetal surgery, as an entity independent of the pregnant person, becomes a second ‘patient’ of the surgeons. However, referring to it as a ‘patient’ implies access to the rights patients are granted in English law, and it is not certain that the subject of a maternal-foetal surgery would have access to these protections. The developing human entity in the course of this surgery, therefore, will be referred to as the foetal operatee when removed from the uterine environment, and the foetus before removal from and after it has been returned to the uterus. These unique entities (the foetal operatee and the gestateling) raise interesting problems for the application of the born alive rule.
310 Smajdor (n277) 89. 311 Jeffrey Lenow, ‘The fetus as a patient: Emerging rights as a person,’ (1983) 9 American Journal of Law and Medicine 1, 17. 312 Scutti (n278). 313 Smajdor (n277) 88.
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The Test for Legal Personality
English law is clear that before birth there is no person on whom legal rights or duties can be bestowed.314 In Paton, Sir George Baker held that ‘a fetus… cannot have a right of its own until it is born and has a separate existence from its mother.’315 Lord Mustill echoed this conclusion almost 20 years later: “it is established beyond doubt for the criminal law, as for the civil law… that the child en ventre sa mere does not have distinct human personality…”316 Birth as the focal point of personality is a product of the criminal law and negligence in civil law, and is a tradition of the time in which the law was formulated. Savell argues that the law’s insistence that subjects with personality have been born is understandable in the civil context, ‘as…conferring legal status on foetuses might bring pregnant women’s rights into direct conflict with those of foetuses.’317 A lack of foetal personhood also precludes criminal charges being levied against pregnant people for harm caused in utero.318 Recognising foetal personhood, in civil or criminal law, would be a significant curtailment of pregnant people’s liberty319 and create incentives for vulnerable people to evade medical and social care, putting themselves (and their foetus) at risk.320
Acquiring legal personality is not just a matter of being born, but also being born ‘alive.’ Stillbirth occurs when a child is born without having demonstrated any signs of life.321 The existence of a stillborn child is legally acknowledged,322 but the law never affords them, or accepts they did at any point have, legal personality. A stillborn child cannot be the victim of a homicide,323 or bring an action (or have another person bring an action on their behalf) in tort.324 To obtain legal personality, therefore, a human entity must be both born (have an independent existence),325 and it must be evident they were born alive.326 ‘Born alive’ is a
314 Kristin Savell, ‘Is the Born Alive Rule Out-dated and Indefensible?’ (2006) 28 Sydney Law Review 625, 624. 315 Paton (n206) per Sir George Baker P at 279. 316 Attorney-General’s Reference (No.3 of 1994) [1998] A.C. 245, per Lord Mustill at 261. 317 Savell (n314) 661. 318 Attorney-General’s Reference (n316); CP (A Child) v Criminal Injuries Compensation Authority [2015] QB 459. 319 Romanis (n126) 78. 320 ibid 78. 321 Births and Deaths Registration Act 1953 s.41, as amended by Still-Birth Definition Act 1992 s.1 (1). 322 Note that if a developing human entity is delivered dead before 24 weeks this is not a stillbirth but is legally recognised as a miscarriage. See Births and Deaths Registration Act 1953 s.41, as amended by Stillbirth Definition Act 1992 s.1 (1). A miscarriage does not involve any recognition that a distinct developing human birth legally existed. 323 Attorney-General’s Reference (n316). 324 Burton v Islington Health Authority [1993] QB 204. 325 Paton (n206). 326 Attorney-General’s Reference (n316316).
91 concept still closely tied to the moment a neonate is delivered, because it is usually easy to observe life in the newborn without complex diagnostic tools. Birth was also, before the advent of techniques like ultrasound, the most reliable confirmation that a developing human entity even existed. Limited medical and obstetrical knowledge about pregnancy and foetal development often meant that ‘it could not be known with certainty if a woman was pregnant [and] if it was reasonably clear that she had been pregnant, it could not be known… if the child was still alive in her womb.’327 With the need to provide a pragmatic answer to the beginning of legal life, birth seemed the most determinative point in the development of human entities that could be used to trigger legal protections.
It has been argued that the born alive rule is not a substantial legal principle, but an outdated evidential presumption.328 Critics point to developments in foetal monitoring,329 such as 3D imaging,330 that have enabled medicine to determine that developing human entities exist and exhibit signs of supported life before birth. With such evidence available, some argue that we should not be so reliant on birth as a starting point.331 There has even been some judicial support for this claim. In the Supreme Court of Canada,332 Major JJ, in a dissenting judgment, posited that technology like fetoscopy333 should mean that the ‘born alive’ rule is abandoned, because birth is no longer the only way to evidence a human entity’s development.334 The possibility of ex utero gestation, for different reasons, provides more ammunition to the argument that the focus on ‘birth’ may be an outdated approach to affording legal personality. The next sections highlight the inherent ambiguities in each element of the test for legal personality, and issues arising with its application to new technologies.
The consequences of the legal status of these novel entities, determined by examining the test for legal personality, are important to emphasise. Without legal personhood the foetal
327 Gerard Casey, ‘Pregnant Woman and Unborn Child: Legal Adversaries?’ (2002) 8 Medico-Legal Journal of Ireland 75, 76. 328 Naffine (n269) 259. 329 ibid 259. 330 Savell (n314) 645. 331 Agota Peterfy, ‘Fetal viability as a threshold to personhood: a legal analysis’ (1995) 16 The Journal of Legal Medicine 607, 630-631. 332 Winnipeg Child and Family Services (Northwest Area) v G (D.F) (1997) 3 SCR 925. 333 ibid per Major JJ at 981. 334 ibid.
92 operatee and the gestateling cannot access some of the most significant protections that the law offers to persons, including protection in the law of homicide or the ability to seek recourse after negligent treatment.335 Determining what protection these entities are afforded will be of the utmost importance to potential intended parent(s) of each entity. Further, the legal status afforded to each has significant implications for pregnant people. If the foetal operatee were afforded legal personality this would subject the pregnant people to external control, on the basis of the interests of another, for the duration of their surgery and potentially for the remainder of their pregnancy. If the gestateling is afforded legal personality this will have the effect of shifting perceptions, or adding legitimacy to shifting perceptions, about viability with significant implications for future abortion provision. These implications are explored in more detail throughout this article.
Maternal-Foetal Surgery: Born or Not Born
In English statute and case law, descriptions of birth all imply birth is a matter of separation of gestator and gestational subject. In Paton, birth was described as ‘a separate existence from [the] mother.’336 The Births and Deaths Registration Act 1953 (BDRA 1953) defines a born entity as a child ‘issued forth from its mother.’337 These definitions, however, provide no clarification about what constitutes separation or a separate existence. This section examines the evolution of the law of birth and its application to AWT and maternal-foetal surgery. It is argued that the dividing line of birth is no longer clear-cut, because these rules and principles have been entirely developed in the context of the boundaries of abortion/homicide and maternal-foetal ‘conflict.’338 Maintenance of an ‘ex utero existence’ as the dividing line between personality and no personality could have disastrous implications
335 It should be noted that if the foetal operatee or gestateling were ‘born alive’ but permanently injured as a result of negligent treatment, the parent(s) could attempt to sue for wrongful birth. See Parkinson v St James and Seacroft NHS Hospital Trust [2001] Lloyds Rep Med 309, CA. The parent’s ability to seek recourse in this circumstance is not insignificant, but it may not always be helpful. There may be instances where the foetal operatee or gestateling do not survive to be ‘born alive’ in law and thus a claim for wrongful birth would be precluded. Moreover, this is not the same as the foetal operatee or gestateling having a claim in its own right. 336 Paton (n206) per Sir George Baker at 279. 337 Births and Deaths Registration Act 1953, s 41, as amended by Still-Birth Definition Act 1992, s 1 (1). Further statutory definitions of birth include: Infant Life Preservation Act 1929, s 1 (1) ‘an existence independent of [the] mother’ and Congenital Disabilities (Civil Liability) Act 1976, s 4 (2)(a) birth is when the baby ‘first has a life separate from its mother.’ 338 Alghrani (n14) 305.
93 for pregnant people. However, erasing the legal significance of birth altogether could leave some ex utero human entities without adequate protection.
Is Birth Just a Matter of ‘In vs. Ex Utero?’ The majority of attempts to interpret the meaning of born are 19th century authorities: criminal cases in which a foetus/infant was killed during delivery. These cases consider whether a defendant was guilty of murder or, because birth was not complete, the lesser crime of infanticide339 and / or concealment of birth.340 In R v Crutchely,341 Parks B directed that an infant was born only when ‘the whole body of the child had come forth from the body of the mother.’342 In R v Poulton, Littledale J instructed that being born meant ‘the whole body is brought into the world.’343 These conclusions were echoed more recently in Rance v Mid-Downs Health Authority.344 Brooke J (as he then was) observed that the law provided no protection to ‘the child while… in the process of being born before it had been completely separated from its mother.’345 It is clear that legal birth is a process in which an infant has been entirely expelled from the uterus.
There is concern in the literature that the focus on birth as the point legal personality is acquired may be unworkable if human entities could be gestated ex utero. This concern has, however, been almost entirely focused on complete ectogenesis. If a child can be gestated entirely in an AW, without a human gestator, at what point has birth taken place?346 However, AWT in its current form and in its immediate anticipated clinical application concerns partial ectogenesis: cases in which a foetus conceived in and gestating in utero347 is removed to continue gestating in an AW.348 This use of AWT does not concern situations in which the gestateling was never inside a person’s body. The question of when birth occurs if
339 Offences against the Person Act 1861, s 58. 340 ibid s 60. 341 R v Crutchely (1837) 7 Car & P 814. 342 ibid per Parks B at 816. 343 R v Poulton (1832) 5 Car & P 328. 344 Rance and Another v Mid-Downs Health Authority and Another [1991] 1 QB 587. 345 ibid per Brooke J at 620. 346 The consensus in the literature seems to be that birth would be the point the gestateling was removed from the artificial womb. See Alghrani and Brazier (n25) 60; Maureen Sander-Staudt, ‘Of Machine Born? A Feminist Assessment of Ectogenesis and Artificial Wombs’ in Scott Gelfand and John Shook (eds), Ectogenesis: Artificial Womb Technology and the Future of Human Reproduction, (Rodopi 2006), 124; Steiger (n21) 155. 347 Or, it may have been created using IVF and then implanted into a person’s uterus for gestation. 348 Gelfand and Shook (n38) 1. 94 a human entity never existed in utero is important, but, as a less immediate possibility, it is not explored here.
Applying the law to partial ectogenesis might seem intuitive. The question of legal birth seems to be purely a pregnancy law question: is it in or ex utero? Extraction at any point, whether by natural premature expulsion or deliberate premature evacuation, transferring the foetus from the uterus to the AW, is a birth. In an AW, the gestateling has a separate existence from the person who previously carried it. A foetus in utero has no legal personality, even if almost at full term. A gestateling ex utero, however, presumably has legal personality and all associated protections, even if premature (and potentially pre-viable) and sustained only by an AW.349
Foetal surgery, however, could demonstrate that a developing human entity’s ex utero existence should not necessarily equate to it having been birthed. During maternal-foetal surgery the foetal operatee (minus the placenta) is extracted from the pregnant person’s body to be operated upon, remaining attached only by umbilical cord, and then returned to the womb. In Margaret Boemer’s case, her foetus was removed for only 20 minutes, but was fully extracted in that time by the same process as a newborn delivered by caesarean and was existing ex utero. Therefore, the consequence of current law (birth is expulsion)350 is the conclusion that the foetal operatee is legally born. Recognising this birth, however, is potentially inconsistent with fundamental principles of English law. For the purposes of analysing this tension, it is assumed a foetal operatee would be born alive if it is birthed, therefore acquiring personality.351 This section considers two intuitive responses to conceptualising the foetal operatee’s ex utero existence; first, that it is born and second, that it is not born, to demonstrate why both are problematic.
349 Provided that it is legally born alive as well as birthed. This will be explored in detail later in this article. 350 Paton (n206). 351 Meaning that if the foetal operatee is legally born, and it is assumed it is legally born alive, it would then acquire legal personality.
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The problem with recognising the foetal operatee’s ‘birth’ Birth is not a homologous event. Pregnant people can give birth by a variety of processes including, but not limited to, vaginal delivery, technologically assisted vaginal delivery and caesarean.352 It is also sometimes difficult to ascertain how far through a delivery a developing human entity has to be in order to be legally birthed. A broad definition of birth, as a matter of only being no longer inside another person, accounts for all these complicating factors. Equally, however, a broad non-exhaustive definition may create problems by being too inclusive. The broad definition potentially encompasses the foetal operatee, thus potentially enabling its acquisition of legal personality.353
The law is clear that the foetus is not a legal person,354 and this protects pregnant people from exploitation. In Re F355 the judgment explicitly precluded any possibility of foetal personhood, because affording it personality would result in the subordination of pregnant people.356 During pregnancy there is often claimed to be unavoidable tension between foetal welfare and a pregnant person’s autonomy. If foetuses were awarded legal personhood, they could be made a ward of court and decisions would be made in their best interests, thus forcing pregnant people to forego basic freedoms.357 Extending legal personhood to foetuses would result in pregnant people’s actions and choices being subverted to external control.358 This subversion contravenes the ‘fundamental principle, plain and incontestable… that every person’s body is inviolate.’359 The law is clear that pregnant people should not have their ability to self-determine negated by pregnancy.360 The foetal operatee is only ex utero as a function of medical convenience, and were the surgeon to operate on the foetus in situ the primacy of the female body could not be disappeared. It might be argued, however, that the foetal operatee is unique because during surgery it is (entirely) ex utero. Can it be argued that
352 Johnson Memorial Health, ‘5 Different Types of Childbirth and Delivery Methods You Should Know,’ (Johnson Memorial Health Blog 15 January 2015)
96 granting it legal protections would affect it alone, without interfering with the pregnant person?
Even when ex utero the foetal operatee is dependent on the placenta, and therefore the pregnant person, for life. Whatever is done to the foetal operatee, therefore, also physically impacts the pregnant person. The pregnant person is the patient for the purposes of the procedure: it is their consent that is significant.361 In providing permission for the procedure the pregnant person chooses to align their interests with those of their foetus / foetal operatee, however they are empowered to determine the boundaries of that permission. If the foetal operatee also obtained legal personality during the procedure, it would be possible for a surgeon to act ultra vires the pregnant person’s consent when necessary to promote the best interests of the foetal operatee. This might empower medical professionals to effectively force a pregnant person to subject to further physical processes, to which they may even have expressly precluded permission, in the course of the surgery that might aid the ex utero foetal operatee. This is a monumental, and ethically indefensible, burden to place on a pregnant person.
If we assume that the foetus was not so dependent on the pregnant person, it might be argued there is still a rational solution in applying the rules of legal birth to the foetal operatee. When ex utero the foetal operatee has its legal birth recognised, but this can simply be undone when it is returned to the uterus, because it has become a foetus (a different entity) once more. There is no legal precedent, however, for the undoing of a human entity’s personhood. Once a person has legal personality the only way it is removed is death.362 There might be concern that if a foetal operatee were recognised as legally born, and consequently assigned legal personality,363 it would carry this status back into the uterus. There is no definitive legal definition of death,364 and there is room for discussion about whether the foetal operatee is
361 Smajdor (n277) 90. 362 Naffine (n269) 357; There are also serious issues in determining how death should be legally defined because of its implications in terms of the loss of legal personhood. See Margaret Brazier and Emma Cave, Medicine, Patients and the Law, (Manchester University Press 2016), 510. 363 Assuming it was legally born alive. 364 In English law death is determined by medical diagnosis in individual circumstances: Re A [1992] 3 Med LR 303; Airedale NHS Trust v Bland (n160).
97 legally alive,365 but it may be counter-intuitive to imagine that re-insertion into the womb is equivalent to death. A foetal operatee carrying legal status back into the womb would cause exactly the subordination of pregnant people the Court of Appeal has deemed ‘intolerable,’366 by enabling a foetus to make legally enforceable claims governing a pregnant person’s behaviour. There are grounds to argue, however, that in this novel situation personality should be treated with more fluidity.
In other areas of law, entities can gain and lose personality by other processes. Companies can be deprived of legal personality because the law, in order to achieve a particular purpose,367 has constructed the personality framework that applies to them. Rules and limitations about the operation of that personality can also be, therefore, constructed. Rules could be constructed to recognise that, although the same living human entity in a physical sense, there need be no continuity in legal recognition between the foetal operatee and foetus. It could be argued that the foetal operatee ceases to exist, which could be akin to a sort of ‘death,’ when it becomes a foetus once more. There seems to be, however, no scope in current law for this possibility of demeaning a human entity to a status lesser than a legal person whilst still biologically ‘living’, even when there are significant changes in their physicality. For example, living human entities with legal personality do not have their status degraded even if they become mentally or physically incapacitated, if they are dependent on others, or even imprisoned. Human legal personality has never been treated as a contextual status.
It might be considered dangerous to set a precedent that human legal personality can be gained and lost by anything other than birth and death (in the biological sense).368 The rights and entitlements associated with legal personality for human entities are treated as more
365 This will be explored later in the meaning of being legally born alive. 366 Re F (n197) per May LJ at 138. 367 For example, to enable limited liability as a logical consequence of a company having its own personality distinct from its shareholders: See Alan Dignam and John Lowry, Company Law, (OUP 2015), 16. 368 Even without legal recognition of birth for the foetal operatee, there may well be a drastic impact on the treatment of pregnant person who have been involved in maternal-foetal surgery. Even if legal personhood could be undone, maternal- foetal surgery would still change the perception of how the foetus should be treated. It has become a second patient that is for a time legally recognised and this will impact on the pregnant person who is carrying it. The effect has been observed with the developments of foetal imaging creating the foetal operatee and influencing decision making in obstetrics: see Lenow (n311).The effect may be more impactful in instances where the foetal operatee has not only been observed, but also has been interacted with ex utero and has been the subject of a procedure that did not involve the pregnant person.
98 innate than those attached to other entities with personality. Human rights provisions explicitly prevent any individual from being demeaned to a lesser status than any other person in law,369 because personality is the vehicle through which the most fundamental human rights are guaranteed and individuals are protected from exploitation and oppression. There may be concern about the normative political implications of recognising that personality can be undone based on a human entity’s capacities or their location. Maternal- foetal surgery can be conceptualised as an isolated case entirely removed from concerns about the denial of rights to vulnerable minorities; however, a legal mechanism of undoing personality by anything less than death still could conjure up these feelings of unease.370
The problem with claiming the foetal operatee is ‘non-birthed’ Those concerned about the normative implications of undoing personhood might argue that the foetal operatee has not been legally born. To make this argument, the foetal operatee’s circumstances must be differentiated from the baby traditionally born. The first significant difference is the connection between the pregnant person and foetal operatee. In obiter in A- G’s Reference, Lord Hope alluded to the significance of an in utero existence being ‘total dependence… on the protective physical environment furnished by the mother, and on the supply of the mother through the physical linkage… of nutrients, oxygen and other substances essential to foetal life and development.’371 This comment suggests that legal birth could be both a matter of location (no longer within the uterine environment) and of connection (no longer reliant on the pregnant person for nutrient supply). The question of whether a remaining physical connection between a pregnant person and their foetus/newborn once ex utero means birth is incomplete has not been addressed in modern case law or commentary.
In older authorities, however, there was substantial discussion of whether a baby was legally born if once ex utero it still remained attached to the pregnant person by the umbilical cord.
369 For example, the Human Rights Act 1998 prohibits all slavery and forced labour (Sch.1, Art 4) and protects the right to liberty and security (Sch.1, Art 5). 370 It might be time to move to a more nuanced perspective of legal personality and how it might be afforded and removed. There might be lessons to be learnt from other areas of the law, for example company law. This will be briefly discussed later in this article. 371 Attorney-General’s Reference (n316) per Lord Hope at 255.
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In Crutchely, Parks B suggested the umbilical cord is irrelevant: the only condition necessary and sufficient for birth is expulsion.372 He directed that if the defendant were found guilty of murder because of umbilical attachment, there would be legal grounds for appeal.373 Crutchely was acquitted, and there was thus no appeal affording an appellate court the opportunity to scrutinise the significance of post-expulsion connection. Erskine J made a more conclusive direction in Trilloe,374 instructing that a baby was legally born even if still attached by naval string.375 This reasoning was adopted in Reeves.376 Modern authorities in other jurisdictions, which form persuasive precedent, also reach this conclusion.377 These authorities all concern situations in which a baby was delivered by natural means and the cord seemed an observable formality. It could be demonstrated, therefore, that maternal- foetal surgery is distinguishable because it involves a technological medical intervention, and the foetal operatee remains dependent on the connection, unlike the newborn. Whilst a distinction can be made, it seems insufficient. The prospect that the intentional killing of an ex utero developing human entity (even if the subject of a surgery) would not be recognised as homicide just because it remained connected by (and dependent on) the umbilical cord, would offend centuries-old legal tradition in defining homicide.
The second difference between foetal operatee and newborn baby is the intentions of the actors around them. The surgeons intend, when delivering a baby by caesarean, that the procedure marks the beginning of that baby’s permanent existence ex utero. Despite initially performing the same incision and removal, a surgical team intends the opposite when undertaking a maternal-foetal surgery. The argument is then that the foetal operatee should not acquire personhood because it is not treated as if it is, and it is not intended that it be, birthed. Including the intentions of other agents in deciding whether something was a someone could have unsettling consequences. If the parent/s of a disabled newborn believed
372 Crutchely (n341) per Parks B at 816. 373 ibid. 374 R v Trilloe (1842) Car & M 650. 375 ibid per Erskine J at 651. 376 In R v Reeves (1839) 9 Car & P 25 at 26 Vaughan J remarked that he would be surprised if ‘the child and the after-birth might be completely delivered and yet because the umbilical cord was not separated the child might be knocked on the head and killed without the party who did it being guilty of murder.’ This observation attempts to put the issue to bed by making any other conclusion seem nonsensical. 377 In R v Hutty [1953] VLR 228 (Supreme Court of Victoria), the Supreme Court of Victoria in Australia had cause to interpret the meaning of birth. The judgment was clear that ‘it is not material that the child may still be connected to its mother by the umbilical cord… but it is required that the child should have an existence separate from and independent of its mother, and that occurs when the child is fully extruded from the mother’s body…’
100 it should not receive life-saving treatment there would be no suggestion that treatment is withheld because, based on the parent’s intentions, it was not a person worthy of recognition. Discussion is instead directed to whether treatment is in the newborn’s best interests.378
If either distinction were successfully drawn, the result would be that a developing human entity exists ex utero without legal personality, albeit temporarily. This also has concerning ramifications. Without personhood during the operation, liability for grossly negligent surgeries causing death in utero and subsequent stillbirth might be precluded. Gross negligence manslaughter could only be established if a baby was born alive with injuries sustained from negligent surgery that later cause death.379 The offence of child destruction (if before 24 weeks), or of procuring miscarriage could not be established because there would be no mens rea.380 There may also be no civil recourse following the stillbirth of a foetus that died in utero as a result of negligent maternal-foetal surgery. If the foetus is not born alive, then it is not an entity that can bring an action in tort. There would only be a course of action in negligence for the baby born alive but injured by negligent surgery.381
Maternal-foetal surgery does not sit easily in the in/out dichotomy that the law of birth has constructed. As the possibilities of maternal-foetal surgery advance to treat more conditions,382 the implications will become more significant. The law must be able to answer the question of status in the event of a claim that maternal-foetal surgery was negligent. Having examined the alternative interpretations of the current rule, a more nuanced approach to birth than ‘in or out’ may be the only appropriate solution. Returning to the possibilities of AWT, related but distinct problems arise when we consider the legal status of the gestateling. The language of birth seems inappropriate for gestatelings at the earliest stages of development. An AW is designed to continue the process of gestating as if the gestateling had
378 Re B (A Minor) (Wardship: Medical Treatment) [1981] 1 WLR 1421. 379 See Attorney-General’s Reference (n316). 380 If the foetus were removed, this procedure then undertaken negligently, and the foetus died after being returned to the uterus, all before the foetus was legally ‘capable of being born alive’ or at 24 weeks gestation the surgeon could not be guilty of the offence of child destruction. The surgeon would also not be guilty of ‘procuring a miscarriage’ in these circumstances because it is unlikely that it could be established that they intended that the foetus be miscarried in utero post-surgery. 381 In these specific circumstances, the ‘baby born alive’ would be able to pursue an action in negligence for damage caused during the surgery, because at birth they attain legal personality and inherit ‘the damaged body for which the [foetal surgeon] (on the assumed facts) [is] responsible:’ Burton v Islington HA (n324) per Dillon LJ at 219. 382 BBC News, ‘Two unborn babies’ spines repaired in womb in UK surgery first,’ (24 October 2018)
101 never been expelled from the uterus. It seems logical to argue that removal from the uterine environment only to be placed in an AW should not be considered legal birth because the processes that traditionally occur before birth are continued. However, if the maternal-foetal surgery problem is reduced to wholly a matter of location, the law’s construction means that extraction to be placed in an AW would be the gestateling’s birth. It might be argued that birth remains, for legal purposes, the clearest and most appropriate point in development to transform legal protections383 even if there are some instances where application of the rules seem less logical. The law, after all, has to draw the line somewhere,384 and affording protection to developing human entities ex utero in an AW does not have the same problems of creating an antagonistic relationship with the female body.
Artificial Wombs: Born Alive or Inactively Alive
Legal protections, however, are not just a matter of being ex utero. They are also conditional on proof that the ex utero human entity is ‘born alive.’385 This section argues that the law cannot simply rely on the convenient dividing line of location (or the bodily autonomy of pregnant people) to deal with the difficult cases of AWT and maternal-foetal surgery and their total impact on the traditional understanding of birth in the law. There are still ambiguities in the meaning of born alive in the substantive test for legal personality that must be addressed. Little attention has been paid to the lack of clarity, however, because courts have had little cause to examine the definition of a legal person in itself, instead examining only the application of the test in particular circumstances.386 With the advent of emerging technologies this may be about to change. The novel developing human entities that are the subjects of emerging technologies demonstrate that given definitions of born alive do not account for the possibility of ex utero gestation. The current definition of ‘born alive’ is too narrow for the gestateling and foetal operatee because they do not breathe or exercise any independent capacity for life.
383 Wicks (n281) 203. 384 Greasley (n117) 190. 385 Births and Deaths Registration Act 1953, s 41, as amended by Still-Birth Definition Act 1992, s 1 (1). 386 Savell (n314) 637.
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In C v S, Sir John Donaldson MR remarked that ‘alive is a simple concept… It should be construed in conformity with the… Births and Deaths Registration Act 1926, which makes the birth of a child which breathes or shows any other signs of life registrable as birth.’387 There remains ambiguity. Is an infant born alive if it breathes only with assistance technology? What signs of life aside from breathing are sufficient proof that a child was born alive? Whilst only some of these complexities have been addressed in the courts, the inherent difficulty in determining whether a child is born alive has been acknowledged. In C v S, Heilbron J observed that questions of ‘when a [born] child is actually alive, are… problems of complexity to even the greatest medical minds.’388
In Re A the legality of surgically separating conjoined twins, where one was entirely dependent on the other exercising all major life functions, was considered.389 Walker LJ observed there could have been grounds to question whether the weaker twin was born alive because she was entirely dependent on her conjoined sister for life.390 His judgment highlighted counsel’s submission that, ‘just as the law has had to redefine death, so it may have to redefine the concept of being alive.’391 The question was abandoned,392 however, Walker LJ’s acknowledgement demonstrates an awareness of the need to explore what legal life encompasses, and in circumstances broader than AWs. Walker LJ asserted there was legally ‘no real analogy between Mary’s dependence on Jodie’s body for her continued life, and the dependence of an unborn foetus on its mother.’393 It is possible, however, to see the similarities between the gestateling in an AW and the foetus in utero. In the AW, the gestateling does not, regardless of whether it is capable of doing so, exercise any independent capacity for life.394 The technology effectively mimics natural gestation prolonging gestation rather than providing invasive support with life functions like current intensive care. Ex utero the gestateling is undergoing the same processes, with the same opportunities for continued
387 C v S [1987] 1 All ER 1230, per Donaldson MR at 149 (my emphasis). 388 ibid per Heilbron J at 145. 389 Re A (Children) (n158). 390 ibid per Walker LJ at 241-242. 391 This was because all parties to the dispute were willing to concede that the weaker twin was born alive. ibid per Walker LJ at 242. 392 ibid. 393 ibid per Walker LJ at 255. 394 Romanis (n274) 753.
103 development, as the foetus in utero,395 only supported by artificial means instead of a human gestator. Is it possible, therefore, to argue that it is not ‘born alive?’
Breathing after birth The BDRA 1953 specifies that a child is born alive if it breathes after birth. In both C v S396 and Rance,397 the Court considered what kind of breathing a foetus would have to be capable of ex utero to demonstrate that it could be born alive. Sir John Donaldson MR concluded in C v S that a foetus was capable of being born alive only if it was capable of breathing after birth, with or without the aid of a ventilator.398 It was not specified whether breathing needed to be demonstrated only immediately after, or for some continuing time after, birth. It seems intuitive that there must be some discernible breathing,399 and thus survival for some reasonable period of, albeit undefined, time400 after birth. Four years later, in Rance, Brooke J (as he then was) appeared to deviate from the conclusion that breathing included assisted breathing. He observed that Parliament had demonstrated awareness of the common law approach to the ‘concept of being alive in its legislation relating to the registration of births and deaths.’401 Thus, he concluded, the BDRA 1953 was clearly drafted to afford legal personality and protection to only ‘the child… breathing and living through its own lungs alone, without deriving any of its living or power of living by or through any connection with its mother.’402
Commentary generally suggests403 that Rance and C v S are conflicting accounts of what post-birth breathing is sufficient to demonstrate a newborn is ‘born alive.’ There is a stark contrast between a newborn able to breathe alone (unaided), and another only able to breathe with a ventilator. The Nuffield Council of Bioethics highlight that conflicting authorities
395 The foetus is of course biologically alive but is not legally alive. Before the viability threshold, a foetus is not capable of an independent existence. 396 C v S (n387). 397 Rance (n344). 398 C v S (n387) per Donaldson MR at 151. 399 This is implied in the wording of the BDRA 1953, as amended by the Still-Birth Definition Act 1992, s 1 (1). 400 J Kenyon Mason, The Troubled Pregnancy: Legal Rights and Wrongs in Reproduction (CUP 2007), 21. 401 Rance (n344) per Brooke J at 619. 402 ibid per Brooke J at 620-21. Brooke J’s judgement echoes R v Handley (1874), in which the jury were informed that they should determine whether a child was born alive by examining whether the child was breathing and living by breathing through its own lungs and deriving no power of life from its mother. See R v Handley (1874) 14 Cox 79, per Brett J at 81. 403 Brazier and Harris (n27) 61.
104 mean the law lacks a ‘sufficiently accurate and certain definition of “born alive” appropriate for use in the light of modern medicine and technology.’404 They recommended that the Royal Colleges405 collaborate to establish a working definition of born alive to inform a statutory definition.406 Whilst some of these organisations acknowledged the report,407 a working definition has not materialised.
It is, however, possible to interpret Rance as complementary to C v S. Brooke J’s statement does not exclude breathing with assistance technology. Brooke J makes no reference to assistance; he merely confirms that a neonate must breathe independently of a pregnant person using its own lungs. Premature neonates in intensive care use their own lungs even when breathing with assistance because ventilation assists lung function, rather than entirely replacing it. Only this interpretation of Rance avoids illogical conclusions. It would be bizarre to claim preterms in intensive care, or patients under general anaesthesia, are not legally alive because ventilators assist breathing. Even if there were a conflict in authorities, a definition encompassing assisted breathing is a better account of the law because the C v S definition is ratio from the Court of Appeal. Moreover, the Abortion Act 1967 specifies that the foetus in utero is ‘capable of being born alive’ from 24 weeks gestation.408 This evidences Parliament’s intention to recognise that neonates that can only breathe with ventilator support are born alive, because most neonates born at 24 weeks require mechanical ventilation.409
Early model AWs subvert our understanding of life ex utero by creating an environment in which the gestateling does not ‘breathe.’ The gestateling does not use its lungs to acquire oxygen. It is placed in amniotic fluid allowing gas exchange, just like the foetus in utero, through cannulae.410 Acquiring oxygen by placental gas exchange, rather than ventilation, is one of the precise benefits of AWs: ensuring the lungs are inactive allows the organ to
404 Nuffield Council on Bioethics (n251) para 8.13. 405 Specific reference is made to the Royal College of Obstetrics and Gynecologists, the Royal College of Pediatrics and Child Health and the British Association of Perinatal Medicine. 406 Nuffield Council on Bioethics (n251) paras 8.15 and 9.11. 407 Some even produced recommendations on when to assist premature neonates: British Association of Perinatal Medicine, Babies Born Extremely Preterm at less than 26 weeks of Gestation: a Framework for Clinical Practice at the Time of Birth, (British Association of Perinatal Medicine 2008, (2008)
105 continue to develop. Greasley, in attempting to demonstrate that there are meaningful differences between the human entity just before and just after birth, argues that significant biological adaptations occur during the process of birth. She makes specific reference to ‘the clearing of fluid from the lungs in order to allow them to inflate and draw in breath.’411 If extraction and placement in an AW were successful, the gestateling would not make or need to make such a biological adaptation for ‘life ex utero.’ Does lack of breathing, thus, mean gestatelings are not born alive?
Signs of Life Some older authorities suggest that breathing alone is insufficient proof of life.412 In R v Enoch, Parks J observed that in addition to breathing, ‘there must have been a[n] independent circulation in the child, or the child cannot be considered alive.’413 The BDRA 1953, however, does state that a child is born alive if it breathes or demonstrates any other signs of life.414 Decisions such as Enoch were made, and the BDRA 1953 was drafted, before modern medical technologies made answering questions about breathing after birth more definitive and determinable. Williams explains that, ‘it is generally true to say that before birth… the child does not breathe air, oxygen being obtained instead through the birth-cord, which is connected with the after birth. When the afterbirth is detached from the womb the child is compelled to breathe to sustain its life. Breathing (that is to say breathing air) has always been taken as evidence of life…’415 In C v S, Donaldson MR observed that primitive circulation and movement of the cardiac muscle in the foetus were ‘real and discernible signs of life.’416 However, without the capacity to breathe, this was not enough to persuade the court that the foetus was capable of being born alive. Breathing is central to the modern interpretation of born alive. Case law focusing on the ‘capacity to be born alive’ is specific about the post-birth ‘alive’ human entity breathing. In C v S, Heilbron J observed that describing a child as ‘live born or alive even though it cannot breathe, would surprise not
411 Greasley (n117) 191. 412 In R v Brain (1834) 6 Car & P 350, per Park J at 350, it was observed that many children are born alive ‘but do not breathe for some time after their birth.’ In R v Sellis (1837) 7 Car & P 350, per Coleman J at 370, it was suggested that breathing is not decisive proof of being born alive because a foetus could breathe and yet have died before birth is complete. The jury were told they must be satisfied that ‘the child was wholly born into the world in a living state’ at the time that it was decapitated, the implication being that a living state encompasses more than breathing. 413 R v Enoch (1833) 5 Car & P 539, per Parks J at 539. 414 Births and Deaths Registration Act 1953, s 41, as amended by Still-Birth Definition Act 1992, s 1 (1). 415 Glanville Williams, The Sanctity of Life and the Criminal Law, (Alfred A. Knopf 1957), 7. 416 C v S (n387) per Donaldson MR at 151
106 only doctors but many ordinary people.’417 In modern coroners’ inquests determining whether a child was born alive, factual findings focus on whether there was post-birth breathing.418
An Australian Court of Appeal, however, endorsed a broader approach to defining born alive than focusing on breathing alone, finding that there could be no single test to define ‘alive.’419 The judgment was deliberately not proscriptive about what signs of life might be satisfactory to evidence an independent life. It remains to be seen whether, in interpreting born alive in light of medical technologies, English courts will continue to focus on breathing alone (dismissing older authorities as based on rudimentary medical knowledge), or embrace a broader and less prescriptive approach examining ‘other signs of life.’ If the latter, medical opinion would feature heavily in decisions about what signs of life would be sufficient.420 The BDRA 1953 is phrased broadly, potentially indicating that Parliament intended medical input in defining being alive because medical evidence could be introduced to evidence ‘any other signs of life’ where necessary. The common law already takes the approach that defining death is a medical question in particular circumstances.421 The same approach might be taken to defining legal life if the question were posed to a court. It is thus important to consider if the gestateling displays any ‘signs of life.’
The gestateling will display some primitive signs of life, particularly later in gestation, for example, primitive circulation and/or increasing movement. The plain meaning of ‘sign of life’ includes only activities that are exertive and that, by definition, demonstrate some independent life. The primitive signs in the gestateling, similar to that of a foetus, do not evidence that the gestateling is working to sustain its own life. This observation also applies
417 ibid per Heilbron J at 146 418 See R (on the application of T) v HM Senior Coroner for West Yorkshire [2018] 2 WLR 211. In this case, a young woman had concealed her pregnancy and the birth of a child. She claimed that the child had not cried or made any noise after birth. She believed it was stillborn and so she hid the body of the child in a shoebox under her bed and did not tell anyone. A post- mortem was inconclusive about whether the infant was stillborn or had died after birth. This case did not focus on the issue of whether the infant had been born alive, but when providing medical evidence the coroner made observations on the issue of whether it was born alive and there were frequent references to evidence about whether it may have breathed post- expulsion. 419 R v Iby (2005) 63 NSWLR 278 (New South Wales Court of Criminal Appeal), per Spigelman J at 280: ‘the common law “born alive” rule is satisfied by an indicia of independent life. There is no single test of what constitutes ‘life.’’ 420 It is clear that this is the case from discussion in R (on the application of T) v Senior Coroner for West Yorkshire (n418). 421 Death is not defined in statute in English law, and there is judicial deference to medical definitions of death. See Brazier and Cave (n362) 511.
107 to the foetal operatee still sustained by its gestational carrier throughout surgery. Greasley, in emphasising the significance of birth, highlights other biological state changes beyond breathing that are demonstrated in the newborn post-birth and not the foetus. These behaviours, such as the activation of the digestive system,422 are likely to be considered those active ‘signs of life’ evidencing (some) self-sufficiency. The gestateling encased in an AW does not make any biological adaptation to life ex utero because it remains a subject of gestation. The gestateling and foetal operatee are unique from any human entities that have existed ex utero before in terms of gestational age and capacities. In the future, AWs could sustain a gestateling that today is unable to survive ex utero and is described as the product of miscarriage.423 These gestatelings, even those just beyond our current viability threshold, are far less prepared to sustain themselves. This determines the function an AW must perform to sustain them.424 The born alive rule applies in the same way to all gestatelings in the AW, at whatever stage of development, because their location and behaviour is the same. The developed gestateling (even at 37 weeks) is still the subject of the same process as the pre- viable (22 weeks or younger) gestateling and equally does not exercise any of its capacities for independent life. Thus, for relevant legal purposes, all gestatelings must be treated the same.
Gestatelings are not ‘dead’? The ambiguity in the BDRA 1953 means it is difficult to isolate what signs of life alone evidence that a person has become ‘legally alive.’ Smolensky notes the inadequacies in the law defining the beginning of life, and posits that the answer lies in the forced symmetry approach.425 She argues that if a defining characteristic can be isolated that makes a person legally dead, the emergence of that characteristic identifies when a person becomes legally alive.426 Using the forced symmetry approach in the English context is difficult because death is not clearly legally defined.427 In England, legal death is determined by medical diagnosis in individual circumstances. This is usually brain stem death.428 If the loss of brain function that
422 Greasley (n117) 191. 423 Re A (n364); Airedale NHS Trust v Bland (n160). 424 Romanis (n274) 754. 425 Kirsten Smolensky, ‘Defining Life from the Perspective of Death: An Introduction to the Forced Symmetry Approach,’ (2006) 41 University of Chicago Legal Forum
108 can sustain life means a person would be described as legally dead,429 does the absence of independent brain function to sustain life logically suggest the entity is not alive?
The Academy of Medical Royal Colleges defines death as, ‘the irreversible loss of those essential characteristics which are necessary to the existence of living human person[s] and thus… death should be regarded as the irreversible loss of consciousness combined with the irreversible loss of the capacity to breathe.’430 It is possible to describe the gestateling as lacking the essential characteristics necessary to the existence of living human persons? During gestation, the gestateling possibly lacks consciousness, does not yet independently co- ordinate necessary bodily functions and lacks the capacity (or does not evidence their capacity) to breathe. The gestateling is, therefore, seemingly not alive in the AW. However, in order to be dead, the absence of identified capacities must be permanent and irreversible. We cannot describe the gestateling as actively alive, but it is completely counter-intuitive to describe it as dead. The gestateling will, at some point, be both capable of exercising an independent life, and eventually will, if undisturbed, be removed from the AW and begin to do that. If the gestateling is not dead but not legally alive, what is its status? Does this problem signal the deconstruction of the binary between legal life and death? This question is in need of exploration not only in the context of AWs, but also in light of other emerging technologies including immortal stem cell lines, artificial gametes and cryonics.
Greasley argues that a binary concept of personhood is important to ensure that all individuals within a certain range of person-relevant capacities are treated of equal moral status regardless of interpersonal variations.431 The law must draw a line affording protection somewhere, even if the line will always be arbitrary in a process of development.432 Birth normally involves the routine delivery of a human entity with particular capacities following 37 weeks gestation in utero. It is assumed intuitive that, even if premature, a baby looking, and acting human should be afforded the same legal protections as a child. Greasley relies on
429 Smolensky (n425) 70-72. 430 Academy of Medical Royal Colleges, A Code of Practice for the Diagnosis and Confirmation of Death, (2008)
109 some of the behavioural patterns only exhibited in born human entities to demonstrate there are more significant behavioural similarities between all human entities ex utero, than between human entities in and ex utero. She references responsiveness to environmental stimuli and interactions with other human entities as behavioural evidence of the significance of birth.433 The gestateling, while encased in an AW, is more removed from the world with limited possibilities for human interaction.434 Based on the importance that might be afforded to interaction, how far would the encasement of the gestateling impact on the social and legal response to it? Greasley’s arguments about the significance of birth only work if ‘birth’ is not defined as emergence from the female body, but re-defined as the emergence of a human entity from the process of gestation and making the necessary biological adaptations for independent life. If this were the case, however, we would face the novel possibility of human entities existing ex utero without legal personality. Similar concerns raised in respect of lack of protection for the foetal operatee during surgery can be voiced about the lack of protection for gestateling during its treatment, especially while AWT is an experimental technology.
The Intersection between ‘Born Alive’ and Viability There might be a temptation to resolve concerns about a gestateling’s lack of legal protection to argue that it should be considered born alive. This argument relies on acceptance that the primitive signs of life that the gestateling demonstrates should be considered sufficient for the purposes of the BDRA 1953, and thus the gestateling should be afforded legal personality. The previous sections have argued why this approach is difficult to ground within the current law, however, the consequences of recognising life in an AW as born alive should be carefully anticipated for thoroughness.
Viability marks the point from which foetuses are granted a limited right not to be aborted435 (to be left alone to continue gestating). A foetus capable of being born alive is protected in the offence of child destruction.436 The Abortion Act 1967 (AA 1967) stipulated that a foetus
433 ibid 191. 434 Romanis (n274) 754. 435 Romanis (n126) 72. 436 Any person who by wilful act intentionally destroys such a foetus is guilty of child destruction: Infant Life Preservation Act 1929, s 1 (1).
110 was assumed capable of being born alive at 24 weeks.437 The terminology in the AA 1967 ensures that foetuses beyond 24 weeks are always protected;438 but this does not necessarily exclude foetuses younger than 24 weeks from protection, if evidence is provided that such a foetus is capable of being born alive. When the AA 1967 was first enacted, or when it was amended in the 1990s, there were ample opportunities, which were not seized, to repeal the offence of child destruction to insert precise terminology to match the 24 week-threshold in the AA 1967. Parliament may, therefore, have intended capable of being born alive to carry some weight beyond the 24 weeks minimum threshold. Interpretation of capable of being born alive has deliberately been left to the courts. Some judgments have acknowledged this in stating that capable of being born alive is ambiguous and lacking in clear meaning.439 Moreover, judges have demonstrated their willingness to entertain consideration of whether foetuses younger than the minimum threshold in the AA 1967 are capable of being born alive. Whether an 18-week foetus was capable of being born alive for the purposes of the offence of child destruction was the focus of the judgment in C v S.440
Affording legal personhood for the gestateling,441 could lead to the contention that a foetus in utero capable of surviving in an AW should be considered capable of being born alive. It could be argued that it is inconsistent to recognise that a gestateling is born alive, whilst a foetus (before current viability) in utero at the same point of development is determined not capable of being born alive. It might be argued that it is illogical that all gestatelings before 24 weeks would be legally ‘born alive’ despite not being, based on their physical capacities, legally capable of it.442 Concern about any inconsistency in recognition afforded to the gestateling and foetus in utero could easily be addressed by acknowledgement that they are fundamentally different entities.443 There is no moral continuity between the foetus and the gestateling because the relationship that each entity has with the female body is different. It is ethically defensible, if not an ethical imperative, to afford the gestateling ex utero and the
437 Abortion Act 1967, s 1 (1) (a), as amended by Human Fertilisation and Embryology Act 1990, s 37. 438 Outside of the specific exceptions in Abortion Act 1967, s 1 (1) (b) – (d), as amended by Human Fertilisation and Embryology Act 1990, s.37. 439 C v S (n387), per Heilbron J at 147. 440 ibid. 441 It would acquire legal personality because it has been birthed (see earlier discussion) and it would be assumed legally born alive. 442 This is the case if, to be capable of being born alive, a foetus in utero must be ‘capable of breathing’ (assisted or otherwise) once ex utero. Before 22 weeks a foetus (and equally a gestateling) lacks the capacity to breathe because it does not have sufficiently developed lungs. 443 Romanis (n274) 753-754.
111 foetus in utero different legal statuses to protect the rights of pregnant people.444 It is not clear, however, that abortion legislation allows for inconsistent treatment based on the differing relationships entities have with the female body. The Infant Life Preservation Act 1929 (ILPA 1929) expressly determines that the protection afforded to foetuses depends on the point at which preterm neonates can survive, despite the foetus and preterm neonate being fundamentally different entities and having a different relationship with the female body. Statutory provisions at present, however, seemingly allow abortion access on the basis of a foetus’s lack of development (and the threshold of development has changed over time), not on the basis that a person has a right to control their own body. There is, thus, the potential for AWT to threaten access to abortion by two mechanisms.
The first mechanism endangers access as technology continues to reduce the point at which a gestateling can survive ex utero. When the English offence of child destruction was constructed in the 1920s, it was not envisaged that medical technology would advance to the point of AWs. However, AWT might be utilised to argue that if the gestateling is born alive, capable of being born alive should then be interpreted to include those foetuses ‘capable of being born alive only if supported in an AW.’ The law has consistently adjusted its viability threshold to encompass evolving medical technologies. Parliament, for example, reduced the initial threshold of prima facie proof that a foetus was capable of being born alive from 28 weeks in the ILPA 1929 to 24 weeks in the AA 1967. Thus, it might be argued that the lack of precise definition of legal viability is intended to further encompass future developments without statutory amendment. The reference to mechanical ventilation in the judicial interpretation of capable of being born alive could be considered further evidence that viability is a moveable concept based on the state of technology. In both C v S445 and Rance,446 judges deferred to experts in foetal medicine when discussing the possibilities of ex utero survival.
Given that there has been no case law since 1991, it is hard to evidence the viability threshold moving backwards beyond 24 weeks’ gestation. In the USA, the movement of the viability
444 This approach has been valued elsewhere in English law. See Re F (n197) per May LJ at 138. 445 C v S (n387). 446 Rance (n344).
112 standard, and consequent restrictions on abortion access from an earlier point in pregnancy, has been evident and stark.447 This steady erosion of abortion rights, however, is unlikely in English courts because of explicit protections embedded in statute.448 The medicalisation of abortion and the construction of defences in the AA 1967 means a person could opt for abortion until 24 weeks, even if carrying a foetus capable of being born alive only because it could be sustained in an AW. A doctor’s decision to permit abortion even when AWT is available is unlikely to be successfully challenged because there has been a consistent display of judicial deference to medical opinion in abortion.449 In Paton, Sir George Baker P remarked that a judge who sought to interfere with the discretion of doctors to provide abortion under the AA 1967 would be both ‘bold and foolish’ unless there were an ‘obvious attempt to perpetrate a criminal offence.’450 The greatest risk is, therefore, an unregulated trend towards medical professionals advising against or refusing to provide abortion.
There should still be cause for concern with the language enshrined in the ILPA 1929. Capable of being born alive is an uncertain term, because how it is interpreted has the potential to change with technology. Thus, capable of being born alive creates an environment of legal uncertainty, which violates the human rights of those subject to the law and creates ambiguity451 and moral uncertainty. Perceptions of viability amongst the medical profession could shift as AWT is increasingly utilised in the treatment of premature neonates.452 Caution might take root amongst medical practitioners who perceive increased gestateling survival ex utero as cause for unease about all abortion provision, or abortion provision earlier in gestation than current understandings of viability. This culture of caution could lead to an increase in conscientious objection,453 or influence the approach taken to patient counselling about abortion. Doctor’s concerns or personal opinions could threaten people’s access to abortion in various ways. Doctors could impart bad or unclear medical
447 In the Roe v Wade (n23) judgment, the Supreme Court held that foetal viability, and therefore the point at which a State had a legitimate interest in foetal life, was 28 weeks. In Planned Parenthood v Casey 1992 112 U.S. 2791, just 19 years later, whilst reaffirming the constitutional right to an abortion for female people, the Supreme Court held that states could restrict abortion access from 22 or 23 weeks. The Supreme Court also noted that viability might soon be established even earlier due to advances in technology. For more in-depth discussion see Matthew Swyers, ‘Abortion and its Viability Standard: The Woman’s Diminishing Right to Choose.’ (1997) 8 George Mason University Civil Rights Law Journal 87, 104. 448 Abortion Act 1967, s 1. 449 E.g. Paton (n206). 450 ibid per Baker P at 282. 451 R v Misra and Srivastava [2005] 1 Cr App R 328. 452 Romanis (n274) 755. 453 Abortion Act 1967, s 4.
113 advice if they approach consultations about termination with caution or objection. Pregnant people who receive confusing advice could leave consultations without understanding that they can seek abortion elsewhere.454 Access to termination could become more difficult for those without access to alternative advice (for example, in rural areas). If access becomes (or is perceived as becoming) more difficult because of doctors’ attitudes, this is of particular concern for younger people or people from lower socio-economic backgrounds who may be less empowered to seek alternative opinions. Any restrictions on abortion arising from increased caution (or conscientious objection)455 without the oversight of the law or democratic institutions would be a dismal state of affairs for female people.
The second mechanism by which AWT threatens access to abortion is by empowering the anti-abortion lobby and subsequent intervention from Parliament. The UK anti-abortion lobby is gaining traction by using more visceral imaging in campaigning.456 They are likely to claim AWT for increased legitimacy and continue to use the language of viability to advocate for a reduction of the time allowed457 for the ‘social ground’ for abortion,458 and to change the point of distinction between miscarriage and stillbirth.459 It might be argued that since 92 per cent of abortions are undertaken early in pregnancy (before 13 weeks),460 a reduction in time limit would have minimal impact. Any restriction, however, on the time a person is afforded to make such an impactful decision concerning their body is a degradation of their bodily autonomy and integrity.
Moving Forward: Being Clearer about Birth and Being Alive
454 Arianne Shahvisi, ‘Conscientious objection: a morally insupportable misuse of authority,’ (2018) 13 Clinical Ethics 82, 84. 455 Abortion Act 1967, s 4. 456 Phoebe Braithwaite, ‘How UK anti-abortion activists use American tactics to shock and shame women’ (Open Democracy, 19 December 2017)
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Innovative maternal-foetal surgeries and AWT clearly pose a problem for the operation of the law. The problems highlighted may seem like science fiction, however, maternal-foetal surgeries are already being performed and AWs are seemingly imminent. Both technologies will have real impact on how we conceive of legal personhood. Ambiguities about what legal birth and legally born alive encompass cannot be left unsettled. The beginning of legal life must be clearly defined because the consequences are immense461 for both pregnant people and novel human entities. A better definition would avoid the presently inevitable but avoidable confusion in potential negligence or wrongful death actions when/if maternal-foetal surgeries or experimental AWs malfunction. The law must adopt a more nuanced approach to respond to emerging technologies. Precisely what this nuance should encompass is a very complex question and beyond the scope of this article. Some questions that legislators or policymakers ought to address, however, are briefly highlighted in this section.
How much should location feature in the law? The total separation of developing human entity and pregnant person should remain an important dividing line in determining appropriate legal protections. The foetus’s location must feature in law, despite causing inequality in treatment between developing human entities in and ex utero, to prevent the subjugation of pregnant people. Some emphasis on location ensures the protection of a person’s right to choose what happens to their body, a right afforded the highest protection in law,462 and to which pregnant people are equally entitled. However, whether the in/out dichotomy is the be all and end all, or whether there should be a distinction between the gestateling and a neonate (not dependent on an AW) is a different, and necessary, discussion. There is scope for argument that legal personality should only be afforded to those human entities that have completed gestation and made the necessary physiological and behavioural transitions allowing independent life.
If legal personality is afforded to the novel human entities discussed in this article, the law would be significantly lowering its threshold for personality. The gestateling and foetal operatee are potentially, though not necessarily, very underdeveloped human entities who have yet to reach the current point of viability. The born alive barrier exists to recognise that
461 Smolensky (n425) 42. 462 Collins v Wilcock (n359). 115 a human entity is exercising some independent capacity for life. The barrier no longer has that symbolism if being legally alive is inclusive of being passively alive in the AW. The born alive rule would no longer distinguish between beings that can exist independently (even with help), and beings that cannot.
What about the process of birth is significant? While location remains important, the law must be clearer about what becoming and being ex utero involves. It seems intuitive that a full-term neonate post-delivery that remains connected to the pregnant person by umbilical cord (because it has not yet been cut), is considered a legal person for the purposes of homicide. It also, however, seems untenable to describe a foetal operatee as born when ex utero on the surgeon’s operating table, but still connected by umbilical cord, because of the potential implications for the pregnant people who consented to the procedure. How might we explain the difference between the ex utero existences of these two developing humans? We might look to the intention that something is birthed, rather than temporarily ex utero, for answers, but detailed examination is necessary to produce a coherent legal account of birth that can be applied consistently.
Should the developing human entity’s capacities feature in the law? The born alive requirement demonstrates birth was intended to be a convenient marker for demonstrating that a human entity has certain capabilities and therefore deserves legal protections. The law must clarify what capacities are relevant to being legally alive. Until recently, the inability to breathe unaided was regarded as a sign of death, but technology allowing the prolonged assistance of individuals without this capacity has enabled the continued life of individuals who would otherwise have died.463 This has meaningfully impacted on our understanding of death.464 Our understanding about breathing at the beginning of life has also been changed by mechanical ventilation in preterm care. How AWT will further impact on our interpretation of references to breathing in law must be determined. Moreover, are there capacities other than breathing, which should be regarded as significant when determining the legal meaning of born alive? The Nuffield Council on
463 Smolensky (n425) 83. 464 ibid 83.
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Bioethics recommended these questions be addressed in 2006,465 and advancing reproductive technologies continue to make these questions ever more pressing. The Nuffield Council recommended a broad definition to encompass various possibilities at the beginning of life.466 But, there is the potential for uncertainty to cause inconsistency. What a legal definition should encompass requires careful examination.
What does it mean to be ex utero and lack personality? Even ignoring legitimate anxieties concerning the application of legal birth to novel human entities, it is apparent that the novel developing human entities in this article would, without parliamentary revision or creative judicial interpretation, fall outside the legal definition of born alive. There is the possibility of developing human entities existing, at least partially ex utero, without legal personality. The AW is an entirely novel legal problem, and maternal- foetal surgery is a rather recent, and rapidly advancing, development that has yet to be thoroughly addressed. Both are cause for concern, because it is unclear what protections human entities subject to these processes would be entitled to.
Could there be a ‘Third Status:’ legal existence before legal personality? Hammack has posited that, ‘the law should avoid bright lines and strict rules… personhood, either fully acknowledged or completely absent, is simply too blunt an instrument to negotiate the complex biological realities of human reproduction in the 21st century.’467 Personhood is currently constructed as a binary, where there is only the possibility of having legal personality or not, and this may be too restrictive to have traction moving forward. However, AWT and maternal-foetal surgeries illustrate problems in the operation of a rule that works well in the overwhelming majority of circumstances. Most births are legally straightforward and the born alive rule is easily applied. There might be an argument to keep the law simple and merely create exceptions for developing human entities that fall outside the norm. This article has discussed the potential harms associated with legal uncertainty in creating exceptions in this context. However, another contemporary solution, that facilitates
465 Nuffield Council on Bioethics (n251). 466 ibid para 8.16. 467 Jaqueline Hammack, ‘Imagining a Brave New World: Towards a Nuanced Discourse of Fetal Personhood,’ (2013) 35 Women’s Rights Law Reporter 357, 370. 117 possibilities outside existing binaries by, for example, acknowledging a new category for recognition, could be appropriate.
Legal personhood is not necessary to afford entities with protection. The human foetus in utero is recognised, and afforded some limited protections, in abortion law.468 Embryos routinely created as part of the IVF process, whilst lacking personality, are also routinely afforded some legal protections.469 Animals, despite lacking legal personhood,470 are recognised as deserving of some protections and afforded them accordingly.471 These are examples of instances in which entities have their legal existence recognised but not valued to the same degree as a legal person.
If a third status - a partially born category for entities like the gestateling and foetal operatee - were created, it could be used to identify subjects accurately, avoid creating a ripple effect in other areas of law and solve relevant discrepancies appropriately. This approach could also be useful in understanding what protections should afforded in other circumstances, for example where a baby is born with anencephaly (absent a brain or a major part of the brain). A third status could also facilitate discussions about what protections should be afforded to novel ex utero human entities without complicating law that operates without issue in the majority of cases.472 There is also scope for discussion about whether there should be less concern for legal consistency. In different contexts the developing human entity’s capacities,
468 Outside of the exceptions in Abortion Act 1967, s 1 (as amended by Human Fertilisation and Embryology Act 1990, s 37) a foetus is protected by the Infant Life Preservation Act, s 1 (1) which criminalises child destruction and the Offences Against the Person Act 1861, s 58 criminalising the procurement of miscarriage. 469 E.g. the Human Fertilisation and Embryology Act 1990, s 3 (3) (a) renders it unlawful to experiment with embryos after 14 days from conception. 470 Notably, however, the Non-human Rights Project (
118 in conjunction with its location and other factors, could justify it being treated and recognised differently to a foetus/newborn. A third status could, however, carry normative concerns regarding setting a precedent of creating different categories of human entity. Further academic discussion on this matter is warranted.
What about abortion access?
Any change to the legal definition of life will change what capable of being born alive, the viability standard enshrined in law, encompasses. Viability has been perceived as a politically ‘neutral’ time limit for abortion,473 and a politically expedient and dispassionate compromise between the pro-choice and anti-choice lobby474 because it plays a crucial role in ensuring English abortion provisions are ‘medicalised.’ However, conventional neonatal intensive care, even with its limitations, challenges the 24 weeks minimum viability threshold,475 because it can secure the survival of preterms younger than 24 weeks. AWT on the horizon will strengthen this challenge to the legal conception of viability further by introducing dependence viability cases476 into the mix. This may ultimately restrict access to abortion by either encouraging cautious medical practice because of the perception that gestatelings lower or should lower the viability threshold, or by aiding the anti-abortion lobby in their quest to amend the AA 1967 to restrict access to terminations. A transparent and less medicalised discussion about abortion provisions, which is not entirely focused on the fetus, is necessary and appears imminent.
Conclusion
Legal personality is afforded to human entities at birth.477 Traditionally birth was a clear-cut marker for legal status, which could be applied with consistent and predictable results. Before birth, a fetus has no legal personality, after live birth a baby becomes a legal person.478 This
473 Jackson (n99) 84. 474 Even though in reality neither the pro-choice, nor anti-abortion lobby can be entirely satisfied with this ‘compromise.’ See McLean (n105). 475 Jackson (n99) 84. 476 These are instances in which a foetus has reached a point of development that means it can be described as capable of being born alive only if it is sustained ex utero in an artificial womb that takes over the gestational process. It would not be capable of surviving with only the assistance of conventional intensive care. 477 Paton (n206). 478 Alghrani and Brazier (n25) 52. 119 article has uniquely demonstrated, however, that emerging reproductive technologies bring with them the need to re-evaluate how the law bestows legal personality. The emergence of new possibilities for human entities at younger stages in development existing ex utero demonstrate that birth is not a simple concept. The two elements of the law of personality, birth and born alive, are in need of further clarification and nuance.
Foetal surgery and AWT do not sit well in the in/out dichotomy that the law of birth has constructed. Both raise concerns about our understanding of birth as just an ex utero existence. Within current law, both the foetal operatee and gestateling might be considered legally birthed because they both exist ex utero, however, they are unlikely to be considered legally born alive. They are not actively and independently alive in a way that fits with traditional conceptions of life in the law. Evidential requirements for being legally born alive are centred on breathing,479 though there may be a move towards greater recognition for480 ‘other signs of life.’481 Gestatelings and foetal operatees are not breathing or exercising an independent capacity for life. The gestateling is in a process of continued gestation almost identical to the foetus in utero, and the foetal operatee is dependent on the umbilical cord and placenta. Foetal operatees and gestatelings, however, are not dead. They are not permanently deprived of the capacity to demonstrate signs of life and/or breathe in the future. These technologies demonstrate that there is a need to delve deeper into what being alive encompasses, and should encompass, in law.
To address the issues that emerging technologies raise involves making difficult decisions about how to classify different developing human entities. If both the gestateling and foetal operatee are not born alive, they will not acquire legal personality. Importantly, the lack of personality for the foetal operatee protects the rights of pregnant people by ensuring they are not made subordinate to the interests of the foetal operatee during a surgery and potentially to their foetus after a surgery. Lack of legal personality for the gestateling prevents its existence from providing ammunition to legal challenges to abortion provision based on an argument that foetuses before 24 weeks could be removed from the uterus and successfully sustained in an AW. Affording legal personality to these developing human entities would significantly
479 C v S (n387). 480 If the law in England and Wales follows the persuasive precedent established in Australia in R v Iby (n419). 481 Births and Deaths Registration Act 1953, s 41, as amended by Still-Birth Definition Act 1992, s 1 (1). 120 lower the threshold of legal protections and would have broad implications for the treatment of foetuses and embryos, and for female people. Despite this, there remain lingering concerns about the possibility of human entities existing ex utero without legal personality. Without it, both the foetal operatee and gestateling are vulnerable to exploitation and a lack of redress if death results from negligent treatment before they are born alive (either by delivery from the uterus at a later time or removal from the AW). There may, therefore, be value in considering a ‘third status’ approach: recognising that there may be harms in a binary approach to legal personality.
This article has also identified some further questions that require renewed discussion about the law of birth. Determining how the law should respond to these issues requires thorough further investigation. It is clear, however, that there must be greater nuance in the law moving beyond the current binary in order to address these important ethico-legal issues. Impactful technologies are here: maternal-foetal surgery is an increasingly important intervention, and AWT is potentially only years away from human testing.482 Careful anticipation of technology and procedures impacting on interpretations of legal birth will prevent reaction in the public, by Parliament, and in courtrooms being driven by fear or confusion,483 thus minimising the danger of clumsy responses having unintended consequences.
482 Couzin-Frankel (n230). 483 Gelfand and Shook (n38) 1. 121
PAPER THREE: Artificial Womb Technology and the Significance of Birth: Why Gestatelings are not Newborns (or Fetuses)
In an earlier publication, I argued that there is a conceptual difference between partial ectogenesis (PE)484 (facilitated by AWs) and neonatal intensive care (NIC).485 I advanced several reasons for this distinction, one being that the subjects of each technology were different entities. The subject of PE, which I termed the ‘gestateling,’486 is undergoing the process of gestation, whereas the subject of NIC, a preterm neonate, is being assisted by incubation. The gestateling is a unique human entity, functionally distinct from the foetus and the newborn. Moreover, referring to the subject of an artificial womb (AW) with unique terminology provides clarity in the discussion. Colgrove published a response to my paper487 arguing that gestatelings are not distinct from ‘newborns.’ Colgrove claims I am over-reliant on medical definitions to distinguish gestatelings from foetuses, but do not adequately account for relevant definitions of birth that demonstrate gestatelings are equivalent to newborns. He claims that gestatelings are not a distinct product of human reproduction because they are newborns by definition. Finally, he suggests that any distinction between gestatelings and preterms would be morally irrelevant.488 Perhaps he was correct to identify that some of my claims could have benefited from further defence. This is not the same, however, as having proven, as he claims, that my distinction is incapable of surviving scrutiny.489
484 The process of gestation continued ex utero in artificial conditions (not dependent on a pregnant person). 485 Romanis (n274). 486 ibid 751. 487 Nick Colgrove, ‘The Subjects of Ectogenesis: Are “Gestatelings” Fetuses, Newborns or Neither?’ (2019) 45 Journal of Medical Ethics 723. 488 ibid 723. 489 It is essential to highlight that no challenge was raised to the claim that gestatelings are different entities from foetuses. Foetuses and gestatelings are different because one is dependent on a pregnant person and the other is not. This is interesting because perhaps a stronger challenge to my work can be made arguing that gestatelings and foetuses are not distinguishable, rather than that gestatelings and newborns are not distinguishable. This is because gestatelings are more ontologically similar to the foetus in utero in terms of behaviour, dependence on their environment, how they are interacted with, and potentially in appearance than to ‘newborn babies.’ 122
Birth
Colgrove argues that gestatelings ‘just are newborns (by definition).’490 He substantiates this only by citing the World Health Organization definition of ‘live birth.’491 He fails to acknowledge, however, that this definition delineates two events encompassed in the process of complete birth: first, the expulsion of the entity from a pregnant person, and second the emergence of that entity from the process of gestation.492 Greasley explains that the birth process involves the developing human entity undergoing meaningful changes beyond changing location.493 These are biological adaptations enabling the entity to survive in an ex utero environment, for example, the clearing of fluid from the lungs to allow breath, and activation of the digestive system.494 Usually, these two events coincide: a baby is delivered by/from a pregnant person, and simultaneously, it makes the necessary adaptations for independent life. There has been little thorough examination of the process of birth495 because it is usually a straightforward, uniform process.496 Both the change in location (facilitated by the pregnant person’s delivery) and the making of the necessary biological adaptations for life (facilitated by the newborn itself) have traditionally been thought of as coetaneous, with the same temporal boundaries. PE, however, demonstrates that these two occurrences are not coextensive; they are independent processes that merely happen to be naturally synchronised.
I previously described AWs as treating the gestateling ‘as if it had not been born.’497 Colgrove answered that ‘being a newborn means having been born recently’ and merely dismissed the nuanced features (such as behaviour) I suggested were material to a birth as irrelevant.498 He, therefore, does not answer the point. AWs continue gestation499 so the
490 Colgrove (n487), 724. 491 The definition of live birth given by the WHO is ‘…the complete expulsion or extraction from its mother of a product of conception, irrespective of the duration of the pregnancy, which after such separation, breathes or shows any other evidence of life:’ World Health Organization, ‘Health statistics and information systems: Maternal mortality ratio (per 100 000 births),’
123 gestateling does not complete the biological state changes in birth. Birth is not completed. Colgrove misconstrues birth as only an ex utero existence and a matter of semantics. This idea that ‘unborn’ is a strict quantitative concept measured on one binary is misleading. It is a reductive approach to a biologically complex situation involving multiple entities, the environment, and their interaction. The gestateling undergoing PE is born only in a geographical sense. It should still be described as unborn because it has not completed all of birth.
Colgrove considers the case of complete ectogenesis (CE).500 He claims that the formal principle of justice501 requires that all subjects of AWs must be treated the same regardless of whether they are gestated in an AW from conception, or after a partial pregnancy.502 He posits that the subject of PE is born and shares the same moral status as a newborn and thus we must also accept that the subject of CE has this same status.503 This seems implausible. If entitlement to equal treatment comes only from being biologically alive and ex utero, this logic counter-intuitively suggests that a non-implanted embryo alive in vivo also be ‘born.’ He fails to provide any substantive reasons why gestatelings should be considered completely born. In fact, he concedes that the subject of CE would, in a sense be ‘unborn.’ His argument about equal treatment, therefore, works just as easily the other way, supporting my claim that even the gestateling that has been removed from a person’s uterus is different from a newborn neonate. Alghrani and Brazier,504 Sander-Staudt,505 Gelfand and Shook506 and Steiger507 all posit that the subject of CE should be considered born only at the point of removal from the AW; when emerging from gestation.508 Intuitively, the subject of CE is not born, and thus, if all subjects of the technology should be treated the same, the subject of PE is not born either.
500 He notes that these claims were beyond the scope of my original paper. I deliberately chose not to address matters of complete ectogenesis because it is far more remote a possibility (if it will ever be possible) due to the political and legal realities restricting embryo research, and the uncertain limits of embryo science. 501 Gelfand and Shook (n38). 502 Colgrove (n487) 725. 503 ibid. 504 Alghrani and Brazier (n25) 52. 505 Sander-Staudt (n346) 124. 506 Gelfand and Shook (n38) 4. 507 Steiger (n21) 155-156. 508 Alghrani and Brazier (n25). 124
The Exercise of Independent Life
Gestatelings and newborn neonates are distinct because a gestateling exercises no independent capacity for life, whereas newborns shoulder the primary burden of sustaining themselves.509 In English law,510 breathing, including assisted breathing has been the focus of determining independent life in the law.511 Breathing after birth is observable without sophisticated technology512 and demonstrates an obvious capacity for self-sufficiency. The newborn, with or without ventilator assistance, is compelled to breathe. The gestateling, however, does not use its lungs to acquire oxygen513 and thus has not made the most obvious biological adaptation (clearing the lungs to allow them to inflate)514 for independent life. Even if one is persuaded that there are features other than breathing / tolerating artificial ventilation that might demonstrate the exercise of independent life,515 I argue that there are two qualities necessary to establishing sufficient proof that a human entity is engaged in the exercise of independent life, and that the gestateling does not perform any activities of this nature.
First, activities sufficient to demonstrate the active exercise of independent life include only those that are suited to, and involve interaction with, the external environment. The significant feature of all the biological adaptions in birth is that they enable entities to survive in the external environment. Unlike a newborn, a gestateling remains dependent on a process of creation in a temporary environment. Greasley also highlights the importance of newborns being responsive to environmental stimuli and interacting with other human entities as behavioural evidence of a meaningful completed birth.516 The gestateling is encased in the
509 This is even the case for newborns in NIC that, while assisted by technology, must have some ability to exercise their own independent capacity for life; otherwise they would not be able to be sustained with conventional assistance; Romanis (n274) 753. 510 This is also the case in the law of multiple other jurisdictions that recognise birth as a meaningful legal moment (usually the trigger of legal personality). 511 This is at least the case in English and Welsh law; C v S (n387); Rance (n344); The Births and Deaths Registration Act 1953. 512 Romanis (n274). 513 Partridge and others (n2). 514 Greasley (n117) 191. 515 Interestingly, An Australian Court of Appeal has recently endorsed a broader approach to determining if a developing human entity is ‘alive.’ In R v Iby (n419) Spigelman J observed that: “the common law “born alive” rule is satisfied by an indicia of independent life. There is no single test of what constitutes ‘life.’” 516 Greasley (n117) 191; 193.
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AW and is incapable of experiencing physical human interaction.517 This is a significant difference that affects how persons will perceive and respond to it.518
Second, activities demonstrating the exercise of life include only those that are exertive. The primitive signs of life (other than breathing) that Colgrove mentions in the definition of birth, such as a heartbeat, are evident in a foetus and while Colgrove could attempt to claim they are ‘active,’ they demonstrate no self-sufficiency. It seems absurd to treat the primitive signs of life during gestation as evidence of self-sufficiency. We would not claim that a foetus sustained by a pregnant person was demonstrating ‘self-sufficiency.’ The coordination of all bodily functions, during gestation, is always reliant on the gestational carrier (pregnant person or machine). There is a useful contrast to be made between living human tissue and an organically integrated live human entity. Embryos are created by the fusion of living tissue, and following brain death, organs remain sufficiently live for harvesting for transplantation.519 It seems hardly intuitive to consider these tissues ‘actively alive.’
Moral Status
Colgrove observes that I did indeed leave open the possibility that gestatelings and newborns have different moral statuses. However, he claims that any distinction between gestatelings and newborn is not morally relevant because they would have the same moral status.520 Colgrove does not substantiate this claim, focusing instead on attempting to establish that a gestateling is not a unique entity. I have demonstrated that there are some morally relevant differences between gestatelings and newborns. I will not further address this claim about any equivalence (or not) in moral status; rather I want to highlight that considering the moral status of the gestateling in this context is not useful in terms of isolating and addressing the important ethico-legal questions stemming from AWs.
517 Romanis (n274) 754. 518 Notably, Colgrove did not respond to these points of difference I raised in my earlier publication. 519 I am grateful to Bernard Dickens for raising this point with me in discussions. 520 Colgrove (n487) 726.
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There is generally a dichotomy in the literature between two alternative accounts of the moral status. Some believe all human life is intrinsically valuable,521 others believe only the lives of persons (and, thus, not developing human entities) have intrinsic value.522 There is little hope of unilaterally resolving the question of the moral worth of developing human entities.523 There are, however, practical problems with AWs that require resolution, such as how to select research participants for innovative technology, or determining when an AW could be ‘switched off.’524 A way of conceptualising of the gestateling should be adopted that allows us to answer some of these emerging questions without falling into the trap of over-relying on theories of what the ‘foetus’ or ‘newborn neonate’525 is and assumptions about a moral status attached to them. Moral status is limited as a consideration because it is subjectively attributed rather than innate. Furthermore, assigning a moral status does not in itself immediately tell us how entities should be treated, because once the status is assigned, we must then make moral judgements about whether that status justifies certain treatment. This is evident from Colgrove’s paper, in which despite his conclusions that a gestateling is morally equivalent to a newborn, he concludes this ‘does not imply they have a right to life nor does it imply that they have a right not be killed.’526
Importantly, attempting to reduce the debate about AWs to a question of moral status frames AWs as something that only concerns the developing human entity. However, AWs are not just about gestatelings. The location of a developing human entity matters because when it is located inside the womb of a pregnant person, this impacts significantly on that individual. There can be no uncertainty about the need to respect the subjective preferences of the pregnant person and allow them to make decisions about their body and gestational labour. Focusing entirely on the value of the foetus/gestateling neglects this fact that decisions about gestation impact on a pregnant person’s self. Choosing to opt for an AW or not, and in what
521 Werner (n91). 522 Tooley (n92); Even those who subscribe to a gradualist approach take a moral position based on the assumption that all life is valuable (similar to the sanctity of life approach) but that there are limits on how seriously we should take that value. 523 Most people have an opinion or an intuition on the subject (for example, I believe that the personhood approach has more merit). However, these positions are not empirically provable. 524 Abecassis (n21) 13. 525 Especially as I have demonstrated that the gestateling is not ontologically identical to either. 526 Colgrove (n487) 726.
127 circumstances, is still a decision that an individual woman527 should be entitled to make, and this decision should be framed with them, rather than the foetus/gestateling, at the centre.
527 It is important to note that pregnancy is a condition that can be experienced by any person with the reproductive biology that allows them to become pregnant (female) irrespective of gender identity. I have generally referred to pregnant persons rather than pregnant women in order to encapsulate this fact. However, here I refer to a choice that women must be allowed to make because the vast majority of people who experience pregnancy identify as women, and this massively impacts on the social experience of pregnant people and the choice to terminate a pregnancy. 128
PART II - REALISING PARTIAL ECTOGENESIS
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PAPER FOUR: Artificial Womb Technology and Clinical Translation: Innovative Treatment or Medical Research?
Two research teams, in the US and Australia, claim to have established proof of principle for artificial womb technology (AWT).528 Both teams have designed ‘artificial womb devices’ that they claim will revolutionise the treatment of preterm neonates. The devices, the EVE529 platform and the biobag, are intended to facilitate the process of gestation ex utero (ectogenesis), enabling preterms to continue to develop. When artificial wombs (AWs) are used to continue gestation ex utero this is described as partial ectogenesis.530 Partial ectogenesis could significantly reduce mortality and morbidity rates amongst preterms. Both teams explicitly anticipate the clinical application of their device as a treatment for preterms in the near future. Little attention has been afforded, however, to how experimental AWs might be ethically justified as an alternative to existing treatment.
Following recent animal studies of the biobag (2017) and EVE platform (2019), there has been renewed interest in the socio-ethical implications of AWs.531 This debate treats the development and human use of AWs as a foregone conclusion. Focus on future implications neglects more immediate ethical problems concerning the translation of AWT from concept and animal studies into treatment. Arguments are frequently made that ectogenesis is a moral imperative532 and a welcome development.533 Claims that AWT should be actively sought imply that risks in research are justified to achieve this end. Often scholars ignore the fact that research on humans, both pregnant people and preterms, would be necessary, or they downplay the risks involved. Work exploring the ethics of experimental AWT focuses on complete ectogenesis (rather than partial ectogenesis)534 or pre-dates the recent scientific studies535 and is therefore more abstract. This paper addresses this gap in the literature. How and when might it be ethical to use experimental AWT on humans? These questions are
528 Partridge and others (n2), Usuda and others (n2). 529 Ex-vivo environment. 530 Kaczor (n101) 113. 531 Cohen (n21). 532 Smajdor (n22) 336. 533 Kendal (n22) 8. 534 Raskin and Mazor (n102); Alghrani (n10). 535 Alghrani and Brazier (n25).
130 increasingly important as researchers consider translating their devices into treatment for preterms.
In this paper I address these questions by considering whether AWT is an innovative treatment, or medical research. A distinction between innovative treatment and research is pervasive in bioethical literature,536 and is at the foundation of regulation in many jurisdictions.537 The basis of this distinction is that research subjects need more protection than patients receiving medical treatment. Research is directed toward the production of generalisable knowledge in the interests of future patients/ medical science.538 Innovative treatment, however, aims to treat the patient in their best interests. The subject of medical research is more vulnerable than a patient receiving medical treatment because there is not the same guarantee that the investigator is acting in their interests.539 Consequently, research is subject to a higher level of ethical oversight540 than the normal ethical constraints of medical practice (treatment in the patient’s best interests)541 to protect the research subject. Because of the ethical tensions innate in the innovative treatment-research distinction, categorising activities is essential wherever possible. Berkman et al advocate that this is the easiest way to ensure activities are afforded the appropriate ethical oversight and that investigators/ clinicians are aware of their responsibilities to subjects/patients.542
It is often assumed that AWs are an extension (but improvement) of current methods in neonatal intensive care (NIC).543 The assumption implies that partial ectogenesis should be conceptualised as innovative medical treatment. The danger with such an approach, however,
536 Tom Beauchamp and Yashar Saghai, ‘The Historical Foundations of the Research-Practice Distinction in Bioethics,’ (2012) 22 Theoretical Medicine and Bioethics 45, 46. The research-innovative treatment distinction has been criticised: Nancy Kass and others, ‘The Research-Treatment Distinction: A Problematic Approach for Determining Which Activities Should Have Ethical Oversight,’ (2013) 43 Hastings Center Report S4. However, the distinction remains widely accepted in the literature, and is embedded in law in the US, UK and Australia. 537 E.g. US: The National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. (1979)
First, I outline the prospects for experimental AWT with human subjects. Second, I review how AWT has been conceptualised in the bioethical literature, demonstrating why these conceptualisations are problematic. I argue experimental AWT must be considered medical research to better reflect the investigatory nature of the process, and to better guarantee protections for the subjects of experimental AWT. I outline that AWT would be required by regulatory authorities to be the subject of extensive clinical trials before such devices are approved for more general use. Third, I consider whether and how such clinical trials should be conducted by highlighting some of the critical ethical questions that must be addressed in designing such trials.
The Prospects for Artificial Womb Technology
In 2017, Partridge et al published the results of their artificial womb-like-device (the biobag) designed to continue gestation ex utero. Catheters imitate umbilical cord access and facilitate water and nutrient provision and waste product removal. An oxygenator ensures oxygen provision but allows the subject’s heartbeat to control circulation as in utero. The subject is sealed in (synthetic) amniotic fluid, facilitating sustenance delivery, and protecting it from infection.544 The biobag was able to sustain preterm lamb foetuses, developmentally equivalent to ‘just-viable’ human preterms, for 28 days. 100% of the biobag subjects survived and were successfully ‘delivered.’ All research subjects appeared healthy and to have developed physiologically (evidencing successfully continued gestation). The biobag
544 Partridge and others (n2) 2-4.
132 researchers acknowledge that the device needs further refinement,545 and their results need additional validation. They conclude, however, that their device might soon be ready for human testing, identify their potential clinical target population, and comment on the justification for use of experimental AWT on humans.546
In 2019, Usuda et al published the second trial of the EVE platform.547 The EVE device has a similar design; sealing the subject in a warm amniotic fluid bath in a sterilised plastic bag. The subject’s heartbeat, an oxygenator and catheters maintain circulation. In a 2017 study,548 the EVE platform had sustained lamb foetuses for a shorter period than the biobag study and had a higher incidence of morbidity and mortality. The authors were reserved about the potential clinical application of EVE therapy and directed their conclusions towards redesign. In 2019, they published the results of a study using their redesign. Usuda et al reported an improved survival rate, and posited that, although preliminary, their findings ‘demonstrate the potential clinical utility of a further refined EVE therapy system to improve outcomes for extremely preterm infants.’549
These studies are encouraging but have limitations. The devices have only been tested on small sample sizes for short durations. Further validation of results is necessary in repeated, longer studies. Moreover, the outcome of these studies should not be considered sufficiently promising to allow use on human subjects without significant refinement. The 2019 EVE study had a survival rate of 87.5%, there was an incidence of brain damage and several subjects displayed early signs of liver dysfunction. These risks may be no worse than those that routinely occur in NIC. It is important, however, that the specific risks and uncertainties are acknowledged. Finally, lambs have different physiology to humans. Thus, the devices may be less successful when used on humans. Testing on animals, such as primates, with physiologies more similar to humans, is necessary to better understand the likelihood of AWs gestating humans. Significant hurdles must be overcome before AWs are ready for human testing. It is clear, however, that researchers believe their preliminary results support the expectation that their devices could prolong human gestation ex utero. The process of
545 ibid 10. 546 ibid 11. 547 Usuda and others (n2). 548 Usuda and others (n236). 549 Usuda and others (n2). 133 refinement and validation may not be lengthy, as development in this area is fast paced. The EVE team produced a redesign in just two years. There are strong incentives driving this research – researchers are primarily concerned with improving outcomes for preterms and their parent(s), but are also intrigued by the bioengineering problems, the possible prestige of developing the first ‘artificial womb,’ - and there is available funding.550 In an interview, Dr Flake (biobag study lead), alludes to a future ‘a decade from now’ when preterms are treated with AWT rather than conventional NIC,551 suggesting we are on the cusp of the technology. It is important that we start considering some of the ethico-legal issues inherent to experimental AWT before they are considered a clinical option.
Identifying how AWT might be translated into a clinically effective device is essential to addressing issues in the process. Both research teams declare that the objective of their device is to provide human preterms with more comprehensive support and improve clinical outcomes. The studies, however, might potentially differ in their approach to future clinical translation. There is a presumption in the literature of AWT being used beyond current conceptions of viability.552 The biobag study, however, identifies their clinical population as the ‘just-viable’ preterm (23-25 weeks) and is explicit that the authors have no intention of challenging the viability timeline. Their aim is only to reduce the incidence of mortality and morbidity amongst those preterms we already know have some capacity to survive.553 In this approach to clinical translation, experimental AWT would involve using a method that is conceptually sound but unproven in humans, in place of the existing approach (conventional NIC) that has mixed results. Conventional NIC routinely ensures the survival of preterms.554 Before 26 weeks, however, preterms remain unlikely to survive the common complications associated with prematurity and resulting from NIC.555 Only approximately 9% of preterms
550 Woolfrey (n245) 130-131. 551 Children’s Hospital of Philadelphia, ‘Unique womb-like device could reduce mortality and disability for extremely premature babies. (Medical Xpress, 25 April 2017)
134 born at 22 weeks survive.556 One study reports that the survival rate increases to 33% at 23 weeks, and 65% at 24 weeks.557 Complications include lung damage caused by ventilation, cardiac failure and infection.558 Of preterms born at 26 weeks that do survive, 50% have a severe impairment following complications.559 This increases to 75% amongst preterms at 23 weeks.560 Despite overall mortality rates improving in NIC over time, outcomes for extremely preterm infants (<28 weeks) have not meaningfully changed in the last two decades.561 Moreover, conventional care does not consistently produce good outcomes, because individual circumstances greatly vary, and thus it is hard to predict the outcome in any individual case.562
The EVE authors make no explicit attempts to identify their clinical population, but note that they envisage the EVE platform aiding preterms ‘close to or at the border of viability.’563 The study emphasises that the lamb subjects on which the device was tested were chosen so that they, as far as possible, ‘approximated the size and weight of a human fetus close to the border of viability (21-24 weeks of gestation).’564 This implies that the authors anticipate the experimental use of EVE on preterms not yet considered viable (just below that threshold). This potentially presents an alternative clinical translation strategy of initially trialling AWT on preterms that are delivered alive but are so functionally immature that resuscitation would not typically be attempted (<22 weeks).565 These two approaches (using viable, or not yet viable preterms) invoke different ethical issues.
556 Barbara Stoll and others, ‘Trends in Care Practices, Morbidity and Mortality of Extremely Preterm Neonates, 1993- 2012,’ (2015) 314 The Journal of the American Medical Association 1039, 1045. 557 ibid 1045 558 Lissauer and Clayden (n225) 159. 559 ibid 159. 560 Moore and others (n223). 561 Stoll and others (n556), 1045. Glass and others (n85). 562 All the data we have about the likelihood of premature infants surviving (based on factors such as gestational age and weight) are prediction models involving a multitude of different factors. Kipnis argues that whilst there may be generalised data to support the likelihood of a good outcome (assuming a certain weight and gestational age) NIC is a unique situation. In providing treatment intended to result in the best outcome (survival with limited deficits) it is also then inevitable that the likelihood of the worst outcome (death after suffering or survival with intolerable deficits) simultaneously increases. Kenneth Kipnis, ‘Harm and Uncertainty in Newborn Intensive Care,’ (2007) 28 Theoretical Medicine and Bioethics 393, 404. There is uncertainty in every individual case, because we cannot accurately predict incidence of every complication, from how developed a particular subject’s lungs are to occurrence of necrotising encephalitis. 563 Usuda and others (n2). 564 ibid. 565 Nuffield Council on Bioethics (n251) 21.
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Experimental AWT is medical research
The conventional account of partial ectogenesis is that it is already a ‘partial reality,’566 and complete ectogenesis will come about in the natural evolution of NIC.567 Singer and Wells argued in 1984 that the ability of modern medicine to ensure the survival of preterms meant ectogenesis was already a partial reality.568 Both Cannold569 and Alghrani570 refer to partial ectogenesis as a reality demonstrated by the ‘gestation of premature babies in incubators.’571 Even those who do not expressly claim that partial ectogenesis is already facilitated by incubators often imply that AWs would be only a slight ‘advancement of’ NIC572 - a case of improving current technology to enable it to support younger preterms.573 Coleman suggests that ‘if premature new-borns are saved at earlier and earlier stages of gestation then eventually… ectogenesis may be discovered by default.’574 Singer and Wells posited that ectogenesis would be further developed ‘by accident,’ not due to ‘researchers deliberately seeking to make ectogenesis possible but rather [as a result of] doctors attempting to save… premature babies.’575 Alghrani suggests that efforts to perfect NIC mean ‘ectogenesis may not be as far off as… imagined.’576
These conceptualisations of AWT as similar to existing routine treatment are an attempt to contextualise claims about the implications of AWs by ‘demonstrating’ that AWT is a ‘real, serious technology and thus something worthy of ethical debate.’577 AWT is ‘already here,’ so ectogenesis is merely trying more of the same type of intervention in preterms born earlier. Singer and Wells assert that, as an extension of current methods, AWT would not be ‘potentially reckless with human life.’578 They envisage AWT as technology that builds on already established medical approaches with therapeutic intention in each use. This characterisation of AWT may not have been intended as commentary on the status of these
566 Singer and Wells (n9) 11. 567 Alghrani (n9) 193. 568 Singer and Wells (n9) 10. 569 Cannold (n14) 55. 570 Alghrani (n10) 146. 571 Cannold (n14) 55. 572 Steiger (n21) 150. 573 Alghrani (n10) 191. 574 Stephen Coleman, The Ethics of Artificial Uteruses: Implications for Reproduction and Abortion. (Ashgate 2004), 45. 575 Singer and Wells (n9) 10. 576 Alghrani (n14) 303. 577 Adam Hedgecoe, ‘Bioethics and the Reinforcement of Socio-technical Expectations, (2010) 40 Social Studies of Science 163, 172. 578 Singer and Wells (n9) 10. 136 technologies as innovative treatments rather than research; however, this is the implication of conceiving of AWT as merely an extension of NIC. This characterisation misleadingly implies that AWT is a beneficial treatment rather than a novel process embroiled in uncertainty. The conceptualisation of AWT as already a partial reality, or a development of an already established technological approach, is flawed for several reasons. These reasons illustrate that AWT is research.
First, underlying the supposition that partial ectogenesis is already a partial reality is the flawed assumption that incubation and gestation are conceptually identical. I have argued elsewhere that incubation is an attempt to ‘rescue’ a preterm by assisting with functions it is attempting or beginning to attempt to sustain itself independently. The process of gestation, however, is different; it is the process of the creation of humans.579 AWT marks a complete shift in approach to the treatment of underdeveloped human preterms: from ‘rescuing’ a preterm by intervening to assist in the performance of life functions necessary for independent life, to facilitating the ‘creation’ of the subject by continuing the process of gestation ex utero. Conventional NIC requires that preterms withstand ventilation580 because oxygen must be obtained through use of their lungs (pulmonary gas exchange). Conventional incubators, therefore, will never be capable of facilitating ectogenesis even as they improve because in requiring a preterm to use their lungs, the continued development of the lung is precluded.581 AWT devices are purposefully designed to avoid the subject having to utilise their lungs. Instead, gas exchange is performed using catheter imitating gas exchange through the placenta in utero.582 The intention is to try and build an environment in which a subject can behave more like a ‘foetus’ than a ‘baby.’ AWT is an attempt to artificially replicate and replace the biological process of gestation and to facilitate the existence of humans ex utero that do not need to exercise their life functions to survive. The important point in raising this distinction is to highlight that experimental AWT is an advancement of NIC only in the sense that it seems conceptually (if successful) superior in process and outcomes. Furthermore, attempting to use AWT on preterms means completely abandoning all previously established, and proven, treatment methods on a vulnerable population to test an approach with unknown
579 Romanis (n274) 754. 580 Hendricks (n9) 405. 581 Romanis (n274) 753. 582 Usuda and others (n2).
137 short- and long-term consequences, thus exposing the subject to risks. Conventional NIC is certainly not risk-free. However, we know what those risks are and how we can attempt mitigate them (even if we cannot be certain that this will work); we also anticipate that after 26 weeks there is a reasonable chance that preterms will survive treatment.583 Experimental AWT could involve unknown risks and potentially result in subjects experiencing worse outcomes than they might if treated by conventional methods. Experimental AWT, therefore, needs justification.
Experimental AWT is embroiled in more uncertainty than conventional NIC. Novel approaches sometimes constitute innovative treatments where there is some clinical basis for believing the patient will experience a direct benefit.584 If there were a reasonable expectation that experimental AWT would directly benefit individual preterms, it would not need to be considered research. If ‘just viable’ preterms were used to trial AWT, it could be argued that there is already evidence that these ‘just-viable preterms’ are capable of surviving with treatment; therefore, there is a valid clinical basis for treating them with AWT. However, knowing there are instances in which this group can survive with support cannot be equated to a reasonable expectation that they will benefit from AWT. In this context, benefit would (or should) mean that the preterm experienced a better outcome than that anticipated from NIC. The approach envisaged by AWT (continuing gestation) is conceptually sound. However, there is uncertainty in translating that theoretical approach into reality. There is preliminary data suggesting that ex utero gestation is possible for periods with animals. Current animal data, however, are not sufficient to demonstrate a reasonable expectation of clinical benefit because of the substantial differences in physiology. This is why standard research pathways involve human trials after animal testing before approval. Until it is tried for the first time, there is no clinical evidence supporting experimental AWT in humans. The lack of clinical validity gives us good reason to presume that AWT should be considered research.
583 Lissauer and Clayden (n225) 159. 584 Robert Levine, ‘The Boundaries Between Biomedical or Behavioral Research and the Accepted and Routine Practice of Medicine,’ in National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Appendix to the Belmont Report: Volume I, (1979)
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Second, in research the investigator primarily intends to produce generalizable knowledge,585 whereas when providing innovative treatment the intention is to benefit the individual patient.586 Where generalisable knowledge is the primary goal, objective scrutiny is necessary to ensure health is not ‘unduly sacrificed in experimental design.’587 Dr Flake envisages that AWT ‘could establish a new standard of care for this subset of extremely premature infants.’588 The EVE team expressly state that their objective is to develop ‘a new therapeutic option’ replacing conventional ventilation.589 The researchers clearly perceive their devices as different from traditional approaches and hope that their research will improve outcomes for preterms. The objective in developing AWT is that eventually, if the devices work as well as anticipated, AWT could more reliably support human preterms and reduce the incidence of mortality and morbidity. Ultimately, if researchers can prove the validity of their approach, AWT may replace conventional NIC (and associated complications). To do this, evidence is needed to establish that AWs can consistently achieve better outcomes. Thus, the primary objective of experimental AWT is the production of generalizable knowledge establishing that AWT is a replacement for conventional technologies.
This objective does not preclude the possibility that physician-investigators hope or intend that experimental AWT will benefit individual subjects of the device, perhaps by ensuring their survival where it was uncertain or reducing the incidence of complications. This intention is, however, secondary to the production of generalisable knowledge. Initial clinical translation will involve trial and error. If researchers intended to provide the best treatment available to a preterm (assuming the preterm was the ‘just viable’ at 23-25 weeks), the reasonable course of action would be to provide conventional therapies known to have some success rather than trial a device with uncertain outcomes as an alternative. For example, survival (irrespective of morbidity) rates of NIC at 25 weeks gestation are around 81%.590 It might be, prima facie, more justifiable to trial the technology on preterms at the threshold of this category- for example 22 weeks, where NIC is a much less reliable option. In any case,
585 National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research (n584), 2-3; Department of Health, Research Governance Framework for Health and Social Care, (Central Office of Information 2005), 3. 586 Howard Brody and Franklin Miller, ‘The Research-Clinical Practice Distinction, Learning Health Systems, and Relationships,’ (2013) 43 Hasting’s Center Report 41, 44. 587 Lewens (n538) 425. 588 Children’s Hospital of Philadelphia (n551). 589 Usuda and others (n2). 590 Stoll and others (n556) 1045.
139 experimental AWT involves uncertainty and substantial risks. Attempting to assist any individual preterm is, consequently, not the primary motivation of experimental AWT. Even if AWT resulted in benefit for individual subjects in every case, this does not render the procedure treatment rather than research.591
Finally, the substantial risks assumed by the subject of experimental AWT are unlikely to be justifiable on the basis that the individual subject will benefit. Some risk of harm is innate in all medical practice (including innovative treatment) and is considered justifiable where the patient stands to benefit from that treatment.592 Because research is not primarily aimed at securing a patient’s medical best interests the justification offered is consequentialist: that any risk tolerated in the experiment might be justifiable based on contribution to knowledge that will have further good outcomes - such as improving the prospects for future patients.593 How risks of treatment are justified is therefore useful in distinguishing between innovative treatment and research. Substantial risks are involved in experimental AWT, such as cardiac failure from circuit overload, liver dysfunction because of improper nutrient supply, or brain injury. Circuit malfunction is also a significant risk because there is a ‘delicate balance between adequate and excessive circuit flow.’594 Animal studies are unhelpful here because circuit flow/ nutrition will be impacted by the size of the subject. The initial use of experimental AWT on humans may not necessarily benefit the first subjects but could benefit preterms in the future.595 Without a reasonable expectation of success, and with an understanding of the substantial risks involved, AWT should not be considered justifiable because it is in any individual preterms’ interests. It could, however, be considered justifiable because of the potential to revolutionise the future of preterm care.
591 Bernard Dickens, ‘What is a Medical Experiment?’ (1975) 113 Canadian Medical Association Journal 635, 635. 592 Berkman, Chandros Hull and Eckstein (n540) 286. 593 Brody and Miller (n586) 44. 594 Partridge and others (n2) 10. 595 Alghrani (n10) 135.
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Research on developing human entities is controversial, especially when of uncertain benefit. The World Medical Association,596 British Medical Research Council597 and US Department for Health and Human Services,598 however, all accept that non-therapeutic research in these circumstances can be justifiable where it is intended to benefit future preterms, and can only be conducted on the identified population.599 Brazier and Alghrani argue that the potential of AWT to ‘improve the care of premature babies provides a strong case for permitting ethically approved research.’600 Thus, experimental AWT can be justified, although the reality, according to Brazier and Alghrani, is that research into ectogenesis being in any initial subject’s best interests is contestable.601 Thus, AWT is research. The functional importance of conceptualising experimental AWT in this way is that research involves formal protocol, robust study design and procedures designed to ensure the protection of subjects and to ensure the production of generalizable knowledge.602 If this research were to go ahead, it would first be in a clinical trial. Regulatory agencies, such as the Food and Drug Administration (FDA) in the United States or Therapeutic Goods Administration (TGA) in Australia (where this technology is currently being developed) would require extensive clinical evidence before these devices could be utilised outside controlled processes. The FDA regulates medical devices by a classification system. ‘High risk devices’ include implanted devices and devices that are ‘life-supporting or life-sustaining… [or that present] a potential unreasonable risk of illness or injury.’603 AWT is likely to fall into this category. By design, it is an advanced life support system. It is not implanted into the subject, but arguably the fact that a subject is so encased and intimately connected to it that the degree of support it provides is similar to an implanted device. Moreover, the uncertainty in the outcome for any individual subject means there is the potential for unreasonable risks of adverse effects. The FDA has the authority to require that high-risk devices secure pre-market approval,604 so they
596 World Medical Association, Ethical Principles for Medical Research Involving Human Subjects, (2000)
141 cannot be generally used before clinical investigations605 have demonstrated their safety and effectiveness.606 The FDA also has the authority to approve, require modifications to or disapprove all clinical trials before they begin.607 Studies with the potential for substantial risk must be approved both by an Institutional Review Board (IRB), and the FDA.608 Similar hierarchical classification systems, with processes requiring extensive evidence for devices considered higher risk, have been established in Australia609 and Europe.610
Clinical Trials and AWT
It has been generally assumed that non-beneficial research on developing human entities with the object of devising AWT could be ethically permissible.611 Such conclusions, however, should be carefully drawn. In this section I consider the justification for AWT research and posit that the consequentialist justification usually offered in the literature would be dependent on certain conditions. This investigation examines some of the questions an IRB or the FDA might consider in deciding whether to approve an AWT clinical trial. The permissibility of these trials, I demonstrate, is embroiled in intricate ethical issues of research design. Before I engage in this discussion, I will briefly address the issue of the status of the subjects in a potential AWT trial.
including the information that must be supplied in order to secure approval. Further detail about the requirements is detailed in the US Premarket Approval of Medical Devices Process Code of Federal Regulations: ibid, §814. 605 There are other research designs that can demonstrate the clinical utility of a medical device. There is, however, a general consensus that clinical trials are the best method to ensure the validity and generalizability of results. The regulatory approval process for a new medical device in multiple jurisdictions is also written assuming clinical trials are the appropriate clinical investigation in the case of high-risk devices. 606 The US Federal Food, Drug and Cosmetic Act (n604) §360e (c) (1) (a) specifies that any application for premarket approval must include details about design, production, manufacturing and ‘full reports of all information… concerning investigations which have been made to show whether or not such device is safe and effective.’ 607 Investigation cannot begin until approval from an IRB and FDA is secured Premarket Approval of Medical Devices Regulations (n603) §812.42. The FDA can approve or disprove an application for investigations if there is reason to believe that the risks do not outweigh the anticipated benefits for subjects or knowledge to be gained, there are issues with the investigational plan or methods, there is reason to believe the device is/will be ineffective or informed consent is ineffective: §812.30. 608 US Food & Drug Administration, ‘IDE Approval Process,’ (16 May 2019)
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I have argued elsewhere that the subject of an AW is a unique entity. A ‘gestateling’612 in an AW is not a neonate because it is not completely born. It is still undergoing the process of gestation (human creation), and is thus more ontologically similar in behaviour and physicality, in terms of both exercising no capacity for independent life or interaction with others, to a foetus.613 It is also distinct from a foetus because it is not dependent on another person;614 a fact that will alter the way we treat it. There is, therefore, room to question whether a gestateling should be treated more like a foetus or a preterm. In the context of a potentially non-beneficial research trial there are significant similarities in the way foetuses and preterms are treated, because regulators generally deem it impermissible to expose either to unnecessary risk and require researchers to maximise potential benefits and obtain parental consent. The US Office for Human Research Protections (OHRP) has produced regulations on protecting human subjects in research615 that provides guidance for IRBs making decisions. Subpart B provides additional protections for foetuses and neonates involved in research. §46.204 details the requirements in relation to foetuses and is explicit that any risk to the foetus must be solely as a result of interventions that have some prospect of direct benefit, or if there is no direct benefit that the risk is only minimal and the purpose of research is the generation of important biomedical knowledge that cannot be otherwise obtained. The informed consent of both parents must be obtained so far as they are both available, and the consent of only the pregnant person is required if the research would also be for their benefit. §46.205 details the requirements for research on neonates of uncertain viability (likely to be those identified for any AWT study). This section requires that the research has the prospect of enhancing the probability of survival with the least possible risk and that the purpose of the research is important biomedical knowledge that cannot be obtained by other means with no added risk. The informed consent of either parent must be sought, unless the neonate is thought to be non-viable and then the consent of both parents is required (dependent on availability). We can see there are significant similarities, therefore, in the practicalities of what IRBs will consider important, for example what risks any subject is exposed to etc. because the approach taken would likely be similar irrespective of the
612 A gestateling is ‘a human [entity] in the process of ex utero gestation exercising, whether or not it is capable of doing so, no independent capacity for life:’ Romanis (n274) 753. 613 Elizabeth Romanis, ‘Artificial womb technology and the significance of birth: why gestatelings are not newborns (or fetuses),’ (2019) 45 Journal of Medical Ethics 727, 727-728. 614 ibid 727. 615 DHHS Regulations (n598). 143 subject’s moral status. The matter of how the moral status of the subject of an AW will determine its treatment in the future should be revisited.
Some might argue that AWT trials are ethically permissible because there is the potential that the subjects may benefit. It might be claimed that some chance of life (or a life without serious medical complications) is better than no chance at all. I have demonstrated that this justification is unlikely to be satisfactory because of uncertainty. I raise it again, however, to highlight that such a justification would be entirely dependent on identifying a particular category of research subject. There could be an identifiable population of subjects for whom the possible reward of ‘some chance at life’ could outweigh the chance of significant risks. These subjects are those who have little chance in NIC. In these cases, AWT could be considered at least as safe as NIC, and there would be no reason to suppose worse outcomes. The question would be instead of how much potential suffering the subject is exposed to, and how much suffering is considered tolerable when weighed against a chance of life. Further, what gain in terms of ‘life’ is sufficient would need to be determined. For some parent(s), any additional time (even days) would be considered a benefit. This would, of course, be harder to justify if the subject were likely to experience heavy burdens in the study. It is difficult to support a claim that more mature preterms (>24weeks) benefit in any way by being subject to experimental AWT. Such a claim is dependent on whether researchers make a good case that AWT is as safe as, and potentially able to produce a better result, than current NIC. The benchmark is much higher for this group since they will have a chance of survival, assuming access to the best care, (>50%) in NIC.616 Irrespective of what clinical population is identified, the only evidence researchers will have to attempt to justify an initial trial would be the results of animal studies. Lamb studies cannot provide sufficient data to demonstrate potential benefit in humans. Therefore, researchers may need to gather data by testing on more comparable animal models, such as primates, to justify a human trial in preterms617 – especially if they want to test the technology on subjects already considered viable. This will encompass its own ethical issues, but they are beyond the scope of this paper.
616 Glass and others (n85) 1338. 617 I am grateful to an anonymous reviewer for raising this point. 144
Any potential AWT trial may be high-risk but could potentially result in high rewards if the devices are proved successful. The general justification offered for these trials is the improved prospects for developing human entities and parent(s) in the future. Around 15 million babies are delivered preterm every year,618 and prematurity remains the leading cause of neonatal death in high-income economies.619 Even though there has been some increase in the number of preterms surviving post-NIC, there has been no improvement for some time in the incidence of long-term illness and complications affecting those who do survive.620 NIC has some innate limitations, and we have potentially reached the limits of the capacities of these rescue technologies to aid preterms. AWT has also been emphasised as a potential aid to persons experiencing dangerous but wanted pregnancies.621 Much good can be generated if AWT can save/improve the prospects for future preterms and persons experiencing (dangerous) pregnancy and limiting the emotional distress experienced by parent(s). If we do not pursue AWT research all of this potential could never be realised.622 This consequentialist justification, frequently offered in the ethical literature,623 should be approached with caution.
First, the logical corollary of a purely consequentialist justification is that, in order to maximise future good to future persons (especially on this scale), exposing research subjects to severe risks with little potential benefit is tolerable. Exposing subjects to considerable suffering, however, would not be compliant with regulatory requirements, which are a reflection of the ethical obligation not to abuse vulnerable populations. The OHRP Regulations, that contain requirements for IRBs making decisions about potential trials, does allow non-beneficial research intended to result in important biomedical knowledge that cannot be obtained by other means, though subject to the caveat that there will be no added risk caused to the developing human entity.624 Second, a consequentialist justification is dependent upon research design, because if the correct research question is not identified and carefully answered (with appropriate methods), the future benefit is not possible. There are ethical issues embroiled in these methods that need to be addressed as part of any justification. Research subjects in any potential AWT trial would be vulnerable to
618 Joy Lawn and others, ‘Born Too Soon: Care for the preterm baby,’ (2013) 10 Reproductive Health S1, S1. 619 Azad and Matthews (n6) 132. 620 Kate Costeloe and others (n8) 621 Some have argued it could potentially aid all female people who want to reproduce but perceive pregnancy as too dangerous or want to avoid the risks associated with pregnancy: Smajdor (n12; n22). 622 Alghrani (n10) 136. 623 ibid 135; Singer and Wells (n9) 16; Alghrani and Brazier (n25) 78. 624 DHHS Regulations (n598), §46.205. 145 exploitation because they are not participating in a wholly therapeutic arrangement. How can we ensure that a research trial is able to answer its research question? How do we mitigate concerns about coercion and parent(s) feeling pressured to consent to experimental procedures? How do we ensure preterms are not exposed to unnecessary additional risk in the course of experimental procedures? These and other questions will require exploration in the process of ethical review before any research study is begun.
Clinical investigations are the only way that experimental AWT can result in generalisable knowledge. Emanuel et al argue that to be ethical, research must be conducted in a methodologically rigorous manner; without ‘validity the research cannot generate the intended knowledge, cannot produce any benefit, and cannot justify exposing subjects to burdens or risks.’625 Reitsma and Moreno explain that doctors struggle to deny parents the newest available technology, regardless of questionable benefits and unknown risks, to facilitate parents’ wishes ‘not to give up.’626 If AWT were provided ad hoc to preterms in uncontrolled circumstances, generalisations about why and how AWT worked sometimes, and not others, could not be made. Collating relevant information and accounting for confounding variables would be impossible. There would be no emerging evidence that could establish whether AWT is a viable alternative to (or replacement for) conventional NIC. Clinical trials ensure suitable research methods capable of producing generalisable knowledge. The Council of International Organisations of Medical Sciences advises that ‘scientifically unsound research on human subjects is ipso facto unethical in that it may expose subjects to risks…. to no purpose.’627 Important research methods in a clinical trial include randomisation,628 blinding and controls.629 These elements of research design guarantee that the research results in statistically significant data that can be used to attain that anticipated future benefit of improving treatment prospects for preterms. Without such data, there can be no guarantee that AWT produces any benefit and it would be unethical to continue to expose future subjects to the associated risks. However, these research methods,
625 Ezekiel Emanuel and others, ‘What Makes Clinical Research Ethical?’ (2000) 283 The Journal of the American Medical Association 2701, 2704. 626 Anqelique Reitsma and Jonathan Moreno, ‘Maternal-Fetal Research and Human Research Protections Policy,’ (2003) 30 Clinics in Perinatology 141, 144. 627 Council for International Organizations of Medical Sciences, International Ethical Guidelines for Biomedical Research Involving Human Subjects, (CIOMS 1993). 628 Berkman, Chandros Hull and Eckstein (n540) 286. 629 Baruch Brody, ‘When Are Placebo-Controlled Trials No Longer Appropriate?’ (1997) 18 Controlled Clinical Trials 602, 605. 146 in particular randomisation, invoke ethical questions. Because the AWT research trial would involve comparing the new technology against the existing technology, prospective subjects would be randomised to receive either NIC or AW care. Only making this direct comparison in outcomes under controlled conditions would allow researchers to conclude AWT is/is not effective.
The concern with randomisation is that some subjects are ‘disadvantaged’ because they receive an inferior treatment (whether this is NIC or AWT) in a research trial. There is broad consensus, according to Freedman, that to be ethical, clinical research must begin with an ‘honest null hypothesis,’ meaning that there is a ‘state of genuine uncertainty regarding the comparative merits of treatments A and B for population P.’630 Uncertainty means there is insufficient evidence to establish that treatment A is better than treatment B (or vice versa) for that population, thus any individual subject is not disadvantaged by receiving one treatment rather than the other. This uncertainty, where there exists ‘an honest, professional disagreement among expert clinicians about the preferred treatment’ is known as clinical equipoise.631 Depending on the clinical population identified as the potential subjects of an AWT trial, clinical equipoise could offer some resolution to the discomfort surrounding randomisation. The best evidence available regarding the efficacy of AWT at the time of initial trials would be animal studies, and outcomes for human subjects would be innately uncertain. If we accept the importance of clinical equipoise as an ethical constraint,632 the treatment for comparison must also be uncertain. Outcomes in NIC markedly improve with gestational age. Identifying the requisite threshold of uncertainty using prediction models (likely based on prospects for a good outcome) would need to be carefully determined. What chance of survival in NIC would be deemed comparatively uncertain? In medical practice, the viability threshold is defined as the gestational age at which the chance of survival with NIC is 50%633 (usually this point is reached at 24 weeks gestation).634 If we accept that a 50% chance of survival is a useful threshold; it is the point at which treatment in NIC is usually deemed appropriate, preterms below this point with a lesser chance of surviving might satisfy
630 Benjamin Freedman, ‘Equipoise and the Ethics of Clinical Research,’ (1987) 317 New England Journal of Medicine 141, 141. 631 ibid 141. 632 For arguments defending the concept of clinical equipoise see Spencer Hey and others, ‘Is the concept of clinical equipoise still relevant to research?’ (2017) 359 British Medical Journal j5787. 633 Glass and others (n85) 1338. 634 ibid. 147 a claim that there is insufficient evidence to suppose AWT would result in a worse outcome. The point of sufficient uncertainty, however, is hard to quantify. Identifying when the likelihood of survival (based on prediction models) is comparatively uncertain to the unknowns in AWT is, ultimately, a subjective matter. It might be argued that a 25% chance of survival in NIC is not comparatively uncertain to AWT, and it equally might be argued that it is. To further complicate things, the analysis so far is dependent on the assumption that the only relevant consideration in identifying a null hypothesis is survival. Long-term morbidity is also considered an important factor in determining the appropriateness of providing or withdrawing current NIC treatment. How might we determine the point at which a chance of certain morbidities is deemed sufficient to gamble on the uncertainty in AWT? Moreover, what kind of complications would be relevant? Gestational age probably would still be an important factor in this determination, because morbidity rates, while still high among all NIC patients, are greater at or below the viability threshold. The critical point is that with these necessary research methods, it is more justifiable to enrol ‘almost viable’ rather than ‘just viable’ subjects in the study. It is easier to apply the concept of clinical equipoise to this group because they are less likely to be exposed to more risk in the study than they would be receiving standard care.
It is expressly within the remit of an IRB to consider the inclusion criteria of a proposed clinical trial.635 Identifying the ‘almost viable’ (as opposed to the ‘just viable’ preterm) as the target population of clinical trials seems prima facie more justifiable. The OHRP Regulations also direct towards this conclusion, because they require that research holds out the ‘prospect of enhancing the probability of survival of the [developing human entity of uncertain viability]… and any risk is the least possible for achieving that objective’ [emphasis added].636 However, it is not uncommon for NIC to be withheld or withdrawn from this population because treatment (ventilation, nasogastric feeding etc.) is often thought to be too burdensome for extreme preterms with limited prospects for improvement.637 ‘Almost viable’ subjects may be inherently more vulnerable because of the greater likelihood of treatment
635 U.S. Food & Drug Administration, ‘FDA 101: Clinical Trials and Institutional Review Boards,’ (16 April 2009)
148 being futile, and therefore potentially an unethical burden.638 How we might balance the researchers’ interest in gathering useful data against some of the ethical considerations in burdensome treatment, in both arms of the trial, would need to be carefully navigated. Moreover, to what extent is opportunity for survival worth the potential for suffering in that process (by subjects in both arms of an AWT trial)? Regulatory requirements impose obligations on researchers to minimise risks and maximise potential benefits for subjects.639 We would need to carefully determine the limits of harm exposure in the experiment. Context is crucial. Lantos explains that in the setting of NIC, standard care is already predictably associated with serious risk of morbidity and mortality.640 We must be careful, therefore, in not judging the study based on risk in its entirety, but by considering whether there is any attributable risk, which Lantos defines as the risk ‘attributed to study participation as opposed to being attributed to the clinical condition of… [the subject] and the known risk of conventional treatments.’641 Those subjects randomly assigned to NIC in a potential AWT trial would not be exposed to any attributable risk. Presumably if their parent(s) were willing to consent to the study, they would also be consenting to standard care in NIC. The group receiving AWT is potentially of more significance, but given the high risk of death/injury in ‘almost viable’ subjects attributable risk is likely to be minimal. There should also be a consideration of safeguards to ensure the safety of research participants. For example, in a recent study evaluating oxygen saturation targets in preterm neonates, a data safety monitoring board was established that continuously compared the incidence rates of serious adverse events between arms of the study.642 Thus, if a statistically significant trend emerges demonstrating that either arm of the trial is resulting in more frequent adverse results the study can be stopped.
Finally, we must consider how consent for AWT research should be obtained. In neonatal/foetal research informed consent must be obtained from the parent(s) of the
638 Ethical arguments for the withdrawal of NIC treatment thought to be futile, and therefore only likely to prolong suffering, have found strong support in the law. Courts (in England and Wales) have overwhelmingly supported the conclusion that withdrawing treatment in these circumstances is in a preterm’s best interests: Neera Bhatia, Critically Impaired Infants and End of Life Decision Making: Resource Allocation and Difficult Decisions, (Routledge 2005), 41. 639 Mason and Laurie (n599) 659. 640 John Lantos, Neonatal research ethics after SUPPORT, (2018) 23 Seminars in Fetal & Neonatal Medicine 68, 71. 641 ibid 70. 642 ibid 70.
149 subject.643 They will only be able to decide to permit participation in a trial if they are provided with adequate information to make an informed decision. The law (of multiple jurisdictions) requires an even greater degree of risk disclosure to parent(s) for research as opposed to treatment.644 Requiring a more stringent consent, involving an understanding of the purpose of the research, any potential risks or benefits, and the alternatives involved,645 is an important mechanism to ensure that parent(s) are not coerced. Principal investigators should be able to clearly explain to parent(s) what the standard course of care would be, and how being in the trial would be different. In the case of AWT, parent(s) should be counselled about the options regarding not enrolling in the study, and the potential harms and benefits of enrolling (including randomisation). Some scholars have expressed concern about parents’ ability to meaningfully consent to research on the cusp of viability, because of the emotional challenges involved in decisions about giving their offspring a ‘chance of life.’646 Specific aspects of the process, for example, randomisation, can also be distressing to comprehend.647 Uncertainty is hard to communicate. The explanation that this process may be unlikely to benefit this subject but may be able to help preterms in the future will be a difficult conversation for researchers to navigate. The emotional impact on parent(s) is a factor that IRBs must carefully consider.648
One of the biggest problems with research is minimising the effect of ‘therapeutic misconception’ when individuals presume that the experiment in which they are participating (or agreeing their preterm should participate) is medical treatment.649 Parent(s) most likely to agree to experimental AWT are those who believe that the experimental technology provides the best possible chance at life, or potentially of life without complications following NIC. Experimental AWT may benefit some of the first preterms that are subjected to it. There is,
643 In the DHHS Regulations (n598) §46.205 (2) stipulates that effective consent to research on a neonate must be provided by either parent, and in the case of non-viable neonates, §46.205 (c) (5) is clear that both parents must provide effective consent unless one is unavailable. §46.204(e) is explicit that in the case of research on foetuses where there is only the prospect of direct benefit to the foetus, (and not the pregnant person), the effective consent of both parents must be sought unless the father is unavailable to provide it. 644 Hazel Biggs, Healthcare Research Ethics and Law: Regulation, Review and Responsibility, (Routledge-Cavendish 2010), 5-7; 82. 645 Mason and Laurie (n599) 668. 646 Helen Harrison, ‘The offer they can’t refuse: parents and perinatal treatment decisions,’ (2008) 13 Seminars in Fetal and Neonatal Medicine 329. 647 Eric Kodish and others, ‘Communication of Randomization in Childhood Leukemia Trials,’ (2004) 291 The Journal of the American Medical Association 470, 472. 648 I am grateful to an anonymous reviewer for raising this point. 649 Paul Appelbaum and others, ‘False Hopes and Best Data: Consent to Research and the Therapeutic Misconception,’ (1987) 17 Hasting’s Center Report 20, 20. 150 however, the danger that parents may not appreciate the real risk that experimental AWT may not work, or may actively cause harm. Such expectations about new approaches are best managed in the context of a research trial because of a shift in perception. There is increased awareness that the purpose of receiving the treatment is to test the hypothesis about a new approach, with the understanding that good results are not likely, or not without risk, or that standard care is received because of randomisation. If the consent process if designed carefully, it should meaningfully address therapeutic misconception. Discussion about treatment in the distressing circumstances that a pregnancy is going to end/ has ended prematurely will always be difficult. Lantos and Feudtner emphasise that grappling with painful decisions, and the details in the process, will be especially hard for parent(s) when time is limited - sometimes they may have only minutes650 - and when they feel pressured by a sense of emergency. They argue, however, that meaningful consent can still be carefully procured if processes are simplified and parent(s) given ‘key information honestly and straightforwardly.’651 Entirely how we determine a sufficient consent process for an AWT trial must be the subject of further discussion.
Conclusion
Two research teams have claimed proof of principle for AWT. It is plausible that there could soon be calls to test their devices, which might drastically improve the prospects for preterms, on humans. It is necessary, therefore, to consider how and when we should use experimental AWT on humans. Little attention has been paid to the ethical issues in AW research. It is often assumed that AWT constitutes an innovative, beneficial treatment, and thus would emerge almost ‘by accident.’ The tendency to conceptualise experimental uses of AWT as innovative treatment – as extensions of current NIC – and therefore justifiable in the best interests of preterms is flawed.
In this paper, I demonstrated that AWT is medical research. AWT is conceptually distinct from NIC, and it is unknown if it will produce desirable outcomes. Experimental AWT is not ipso facto in any individual preterm’s best interests. Clinical trials will be a necessary part of
650 John Lantos and Chris Feudtner, ‘SUPPORT and the Ethics of Study Implementation,’ (2015) 45 Hastings Centre Report 30, 38. 651 ibid 38. 151 the clinical translation of these devices because of regulatory processes. Clinical trials are thought to ensure protection for research subjects, to produce reliable generalisable knowledge and to better manage therapeutic misconceptions. However, these benefits are contingent upon the conditions of the research trials. Moreover, clinical trials would only be justifiable under particular conditions. In this paper, I highlighted some of the important ethical questions that would need to be considered in designing research trials of AWT devices. I considered the appropriate clinical population for such a trial, the ethical issues in research methods such as randomisation, and the importance of carefully addressing consent and therapeutic misconception. These identified issues remain in need of further scrutiny, but it is hoped that this paper has started the necessary ethico-legal conversation about experimental AWT. It is common in the literature for the development and use of AWT in humans to be discussed as a foregone conclusion. However, we should be careful to avoid focusing on the potential implications of AWT while neglecting issues in the development of the technology.
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PART III - IMPLICATIONS OF PARTIAL ECTOGENESIS
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PAPER FIVE: Artificial Womb Technology and the Choice to Gestate Ex Utero: Is Partial Ectogenesis the Business of the Criminal Law?
In 2017 and 2019, two teams of researchers claimed that their prototype artificial womb (AW) devices, successfully tested on animals, might soon be ready for use on humans.652 It is thought that AWs can better guarantee that preterm delivery does not necessarily result in death/severe complications. Moreover, because the technology is designed to continue the process of gestation ex utero653 (this process is known as partial ectogenesis),654 AWs could become a reliable alternative to later-term pregnancy. There is general consensus that AWs should be welcomed both to aid preterms655 and to alleviate female people656 of the burdens placed solely on them in human reproduction.657 It has been posited that AWs could reduce the burdens placed exclusively on female people in reproduction, because the technology might reduce the need for pregnancy.658 In this article, I demonstrate how artificial womb technology (AWT) will change how risk is perceived and assessed during pregnancy. AWs could present an empowering choice for some pregnant people; enabling them to choose an alternative to pregnancy without risking the loss of their future child. This choice could be sought by pregnant people for a variety of reasons, but it would be particularly empowering for those experiencing dangerous yet wanted pregnancies. The availability of AWs in place of neonatal intensive care (NIC) would shift perceptions of risk in pregnancy, potentially resulting in an increase in terminations of pregnancy that are not intended to result in foetal death. There is, therefore, a need to consider the legalities of opting for ex utero gestation.
652 Partridge and others (n2), Usuda and others (n2). 653 The AWs from recent experiments are designed with the intention of facilitating the continued gestation of developing human entities delivered from a pregnant person’s uterus prematurely. Usuda and others (n2) are explicit that the object of their AW device is to provide an environment in which the subject can behave ‘more like a foetus than a baby.’ 654 Partial ectogenesis is the development of a human entity in an AW for part of the typical gestational period following transfer from a pregnant person’s womb. Kaczor (n101) 113. 655 Romanis (n274). 656 This burden is placed on any person with the reproductive biology that allows them to become pregnant (female) irrespective of gender identity. In the published version of this article, I used the term women (and pregnant women) because the vast majority of people who experience pregnancy identify as women, and this massively impacts on the social experience of pregnant people and the social and medical response to them. However, I chose, in formatting this thesis to use gender neutral language throughout for the reasons explained in chapter two. 657 Hendricks posits that AWs could reduce the risks to health incumbent on female people in pregnancy. Smajdor argues that AWs are a moral imperative because they will alleviate female people from the burdens and suffering innate in pregnancy. See Hendricks (n9) 408-409; Smajdor (n22) 337. Kendal posits that artificial wombs are a ‘much needed option for those women who wish to have children without submitting to the physical burdens of gestation and childbirth…’ and to potentially evade some of the ‘social burdens’ associated with gestation. See Kendal (n9) 8. 658 ibid.
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The clinical translation of prototype AW devices into treatment for human neonates is fraught with ethico-legal issues.659 In this article, I do not deal with these questions, but rather I focus on technical legal questions that AWs will bring. It should be noted, however, that pregnant people will necessarily shoulder any risks associated with AW development. Thus, that female people may not necessarily be as emancipated by AWT as has been suggested,660 because of potential legal restrictions, is all the more concerning. Examining the extent to which the current legal framework is compatible with future reproductive technologies is essential, because AWs bring new challenges concerning their accessibility and application.661 While aspects of my analysis are unavoidably speculative, it is important to raise these questions before the first human use of AWs.662 Moreover, this investigation allows for a meaningful critique of current provisions. The Abortion Act 1967 has been frequently been criticised for affording doctors, rather than pregnant people, the power to make choices about female bodies.663 In light of emerging technologies, it remains important to continue the debate about whether the medical monopoly on termination decisions is appropriate. Such analysis can meaningfully add to the contemporary debate about decriminalisation.
Scholarship exploring the ethico-legal implications of AWs has been primarily directed towards the potential movement of the viability threshold, and thus whether there will be,664 or should be665 more limitations on access to conventional abortion (a termination of pregnancy resulting in foetal death).666 In this article, I do not raise such questions because AWs do not present an alternative to conventional abortion. Firstly, ‘foetal extraction’ for gestation ex utero would be a much more invasive procedure than a conventional abortion667 (drug-induced or vacuum/surgical). Secondly, AWT will not be able to sustain embryonic
659 These important issues related to clinical translation are explored in Elizabeth Chloe Romanis, ‘Artificial Womb Technology and Clinical Translation: Innovative Treatment or Medical Research?’ (2020) 34 Bioethics 392. 660 Hendricks (n9); Smajdor (n9); Kendal (n9). 661 Andrew Grubb, ‘Abortion Law in England,’ (1990) 18 Law, Medicine and Healthcare 146, 156. 662 Issues related to speculative discourse are addressed in co-authored research with Claire Horn at Birkbeck, University of London. See Romanis and Horn (n44); Horn and Romanis (n71). 663 E.g. Sally Sheldon, Beyond Control: Medical Power and Abortion Law, (Pluto Press 1997); Jackson (n99), 80; Sally Sheldon, ‘Abortion Act 1967: a Critical Perspective,’ in Ellie Lee (ed), Abortion Law and Politics Today, (Macmillian Press 1998). 664 Dalzell (n21); Schultz (n21); Alghrani (n22). 665 Overall (n107); Räsänen (n82); Perry Hendricks, ‘There is no right to the death of the fetus,’ (2018) 32 Bioethics 395. 666 I use the term ‘conventional abortion’ to refer to the medical process of terminating a pregnancy that results in foetal death. Conventional abortions include drug-induced abortion and surgical abortion. 667 Alghrani (n14) 316.
155 products of conception in the foreseeable future, and most people seeking conventional abortion opt for abortion before 13 weeks.668 Finally, the claim that AWT is an ‘alternative’ to abortion fundamentally misunderstands why abortion is protected in liberal societies,669 including (predominantly women’s) experiences and motivations in seeking abortion.670 For these reasons, it is important that we preserve liberal access to conventional abortion.
In this article, I argue that partial ectogenesis to allow a person who might otherwise have to continue a pregnancy experiencing some burden to themselves (or have an unwanted conventional abortion) should be lawful. I argue that pregnant people, rather than medical professionals, should be empowered to determine what threshold of risk in their pregnancy justifies foetal transfer to an AW. I demonstrate in this article, however, that present law does not accommodate this possibility. Thus, we should either decriminalise terminations of pregnancy in England and Wales, or reform current legal provisions on the grounds that they are too broad, and the circumstances in which terminations are lawful are too restrictive. It is clear that the criminal law, in particular such old and outdated offences, should not be the basis of medical regulation in this matter. However, since pregnancy termination remains a criminal offence, I offer an account of the problems the current legal framework creates. I limit my discussion to partial ectogenesis671 and to situations in which pregnant people want to end their pregnancies without corresponding foetal death.
First, I outline the prospects for, and potential uses for, AWs in place of neonatal intensive care. Second, I outline the potential impact of the technology on perceptions of risk in pregnancy and demonstrate how AWs have particular utility in minimising the burdens female people have to experience in pregnancy, especially in those instances in which pregnancy is, or becomes, dangerous. Third, I outline the criminal law surrounding
668 Department of Health (n460) 4. 669 The account given as to why AWT is not an alternative to conventional abortion has been greatly influenced by research collaboration with Claire Horn; Romanis and Horn (n44); Horn and Romanis (n71). Also see Sarah Langford, ‘An End to Abortion? A Feminist Critique of the “Ectogenetic Solution” to Abortion,’ (2008) 31 Women’s Studies International Forum 263. 670 Cannold (n14). 671 There might be future calls to attempt to use the current prototype AW devices to develop complete ectogenesis whereby embryos could be gestated entirely ex utero (without the need for a pregnancy). The prospects of AWT being realistically used for this process are far less likely. Complete ectogenesis (if possible) is still decades away, because of the legal and political realities limiting embryo research, and because of the uncertain realities of embryo science. The technology we have, at least for now, is only a viable facilitator of partial ectogenesis (rather than eliminating the need for all pregnancy).
156 termination of pregnancy and some of the inadequacies in this regulation, particularly with regard to the application of the legal framework to emerging biomedical technologies. It may be surprising to many that in 2019 the termination of pregnancy remains a criminal offence in England and Wales.672 The Offences Against the Persons Act 1861 (OAPA 1861)673 established the offence of unlawfully procuring miscarriage that remains the basis of the law today, 158 years later. The offence is committed when a pregnant person, or any other person, takes steps to unlawfully procure miscarriage with the intention of procuring miscarriage.674 A pregnant person is only guilty if they are actually pregnant at the time of the attempt,675 whereas other persons can be found guilty of unlawfully procuring miscarriage irrespective of whether the person is pregnant.676 Medical professionals are afforded a defence in England and Wales under particular circumstances prescribed in the Abortion Act 1967 (AA 1967). Despite the offences contained in the OAPA 1861 forming the foundations of the law, I demonstrate that the terminology used to describe the offence is vague. There is no definition of ‘miscarriage’ in any criminal statute. Miscarriage was interpreted to mean ‘the termination of an established pregnancy’ in a high court challenge concerning the legality of contraceptives.677 This is so broad, however, that it becomes confusing when applied to decisions made later in pregnancy. The definition does not illuminate whether ‘miscarriage’ encompasses any deliberate ending of a pregnancy, or only those resulting/ intending to result in foetal death. I demonstrate that there are plausible different interpretations that might be afforded to ‘unlawful miscarriage,’ such that there are different legal consequences to opting for ex utero gestation depending on the analytical lens that is adopted in interpreting the OAPA 1861. Moreover, the use of the phrase ‘unlawfully’ in the OAPA 1861 itself means that the parameters of the offence are ill defined. If a doctor terminates a pregnancy outside of the specific defences granted in the AA 1967, but with the intention of ‘treating’ the delivered foetus in an AW, have they committed the offence of
672 The Offences Against the Person Act 1861 also criminalised termination of pregnancy in Northern Ireland. However, a majority vote of the House of Commons voted to decriminalise termination in Northern Ireland in early July 2019. Abortion has been decriminalised since the repealing of the law in Northern Ireland (Executive Formation) Act 2019, s.9 came into effect on 22nd October 2019. The Government has now launched a consultation about what regulatory framework should be put in place concerning abortion provision. See HM Government, ‘A New Legal Framework for Abortion Services in Northern Ireland’
157 unlawfully procuring a miscarriage?678 Answering this question is crucial because it establishes whether all medical interventions to end pregnancy are in need of legal justification, or only a subset of terminations with particular consequences. Finally, I consider the defences available in the AA 1967 for doctors providing terminations of pregnancy with the intention of continuing gestation ex utero. I argue that the AA 1967 does not account for shifting perceptions of risk that AWs could bring because it does not provide permission to end a pregnancy for less severe risks or non-medical reasons, even if the foetus survives the termination. This analysis exposes quite how restrictive the AA 1967 is.
The Prospects for Artificial Womb Technology
In 2017, a US research team announced the development of the ‘biobag.’679 This prototype AW had, in early trials, successfully supported lamb foetuses on the viability threshold for four weeks.680 In 2019, a second research team in Australia/Japan published the results of an alternative design named the ‘EVE platform’ with some comparable success.681 These devices are designed to replicate the conditions and function of the human uterus so that the developing human entity subject to the device (the gestateling)682 is able to continue to gestate. The gestateling is submerged in artificial amniotic fluid in a sealed plastic bag. Circulation is maintained by the gestateling’s own heartbeat (assisted by an oxygenator) and catheters imitating umbilical cord access. These studies signal a change in approach: from assisting a preterm with the necessary bodily functions for survival in the external environment that they are attempting, but struggling, to perform themselves, to continuing the process of gestation ex utero.683
678 Alghrani and Brazier (n25) 75. 679 The biobag has also been referred to as ‘EXTEND’ therapy in more recent publications by this research team. See Avery Rossidis and others, ‘Premature Lambs Exhibit Normal Mitochondrial Respiration after Long-Term Extrauterine Support,’ (2019) 46 Fetal Diagnosis and Therapy 306. 680 Partridge and others (n2). 681 Note that this research group first published results in 2017 (n236), but published results of a refined device in 2019 (n2). 682 A gestateling is ‘a human [entity] in the process of ex utero gestation exercising, whether or not it is capable of doing so, no independent capacity for life:’ Romanis (n274) 753. The term gestateling will be used throughout this article to refer to a human entity in the process of gestation ex utero. A unique term is used because the subject of an artificial womb is conceptually distinct from both a foetus and a neonate. 683 Romanis (n274) 753.
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Prematurity remains the leading cause of death for infants born at or before 24 weeks,684 because the infant is usually too functionally immature685 to survive, even with assistance. In addition to the innate risks of mortality and morbidity in prematurity, the use of conventional NIC technologies also harbours significant risk of serious injury or death due to infection,686 irreversible lung damage687 and heart failure.688 The biobag demonstrates the opportunity to deal with these problems. The lamb subjects in the trial all exhibited organ maturation and growth.689 Moreover, there were no incidences of infection or heart failure during the experiment and, after the experiment, all subjects were delivered from the AW ‘healthy’ with normal heart and lung function.690 Similar results691 were reported with the EVE platform, leading the research team to conclude that their findings demonstrate ‘the potential clinical utility of a further refined EVE therapy system to improve outcomes for extremely preterm infants.’692 The biobag team suggest that, following further scientific and safety validation,693 they will soon start preparing for testing on humans.694
It is initially anticipated that these AW devices could aid gestatelings removed from the uterus at, or just below, the borderline of viability (23-24 weeks).695 Current methods of NIC have succeeded in pushing back our understanding of viability,696 but this appears to have reached a natural limit at 22 weeks.697 Resuscitation, and/or subsequent support provision, is usually not given to preterms delivered before 22 weeks,698 because these preterms are thought to be too developmentally immature to benefit.699 In theory, AWs would not be
684 Azad and Matthews (n6) 132. 685 In particular, infants born at or before 24 weeks often have lungs too immature to withstand pulmonary gas exchange, and thus cannot acquire sufficient oxygen. 686 Lissauer and Clayden (n225) 164. 687 ibid 159. 688 ibid 167. 689 Partridge and others (n2) 6. 690 ibid 2 and 6. 691 The EVE platform study has a lower survival rate (of 87.5%) and incidences of white matter brain injury and early signs of liver dysfunction amongst trial subjects (lamb foetuses): Usuda and others (n2). 692 Usuda and others (n2). 693 ibid 10 694 Couzin-Frankel (n230); Dr Flake, leading the biobag study, suggests that even only a decade from now AWT could have completely replaced NIC: Children’s Hospital of Philadelphia (n551). 695 Partridge and others (n2) 11. 696 Alghrani (n10) 307. 697 This point is identified because it is the age of the youngest premature neonate that has ever survived. It is notable, however, that lung development will occur at a slightly different rate for different foetuses and so this is not a fixed point. 698 This approach was actually recommended by the Nuffield Council on Bioethics in their 2006 Report. See (n251). 699 The exact point of foetal viability is disputed, but there is broad consensus that lung maturity is the deciding factor. Whilst there are some examples of foetuses having survived before 22 weeks, the vast majority of foetuses born before this point do not have solid lungs. This is why viability is usually estimated to be between 22-24 weeks.
159 subject to the same constraints of gestational maturity.700 Therefore, if AWT is used to sustain ‘just-viable’ preterms successfully by imitating gestation, there could eventually be instances where the technology is used to sustain younger preterms. Doctors will have clinical incentives to attempt to use the technology at the request of pregnant people701 to support preterms delivered before the current threshold.702 Over time, it is plausible that the technology could increasingly be used to sustain less functionally mature developing human entities, for example, gestatelings removed from the uterus as young as 18 weeks.703
In the animal studies discussed, the subjects were transferred into the AW devices after caesarean delivery. As a result, attempts were made to control the stress experienced by the subject in transfer. For example, a drug was administered to the subject to ensure that fluid did not drain from the lungs.704 In addition, the subjects did not experience any of the potential pressures or trauma in a natural birth. For this reason, I envisage these AW devices being most effective in situations where delivery can be managed by caesarean, rather than following spontaneous preterm deliveries. This is not to say that attempts would not be made to utilise AWs as treatment in those cases, only that there is cause for speculation that outcomes might not be as promising. For the purposes of this article, those instances in which preterm delivery is anticipated and is actively undertaken are of more interest.
Changing Choices in Obstetrics
AWs could empower pregnant people who struggle to make decisions about pregnancies that have become, could become, or are perceived to be, dangerous. Moreover, AWs could provide individuals with an increased ability to decide what risks they are willing to assume during gestation. In this section, I demonstrate a potential shift in risk perception that occurs with the availability of AWs, and how this might lead to a change in demand (both in nature and frequency) for endings to pregnancy. The choice to end a pregnancy and deliver a foetus
700 Romanis (n274) 752. 701 Alghrani and Brazier point out that ‘once the foetus is ex utero, alive or dead, and once a woman’s bodily integrity is no longer at stake, the male progenitor should have an equal say with regard to foetal treatment and paternal consent should also be sought.’ See Alghrani and Brazier (n25) 62. 702 Romanis (n274) 753. 703 Alghrani and Brazier identify this point as a meaningful point to engage with a shifting viability threshold and the law, thus I also adopt this point in this article. See Alghrani and Brazier (n25) 62. 704 Partridge and others (n2).
160 preterm (before 37 weeks)705 is a difficult, but not uncommon, choice that pregnant people and obstetricians must navigate when pregnancies go wrong. This choice (to induce a premature end to the pregnancy) is a response to complications that threaten the life or health of the pregnant person or their foetus. Examples of cases in which premature ending of pregnancy is considered necessary to manage risks in a pregnancy include: placental abruption,706 severe traumatic injury,707 preeclampsia,708 chronic hypertension,709 diabetes,710 unmanaged uterine infection,711 significant foetal compromise,712 maternal cancer, and foetal growth restriction.713 Combined, these complications in pregnancy are not uncommon, and therefore the induced ending of a pregnancy to manage them is also not uncommon.
The decision about whether a pregnancy should be continued, or ended either by a termination likely to result in foetal death, or by ‘premature delivery’ with the intention that the delivered preterm will be sustained with NIC, depends on a number of factors that have to be balanced. The crucial relevant factors include: the gestational age and maturity of the foetus, the severity (and nature) of the complication, additional risks increasing with the duration of pregnancy, the risk for the foetus in utero, and the risk to the foetus of being born premature.714 The removal of the foetus before complete gestation is risky because the foetus
705 Ian Symonds and others, Problem Orientated Obstetrics and Gynaecology, (Arnold Publishers 2002), 302. 706 Where the placenta becomes detached from the uterine wall and compromises the foetal condition: see ibid, 103. During or following placental abruption, terminating the pregnancy is the only chance to save the life of the pregnant person, and depending on the duration of gestation, their foetus. 707 If a pregnant person suffers a severe traumatic injury their prognosis, and that of the foetus when their vital signs are weak or absent, are often improved by terminating the pregnancy preterm. See Charles Beckman and others, Obstetrics and Gynaecology, (Wolters Kluwer 2014), 203. 708 Preeclampsia is a serious condition characterised by high blood pressure, which if unmanaged leads to organ damage, neurological symptoms and fluid in the lungs. Substances being released from the placenta into the maternal blood vessels cause the condition to develop. See Cari Nierenberg, ‘Preeclampsia: Signs, Symptoms & Treatment,’ (Live Science 2017)
161 is underdeveloped715 and usually cannot survive without support. NIC can improve the chances of survival, but there remains a high risk of complications716 causing disability or death.717 As gestation advances, the threshold of risk of early delivery falls,718 because the likelihood of complications resulting from premature birth decrease with gestational age719 and maturity.720 Where the pregnant person is stable enough and anxious to save their foetus, termination is undertaken as late as possible. Ending the pregnancy is seen as a last resort, because NIC is no guarantee that a delivered preterm can survive.
Once a decision is made to end a pregnancy, and the timing decided, the mode of ending the pregnancy must be determined. The mode of termination can determine the outcome. In what are thought of as ‘attempted premature deliveries’, the foetus is extracted from the uterus by caesarean (the surgical opening of the abdomen and womb)721 or drug induced vaginal delivery.722 These methods of ending pregnancy carry their own risks.723 Deciding if, when and how to end a pregnancy is a case of balancing the risks affecting the pregnant person and foetus in continuing the pregnancy, versus ending it. In some cases, when continuing the pregnancy endangers both the pregnant person and the foetus, opting to end the pregnancy (and provide NIC post-birth) can be a clear decision to make in order to attempt to save both. This decision can be difficult in cases where continuing with the pregnancy is dangerous for the pregnant person, but would be beneficial for the foetus, and termination carries greater risks for it. In deciding whether to continue or end the pregnancy, such risks can be hard to weigh both for doctors exercising clinical judgement, and for pregnant people anxious for
715 Common risks associated with premature delivery for the foetus include, but are not limited to, underdeveloped lungs and respiratory issues, circulatory problems, low blood pressure, and an inability to swallow or suck: Lissauer and Clayden (n225) 164; 167. 716 For example, infection: ibid 164. 717 For further discussion of the conceptual differences between AWs and conventional neonatal intensive care: Romanis (n274). 718 Symonds and others (n705) 55. 719 Lissauer and Clayden (n225) 159. 720 In some instances, when complications and the need for premature termination of pregnancy become evident earlier in the pregnancy, steroids can be administered to accelerate lung maturity to reduce some of the most significant risks associated with preterm birth: Symonds and others (n705) 90. 721 National Institute for Health and Care Excellence, ‘Information for the Public; Caesarean Section,’ (2011)
Used as an alternative to conventional methods of NIC, AWs have the potential to produce better and more consistent outcomes for developing human entities removed from the uterus before 37 weeks. Current NIC is seen as an unreliable/ dangerous alternative to remaining pregnant (because of the inherent risks and limitations) for pregnant people who are concerned with not losing their foetuses. Most pregnant people who seek to end their wanted pregnancies before full term do so only because their pregnancy is dangerous, and they seek to remain pregnant for as long as possible because of their concerns about their foetuses and prematurity/ conventional NIC. AWs, however, could eliminate much of the concern over the risks of prematurity, and the limited success of NIC. This could enable a new kind of decision-making in obstetric practice, shifting the focus to the person’s experience of pregnancy, rather than the ‘foetus’s interests’ in not being removed from the uterus prematurely. AWs thus have the potential to enhance pregnant people’s autonomy by lessening the pressure incumbent on them to act in self-sacrificial ways during a wanted pregnancy. This change in focus could result in more ‘endings of pregnancy’ being considered clinically appropriate, and/or endings of pregnancy on medical grounds being advised earlier in gestation. This could then reduce the pressure on pregnant people in terms of forcing them to make difficult decisions about termination themselves.724AWs have the potential to become not just about rescuing developing human entities from the effects of prematurity, but also about rescuing pregnant people from aspects of pregnancy without requiring them to sacrifice or risk their foetus. There are four ways in which AWs will reframe perceptions of risk in pregnancy.
First, taking the case of dangerous pregnancies, it is possible that AWs will shift perceptions of what level of risk would be sufficient to justify an intervention to end a pregnancy on the grounds of a person’s health. At present, the concerns about prematurity mean that only the most serious risks to the pregnant person’s health and life are considered medically sufficient
724 In instances where a pregnant person faces a threat to their own health, but wants to give their foetus the best chance of life, this can be a very difficult decision to make: AWT might effectively make it so that pregnant people do not have to actively make a choice between their health and their foetuses.
163 grounds to end pregnancies prematurely. This often results in pregnant people making the choice to sacrifice their own health.725 If there were a more reliable alternative to natural gestation than conventional NIC, there is every possibility that the threshold of sufficient risk to justify terminations will be lowered. This might be lowered to include less severe complications (such as the earlier stages of preeclampsia or less serious traumas) that are not thought sufficiently grave to justify risking a pregnant person’s wanted foetus being born premature, but might be thought sufficient to justify ending a pregnancy in favour of artificially-continued gestation. Pregnant people concerned for their foetuses would consequently no longer have to be advised on the basis of needing to tolerate the same level or degree of risk. Moreover, lesser dangers to their health and well-being will be considered more serious.
Secondly, AWs could impact perceptions of viability and could, therefore, remove the importance placed on gestational maturity in obstetric decision-making. If foetuses are considered ‘viable by virtue of technology’726 earlier in a pregnancy, this could diminish the emphasis placed on the timing of delivery from the decision-making process that obstetricians evoke when considering bringing a high-risk pregnancy to an end. With the concern about foetal viability increasingly removed from the equation, and because lower levels of risk that signal the need for intervention are likely to occur earlier in pregnancy, there could not only be an increase in premature endings to pregnancy, but these terminations could be more ‘premature.’ There might be attempts to transfer foetuses to AWs very early in gestation (18 weeks), but also more routine attempts to end pregnancies closer to the threshold of viability (22-24 weeks) as opposed to continuing and monitoring the pregnancy to ensure delivery is as far along as possible.
Thirdly, if AWs become reliable, obstetricians would not have to frame their advice to pregnant people as a ‘balancing act’ in terms of weighing up the risk to their foetuses against
725 In 2016, Heidi Loughlin was diagnosed with an aggressive cancer whilst pregnant and was forced to choose between life- saving treatment and remaining pregnant. This case caught the attention of the national media. Heidi opted for premature delivery at 28 weeks to receive treatment in the hope that her preterm daughter would be developed enough to successfully be supported by NIC. Waiting this long for treatment was extremely risky for Heidi because the cancer continued to grow and spread during the time she remained pregnant. She fortunately survived, however her neonate, Ally Loughlin, died soon after delivery: Walker (n264). 726 By this phrase I mean to suggest that foetuses could be considered viable if they were placed in a machine able to continue gestation, but they are not ‘naturally viable’ because they have not reached sufficient developmental maturity to survive without gestational support aiding continued organ maturation. 164 the risks to their health in remaining pregnant. Presently, even when a person’s health is at risk due to their pregnancy, they are often advised (by choice) about the severity of the risk to her, in comparison to the severity of the risk to their wanted foetus of terminating early. Often pregnant people are advised to end pregnancy only when the threat to their health is serious, because only this is thought to outweigh the risk to the foetus of prematurity/ NIC. If AWs were available, and could mitigate the impact of prematurity, less emphasis would be placed on a comparative account of risk. Whilst it could never be guaranteed that there is no risk to the foetus in removal for gestation ex utero, there would not be the same impetus to evaluate risks to the foetus. If the technology were considered reliable, any risks to the foetus would result only from the process of transfer, as opposed to the risks of preterm delivery coupled with the inherent risks of being born premature. With less concern regarding the impact of prematurity on the part of both pregnant people and their obstetricians, it becomes possible for the nature of the discussions regarding management of dangerous pregnancies to shift. Instead of a comparative account of risk to the pregnant person and to their foetus, conversations could be directed more toward the pregnant person’s condition in itself, and the associated risks for them in continuing the pregnancy. The pregnant person would be free to make decisions predominantly on the basis of their own health with the knowledge (if their concern) that prioritising their health will not always be in direct conflict with foetal welfare. The technology will have the potential to change the language used in these circumstances of the ‘maternal-foetal conflict,’727 a common conceptualisation that is the result of the pregnant person and foetus’s physical interests being understood as in competition with each other.
The decision about whether to end a pregnancy for medical reasons could be reduced to a case of considering the impact of pregnancy on a person’s health, and weighing up the risk to their health of termination against remaining pregnant and delivering at the end of 37 weeks. In most cases, especially when a person’s life or health is at risk, these risks are likely easily resolved because the mode of delivery would be the same whether the pregnancy is delivered preterm, or at term (by caesarean). Arguably, a managed elective caesarean is likely to be less
727 The ‘maternal-foetal conflict’ model is a way of conceptualising pregnancy that presents the interests of the pregnant person and foetus as in contention with each other. Bowden presents a compelling argument, even outside of the possibility of technology like AWT, as to why there is an inherent problem in adopting this conceptualisation, because the welfare of a pregnant person and their foetus are interconnected: Catherine Bowden, ‘Are We Justified in Introducing Carbon Monoxide Testing to Encourage Smoking Cessation in Pregnant Women?’ (2019) 27 Health Care Analysis 128, 139; also see the argument about the need to deconstruct the maternal-foetal conflict conceptualisation of pregnancy made in the AWT context in Romanis and others (n29).
165 risky for pregnant people in such cases than an emergency caesarean.728 Even if this were not the case, such a balancing exercise would more often be resolved in favour of termination when there is any risk in remaining pregnant to a person’s life or health. I will return to the issue of balancing the risk of termination versus the risk of remaining pregnant in legal terms later in this article.
Finally, if AWs were a reliable alternative to pregnancy a demand might emerge for endings to pregnancy (in favour of ex utero gestation) in less urgent or in non-medical circumstances. Pregnant people whose pregnancies pose a lesser risk to health may request to opt for an alternative to their gestation. Unpleasant or uncomfortable, but not actively dangerous, experiences during pregnancy might encourage pregnant people to seek termination in favour of AWs. Unrelenting morning sickness, mobility issues and swollen limbs, migraines, insomnia, anxiety, fear of developing post-partum depression and plenty of other side effects can be difficult to endure for some pregnant people. Kendal suggests that there could also be pregnant people who seek termination in favour of an AW to evade social stigmas associated with pregnancy.729 For example, those concerned about the impact on their work and potential discrimination or struggling with addiction.730 There could, in these cases, be innate risks apparent in the preterm extraction of a foetus for ex utero gestation, that are not apparent in a person’s remaining pregnant and delivering after 37 weeks. For these reasons, the use of AWs for social considerations is less likely to be considered medically acceptable than in circumstances involving some clinical justification. In English law, patients are not empowered to demand any particular form of prenatal care731 (presumably including ex utero gestation), and simultaneously, doctors cannot be compelled to perform medical interventions in non-emergencies.732 It is unlikely, especially in communal health systems, that pregnant
728 Oonagh Keag and others, ‘Long term risks and benefits associated with caesarean delivery for mother, baby and subsequent pregnancies: Systematic review and meta-analysis’ (2018) 15 PLOS Medicine e1002494. 729 Kendal (n9) 12-13. 730 In using these examples, I am not trying to suggest that pregnant people in these circumstances should seek AWs in place of conventional termination or remaining pregnant. I only wish to suggest that, in those instances where a person wants to become a parent or wants to give up their foetus for adoption (rather than pursue abortion for their own reasons), partial ectogenesis could be a favorable option for someone with those preferences in some circumstances. 731 The law is clear that, outside of emergencies, patients do not have the right to demand any particular treatment over another following R (Burke) v General Medical Council [2005] EWCA Civ 1003. This is evident in the context of prenatal care: for example, while the law is supportive of choice in childbirth a person cannot demand one form of childbirth over another, e.g. a maternal request caesarean section, if their doctor is unwilling to offer that choice: Romanis (n78), 252. 732 ibid, also the law is supportive of doctors’ right to conscientiously object to certain treatments in a number of instances. In this context, it is notable that doctors are entitled to object, on the grounds of conscience, to provide pregnancy terminations when the termination is not necessary to save the life of the pregnant person: Abortion Act 1967, s 4.
166 people would be routinely enabled to opt for ex utero gestation without medical cause. However, the possibility that such a demand for an alternative to natural gestation to allow pregnant people to avoid any (social) risks in order to reproduce is something we should take seriously.
This possibility raises new ethico-legal (and socio-political)733 issues. Should the AW be seen as, and used only as, a healthcare resource, or should it be welcomed as a new reproductive choice? Hammond-Browning argues that although partial ectogenesis provides many benefits to those carrying a pregnancy, ‘foetal welfare’ and ‘uterine experience’734 must be taken into account. She argues, therefore, that an elective foetal transfer would only be justifiable in instances of dangerous pregnancy and/or where it can be ‘shown to be in the foetus’s best interest.’735 In contrast, Kendal argues that the AW must be utilised as a reproductive choice in order to afford those of female reproductive biology the potential for equal opportunity, both in terms of enabling them to reproduce with minimal physical risks and to evade what she terms the ‘social burdens’ that she claims inevitably result from pregnancy.736 If pregnant people could be enabled to exercise greater choice about what risks they are willing to assume in pregnancy without risking their foetuses, to what extent does the law empower them to opt for partial ex utero gestation? I now proceed to demonstrate that if all foetal extraction before 37 weeks requires legal justification, then it is unlikely that the current legal framework would permit pregnant people to end their pregnancies in order to opt for AWT for social reasons. This is because these circumstances fall outside of the AA 1967 and, potentially, the defence at common law. Moreover, pregnant people may not be able to opt for AWs at lower thresholds of maternal risk, because the AA 1967 is drafted to justify the ending of pregnancy only in instances of severe risk.
733 There are interesting socio-political implications associated with the increasing availability of AWs –for example, the negative implications of people (predominantly women) feeling the need to opt out of complete pregnancy in order to return to work earlier, or the use of AWs to police pregnancy where pregnant people are non-compliant e.g. drug-users. Such issues are beyond the scope of this paper. 734 Hammond-Browning (n9) 365. 735 ibid 362. 736 Kendal (n9) 8 and 12-13. I agree that ectogenesis could present an important reproductive choice for female people; however, it is inappropriate to label ectogenesis as a solution to social problems since this suggests that there is something inferior about the female body and its role in gestation. The argument has the implication that we should remove gestation from the body to solve discrimination against women, rather than attempt to deconstruct the problematic social reactions to gestation and the female body: Horn and Romanis (n71).
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The Legal Permissibility of Pregnancy Termination
The AA 1967 specifies that the law regarding termination is contained in sections 58 and 59 of the OAPA 1861. The actus reus of unlawfully procuring miscarriage is completed when an individual takes any unlawful steps to procure miscarriage (by any means). The requisite mens rea is that the object of that individual’s actions is the procurement of miscarriage. 737 The offence is committed only in the absence of a defence. Defences are clearly listed in the AA 1967, which I will explore in detail later in this article. The offence of unlawfully procuring miscarriage is broad in its construction and lacks detail. The possibility of prematurely ending a pregnancy without it necessarily resulting in foetal death was not envisaged when the OAPA 1861 was first constructed. Acts of Parliament that have subsequently added and amended defences to the offence of procuring miscarriage (AA 1967, Human Fertilisation and Embryology Act 1990) were also drafted with the reasonable assumption that termination of pregnancy usually results in foetal death, and that other forms of termination later in pregnancy to save a pregnant person’s life are ‘premature deliveries’ that only occur later in pregnancy, and in circumstances encompassed in the AA 1967. The offence of unlawfully procuring miscarriage, therefore, was deliberately designed to be all encompassing due to the limited knowledge of pregnancy and foetal development in 1861, and to include all the various different methods of procuring abortion that could be used by back-street abortionists.
The advent of AWs, and other technologies, that have enabled the possibility of prematurely ending a pregnancy without causing foetal death, is a blind spot for many areas of the law. The broad construction of the offence, in light of advancing technology, causes increasing uncertainty. This is primarily because the offence turns on the definition afforded to miscarriage,738 and subsequently how we might then define an ‘unlawful miscarriage,’ as this is somewhat dependent on the meaning of miscarriage itself.
737 Offences Against the Person Act 1861, ss 58 and 59. 738 Smeaton (n677) per Munby J at para 338.
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The term ‘abortion’ featured in the first British statute to regulate terminations, Lord Ellenborough’s Act of 1803,739 but was subsequently abandoned in other statutes until the AA 1967. The term ‘termination of pregnancy’ was not used in law until the AA 1967.740 Notably, despite the use of these terms in more modern statutory provisions there were no amendments introduced to change, clarify or supersede the terminology of miscarriage in the OAPA 1861. Whilst miscarriage might seem straightforward in meaning, there are two possible interpretations with different consequences for how the offence is understood and where it applies, that could be adopted. For the purposes of this article, these interpretations must be explored in the context of terminations later in pregnancy. Dickens noted that ‘one may allege that “miscarriage” is the wider expression covering a removal or discharge of the contents of the uterus before natural birth,’ however he also posited that the phrase in its natural meaning should be accepted as a synonym of abortion (a deliberate intervention to end a pregnancy resulting in foetal death).741 There has been limited further exploration of this issue, because we tend to think of terminations not intended to result in foetal death as ‘premature deliveries’ accounted for under the AA 1967. In the context of contemporary and future medical developments, however, the uncertainty in the meaning of ‘miscarriage’ may become more problematic because of the possibility of ending pregnancy in favour of ex utero gestation if AWs did replace conventional NIC.
Smeaton,742 the only case in which a court has been required to consider the meaning of miscarriage in the OAPA 1861, concerned the legality of the morning-after pill. The Society for the Protection of Unborn Children alleged that contraceptives designed to ensure the prevention of a fertilised egg to implant in the uterus amounted to a ‘criminal miscarriage.’ Munby J was unsympathetic, holding that ‘whatever it may or may not have meant in 1861 the word miscarriage today means the ending of an established pregnancy, and there is no established pregnancy prior to implantation…”743 It was held that miscarriage was ‘the expulsion of the contents of a pregnant uterus’ at any point in pregnancy.744 This interpretation of miscarriage is too broad, because it makes no reference to the outcome of the
739 Bernard Dickens, Abortion and the Law, (MacGibbon & Kee 1966), 25. 740 Vivienne Harpwood, Legal Issues in Obstetrics, (Aldershot 1996), 216. 741 Dickens (n739) 30. 742 ibid. 743 Smeaton (n677) per Munby J at para 17 (my emphasis). 744 Harpwood (n740) 216. 169 miscarriage. If this interpretation were correct, unlawfully procured miscarriage would be any deliberate cessation of pregnancy in the absence of a defence.
There are grounds to believe an alternative definition of miscarriage might be adopted if the question were re-examined, particularly in the context of later term pregnancy. Smeaton745 focused on the beginning of pregnancy. The judgment emphasised that an instrument of procuring miscarriage had to have the capacity of ending an established pregnancy. Later in pregnancy, there is no issue regarding the established status of a pregnancy. Instead, the question is a much more explicit one. Does (unlawfully) procuring miscarriage necessarily involve intent to cause foetal death? There was a heavy reliance in the Smeaton judgment on medical evidence; many expert witnesses were called, and medical texts were utilised. Munby J was clear that the definition of miscarriage that he arrived at was also ‘the current understanding of what is meant by miscarriage when used by lay people in the popular sense.’746 This implies that medical and lay opinion of what a miscarriage involves is relevant in understanding what it legally encompasses. When the OAPA 1861 was drafted there was no comprehension that there might be the possibility of ending a pregnancy without foetal death being both a necessary part of, and the intention of, the process. Common understandings of, and some medical definitions747 of, miscarriage include death as integral to the process. The second potential interpretation of miscarriage is, therefore, the ending of an established pregnancy resulting in foetal death. This will be referred to as ‘miscarriage as foetal death.’ The difference between the two interpretations is that one is concerned with the condition of the foetus, and the other is not.
The actus reus and mens rea of the offence differ wildly depending on which interpretation is adopted. If miscarriage means any deliberate cessation of pregnancy (in the absence of a defence) then ending a pregnancy in order to facilitate ex utero gestation would fall within the parameters of procuring miscarriage (and, therefore, a doctor would need to demonstrate lawfulness in common law or under the AA 1967). However, if miscarriage necessarily includes only terminations that result in foetal death, ending a pregnancy to opt for ex utero
745 Smeaton (n677). 746 ibid per Munby J at para 17. 747 Martin (n254) 480-481; Martyn Page (ed), British Medical Association Illustrated Medical Dictionary, (Dorling Kindersley 2013), 370. 170 gestation would not be a criminal matter so long as the intention was that the foetus survives the ending of pregnancy. There is an important distinction to be remembered here between endings to pregnancy where foetal death can be considered deliberate, and those where it can only be considered incidental.748 It is necessary that we ascertain which interpretation is, and should be adopted, in the criminal law. Medical technologies, of which AWs are just one, are increasingly blurring the distinction between those events that we would conceptualise as ‘medical premature deliveries’ and the deliberate unlawful ending of pregnancy. These technologies are making it more likely that questions surrounding the parameters of unlawfully procuring miscarriage will become a real issue in obstetric practice. Is the ending a pregnancy to opt for an AW the unlawful procurement of miscarriage and thus in need of legal justification? If so, are there available defences in the AW context? This investigation, which I now undertake, involves examining the meaning of ‘miscarriage’ and the meaning of ‘unlawful,’ as used in s.58. It should be noted that such an investigation of the law would not be necessary if termination were decriminalised, as questions of criminal liability would become irrelevant.
Is All ‘Foetal Extraction’ Unlawful Procurement of Miscarriage?
In this section, I explore the possible interpretations that might be afforded to ‘miscarriage’ and ‘unlawful miscarriage’ in the OAPA 1861. I consider whether the law could be interpreted to mean that all deliberate endings to a pregnancy are prima facie criminal, or whether only terminations resulting in foetal death are ‘miscarriages’ for the purposes of the criminal law. I consider the possible arguments that might be offered to support each interpretation and I analyse the law from both of these differing perspectives to show that there would be different conclusions reached about the legal consequences of foetal death depending on the analytical lens adopted. I demonstrate that we cannot be certain how miscarriage would be interpreted if the matter came before a court of law, as there are compelling reasons that mean both are plausible accounts of the law. However, I advocate that (assuming criminalisation is appropriate), the most ethically sound operation of the law is
748 Under this interpretation (miscarriage as termination resulting in foetal death) there would be no offence even where the foetus dies (despite best efforts), so long as there was no intention that it would not survive the ending of the pregnancy, because the mens rea of the offence would be ‘an intention to procure a termination of pregnancy resulting in the death of the foetus.’ In some instances, there might be considered to be an oblique or indirect intention if it could be demonstrated that the doctor ending the pregnancy was ‘virtually certain’ that the foetus would die as a result of their actions, to such an extent that they can be said to have intended that outcome. 171 dependent on unlawful procurement of miscarriage being understood as referring only to those terminations intending to cause foetal death. I argue that law reform is necessary.
All deliberate endings to a pregnancy are prima facie criminal? By looking to other statutes concerning the law of terminating pregnancy, it could be argued that Parliament did not intend that miscarriage would refer only to deliberate interferences to end a pregnancy that is intended to result in foetal death. There is significant overlap between the offence of child destruction contained in the Infant Life (Preservation) Act 1929 (ILPA 1929)749 and the offence of procuring miscarriage in the OAPA 1861. Terminating a pregnancy that results in the death of a foetus ‘capable of being born alive’750 would amount to an offence under both provisions.751 Grubb posits that the only distinction between the two statutes is that the offence of procuring miscarriage can be committed before the 24-week viability threshold.752 There is, however, a further distinction Grubb did not account for. The ILPA 1929 is explicit that the actus reus of child destruction is complete only when action results in foetal death, whereas the OAPA 1861 is too vague to be explicit to this effect. Brazier and Harris posit that the language used to construct the OAPA 1861 and AA 1967 imply that ending pregnancy and foetal death are “one and the same.”753 Alghrani and Brazier expand on this, arguing that ‘s.58 envisages [and criminalises] a process inevitably designed to kill the foetus.’754 The offence does imply that there is usually some action in procuring a miscarriage that is associated with the causing of death. The provision makes references to some methods of procuring miscarriage that might cause damage to a foetus; ‘any poison or other noxious things.’755 The offence is not explicit, however, that only those methods of procuring miscarriage that would have noxious effect, are criminal. It could be argued that the offence is specific to the contrary because it states that ‘any other method whatsoever’756 of ending a pregnancy is criminal. Any other method could have been a direct reference to action that was not in any way designed to cause immediate harm to the foetus. It certainly encompasses that possibility in its plain meaning.
749 Infant Life (Preservation) Act 1929, s 1. 750 ibid. 751 Grubb (n661) 149. 752 ibid 149. 753 Brazier and Harris (n27) 55. 754 Alghrani and Brazier (n25) 75. 755 Offences Against the Person Act 1861, s 59. 756 ibid ss 58 and 59.
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Moreover, the offence of unlawfully procuring miscarriage was constructed as an offence committed against the pregnant person’s body, not against an unborn foetus. The offence appears in the Offences Against the Person Act 1861, and the law has always been clear, even in 1861,757 that the foetus is not a person in law.758 As already noted, where it is a person other than the pregnant person accused of unlawfully procuring miscarriage there is no requirement that the ‘woman’ is actually pregnant when an attempt is made to procure miscarriage.759 This suggests that the condition of the foetus is not the primary concern of the offence, because there need not be any foetus at all for the offence to be committed. In either case, no reference is made at all to the foetal body, its condition, or its experience. It seems, therefore, almost counter-intuitive, to read any meaning into ‘miscarriage’ that involves the condition of the foetus.
Finally, the AA 1967 provides a defence to terminations of pregnancy on a medical model in limited instances. It is interesting that defences were provided expressly to cover those cases that would conventionally be termed ‘premature deliveries:’ the ending of a (later term) pregnancy to save a pregnant person’s life with attempts to ‘save’ the preterm neonate pre- empted and engaged. The fact that explicit legal authority for such actions was deemed to be necessary in the form of a defence in the AA 1967 (to the extent that implicit common law defences were codified for this context), strongly implies that the ending of the pregnancy is always prima facie criminally relevant, because even those instances where there is an attempt to save the foetus are encompassed in the AA 1967.
Only terminations intending foetal death are criminal? There are, however, also compelling reasons to suggest that miscarriage would be interpreted more narrowly. Criminal statutes are generally interpreted narrowly, in favour of an accused
757 An unborn foetus has never been considered a person for the purposes of the law of homicide: R v Senior (1832) 1 Mood. C.C. 346. 758 Paton (n206). 759 The language of the statute is explicit that the offence is committed when an attempt is made to procure ‘the miscarriage of any woman, whether she be or be not with child,’ Offences Against the Person Act 1861, s 59.
173 person,760 as part of the principle of fair warning.761 It is unlikely that when first drafted Parliament intended the offence to cover instances where individuals had not attempted to undertake a termination resulting in foetal death (irrespective of whether this was the result). This is because there was no such thing as induced premature delivery in 1861. Knowledge of obstetric complications was limited. Deliveries could not be chemically induced.762 Caesareans, while possible, were not yet routinely available or safe (and mortality rates were high).763 There was no NIC to support premature babies.764 Premature labours were only spontaneous occurrences765 dangerous for the pregnant person and foetus. These factors combined meant doctors had no incentives to attempt ‘premature deliveries.’ It could be argued, therefore, that since Parliament could not have intended to render these circumstances the concern of the criminal law, miscarriage should not be interpreted to have this effect.
There are clues in language elsewhere in the offence that might be used to argue that only conduct intended to cause foetal death should be considered criminal. It is not to be ignored, as Alghrani and Brazier, and Brazier and Harris suggest (discussed above), that Parliament specified only the language of ‘violence’ in the offence. The fact that non-violent methods of ending a pregnancy were not explicitly excluded does not mean the offence meant to encompass those situations. The non-exclusion of ‘non-violent’ means of termination may have intended to refer to scenarios in which the foetus did not survive because it was removed unharmed from the uterus before the end of gestation and, being underdeveloped, it died ‘naturally’ ex utero. Such arguments, however, are likely to be insufficient without creative judicial interpretation. Principles of statutory interpretation could direct us to the conclusion that the term miscarriage encompasses only the deliberate ending of pregnancy intended to result in foetal death. Smeaton was an instance in which the law was faced with an unanticipated medical development.766 In 1861, contraception as efficient as the morning-
760 As in R v Bourne [1939] 1 KB 687. 761 Winnie Chan and Andrew Simester, ‘Four Functions of Mens Rea’ (2011) 70 Cambridge Law Journal 381. 762 Some of most common pharmaceuticals inducing delivery, prostaglandins, were not discovered until 1976. 763 US National Library of Medicine, ‘Caesarean Section – A Brief History,’ (2018)
174 after pill would have been equally as unimaginable as partial ectogenesis. Parliament was not intending when legislating on abortion ‘to ban abortion whilst permitting contraception. It was simply legislating to punish abortion.’767 The same is true in this instance; Parliament was not attempting to ban ‘premature deliveries.’ It was making rules about abortion. How should a term used in ignorance of future medical developments be interpreted? In Smeaton, Munby J approached the issue using the principle of updating construction.768 The language, and the parameters of the language, used in the 1861 Act cannot be abandoned because this is how Parliament chose to legislate,769 and thus the question of interpreting the boundaries of the offence of procuring miscarriage in the context of AWs must be determined using the given language. This does not mean, however, that the language used in the OAPA 1861 should convey only the meaning it had at the time it was written.
In Smeaton, Munby J held that the 1861 Act was an ‘always speaking Act’ and there was significance in Parliament having left the word ‘miscarriage,’ so central to the offence, undefined. There have been plenty of opportunities even following this judgment for Parliament to intervene and yet a definition has not materialised. Accordingly, Munby J observed that miscarriage should be ‘interpreted as it would be currently understood and it should be interpreted in light of the best scientific and medical knowledge that is available to the court.’770 In advancing this conclusion, Munby J was relying on the approach adopted by the House of Lords in R v Ireland.771 Lord Steyn was explicit that in interpretation exercises ‘courts of law must act on the best medical insight of the day.’772 The judiciary are likely, and entitled, to use medical evidence and medical definitions as an external aid to interpreting773 the OAPA 1861. This was an important exercise in the Smeaton judgment, in which expert advice was sought as to the meaning of an established pregnancy that could be ‘miscarried.’ The same approach is likely to be taken to determining the modern meaning of miscarriage and whether this is intended to refer only to endings of pregnancy intended to result in foetal
767 ibid. 768 ibid per Munby J at para 329. 769 ibid per Munby J at para 334. 770 ibid per Munby J at para 350. 771 R v Ireland [1998] AC 147. 772 ibid per Lord Steyn at 156. 773 Gary Slapper and David Kelly, The English Legal System, (Routledge 2012), 103.
175 death. There has consistently been deference to medical opinion on the part of the judiciary in the realm of abortion law.774
There are varying medical definitions of miscarriage. There is no uniformity in definitions in explicitly referring to foetal death. Miscarriage is often defined in medical dictionaries as ‘the spontaneous loss of pregnancy before 24 weeks.’775 Such definitions are confusing because they refer to the loss of a pregnancy as opposed to the deliberate ending of pregnancy. They are still, however, helpful in demonstrating that the term miscarriage is most often used in situations in which foetal death has occurred or is inevitable. Other medical dictionaries define miscarriage as ‘the loss of the foetus,’776 more explicitly indicating that foetal death is the consequence of a miscarriage. Others, however, vaguely refer to miscarriage as only the ‘induced expulsion of a human fetus.’777 Medical opinion would be likely, on balance, to support the opinion that procurement of miscarriage encompasses only endings to a pregnancy that result in foetal death. Medical books mentioned in the Smeaton judgment were implicit that this was the case, and even defined a spontaneous miscarriage earlier in gestation in juxtaposition to a spontaneous premature labour later in gestation.778 Moreover, management of difficult complications in pregnancy by its premature ending is common professional practice. The methods undertaken to end a pregnancy are often intended to ensure the foetus survives delivery. In the chosen methods of termination, the juxtaposition between induced loss of pregnancy resulting in foetal death and induced delivery of pregnancy is easy to see.
In interpreting the relevant provisions, beyond only taking a literal approach examining language, the judiciary are empowered to interpret terms in light of what their use in the provision was attempting to achieve.779 The two ‘purposes of the… [OAPA 1861] were plainly the protection of women and the protection of the unborn.’780 The Act intended primarily to limit abortion, and to protect pregnant people from the dangers of termination
774 See deference to medical opinion in the judgments of Paton (n206) and Bourne (n760). 775 Elizabeth Martin, Concise Colour Medical Dictionary, (OUP 2015), 480. 776 Roger Pease (ed), Merriam-Webster’s Medical Dictionary, (Merriam-Webster 1995), 2. 777 Harvey Marcovitch (ed), Black’s Medical Dictionary, (Bloomsbury 2017). 778 Smeaton (n677) at para 157; Burns (n765). 779 See Heydon’s case (1584) EWHC Exch J36. 780 Smeaton (n677) per Munby J at para 354.
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(inevitable in 1861 because even terminations performed by doctors were unsafe) and, in particular, from back-street abortion. The danger posed by all premature endings of pregnancies is now minimal in medical settings, and the concern regarding back-street abortion almost eliminated. It is believed that there has not been a death resulting from back- street abortion in England and Wales since 1982.781 Thus, in placing limitations on access, the OAPA 1861 serves the purpose of enforcing some protection for foetuses. This raises the important issue, however, of how far that protection was intended to extend. This issue of quantifying protection was explicitly acknowledged but dismissed as irrelevant to the issue before the court in Smeaton.782 Munby J asked ‘how far back [in pregnancy] does the protection afforded by the Act extend?’783 In the case of ending a pregnancy in order to facilitate gestation ex utero, we need to be asking a similar question about what the protection afforded to the foetus in the law substantively entails. Specifically, how late in pregnancy is this protection extended? I argue that unlawful procurement of miscarriage should be interpreted to refer only to those incidents intending to cause foetal death, however, this is by no means a concretely established interpretation of the law; there are equally compelling reasons to believe that the law as it is currently written necessitates that, legally, miscarriage encompasses any deliberate cessation of pregnancy. Reform of the law for clarity (provided decriminalisation is not possible),784 is necessary.
If the legal definition of ‘miscarriage’ necessarily included foetal death, this would result in the most ethically sound operation of the law (again, making the questionable assumption that criminalisation is appropriate)785 because it would not require doctors, acting on behalf of pregnant people, to justify the ending of a pregnancy in favour of ex utero gestation. Intuitively, if we accept the legitimacy of a criminal, and medical, model of termination provision, there is a meaningful distinction between procurement of miscarriages later in pregnancy that should be considered criminal, and thus in need of some justification,786 and
781 Symonds and Symonds (n714) 303. 782 Smeaton (n677) per Munby J at para 354. 783 ibid per Munby J at para 354. 784 There are political complications to the decriminalization debate; however, the developments referred to above (n672) do demonstrate that it is politically possible. 785 There are good reasons to question the legitimacy of criminalisation: Jackson (n42). For the current campaign for decriminalisation of abortion in the UK: ‘We Trust Women’ (n42). 786 Here I make no comment on the ethics of conventional abortion as I have already advocated that AWs should not be thought of as an alternative to conventional abortion and, thus, AWs should not be used as grounds to limit abortion access. Here, I am only attempting to delineate conventional abortion from termination to continue gestation ex utero to suggest that even if regulation of conventional abortion is appropriate on the grounds of some ‘state interest’ in the foetus, this same reasoning should not be used to regulate terminations not intended to result in foetal death. 177 endings to pregnancy that are in need of no such explanation. That distinction would be the intention of the doctor in bringing the pregnancy to an end. In reality, when it is decided that a later-term pregnancy should be ended, what efforts are made to preserve the foetus are influenced by judgments of viability, and determined by the approach and subsequent actions adopted by attending doctors, influenced by the wishes of the parent(s). Grubb observes that often, ‘providing it is not inconsistent with saving the mother, saving the foetus and producing a live birth will be desired by the mother. Therefore, these abortions amount to induced labour… A late abortion in these circumstances is consistent with foetal survival.’787 If decisions regarding mode and timing of ending pregnancy are made with the intention that a foetus will survive, this seems like a ‘premature delivery.’ This ending of a pregnancy would be hard to criticise as ‘unethical’ because it encompasses action being taken to preserve a pregnant person’s life and health, while simultaneously respecting their desire to protect their foetus. With the direction of the pregnant person, thought is being directed to the foetus, and action can be taken to promote its survival. A ‘premature delivery,’ in an intuitive sense, implies an intention to ‘birth’ the developing human entity to the world. The term ‘delivery’ implies the conveyance of a good and the connotation is that the usual outcome of pregnancy (a baby) would be that good.
Conversely, miscarriage implies that the conveyance of the usual good of pregnancy (the baby) has failed or is intentionally prevented. If decisions regarding mode and timing of ending pregnancy are made with no intention towards the survival of, or actively to secure the death of, the foetus this seems, intuitively, the kind of miscarriage the criminal law was intending to regulate. The distinction is not based on when an attempt is made to end pregnancy, making assumptions about likely outcomes, but on a combination of why, how and when the deliberate intervention into pregnancy is undertaken. This distinction is easily read into the law if, first, miscarriage is defined as the termination of pregnancy resulting in foetal death (thereby requiring a mens rea of intent to cause foetal death), and/or, secondly, if the word ‘unlawful’ in s.58 were, by definition, to exclude those instances in which there was no foetal death. Making the mens rea the distinction - considering the object of the ending of the pregnancy and/or intentions of the person ending the pregnancy - provides a consistent approach to determining what endings to a pregnancy are ‘in need of justification’ that would
787 Andrew Grubb, ‘The new law of abortion: clarification or ambiguity?’ (1991) Criminal Law Review 659, 665. 178 match common intuitions about the purpose of the criminal law. Moreover, considering intention is future proof, in that it could continue to isolate activities for regulation, even with the introduction of technologies like AWT.
It is possible that I have overestimated the extent to which Parliament was, in legislating to prohibit procurement of miscarriage, concerned with the protection of foetal welfare. It is certainly plausible that the OAPA 1861 was intended to be broadly interpreted and is interested in reinforcing the heteronormative regulation of female bodies. If miscarriage is interpreted broadly to mean any unlawful deliberate cessation of pregnancy, regardless of outcome, this effectively prioritises the protection of foetuses over the interests of pregnant people (and thus does not protect pregnant people). This is because it places a burden on pregnant people to provide some legal justification for their decision to opt for artificial gestation. The criminalisation of opting for ex utero gestation would have very negative emotional and moralistic connotations, such that, even if it was prima facie defensible, it would have real consequences for female people. The construction of ‘criminal abortion’ in the law is used to implicate activities deemed to be ‘deviant.’788 Requiring some justification to avoid criminal sanction, even if it is easily done, still has the impact of stigmatising that decision, categorising it as ‘in need of explanation,’ and labelling pregnant people who want to escape some of the burdens of pregnancy as making a prima facie ‘bad’ choice.
Moreover, if all endings to a pregnancy were unlawful outside of the applicable defences in the AA 1967,789 this could place a legal obligation to undertake gestational work (remaining pregnant) in place of alternative forms of gestation on pregnant people who are not facing an immediate serious risk to health or any risk to life.790 Was the Act intended to place such an onerous requirement on the female body and entirely subjugate the right to bodily autonomy and integrity to privilege foetuses? In 1861, the answer would have been ‘yes’ because ending a pregnancy was unlawful in any circumstances, save where necessary to save a pregnant person’s life.791 However, would Parliament have intended to place this onerous
788 The stigma automatically attached to ‘criminal termination of pregnancy’ is another good reason to support decriminalisation of termination of pregnancy (including abortion): Rebecca Cook, ‘Stigmatized Meanings of Criminal Abortion Law,’ in Rebecca Cook and others (eds), Abortion Law in Transnational Perspective: Cases and Controversies, (University of Philadelphia Press 2014). 789 Abortion Act 1967, s 1 (1), as amended by Human Fertilisation and Embryology Act 1990, s 37. 790 ibid s 1 (1) (b) and (c). 791 The defence of necessity is likely to have applied. See Bourne (n760). 179 obligation on female people in a world in which AWs were available to free pregnant people from pregnancy without corresponding foetal death? In interpreting the meaning of miscarriage, the impact of an all-encompassing definition of termination on the rights of pregnant people should be considered. Bodily autonomy is afforded the highest respect in law.792 Today, interference with pregnant people’s choices about their body regarding remaining pregnant is only arguably justifiable because of the state’s interest in the foetus.793 There are good reasons to believe this is not the case, but for the purposes of the current discussion this is assumed. If gestation can be continued without the use of a person’s body, there should be no legal requirement that a person remain pregnant for any reason.794 If miscarriage encompasses only termination resulting in foetal death, the state is still able to enforce its ‘interest’ in foetuses. The OAPA 1861 would penalise only individuals who attempt to procure termination resulting in foetal death without an applicable defence. This aspect of the criminal law would not concern itself with attempts to extract foetuses for continued gestation ex utero. For this reason alone, if criminalisation is thought appropriate, ‘miscarriage as foetal death’ should be adopted as the definition of miscarriage in criminal law.
Another important point to be made about the parameters of the offence is the use of the term ‘unlawful’, further qualifying the meaning of miscarriage in the 1861 Act. In R v Bourne,795 Macnaghten J held that the explicit use of the term ‘unlawful’ in the offence of procuring a miscarriage was not ‘meaningless,’ and thus imported the defence that had always been in the common law. According to this judgment, a doctor ending pregnancy in good faith and to preserve a pregnant person’s life or health does not act unlawfully.796 Whilst this can be conceptualised as a defence, and one that is now incorporated into the AA 1967,797 this case demonstrates that the use of the term ‘unlawful’ in the construction of the offence is thought to be crucial. The fact that the word features no less than four times in section 58 means it is central to the actus reus of ‘unlawful miscarriage.’ It is arguable that foetal extraction with
792 Re T (Adult: Refusal of Treatment) [1993] Fam 95, per Lord Donaldson at 102. 793 The language of ‘state interest in fetal life’ is explicit in US law following Roe v Wade (n23). In the UK, a similar approach is adopted (though less explicitly justified in terms of ‘state interest’), because a foetus is afforded more protection in law from 24 weeks gestation when it is deemed ‘capable of being born alive:’ Infant Life (Preservation) Act 1929, s 1 (1). 794 Abortion Act 1967, s 1 (1) (a), as amended by Human Fertilisation and Embryology Act 1990, s 37. 795 Bourne (n760). 796 ibid per Macnaghten J at 691. 797 Abortion Act 1967, s 1 (1) (c), as amended by Human Fertilisation and Embryology Act 1990, s 37.
180 the intent of completing gestation would not be considered unlawful and, in not satisfying an actus reus requirement, there would be no need to consider defences. The 1909 Re McCready judgment798 in the Supreme Court of Saskatchewan (Canada) came to such a conclusion. The Canadian Criminal Code (at that time) closely mirrored the provision in the 1861 Act, specifying that the offence was committed when the action to procure miscarriage undertaken with intent to procure miscarriage was unlawful.799 Lemont J held that, on the facts, it was not possible to confirm that the miscarriage was not necessary to preserve the woman’s life, ‘in which case it is not unlawful.’800 He posited that ‘every miscarriage brought on by a physician is not unlawful…’801 and, despite the evidence that the defendant was involved in the procurement of miscarriage, he found no reason to believe it was an unlawful one and, therefore, discharged the defendant.802 This case strongly suggests that the actus reus of the offence centres on unlawful miscarriage.
The Bourne803 judgment is also good law supporting the same conclusion in the English context. Just as it was held in this case that saving the life of, or preserving the mental health of, the pregnant woman was lawful under s.58, it might be that ending a pregnancy whilst preserving the foetus would also be a ‘lawful miscarriage.’ As Dickens points out, however, ‘one may question historically whether the word was intended or realised by the legislature to imply what Macnaghten J saw in it.’804 The significant legal developments since Bourne – the passing of the AA 1967 and subsequent parliamentary debate about those circumstances in which the ending of pregnancies is thought to be lawful - raise the question of whether a different approach would be taken to deny that such importance be placed on ‘unlawful’ in circumstances not proscribed by that Act. It remains to be seen how this turn of phrase would be interpreted, and whether there would be any need to look to the AA 1967. For the sake of thoroughness, it is important that we consider the circumstances in which there would be a defence to unlawfully procuring miscarriage if all deliberate endings of pregnancy (including those instances where the intention is to continue gestation ex utero for medical or social reasons) were prima facie criminal. If a defence can be successfully raised in situations where
798 Re McCready [1909] 2 Sask LR 46 (Supreme Court of Saskatchewan). 799 The Criminal Code 1892, Section 303 (Canada). This version of the Criminal Code has since been repealed and replaced. 800 Re McCready (n798) per Lamont J at para 9. 801 ibid per Lamont J at para 9. 802 ibid per Lamont J at para 10. 803 Bourne (n760). 804 Dickens (n739) 39. 181 a doctor terminates a pregnancy intending that the foetus will continue gestating ex utero, then their conduct would not be unlawful.
Are there available Defences to Unlawfully Procuring Miscarriage?
For all terminations before 24 weeks’ gestation, there is a defence available to medical practitioners under the AA 1967.805 Access to conventional terminations of pregnancy is relatively liberal before 24 weeks because s.1 (1) (a) of the AA 1967, the defence under which the majority of abortions are performed,806 is so broad it renders ‘every pregnancy legally terminable within the first 24 weeks.’807 In practice, doctors do not tend to justify their decision to perform termination before 24 weeks on clinical grounds. However, this does not mean that it is necessarily lawful for doctors to provide terminations (even to allow for ex utero gestation) before 24 weeks for any non-medical or social reason. This is because the so-called ‘social ground’ for abortion is still framed in medical terms; it provides a defence before 24 weeks where the risk of continuing the pregnancy is greater than the risk of ending pregnancy. Methods of conventional abortion have now developed to the point that it is seemingly statistically always the case that performing an abortion (usually drug induced) within the time frame that most are requested is less risky than continuing pregnancy.808 It seems unlikely that the foetal extraction procedure necessary for transfer to an AW would be less risky for a pregnant person than remaining pregnant (or having a conventional termination) in the vast majority of circumstances. Of course, all pregnancy is inherently risky, but if the process of foetal transfer were to involve an intricate caesarean procedure,809 it might be argued that this is far riskier than continuing the pregnancy if the pregnant person is healthy and a natural delivery is anticipated. Moreover, this provision of the AA 1967 does not mean that all pregnant people are legally entitled to a termination of pregnancy (by any method, with any outcome). The AA 1967 has effectively ‘transferred’ the right to self-determination, specifically regarding decisions about whether to remain
805 The ‘social’ ground for abortion in Abortion Act 1967, s 1 (1) (a), as amended by Human Fertilisation and Embryology Act 1990, s 37, provides a defence for all terminations carried out before 24 weeks where the risk of continuing the pregnancy is greater than the risk of terminating the pregnancy. This is easily established today in the vast majority of pregnancies, given the availability of abortifacient drugs carrying far fewer risks than surgical abortions, and than remaining pregnant: Brazier and Cave (n362) 404. 806 Mason and Laurie (n599) 336. 807 Jackson (n99) 80. 808 Brazier and Cave (n362) 404. 809 Murphy (n265) 34; Schultz (n21) 880.
182 pregnant, from female people to the medical profession.810 The way that the law is framed means pregnant people have no positive right to end their pregnancy. Pregnant people must convince a doctor that they require intervention into their pregnancy, and that they are entitled to it because their circumstances fit within the medical model.
Furthermore even where it may be lawful for doctors to perform interventions to end a pregnancy, they are under no obligation to do so unless it is an emergency.811 As already noted, the law is clear that patients are not entitled to demand any particular treatment, and doctors cannot be compelled to provide treatments that they are uncomfortable with.812 Pregnant people are effectively subjected to an enormous constraint on their decision-making, because they are empowered only to make decisions about ending pregnancies for reasons that satisfy medical practitioners. This is even assuming that medical practitioners would be willing to end pregnancies in favour of ex utero gestation before 24 weeks for less urgent medical considerations, or non-medical reasons. This raises some ethical issues for exploration about the role of medicine in reproduction, the parameters of what treatment is, and when it can be demanded. This discussion is important to revisit but is beyond the scope of this article.
For pregnant people experiencing high-risk or dangerous pregnancies, it would potentially be lawful for them to end their pregnancies in favour of ex utero gestation before 24 weeks gestation. After 24 weeks, a lawful defence to a deliberate ending of a pregnancy becomes much harder to establish. The two relevant grounds of the AA 1967 that could be invoked as a defence to the circumstances of potentially dangerous/ high-risk pregnancies are risk to the pregnant person’s life813 and risk of grave, permanent injury to the physical or mental health of the pregnant person.814 These defences are available when two medical practitioners form the opinion,815 in good faith, that a pregnant person’s circumstances fall within these grounds. There is no time limit imposed on these grounds for termination. They are, therefore, harder
810 Mason (n400) 25. 811 Abortion Act 1967, s.4. 812 Burke (n731). 813 Abortion Act 1967, s 1 (1) (c), as amended by Human Fertilisation and Embryology Act 1990, s 37. 814 ibid s 1 (1) (b). 815 ibid s 1 requires that two medical professionals form this opinion, however if a medical professional forms the opinion in good faith that termination of pregnancy is immediately necessary to save the pregnant person’s life or to prevent serious injury to their health, the medical practitioner may act alone: Brazier and Cave (n362), 404.
183 to establish and require ‘clear proof of the more serious danger specified.’816 The separation of these two grounds related to the pregnant person’s condition in the statute, which distinguish life from health, is an attempt to demark that the ground of risk to health requires more substantial proof than risk to life.817 In the following sub-sections, I consider what level of risk is sufficient to justify deliberately ending pregnancy, and whether these legal requirements satisfactorily account for the change in risk perception that might follow AWs.
Risk to life Doctors need not wait until a pregnant person is in peril of immediate death to end a pregnancy818 since, as noted, there is a defence to unlawfully procuring miscarriage when pregnancy poses a risk to the pregnant person’s life that is greater than the risk of termination.819 The risk to life and risks of termination must be weighed against each other.820 Most premature deliveries that are currently undertaken are attempted because the pregnancy poses specific risks to the pregnant person’s life.821 The method by which the pregnancy is ended often carries the same risks as delivery at the end of the normal gestational period when a pregnancy has to be managed.822 The risk of termination will have to be assumed at some point in order for the pregnancy to end, whether before, or at the end of, the normal period of pregnancy. Therefore, when there is risk, it is often easy to demonstrate that the risk of remaining pregnant is greater than the risk of inducing the end of the pregnancy by vaginal expulsion or caesarean. This defence encompasses the decision-making calculus currently adopted in obstetric practice.823 However, if AWs shift perceptions about which pregnancies are risky, what does this mean for the interpretation of ‘risk to life?’
816 A Grubb (n787) 661. 817 This will be explored in detail later in this article. For now, it is sufficient to note that if doctors are concerned that pregnancy poses a risk to life, they can act when that risk is greater than the risk of termination. Yet when doctors are concerned only about the impact of pregnancy to health (but not life), that impact on health must be ‘grave’ or ‘permanent.’ Thus, there are more qualifications on the risk to health, than potential risks to life. 818 This was established in Bourne (n760), a case that considered the legality of termination of pregnancy before the Abortion Act 1967; Derek Morgan and Robert Lee, Blackstone’s Guide to the Human Fertilisation and Embryology Act 1990, (Blackstone Press 1990), 51. 819 Abortion Act 1967, s 1 (1) (c), as amended by Human Fertilisation and Embryology Act 1990 s.37. 820 Harpwood (n740) 231. 821 For example, when a pregnant person is suffering from a severe traumatic injury, preeclampsia, or gestational diabetes. 822 If a pregnant person has preeclampsia, for example, regardless of when the ending of the pregnancy takes place, it is safest for the product of pregnancy to be removed by caesarean section. Therefore, the risks of a cesarean are inherent to that pregnancy whenever it is ended. These risks thus become almost irrelevant for the purposes of the defence in Abortion Act 1967, s 1 (1) (a), as amended by Human Fertilisation and Embryology Act 1990, s 37. 823 There might be questions about whether this defence technically applies in some instances in which ‘premature delivery’ is routinely performed – for example, when termination is performed to extract a foetus with stunted growth. 184
The explicit balancing exercise that the defence requires means a lower threshold of risk to life is not easily read into the provision. Even if a doctor believes a lower level of risk earlier in a pregnancy justifies ending the pregnancy (because they no longer concern themselves with balancing risk against the impact of foetal immaturity), it will not necessarily mean they can form the opinion in good faith that ending the pregnancy carries a lesser risk to life than remaining pregnant. The serious conditions that termination is necessary to manage at present will fit within the defence in milder forms and perhaps earlier in their onset. Conditions that do, or will, pose some risk to life, can be balanced against the risks of the method of ending the pregnancy accordingly.
AWs, however, could result in pregnant people with a broader range of medical complications, some of lesser severity, wanting to end their pregnancies because there is a better guarantee that this will not result in foetal loss. Consider a pregnant person struggling to manage unrelenting nausea. Their symptoms may not pose an obvious risk to life,824 and would certainly not constitute such a risk that continuing pregnancy could be described, in good faith, as more of a threat than the risk of complications in a medically induced ending of pregnancy. This is particularly evident in circumstances where a routine vaginal birth at the end of the normal gestational period is anticipated. The question is ultimately whether a doctor could, in good faith, come to the opinion that their patient’s circumstances are encompassed under the defence.825 It is notoriously difficult to prove a doctor did not form their opinion in good faith.826 There seems to be scope, however, to question the opinion of a doctor who believes sickness, swelling limbs or limited mobility during pregnancy is a threat to life, or a greater threat than induction or caesarean. It appears that a ‘foetal extraction’ for gestation ex utero in an AW before the end of the usual gestational period would only be lawful by virtue of s.1 (1) (c) of the AA 1967827 outside of conventionally serious circumstances in which the threat to the pregnant person’s life is easily observable.
824 This is obviously dependent on the pregnant person’s particular circumstances. A pregnant person with very severe nausea who risks developing kidney problems, for example, could argue there could be some risk to their life. 825 Jackson (n99) 78. 826 Harpwood (n740) 228. 827 As amended by Human Fertilisation and Embryology Act 1990, s 37.
185
Risk of grave, permanent injury to physical or mental health For a doctor to avail herself of the defence related to preventing a grave and permanent injury to a pregnant person’s physical or mental health, she must believe that the termination is necessary to prevent the injury, but it need not be immediately necessary.828 The doctor can act where permanent and grave injury is foreseen.829 There is no further statutory guidance as to the meaning of ‘grave’ and ‘permanent’ and what conditions would be severe enough to establish this defence. This is open to the interpretation of doctors forming their opinion in good faith, though it is clear that only serious and long-term illnesses resulting directly from the continuation of pregnancy would be sufficient.830 There is no balancing exercise; the defence is not a question of whether there is a risk of injury from remaining pregnant greater than the risks associated with early ending of pregnancy.831 The doctor must be of the opinion that grave, permanent injury is ‘reasonably certain to occur if pregnancy [is] continued.’832 This reinforces the notion that the defence is extended to serious injury only.
In the 1990 House of Lords debates about amendments to the AA 1967, the Lord Chancellor stipulated that the terms ‘grave’ and ‘permanent’ were deliberately used to create a stiff legal test. He suggested examples of sufficiently serious injury included ‘where [the pregnant person] has severe hypertension and continuation of the pregnancy might result in permanent kidney, brain or possibly heart damage.’833 Morgan and Lee suggest further examples; ‘mild preeclampsia; breast or cervical cancer…. uncontrolled diabetes, [and] conditions which may improve or deteriorate during pregnancy, such as asthma or epilepsy….’834 It is interesting that the debate focused on physical, rather than mental, health. This defence was clearly designed to encompass the kinds of decisions currently made in practice. In the House of Lords, there was implicit acknowledgement that the defence was designed with ‘premature deliveries,’ rather than terminations resulting in foetal death, in mind. There was explicit reference made to the bond that develops between ‘woman’ and foetus throughout pregnancy835 and Lord Mackay remarked that later in pregnancy he expected that ‘the method
828 Morgan and Lee (n818) 50. 829 ibid 52. 830 Harpwood (n740) 231. 831 Morgan and Lee (n818) 50. 832 Emily Jackson, ‘Abortion,’ in Ian Kennedy and others (eds), Principles of Medical Law, (Oxford University Press 2017), 867. 833 HL Vol 522 Col 1039. 834 Morgan and Lee (n818) 51. 835 HL Vol 522 Col 1039.
186 of termination would be selected in the best interests of the woman, but the intention would be to deliver a living baby where possible.’836 It was anticipated that terminations necessarily resulting in foetal death would usually only be carried out when this was the only possible method of ending pregnancy that would spare or significantly reduce the likelihood of injury to the pregnant person. An example would be those instances where there is a birth canal obstruction that requires cranial crushing of the foetus in order to extract it.837 The AA 1967, however, still provides a defence to unlawfully procuring miscarriage when the pregnancy threatens serious injury and a miscarriage resulting in foetal death is chosen for any reason.838 In practice, it is most often the case that when pregnancies are ended early by interference, the pregnant person wants their foetus to have the best chance of surviving and decisions are made regarding the timing and method of delivery accordingly.
If the decision-making calculus regarding ending pregnancies starts to shift because of AWs, there may be instances when the ending of a pregnancy might be medically advantageous to a pregnant person (given the reliable alternative form of gestation), but where pregnancy is not anticipated to cause a ‘grave permanent injury’ to their health. The serious conditions, for which intervention to end pregnancy is currently recommended, even earlier in their onset, would still be encompassed under this defence. There are compelling arguments that all pregnancies cause grave and permanent injury to female people’s bodies.839 However, the defence is constructed in such a way as to prevent such an argument being legally entertained.
Many pregnant people’s experiences of comparatively milder complications or ‘side effects’ during gestation make their pregnancy difficult. For some pregnant people, it would be better
836 ibid. 837 In these instances, a caesarean delivery cannot be performed as, once the foetus is not fully in the uterus, it is too late to perform the procedure, and the foetus is stuck in the birth canal. 838 An attempted amendment in the House of Lords to explicitly stipulate that later terminations when the foetus may be ‘capable of being born alive’ should mean that the medical practitioner is required to take ‘all reasonable steps to procure that the child is born alive’ was defeated in a vote. See HL Vol 522 Cols 1043-1087. 839 Pregnancy forces a person to share their bodily resources, literally stripping them of nutrients and draining them of the energy needed to conduct daily activities. The occupation of their body causes them to experience severe hormonal and chemical changes that affect how they feel, behave, and perceive the world. Changes to physical appearance necessarily affect how a pregnant person is treated. Lots of this cannot be undone. After nine months their body is (often) torn apart by the process of childbirth and there will be permanent scars, and even damage. Even following the pregnancy, they face serious risks associated with it: for example, there is the risk of experiencing post-partum depression and suicide. This is, of course, not to say that all experiences of pregnancy are negative, but it is important that we acknowledge some of the negative experiences often innate to an individual pregnancy. 187 for their physical and mental health not to experience these symptoms. However, these side effects are unlikely to be considered ‘grave,’ a threat to long-term health, or likely to cause serious and/or long-term damage to health. Morning sickness, limited mobility and swollen limbs are temporary hindrances to health that will end with the pregnancy; therefore, they could not be described as long-term injuries. There will be a huge difference of opinion as to how grave these symptoms are to experience. Many pregnant people who desire to remain pregnant despite these side effects do so because they want a future child, not because they enjoy pregnancy (though this is, of course, not universally the case). If AWs were available as a reliable alternative to pregnancy, continuing gestation and better guaranteeing the desired outcome, it is plausible that some pregnant people would want to end their pregnancies, opting for AWs. Continuing a pregnancy that encompasses difficult symptoms that pose a hindrance to short-term health or quality of life would not be in these pregnant people’s interests. However, the AA 1967 provides no express permission for a doctor to procure the ending of a pregnancy to improve a pregnant person’s short-term heath, or (what might be perceived as) quality of life, after 24 weeks.
Notably, this ground of the AA 1967 also provides a defence if a doctor believes that termination would prevent grave and permanent injury to a person’s mental health. In Bourne, the judge stressed that termination would be lawful if a doctor was of the reasonable opinion ‘that the probable consequence of the continuance of pregnancy would be to make the woman a physical or mental wreck.’840 In this judgment, recognition was afforded to the inevitable emotional and psychological trauma if a young girl was forced to carry a foetus conceived by violent rape. Quite what other circumstances would be considered legally sufficient here, or under the AA 1967, is uncertain.
In short, without amendment to the AA 1967, there is mismatch between the law and the decision-making calculus based on AWs that obstetricians would want to deploy in pregnant people’s interests. Current statutory provisions potentially require pregnant people to sustain their foetuses by remaining pregnant, rather than opting for artificial gestation. This framing of the law, even if only symbolically, subjugates the female body for the purposes of reproduction. This seems particularly callous if the female body is not necessary for
840 Bourne (n760) per Macnaghten J at 694. 188 gestation. This is an ethical issue deserving of more attention in the legal discourse surrounding AWs.
Doctors’ Discretion? The defences in the AA 1967 can be interpreted broadly. The legality of ending pregnancy is dependent on whether doctors acting in good faith perceive that a pregnant person’s circumstances meet the grounds in the AA 1967, not on whether their circumstances actually do.841 Furthermore, the defences in the AA 1967 were not the first available for doctors procuring miscarriage. The common law implicitly provided doctors with a defence to unlawful procurement of miscarriage long before 1967. In 1938, R v Bourne842 highlighted that doctors could lawfully end pregnancies where their object was to save the life of the mother or prevent permanent damage to their health.843 This case demonstrates that the use of the term ‘unlawful’ in the construction of the offence of procuring miscarriage means that there is significant judicial discretion in determining which procurements of miscarriage are ‘unlawful.’ There are several reasons, therefore, to believe that the power to determine the legality of procuring miscarriages has been placed firmly in the hands of the medical profession. It seems unlikely that any decision-making process regarding ending pregnancy that is not intended to harm the pregnant person or foetus, therefore, would be treated as criminal.
Firstly, judges are likely to direct juries in such a way that encourages acquittal on charges of procurement of miscarriage where a doctor did not cause foetal death or intend for miscarriage to result in foetal death. On these charges in the past, judges (even before public opinion about abortion liberalised, and in circumstances where termination inevitably would result in foetal death) have been keen to emphasise the difference between a medicalised ending of pregnancy and the illegal actions of ‘back-street abortionists.’ In Bourne,844 Macnaghten J emphasised on three separate occasions in his jury direction how the actions of the doctor procuring a miscarriage for a woman following his perceived belief it was in her
841 Jackson (n99) 78. 842 Bourne (n760). 843 ibid per Macnaghten J at 694. 844 ibid.
189 interests was different to what is normally understood as ‘illegal abortion.’845 A similar emphasis might be attached to a medical decision to procure miscarriage based on decision- making calculus with medical merit, even if focused on a lower level of risk.
Secondly, a jury is unlikely to convict a doctor846 unless there is evidence that the doctor was behaving with blatant disregard for the purpose of the law. If the intention of a doctor in ending a pregnancy was not to cause foetal death and to best protect the pregnant person’s health, it is hard to imagine any jury questioning the decision-making process unless things go wrong and/or the doctor is shown to be acting in bad faith. Thirdly, judges are likely to quash convictions that they feel may be unsafe. In the Paton847 judgment, Baker P was explicit that a judge who sought to interfere with the discretion of doctors under the AA 1967 would be both bold and foolish, ‘unless, possibly, where there is clear bad faith and an obvious attempt to perpetrate a criminal offence.’848 It is unlikely that a doctor who sought to preserve the life of both the pregnant person and their foetus would be seen as making an obvious attempt to behave criminally. Even before the advent of AWs, and before a doctor undertaking an earlier termination could claim they explicitly intended that the foetus would continue gestation ex utero, the judiciary have been unwilling to question doctors’ decision- making in this arena. In Smith849 the Court of Appeal, overturning a doctor’s conviction of criminally procuring miscarriage, posited that without clear evidence that behaviour was not within the reasonable bounds of professional practice and medical probabilities, ‘a verdict against a doctor is often unlikely to be unsafe.’850 And Keown has argued that ‘medical control of pregnancy and childbirth has long been established as has the termination of pregnancies that threaten life or health.’851
It is thus unlikely that, whatever the legal definition of miscarriage, there will be a charge or a conviction for unlawful procurement of miscarriage upheld against a doctor who ends a pregnancy intending that gestation is completed ex utero. Despite this, the legal uncertainty
845 Macnaghten J commented that the doctor’s decision, ‘you will observe… has nothing to do with the ordinary case of procuring abortion to which I have already referred.’ ibid per Macnaghten J at 691. 846 Jonathan Montgomery, ‘Medicine, Accountability and Professionalism,’ (1989) 16 Journal of Law and Society 319, 325. 847 Paton (n206). 848 ibid per Baker P at 282. 849 R v Smith (John) [1973] 1 WLR 1510. 850 ibid per Scarman LJ at 1516. 851 John Keown, Abortion, Doctors and the Law: some aspects of the legal regulation of abortion in England and Wales from 1803 to 1982, (CUP 1988), 165.
190 that I have examined is problematic, because ambiguity violates the human rights of those subject to the law.852 Legal uncertainty has the potential to foster moral uncertainty amongst the medical profession,853 and potentially restrict the use of future medical technologies that might help reduce the physical burdens placed on female people during pregnancy. It has long been observed that the AA 1967 firmly placed decisions about ending pregnancies into the ambit of the medical profession; however, as more avenues of potential choice open to pregnant people, it is important that the degree of medical control over those choices is re- examined. This degree of medical control over individual’s decisions to end their pregnancy in favour of ex utero gestation is not justifiable for the reasons reflected in the termination jurisprudence thus far. This reasoning has focused on the ‘state interest’ in preserving a foetus’s limited right to be gestated and the state’s interest in life, and this does not apply in these circumstances. Pregnant people should be permitted to decide how long they wish to be pregnant for. In this article, I have considered the case of dangerous pregnancies; however, some of my arguments may equally apply to those instances in which pregnant people want to opt out of undertaking gestational work in favour of an AW in a broader range of circumstances. In considering whether the law should interfere with a choice to gestate ex utero, there can be no objections from those who believe that foetal welfare should prevent (conventional) termination because foetal death is not at issue here. The fact that pregnant people are unlikely to gain greater control over their pregnancies even if/when future technologies enable greater choice, is an important problem that should be addressed. Sheldon observes that the medicalisation of termination decisions in the AA 1967 was useful to aid the partial de-politicisation of abortion, and to liberalise access to terminations for female people in England and Wales. However, the framing of the AA 1967 has limited utility in ‘defending and furthering women’s reproductive rights…’854 There are two reasons for this: first, because pregnant people have no formal legal right to demand termination and, secondly, because ‘clinically unsupported restrictions on abortion provision have been retained as part of a system of tight medicalised control.’855 It is time to decriminalise all methods of pregnancy termination regardless of their intended outcome.856 In other words, it is time that we trust pregnant people to make pregnancy termination decisions.
852 R v Misra and Srivastava (n451). 853 Romanis (n492) 116. 854 Sally Sheldon, ‘The Medical Framework and Early Abortion in the UK: How Can a State Control Swallowing?’ in Rebecca Cook and others (eds), Abortion Law in Transnational Perspective, (University of Pennsylvania Press 2014), 207. 855 ibid 207. 856 Unfortunately, there has only been limited scope in this article to explain why this argument should also apply to conventional abortion. 191
Conclusion
In this article, I have considered the claim that AWT could relieve some of the physical burdens placed on female people during pregnancy. I argued that AWT, with the capability to continue gestation, has the capacity to empower pregnant people to escape potentially dangerous pregnancies without risking their wanted foetuses (if this is their concern). Given the capacity of AWT to shift the focus of decision-making in obstetrics to empower pregnant people, it is important to consider whether those choices would be accessible to pregnant people under current legal provisions. The legality of ending pregnancy in English law still turns on the offence of ‘unlawfully procuring miscarriage,’ to which doctors have a defence if they can demonstrate that the termination they provide is ‘lawful’ by virtue of the circumstances contained in the AA 1967, or potentially the more implicit necessity defence from Bourne.857 How the present legality of ending pregnancy to opt for gestation ex utero is determined depends on whether the term ‘miscarriage,’ and specifically ‘unlawful miscarriage,’ neither of which are usefully defined in any statute or case law, means the deliberate cessation of any pregnancy, or only those attempts to end a pregnancy in such a way that results in foetal death. I have demonstrated that there is ambiguity here; whilst an interpretation of ‘miscarriage’ as only encompassing those instances where there is intent to cause foetal death is the most ethically justifiable (if we accept that criminalisation is appropriate), such an interpretation involves judicial creativity.
It is important to determine what miscarriage means, because if miscarriage includes ending pregnancy to opt for ex utero gestation, this action would be prima facie criminal unless ‘lawful’ or a doctor could raise a defence. I demonstrated that it was unlikely that a doctor would be found guilty of unlawfully procuring miscarriage in instances where there was no attempt to procure foetal death in the process. However, pregnant people’s access to a choice to end pregnancy in favour of an AW could be based entirely on medical perceptions of risk. A question for further consideration remains: is it appropriate for doctors to remain in control of decisions about ending pregnancies in light of AWs? AWT has the potential to alleviate female people of the burdens placed solely on them in reproduction, but this is only possible
857 Bourne (n760). 192 if they are empowered to decide which risks are tolerable. It is possible that healthcare policy might still present high hurdles in terms of access to this technology in future; however, it is not appropriate for the criminal law to impose heteronormative conceptions of the female body and its role in gestation.
193
PAPER SIX: Partial Ectogenesis: Freedom, Equality and Political Perspective
While Cavaliere narrows her focus in ‘Gestation, equality and freedom: ectogenesis as a political perspective,’ to considering the justifications offered for complete ectogenesis,858 it is notable that her arguments about the limited reach of these justifications could have even greater implications in the context of partial ectogenesis (the continued gestation of a foetus after it has been removed from a pregnant person’s womb). There is greater urgency in considering these issues in this context because partial ectogenesis will be possible long before complete ectogenesis. Recent studies859 have demonstrated some proof of principle for gestation ex utero but are being designed as a replacement for neonatal intensive care (for partial ectogenesis), rather than as an alternative to pregnancy.860 Furthermore, in partial ectogenesis there necessarily remains a pregnant person whose rights and freedoms are impacted by the use of, and by narratives surrounding, the artificial womb. The justifications for ectogenesis that Cavaliere labels as ‘freedom-promoting’ and ‘equality-promoting’ have been, or plausibly could be, advocated in the context of partial ectogenesis. In this commentary, I highlight concerns about potentially harmful narratives about pregnancy that might result from partial ectogenesis, and about limited or unequal access to technology enabling a choice about the duration of pregnancy. Like Cavaliere, I do not advocate that these concerns mean we should not develop artificial wombs, but in the introduction of this technology we must be mindful of its capacity to perpetuate stigma and inequality and take steps to mitigate this.
Freedom
It has been argued that partial ectogenesis offers pregnant people an increasing range of choices about pregnancy, and thus is freedom promoting. With the availability of artificial wombs people experiencing pregnancies that are, or are perceived as, dangerous might welcome the opportunity to opt to end their pregnancy (opting out of gestation) without necessarily having to make the decision not to reproduce.861 These arguments assume the availability of such
858 Cavaliere (n48). 859 Partridge and others (n2); Usuda et al (n2). 860 Romanis and Horn (n44). 861 Kendal (n9); Romanis (n11).
194 choices both legally and socially. Access to technology during pregnancy is strictly medically controlled (and equally dictated). Doctors are installed by the law as gatekeepers to decisions about ending pregnancy862 and childbirth,863 and the law is likely to place doctors in the position of gatekeepers to partial ectogenesis as well.864 The suggestion that persons with female biology, predominantly women,865 will be subject to a lesser burden in pregnancy because of partial ectogenesis has little merit, unless there is legal reform to address the fact that pregnant people themselves are not legally empowered to determine the level of tolerable risk in pregnancy.866 Legal reform is also necessary to mitigate how social circumstances may limit women’s freedom to make the choice to opt for assistance with late-term gestation. It may be that pregnant people wanting to opt for extra uterum gestation for health reasons would be subject to the same stigma as women who request a caesarean (in place of vaginal delivery). These women are often labelled selfish, or ‘too posh to push’867 despite the reality that those who make this decision do so because they believe it is best for their wellbeing.868 Social conditions can make decisions about a pregnancy much harder for pregnant people to access and this will be no less true for people considering ectogenesis (full or partial). The law perpetuates harmful social conditions by labelling decisions about pregnancy as requiring explanation and supervision, thus subjecting pregnant people to unwarranted stigma.869
It is also possible that constructing the artificial womb as an ‘alternative’ to later-term gestation may come to limit pregnant people’s freedom. Cavaliere highlights the risk that ‘certain
862 In English law there is no right to pregnancy termination (potentially inclusive of ending to a pregnancy in order to opt for gestation extra uterum outside of emergency circumstances see Romanis (n11). A doctor merely has a defence to the crime of procurement of miscarriage under the Offences Against the Person Act 1861 and/ or child destruction under the Infant Life (Preservation) Act 1929 in a list of prescribed, and heavily medicalized, circumstances that are listed in s 1 of the Abortion Act 1967. 863 National Institute of Health and Care Excellence, ‘Caesarean Section: Clinical Guideline [CG132],’ (2011)
195 women, especially from disadvantaged groups, would be regarded as substandard gestators’ and notes the potential for ‘increased control and pressure to use ectogenesis to secure the safety of the foetus.’870 Ectogenesis is frequently cited as a welcome development to provide a more secure ‘uterine experience’871 for a foetus when maternal behaviour is thought to be concerning, for example because of substance misuse.872 The narrative of an accessible ‘alternative’ can be mechanised as a powerful tool for increased monitoring of pregnant women. In the context of pregnancy, false alternatives are frequently deployed to regulate behaviour; pregnant people are systematically denied access to abortion after ‘viability’ because it is advocated that the foetus could survive in an alternate space (and this is enshrined in law),873 and pernicious narratives persist about birth control and the necessity of abortion.
Legal reform must accompany technological developments. A reproductive agenda that is genuinely freedom-promoting must place emphasis on scaling back excessive medical control over, and legislative interference into, female reproductive health, and foster trust in women, female people and pregnant people to make decisions for themselves.
Equality
Cavaliere explains that the proposals for ‘state sponsored ectogenesis’ by Kendal874 and others are infeasible, and thus there are likely to be financial barriers to accessing ectogenesis.875 Such concerns are also evident in the context of partial ectogenesis, because if the technology has the capacity to be revolutionary in minimising the risks that pregnant people have to tolerate in gestation,876 or the likelihood of human entities dying after delivery due to prematurity, equal access to such technology must be ensured. In public and private health systems alike, there are already significant inequities in access to pre- and post-natal care, as well as neonatal
870 Cavaliere (n48) 79. 871 Hammond-Browning (n9) 367. 872 ibid 372; Gregory Pence, ‘What’s so Good about Natural Motherhood? (In Praise of Unnatural Gestation)’ in Scott Gelfand and John Shook (eds), Ectogenesis: Artificial Womb Technology and the Future of Human Reproduction, (Rodopi 2006), 82. 873 The use of viability to regulate abortion is prevalent in the law of multiple jurisdictions, including the US following the explicit Supreme Court ruling in Roe v Wade (n23). An implicit viability threshold is also installed in English law because of the much-narrowed grounds for legally permissible abortion after 24 weeks in s.1 of the Abortion Act 1967. 874 Kendal (n9). 875 Cavaliere (n48) 78. 876 Romanis (n11) 349-354.
196 intensive care.877 Horn and I have argued elsewhere that these disparities risk worsening if some pregnant people have the means to opt out of full-term pregnancy and others do not.878
Political Perspective
Cavaliere concludes that ‘ectogenesis should be defended as a provocation, one that demands: better medical and social services for gestating women; a decrease in the medical hazards associated with gestation and childbirth; better working… conditions for future mothers, gestating mothers, mothers and women more generally; and a true redistribution of the burdens of responsibilities of social reproduction.’879 Ectogenesis makes for an interesting theoretical perspective to highlight how present conditions (including gestation taking place inside a person of female biology) have resulted in some structural inequalities. Examining the law surrounding partial ectogenesis is useful to demonstrate quite how restrictive the law is in relation to gestation and female reproductive health.880 Historically, technology has been politically captured to afford increased legitimacy for measures that subject pregnant people to greater control. Better neonatal intensive care has resulted in increased legal restrictions on abortion,881 and birth control has resulted in legal and political manoeuvres to determine who is allowed to reproduce.882 In the literature, as well as those writing from the perspective that ectogenesis presents a possible tool for female liberation,883 there are equally those claiming that ectogenesis is a justification for restricting access to reproductive healthcare (namely, abortion).884 Carefully framed political provocation, analysing ‘the risks and burdens of pregnancy and childbirth, as well as the unfair distribution of childbearing responsibilities between men and women’885 through the prism of value in social reproduction, can prevent political capture of technology. Focusing on the extent to which society’s treatment of the (potentially) gestating person, both before, during and after gestation, has resulted in structural
877 Horn and Romanis (n71). 878 ibid. 879 Cavaliere (n48) 79. 880 Romanis (n11) 344; 346. 881 For example, the British Parliament explicitly chose to amend the viability threshold in English law from 28 weeks in the Infant Life (Preservation) Act 1929 to 24 weeks in the 1990 amendments (s 37 of the Human Fertilisation and Embryology Act 1990) to s 1 of the Abortion Act 1967 because developments in neonatal intensive care meant an increased likelihood of survival at an earlier point in gestation. 882 Ross and Solinger (n203) 142-143. 883 Romanis and Horn (n44); Smajdor (n12); Kendal (n9); Tuija Takala, ‘Human Before Sex? Ectogenesis as a Way to Equality,’ in Frieda Simonstein (ed), Reprogen-ethics and the Future of Gender, (Springer Dordecht 2009). 884 Kaczor (n82); Blackshaw and Rodger (n101); Randall and Randall (n21); Simkulet (n101); Mathison and Davis (n101); Hendricks (n665). 885 Cavaliere (n48) 81. 197 inequality in the labour market and beyond, emphasises the importance of good reproductive healthcare to better guarantee equality and freedom.
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CONCLUSION
The research teams currently developing AW device prototypes continue to report successful testing on animals and confidently claim a future in which these devices are successfully tested on humans and eventually translated into clinical settings. In 2019 the ‘EXTEND’ therapy (or ‘Biobag’) team in Philadelphia successfully tested their prototype design on lambs even more premature than those in their initial studies in 2017.886 They concluded that ‘umbilical cannulation is technically feasible in lambs size-matched to the 23-27 week human fetus, which represents a critical step in translating EXTEND to clinical practice.’887 In 2020 the same lab reported that lamb subjects post-EXTEND appeared to exhibit no signs of neurologic deficits suggesting that the fluid-filled EXTEND environment is able to facilitate continued central nervous system development sufficient to promote normal maturational progression.888 This finding is significant because in human preterms the burden of neurodevelopmental complications are common and significant amongst those that survive in conventional NIC. McGovern and others explain that ‘despite decreases in mortality over the past two decades, no improvement in the rates of severe neurologic disability and neurodevelopmental impairment have followed’ and this has a substantial individual and societal cost.889 A significant number of studies890 have now demonstrated in lambs that ‘important components of fetal physiology are maintained on artificial placental support develop more naturally than in a ventilated newborn.’891
886 Matthew Hornick and others, ‘Technical feasibility of umbilical cannulation in midgestation lambs supported by the EXTra-teruine Environment for Neonatal Development (EXTEND),’ (2019) 43 Artificial Organs 1154 887 ibid 1160 888 Patrick McGovern and others, ‘Neurologic Outcomes of the Premature Lamb in an Extrauterine Environment for Neonatal Development,’ (2020) Journal of Pediatric Surgery doi: 10.1002/pf.5632. 889 ibid. 890 Partridge and others (n2), Usuda and others (n2; n236), Hornick and others (n886), McGovern and others (n888); Rossidis and others (n679); Yuichiro Miura and others, ‘Stable control of physiological parameters, but not infection, in preterm lambs maintained on ex vivo uterine environment therapy,’ (2017) 41 Artificial Organs 959; Katsusuke Ozawa and others, ‘Fetal echocardiographic assessment of the cardiovascular impact of prolonged support in the EXTra-uterine Environment for Neonatal Development (EXTEND) system,’ (2019) Ultrasound in Obstetrics & Gynecology doi:10.1002/uog.20295; Joseph Church and others, ‘Effects of an artificial placenta on brain development and injury in premature lambs,’ (2018) 53 Journal of Pediatric Surgery 1234; Ali Mejaddam and others, ‘Erythopoietin prevents anemia and transfusions in extremely premature lambs supported by an EXTra-uterine Environment for Neonatal Development (EXTEND),’ (2019) 46 Fetal Diagnosis and Therapy 231. 891 Lyn Chitty and others, ‘In case you missed it: The Prenatal Diagnosis editors bring you the most significant advances of 2019,’ (2019) 40 Prenatal Diagnosis 287, 293.
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The editors of Prenatal Diagnosis placed a spotlight on AW devices as one of the most significant developments in the field of foetal and paediatric medicine in 2019. The editors predicted that, although there are still significant hurdles to be overcome in the development of AW devices, ‘over the next 5 to 10 years, we expect further dissemination of the artificial placenta system throughout research labs worldwide, providing us with more information on the physiology’ of foetal development.’892 Work towards the development of these devices is fast paced and likely to continue because prematurity remains a leading cause of death in premature neonates worldwide.893 The incidence of prematurity is rising in high-income economies894 and yet ‘prematurity remains an unsolved clinical challenge.’895 It is clear that to overcome some of the inherent limitations with, and co-morbidities resulting from, conventional neonatal intensive care, devices of care need to be developed that are capable of facilitating liquid-based ventilation.896
Significant progress is being made towards the development of technology capable of continuing gestation ex utero and it is hoped that with the amount of scientific interest and energy invested in prototype projects this technology might be available within the next decade in order to improve outcomes amongst preterms delivered prematurely. It is clearly important, therefore, to address some of the ethico-legal implications arising from the potential introduction of technology capable of facilitating PE. Interest in the bioethical and legal literature, however, has continued to focus on the prospect of complete ectogenesis (CE)897 and recent scientific studies are cited as evidence of the development of technology capable of facilitating gestation entirely ex utero (from assisted conception through to full- term).898 This is despite the fact that this is an empirically false claim to make about the prototype devices being developed because these models require that the subject has developed fetal physiology.899 The models of both EXTEND and EVE therapy are both based
892 ibid 293. 893 Li Liu and others, ‘Global, regional and national causes of child mortality in 2000-13, with projections to inform post- 2015 priorities: an updated systematic analysis,’ (2015) 385 The Lancet 430, 432. 894 Rahul Gupta and Katherine Froeb, ‘Preterm Birth: Two Startling Trends, One Call to Action,’ (2020) The Journal of Perinatal & Neonatal Nursing doi: 10.1097/JPN.0000000000000469. 895 Emily Partridge and Alan Flake, ‘The Artificial Womb,’ in Mark Kilby and others (eds), Fetal Therapy: Scientific Basis and Critical Appraisal of Clinical Benefits, (CUP 2020), 83. 896 ibid. 897 Cavaliere (n48); Kathryn MacKay, ‘The ‘tyranny of reproduction’: Could ectogenesis further women’s liberation?’ (2020) 34 Bioethics 446. 898 For example, Cavaliere (n48) and MacKay (n897) both make reference to the biobag / EXTEND therapy studies; McKay suggests of complete ectogenesis that ‘what was once perhaps mere science fiction is now much closer to reality’ at 347. 899 This observation results from collaborative work with Elselijn Kingma and Joanne Verweij.
201 on principles of normal foetal circulation including, for example, a ‘pumpless extracorporeal oxygenation circuit connected via umbilical vessels powered by the fetal heart…’900 There are inevitably some restraints on when this technology might be utilised based on gestational maturity, at least until techniques are developed and tested for the device to be able to facilitate processes in the earlier stages of gestation (embryogenesis), including some crucial organ formation.
It is crucial that bioethical and legal literature is re-oriented to focus on some of the key ethico-legal issues arising from more immediate uses of this technology. With this thesis I sought to address some of the conceptual and ethical issues in the use of AW technologies as an alternative to neonatal intensive care. It is important to anticipate the more imminent consequences of future technologies in order to understand their potential implications. AWs capable of facilitating PE are far more likely than those capable of facilitating CE and we are moving quickly towards the development of technology that can partially gestate human entities, rather than completely gestate them from conception to birth.
In this final chapter I will reiterate the key findings of this work, demonstrating how I have addressed the identified research questions and highlighting some additional findings. I will also demonstrate my contribution to the literature and consider some of the potential future research that might result from the arguments made in this thesis. Since publication, the papers in this thesis have attracted significant interest in the literature, most notably on the distinction between incubation and gestation. Therefore, much of this conclusion will address some of the responses of others to my published work.
Key Findings
The primary object of this project was to consider practical ethico-legal issues that might arise during or following the development of AWT. To that end, this thesis was presented in three parts with each addressing an important stage of the development of this technology and the ethico-legal issues arising in the quest to develop AWT. The first part, understanding PE,
900 Partridge and Flake (n895) 83. 202 considered questions about ectogenesis in form and the conceptual distinction between ectogestative technologies and neonatal intensive care. The purpose of this investigation was to highlight the importance of properly conceptualising and understanding the design and working of AW devices in order to identify potential problems in the workability of applying current legal and ethical paradigms to this technology. This investigation primarily focused on the subject of the AW and ascertaining whether or not it is ‘born’ in both practical, ethical and legal terms. The second part of this thesis, realising PE, focused on some of the practical ethical questions that must be addressed in the design of a clinical trial of current AW prototype devices. The final part, implications of PE, considered some potential socio-legal implications of the use of AW technologies in place of NIC. Together, the investigation conducted a thorough examination of some of the more immediate questions in the realisation and development of PE. The final section is the most speculative, but still raises important questions that add meaningfully to contemporary debate about access to reproductive healthcare.
Research Questions Revisited In what follows I revisit the research questions introduced in at beginning of this thesis.
Is artificial womb technology to facilitate partial ectogenesis conceptually different from neonatal intensive care? I demonstrated in papers one, two and three that there is a clear conceptual distinction between AWT and neonatal intensive care on the basis of differences in the function of AWT devices and the behaviour, physiology and physicality of the subject of AWT. It is important that we do not neglect this conceptual distinction, because doing so results in a failure to highlight some of the appropriate ethico-legal questions for consideration.
The crux of the distinction between the technologies is the fact that AWT is capable of continuing gestation – the process of human development that happens before birth – ex utero, as opposed to facilitating incubation. Incubation techniques in neonatal intensive care are based primarily on gas-based ventilation and thus require that the neonate is able to undertake at least some of the burden of sustaining itself through exertive life-sustaining activities suited to the external environment. However, AWT ‘obviates air ventilation by 203 more closely replicating conditions in utero,’901 and thus enables continued lung maturation in the gestateling. The environment created by the AW enables the gestateling to maintain fetal physiology; because the placenta is effectively mimicked by the technology the gestateling is not forced to make the biological adaptations, such as the ‘transition from liquid- to gas-based ventilation’902 or activation of the digestive system. Thus, the gestateling is, in physicality, more similar to the foetus in utero (the only difference seemingly being location) than the newborn. This is also evident in the fact that while gestating in an AW a gestateling is not available for social interaction like the newborn, even those newborns that receive treatment in NIC. I concluded in the papers in this thesis that the gestateling, while delivered by/from a pregnant person, is not born because birth encompasses both a change in location and a change in physiology – meaning making the biological adaptations necessary to survive in the external environment. These two events are usually coetaneous and thus little attention has been afforded to the fact that these occurrences, while linked, are separate events that must both occur for a live birth. AWT demonstrates that the two crucial events in birth, being in the external environment and being physiologically adapted to that environment, are not coextensive despite seeming so.903 A gestateling is not born because birth is a concept broader than merely an ex utero existence; the gestateling is still being gestated and has not made the necessary physiological adaptations to the external environment. Moreover, it is not ‘in the world’ in that it does not experience interaction with the external environment and the other actors in it like a newborn baby does.904
On this point, I note the work of Alison Stone who writes that ‘to be born is to be natal, and one’s existence is natal in that we exist as human being that are born’ and that to be born is to, among other things, come ‘into the world with and as a specific body, and in a given place, set of relationships, situation in society, culture and history…’905 She also emphasises that relationality and dependency are key aspects of being born.906 Stone, however, posits that if AWT were to enable gestation ex utero there might still be ways in which gestatelings
901 McGovern and others (n888). 902 Partridge and Flake (n895) 83. 903 This is a point on which Kingma and Finn (n75) reach the same conclusions as I have. They label the distinction I am making in their own work as ‘birth-by-location-change’ and ‘birth-by-physiology-change,’ at 360. 904 This is often thought of as a crucial part of birth in philosophy of birth texts: e.g. Alison Stone, Being Born: Birth and Philosophy, (OUP 2019). 905 ibid 1. 906 ibid 3
204 could be ‘inducted into relational, emotional and value-laden settings’907 and thus (in footnotes) she concludes that ‘foetuses gestated ex utero would still be born; their existential condition would still be natal; and they would still be dependent and relational in ways that flow out of their birth.’908 This point, firstly, neglects to consider the function of the AW that continues gestation. It is true that there are design elements of the AW that might be fashioned to account for relational aspects of gestation,909 and that there are individuals who will be ‘caretakers’ providing care to subjects gestating ex utero,910 however, it is not clear that the gestateling has the natality that Stone has described. The gestateling is not ‘in the world’ as they are unable to experience or interact with the external environment and they have not yet undergone the physiological adaptations that would make that possible. Any designed relational aspects of the gestateling’s condition would likely be modelled somewhat on those ways in which we can say that a foetus gestating in utero experiences the world through a pregnant person. This relationship features sounds and a form of touch/feel between pregnant person and foetus but does not allow for touching and holding and other aspects of situated care that we imagine when we consider the dependency of being a newborn neonate. The gestateling is dependent on gestation and the machine that is continuing to create it and not on human relationships in the same way as an infant.911 Those caring human relationships that surround the gestateling remain mediated by machine. Stone’s conclusion also neglects to consider the aspects of birth that are beyond a matter of a developing human entity’s location, which I have emphasised the importance of throughout my work.
907 ibid 17 908 ibid 17. 909 Elsewhere I have noted with interest some of the design choices that are being made by the LiFE-S team in the Netherlands (compared to the EXTEND and EVE teams in the US and Australia/Japan) because in their press release they expressly mention an intention to design an AW not only mechanically capable of gestation but that mimicked some aspects of ‘uterine experience.’ Professor Oei, the team lead, stated that their device would attempt to ensure that a gestateling can ‘feel, and see, and smell, and hear the same sounds as when they are in the womb.’ See Elizabeth Chloe Romanis, ‘We need to talk about the artificial womb,’ (Bionews, 14 October 2019)
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In a recent paper, Kingma and Finn912 provided further justification, based on their account of the metaphysics of pregnancy, for my conclusions about the conceptual distinction between incubation and gestation and the uniqueness of the gestateling. They observe in this paper that ‘using Romanis’ helpful terminology, we should distinguish fetuses, gestatelings and neonates.’913 They also note that paper one in this thesis ‘deserves credit for identifying the right questions, but falls short of providing answers. This is not surprising. To actually understand these issues (or so we submit), we need to understand the under-considered nature of gestation and birth.’914 However, both papers two915 and three916 in this thesis had provided a more substantive defence – though not using the language associated with philosophical metaphysics – of the distinction raised. I note that Kingma and Finn primarily distinguish between gestatelings and newborns on the basis of physiology, which is a claim I had advanced in paper three, relying on the work of Greasley917 to explain how birth is a process that delineates two meaningful events – that of expulsion from a pregnant person and emergence from the process of gestation (e.g. meaningful physiological adaption to the external environment).918 I had also detailed this in the second paper in this thesis, ‘Challenging the ‘Born Alive’ Threshold,’919 in which I explored some of the important physiological differences between gestatelings and newborns – notably, a lack of breathing physiology,920 its similarity to the foetus in the display of only non-exertive signs of life (though differing in location)921 and the non-activation of other physiological changes necessary to survive ex utero – such as the digestive system.922
The distinction between foetus, gestateling, and newborn is illustrated well in this table by Kingma923 (based on conclusions reached in my research924 and her co-authored work with Finn):925
912 Kingma and Finn (n75). 913 ibid 360. 914 ibid 358. 915 Romanis (n492). 916 Romanis (n613). 917 Greasley (n117). 918 ibid 191; 193. 919 Romanis (n492). 920 ibid 110. 921 ibid 98. 922 ibid 112. 923 I am grateful to Elselijn Kingma for continuing discussion on the nature of the gestateling. 924 In highlighting the conceptual distinctions between developing human entities Kingma refers to the first three papers in this thesis: Romanis (n274); (n492); (n613). 925 Kingma and Finn (n75). 206
Location / Inside gestating Outside gestating Physiology mammal mammal
Early embryonic [Early] In Vivo [Early] In Vitro physiology Embryo Embryo
Fetal physiology Fetus Gestateling
Neonatal N/A Infant / Neonate926 physiology
Kingma and Finn, and I all offer the distinctions outlined, based on both physiology and location, in order to clarify discussion of the ethical issues surrounding AWT. There are substantive and practical reasons why each of the highlighted entities might be treated differently from each other; those entities located inside a gestating person must have account taken of where they are situated (which is relational to a pregnant person)927 and those that are still undergoing the process of gestation are not yet adapted to the external environment making their capacities materially different from entities with neonatal physiology. I have not, and neither have Kingma and Finn, reached any definitive conclusions about the moral
926 This table features in work by Kingma that is, at present, unpublished. I am grateful to Kingma for sharing the draft of her work entitled: Elselijn Kingma, ‘In Defence of Gestatelings: careful conceptual distinction around ectogestation, birth and developing human life’ (unpublished manuscript – May 2020), and for giving me permission to reproduce this table in this work. 927 Romanis (n492) 118. 207 status of the gestateling; except to say that there might be reasons to suppose that it is entitled to more legal protections or have greater claims to care obligations because those protections would not impact on a pregnant person. However, there are also plausible reasons why we might imagine the gestateling was deserving of fewer protections than a neonate that is adapted to the external environment because the former is less developed and because it is not interacting with other persons in the same way as the latter.
Colgrove has challenged my claims about birth as a more complex process than ‘only a matter of being ex utero’ in two papers in the Journal of Medical Ethics.928 Colgrove accepts that birth involves two processes; that to be born a human entity must be both delivered by/from a pregnant person and the entity must breathe or exhibit any other signs of life.929 These criteria, breathing or exhibiting any other sign of life, he is correct to point out, form the basis of the legal definition of live birth in some jurisdictions.930 However, his response does not fully appreciate the nuances in the term ‘signs of life’ and how it is interpreted. He criticises me for effectively substituting in my account of birth and what signs of life would be sufficient to meet this criterion, claiming that I have simply read ‘evidence of self- sufficiency’ into ‘signs of life’ when this is not the plain meaning of the term.931 He makes reference to the fact that the WHO explicitly list the beating of the heart as a sign of life sufficient for the purposes of their definition of being born alive,932 and posits that since a gestateling would have a heart beat it is completely birthed.933 I note here that even if Colgrove is correct I have advanced a persuasive, normative case as to why a gestateling is not birthed that he has chosen not to answer – instead deferring to (his interpretation of) established guidelines and law. However, his conclusion that the gestateling would be legally considered birthed is not universally accepted.
I have demonstrated in this thesis that English law is specific that signs of life are inclusive of (only) those that are actively exertive and seemingly involve interaction with the external
928 Colgrove (n487); N Colgrove, ‘Artificial Wombs, birth and ‘birth’: a response to Romanis,’ (2019) Journal of Medical Ethics doi: 10.1136/medethics-2019-105845. 929 ibid. 930 He refers to the WHO definition of birth (n491) and the law in the European Union and the United States. 931 Colgrove (n928). 932 ibid. 933 ibid.
208 environment in some sense.934 The Court of Appeal in C v S935 expressly precluded the possibility of aspects of foetal physiology such as a primitive heartbeat that Colgrove mentioned being sufficient to demonstrate ‘signs of life.’936 The statutory term ‘signs of life,’ and what might be considered sufficient evidence of ‘signs of life,’ is in need of interpretation. I have not advocated for an entirely new definition of birth, but rather I have suggested a reasonable interpretation of existing rules. Colgrove claims that gestatelings ‘just are’ newborns because they satisfy a definition of birth he highlights, whilst simultaneously declaring that a need to redefine birth is outside his scope in criticising my conceptual distinction between foetuses, gestatelings and newborn infants. This claim does not recognise the difference between redefinition and understanding terms in context.
I argued that it is counter-intuitive to interpret ‘signs of life’ as encompassing the primitive and non-exertive signs of life associated with foetal physiology.937 Colgrove has not established, in my view, that his interpretation of definitions of ‘live birth’ are either plausible or appropriate. He has conflated any sign of biological life as evidence of meaningful (in a philosophical or legal sense) life or birth. I pointed out in response that938 - if he is correct that birth is a matter of demonstrating some small ‘sign of life’ - then any organically integrated human tissue (such as an organ) that has been harvested for transplantation, or an early stage embryo, should be afforded the moral status after ‘meaningful birth.’ Since Colgrove is so reliant on the WHO definition, it also important here to note what this definition is written in reference to: specifically, for the purpose of accurately recording statistics about maternal mortality. Thus, the term is clearly functional to distinguish cases in which human entities have definitively died before delivery rather than during the process. This definition, given in reference to these statistics, certainly is not intending to be a definitive recommendation about the meaning of birth in the event that technology would enable gestation to be continued ex utero.
934 Romanis (n492) 112. 935 C v S (n387). 936 ibid; see analysis Romanis (n492) 111. 937 Romanis (n613) 728. 938 ibid.
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Irrespective of whether the gestateling should be described as ‘born’ (which it should not)939 there are still other reasons to highlight the conceptual distinction between AWT and NIC that are material in the development of the technology – such as their function and the environment they create. These sorts of material differences are crucial in understanding ethico-legal issues in context, which I demonstrated in this thesis is pivotal when thinking about clinical translation as well as potential different uses of the technology.
What does the artificial womb, used to facilitate partial ectogenesis, illustrate about the meaning and significance of birth in the law? This question arose because, having established the conceptual difference between a complete birth and extraction for continued gestation ex utero, I was interested in how birth was construed in the law and whether the law accounted for the distinction between incubation and gestation that I had highlighted and defended. I found that the two components of the test for legal personality, birth and born alive, contained some substantive ambiguities when applied to the examples of AWT and maternal-foetal surgery.
This investigation revealed that the law of birth in England and Wales is in some ways more nuanced than it might first appear, because in stipulating that a human entity must be both born and born alive to attain legal personality940 English law appears, in defining born alive narrowly, to afford recognition to the claim that a complete birth would occur on exit from an AW in PE (rather than delivery from the pregnant person alone). It is clear, however, with the advent of technology capable of facilitating ex utero gestation, that there is the need to consider whether legal personality constructed as a binary is tenable in future. My investigation provided some helpful conceptual clarifications about the test for legal personality and its potential application in the context of AWT, however it is clear that many questions remain about the operation of these rules in the event of the development of technology capable of gestating ex utero. These were highlighted at the end of paper two, ‘Challenging the Born Alive Threshold: Fetal Surgery, Artificial Wombs, and the English
939 See ibid; Kingma and Finn (n75). 940 Romanis (n492) 100.
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Approach to Legal Personhood,’941 and a future research agenda might encompass these substantive issues.
How the ‘born alive’ rule is applied to AWT will have significant implications for the subject of the AW; determining whether the gestateling is recognised by the law as a ‘person,’ with the associated rights and protections, or as a different entity that might lawfully be treated differently. Either outcome is significant in terms of either substantially lowering the threshold for persons in law, or leaving human entities developing ex utero vulnerable, for example, because there might be a lack of redress in circumstances in which they die as a consequence of negligence before being delivered from the AW. It is necessary to clear up some of the ambiguities in the law surrounding birth – and, in particular, definitional issues arising around what it is to be ‘born alive.’ The Births and Deaths Registration Act 1953 and subsequent case law provides little help in understanding how to define life at birth and this is of significant concern to medical professionals who struggle to diagnose in some instances whether a delivery is a stillbirth or a live birth in which a neonate dies shortly after delivery.942 The ambiguities demonstrated in the context of the AW add to the case to revisit questions about the meaning of life and of birth in the law.
Can experimental partial ectogenesis be justified in the best interests of the ‘foetus’? Alghrani and Brazier remarked that it was ‘contestable’943 that technologies attempting to emulate gestation, at least in their initial stages of use, would benefit their subjects. I noticed that it was otherwise frequently assumed, or asserted, in the literature that the development of AWT would be ‘innately ethical’ as a result of being an innovative beneficial treatment for preterms as an extension of neonatal intensive care.944 In this thesis I sought to interrogate these assumptions by asking whether it was justifiable to test experimental AW devices for facilitating PE on underdeveloped ‘preterm neonates.’ This discussion involved questioning the justification most often offered – that using an experimental device in place of conventional neonatal intensive care technologies would be justifiable because it was in the best interests of the ‘preterm.’
941 ibid 117-121. 942 Nuffield Council on Bioethics (n251) para 8.13. 943 Alghrani and Brazier (n25) 70. 944 Singer and Wells (n9) 22; Alghrani (n10) 131; Alghrani and Brazier (n25) 71. 211
The assumption that AWT is ‘innately ethical’ is unwarranted because of the distinction between AWT therapies and neonatal intensive care (particularly the difference between a liquid- and gas-based environment). This further demonstrates the importance of properly understanding the function and nature of AWT devices (and why they are distinct from conventional technologies) to then understand the ethical issues arising in their use. I argued that to conceptualise AWT in development as in the ‘best interests’ of any individual preterm is flawed because it is not clear (and there is insufficient evidence at present to establish) that the technology will necessarily result in good outcomes. Moreover, if an inappropriate clinical population is identified there might be instances in which using an experimental AWT device might mean denying a developing human entity an alternative form of care that has known risks, but also known benefits.
I also considered the other justification frequently offered for the experimental use of AWT (correctly conceptualised as medical research) – that the consequences of its development, being both a real improvement in outcomes for human entities delivered from pregnancy prematurely and having the potential to aid women experiencing dangerous but wanted pregnancies, justify experimental use of AWT.945 I demonstrated that this justification was entirely dependent on the clinical translation strategy adopted by research teams in selecting their target clinical population in human trials. I argued that experimental use of AWT was potentially justifiable if used exclusively with (at least in initial stages of introduction) those preterms that would have a limited, if any, chance of survival in NIC. It is only in these instances, those cases where it can be claimed that AWT is likely to be no worse for the subject than conventional NIC, in which it might be claimed that there is some clinical equipoise.
Clinical trials will be a necessary part of the development and clinical translation of AWT, and thought must be directed to the appropriate clinical population for testing. This will also involve thinking about how statistically significant data can be generated from human studies; without which subjects have been exposed to attributable risk without any of the
945 Smajdor (n22); Alghrani (n10) 136; Singer and Wells (n9) 16. 212 generalisable knowledge that might make the experiment justifiable having been generated. I considered some elements of study design that might be relevant including, but not limited to, randomisation, data monitoring, blinding and other controls. The aspects of design that I highlighted all introduce further ethical questions. Finally, I raised some concerns about how researchers can ensure they have, in both ethical and legal terms, adequate consent from parent(s) or guardian(s) for the participation of any preterm in a human trial of AWT.
How does/how might partial ectogenesis present liberating choices for female people / pregnant people? AWT, even if only capable of facilitating PE, may have the potential to aid pregnant people by releasing them from some of the burdens and risks in pregnancy by providing an alternative form of gestation.946 This might be particularly welcome for those pregnant people for whom complications have developed or for whom pregnancy is not safe. These individuals will now not have to choose between delivering their foetus preterm (and thus exposing it to the risks and burdens of NIC) or continuing to risk their life in remaining pregnant. AWT may also change perceptions of tolerable risk in pregnancy and gestation and allow a different kind of decision-making in which pregnant people may be able to opt out of pregnancy to minimise the burdens they are experiencing in their gestation. This argument is, of course, predicated on the notion that a pregnant person is willing to undergo an invasive surgery947 to opt out of gestation – but for some people this might be a choice they would want to make in their circumstances. This decision, I argued, will be highly individual to every pregnant person’s experience of pregnancy and of gestation; which some value more than others, some find gestation more difficult than others and some find that pregnancy threatens their long-term health or life. AWT could introduce more choice for individuals about pregnancy and what gestation they are able or willing to undertake, and this would be beneficial for those persons.
946 It is important to note that there is a distinction between gestation (which is the necessary process of development between conception and birth that enables the creation of a human entity) and pregnancy (the task performed by a pregnant person and their body in sustaining gestation). This means that while the two are related gestation ex utero is not strictly speaking an ‘alternative’ to pregnancy because an artificial womb does not encompass this same psychological work of a human body facilitating the process itself. This is a point I have noted in co-authored work since completion of the papers in this project: Romanis and others (n29). 947 The fact that extraction for gestation ex utero is an invasive procedure is a fact rarely acknowledged, exceptions include Jackson (n9); Alghrani (n14); Murphy (n265) 34; Schultz (n21). 213
To what extent does the current legal framework support any potential choices about alternatives to gestation resulting from partial ectogenesis?
The law regarding pregnancy, gestation, and specifically ex utero gestation contains some substantive ambiguities that, I demonstrated, will certainly prove problematic with the development of AW technology. This is particularly evident when thinking about access to AWT as a means of ‘opting for gestation ex utero.’ The offence of ‘procuring miscarriage’ in the OAPA 1861 is not specific about the condition of the foetal body in the commission of the offence, and the actus reus and mens rea can seemingly technically be satisfied in instances in which persons end a pregnancy without causing foetal death and where their intention was only to end a pregnancy (rather than to kill a foetus). I demonstrated that it was thus plausible, in the absence of creative judicial interpretation, that there is potential criminal liability involved in the decision to opt out of pregnancy in order to have gestation continued in an AW in circumstances beyond those described in the AA 1967. I argued both that the OAPA 1861 and AA 1967 should be interpreted so that such liability was not possible, but more importantly, that AWT adds to the case for decriminalisation of pregnancy termination by demonstrating quite how restrictive and regressive the current legal regime is regarding the female body and pregnant people’s choices about ending a pregnancy.
Additional Findings In addition to the specific research questions addressed there are several themes arising in this thesis that I wish to briefly highlight. One thing that is resoundingly clear is that the law regarding gestation and birth, including gestation ex utero, is uncertain and the current legal framework will prove inadequate with the development of AWs. On this point I wish to reiterate the value of speculating about the future of the law and the ethics of future technologies and the importance of understanding that terminology is context-specific and the confusion that can be propagated if terminology used in the law is not interpreted appropriately as ‘live.’
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Speculating about the future, the law, and ethics While Dickens is correct that, ‘no criticism can be made of the law for its underlying premise that human conception occurs within a mother’s body and that gestation occurs there until birth,’948 it is clear that we need to begin to postulate about the suitability of current legal frameworks given the ongoing development of technology that might offer an alternative to later-term gestation and/or NIC. This is so that the nuances of the implications of, and the potential uses for, technological alternatives to gestation can be well understood and carefully anticipated.
Examining these technologies in advance of their innovative application ensures there is room for nuance in discussion without regulation and social interference being determined by misunderstanding or dangerous over-enthusiasm. The law is, by its nature, generally reactive, and because innovative science can move quickly it is important for ethico-legal literature to reduce the implications of any regulatory gap. If the law has a significant social function, in regulating or signalling the normative legitimacy of activity, then uncertainty surrounding the legality of different uses for technology, who can access technology, and in what circumstances that technology can be accessed, can cause real anxiety for individuals. This is particularly evident in the context of gestation, where those wanting access to technological alternatives would consider aspects of their identity as parent, as gestator or as female person to be at stake. While all technology changes our relationships with each other, ‘assisted reproductive technologies [especially those related to gestation]... harness the biology of existing humans... [and inevitably] raise questions about the commodification and commercialisation of human life in a way few [bio]medical advancements have done before.’949 There are many complicating societal factors and political, social and legal rights (as has been demonstrated in this thesis) that must be considered in order to understand the restraints on technologies that could have boundless applications revolutionising reproduction.
The progress that has been made on the development of AW prototypes during the time I have been writing this thesis has been astounding and fascinating to follow. As progress
948 Dickens (n130) 249. 949 Trudo Lemmens and Andrew Flavelle Martin, ‘Introduction,’ in Trudo Lemmens and others (eds), Regulating Creation: The Law, Ethics and Policy of Assisted Human Reproduction, (University of Toronto Press, 2017), 7-8. 215 continues to be made, it is imperative that legal and bioethical scholars understand the function and design of the technology and consider questions related to its development. Grounding this speculation is something I have had cause to reflect on in writing this PhD and in my work related to it;950 because there must be a comfortable middle ground between failing to think about the future at all and wandering into the realms of science fiction. With AWT, this ground is the consideration of the ethico-legal aspects of the technology used for partial, rather than complete, gestation ex utero.
Terminology I was not expecting to spend so much of this thesis postulating about etymology and the meaning of words, in context and abstractly, and the impact of how words are understood – both in terms of how words can convey multiple meanings in legal instruments and in considering how to communicate my ideas with sufficient clarity. The use of specific terms in the ectogenesis conversation, however, became key in my thought process – in this thesis I had cause to examine the meaning of terms, such as ‘miscarriage,’ ‘alive,’ ‘birth,’ and many others, that are frequently deployed in the law and have specific connotations to them in everyday life that simply no longer appeared to have an obvious ‘ordinary meaning.’ I argued throughout this thesis that there was a need to pay attention to contextualised meaning of legal language as ‘updating.’ Furthermore, in writing I had cause to consider how the use of certain terms convey with them ethical assumptions that are hard to shake.
I am often asked about the origin of the term ‘gestateling’ – which I coined as the descriptor of a human entity gestating ex utero in an AW. The reasons for the necessity of a unique term are outlined in the first paper of this thesis;951 once I had decided that a unique term was necessary I wanted to devise and use a new term that was very distinct from those terms with ethical connotations that I was determined to avoid (foetus and newborn/infant). Here I note that others have used different terms to make clear that they are making reference to the subject of the artificial womb. Smajdor refers to the ‘ecto-fetus’952 and Hammond-Browning refers to both ‘ecto-foetuses’ and ‘ecto-children’953 in her work.954 However, these terms are
950 See Romanis and Horn (n44); Horn and Romanis (n71); Romanis and others (n29). 951 Romanis (n274) 753. 952 Anna Smajdor, ‘Ectogenesis’ in Henk ten Have (ed), Encylopedia of Global Bioethics, (Springer, 2016), 1012. 953 I note that she does use the term largely to refer to future potential children that have been born of the artificial womb. 954 Hammond-Browning (n9) 356; 357. 216 unhelpful because they do little to emphasise the uniqueness of the gestateling. It is, I believe, important to use a term for the subject of the artificial womb that does not immediately conjure an image of a foetus or neonate because the gestateling is so different from both. The only feature of the ‘gestateling’ of which I was certain three years ago at the beginning of my thinking was that it was the subject of gestation rather than incubation, so I wanted to use ‘gestate’ within the term adopted. After considering different ways in which I might create a derivative, I settled on the suffix ‘-ling;’ adding it on to the end of gestate because this denoted the subject of the AW as defined by its quality in being the subject of gestation. Moreover, in the English language the suffix ‘ling’ is not only used to describe an entity in relation to its origin or qualities, but is also frequently used to denote small, developing beings/animals e.g. ‘duckling,’ ‘suckling’ ‘mouseling’ etc. Thus, I thought it seemed suitable for a developing human entity.
Since writing the papers that make up this thesis I have had cause to reflect further on some of the terms that I routinely used in keeping with the literature to date; in particular ‘ectogenesis’ and ‘artificial womb.’ Just as I argued that using misleading terms with improper moral connotations of the different products of human reproduction is important, the same might be said also of ‘artificial womb.’ Kingma and Finn note that it is misleading to term contemporary AW prototype devices as artificial wombs because the womb is not ‘replaced’ by these devices, rather these devices are ‘artificial amnion and placenta technology (AAPT)’ as they are the ‘provision of engineered replacements for parts of the fetus/gestateling’s body’955 rather than as a replacement for the female organ (womb). In reflecting further, beyond just the inaccuracy of the term, it might be that continuing to refer to these devices as ‘artificial wombs’ rather than AAPT or by their specific names - EXTEND/Biobag, EVE therapy or LiFE-S - we encourage a false narrative that these devices are an ‘alternative’ to the womb and in allowing us to watch gestation generate harmful attitudes about the need to control the process of gestation even when it is supported by a pregnancy. I mentioned the ‘narrative of alternative’ and how it might be a harm in paper six of this thesis,956 but have since reflected in co-authored work on exactly how this might be perpetuated957 and I am now considering whether we should adjust our language on this point
955 Kingma and Finn (n75) 361. 956 E C Romanis, ‘Partial Ectogenesis: Freedom, Equality and Political Perspective, (2020) 46 Journal of Medical Ethics 89. 957 Romanis and others (n29). 217 to punctuate the difference between a womb (an organ of the female body where gestation has historically been biologically confined) and a device capable of facilitating the process of gestation in a different way. I did not decide to alter the term as used throughout this thesis because AW was used in a variety of ways throughout my work and I was not always referring to specific prototypes with specific functions. The term AW is also accessible and clear, but I think in future I will reflect more on whether its use is helpful.
When first writing about the primary difference between AWT and NIC being that of the distinction between gestation and incubation, I came across literature considering whether the creative process of human entities is confined to gestation or not.958 It is true that human entities are delivered from gestation still vulnerable and underdeveloped human entities and they continue to grow and develop through into adulthood. Hayden and Wilkinson note that ‘physical and cognitive development continues for a long period after a child is born (even at full term). For example, postnatal neural development…’959 Kingma and Finn note that ‘strictly speaking, the roots of the words “ecto” (outside) and “genesis” (development), suggests that this literally means development outside – i.e. outside the body.’960 They suggest, therefore, that ectogestation961 is the appropriate term to adopt to distinguish the processes of gestation that is facilitated extra uterum from the ordinary mammalian development after birth. This terminology is complementary to the distinction I made between the gestateling and the newborn/infant and I believe it is useful in advancing that case with clarity. I have adopted this term in work I have undertaken since the papers in this PhD were published, in recognition of the importance of linguistic clarity. However, I chose not to amend the language I had used (referring to ectogenesis) throughout this thesis because I did not address (in detail) the question of the difference between the creative process in gestation and normal human development after birth. In work since this thesis, however, I do instead refer to ‘ectogestation’ where referring to the use of ‘AW’ technologies, and I will continue to do so in future.
958 E.g. Rieder (n259); Hayden and Wilkinson (n261). 959 Hayden and Wilkinson (n261) 13. 960 Kingma and Finn (n75) 356. 961 ibid 356. 218
Contribution to Literature
In the following sections I outline how each of the papers contained in this thesis made an original and meaningful contribution to existing literature in both law and bioethics. There are four particular areas in which my thesis contributes to knowledge: first, in attempting to re-orient discussion towards PE (as opposed to CE). Second, in advocating and defending the important conceptual distinctions between AWT and NIC technologies, thus allowing for the formulation of appropriate ethical and legal questions surrounding PE. Third, in addressing issues of clinical translation of AW technologies in light of scientific context and the arising ethico-legal issues that it is hoped will have some practical application. Finally, in addressing questions about the potential legal restrictions of the use of AW technologies beyond questions about the implications for conventional termination of pregnancy I have opened a new avenue of socio-legal inquiry about AWs that is deserving of more attention. These contributions all address the gaps in the literature that were outlined at the beginning of this thesis; a failure to examine and recognise metaphysical aspects of AWT that make it distinct from NIC, and a lack of grounded literature in both bioethics and law considering the more immediate impacts of technology capable of (partial) gestation ex utero.
Re-orienting Towards Partial Ectogenesis As highlighted, the overwhelming majority of ethical and legal literature focuses on the possibilities arising from CE. While this is an interesting legal imaginary that can expose some of the conceptual flaws in the formation of legal frameworks surrounding birth, gestation and pregnancy, it is necessary that this speculation is accompanied by more grounded analysis. This is crucial in order to take proper account of the scientific, ethical, legal, social and cultural barriers to the development of CE962 and any potential benefits that are claimed for it. Furthermore, as stressed in paper six of this thesis, Partial Ectogenesis: Freedom, Equality and Political Perspective,963 PE also makes for a more interesting theoretical perspective to speculate about how the development of an AW might impact on women, female people and pregnant people because in this process there necessarily remains
962 For more on the barriers to the development of complete ectogenesis see the section on scope in chapter one of this thesis; Romanis and Horn (n44); Horn and Romanis (n71). 963 Romanis (n956). 219 a pregnant person and so it is easier to illustrate how that person’s rights and freedoms might be impacted by the use of, and the narratives resulting from the use of, AWs.
Cavaliere responded to my claim about the necessity of grounding speculation about AWs by thinking about PE as opposed to CE by stating that ‘the focus should be on both partial and full ectogenesis… both practices raise specific ethical and political challenges that need to be addressed.’964 While Cavaliere is correct that there is room for speculation of different future uses and models of AWT, what concerns me about this view is that it implies that there has been equal attention paid to each technological possibility. As I have argued elsewhere, there is an observable and continuing trend in the literature towards complete ectogenesis and to overstating the technological possibilities of current developments965 (ignoring the scientific realities).966 This is happening to such an extent that the literature as a collective is reinforcing and increasingly abstracting from the realities of technological possibility. There has, in contrast, been very little debate about PE despite the very real legal, ethical and socio- political issues innate to its development that are deserving of attention. This thesis sought to contribute to the re-orientation of the bioethical and legal literature to biological realities and to encourage more conversation about PE and its implications.
Important Conceptual Distinctions and the Formulation of Appropriate Ethical and Legal Questions The first paper in this thesis, ‘Artificial womb technology and the frontiers of human reproduction: conceptual differences and potential implications,’967 made a conceptual clarification about AWs, PE and the subject of gestation ex utero that had not yet been made and defended in the literature at the time of its publication. As I have demonstrated, there has been a tendency to conflate gestation and incubation, and thus to assume that AWT models (whether Biobag/EXTEND, EVE platform or LiFE-S)968 are an extension of conventional methods in NIC. This distinction I raised was therefore important because it enables us to
964 Giulia Cavaliere, ‘Gestation, Equality and Freedom: Ectogenesis as a Political Perspective response to commentaries,’ (2020) 46 Journal of Medical Ethics 91, 91. 965 Romanis and Horn (n44); Horn and Romanis (n71). 966 I have outlined the importance of biological realities in bioethics in the section on speculation in chapter one of this thesis and in good scientific understanding in the section on methodology in chapter two of this thesis. 967 Romanis (n274). 968 LiFE-S is the term used for the prototype being developed by a research group based at the Eindhoven University of Technology. 220 isolate the meaningful differences between emerging technologies and those already in use, and thus enables the formation of appropriate ethico-legal questions for investigation. Most importantly, a crucial contribution of this paper was to interrogate what it is to be a subject of the AW, by paying close attention to the scientific realities of technology, and to highlight that this is a unique entity – the ‘gestateling.’ Furthermore, the methodology of this paper - paying close attention to scientific sources regarding current prototypes (and how they function) in order to isolate metaphysical properties of technology and related ethical issues – was unique at the time of publication.
This paper has become a key reference point for the distinction between incubation and gestation in this context, and for the appropriate terminology for the subject of the AW. This paper has also generated substantial debate and has resulted in the emergence of a novel research agenda about these conceptual distinctions (gestation vs. incubation in the AW context and foetus vs. newborn vs. gestateling). As detailed above there has been much engagement with the arguments advanced in this thesis, most notably by Kingma and Finn and Colgrove. Thus, these papers have made an important contribution by opening up important inquiry about the nature of gestation, the entity gestating ex utero and of birth, as well as having made a substantive contribution to these debates.
The second paper, ‘Challenging the ‘Born Alive’ Threshold,’ as well as expanding on my defence of the conceptual distinction between AW and incubation and between gestatelings and newborns/foetuses, undertook a necessary doctrinal investigation to ascertain the legal status of the human entity being gestated artificially. Questions about what the human entity gestating ex utero is and how it would be legally recognised have been raised by a handful of legal scholars have raised as deserving of interrogation; but none had addressed this question in detail. Jackson observes that ‘a final issue raised by ectogenesis is the status of the fetus that is being gestated artificially.’969 Dickens comments that there is a ‘definitional problem’ in the failure of legislation ‘to consider that… [a] foetus can exist in a living state outside a female’s body.’970 Thus, both scholars, amongst others, have acknowledged that there was an unresolved question of legal status for the subject of an AW and a need to re-examine the
969 Jackson (n9) 364. 970 Dickens (n130) 250. 221 legal status of human entities ex utero. Alghrani and Brazier posited that ‘research into ectogenesis raises questions regarding the transitional phase between fetus and baby… and the artificialities of the born alive rule….’ They assume, however, that the subject of PE should be afforded legal personality.
I engaged substantively with this question by examining the test for legal personality in primary legal sources and illuminating some of the problematic consequences of the binary constructed. This meaningfully contributed to knowledge by investigating the legal status of a subject gestating ex utero, which had been highlighted as in need of investigation. This investigation is significant because the legal status of a gestateling has immense consequences for gestatelings, pregnant people and the construction of legal frameworks concerning gestation more broadly. In this paper, I also highlighted a set of questions in need of further exploration, including whether it is appropriate that legal personality is constructed as a binary and/or whether there are other ways of affording gestating human entities protections without affording personality. What the parameters of legal personality are is an ongoing debate971 to which I believe this contribution is valuable as it offers a unique perspective by applying these rules in a different context that is another an example of how the nature of human existence may be changing with technology.
Practical Inquiry about the Ethico-Legal Conditions for AW Human Trials / Clinical Translation Paper four of this thesis, Artificial Womb Technology and Clinical Translation,972 was the first paper to consider some of the practical ethico-legal questions arising from potential human trials of the recent animal models; the Biobag and EVE therapy. Alghrani and Brazier earlier raised the question of ‘how should a research ethics committee approach… a proposed trial?’973 However, they did not address the questions that an ethics committee might have to consider including questions of research design. Of the other published work considering research ethics and ectogenesis,974 all was focused on CE and pre-dated the recent scientific
971 Scholars such as Brazier and Lawrence (n43) and Quigley and Ayihongbe (n43) have been considering the application of personality rules in the context of transhumanism; AWT is a meaningful addition to this conversation as another example of how the nature of human existence is changing. 972 Romanis (n659). 973 Alghrani and Brazier (n25) 69. 974 Raskin and Mazor (n102); Alghrani and Brazier (n25). 222 studies, which meant that they were inevitably incredibly speculative and more abstract in approach. Therefore, this paper addressed a real gap in the literature – considering some of the ethical issues in the clinical translation of current AW prototypes being designed. This gap had largely resulted from a failure to acknowledge the ethical issues in the development of the technology975 and / or an assumption that experimental PE would likely be in the best interests of a fetus/newborn.976 Even those who question whether it is in the best interests of a developing human entity to be subject to experimental PE, for example Alghrani and Brazier977 and Hammond-Browning,978 still do not consider practical questions about clinical translation. In this paper, I addressed these practical questions utilising crucial scientific context to highlight the issues in need of consideration.
More academic and practical discussion regarding the research ethics of human trials to develop AW technologies is necessary; the contribution of this paper was to demonstrate the necessity of having these conversations imminently because the technology is on the cusp of development according to researchers currently working on prototypes, and because the tendency to conceptualise AWT as experimental treatment, as opposed to research, in the bioethical literature is flawed. There is a substantive need for more discussion about how we realise PE as well as the potential implications of the technology.
Ending Pregnancy ‘Beyond Abortion’ and the Law In this thesis, I undertook a critical doctrinal analysis of key provisions that had not yet been examined in detail in this context. The vast majority of legal discourse was focused on the claim that ectogenesis might endanger access to abortion rights in current legal frameworks.979 The purpose of the fifth paper in this thesis, Artificial Womb Technology and the Choice to Gestate Ex Utero: Is Partial Ectogenesis the Business of the Criminal Law?,980
975 I explain elsewhere that arguments that suggest that the development of AWT is a moral imperative for example, Smajdor (n22), have the ‘logical corollary that we must actively seek to achieve these ends:’ and often fail to engage, because of sweeping claims, questions about the development of the technology: Romanis and Horn (n44). In some instances, this can almost read, particularly where there are no disclaimers as to the fact, as though the development of AWT is not controversial. 976 Singer and Wells (n9) 22; Alghrani (n10) 131; Alghrani and Brazier (n25) 71. 977 Alghrani and Brazier (n25) 70. 978 Hammond-Browning (n9) 357. 979 Randall and Randall (n21); Abecassis (n21); Favole (n21); Goldstein (n21); Abel (n21); Alghrani (n9; n10), Steiger (n21), Son (n21) and Horn (n910). There are few exceptions: Hammond-Browning (n9) and Jackson (n9). 980 Romanis (n11).
223 was to encourage conversation about the compatibility of the English legal framework with access to alternatives to gestation (as opposed to conceptualising of technology as an alternative to abortion). I wanted to move away from the narrative of this technology as an alternative to abortion,981 but moreover, I believed it was important to interrogate the assumption in bioethical literature that alternatives to gestation might be beneficial for pregnant people (which, of course, assumes that if perfected such alternatives would be made available). There have been suggestions, most notably by Kendal982 and Smajdor,983 that AW technologies might be emancipatory in introducing a choice for female people about how to gestate. However, their analysis was focused on CE, thus neglecting the very real benefits that might be realised for pregnant people by technology that can ‘take over’ their gestation, and their claims were also absent an investigation of whether legal conditions would enable such choices. There was a lack of literature, before this thesis, considering the extent to which legal frameworks might interfere with choices about how to gestate by limiting the availability of technological alternatives.
My work thus makes an important contribution in critically analysing the extent to which the law is permissive of choices about gestation and this is useful for critiquing the claim that AWT is beneficial for minimising the risks and burdens placed on pregnant people in reproduction. Furthermore, this analysis can meaningfully contribute to the contemporary discussion about the necessity of decriminalising termination of pregnancy by further demonstrating how regressive the legal regime is when applied in a new set of circumstances. It demonstrated the substantive uncertainty around some of the terminology defining the parameters of criminal termination of pregnancy and the medical defences to that offence. At the time of publication, this paper was unique in both approach and substance to questions about the extent to which the legal framework in England and Wales would enable a choice between late-term pregnancy and an AW. Moreover, it exposes a large conceptual flaw in the regulation of pregnancy and how the role of the female body in reproduction is
981 This is the dominant narrative of AWs and choice in the ethical literature. See Simkulet (n101); Räsänen (n82); Mathison and Davis (n101); Cannold (n14); Overall (n107); Blackshaw and Rodger (n101); Cohen (n21); Iain Brassington, ‘The Glass Womb,’ in Frieda Simonstein (ed), Reprogen-ethics and the Future of Gender, (Springer Dordecht 2009); Langford (n669), Coleman (n574); Kaczor (n82, n101); Hendricks (n665). Note there are a few exceptions that are marked on the landscape of ethical debate: Smajdor (n12); Kendal (n9); Cavaliere (n48); MacKay (n897). 982 Kendal (n9). 983 Smajdor (n12).
224 conceptualised in the law that becomes especially problematic if this technology comes to fruition.
The sixth paper in this thesis, Partial Ectogenesis: Freedom, Equality and Political Perspective,984 while only a commentary, provided a meaningful contribution to the literature by highlighting the importance of situating concerns about the legal framework in the ethical literature. I explained in the methodology section of this thesis why legal literature is important in bioethical conversation,985 and this paper does the work of raising the issue of legal restrictions on access to choices, both legally and socially, into the bioethical debate about alternatives to gestation and emancipatory effects for pregnant people.
Future Research
Through the course of writing this thesis, I feel that I have generated as many further questions as I have answers. When beginning this PhD, I had envisaged the focus would be on the regulatory conditions of this technology: when might it be appropriate to switch an AW off?986 How might issues of resource allocation and equal access be ensured?987 What action might be brought by intended parent(s) of a gestateling if the AW malfunctioned?988 These were just some of the questions listed on my proposal when applying to undertake this project just over three years ago. However, I found myself unable to get to any of these issues in this project. Broader practical regulatory issues surrounding AWT are important and in need of examination, of course, however, every time I tried to investigate one of these issues I found myself unable to broach it without ultimately circling back to the same questions; was this technology new – was it distinct from other technologies? What is the meaning of birth? What is the status of an entity gestating ex utero? What might be the ethical issues in trialling this technology? Would the decision to opt for an AW be a legal one? These investigations all seemed preliminary and foundational to the consideration of the potential broader regulatory conditions of an AW in use as an alternative to NIC. My thesis has gone some way to influencing my preliminary ideas about these more specific questions of regulation in that, for example, I have reached firm conclusions about the moral and legal significance of birth and
984 Romanis (n956). 985 See chapter one of this thesis. 986 Alghrani raised this issue in asking whether the decision to ‘switch off’ an AW device would be treated as equivalent to abortion and what might happen in the event that genetic progenitors of a gestateling disagree: Alghrani (n9) 202. 987 I have highlighted the need to consider these questions elsewhere: Romanis and Horn (n44); Horn and Romanis (n71). 988 This issue was raised by Schultz (n21) in relation to the US context. 225 that AWT has the capacity to assist pregnant people with some of the burdens in reproducing. In future work I want to develop my understanding of gestation and birth and consider how we might create a regulatory structure for assisted gestative technologies (AGTs). I also note here that it is essential that there is more research on aspects of ethical experimentation with AGTs (particularly AWT).
Understanding Gestation and Birth While I have spent much of this thesis considering and developing a coherent legal and ethical account of birth following the development of AWT, further research is still needed to understand how gestation and birth are both legally and socially constructed and how these conceptualisations take account of the metaphysical and relational realities of gestation, pregnancy and birth. These questions all result from the isolation of the important conceptual differences raised between NIC and AWT in this thesis. However, thorough investigation of the processes of gestation and birth in the law still needs further consideration.
Is gestation a process and/or a relationship? In the law gestation is conceptualised as both; it is a process of creation that must be complete in order for a human entity to be recognised as a legal person,989 but it is also a fact used to define who the mother of a human entity is,990 and thus gestation legally denotes a relationship. There are clearly physical, and metaphysical, relational aspects to gestation – but it is hard to know whether these are innate to gestation, or to a pregnancy. I have noted elsewhere that gestation ‘is the process of genesis of a human entity in the womb; [while] pregnancy is the task performed by the womb and female body in sustaining gestation.’991 The relationship in a pregnancy is often described in juxtaposing terms; both as meaningful, individual and desirable, but also difficult, absolute and temporary.992 The literature examining gestation is confined largely to debates about abortion and ‘natural’ pregnancy.993 We need to consider how these ideas
989 E.g. in England and Wales legal personality is only afforded to persons ‘born alive.’ The features required to demonstrate ‘life’ require a human entity to have sufficiently formed in utero. See Romanis (n492). 990 In England and Wales the recent case of R (on the application of TT) [2019] EWHC 2384 (Fam) affirmed that the legal mother of a child is the person who undertook gestation because of their biological role in birth irrespective of gender identity. This decision was recently upheld by the Court of Appeal in R (on the application of McConnell) v Registrar General for England and Wales [2020] EWCA Civ 559 who confirmed that current legislation on birth registration required Mr McConnell to be registered as ‘mother’ and found that this did not violate his rights or the rights of the child. 991 Romanis and others (n29). 992 Firestone (n12) 188-189. 993 E.g. Little (n115). 226 translate outside of that context. What is morally significant about gestation? Is gestation absent a pregnant person to be understood differently? If so, does this enable more public and social interference in the process of human creation and its conditions? Is gestation then sometimes a public, or always a private matter? If dependent on where gestation is located, how can we ensure conceptual separation of different forms of gestation? How gestation is conceptualised will determine how technological alternatives are socially and legally regulated. In particular, I have concerns about what expectations might be placed on pregnant people if gestation becomes more public, or how we might reconceptualise caring relationships (such as defining a ‘mother’) absent a person undertaking a particular role in the entire process of creation.
There also remain questions about the moral and legal significance of birth. As noted, I refrained from making firm conclusions about the moral status of the gestateling in this thesis. Questions remain about the extent to which the physiological distinctions I outlined, and that have been reiterated and further supported by Kingma and Finn, delineate a difference in moral status. There are interesting aspects of birth, particularly related to relationality, dependency, situatedness and natality, in need of further consideration in relation to metaphysical aspects of ‘natural delivery’ and of AWT. Further, anticipating the social consequences of the separation of ‘birth-by-physiology-change’ and ‘birth-by-location- change’994 outlined will be a complex matter.
Gestation and giving birth have historically been gendered occupations. There has been some discussion in the literature about how AWT has the capacity to ‘de-gender gestation.’995 In the public consciousness there is generally a conceptual integration of gender and gestation. This is because it is primarily people of female biology who identify as women that undertake gestation (whether to reproduce themselves or acting as gestational surrogates). Could it be claimed that replacing or changing the nature of gestation may be able to erode the association between gender and gestation if it becomes possible for persons of different gender to more routinely undertake gestation? Or because gestation becoming (completely or
994 Here I have used Kingma and Finn’s terminology (n75) for the distinction between delivery from a pregnant person and a complete birth that was first outlined in this thesis: Romanis (n274); (n492); (n613), and that they also defend. 995 Takala (n883); MacKay (n897); Sander-Staudt (n346) make claims about the ‘de-gendering of gestation:’ these are disputed by some feminist scholars: Jackson (n9); Horn and Romanis (n71); Horn (n910). 227 partially) automated disassociates it from personal characteristics entirely? Are technologies replacing or changing the nature of gestation able to sufficiently challenge norms about reproduction, or will they only reinforce traditional conceptions of gendered roles in reproduction by the ‘otherisation’ of those who access AGTs?
Regulating Assisted Gestative Technologies (AGTs) While undertaking this project I became increasingly aware that discourse surrounding AWT could benefit more from being situated with technologies (both cutting-edge and age-old)996 that also constitute forms of assisted gestation, for example uterus transplantation (UTx) and gestational surrogacy. All these forms of assisted gestation involve a technological intervention that allows persons who want to reproduce (potentially using their own genetic material) but are unable, or potentially unwilling, to undertake gestation themselves for a variety of reasons: whether biological or social. Many of the ethical and social issues with assisted gestation arise in the context of more than one of these technologies or all of them. Further, many of the ethico-legal issues that have, will, or could, arise as regulatory issues with assisted gestation also occur in similar ways amongst these technologies.
I raise here a preliminary suggestion that we should look to consider a broad regulatory structure for AGTs as we have for assisted conception technologies (ACTs). ACTs are usually referred to as assisted reproductive technologies but for conceptual clarification I have adopted a more accurate descriptor. The Human Fertilisation and Embryology Acts 1990 and 2008 consolidate the regulatory framework for ACTs and embryo research; something similar encompassing the common regulatory issues in assisted gestation is a thought that occurred to me towards the end of this project that I believe may have some merit. Here I outline two of the common issues that this framework might address that could form a novel research agenda grounded in the conclusions demonstrated (namely the
996 The reference to age-old assisted gestation is to ‘genetic surrogacy’ in which, even before the advent of more complex assisted conception techniques, a woman might conceive and gestate a child conceived for another woman to raise as her own. In some ways, though not the intention of the act of conception, adoption might be thought of as a technologically non- advanced form of assisted conception for individuals wanting to parent a child who are less concerned about the genetic relationship between themselves and the child.
228 inadequacies of some legal instruments) in this thesis. Such an approach is also timely, given the Law Commission’s recent report detailing the very real need to reform surrogacy law.997
A moral right to opt in to or out of gestation? As outlined in this thesis, the AW introduces a form of ending a pregnancy without ending gestation. In this thesis I focused primarily on the emancipatory effect this might have for pregnant people experiencing a dangerous, but wanted, pregnancy. I noted that there remain broader questions about the circumstances in which pregnant people would be and should be empowered to opt out of gestation. Is there a moral right to opt out of a healthy pregnancy in favour of ex utero gestation? Potential concerns about the invasiveness of the process to extract for gestation extra uterum (especially when it is a pregnancy progressing naturally) seem to echo concerns throughout the UTx literature about the invasiveness and riskiness of the procedure (for both donor and recipient)998 when there are other forms of assisted gestation (gestational surrogacy) available.999 Alghrani also questions whether AWT should be restricted only to those pregnant persons who have a demonstrable medical need for assistance with gestation during their pregnancy.1000
Is there a moral right to demand an alternative form of gestation as a form of assistance healthcare1001 (and how might this be facilitated without pathologising gestation)?1002 This question relates very closely to those already being explored in the literature surrounding UTx; is there a positive right to experience gestation1003 and pregnancy that people can rely on to claim a right to UTx in place of gestational surrogacy?1004 In these examinations close
997 The Law Commission and Scottish Law Commission, Building families through surrogacy: a new law,
229 attention should be paid to the metaphysical realities of gestation that I have outlined in this thesis as a creative process, but also potentially as a relationship. Should a moral right to gestate be considered as a part of the right to become a parent? And if so, would this entail a decision about how to gestate (much like how parents are socially afforded a significant amount of freedom to parent in different ways)?1005 It would be difficult come to any conclusions about this right in the case of UTx or AWT without the conclusion reached impacting on conclusions about access to the other. For example, is a moral right to opt into gestation dependent on the complete absence of comparable1006 alternatives to controlling gestation (such as the AW)? Thus, it seems logical to think about, and suggest any potential regulatory solutions for, the two together.
Who is the legal parent/mother? Concerns about the attribution of legal parenthood, and motherhood, have long been apparent in the context of surrogacy and are emerging in the context of UTx. In the UK, a mother is the person who undertakes gestation.1007 This legal principle dates back to Roman law which emphasised that mater semper certa est (the mother is always certain).1008 This principle has been widely criticised in the context of surrogacy arrangements for failing to account for the intentions of both intended parent(s) and surrogates assisting in gestation.1009 A strictly biological definition fails to account for the broader circumstances surrounding reproduction, and privileges heteronormative accounts of reproduction in which a female person is able to undertake gestation themselves; it fails also to recognise the care work that goes into the rearing of children beyond the period of gestating.1010 The definition of mother has also been seen to be somewhat de-gendered in that a mother is the person who gestates irrespective of
1005 There is also a significant amount of parental autonomy that is protected in the law. Baroness Hale has noted that ‘children have the right to be properly cared for and brought up so they can fulfil their potential and play their part in society. Their parents have both the primary responsibility and right to do this... it is important in a free society that parents should be allowed a large measure of autonomy in the way in which they discharge their parental responsibilities. A free society is premised on the fact that people are different from one another. A free society respects that people are different from one another. A free society respects individual differences.’ R (on the application of Williamson) v Secretary of State for Education and Employment [2005] 1 FCR 498, at para 72. 1006 Gestational surrogacy is often, for people wanting to become mothers, thought of as an alternative to parenthood but not to other aspects of motherhood because of the absence of the gestational experience. 1007 Ampthill Peerage Case [1977] AC 547 at 577; Re G (Residence: Same Sex Partner) [2006] UKHL 43; S.33 (1) Human Fertilisation and Embryology Act 2008. 1008 Janet Dolgin, Defining the Family: Law, Technology and Reproduction in an Uneasy Age, (NYU 1997), 119. 1009 E.g. Gillian Douglas, ‘The Intention to be a Parent and the Making of Mothers,’ (1994) 57 Modern Law Review 636. Horsey notes that ‘the law singularly fails to reflect… lived experience: the view of surrogates that they are not mothers:’ Kirsty Horsey, ‘Fraying at the Edges: UK Surrogacy Law in 2015,’ (2016) 24 Medical Law Review 608. 1010 This is a fact that Jackson (n9), Horn and Romanis (n71) and Horn (n910) have all examined in relation to claims about equity and degendering gestation in the AWT debate.
230 gender,1011 however this has forced some trans-men into being formally identified as legal mothers when they want to be recognised as fathers.1012 Thus, ‘the mother is always certain’ actually demonstrates the curious reinforcement of gender in reiterating a link between female biology and a term that remains gendered in its popular use.1013 The legal definition of mother then has ramifications for UTx if this enables cis men to undertake gestation in reproduction1014 since they might find themselves both legal mother because of their role in gestation and legal father because of a genetic contribution.1015
Questions have been raised about legal parentage in the context of AWT when gestation is undertaken by a machine (the vast majority of this literature examines the case of CE in which gestation takes place entirely ex utero) because in such an instance a gestateling might appear legally ‘motherless?’ Or, have a machine for a mother?1016 In the context of PE, the legal mother will still be easily identified as the person who undertook gestation before the AW ‘took over,’1017 however there is scope for semi-automated gestation to reorient our thinking about the relationships produced throughout gestation in non-gender-essentializing ways.1018 The Law Commission has recognised a need for reform of how parenthood is assigned in the context of assisted gestation (surrogacy),1019 noting, in response to potential concerns about the absence of a ‘mother’ in the event that the person who gestates and gives
1011 In R (on the application of TT) (n990) and R (on the application of McConnell) (n990) the Court emphasised that ‘mother’ is not intended to be a gender-specific term but to identify the person who gestated and birthed a child. 1012 The Gender Recognition Act 2004, s 12 states that ‘the fact that a person’s gender has become the acquired gender under this Act does not affect the status of the person as the father or mother of a child.’ 1013 The term ‘father’ also appears to be similarly gendered as only a man can be a father: J v C [2006] EWCA Civ 551 confirming X, Y, Z v UK [1997] ECHR 20. 1014 There has not yet been an attempt to transplant a uterus into a non-biologically female person, but a group of gynaecological surgeons based in the UK conclude that, ‘despite a number of anatomical, hormonal, fertility and obstetric considerations that require consideration, there is no overwhelming clinical argument against performing UTx as part of [gender reassignment].’ Benjamin Jones and others, ‘Uterine transplantation in transgender women,’ (2019) 126 British Journal of Obstetrics and Gynaecology 152, 156. There has also been the suggestion that cis-gendered men, might also be interested in the possibility of receiving a transplanted uterus in order to undertake gestation and experience pregnancy: Robert Sparrow, ‘Is it Every Man’s Right to Have Babies if He Wants Them? Male Pregnancy and the Limits of Procreative Liberty (2008) 18 Kennedy Institute of Ethics Journal 275. 1015 A man is a father where they are the genetic father of a child: Leeds Teaching Hospital NHS Trust v A [2003] EWHC 259 or where they adopt the child. 1016 Hendricks (n234); Alghrani suggests that a mechanical or ectogenic device cannot be a ‘mother’ (n10) 259. 1017 Since the initial conception and gestation of the human entity in the pregnant person’s body would surely be sufficient, for the purposes of the Human Fertilisation and Embryology Act 2008, to identify that person as the legal mother. 1018 See Horn (n910); Sophie Lewis, ‘Cyborg Uterine Geography: Complicating ‘care’ and social reproduction,’ (2018) 8 Dialogues in Human Geography 300; Claire Horn, ‘Gender, gestation and ectogenesis: self-determination for pregnant people ahead of artificial wombs,’ (2020) Journal of Medical Ethics doi:10.1136/medethics-2020-106156. The arguments in these works are made in the relation to complete ectogenesis but might equally apply to technology capable of partial ectogenesis. 1019 Potential proposals are set out in the Law Commission’s recent consultation report (n997) paras 8.1. – 8.138 and 9.1 – 9.6.
231 birth as a surrogate is not recorded on a birth certificate, that ‘there already exist “legal fictions” around parenthood, if by “fiction” we mean that parenthood is not based on a genetic or gestational relationship.’1020 Legal, and social, issues about the assignment of parenthood, and the impact on potential future children,1021 affect all forms of assisted gestation and are in need of further investigation.
Ethical Experimentation In considering some of the lingering questions I have at the end of the thesis about assisted gestation, I have somewhat moved away from the issue of the experimental aspects of AWT in its current form into the realm of regulatory conditions when this technology, capable of PE, comes to fruition. I want to finish my thesis on the subject of ethical experimentation, since my thesis title indicates that the journey to ectogenesis is and should be our primary concern, and I have criticised the literature for failing to properly attend to these questions.
The clinical translation of this technology will be a considerable challenge, something noted by the teams currently working on the development of EXTEND and EVE therapy. In this thesis I highlighted some of these potential issues: the isolation of an appropriate clinical population, and aspects of study design that are necessary for ethical experimentation, but that entail ethical issues of their own including randomisation, blinding, data monitoring and controls. Furthermore, I raised a concern about the consent process with parent(s) and how it can be ensured that this is appropriately handled (within current ethical and legal paradigms relating to the importance of maximally autonomous choices and protection of the vulnerable). There is far more research to be done here, and this work should involve collaboration with scientists, medical engineers and clinicians that are directly involved in the development of the technology and in the design of clinical trials. This research should consider the ethical and legal status of the subject of the experimental technology, translational research ethics and values-sensitive design and social framing.1022 With researchers anticipating that these trials might take place in the foreseeable future (over the
1020 ibid para 8.102. 1021 There is an interesting body of work on both the right to know one’s genetic origins, and similarly the right to know one’s gestational origins: see Paula Gerber and Kate O’Byrne, Surrogacy, Law and Human Rights, (Routledge 2015). 1022 Elselijn Kingma, Joanne Verweij, and I have been awarded a grant from the Brocher Institute in Geneva to host an interdisciplinary workshop on these issues in May 2021.
232 last few years it has been repeatedly estimated that this technology might be available in the next 5-10 years),1023 these questions are a matter of priority.
***
While important and complex questions arising from AWT used for PE remain, this thesis has made important clarifications and highlighted some key potential legal problems posed by AWT. These are valuable in ensuring the better formulation of ethico-legal questions moving forward with AWT on the horizon.
1023 Children’s Hospital of Philadelphia (n551); Partridge and others (n2), 11; Usuda and others (n2), e2; Chitty and others (n891). 233
BIBLIOGRAPHY
Abecassis M, ‘Artificial Wombs: The Third Era of Human Reproduction and the Likely Impact on French and US Law,’ (2016) 27 Hasting’s Law Journal 3 Abel K, ‘The Legal Implications of Ectogenetic Research,’ (1974) 10 Tulsa Law Journal 243 Academy of the Medical Royal Colleges, A Code of Practice for the Diagnosis and Confirmation of Death, (2008)
234
Beckman C and others, Obstetrics and Gynecology, (Wolters Kluwer 2014) Beauchamp T and Childress J, Principles of Biomedical Ethics, (OUP 2001) -- and Saghai Y, ‘The Historical Foundations of the Research-Practice Distinction in Bioethics,’ (2012) 33 Theoretical Medicine and Bioethics 45 Bennett P, ‘Preterm Labour,’ in Keith Edmonds (ed), Dewhurst’s Textbook of Obstetrics and Gynaecology, (Blackwell Publishing 2007) Berkman B, Chandros Hull S and Eckstein L, ‘The Unintended Implications of Blurring the Line Between Research and Clinical Care in a Genomic Age,’ (2014) 11 Personalized Medicine 285 Bhatia N, Critically Impaired Infants and End of Life Decision Making, (Routledge 2015) Biggs H, Healthcare Research: Regulation, Review and Responsibility, (Routledge-Cavendish 2010) Blackshaw B and Rodger D, ‘Ectogenesis and the Case against the Right to the Death of the Foetus,’ (2019) 33 Bioethics 76 Blahuta J, ‘Liability for Harms Caused in Utero: New Technologies, New Problems,’ (2017) 21 The International Journal of Human Rights 758 Boonin D, A Defense of Abortion, (CUP 2002) Bowden C, ‘Are We Justified in Introducing Carbon Monoxide Testing to Encourage Smoking Cessation in Pregnant Women? (2019) 27 Health Care Analysis 128 Bradney A, ‘Law as a Parasitic Discipline,’ (1998) 25 Journal of Law and Society 71 Braithwaite P, ‘How UK anti-abortion activists use American tactics to shock and shame women’ (Open Democracy, 19 December 2017)
235
Callahan D, ‘Bioethics as a Discipline,’ (1973) 1 Hastings Center Studies 66 Camporesi S, ‘Bioethics and Biopolitics: Presents and Futures of Reproduction,’ (2017) 14 Journal of Bioethical Inquiry 177 Cannold L, ‘Women, Ectogenesis and Ethical Theory,’ (1995) 12 Journal of Applied Philosophy 55 Capron A and Michel V, ‘Law and Bioethics,’ (1993) 27 Loyola of Los Angeles Law Review 25 Casey G, ‘Pregnant Women and Unborn Child: Legal Adversaries,’ (2002) 8 Medico-Legal Journal of Ireland 75 Cavaliere G, A 14-day Limit for Bioethics: the Debate over Human Embryo Research,’ (2017) 18 BMC Medical Ethics 38 -- ‘Gestation, Equality and Freedom: Ectogenesis as a Political Perspective,’ (2020) 46 Journal of Medical Ethics 76 -- ‘Gestation, Equality and Freedom: Ectogenesis as a Political Perspective response to commentaries,’ (2020) 46 Journal of Medical Ethics 91 Chan, S, ‘More than Cautionary Tales: The Role of Fiction in Bioethics,’ (2009) 35 Journal of Medical Ethics 398 -- ‘A Bioethics for All Seasons,’ (2015) 41 Journal of Medical Ethics 17 -- ‘Research Translation and Emerging Health Technologies: Synthetic Biology and Beyond,’ (2016) 26 Healthcare Analysis 310 -- ‘How and Why to Replace the 14-Day Rule,’ (2018) 4 Current Stem Cell Reports 228 Chan W and Simester A, ‘Four Functions of Mens Rea,’ (2011) 70 The Cambridge Law Journal 381 Chervenak F and McCullough L, ‘The ethics of maternal-fetal surgery,’ (2018) 23 Seminars in Fetal and Neonatal Medicine 64. Children’s Hospital of Philadelphia, ‘Unique womb-like device could reduce mortality and disability for extremely premature babies. (Medical Xpress, 25 April 2017)
236
Cook R, ‘International Human Rights and Women’s Reproductive Health,’ (1993) 24 Studies in Family Planning 73 -- ‘Stigmatized Meanings of Criminal Abortion Law,’ in Rebecca Cook and others (eds), Abortion Law in Transnational Perspective: Cases and Controversies, (University of Pennsylvania Press 2014) Costeloe K and others, ‘Short term outcomes after extreme preterm birth in England: comparison of two birth cohorts in 1995 and 2006 (the EPICure studies),’ (2012) 345 British Medical Journal e7976 Cownie F, Legal Academics: Culture and Identities, (Hart Publishing 2004) Council for International Organizations of Medical Sciences, International Ethical Guidelines for Biomedical Research Involving Human Subjects, (CIOMS 1993). Council of Australian Law Deans, ‘CALD Statement on the Nature of Research (May and October 2005),’ (2005)
237
Drane J, ‘What is Bioethics? A History?’ in Lolas F and Agar L (eds), Interfaces between bioethics and the empirical social sciences [Regional program on bioethics publication series 2002], (Pan American Health Organisation and WHO 2001) Drapkin Lyerly A, ‘Maternal-Fetal Surgery: The Fallacy of Abstraction and the Problem of Equipoise,’ (2001) 9 Health Care Analysis 151 Dworkin R, Life’s Dominion: An Argument about Abortion, Euthanasia, and Individual Freedom, (Alfred A. Knopf 1993) Ellen B, ‘It’s time to debunk the myth of too posh to push,’ (The Guardian, 21 November 2010)
238
Goldstein M, ‘Choice, Rights and Abortion: The Begetting Choice Right and State Obstacles to Choice in Light of Artificial Womb Technology,’ (1978) 51 Southern California Law Review 877 Goodwin M, Policing the Womb: Invisible Women and the Criminalization of Motherhood, (CUP 2020) Gray J, The Nature and Sources of the Law, (Columbia University Press 1909) Greasley K, Arguments about Abortion: Personhood, Morality and Law, (OUP 2017) Great Ormond Street Hospital for Children NHS Foundation Trust, ‘Necrotising enterocolitis,’ (16 July 2016)
239
Hemphill L, ‘American Abortion Law Applied to New Reproductive Technology,’ (1992) 32 Jurimetrics 361 Hendricks J, ‘Not of Woman Born: A Scientific Fantasy,’ (2011) 62 Case Western Law Review 399 -- ‘Of Woman Born? Technology, Relationship and the Right to a Human Mother,’ (2011)
240
-- ‘Abortion,’ in Ian Kennedy, Judith Laing and Jean McHale, Principles of Medical Law, (OUP 2017) Jensvold M, ‘Affidavit of Mary Lee Jensvold in The Nonhuman Rights Project v Stanley,’
241
The Law Commission and Scottish Law Commission, Building families through surrogacy: a new law,
242
Matambanadzo S, ‘Embodying Vulnerability: A Feminist Theory of the Person,’ (2012) 20 Duke Journal of Gender Law and Policy 45 Mathison E and David J, ‘Is there a Right to the Death of the Foetus?’ (2017) 31 Bioethics 313 Medical Research Council, Medical Research Involving Children, (2004)
National Institute for Health and Care Excellence, ‘Information for the Public; Caesarean Section,’ (2011)
244
Pineau E, ‘French Senate approves bill allowing IVF for single women, lesbians,’ (Reuters, 22 January 2020)
245
-- ‘Artificial Womb Technology and the Choice to Gestate Ex Utero: is Partial Ectogenesis the Business of Criminal Law?’ (2020) 28 Medical Law 342 -- ‘Partial Ectogenesis: Freedom, Equality and Political Perspective, (2020) 46 Journal of Medical Ethics 89 -- ‘Is ‘Viability’ Viable? Abortion, Conceptual Confusion and the Law in England and Wales and the United States,’ (forthcoming) Journal of Law and the Biosciences -- and Begović D, Brazier M and Mullock A, ‘Re-Viewing the Womb,’ (2020) Journal of Medical Ethics doi:10.1136/medethics-2020-106160 -- and Horn C, ‘Artificial Wombs and the Ectogenesis Conversation: A Misplaced Focus? Technology, Abortion and Reproductive Freedom,’ (forthcoming) International Journal of Feminist Approaches to Bioethics Ross L and Solinger R, Reproductive Justice: An Introduction, (University of California 2017) Rossidis A and others, ‘Premature Lambs Exhibit Normal Mitochondrial Respiration after Long-Term Extrauterine Support,’ (2019) 46 Fetal Diagnosis and Therapy 306 Sander-Staudt M, ‘Of Machine Born? A Feminist Assessment of Ectogenesis and Artificial Wombs’ in Scott Gelfand and John Shook (eds), Ectogenesis, Artificial Womb Technology and the Future of Human Reproduction, (Rodopi 2006) Savell K, ‘Is the Born Alive Rule Outdated and Indefensible,’ (2006) 28 Sydney Law Review 625 Schick A, ‘Whereto Speculative Bioethics? Technological Visions and Future Simulations in a Science Fictional Culture,’ (2016) 42 Journal of Medical Humanities 225 Schiff D, ‘Socio-Legal Theory: Social Structure and Law,’ (1976) 39 The Modern Law Review 287 Schultz J, ‘Development of Ectogenesis: How Will Artificial Wombs Affect the Legal Status of a Fetus or Embryo,’ (2009) 84 Chicago-Kent Law Review 877 Scutti S, ‘Meet the baby who was born twice,’ (CNN 20 October 2017)
246
Sifferlin A, ‘Exclusive: First U.S. Baby Born After a Uterus Transplant,’ (Time, 1 December 2017)
247
Tooley M, Abortion and Infanticide, (Clarendon Press 1983) Topping J and Farquarson R, ‘Spontaneous Miscarriage,’ in Keith Edmonds (ed), Dewhurst’s Textbook of Obstetrics and Gynaecology, (Blackwell Publishing 2007) Travis M, ‘Making Space: Law and Science Fiction,’ (2011) 23 Law and Literature 241 Tribe L, Abortion: The Clash of the Absolutes, (Norton & Co 1990) US Food & Drug Administration, ‘IDE Approval Process,’ (16 May 2019)
248
World Health Organization, ‘Health statistics and information systems: Maternal mortality ratio (per 100 000 births),’
249
APPENDIX
Thesis Papers in Published Form
Appendix 1 – Artificial Womb Technology and the frontiers of human reproduction: conceptual differences and potential implications (2018) 44 Journal of Medical Ethics 751
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Reproductive ethics J Med Ethics: first published as 10.1136/medethics-2018-104910 on 10 August 2018. Downloaded from Paper Artificial womb technology and the frontiers of human reproduction: conceptual differences and potential implications Elizabeth Chloe Romanis
Centre for Social Ethics and Abstract would come about ‘by accident’ as developments in Policy, School of Law, University In 2017, a Philadelphia research team revealed the neonatal intensive care (NIC).3 Others argue that of Manchester, Manchester, UK closest thing to an artificial womb A( W) the world had partial ectogenesis is already a partial reality;4 NIC ever seen. The ’biobag’, if as successful as early animal is one of modern medicine’s clearest success stories. Correspondence to Elizabeth Chloe Romanis, Centre testing suggests, will change the face of neonatal Constantly improving technology has supported for Social Ethics and Policy, intensive care. At present, premature neonates born increasingly premature neonates.5 I argue, however, School of Law, University of earlier than 22 weeks have no hope of survival. For some that the biobag is not another improvement in Manchester, Manchester M13 time, there have been no significant improvements in conventional NIC, but an entirely novel approach. 9PL, UK; elizabeth. romanis@manchester. mortality rates or incidences of long-term complications The distinctiveness of artificial womb technology ac.uk for preterms at the viability threshold. Artificial womb (AWT) must be recognised in discussion regarding technology (AWT), that might change these odds, future clinical applications to prevent harmful Received 23 April 2018 is eagerly anticipated for clinical application. We decision-making for and by affected parties. High- Revised 4 June 2018 need to understand whether AWT is an extension of lighting this distinction is important, as clinicians Accepted 6 July 2018 current intensive care or something entirely new. This Published Online First may easily overlook it because their use of AWT will 10 August 2018 question is central to determining when and how the have the same clinical objective as NIC. biobag should be used on human subjects. This paper First, I explore the current limitations restricting Protected by copyright. examines the science behind AWT and advances two NIC and prospects for AWT to provide important principal claims. First, AWT is conceptually different from context for ethical discussion. Second, I argue conventional intensive care. Identifying why AWT should that AWT will challenge perceptions of viability, be understood as distinct demonstrates how it raises a concept referring to the ability of a developing different ethico-legal questions. Second, these questions human being to survive ex utero.6 AWT, I argue, will should be formulated without the ’human being growing most likely be used beyond the current recognised in the AW’ being described with inherently value laden viability threshold (24 weeks from conception) to terminology. The ’human being in an AW’ is neither a facilitate partial ectogenesis. During partial ecto- fetus nor a baby, and the ethical tethers associated with genesis, a fetus already developing in utero is trans- http://jme.bmj.com/ these terms could perpetuate misunderstanding and ferred to an AW to continue gestating ex utero. This confusion. Thus, the term ’gestateling’ should be adopted process is distinct from complete ectogenesis (the to refer to this new product of human reproduction: a creation of an embryo using in vitro fertilisation developing human being gestating ex utero. While this 2 paper does not attempt to solve all the ethical problems that is gestated entirely in an AW). The possibility associated with AWT, it makes important clarifications of biobags being used for complete ectogenesis is that will enable better formulation of relevant ethical a more remote possibility and encompasses some on July 5, 2020 at The University of Manchester Library. questions for future exploration. distinct ethical issues. Therefore, it is not discussed in this paper. Partial ectogenesis exposes a problem of terminology that will be examined. New termi- nology should be used to describe the subject of Introduction the AW to evade the ethical tethers that existing In early 2017, news broke of the closest thing to terms imply, which cloud discussion. The term an artificial womb (AW) the world had ever seen. ‘gestateling’ is introduced to refer to a developing The prototype ‘biobag’ successfully supported human being in the process of ex utero gestation. lamb fetuses on the current viability threshold. All Finally, I argue AWT should be treated as concep- emerged from the biobag healthy, having seemingly tually distinct from conventional rescue technol- evaded common complications associated with ogies. I provide three reasons for the distinction: preterm birth.1 The biobag facilitates the process of innate differences between the features of AWT and partial ectogenesis: the development of a fetus in an NIC, differences between the subjects of each tech- © Author(s) (or their AW during part of the gestational period following nology and further potential uses for AWT beyond employer(s)) 2018. Re-use transfer from the maternal womb.2 It shows real newborn rescue. While this paper does not attempt permitted under CC BY. to solve all the ethical problems associated with Published by BMJ. promise of a future in which more sophisticated technology could secure better long-term prognoses AWT and its experimental use, the crucial clarifi- To cite: Romanis EC. for premature neonates. cations it provides are necessary to consider when J Med Ethics formulating relevant ethical questions for future 2018;44:751–755. Singer and Wells argued that technologies enabling the artificial gestation of human beings discussion.
Romanis EC. J Med Ethics 2018;44:751–755. doi:10.1136/medethics-2018-104910 751 Reproductive ethics J Med Ethics: first published as 10.1136/medethics-2018-104910 on 10 August 2018. Downloaded from Artificial wombs—where are we? The biobag Preterm birth, before 37 weeks gestation, is the leading cause In early testing, the newly designed AW was able to sufficiently of death among newborns globally.7 The swift advancement mimic the uterine environment to sustain preterm lamb ‘fetuses’ of NIC, however, was an example of medicine overcoming for 4 weeks.1 These lambs were developmentally equivalent to some of the biological body’s inherent vulnerabilities. The human preterms at the recognised viability threshold: 24 weeks. survival prospects for preterms in developed countries had After the incubation period, all subjects were ‘delivered’ and been steadily improving over the last few decades. So much so survived. News of the Philadelphia-based team’s success made that the survival of extremely premature neonates, born at 28 global headlines.17 weeks or less,7 is no longer wholly irregular. ‘Infant incubators’ The biobag consists of a sealed bag to contain the subject, a have sustained preterms born as early as 21 weeks and 6 days.8 ‘pump-less oxygenator circuit’ and umbilical cord access. The However, survival this premature is not the norm. A recent study sealed system prevents outside exposure, minimising the risk of reported a survival rate of only 0.7% among preterms born at infection. The bag enables constant exchange of amniotic fluid, 22–23 weeks.9 There is no hope of survival before this point. providing all necessary water and nutrients. Cannulae act as an Preterms on the viability threshold that survive birth often ‘umbilical cord’ carrying required nutrients and oxygen into the develop complications, resulting in severe disability or death.8 In subject’s bloodstream. Circulation is dependent on the subject’s the last 20 years, there has been a 44% increase in preterms born heart working with an oxygenator. This mimics normal placental at 22–25 weeks surviving long enough to receive NIC,10 but circulation, ensuring sufficient oxygen and a safe blood pres- the pattern of mortality and proportion with severe long-term sure.1 The biobag effectively simulates natural gestation in utero. health problems has not meaningfully changed for some time.11 All biobag test subjects had continued normal lung development and circulation without any infection.1 The three most common Limitations of neonatal intensive care complications (lung development, circulation, infection) experi- The occurrence and severity of complications associated with enced in NIC appear to have been sidestepped. Another research preterm birth decline markedly with increased gestation.12 team based in Australia has also developed an AW system with Neonates born before 26 weeks gestation remain unlikely to comparable success in animal studies.16 The AW this team has survive common complications.12 Around 50% of surviving developed, however, is not the focus of this paper because the preterms at 26 weeks have a severe long-term impairment. This team are more tentative about the potential clinical application increases to 75% among those born at 23 weeks.10 The biggest of their technology in humans.16 The enormity of these findings,
issues plaguing preterms include: underdeveloped lungs and and their capacity to reduce morbidity among preterms, is hard Protected by copyright. respiratory problems, circulatory problems causing low blood to overstate. pressure and oxygen deprivation and an underdeveloped ability Further refinement of the biobag as well as scientific and safety to swallow or suck.12 These complications are almost inevitable validation is necessary before clinical use can be anticipated.1 It before 26 weeks. They can be managed by providing mechan- seems probable, however, that we are only several years away ical ventilation, administering oxygen, using external pumps to from testing on human subjects.13 If the results of this animal aid circulation and nasogastric feeding.12 These functions are all study are repeated with similar success there will soon be calls interventions facilitated in infant incubators, and they each carry for its use from parents trying to overcome troubled pregnan- risks and limitations. Mechanical ventilation and the administra- cies18 or aid preterm children. The biobag study authors iden- tion of oxygen can hinder further lung development or damage tify their ‘clinical target population’ as preterms between 23 and http://jme.bmj.com/ the lungs.13 External aids for circulation can cause heart failure 25 weeks gestation.1 The researchers comment that if animal by effecting imbalances in blood flow.13 Nasogastric feeding testing continues to yield positive results the morbidity rate carries a high risk of necrotising enterocolitis (death and leakage among human preterms alone justifies use of the technology.1 of intestinal tissue)14 and infection.12 They are already foreseeing the clinical application of the Due to the risks and limitations of interventions, some biobag.ii The team’s brief mention of a justification for exper- scientists believe the clinical possibilities of NIC have been imental use implies they see no meaningful difference between exhausted.15 There is only so much medicine can do for a
the AW they have designed and NIC relevant to decision-making on July 5, 2020 at The University of Manchester Library. neonate born without the capacity for an independent life. This about its use. It could be argued there is no difference for now, is why between 60% and 80% of NIC deaths occur after with- because the objective of the technology’s use will be similar to drawal of interventions.11 Conventional NIC also raises ethical NIC. However, because of the implications that will be explored concerns. When treatment is withdrawn, as is often the case, all the assumption that there is little difference between AWT and treatment achieved was the prolonging of the neonate’s phys- current NIC must be critiqued. ical suffering and the emotional distress of its parent/s. Possible alternative forms of intervention to those used routinely will still harbour risks and similar barriers to success. With this in mind, Subjects in the biobag researchers are seeking an alternative physiological approach to In this section, I demonstrate how the biobag is likely to be used sustaining underdeveloped human beings by better mimicking beyond the current viability threshold, and why this means we the uterine environment to effectively prolong gestation.i16 need new terminology to describe the subject of an AW. The This encompasses a support system closer to an AW, facilitating authors of the biobag study are explicit that their research aims continuing development as if the neonate had never been born, as opposed to infant incubators assisting preterms with bodily ii It should be noted that while the technology has shown significant functions they cannot perform adequately for themselves. promise, the experiments were conducted on living beings with a different physiology to human beings. The success of the project does not necessarily mean that the biobag will be as successful when used to attempt to save human preterm neonates. The researchers, however, do imply there is enough reason to believe the technology might success- i A research team based in Australia attempting to design an AW system fully be used on human subjects to justify experimental application on similar to the biobag explicitly acknowledges this shift in their approach. human beings in future.
752 Romanis EC. J Med Ethics 2018;44:751–755. doi:10.1136/medethics-2018-104910 Reproductive ethics J Med Ethics: first published as 10.1136/medethics-2018-104910 on 10 August 2018. Downloaded from only to reduce incidences of death and disability among ‘just-vi- The terms used to describe preterms and fetuses are inap- able’ preterms. Their objective is not to ‘push back’ the viability propriate in this context and so a different term, which avoids threshold,1 and they have identified their future clinical target the connotations of using either ‘newborn’ or ‘fetus’, is needed. population accordingly. Though the authors do not explain why, I will, therefore, refer to the human being in the AW as the narrowing their scope at this stage of experimentation is under- ‘gestateling’. This term provides useful clarity and an accurate standable. Viability is, in many countries, the point at which descriptor for the AW subject. A gestateling is a human being the fetus is afforded some legal protections limiting abortion in the process of ex utero gestation exercising, whether or not access19 because, in providing a medicalised model for abortion, it is capable of doing so, no independent capacity for life. The viability is a pragmatic compromise between the anti-abortion gestateling might soon, through experimental treatment, become lobby and pro-choice activists. The researchers may wish to a medical reality complicating ethico-legal discussion in obstet- avoid their work becoming embroiled in discussions of broader rics and neonatology. ethical implications relating to abortion. However, if the biobag is as successful for human preterms as it has been for animals, it will eventually have the effect of changing, at least, perceptions Beyond just another form of intensive care about where the viability threshold lies. In this section, I advance three justifications for treating AWT Even with conventional NIC, and its evident limitations, as distinct from NIC. There is noticeably a paucity of academic there has been a huge shift in perception regarding when tech- commentary on this matter. However, this investigation is nology should be used to support preterms. Despite the current necessary to determine how biobag trials with human subjects recognised viability threshold of 24 weeks, and high prob- can begin in an ethical manner. Singer and Wells argued AWT ability of complications before 26 weeks, rescue is frequently would be just an extension of conventional NIC. Therefore, attempted on preterms as young as 22 weeks. Only attempts to experimentation would be inherently ethical. By only extending resuscitate before 22 weeks are deemed experimental.20 There existing interventions, it would not be reckless with human life, is much societal conditioning encouraging intervention to save but consist of connected medical treatments undertaken to aid preterm babies often regardless of the likely outcome.5 The will- a particular patient.3 However, AWT is potentially emerging ingness to attempt rescues is the result of clinicians trying their as the only feasible technology to erode the current viability upmost to aid the patient in front of them at the request of the threshold, despite intentions to the contrary. Many scientists parent/s. When the neonate is only fractionally less developed believe conventional NIC has ‘hit a wall’ that will seemingly 15 than preterms routinely sustained, this increases the pressure to always hinder its ability to support younger preterms. AWs, Protected by copyright. attempt rescue. Parents are often willing to challenge clinicians having different innate features, are more radical in approach. to ensure their premature infant is provided with treatment The three reasons for treating AWT as distinct I defend are rele- offering it a chance at life. Challenges sometimes develop into vant in considering future clinical applications of AWT and how high-profile legal disputes.21 we might treat affected parties. Harmful decision-making by or Once AWs can ensure the consistent and healthy survival on behalf of parties involved is likely if conceptual differences of preterms on the viability threshold, there will be imme- are ignored. diate calls, from medical practitioners and parents alike, to use AWT to aid preterms not far behind the current threshold. The innate features of AWT Similar trends with conventional NIC are how we arrived at When two medical technologies provide the same function they http://jme.bmj.com/ the current viability standard. If the biobag works as designed, can be treated as interchangeable, unless the process of each its subjects will be less likely to suffer complications than if markedly distinguishes them. Medical and surgical remedies, for they are supported using conventional NIC. Clinicians will see example, are distinguished by comparative invasiveness. AWT more value in treatment for younger preterms when AWs are and conventional NIC both support underdeveloped humans. available because outcomes will be better. This willingness to Hendricks observes, however, that AWT is different in nature try something different to aid ‘almost surviving’ preterms was because it provides more comprehensive support.23 Current care
ultimately the motivation behind the biobag study. It is unlikely is dependent on the preterm ‘tolerating artificial ventilation’, on July 5, 2020 at The University of Manchester Library. that placing younger subjects in AWs would be seen as contro- which is limited by a natural threshold of lung development. versial, with little opposition to attempts, if AWT is successful This threshold does not limit the AW because it better resembles for older neonates. natural gestation,23 and thus does not rely on the lungs for gas The potential use of AWs, which challenges our understanding exchange. There appears to be no natural limit, at least related of viability, exposes a terminology problem. The human being to lung development, restricting the AW. growing in the AW is in the process of artificially induced gesta- The inherent difference between AWT and NIC is more tion. It will, in some cases, be incapable of exercising any inde- nuanced than its effect on one aspect of development. AWT pendent capacity for life and be more ontologically similar to has the capacity to entirely replace a human function: it works the pre-viability fetus in utero, than to what is thought of as by replicating and replacing a biological process, rather than a ‘newborn baby’. The terminology used to describe preterms attempting a rescue. This makes it, in effect, a move into the is similar to that for newborns at full-term. Calling the human realm of automation. The purpose of AWT is to treat a gestateling being gestating ex utero a ‘preterm’ or ‘newborn’ is arguably as if it had never been born, and thus requires the gestateling to misleading as to its behaviour and the extent of its develop- exercise, regardless of its capabilities, no independent capacity ment. This will be explored further when comparing AWT and for life. The traditional infant incubator, in contrast, has the NIC. Notably, the biobag team refer to their subjects as fetuses. purpose of only supporting what capacity for life the newborn Describing the human being gestating ex utero in the AW as a is already exercising or beginning to exercise. Therefore, the fetus, in an attempt to distinguish it from a neonate receiving neonate shoulders some of the burden of sustaining itself. The NIC, is also confusing and misleading. Most medical defini- gestateling, however, has no such pressure incumbent on them tions of the fetus imply it is located inside a human gestator by during partial ectogenesis. AWT requires of its subject no exercise describing it as ‘unborn’.22 of any independent capacity for life. If the AWT were switched
Romanis EC. J Med Ethics 2018;44:751–755. doi:10.1136/medethics-2018-104910 753 Reproductive ethics J Med Ethics: first published as 10.1136/medethics-2018-104910 on 10 August 2018. Downloaded from off or malfunctioned, an underdeveloped gestateling would die capacities. This difference is meaningful in terms of the function just as a fetus would in utero during a severe placental abruption. technology must serve to sustain them. The underdeveloped premature neonate in an infant incubator Let us assume AWT does not confuse the viability threshold that is then switched off, however, might survive a short time further and it has the same natural limitations as NIC in before life functions dwindled. AWT is closer to technologies terms of the subjects it could support.iii There remains a sustaining individuals with brain stem death, than to forms of distinction in the way the subjects behave. The significance artificial support provided to comatose patients with working of the subjects’ contributing, or not, to their own survival nervous systems still coordinating some important bodily func- has already been highlighted. Additionally, the premature tions. The latter is more comparable to NIC. neonate is available for social interaction, can experience the Rieder argues that when physicians, at present and with only benefits of connection with other human beings and become current technologies available, engage in the resuscitation and embedded in social networks. Other individuals can interact treatment of extremely premature infants they effectively take directly and physically with it. The gestateling is shut off 24 over the process of creating them. He argues that conventional from the outside world and does not touch, smell or interact NIC does not rescue when used to aid extremely premature with anything other than its artificial gestator. This isolation infants, but attempts to uptake the creative process and ‘artifi- will influence the perception of and, on occasion, the feeling cially continue gestation’. He posits this observation needs little attached to each entity. These perceptions will impact, in 24 defence. It is my contention, however, that his observations various meaningful ways, on the decision-making of those work when applied to technologies like the biobag, but are surrounding the gestateling. misplaced when applied to conventional NIC. Rieder conflates a human being continuing to develop with gestation (the creative process). Gestation, whether in or ex utero, is distinct from Potential uses of partial ectogenesis ‘continuing to develop after being born’. Human beings continue Finally, AWT introduces opportunities beyond more effica- to develop long after the gestational process is complete, for cious care for preterms. Partial ectogenesis, once AWs are example as part of development continuing into childhood.25 available, could become a distinct course of action in obstet- Gestation, however, is different in that it is a process of forma- rics to manage dangerous pregnancies. A dangerous, but tion, which if not completed adequately the human being has wanted, pregnancy is not wholly uncommon and the choices no capacity for life independent. The limitations of conven- at present seem painfully bleak. When pregnancy threatens a tional NIC demonstrate it is not capable of anything other than woman’s life, she is usually advised to have an abortion. The Protected by copyright. providing assistance with life functions a preterm is struggling alternative is that she continues the pregnancy hoping she to perform itself. Conventional NIC is not a ‘creative process’, survives long enough to deliver a healthy child, but taking AWT, however, is. the risk that neither she, nor her fetus, will survive. In 2016, A further distinction between AWT and conventional NIC is Heidi Loughlin faced this decision after being diagnosed with in environment. Intensive assistance with life functions is wholly a cancer untreatable during pregnancy. Loughlin refused invasive, and yet also leaves the preterm exposed and within to accept there was no alternative to choosing between her an environment where some human interaction (skin-to-skin life and her fetus. She elected for a third choice: remaining contact) is possible. The gestateling in the biobag, however, is pregnant until 28 weeks and opting for premature delivery.
encased and support is almost entirely non-invasive. Support Unfortunately, the premature neonate did not survive long http://jme.bmj.com/ mechanisms surround rather than aggressively invade the after delivery.26 This decision was partial ectogenesis in action, gestateling. One imagines the process of AWT would be less but before AWT was available. An AW, were it accessible, may stressful and painful for the developing human. Less is required have changed the odds. AWT might encourage more women of, and there is less to disturb, the gestateling. Notably, AWT is with dangerous pregnancies to make Loughlin’s choice. It so unique in method that outcomes will be different and, outside might even be that, in future, women wish to opt for AWT of one study, are unknown. There is no way of knowing now, or over continuing pregnancy in situations of less concern, for
anytime soon, what the long-term implications of artificial gesta- example to avoid unpleasant symptoms like morning sickness. on July 5, 2020 at The University of Manchester Library. tion might be. Gestatelings may be subjects of a research trial AWT is, therefore, distinct from rescue technologies because it long after removal from the biobag. For some time, the biobag introduces the possibility of the extraction of gestatelings that will remain a new experimental treatment, while conventional would never have existed ex utero otherwise. AWT in these NIC is business as usual. The unknown implications should situations performs the function of reliably sustaining gestatel- encourage some caution. ings removed from pregnant women and unable to sustain themselves. However, AWT is then functionally not just about The subject of partial ectogenesis ‘sustaining a fetus/gestateling’ but enabling pregnant women AWT could in theory, and possibly in practice, support a to choose an alternative to pregnancy without risking the loss gestateling unable to exercise any independent life functions of the product of reproduction. NIC, because of its risks and ex utero at all. The marked difference in terms of gestational limitations, will never be considered a reliable enough alterna- age, and consequent abilities, of the subject potentially sustained tive to gestation to enable this choice. by each support mechanism is striking. Hendricks argues the If AWT is chosen as an alternative to the ‘dangerous preg- status of the subject would, therefore, be an important distin- nancy-abortion’ dichotomy, an extraction procedure will be guishing factor. We may be inclined to accept that AWT is part of the therapeutic process and is also experimental. A safe different because it can sustain something that ‘does not look method of extraction, potentially a ‘more complex and intri- like a baby’.23 Whether there is any difference in moral status cate’ C-Section must be developed27 28 inevitably involving between the gestateling and the premature neonate is beyond the scope of this paper. There is, however, based on their dissimilar- iii It is worth emphasising, given the reasoning advanced elsewhere in this ities in development and appearance, a huge difference in their paper that this is a big and unwarranted assumption to make.
754 Romanis EC. J Med Ethics 2018;44:751–755. doi:10.1136/medethics-2018-104910 Reproductive ethics J Med Ethics: first published as 10.1136/medethics-2018-104910 on 10 August 2018. Downloaded from trial and error. We are considering experimenting on gestatel- others to copy, redistribute, remix, transform and build upon this work for any ings and also potentially considering experimenting on the purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/ women who carried them. licenses/by/ 4.0/.
Conclusion References The possibility of gestation ex utero begins with technology 1 Partridge E, Davey M, Hornick M, et al. An extra-uterine system to physiologically support the extreme premature lamb. Nat Commun 2017;8:1–15. initially used as an alternative to conventional NIC before 2 Gelfand S, Shook J. Ectogenesis; artificial womb technology and the future of human inevitably challenging the viability threshold. The biobag, reproduction. New York, Rodopi, 2006. however, is more than a mere extension of conventional 3 Singer P, Wells D. Ectogenesis. In: Shook J, ed. Ectogenesis; artificial womb technology preterm care. It marks a shift in physiological approach for and the future of human reproduction. New York, Rodopi, 2006:9–25. 4 Cannold L. Women, ectogenesis and ethical theory. In: Gelfand S, Shook J, eds. three reasons. Ectogenesis; artificial womb technology and the future of human reproduction. New First, AWT replaces a natural function rather than facilitating York, Rodopi, 2006:47–58. a newborn rescue. Instead of assisting a premature neonate 5 Simonstein F. Artificial reproduction technologies (RTs) - all the way to the artificial womb? Med Health Care Philos 2006;9:359–65. with functions it is struggling to perform alone, AWT treats its 6 Glover J. Causing death and saving lives. London: Penguin Books, 1990. subject as if had not been born. Unlike a preterm in intensive 7 azad K, Mathews J. Preventing newborn deaths due to prematurity. Best Pract Res care does, the gestateling does not have to exercise any inde- Clin Obstet Gynaecol 2016;36:131–44. 8 alghrani A. Regulating the reproductive revolution: ectogenesis – a regulatory pendent capacity for life. AWT also places the gestateling in minefield? In: Freeman M, ed. Law and bioethics: volume 11. Oxford: Oxford a different environment, the consequences of which are still University Press, 2008:303–32. unknown. Second, if testing on human ‘just-viable’ preterms 9 Pierrat V, Marchand-Martin L, Arnaud C, et al. Neurodevelopmental outcome at 2 is successful, the technology is likely to be used beyond the years for preterm children born at 22 to 34 weeks’ gestation in France in 2011: EPIPAGE-2 cohort study. BMJ 2017;358:j3448. current viability threshold. Clinicians and parents have incen- 10 Moore T, Hennessy EM, Myles J, et al. Neurological and developmental outcome in tives to try AWT to sustain preterms only slightly below the extremely preterm children born in England in 1995 and 2006: the EPICure studies. threshold, shifting perceptions of viability. Thus, AWT could BMJ 2012;345:e7961. 11 Costeloe KL, Hennessy EM, Haider S, et al. Short term outcomes after extreme preterm sustain subjects with very different capacities. These subjects birth in England: comparison of two birth cohorts in 1995 and 2006 (the EPICure cannot be appropriately described as either babies or fetuses studies). BMJ 2012;345:e7976. because they are unique in behaviour, location and the process 12 Lissauer T, Clayden G. Illustrated textbook of pediatrics. London: Mosby Elsevier, 2012. they are undergoing. The term ‘gestateling’ should be used to 13 Couzin-Frankel J. Fluid-filled ’biobag’ allows premature lambs to develop outside the Protected by copyright. womb. Science 2017;25. identify the developing human being in the AW. Third, AWs 14 Great Ormond Street Hospital for Children NHS Foundation Trust. Necrotising have potential clinical uses beyond conventional rescue tech- enterocolitis. 2016 http://www.gosh. nhs.uk/ medical-information/ search-medical- nologies. AWT might appear just a better alternative to NIC, conditions/necrotising-enterocolitis (accessed 7 Nov 2017). 15 Hendricks J. Not of woman born? Technology, relationship and right to a human but its development is more significant and will enable the mother. College of Law Faculty Scholarship. 2011 http://trace. tennessee.edu/ utk_ birth of partial ectogenesis as a therapeutic process in itself. lawpubl/45 (accessed 28 Feb 2018). Identifying these distinctions is crucial to inform ethicolegal 16 Usuda H, Watanabe S, Miura Y, et al. Successful maintenance of key physiological parameters in preterm lambs treated with ex vivo uterine environment therapy for a discussion and ensure better protection for affected parties. period of 1 week. Am J Obstet Gynecol 2017;217:457.e1–457.e13. Recognising the difference in subject, and terminology that 17 roberts M. Premature lambs kept alive in ’plastic bag’ womb, BBC News. 2017 http:// www.bbc. co.uk/ news/health- 39693851
might helpfully be deployed to describe it, will also prevent http://jme.bmj.com/ the interference of value laden terms and bring clarity to this 18 ectogenesis WJ. Liberation, technological tyranny or just more of the same? In: Gelfand S, Shook J, eds. Ectogenesis; artificial womb technology and the future of discussion. Being mindful of these differences allows us to human reproduction. New York, Rodopi, 2006:129–38. consider what, if any, additional regulation is appropriate to 19 roe v Wade 410 U.S. 113. 1973. ensure AWT research and its potential clinical applications are 20 Nuffield Council on Bioethics. Critical care decisions in fetal and neonatal medicine: ethical issues: Latimer Trend & Company, 2006. ethical. 21 Great ormond street hospital nhs foundation trust v yates and others (No 2) EWHC 1909 (Fam). 2017. Acknowledgements I am grateful to Alexandra Mullock, Rebecca Bennett and 22 Martin E. Concise medical dictionary. Oxford: Oxford University Press, 2015. on July 5, 2020 at The University of Manchester Library. fellow students at the Centre for Social Ethics and Policy for their helpful comments 23 Hendricks J. Not of woman born: a scientific fantasy. Case Western Reserve Law Rev on earlier drafts of this paper. I would also like to thank the two anonymous 2012;62:399–445. reviewers for their thorough and constructive feedback. 24 rieder TN. Saving or creating: which are we doing when we resuscitate extremely preterm infants? The American Journal of Bioethics 2017;17:4–12. Funding This study was funded by Wellcome Trust (10.13039/100004440) and 25 Hayden D, Wilkinson D. Asymmetrical reasons, newborn infants, and resource grant number: 208245/Z/17/Z. allocation. The American Journal of Bioethics 2017;17:13–15. Competing interests None declared. 26 Walker P. Baby delivered early to allow mother’s cancer treatment dies. The Guardian 2015;20. Patient consent Not required. 27 Murphy J. Is pregnancy necessary? Feminist concerns about ectogenesis. In: Gelfand Provenance and peer review Not commissioned; externally peer reviewed. S, Shook J, eds. Ectogenesis; artificial womb technology and the future of human reproduction: New York, Rodopi, 2006:27–46. Open access This is an open access article distributed in accordance with the 28 Schultz J. Development of ectogenesis: how will artificial wombs affect the legal Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits status of a fetus or embryo. Chic-Kent Law Rev 2010;84:877–906.
Romanis EC. J Med Ethics 2018;44:751–755. doi:10.1136/medethics-2018-104910 755 Appendix 2 – Challenging the ‘Born Alive’ Threshold: Fetal Surgery, Artificial Wombs and the English Approach to Legal Personhood (2020) 28 Medical Law Review 93
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Medical Law Review, Vol. 28, No. 1, pp. 93–123 doi:10.1093/medlaw/fwz014 Advance Access Publication: June 1, 2019 Downloaded from https://academic.oup.com/medlaw/article-abstract/28/1/93/5510054 by University of Manchester user on 05 July 2020 CHALLENGING THE ‘BORN ALIVE’ THRESHOLD: FETAL SURGERY, ARTIFICIAL WOMBS, AND THE ENGLISH APPROACH TO LEGAL PERSONHOOD ELIZABETH CHLOE ROMANIS *
Centre for Social Ethics and Policy, School of Law University of Manchester, Manchester M13 9PL, UK *Email: [email protected]
ABSTRACT English law is unambiguous that legal personality, and with it all legal rights and protec- tions, is assigned at birth. This rule is regarded as a bright line that is easily and consis- tently applied. The time has come, however, for the rule to be revisited. This article demonstrates that advances in fetal surgery and (anticipated) artificial wombs do not marry with traditional conceptions of birth and being alive in law. These technologies introduce the possibility of ex utero gestation, and/or temporary existence ex utero, and consequently developing human beings that are novel to the law. Importantly, therefore, the concepts of birth and born alive no longer distinguish between human beings deserv- ing of legal protection in the way originally intended. Thus, there is a need for reform, for a new approach to determining the legal significance of birth and what being legally alive actually encompasses. Investigating the law of birth is of crucial importance, be- cause of the implications of affording or denying the subjects of new reproductive tech- nologies rights and protections. A determination of the legal status of the subject of fetal surgery or an artificial womb will determine what can and cannot be done to each entity. Moreover, the status afforded to these entities will drastically impact on the freedoms of pregnant women. KEYWORDS: Artificial Wombs, Born Alive Rule, Fetal Surgery, Law of Birth, Legal Personhood, Viability
VC The Author(s) 2019. Published by Oxford University Press. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creative commons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited. •93 94 • MEDICAL LAW REVIEW
I. INTRODUCTION The law of England and Wales is clear that legal personality is afforded to all persons born alive.1 The law does, and seemingly always has, unambiguously distinguished be- tween a child before and just after birth. Before birth, a fetus has no legal personality, Downloaded from https://academic.oup.com/medlaw/article-abstract/28/1/93/5510054 by University of Manchester user on 05 July 2020 whereas after it has been born it is afforded all the rights and protections of a child.2 There is not, however, much further clarification about the meaning of birth or what it means to be born alive. The law makes its distinction at birth, despite apparent biologi- cal similarities between human beings just before and just after birth,3 because ‘for le- gal purposes there are great differences...[before and after birth] that raise a whole host of complexities’.4 This article argues that these complexities are no longer limited to the unborn/born dichotomy. The legal principles determining what constitutes be- ing (born) alive will be examined, further developing the debate about how the law manages difficult questions on the cusp of life and death. Emerging medical advances in the treatment of fetuses in utero and premature infants give cause to question whether the legal concepts of birth and born alive provide a sound legal and ethical ap- proach to assigning personhood. In 2017, a Philadelphia team of scientists and fetal surgeons announced the devel- opment of the ‘biobag’.5 This was an artificial womb prototype (AW) that had, in clin- ical trials, successfully supported lamb fetuses on the viability threshold for four weeks.6 The biobag is significant for three reasons. First, all test subjects survived the experiment without experiencing any of the common complications associated with (lamb) preterm birth.7 It is hoped that this technology will also have the capacity to overcome the present limitations of neonatal intensive care and improve patterns of morbidity and poor prognoses in human preterms.8 AWs could have an immediate clinical application as an alternative to neonatal intensive care.9 Secondly, the biobag marks a shift in physiological approach to intensive care for developing human beings. It treats the subject as if it had not been born (removed from the uterus) by closely mimicking uterine conditions to effectively prolong gestation.10 Thirdly, the subject of an AW is distinct from both a fetus in utero and a premature neonate treated by traditional intensive care.11 The subject is an underdeveloped human being
1 Paton v British Pregnancy Advisory Service Trustees [1979] QB 276. 2 A Alghrani and M Brazier, ‘What is it? Whose it? Re-positioning the Foetus in the Context of Research?’ (2011) 70 Cambridge Law Journal 51, 52. 3 P Singer, Practical Ethics, 1st edn (CUP 1993), 126. 4 N Naffine, ‘Who are Law’s Persons? From Cheshire Cats to Responsible Subjects,’ (2003) 66 Modern Law Review 346, 359. 5 E Partridge et al, ‘An Extra-Uterine System to Physiologically Support the Extreme Premature Lamb’ (2017) 8 Nature Communications 1. 6 ibid. 7 ibid, 2; ibid, 6. 8 K Costeloe et al, ‘Short Term Outcomes after Extreme Preterm Birth in England: Comparison of Two Birth Cohorts in 1995 and 2006 (the EPICure studies)’ (2012) 345 British Medical Journal
12 A Smajdor, ‘Ethical Challenges in Fetal Surgery’ (2010) 37 Journal of Medical Ethics 88, 88. 13 S Scutti, ‘Meet the Baby who was Born Twice’ (CNN 20 October 2017)
II. ARTIFICIAL WOMBS AND FETAL SURGERY: THE FUTURE OF OBSTETRICS AWT offers the ability to gestate fetuses ex utero. The technology, if perfected, will mimic the uterine environment and support a developing human being throughout the gestational period. In the distant future, AWT might eliminate the need for preg- nancy at all. Human beings could be created in laboratories by in vitro fertilisation and grown in an AW until 36 weeks from conception. This process, known as complete ectogenesis, however, remains a remote possibility. English legislative provisions cur- rently prevent experimentation on embryos after 14 days from development,21 hinder- ing potentially illuminating research about how embryo development in artificial conditions might be achieved.22 Partridge et al’s recent publication of the biobag study, however, revealed a prototype AW with potential. In the study, lambs were re- moved from the uteri of ewes and placed into the biobag when developmentally equivalent to the human preterm neonate on the recognised viability threshold:
19 J Couzin-Frankel, ‘Fluid-filled “biobag” allows Premature Lambs to Develop Outside the Womb’ (Science 25 April 2017)
23–25 weeks.23 All test subjects were successfully ‘delivered’ from the biobag after a 4-week period and survived. All subjects also avoided developing the most common, and often fatal, complications that plague (lamb) preterms.24 These same complica- Downloaded from https://academic.oup.com/medlaw/article-abstract/28/1/93/5510054 by University of Manchester user on 05 July 2020 tions have seemingly prevented meaningful change in mortality rates and long-term prognoses in human preterm-neonates for some time.25 The biobag study was so suc- cessful that, subject to further animal testing, the authors suggest testing on humans is on the horizon.26 They identify their clinical target population as prematurely born neonates.27 We are seemingly on the verge of AWT not as an alternative to all preg- nancy, but as a viable alternative to neonatal intensive care. While complete ectogene- sis is not in our immediate future, partial ectogenesis (the development of a human being in an AW for part of the typical gestational period)28 may well be.29 It is a mistake to presume newly designed AWs should be treated just like all other neonatal intensive care. Firstly, the subject of this technology will have, at some point, been gestated in utero. The process still involves the pregnant woman, because sub- jects of the technology will be either delivered prematurely or extracted by C-section30 with the pregnant woman’s consent. Secondly, AWT treats its subject as if it had not been born. During the incubation period, the subject of the AW is not exercising any capacity for life, whether it is capable of exercising any independent life functions or not.31 AWT is able to mimic the uterine environment almost entirely, and thus con- tinues the process of gestation. In contrast, conventional care for preterms provides interventions and assistance to perform life functions that the preterm is attempting or beginning to attempt alone.32 Thirdly, AWT has the capacity to support much younger subjects than conventional neonatal intensive care, and it is likely that it will be used to support these less developed preterms.33 Conventional support for pre- terms, such as mechanical ventilation, has proved inadequate beyond the viability threshold because they cannot support developing human beings without any capacity for independent life.34 Traditional intervention can assist the inherent vulnerabilities
23 Partridge et al (n 5). 24 ibid 2; ibid 6; Biobag technology has at least demonstrated that this is true in respect of preterm lambs. The success of the project in preterm lambs does not necessarily mean that the biobag will be as successful at addressing these complications that result from being preterm in human preterm neonates. There are also limitations to these studies in respect of sample size etc. The researchers, however, do imply in their paper that the results give enough reason to believe the biobag might be as successful in humans (experiencing similar complications) so as to justify the experimental application of the technology on human beings in the future. 25 Costeloe et al (n 8). 26 Partridge et al (n 5) 11. 27 ibid,11. 28 Partial ectogenesis is the development of a human being in an AW for part of the typical gestational period following transfer from the maternal womb. C Kaczor, The Edge of Life: Human Dignity and Contemporary Bioethics, Philosophy and Medicine, 1st edn (Springer 2005), 113. 29 S Gelfand and J Shook (eds), Ectogenesis; Artificial Womb Technology and the Future of Human Reproduction, 1st edn (Rodopi 2006), 1. 30 Until this technology becomes more commonplace, it is probable that the subjects of AWT are likely to be preterm neonates, which would have otherwise been treated with conventional neonatal intensive care. 31 Romanis (n 9) 753. 32 ibid 753. 33 ibid 753. 34 ibid 752. 98 • MEDICAL LAW REVIEW of an underdeveloped human body, but it cannot aid the further development of the human being if that human does not have the capacity to develop. For example, me- chanical ventilation cannot support lungs before a certain threshold of development35 Downloaded from https://academic.oup.com/medlaw/article-abstract/28/1/93/5510054 by University of Manchester user on 05 July 2020 (around 22 weeks).36 The AW prototype, however, does not appear to have this limi- tation.37 The subject of the AW does not need semi-functional lungs: it is reliant on gas exchange through cannulae and amniotic fluid,38 just as the fetus in utero is reliant on amniotic fluid and the umbilical cord. The AW thus can, and will, challenge current conceptions of viability.39 Finally, the subject of AWT could have different capacities to, will behave differ- ently to, and will be treated differently to, a newborn baby.40 Adopting the terminol- ogy applied to newborn babies and premature neonates is inappropriate, because this fails to account for the differences in behaviour and location between the AW subject and the baby in intensive care. The subject is more ontologically similar to, and is un- dergoing the same processes as, a fetus in utero. However, its ex utero location makes it inappropriate to label it as a fetus because most medical definitions (and lay concep- tions) of the fetus refer to it being ‘unborn’,41 implying it remains located in a preg- nant woman’s uterus.42 Because all terminology used to describe the product of reproduction at various different points in development is inappropriate for the being in the AW, a different term should be adopted.43 The term ‘gestateling,’ that I first coined elsewhere, refers to the ‘human being in the process of ex utero gestation in an AW exercising...[regardless of whether] it is capable of doing so, no independent ca- pacity for life’.44 We must be mindful of the conceptual differences between AWT and neonatal intensive care to ensure that the implications of AWT, such as the im- pact on the law of birth, are fully investigated. A second important development profoundly changing our understanding of birth is advanced fetal surgery, most famously performed on LynLee Boemer in 2016. The advent of different techniques for surgical procedures on the in utero fetus brings much needed aid to fetuses with conditions that would otherwise prevent them sur- viving long enough to be born alive.45 Lenow describes how ‘the ultimate achievement in fetal surgery was the partial removal of the fetus from its mother’s uterus and onto an operation field’.46 Surgeries involving the fetus’s removal partially resemble a
35 Couzin-Frankel (n 19). 36 This point is identified because it is the age of the youngest premature neonate that has ever survived. It is notable, however, that lung development will occur at a slightly different rate for different fetuses and so this is not a fixed point. 37 J Hendricks, ‘Not of Woman Born: A Scientific Fantasy’ (2011) 62 Case Western Reserve Law Review 399, 405. 38 See Partridge et al (n 5) 2–4 for a detailed description for how the biobag functions. 39 Romanis (n 9) 753. 40 ibid 753–54. 41 Eg E Martin, Concise Medical Dictionary, 9th edn (OUP 2015), 275. 42 Romanis (n 9) 753. 43 ibid 753. 44 ibid 753. For further conceptual differences between artificial wombs and conventional neonatal intensive care discussed in more detail see: ibid. 45 Smajdor (n 12) 89. 46 J Lenow, ‘The Fetus as a Patient: Emerging Rights as a Person’ (1983) 9 American Journal of Law and Medicine 1, 17. Challenging the ‘Born Alive’ Threshold •99 caesarean because the same incision is made into the uterus. The patient of the sur- gery is the pregnant woman, who must consent to the procedure. The fetus is then re- moved from the incision and operated upon. Baby Boemer’s surgeon described his Downloaded from https://academic.oup.com/medlaw/article-abstract/28/1/93/5510054 by University of Manchester user on 05 July 2020 procedure in a press interview, explaining the fetus was ‘hanging out in the air...the foetus is outside, like completely out, all the amniotic fluid falls out, it’s actually fairly dramatic’.47 During surgery, the fetus remains dependent on the placenta (attached by umbilical cord), and is returned to the uterus on completion of the procedure.48 In utero, the fetus continues undergoing natural gestation for the remaining period. What terminology should be used to describe the subject of a fetal surgery while ex utero? The subject of a fetal surgery differs from a fetus because it is ex utero. Thus, a distinct term for this unique entity will ensure clarity in the discussion and potentially avoid attaching misleading moral connotations to the subject of a fetal surgery. In some ways, the subject of a fetal surgery, as an entity independent of the pregnant woman, becomes a second ‘patient’ of the surgeons. However, referring to it as a ‘pa- tient’ implies access to the rights patients are granted in English law, and it is not cer- tain that the subject of a fetal surgery would have access to these protections. The developing human being in the course of this surgery, therefore, will be referred to as the fetal operatee when removed from the uterine environment, and the fetus before removal from and after it has been returned to the uterus. These unique entities (the fetal operatee and the gestateling) raise interesting problems for the application of the born alive rule.
III. THE TEST FOR LEGAL PERSONALITY English law is clear that, before birth, there is no person on whom legal rights or duties can be bestowed.49 In Paton, Sir George Baker held that ‘a fetus...cannot have a right of its own until it is born and has a separate existence from its mother’.50 Lord Mustill echoed this conclusion almost 20 years later: ‘it is established beyond doubt for the criminal law, as for the civil law... that the child en ventre sa mere does not have distinct human personality...’.51 Birth as the focal point of personality is a prod- uct of the criminal law and negligence in civil law, and is a tradition of the time in which the law was formulated. Savell argues that the law’s insistence that subjects with personality have been born is understandable in the civil context, ‘as...conferring le- gal status on fetuses might bring pregnant women’s rights into direct conflict with those of fetuses’.52 A lack of fetal personhood also precludes criminal charges being levied against pregnant women for harm caused in utero.53 Recognising fetal person- hood, in civil or criminal law, would be a significant curtailment of pregnant women’s
47 Scutti (n 13). 48 Smajdor (n 12) 88. 49 K Savell, ‘Is the Born Alive Rule Out-dated and Indefensible?’ (2006) 28 Sydney Law Review 625, 624. 50 Paton (n 1), per Sir George Baker P at 279. 51 Attorney-General’s Reference (No 3 of 1994) [1998] AC 245, per Lord Mustill at 261. 52 Savell (n 49) 661. 53 Attorney-General’s Reference (n 51); CP (A Child) v Criminal Injuries Compensation Authority (2015) QB 459. 100 • MEDICAL LAW REVIEW liberty54 and would create incentives for vulnerable women to evade medical and so- cial care, putting themselves (and their fetus) at risk.55 Acquiring legal personality is not just a matter of being born, but also being born Downloaded from https://academic.oup.com/medlaw/article-abstract/28/1/93/5510054 by University of Manchester user on 05 July 2020 ‘alive’. Stillbirth occurs when a child is born without having demonstrated any signs of life.56 The existence of a stillborn child is legally acknowledged,57 but the law never affords them, or accepts they did at any point have, legal personality. A stillborn child cannot be the victim of a homicide,58 or bring an action (or have another person bring an action on their behalf) in tort.59 To obtain legal personality, therefore, a human be- ing must be both born (have an independent existence),60 and it must be evident they were born alive.61 ‘Born alive’ is a concept still closely tied to the moment a neonate is delivered, because it is usually easy to observe life in the newborn without complex diagnostic tools. Birth was also, before the advent of techniques like ultrasound, the most reliable confirmation that a developing human being even existed. Limited medi- cal and obstetrical knowledge about pregnancy and fetal development often meant that ‘it could not be known with certainty if a woman was pregnant [and] if it was rea- sonably clear that she had been pregnant, it could not be known... if the child was still alive in her womb’.62 With the need to provide a pragmatic answer to the begin- ning of legal life, birth seemed the most determinative point in the development of human beings that could be used to trigger legal protections. It has been argued that the born alive rule is not a substantial legal principle, but an out-dated evidential presumption.63 Critics point to developments in fetal monitor- ing,64 such as 3D imaging,65 that have enabled medicine to determine that developing human beings exist and exhibit signs of supported life before birth. With such evi- dence available, some argue that we should not be so reliant on birth as a starting point.66 There has even been some judicial support for this claim. In the Supreme Court of Canada,67 Major JJ, in a dissenting judgment, posited that technology like fetoscopy68 should mean that the ‘born alive’ rule is abandoned, because birth is no
54 E Romanis, ‘Pregnant Women may have Moral Obligations to Foetuses they have Chosen to Carry to Term, but the Law should never Intervene in a Woman’s Choices during Pregnancy’ (2017) 6 Manchester Review of Law, Crime and Ethics 69, 78. 55 ibid 78. 56 Births and Deaths Registration Act 1953 s 41, as amended by Still-Birth Definition Act 1992 s 1(1). 57 Note that if a developing human birth is delivered dead before 24 weeks this is not a stillbirth, but is legally recognised as a miscarriage. See: Births and Deaths Registration Act 1953 s 41, as amended by Stillbirth Definition Act 1992 s 1(1). A miscarriage does not involve any recognition that a distinct developing human birth legally existed. 58 Attorney-General’s Reference (n 51). 59 Burton v Islington Health Authority [1993] QB 204. 60 Paton (n 1). 61 Attorney-General’s Reference (n 51). 62 G Casey, ‘Pregnant Woman and Unborn Child: Legal Adversaries?’ (2002) 8 Medico-Legal Journal of Ireland 75, 76. 63 Naffine (n 4) 259. 64 ibid 259. 65 Savell (n 49) 645. 66 A Peterfy, ‘Fetal Viability as a Threshold to Personhood: A Legal Analysis’ (1995) 16 The Journal of Legal Medicine 607, 630–31. 67 Winnipeg Child and Family Services (Northwest Area) v G (DF) (1997) 3 SCR 925. 68 ibid per Major JJ at 981. Challenging the ‘Born Alive’ Threshold • 101 longer the only way to evidence a human being’s development.69 The possibility of ex utero gestation, for different reasons, provides more ammunition to the argument that the focus on ‘birth’ may be an out-dated approach to affording legal personality. The Downloaded from https://academic.oup.com/medlaw/article-abstract/28/1/93/5510054 by University of Manchester user on 05 July 2020 next sections highlight the inherent ambiguities in each element of the test for legal personality, and issues arising with its application to new technologies. The consequences of the legal status of these novel entities, determined by examin- ing the test for legal personality, are important to emphasise. Without legal person- hood the fetal operatee and the gestateling cannot access some of the most significant protections that the law offers to persons, including protection in the law of homicide or the ability to seek recourse after negligent treatment.70 Determining what protec- tion these entities are afforded will be of the utmost importance to potential intended parents of each entity. Further, the legal status afforded to each has significant implica- tions for pregnant women. If the fetal operatee were afforded legal personality this would subject the pregnant women to external control, on the basis of the interests of another, for the duration of her surgery and potentially for the remainder of her preg- nancy. If the gestateling is afforded legal personality this will have the effect of shifting perceptions, or adding additional legitimacy to shifting perceptions, about viability with significant implications for future abortion provision. These implications are ex- plored in more detail throughout this article.
IV. FETAL SURGERY: BORN OR NOT BORN In English statute and case law, descriptions of birth all imply birth is a matter of sepa- ration of gestator and gestational subject. In Paton, birth was described as ‘a separate existence from [the] mother’.71 The Births and Deaths Registration Act 1953 (BDRA 1953) defines a born child as a child ‘issued forth from its mother’.72 These defini- tions, however, provide no clarification about what constitutes separation or a separate existence. This section examines the evolution of the law of birth and its application to AWT and fetal surgery. It is argued that the dividing line of birth is no longer clear- cut, because these rules and principles have been entirely developed in the context of abortion/murder and the maternal-fetal conflict.73 Maintenance of an ‘ex utero exis- tence’ as the dividing line between personality and no personality could have disas- trous implications for women. However, erasing the legal significance of birth altogether could leave some ex utero human beings without adequate protection.
69 ibid. 70 It should be noted that if the fetal operatee or gestateling were ‘born alive’ but disabled as a result of negli- gent treatment, the parents could sue for wrongful birth. See: Parkinson v St James and Seacroft NHS Hospital Trust [2001] Lloyds Rep Med 309, CA. The parent’s ability to seek recourse in this circumstance is not insignificant, but it may not always be helpful. There may be instances where the fetal operatee or gesta- teling do not survive to be ‘born alive’ in law and thus a claim for wrongful birth would be precluded. Moreover, this is not the same as the fetal operatee or gestateling having a claim in their own right. 71 Paton (n 1) per Sir George Baker at 279. 72 Births and Deaths Registration Act 1953 s 41, as amended by Still-Birth Definition Act 1992 s 1(1). Further statutory definitions of birth include: Infant Life Preservation Act 1929 s 1(1) ‘an existence independent of [the] mother’ and Congenital Disabilities (Civil Liability) Act 1976 s.4 (2)(a) birth is when the baby ‘first has a life separate from its mother’. 73 A Alghrani, ‘Regulating the Reproductive Revolution: Ectogenesis – A Regulatory Minefield’ in M Freeman (ed), Law and Bioethics: Volume 11, 1st edn (OUP 2008), 305. 102 • MEDICAL LAW REVIEW
A. Is Birth Just a Matter of ‘In vs. Ex Utero?’ The majority of attempts to interpret the meaning of born are 19th century authori- ties: criminal cases in which a fetus/infant was killed during delivery. These cases con- Downloaded from https://academic.oup.com/medlaw/article-abstract/28/1/93/5510054 by University of Manchester user on 05 July 2020 sider whether a defendant was guilty of murder or, because birth was not complete, the lesser crime of infanticide74 and/or concealment of birth.75 In R v Crutchely,76 Parks B directed that an infant was born only when ‘the whole body of the child had come forth from the body of the mother’.77 In R v Poulton, Littledale J instructed that being born meant ‘the whole body is brought into the world’.78 These conclusions were echoed more recently in Rance v Mid-Downs Health Authority.79 Brooke J (as he then was) observed that the law provided no protection to ‘the child while... in the process of being born before it had been completely separated from its mother’.80 It is clear that legal birth is a process in which an infant has been entirely expelled from the uterus. There is concern in the literature that the focus on birth as the point legal personal- ity is acquired may be unworkable if human beings could be gestated ex utero. This concern has, however, been almost entirely focused on complete ectogenesis. If a child can be gestated entirely in an AW, without a human gestator, at what point has birth taken place?81 However, AWT in its current form and in its immediate antici- pated clinical application concerns partial ectogenesis: cases in which a fetus con- ceived in and gestating in utero,82 is removed to continue gestating in an AW.83 This use of AWT does not concern situations in which the gestateling was never inside a woman’s body. The question of when birth occurs if a human being never existed in utero is important, but, as a less immediate possibility, it is not explored here. Applying the law to partial ectogenesis might seem intuitive. The question of legal birth seems to be purely a pregnancy law question: is it in or ex utero? Extraction at any point, whether by natural premature expulsion or deliberate premature evacua- tion, transferring the fetus from the uterus to the AW, is a birth. In an AW, the gesta- teling has a separate existence from the woman who previously carried it. A fetus in utero has no legal personality, even if almost at full term. A gestateling ex utero, how- ever, presumably has legal personality and all associated protections, even if premature (and potentially pre-viable) and sustained only by an AW.84
74 Offences against the Person Act 1861 s 58. 75 ibid s 60. 76 R v Crutchely (1837) 7 Car & P 814. 77 ibid per Parks B at 816. 78 R v Poulton (1832) 5 Car & P 328. 79 Rance and Another v Mid-Downs Health Authority and Another [1991] 1 QB 587. 80 ibid per Brooke J at 620. 81 The consensus in the literature seems to be that birth would be the point the gestateling was removed from the artificial womb. See Alghrani and Brazier (n 2) 60; M Sander-Staudt, ‘Of Machine Born? A Feminist Assessment of Ectogenesis and Artificial Wombs’ in S Gelfand and J Shook (eds), Ectogenesis: Artificial Womb Technology and the Future of Human Reproduction, 1st edn (Rodopi 2006) 124; E Steiger, ‘Not of Woman Born: How Ectogenesis will Change the Way we View Viability, Birth and the Status of the Unborn’ (2010) 23 Journal of Law and Health 143, 155. 82 Or, it may have been created using IVF and then implanted into a woman’s uterus for gestation. 83 Gelfand and Shook (n 29) 1. 84 Provided that it is legally born alive as well as birthed. This will be explored in detail later in this article. Challenging the ‘Born Alive’ Threshold • 103
Fetal surgery, however, could demonstrate that a developing human being’s ex utero existence should not necessarily equate to it having been birthed. During fetal surgery the fetal operatee (minus the placenta) is extracted from the pregnant wom- Downloaded from https://academic.oup.com/medlaw/article-abstract/28/1/93/5510054 by University of Manchester user on 05 July 2020 an’s body to be operated upon, remaining attached only by umbilical cord, and then returned to the womb. In Margaret Boemer’s case, her fetus was removed for only 20 minutes, but was fully extracted in that time by the same process as a newborn deliv- ered by caesarean and was existing ex utero. Therefore, the consequence of current law (birth is expulsion)85 is the conclusion that the fetal operatee is legally born. Recognising this birth, however, is potentially inconsistent with fundamental princi- ples of English law. For the purposes of analysing this tension, it is assumed a fetal operatee would be born alive if it is birthed, therefore acquiring personality.86 This sec- tion considers two intuitive responses to conceptualising the fetal operatee’s ex utero existence, first that it is born and second that it is not born, to demonstrate why both are problematic.
1. The Problem with Recognising the Fetal Operatee’s ‘Birth’ Birth is not a homologous event. Women can give birth by a variety of processes in- cluding, but not limited to, vaginal delivery, technologically assisted vaginal delivery and caesarean.87 It is also sometimes difficult to ascertain how far through a delivery a developing human being has to be in order to be legally birthed. A broad definition of birth, as a matter of only being no longer inside another person, accounts for all these complicating factors. Equally, however, a broad non-exhaustive definition may create problems by being too inclusive. The broad definition potentially encompasses the fetal operatee, thus potentially enabling its acquisition of legal personality.88 The law is clear that the fetus is not a legal person,89 and this protects pregnant women from exploitation. In Re F90 the judgment explicitly precluded any possibility of fetal personhood, because affording it personality would result in the subordination of pregnant women.91 During pregnancy there is often unavoidable tension between fetal welfare and a pregnant woman’s autonomy. If fetuses were awarded legal person- hood, they could be made a ward of court and decisions would be made in their best interests, thus forcing pregnant women to forego basic freedoms.92 Extending legal personhood to fetuses would result in pregnant women’s actions and choices being subverted to external control.93 This subversion contravenes the ‘fundamental princi- ple, plain and incontestable...that every person’s body is inviolate’.94 The law is clear
85 Paton (n 1). 86 Meaning that if the fetal operatee is legally born, and it is assumed it is legally born alive, it would then ac- quire legal personality. 87 Johnson Memorial Health, ‘5 Different Types of Childbirth and Delivery Methods You Should Know’ (Johnson Memorial Health Blog 15 January 2015)
95 Re MB (An adult: medical treatment) [1997] EWCA Civ 3093. 96 Smajdor (n 12) 90. 97 Naffine (n 4) 357; There are also serious issues in determining how death should be legally defined because of its implications in terms of the loss of legal personhood. See: M Brazier and E Cave, Medicine, Patients and the Law, 6th edn (Manchester University Press 2016) 510. 98 Assuming it was legally born alive. 99 This will be explored later in the meaning of being legally born alive. 100 Re F (n 90) per May LJ at 138. Challenging the ‘Born Alive’ Threshold • 105 particular purpose,101 has constructed the personality framework that applies to them. Rules and limitations about the operation of that personality can also, therefore, be constructed. Rules could be constructed to recognise that, although the same living Downloaded from https://academic.oup.com/medlaw/article-abstract/28/1/93/5510054 by University of Manchester user on 05 July 2020 human being in a physical sense, there need be no continuity in legal recognition be- tween the fetal operatee and fetus. It could be argued that the fetal operatee ceases to exist, which could be akin to a sort of ‘death,’ when it becomes a fetus once more. There seems to be, however, no scope in current law for this possibility of demeaning a human being to a status lesser than a legal person whilst still biologically ‘living’, even when there are significant changes in their physicality. For example, living human beings with legal personality do not have their status degraded even if they become mentally or physically incapacitated, if they are dependent on others, or even impris- oned. Human legal personality has never been treated as a contextual status. It might be considered dangerous to set a precedent that human legal personality can be gained and lost by anything other than birth and death (in the biological sense).102 The rights and entitlements associated with legal personality for human beings are treated as more innate than those attached to other entities with personal- ity. Human rights provisions explicitly prevent any individual from being demeaned to a lesser status than any other person in law,103 because personality is the vehicle through which the most fundamental human rights are guaranteed and individuals are protected from exploitation and oppression. There may be concern about the norma- tive political implications of recognising that personality can be undone based on a human being’s capacities or their location. Fetal surgery can be conceptualised as an isolated case entirely removed from concerns about the denial of rights to vulnerable minorities; however, a legal mechanism of undoing personality by anything less than death still could conjure up these feelings of unease.104
2. The Problem with Claiming the Fetal Operatee is ‘Non-birthed’ Those concerned about the normative implications of undoing personhood might argue the fetal operatee has not been legally born. To make this argument, the fetal opera- tee’s circumstances must be differentiated from the baby traditionally born. The first significant difference is the connection between the pregnant woman and fetal opera- tee. In obiter in A-G’s Reference, Lord Hope alluded to the significance of an in utero
101 For example, to enable limited liability as a logical consequence of a company having its own personality dis- tinct from its shareholders: See A Dignam and J Lowry, Company Law, 8th edn (OUP 2015) 16. 102 Even without legal recognition of birth for the fetal operatee, there may well be a drastic impact on the treat- ment of pregnant woman who have been involved in fetal surgery. Even if legal personhood could be un- done, fetal surgery would still change the perception of how the fetus should be treated. It has become a second patient that is, for a time, legally recognised and this will impact on the pregnant woman who is carry- ing it. The effect has been observed with the developments of fetal imaging creating the fetal operatee and influencing decision making in obstetrics: see Lenow (n 46). This effect may be more impactful in instances where the fetal operatee has not only been observed, but also has been interacted with ex utero and has been the subject of a procedure that did not involve the pregnant woman. 103 For example, the Human Rights Act 1998 prohibits all slavery and forced labour (Sch 1, art 4) and protects the right to liberty and security (Sch 1, art 5). 104 It might be time to move to a more nuanced perspective of legal personality and how it might be afforded and removed. There might be lessons to be learnt from other areas of the law, for example company law. This will be briefly discussed later in this article. 106 • MEDICAL LAW REVIEW existence being ‘total dependence... on the protective physical environment fur- nished by the mother, and on the supply of the mother through the physical link- age... of nutrients, oxygen and other substances essential to fetal life and Downloaded from https://academic.oup.com/medlaw/article-abstract/28/1/93/5510054 by University of Manchester user on 05 July 2020 development’.105 This comment suggests legal birth could be both a matter of loca- tion (no longer within the uterine environment) and of connection (no longer reliant on the pregnant woman for nutrient supply). The question of whether a remaining physical connection between a pregnant woman and her fetus/newborn once ex utero means birth is incomplete has not been addressed in modern case law or commentary. In older authorities, however, there was substantial discussion of whether a baby was legally born if, once ex utero, it still remained attached to the pregnant woman by the umbilical cord. In Crutchely, Parks B suggested the umbilical cord is irrelevant: the only condition necessary and sufficient for birth is expulsion.106 He directed that if the defendant were found guilty of murder because of umbilical attachment, there would be legal grounds for appeal.107 Crutchely was acquitted, and there was thus no appeal affording an appellate court the opportunity to scrutinise the significance of post-expulsion connection. Erskine J made a more conclusive direction in Trilloe,108 instructing that a baby was legally born even if still attached by naval string.109 This reasoning was adopted in Reeves.110 Modern authorities in other jurisdictions, which form persuasive precedent, also reach this conclusion.111 These authorities all concern situations in which a baby was delivered by natural means and the cord seemed an ob- servable formality. It could be demonstrated, therefore, that fetal surgery is distin- guishable because it involves a technological medical intervention, and the fetal operatee remains dependent on the connection, unlike the newborn. While a distinc- tion can be made, it seems insufficient. The prospect that the intentional killing of an ex utero developing human being (even if the subject of a surgery) would not be rec- ognised as homicide just because it remained connected by (and dependent on) the umbilical cord, would offend centuries-old legal tradition in defining homicide. The second difference between fetal operatee and newborn baby is the intentions of the actors around them. The surgeons intend, when delivering a baby by caesarean, that the procedure marks the beginning of that baby’s permanent existence ex utero. Despite initially performing the same incision and removal, a surgical team intends the opposite when undertaking a fetal surgery. The argument is then that the fetal
105 Attorney-General’s Reference (n 51) per Lord Hope at 255. 106 Crutchely (n 76) per Parks B at 816. 107 ibid. 108 R v Trilloe (1842) Car & M 650. 109 ibid per Erskine J at 651. 110 In R v Reeves (1839) 9 Car & P 25, at 26 Vaughan J remarked that he would be surprised if ‘the child and the after-birth might be completely delivered and yet because the umbilical cord was not separated the child might be knocked on the head and killed without the party who did it being guilty of murder’. This observa- tion attempts to put the issue to bed by making any other conclusion seem nonsensical. 111 In R v Hutty [1953] VLR 228 (Supreme Court of Victoria), the Supreme Court of Victoria in Australia had cause to interpret the meaning of birth. The judgment was clear that ‘it is not material that the child may still be connected to its mother by the umbilical cord...but it is required that the child should have an existence separate from and independent of its mother, and that occurs when the child is fully extruded from the mother’s body...’. Challenging the ‘Born Alive’ Threshold • 107 operatee should not acquire personhood because it is not treated as if it is, and it is not intended that it be, birthed. Including the intentions of other agents in deciding whether something was a someone could have unsettling consequences. If the parent/s Downloaded from https://academic.oup.com/medlaw/article-abstract/28/1/93/5510054 by University of Manchester user on 05 July 2020 of a disabled newborn believed it should not receive life-saving treatment there would be no suggestion that treatment is withheld because, based on the parent’s intentions, it was not a person worthy of recognition. Discussion is instead directed to whether treatment is in the newborn’s best interests.112 If either distinction was successfully drawn, the result would be that a developing human being exists ex utero without legal personality, albeit temporarily. This also has concerning ramifications. Without personhood during the operation, liability for grossly negligent surgeries causing death in utero and subsequent stillbirth of fetuses might be precluded. Gross negligence manslaughter could only be established if a baby was born alive with injuries sustained from negligent surgery that later cause death.113 The offence of child destruction (if before 24 weeks), or of procuring mis- carriage could not be established because there would be no mens rea.114 There may be no civil recourse following the stillbirth of a fetus that died in utero as a result of negligent fetal surgery. If the fetus is not born alive, then it is not an entity that can bring an action in tort. There would only be a course of action in negligence for the baby born alive but injured by negligent surgery.115 Fetal surgery does not sit easily in the in/out dichotomy that the law of birth has constructed. As the possibilities of fetal surgery advance to treat more conditions,116 the implications will become more significant. The law must be able to answer the question of status in the event of a claim that fetal surgery was negligent. Having ex- amined the alternative interpretations of the current rule, a more nuanced approach to birth than ‘in or out’ may be the only appropriate solution. Returning to the possi- bilities of AWT, related but distinct problems arise when we consider the legal status of the gestateling. The language of birth seems inappropriate for gestatelings at the earliest stages of development. An AW is designed to continue the process of gestat- ing as if the gestateling had never been expelled from the uterus. It seems logical to ar- gue that removal from the uterine environment only to be placed in an AW should not be considered legal birth because the processes that traditionally occur before birth are continued. However, if the fetal surgery problem is reduced wholly to a mat- ter of location, the law’s construction means extraction to be placed in an AW would be the gestateling’s birth. It might be argued that birth remains, for legal purposes, the
112 Re B (A Minor) (Wardship: Medical Treatment) [1981] 1 WLR 1421. 113 See Attorney-General’s Reference (n 51). 114 If the fetus were removed, this procedure then undertaken negligently, and the fetus died after being returned to the uterus, all before the fetus was legally ‘capable of being born alive’ or at 24 weeks gestation, the surgeon could not be guilty of the offence of child destruction. The surgeon would not be guilty of ‘pro- curing a miscarriage’ in these circumstances because it is unlikely that it could be established that they intended that the fetus be miscarried in utero post-surgery. 115 In these specific circumstances, the ‘baby born alive’ would be able to pursue an action in negligence for damage caused during the surgery, because at birth they attain legal personality and inherit ‘the damaged body for which the [foetal surgeon] (on the assumed facts) [is] responsible:’ Burton v Islington HA (n 59) per Dillon LJ at 219. 116 BBC News, ‘Two Unborn Babies’ Spines Repaired in Womb in UK Surgery First’ (24 October 2018)
V. ARTIFICIAL WOMBS: BORN ALIVE OR INACTIVELY ALIVE Legal protections, however, are not just a matter of being ex utero. They are also con- ditional on proof that the ex utero human being is ‘alive’.119 This section argues that the law cannot simply rely on the convenient dividing line of location (or the bodily autonomy of pregnant women) to deal with the difficult cases of AWT and fetal sur- gery and their total impact on the traditional understanding of birth. There are still ambiguities in the meaning of born alive in the substantive test for legal personality that must be addressed. Little attention has been paid to the lack of clarity, however, because courts have had little cause to examine the definition of a legal person in itself, instead examining only the application of the test in particular circumstances.120 With the advent of emerging technologies this may be about to change. The novel develop- ing human beings that are the subjects of emerging technologies demonstrate that given definitions of born alive do not account for the possibility of ex utero gestation. The current definition of ‘born alive’ is too narrow for the gestateling and fetal opera- tee because they do not breathe or exercise any independent capacity for life. In CvS, Sir John Donaldson MR remarked that ‘alive is a simple concept... It should be construed in conformity with the...Births and Deaths Registration Act 1926, which makes the birth of a child which breathes or shows any other signs of life registrable as birth’.121 There remains ambiguity. Is an infant born alive if it breathes only with assis- tance technology? What signs of life aside from breathing are sufficient proof that a child was born alive? While only some of these complexities have been addressed in the courts, the inherent difficulty in determining whether a child is born alive has been acknowl- edged. In CvS, Heilbron J observed that questions of ‘when a [born] child is actually alive, are...problems of complexity to even the greatest medical minds’.122 In Re A the legality of surgically separating conjoined twins, where one was entirely dependent on the other exercising all major life functions, was considered.123 Walker LJ observed there could have been grounds to question whether the weaker twin was born alive because she was entirely dependent on her sister for life.124 His judgment highlighted counsel’s submission that, ‘just as the law has had to redefine death, so it may have to redefine the concept of being alive’.125 The question was
117 Wicks, (n 16) 203. 118 K Greasley, Arguments about Abortion: Personhood, Mortality and Law, 1st edn (OUP 2017), 190. 119 Births and Deaths Registration Act 1953 s 41, as amended by Still-Birth Definition Act 1992 s 1 (1). 120 Savell (n 49) 637. 121 CvS[1987] 1 All ER 1230, per Donaldson MR at 149 (my emphasis). 122 ibid per Heilbron J at 145. 123 Re A (Children) (Conjoined twins: Surgical Separation) [2001] Fam 147. 124 ibid per Walker LJ at 241–42. 125 This was because all parties were willing to concede that the weaker twin was born alive. ibid per Walker LJ at 242. Challenging the ‘Born Alive’ Threshold • 109 abandoned,126 however, his acknowledgement demonstrates an awareness of the need to explore what legal life encompasses, and in circumstances broader than AWs. Walker LJ asserted that there was legally ‘no real analogy between Mary’s dependence Downloaded from https://academic.oup.com/medlaw/article-abstract/28/1/93/5510054 by University of Manchester user on 05 July 2020 on Jodie’s body for her continued life, and the dependence of an unborn fetus on its mother’.127 It is possible, however, to see the similarities between the gestateling in an AW and the fetus in utero. In the AW, the gestateling does not, regardless of whether it is capable of doing so, exercise any independent capacity for life.128 The technology effectively mimics natural gestation prolonging gestation rather than providing inva- sive support with life functions like current intensive care. Ex utero the gestateling is undergoing the same processes, with the same opportunities for continued develop- ment, as the fetus in utero,129 only supported by artificial means instead of another human being. Is it possible, therefore, to argue that it is not ‘born alive?’
A. Breathing after Birth The BDRA 1953 specifies that a child is born alive if it breathes after birth. In both C vS130 and Rance,131 the Court considered what kind of breathing a fetus would have to be capable of ex utero to demonstrate that it could be born alive. Sir John Donaldson MR concluded in CvSthat a fetus was capable of being born alive only if it was capable of breathing after birth, with or without the aid of a ventilator.132 It was not specified whether breathing needed to be demonstrated only immediately after, or for some continuing time after, birth. It seems intuitive that there must be some discernable breathing,133 and thus survival for some reasonable period of, albeit unde- fined, time134 after birth. Four years later, in Rance, Brooke J (as he then was) appeared to deviate from the conclusion that breathing included assisted breathing. He observed that Parliament had demonstrated awareness of the common law ap- proach to the ‘concept of being alive in its legislation relating to the registration of births and deaths’.135 Thus, he concluded, the BDRA 1953 was clearly drafted to af- ford legal personality and protection to only ‘the child...breathing and living through its own lungs alone, without deriving any of its living or power of living by or through any connection with its mother’.136
126 ibid. 127 ibid per Walker LJ at 255. 128 Romanis (n 9) 753. 129 The fetus is of course biologically alive, but is not legally alive. Before the viability threshold, a fetus is not capable of an independent existence. 130 CvS(n 121). 131 Rance (n 79). 132 CvS(n 121) per Donaldson MR at 151. 133 This is implied in the wording of the BDRA 1953, as amended by the Still-Birth Definition Act 1992 s 1(1). 134 J K Mason, The Troubled Pregnancy: Legal Rights and Wrongs in Reproduction, 1st edn (CUP 2007), 21. 135 Rance (n 79) per Brooke J at 619. 136 ibid per Brooke J at 620–21. Brooke J’s judgement echoes R v Handley (1874), in which the jury were in- formed that they should determine whether a child was born alive by examining whether the child was breathing and living by breathing through its own lungs and deriving no power of life from its mother. See R v Handley (1874) 14 Cox 79, per Brett J at 81. 110 • MEDICAL LAW REVIEW
Commentary generally suggests137 that Rance and CvSare conflicting accounts of what post-birth breathing is sufficient to demonstrate a newborn is ‘born alive.’ There is a stark contrast between a newborn able to breathe alone (unaided), and another Downloaded from https://academic.oup.com/medlaw/article-abstract/28/1/93/5510054 by University of Manchester user on 05 July 2020 only able to breathe with a ventilator. The Nuffield Council of Bioethics highlight that conflicting authorities mean the law lacks a ‘sufficiently accurate and certain definition of “born alive” appropriate for use in the light of modern medicine and technology’.138 They recommended that the Royal Colleges139 collaborate to establish a working defi- nition of born alive to inform a statutory definition.140 While some of these organisa- tions acknowledged the report,141 a working definition has not materialised. It is, however, possible to interpret Rance as complementary to CvS.BrookeJ’s statement does not exclude breathing with assistance technology. Brooke J makes no reference to assistance; he merely confirms that a neonate must breathe independently of a pregnant woman using its own lungs. Premature neonates in intensive care use their own lungs even when breathing with assistance because ventilation assists lung function, rather than entirely replacing it. Only this interpretation of Rance avoids il- logical conclusions. It would be bizarre to claim preterms in intensive care, or patients under general anaesthesia, are not legally alive because ventilators assist breathing. Even if there were a conflict in authorities, a definition encompassing assisted breath- ing is a better account of the law because the CvSdefinition is ratio from the Court of Appeal. Moreover, the Abortion Act 1967 specifies that the fetus in utero is ‘capa- ble of being born alive’ from 24 weeks gestation.142 This evidences Parliament’s inten- tion to recognise that neonates that can only breathe with ventilator support are born alive, because most neonates born at 24 weeks require mechanical ventilation.143 Early model AWs subvert our understanding of life ex utero by creating an envi- ronment in which the gestateling does not ‘breathe’. The gestateling does not use its lungs to acquire oxygen. It is placed in amniotic fluid allowing gas exchange, just like the fetus in utero, through cannulae.144 Acquiring oxygen by placental gas exchange, rather than ventilation, is one of the precise benefits of AWs: ensuring the lungs are inactive allows the organ to continue to develop. Greasley, in attempting to demon- strate that there are meaningful differences between the human being just before and just after birth, argues that significant biological adaptations occur during the process of birth. She makes specific reference to ‘the clearing of fluid from the lungs in order
137 M Brazier and J Harris, ‘“Fetal Infants”: At the Edge of Life’, in P Ferguson and G Laurie (eds), Inspiring a Medico-Legal Revolution; Essays in Honour of Sheila McLean, 1st edn (Ashgate Publishing 2015) 61. 138 Nuffield Council on Bioethics, Critical Care Decisions in Fetal and Neonatal Medicine: Ethical Issues (2006)
B. Signs of Life Some older authorities suggest that breathing alone is insufficient proof of life.146 In R v Enoch, Parks J observed that in addition to breathing, ‘there must have been a inde- pendent circulation in the child, or the child cannot be considered alive’.147 The BDRA 1953, however, does state that a child is born alive if it breathes or demon- strates any other signs of life.148 Decisions such as Enoch were made, and the BDRA 1953 was drafted, before modern medical technologies made answering questions about breathing after birth more definitive and determinable. Williams explains that, ‘it is generally true to say that before birth... the child does not breathe air, oxygen being obtained instead through the birth-cord, which is connected with the after birth. When the afterbirth is detached from the womb the child is compelled to breathe to sustain its life. Breathing (that is to say breathing air) has always been taken as evi- dence of life...’149 In CvS, Donaldson MR observed that primitive circulation and movement of the cardiac muscle in the fetus were ‘real and discernable signs of life’.150 However, without the capacity to breathe, this was not enough to persuade that the fetus was capable of being born alive. Breathing is central to the modern inter- pretation of born alive. Case law focusing on the ‘capacity to be born alive’ is specific about the post-birth ‘alive’ human being breathing. In CvS, Heilbron J observed that describing a child as ‘live born or alive even though it cannot breathe, would surprise not only doctors but many ordinary people’.151 In modern coroners’ inquests deter- mining whether a child was born alive, factual findings focus on whether there was post-birth breathing.152 An Australian Court of Appeal, however, endorsed a broader approach to defining born alive than focusing on breathing alone, finding that there could be no single test
145 Greasley (n 118) 191. 146 In R v Brain (1834) 6 Car & P 350, per Park J at 350, it was observed that many children are born alive ‘but do not breathe for some time after their birth.’ In R v Sellis (1837) 7 Car & P 350, per Coleman J at 370, it was suggested breathing is not decisive proof of being born alive because a fetus could breathe and yet have died before birth is complete. The jury were told they must be satisfied that ‘the child was wholly born into the world in a living state’ at the time that it was decapitated, the implication being that a living state encom- passes more than breathing. 147 R v Enoch (1833) 5 Car & P 539, per Parks J at 539. 148 Births and Deaths Registration Act 1953 s 41, as amended by Still-Birth Definition Act 1992 s 1(1). 149 G Williams, The Sanctity of Life and the Criminal Law, 1st edn (Alfred A Knopf 1957) 7. 150 CvS(n 121) per Donaldson MR at 151. 151 ibid per Heibron J at 146. 152 See: R (on the application of T) v HM Senior Coroner for West Yorkshire [2018] 2 WLR 211. In this case, a young woman had concealed her pregnancy and the birth of a child. She claimed that the child had not cried or made any noise after birth. She believed it was stillborn and so she hid the body of the child in a shoebox under her bed and did not tell anyone. A post mortem was inconclusive about whether the infant was still- born or had died after birth. This case did not focus on the issue of whether the infant had been born alive, but in the medical evidence the coroner submitted on the issue of whether it was born alive, there were fre- quent references to evidence about whether it may have breathed post-expulsion. 112 • MEDICAL LAW REVIEW to define ‘alive’.153 The judgment was deliberately not proscriptive about what signs of life might be satisfactory to evidence an independent life. It remains to be seen whether, in interpreting born alive in light of medical technologies, English courts will Downloaded from https://academic.oup.com/medlaw/article-abstract/28/1/93/5510054 by University of Manchester user on 05 July 2020 continue to focus on breathing alone (dismissing older authorities as based on rudi- mentary medical knowledge), or embrace a broader and less proscriptive approach ex- amining ‘other signs of life’. If the latter, medical opinion would feature heavily in decisions about what signs of life would be sufficient.154 The BDRA 1953 is phrased broadly, potentially indicating that parliament intended medical input in defining be- ing alive because medical evidence could be introduced to evidence ‘any other signs of life’ where necessary. The common law already takes the approach that defining death is a medical question in particular circumstances.155 The same approach might be taken to defining legal life if the question were posed to a court. It is thus important to consider if the gestateling displays any ‘signs of life’. The gestateling will display some primitive signs of life, particularly later in gesta- tion, for example, primitive circulation and/or increasing movement. The plain mean- ing of ‘sign of life’ includes only activities that are exertive and that, by definition, demonstrate some independent life. The primitive signs in the gestateling, similar to that of a fetus, do not evidence that the gestateling is working to sustain its own life. This observation also applies to the fetal operatee still sustained by its gestational car- rier throughout surgery. Greasley, in emphasising the significance of birth, highlights other biological state changes beyond breathing that are demonstrated in the newborn post-birth and not the fetus. These behaviours, such as the activation of the digestive system,156 are likely to be considered those active ‘signs of life’ evidencing (some) self-sufficiency. The gestateling encased in an AW does not make any biological adap- tation to life ex utero because it remains a subject of gestation. The gestateling and fetal operatee are unique from any human beings that have existed ex utero before in terms of gestational age and capacities. In the future, AWs could sustain a gestateling that today is unable to survive ex utero and is described as the product of miscar- riage.157 These gestatelings, even those just beyond our current viability threshold, are far less prepared to sustain themselves. This determines the function that an AW must perform to sustain them.158 The born alive rule applies in the same way to all gestatelings in the AW, at whatever stage of development, because their location and behaviour is the same. The developed gestateling (even at 36 weeks) is still the subject of the same process as the pre-viable (22 weeks or younger) gestateling and equally does not exercise any of its capacities for independent life. Thus, for relevant legal pur- poses, all gestatelings must be treated the same.
153 R v Iby (2005) 63 NSWLR 278 (New South Wales Court of Criminal Appeal), per Spigelman J at 280: ‘the common law “born alive” rule is satisfied by an indicia of independent life. There is no single test of what constitutes “life”’. 154 It is clear that this is the case from discussion in R (on the application of T) v HM Senior Coroner for West Yorkshire (n 152). 155 Death is not defined in statute in English law, and there is judicial deference to medical definitions of death. See Brazier and Cave (n 97) 511. 156 Greasley (n 118) 191. 157 Re A [1992] 3 Med LR 303; Airedale NHS Trust v Bland [1993] 1 All ER 821. 158 Romanis (n 9) 754. Challenging the ‘Born Alive’ Threshold • 113
C. Gestatelings are not ‘Dead’? The ambiguity in the BDRA 1953 means it is difficult to isolate what signs of life alone evidence that a person has become ‘legally alive’. Smolensky notes the inadequa- Downloaded from https://academic.oup.com/medlaw/article-abstract/28/1/93/5510054 by University of Manchester user on 05 July 2020 cies in the law defining the beginning of life, and posits that the answer lies in the forced symmetry approach.159 She argues that if a defining characteristic can be iso- lated that makes a person legally dead, the emergence of that characteristic identifies when a person becomes legally alive.160 Using the forced symmetry approach in the English context is difficult because death is not clearly legally defined.161 In England, legal death is determined by medical diagnosis in individual circumstances. This is usually brain stem death.162 If the loss of brain function that can sustain life means a person would be described as legally dead,163 does the absence of independent brain function to sustain life logically suggest the entity is not alive? The Academy of Medical Royal Colleges defines death as ‘the irreversible loss of those essential characteristics which are necessary to the existence of living human person[s] and thus... death should be regarded as the irreversible loss of conscious- ness combined with the irreversible loss of the capacity to breathe’.164 It is possible to describe the gestateling as lacking the essential characteristics necessary to the exis- tence of living human persons? During gestation the gestateling possibly lacks con- sciousness, does not yet independently co-ordinate necessary bodily functions and lacks the capacity (or does not evidence their capacity) to breathe. The gestateling is, therefore, seemingly not alive in the AW. However, in order to be dead the absence of identified capacities must be permanent and irreversible. We cannot describe the ges- tateling as actively alive, but it is completely counter-intuitive to describe it as dead. The gestateling will, at some point, be both capable of exercising an independent life, and eventually will, if undisturbed, be removed from the AW and begin to do that. If the gestateling if not dead but not legally alive, what is its status? Does this problem signal the deconstruction of the binary between legal life and death? This question is in need of exploration not only in the context of AWs, but also in light of other emerging technologies including immortal stem cell lines, artificial gametes and cryonics. Greasley argues that a binary concept of personhood is important to ensure that all individuals within a certain range of person-relevant capacities are treated of equal moral status regardless of interpersonal variations.165 The law must draw a line afford- ing protection somewhere, even if the line will always be arbitrary in a process of de- velopment.166 Birth normally involves the routine delivery of a human being with
159 K Smolensky, ‘Defining Life from the Perspective of Death: An Introduction to the Forced Symmetry Approach,’ (2006) 41 University of Chicago Legal Forum
D. The Intersection between ‘Born Alive’ and Viability There might be a temptation to resolve concerns about a gestateling’s lack of legal protection by arguing that it should be considered born alive. This argument relies on acceptance that the primitive signs of life that the gestateling demonstrates should be considered sufficient for the purposes of the BDRA 1953, and thus the gestateling should be afforded legal personality. The previous sections have argued why this ap- proach is difficult to ground within the current law, however, the consequences of rec- ognising life in an AW as born alive should be carefully anticipated for thoroughness. Viability marks the point from which fetuses are granted a limited right not to be aborted169 (to be left alone to continue gestating). A fetus capable of being born alive is protected in the offence of child destruction.170 The Abortion Act 1967 (AA 1967) stipulated that a fetus was assumed capable of being born alive at 24 weeks.171 The ter- minology in the AA 1967 ensures that fetuses beyond 24 weeks are always protected172; but this does not necessarily exclude fetuses younger than 24 weeks from protection, if evidence is provided that such a fetus is capable of being born alive. When the AA 1967 was first enacted, or when it was amended in the 1990s, there were ample opportunities, which were not seized, to repeal the offence of child de- struction to insert precise terminology to match the 24 weeks threshold in the AA 1967. Parliament may, therefore, have intended capable of being born alive to carry
167 Ibid 191. 168 Romanis (n 9) 754. 169 Romanis (n 54) 72. 170 Any person who by wilful act intentionally destroys such a fetus is guilty of child destruction: Infant Life Preservation Act 1929 s 1(1). 171 Abortion Act 1967 s 1(1)(a), as amended by Human Fertilisation and Embryology Act 1990 s 37. 172 Outside of the specific exceptions in Abortion Act 1967 s 1(1)(b)–(d), as amended by Human Fertilisation and Embryology Act 1990 s 37. Challenging the ‘Born Alive’ Threshold • 115 some weight beyond the 24 weeks minimum threshold. Interpretation of capable of be- ing born alive has deliberately been left to the courts. Some judgments have acknowl- edged this in stating that capable of being born alive is ambiguous and lacking in clear Downloaded from https://academic.oup.com/medlaw/article-abstract/28/1/93/5510054 by University of Manchester user on 05 July 2020 meaning.173 Moreover, judges have demonstrated their willingness to entertain con- sideration of whether fetuses younger than the minimum threshold in the AA 1967 are capable of being born alive. Whether an 18-week fetus was capable of being born alive for the purposes of the offence of child destruction was the focus of the judgment in CvS.174 Affording legal personhood for the gestateling175 could lead to the contention that a fetus in utero capable of surviving in an AW should be considered capable of being born alive. It could be argued that it is inconsistent to recognise that a gestateling is born alive, while a fetus (before current viability) in utero at the same point of devel- opment is determined not capable of being born alive. It might be argued that it is illog- ical that all gestatelings before 24 weeks would be legally ‘born alive’ despite not being, based on their physical capacities, legally capable of it.176 Concern about any in- consistency in recognition afforded to the gestateling and fetus in utero could easily be addressed by acknowledgement that they are fundamentally different entities.177 There is no moral continuity between the fetus and the gestateling because the rela- tionship that each entity has with the female body is different. It is ethically defensible, if not an ethical imperative, to afford the gestateling ex utero and the fetus in utero dif- ferent legal statuses to protect the rights of pregnant women.178 It is not clear, how- ever, that abortion legislation allows for inconsistent treatment based on the differing relationships that entities have with the female body. The Infant Life Preservation Act 1929 (ILPA 1929) expressly determines that the protection afforded to fetuses depends on the point at which preterm neonates can survive, despite the fetus and preterm neonate being fundamentally different entities and having a different relation- ship with the female body. Statutory provisions seemingly allow abortion access on the basis of a fetus’s lack of development (and the threshold of development has changed over time), not on the basis that a woman has control over her own body. There is, thus, the potential for AWT to threaten access to abortion by two mechanisms. The first mechanism endangers access as technology continues to reduce the point at which a gestateling can survive ex utero. When the English offence of child destruc- tion was constructed in the 1920s, it was not envisaged that medical technology would advance to the point of AWs. However, AWT might be utilised to argue that if the gestateling is born alive, capable of being born alive should then be interpreted to in- clude those fetuses ‘capable of being born alive only if supported in an AW’. The law
173 CvS(n 121) per Heilbron J at 147. 174 ibid. 175 It would acquire legal personality because it has been birthed (see earlier discussion) and it would be as- sumed legally born alive. 176 This is the case if, to be capable of being born alive, a fetus in utero must be ‘capable of breathing’ (assisted or otherwise) once ex utero. Before 22 weeks a fetus (and equally a gestateling) lacks the capacity to breathe because it does not have sufficiently developed lungs. 177 Romanis (n 9) 753–54. 178 This approach has been valued elsewhere in English law. See: Re F (n 90) per May LJ at 138. 116 • MEDICAL LAW REVIEW has consistently adjusted its viability threshold to encompass evolving medical tech- nologies. Parliament, for example, reduced the initial threshold of prima facie proof that a fetus was capable of being born alive from 28 weeks in the ILPA 1929 to 24 Downloaded from https://academic.oup.com/medlaw/article-abstract/28/1/93/5510054 by University of Manchester user on 05 July 2020 weeks in the AA 1967. Thus, it might be argued that the lack of precise definition of legal viability is intended to further encompass future developments without statutory amendment. The reference to mechanical ventilation in the judicial interpretation of capable of being born alive could be considered further evidence that viability is a moveable concept based on the state of technology. In both CvS179 and Rance,180 judges deferred to experts in fetal medicine when discussing the possibilities of ex utero survival. Given that there has been no case law since 1991, it is hard to evidence the viability threshold moving backwards beyond 24 weeks gestation. In the USA, the movement of the viability standard, and consequent restrictions on abortion access from an ear- lier point in pregnancy, has been evident and stark.181 This steady erosion of abortion rights, however, is unlikely in English courts because of explicit protections embedded in statute.182 The medicalisation of abortion and the construction of defences in the AA 1967 means a woman could opt for abortion until 24 weeks, even if carrying a fetus capable of being born alive only because it could be sustained in an AW. A doc- tor’s decision to permit abortion even when AWT is available is unlikely to be success- fully challenged because there has been a consistent display of judicial deference to medical opinion in abortion.183 In Paton, Sir Baker P remarked that a judge who sought to interfere with the discretion of doctors to provide abortion under the AA 1967 would be both ‘bold and foolish’ unless there were an ‘obvious attempt to perpe- trate a criminal offence.’184 The greatest risk is, therefore, an unregulated trend to- wards medical professionals advising against or refusing to provide abortion. There should still be cause for concern with the language enshrined in the ILPA 1929. Capable of being born alive is an uncertain term, because how it is interpreted has the potential to change with technology. Thus, capable of being born alive creates an environment of legal uncertainty, which violates the human rights of those subject to the law, and creates ambiguity185 and moral uncertainty. Perceptions of viability among the medical profession could shift as AWT is increasingly utilised in the treat- ment of premature neonates.186 Caution might take root amongst medical practi- tioners who perceive increased gestateling survival ex utero as cause for unease about
179 CvS(n 121). 180 Rance (n 79). 181 In the Roe v Wade 1973 410 US 113 judgment, the Supreme Court held that fetal viability, and therefore the point at which a State had a legitimate interest in fetal life, was 28 weeks. In Planned Parenthood v Casey 1992 112 US 2791, just 19 years later, while reaffirming the constitutional right to an abortion for women, the Supreme Court held that states could restrict abortion access from 22 or 23 weeks. The Supreme Court also noted that viability might soon be established even earlier due to advances in technology. For more in- depth discussion see: M Swyers, ‘Abortion and its Viability Standard: The Woman’s Diminishing Right to Choose’ (1997) 8 George Mason University Civil Rights Law Journal 87, 104. 182 Abortion Act 1967 s 1. 183 Eg Paton (n 1). 184 ibid per Baker P at 282. 185 R v Misra and Srivastava [2005] 1 Cr App R 328. 186 Romanis (n 9) 755. Challenging the ‘Born Alive’ Threshold • 117 all abortion provision, or abortion provision earlier in gestation than current under- standings of viability. This culture of caution could lead to an increase in conscientious objection,187 or influence the approach taken to patient counselling about abortion. Downloaded from https://academic.oup.com/medlaw/article-abstract/28/1/93/5510054 by University of Manchester user on 05 July 2020 Doctors’ concerns or personal opinions could threaten women’s access to abortion in various ways. Doctors could impart bad or unclear medical advice if they approach consultations about termination with caution or objection. Women who receive con- fusing advice could leave consultations without understanding that they can seek abor- tion elsewhere.188 Access to termination could become more difficult for women without access to alternative advice (for example, in rural areas). If access becomes (or is perceived as becoming) more difficult because of doctors’ attitudes, this is of partic- ular concern for younger women or women from lower socio-economic backgrounds who may be less empowered to seek alternative opinions. Any restrictions on abortion arising from increased caution (or conscientious objection)189 without the oversight of the law or democratic institutions would be a dismal state of affairs for women. The second mechanism by which AWT threatens access to abortion is by empow- ering the anti-abortion lobby and subsequent intervention from Parliament. The UK anti-abortion lobby is gaining traction by using more visceral imaging in campaign- ing.190 They are likely to claim AWT for increased legitimacy and continue to use the language of viability to advocate for a reduction of the time allowed191 for the ‘social ground’ for abortion,192 and to change the point of distinction between miscarriage and stillbirth.193 It might be argued that since 92 per cent of abortions are undertaken early in pregnancy (before 13 weeks),194 a reduction in time limit would have minimal impact. Any restriction, however, on the time a woman is afforded to make such an impactful decision concerning her body is a degradation of her bodily autonomy and integrity.
VI. MOVING FORWARD: BEING CLEARER ABOUT BIRTH AND BEING ALIVE Innovative fetal surgeries and AWT clearly pose a problem for the operation of the law. The problems highlighted may seem like science fiction, however, fetal surgeries are already being performed and AWs are seemingly imminent. Both technologies will
187 Abortion Act 1967 s 4. 188 A Shahvisi, ‘Conscientious Objection: A Morally Insupportable Misuse of Authority’, Institute of Medical Ethics Summer (Research) Conference 16 June 2017. 189 Abortion Act 1967 s 4. 190 P Braithwaite, ‘How UK Anti-abortion Activists Use American Tactics to Shock and Shame Women’ (Open Democracy 19 December 2017)
A. How much Should Location Feature in the Law? The total separation of developing human being and pregnant woman should remain an important dividing line in determining appropriate legal protections. The fetus’s lo- cation must feature in law, despite causing inequality in treatment between developing human beings in and ex utero, to prevent the subjugation of pregnant women. Some emphasis on location ensures the protection of a person’s right to choose what hap- pens to their body, a right afforded the highest protection in law,196 and to which pregnant women are equally entitled. However, whether the in/out dichotomy is the be all and end all, or whether there should be a distinction between the gestateling and a neonate (not dependent on an AW) is a different, and necessary, discussion. There is scope for argument that legal personality should only be afforded to those human beings that have completed gestation and made the necessary physiological and behavioural transitions allowing independent life. If legal personality is afforded to the novel human beings discussed in this article, the law would be significantly lowering its threshold for personality. The gestateling and fetal operatee are potentially, though not necessarily, very underdeveloped human beings that have yet to reach the current point of viability. The born alive barrier exists to recognise that a human being is exercising some independent capacity for life. The barrier no longer has that symbolism if being legally alive is inclusive of being passively alive in the AW. The born alive rule would no longer distinguish between beings that can exist independently (even with help), and beings that cannot.
B. What about the Process of Birth is Significant? While location remains important, the law must be clearer about what becoming and being ex utero involves. It seems intuitive that a full-term neonate post-delivery, but remaining connected to the pregnant woman by umbilical cord, is considered a legal person for the purposes of homicide. It also, however, seems untenable to describe a fetal operatee as born when ex utero on the surgeon’s operating table, but still con- nected by umbilical cord, because of the potential implications for the pregnant women who consented to the procedure. How might we explain the difference be- tween the ex utero existences of these two developing humans? We might look to the intention that something is birthed, rather than temporarily ex utero, for answers, but
195 Smolensky (n 159) 42. 196 Collins v Wilcock (n 94). Challenging the ‘Born Alive’ Threshold • 119 detailed examination is necessary to produce a coherent legal account of birth that can be applied consistently.
C. Should the Developing Human Being’s Capacities Feature in the Law? Downloaded from https://academic.oup.com/medlaw/article-abstract/28/1/93/5510054 by University of Manchester user on 05 July 2020 The born alive requirement demonstrates birth was intended to be a convenient marker for demonstrating that a human being has certain capabilities and therefore deserves legal protections. The law must clarify what capacities are relevant to being legally alive. Until recently, the inability to breathe unaided was regarded as a sign of death, but technology allowing the prolonged assistance of individuals without this ca- pacity has enabled the continued life of individuals who would otherwise have died.197 This has meaningfully impacted on our understanding of death.198 Our understanding about breathing at the beginning of life has also been changed by mechanical ventila- tion in preterm care. How AWT will further impact on our interpretation of referen- ces to breathing in law must be determined. Moreover, are there capacities other than breathing, which should be regarded as significant when determining the legal mean- ing of born alive? The Nuffield Council on Bioethics recommended these questions be addressed in 2006,199 and advancing reproductive technologies continue to make these questions ever more pressing. The Nuffield Council recommended a broad defi- nition to encompass various possibilities at the beginning of life.200 But, there is the potential for uncertainty to cause inconsistency. What a legal definition should en- compass requires careful examination.
D. What does it mean to be Ex Utero and Lack Personality? Even ignoring legitimate anxieties concerning the application of legal birth to novel human beings, it is apparent that the novel developing human beings in this article would, without parliamentary revision or creative judicial interpretation, fall outside the legal definition of born alive. There is the possibility of developing human beings existing, at least partially ex utero, without legal personality. The AW is an entirely novel legal problem, and fetal surgery is a rather recent, and rapidly advancing, devel- opment that has yet to be thoroughly addressed. Both are cause for concern, because is unclear what protections human beings subject to these processes would be entitled to.
E. Could there be a ‘Third Status:’ Legal Existence before Legal Personality? Hammack has posited that ‘the law should avoid bright lines and strict rules... per- sonhood, either fully acknowledged or completely absent, is simply too blunt an in- strument to negotiate the complex biological realities of human reproduction in the 21st century’.201 Personhood is currently constructed as a binary, where there is only the possibility of having legal personality or not, and this may be too restrictive to have traction moving forward. However, AWT and fetal surgeries illustrate problems
197 Smolensky (n 159) 83. 198 ibid 83. 199 Nuffield Council on Bioethics (n 138). 200 ibid para 8.16. 201 J Hammack, ‘Imagining a Brave New World: Towards a Nuanced Discourse of Fetal Personhood’ (2013) 35 Women’s Rights Law Reporter 357, 370. 120 • MEDICAL LAW REVIEW in the operation of a rule that works well in the overwhelming majority of circumstan- ces. Most births are legally straightforward and the born alive rule is easily applied. There might be an argument to keep the law simple and merely create exceptions for Downloaded from https://academic.oup.com/medlaw/article-abstract/28/1/93/5510054 by University of Manchester user on 05 July 2020 developing human beings that fall outside the norm. This article has discussed harms potentially associated with legal uncertainty in creating exceptions. However, another contemporary solution, that facilitates possibilities outside existing binaries by, for ex- ample, acknowledging a new category for recognition, could be appropriate. Legal personhood is not necessary to afford entities with protection. The human fetus in utero is recognised, and afforded some limited protections, in abortion law.202 Embryos routinely created as part of the IVF process, whilst lacking personality, are also routinely afforded some legal protections.203 Animals, despite lacking legal per- sonhood,204 are recognised as deserving of some protections and afforded them ac- cordingly.205 These are examples of instances in which entities have their legal existence recognised but not valued to the same degree as a legal person. If a third status—a partially born category for entities like the gestateling and fetal operatee—were created, it could be used to identify subjects accurately, avoid creating a ripple effect in other areas of law, and solve relevant discrepancies appropriately. This approach could also be useful in understanding what protections should be afforded in other circumstances, for example where a baby is born with anencephaly (absent a brain or a major part of the brain). A third status could also facilitate discus- sions about what protections should be afforded to novel ex utero human beings with- out complicating law that operates without issue in the majority of cases.206 There is also scope for discussion about whether there should be less concern for legal consis- tency. In different contexts the developing human being’s capacities, in conjunction with its location and other factors, could justify it being treated and recognised differ- ently to a fetus/newborn. A third status could, however, carry normative concerns re- garding setting a precedent of creating different categories of human being. Further academic discussion on this matter is warranted.
202 Outside of the exceptions in Abortion Act 1967 s 1 (as amended by Human Fertilisation and Embryology Act 1990 s 37) a fetus is protected by the Infant Life Preservation Act, which criminalises child destruction (s 1(1)) and the Offences Against the Person Act 1861 s 58 criminalising the procurement of miscarriage. 203 Eg the Human Fertilisation and Embryology Act 1990 s 3(3)(a), as amended by the Human Fertilisation and Embryology Act 2008 renders it unlawful to experiment with embryos after 14 days from conception. 204 Notably, however, the Non-human Rights Project (
F. What about Abortion Access? Any change to the legal definition of life will change what capable of being born alive, the viability standard enshrined in law, encompasses. Viability was perceived as a polit- Downloaded from https://academic.oup.com/medlaw/article-abstract/28/1/93/5510054 by University of Manchester user on 05 July 2020 ically ‘neutral’ time limit for abortion,207 and a politically expedient and dispassionate compromise between the pro-choice and anti-abortion lobby208 because it plays a cru- cial role in ensuring English abortion provisions are ‘medicalised’. However, conven- tional neonatal intensive care, even with its limitations, challenges the 24 weeks minimum viability threshold,209 because it can secure the survival of preterms younger than 24 weeks. AWT on the horizon will strengthen this challenge to the legal con- ception of viability further by introducing dependence viability cases210 into the mix. This may ultimately restrict access to abortion by either encouraging cautious medical practice because of the perception that gestatelings lower or should lower the viability threshold, or by aiding the anti-abortion lobby in their quest to amend the AA 1967 to restrict access to terminations. A transparent and less medicalised discussion about abortion provisions, which is not entirely focused on the fetus, is necessary and appears imminent.
VII. CONCLUSION Legal personality is afforded to human beings at birth.211 Traditionally birth was a clear-cut marker for legal status, which could be applied with consistent and predict- able results. Before birth, a fetus has no legal personality, after live birth a baby becomes a legal person.212 This article has uniquely demonstrated, however, that emerging reproductive technologies bring with them the need to re-evaluate how the law bestows legal personality. The emergence of new possibilities for human beings at younger stages in development existing ex utero demonstrate that birth is not a simple concept. The two elements of the law of personality, birth and born alive, are in need of further clarification and nuance. Fetal surgery and AWT do not sit well in the in/out dichotomy that the law of birth has constructed. Both raise concerns about our understanding of birth as just an ex utero existence. Within current law, both the fetal operatee and gestateling might be considered legally birthed because they both exist ex utero, however, they are un- likely to be considered legally born alive. They are not actively and independently alive in a way that fits with traditional conceptions of life in the law. Evidential require- ments for being legally born alive are centred on breathing,213 though there may be a move towards greater recognition for214 ‘other signs of life’.215 Gestatelings and fetal
207 E Jackson, Regulating Reproduction: Law, Technology and Autonomy,1st edn (Hart Publishing 2001) 84. 208 Even though in reality neither the pro-choice, nor anti-abortion lobby can be entirely satisfied with this ‘compromise’. See: McLean (n 190). 209 Jackson (n 207) 84. 210 These are instances in which a fetus has reached a point of development that means it can be described as capable of being born alive only if it is sustained ex utero in an artificial womb that takes over the gestational process. It would not be capable of surviving with only the assistance of traditional intensive care. 211 Paton (n 1). 212 Alghrani and Brazier (n 2) 52. 213 CvS(n 121). 214 If the law in England and Wales follows the persuasive precedent established in Australia in R v Iby (n 153). 215 Births and Deaths Registration Act 1953 s 41, as amended by Still-Birth Definition Act 1992 s 1(1). 122 • MEDICAL LAW REVIEW operatees are not breathing or exercising an independent capacity for life. The gesta- teling is in a process of continued gestation almost identical to the fetus in utero, and the fetal operatee is dependent on the umbilical cord and placenta. Fetal operatees Downloaded from https://academic.oup.com/medlaw/article-abstract/28/1/93/5510054 by University of Manchester user on 05 July 2020 and gestatelings, however, are not dead. They are not permanently deprived of the ca- pacity to demonstrate signs of life and/or breathe in the future. These technologies, demonstrate that there is a need to delve deeper into what being alive encompasses and should encompass in law. To address the issues that emerging technologies raise involves making difficult decisions about how to classify different developing human beings. If both the gesta- teling and fetal operatee are not born alive, they will not acquire legal personality. Importantly, the lack of personality for the fetal operatee protects the rights of preg- nant women by ensuring they are not made subordinate to the interests of the fetal operatee during a surgery and, potentially, to their fetus after a surgery. Lack of legal personality for the gestateling prevents its existence from providing ammunition to le- gal challenges to abortion provision based on an argument that fetuses before 24 weeks could be removed from the uterus and successfully sustained in an AW. Affording legal personality to these developing human beings would significantly lower the threshold of legal protections, and would have broad implications for the treatment of fetuses and embryos, and for women. Despite this, there remain lingering concerns about the possibility of human beings existing ex utero without legal person- ality. Without personhood, both the fetal operatee and gestateling are vulnerable to exploitation and a lack of redress if they die as a result of negligent treatment before they are born alive (either by delivery from the uterus at a later time or removal from the AW). There may, therefore, be value in considering a ‘third status’ approach: rec- ognising that there may be harms in a binary approach to legal personality. This article has also identified some further questions that require renewed discus- sion about the law of birth. Determining how the law should respond to these issues requires thorough further investigation. It is clear, however, that there must be greater nuance in the law moving beyond the current binary in order to address these impor- tant ethico-legal issues. Impactful technologies are here: fetal surgery is an increasingly important intervention, and AWT is potentially only years away from human test- ing.216 Careful anticipation of technology and procedures impacting on interpreta- tions of legal birth will prevent reaction in the public, by Parliament, and in courtrooms being driven by fear or confusion,217 thus minimising the danger of clumsy responses having unintended consequences.
FUNDING The author is a recipient of a Wellcome Trust Doctoral Studentship in Society and Ethics (grant reference 208245/Z/17/Z).
216 Couzin-Frankel (n 19). 217 Gelfand and Shook (n 29) 1. Challenging the ‘Born Alive’ Threshold • 123
ACKNOWLEDGEMENTS I am grateful to Alexandra Mullock and Rebecca Bennett for their helpful comments on earlier drafts of this paper and to the Wellcome Trust for funding this research. I Downloaded from https://academic.oup.com/medlaw/article-abstract/28/1/93/5510054 by University of Manchester user on 05 July 2020 would also like to thank my reviewers for their thorough and constructive feedback. Conflict of interest statement. None declared. Appendix 3 – Artificial Womb Technology and the significance of birth: why gestatelings are not newborns (or fetuses) (2019) 45 Journal of Medical Ethics 727
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Response J Med Ethics: first published as 10.1136/medethics-2019-105723 on 31 August 2019. Downloaded from second, the emergence of that entity from Artificial womb technology and the the process of gestation.4 Greasley explains that the birth process involves the devel- significance of birth: why gestatelings oping human entity undergoing meaningful changes beyond changing location.5 These are not newborns (or fetuses) are biological adaptations enabling the entity to survive in an ex utero environment, for Elizabeth Chloe Romanis example, the clearing of fluid from the lungs to allow breath and the activation of the digestive system.5 Usually, these two events Abstract entity, functionally distinct from the fetus coincide: a baby is delivered by/from a preg- In a recent publication, I argued that and the newborn. Moreover, referring to the nant person, and simultaneously, it makes there is a conceptual difference between subject of an AW with unique terminology the necessary adaptations for independent artificial womb (AW) technology, capable provides clarity in the discussion. Colgrove life. There has been little thorough exam- of facilitating gestation ex utero, and responded to my paper,2 arguing that ination of the process of birth4 because it is neonatal intensive care, providing incubation gestatelings are not distinct from newborns. usually a straightforward uniform process.iv to neonates born prematurely. One of Colgrove claims I am over-reliant on Both the change in location (facilitated by the reasons I provided for this distinction medical definitions to distinguish gestatel- the pregnant person’s delivery) and the was that the subjects of each process are ings from fetuses, but do not adequately making of the necessary biological adap- different entities. The subject of the process account for relevant definitions of birth tations for life (facilitated by the newborn of gestation ex utero is a unique human that demonstrate gestatelings are equivalent itself) have traditionally been thought of as entity: a ’gestateling’, rather than a fetus or to newborns. He claims that gestatelings are coetaneous, with the same temporal bound- a newborn preterm neonate. Nick Colgrove not a distinct product of human reproduc- aries. PE, however, demonstrates that these wrote a response to my paper, claiming that tion because they are newborns by defini- two occurrences are not coextensive; they my distinction between the subject of an tion. Finally, he suggests that any distinction are independent processes that merely AW and a newborn (in intensive care) was between gestatelings and preterms would be happen to be naturally synchronised. false. He claims that I have not accounted morally irrelevant.2 Perhaps he was correct I previously described AWs as treating 1 for the proper definition of ’birth’ and that to identify that some of my claims could the gestateling ‘as if it had not been born’. Protected by copyright. gestatelings are not a distinct product of have benefited from further defence. This is Colgrove answered that being ‘a newborn human reproduction. Further, Colgrove posits not the same, however, as having proven, as means having been born recently’ and that even if I can successfully distinguish he claims, that the distinction as I advanced merely dismissed the nuanced features gestatelings from preterms, such a distinction it is incapable of surviving scrutiny.2ii (such as behaviour) I suggested were mate- is morally irrelevant because the entities rial to a birth as irrelevant.2 He, therefore, would have the same moral status. In this does not answer the point. AWs continue paper, I address the three challenges raised Birth gestationv, 6 so the gestateling does not Colgrove argues that gestatelings just are and defend the claim that gestatelings are 2 complete the biological state changes in unique entities. Moreover, I argue that moral newborn (by definition). He substantiates birth. Birth is not completed. Colgrove this only by citing the WHO’s definition http://jme.bmj.com/ status should not be considered ipso facto 3iii misconstrues birth as only an ex utero exis- determinative in the debate about AWs. of ‘live birth’. He fails to acknowledge, tence and a matter of semantics. This idea however, that this definition delineates that ‘unborn’ is a strict quantitative concept two events encompassed in the process measured on one binary is misleading. It In an earlier publication, I argued that there of complete birth: first, the expulsion of is a reductive approach to a biologically is a conceptual difference between partial the entity from a pregnant person, and complex situation involving multiple enti- ectogenesis (PE)i (facilitated by artificial
ties, the environment and their interaction. on July 5, 2020 at The University of Manchester Library. wombs (AWs)) and neonatal intensive care ii It is essential to highlight that no chal- The gestateling undergoing PE is born 1 (NIC). I advanced several reasons for this lenge was raised to the claim that gestatel- only in a geographical sense. It should still distinction, one being that the subjects of ings are different entities from fetuses. Fetuses and gestatelings are different be described as unborn because it has not each technology were different entities. because one is dependent on a pregnant completed all of birth. The subject of PE, which I termed the person and the other is not. This is inter- ‘gestateling’,1 is undergoing the process of esting because perhaps a stronger chal- iv gestation, whereas the subject of NIC, a lenge to my work can be made arguing In instances where it is not a straight- preterm neonate, is being assisted by incu- that gestatelings and fetuses are not forward or uniform process, it is usually distinguishable, rather than that gestatel- considered a stillbirth, in that the entity bation. The gestateling is a unique human ings and newborns are not distinguishable. either died as a fetus in utero, died during This is because gestatelings are more onto- the process of being delivered or died logically similar to the fetus in utero in almost immediately after being removed i terms of behaviour, dependence on their from the uterus because the entity was The process of gestation continued ex environment, how they are interacted incapable of making the necessary biolog- utero in artificial conditions (not depen- with and potentially in appearance than to ical adaptations to survive after gestation. dent on a pregnant person). ‘newborn babies’. v The authors of a 2019 pilot study of a iii The definition of live birth given by the refined AW system named ‘EVE therapy’ Centre for Social Ethics and Policy, University of WHO is ‘…the complete expulsion or expressly state that the ‘central principle Manchester Manchester School of Law, Manchester, UK extraction from its mother of a product underling the iterative development of Correspondence to Elizabeth Chloe Romanis, Centre of conception, irrespective of the duration (EVE therapy)… is to treat extremely for Social Ethics and Policy, University of Manchester of the pregnancy, which after such separa- preterm infants as fetuses, rather than Manchester School of Law, Manchester M13 9PL, UK; tion, breathes or shows any other evidence as small babies, and to avoid the use of elizabeth. romanis@manchester. ac.uk of life….’3 pulmonary gas exchange’.6
Romanis EC. J Med Ethics November 2019 Vol 45 No 11 727 Response J Med Ethics: first published as 10.1136/medethics-2019-105723 on 31 August 2019. Downloaded from Colgrove considers the case of complete birth is observable without sophisticated human tissue and an organically integrated ectogenesis (CE).vi He claims that the technology4 and demonstrates an obvious live human entity. Embryos are created by formal principle of justice7 requires that all capacity for self-sufficiency. The newborn, the fusion of living tissue, and following subjects of AWs must be treated the same with or without ventilator assistance, is brain death, organs remain sufficiently live regardless of whether they are gestated in compelled to breathe. The gestateling, for harvesting for transplantation.xii It seems an AW from conception or after a partial however, does not use its lungs to acquire hardly intuitive to consider these tissues pregnancy.2 He posits that the subject of PE oxygen14 and thus has not made the most ‘actively alive’. is born and shares the same moral status as obvious biological adaptation (clearing the 5 a newborn, and thus, we must also accept lungs to allow them to inflate ) for indepen- Moral status 2 that the subject of CE has this same status. dent life. Even if one is persuaded that there Colgrove observes that I did indeed leave This seems implausible. If entitlement to are features other than breathing / tolerating open the possibility that gestatelings and equal treatment comes only from being artificial ventilation that might demonstrate newborns have different moral statuses. 2x biologically alive and ex utero, this logic the exercise of independent life I argue However, he claims that any distinction counterintuitively suggests that a non-im- that there are two qualities to sufficient proof between gestatelings and newborns is not planted embryo alive in vivo would also that a human entity is engaged in the exercise morally relevant because they would have be ‘born.’ He fails to provide any substan- of independent life, and the gestateling does the same moral status.2 Colgrove does not tive reasons why gestatelings should be not perform any activities of this nature. substantiate this claim, focusing instead on considered completely born. In fact, he First, activities sufficient to demonstrate attempting to establish that a gestateling is concedes that the subject of CE would, in the active exercise of independent life not a unique entity. I have demonstrated a sense, be ‘unborn.’ His argument about include only those that are suited to, and that there are some morally relevant differ- equal treatment, therefore, works just as involve interaction with, the external envi- ences between gestatelings and newborns. easily the other way, supporting my claim ronment. The significant feature of all the I will not further address this claim about that even the gestateling that has been biological adaptions in birth is that they any equivalence (or not) in moral status; removed from a person’s uterus is different enable entities to survive in the external envi- rather I want to highlight that considering 8 from a newborn. Alghrani and Brazier, ronment. Unlike a newborn, a gestateling the moral status of the gestateling in this 9 7 Sander-Staudt, Gelfand and Shook, and remains dependent on a process of creation context is not useful in terms of isolating 10 Steiger all argue that the subject of CE in a temporary environment. Greasley also and addressing the important ethico-legal should be considered born only at the point highlights the importance of newborns also questions stemming from AWs. Protected by copyright. of removal from the AW, when emerging being responsive to environmental stimuli There is generally a dichotomy in the 8 from gestation. Intuitively, the subject of and interacting with other human beings literature between two alternative accounts CE is not born, and thus, if all subjects of as behavioural evidence of a meaningful of moral status. Some believe all human 5 the technology should be treated the same, completed birth. The gestateling is encased life is intrinsically valuable,15 others believe the subject of PE is not born either. in the AW and is incapable of experiencing only the lives of persons (and, thus, not 1 physical human interaction. This is a signif- developing human entities) have intrinsic The exercise of independent life icant difference that affects how persons value.16xiii There is little hope of unilaterally xi Gestatelings and newborns are distinct will perceive and respond to it. resolving the question of the moral worth Second, activities demonstrating the xiv because a gestateling exercises no indepen- of developing human entities. There are, http://jme.bmj.com/ dent capacity for life, whereas newborns exercise of independent life include only however, practical problems with AWs that shoulder the primary burden of sustaining those that are exertive. The primitive signs require resolution, such as how to select themselves.1[vii] This is an important distin- of life (other than breathing) that Colgrove research participants for innovative tech- guishing feature that Colgrave did not mentions in the definition of birth, such as a nology or when an AW could be ‘switched address in his paper. In English law,viii heartbeat, are evident in a foetus and while off’.17 A way of conceptualising of the breathing, including assisted breathing, has Colgrove could attempt to claim they are gestateling should be adopted that allows us
been the focus of determining indepen- ‘active’, they demonstrate no self-sufficiency. to answer some of these emerging questions on July 5, 2020 at The University of Manchester Library. dent life in the law.[ix]11–13 Breathing after It seems absurd to treat the primitive signs of without falling into the trap of over-relying life during gestation as evidence of self-suf- on theories of what the ‘fetus’ or ‘newborn’xv ficiency. We would not claim that a fetus vi is and assumptions about a moral status Colgrove notes that these claims were sustained by a pregnant person was demon- beyond the scope of my original paper. I attached to them. Moral status is limited deliberately chose not to address matters strating ‘self-sufficiency’. The coordination as a consideration because it is subjectively of CE because it is far more remote a possi- of all bodily functions during gestation is bility (if it will ever be possible) due to always reliant on the gestational carrier xii the political and legal realities restricting (pregnant person or machine). There is a I am grateful to Professor Bernard Dickens embryo research, and the uncertain limits for raising this point with me in discussion. useful contrast to be made between living of embryo science. xiii Even those who subscribe to a gradu- vii This is even the case for newborns in alist approach take a moral position based NIC that, while assisted by technology, x Interestingly, an Australian Court of on the assumption that all life is valuable must have some ability to exercise their Appeal has recently endorsed a broader (similar to the sanctity of life approach) own independent capacity for life; approach to determining if a developing but that there are limits on how seriously otherwise, they would not be able to be 18 we should take that value. 1 human entity is ‘alive’. In R v Iby, sustained with conventional assistance. Spigelman J observed that ‘the common xiv Most people have an opinion or an intuition viii This is also the case in the law of law “born alive” rule is satisfied by an on the subject (eg, I believe that the person- multiple other jurisdictions that recog- indicia of independent life. There is no hood approach has more merit). However, nise birth as a meaningful legal moment single test of what constitutes “life”’. these positions are not empirically provable. (usually the trigger of legal personality). xi Notably, Colgrove did not meaningfully xv Especially as I have demonstrated that ix This is at least the case in English and respond to these points of difference I the gestateling is not ontologically iden- Welsh law. raised in my earlier publication. tical to either.
728 Romanis EC. J Med Ethics November 2019 Vol 45 No 11 Response J Med Ethics: first published as 10.1136/medethics-2019-105723 on 31 August 2019. Downloaded from attributed rather than innate. Furthermore, to make, and this decision should be framed References assigning a moral status does not in itself with them, rather than the fetus/gestateling, 1. Romanis EC. Artificial womb technology and the frontiers of human reproduction: conceptual immediately tell us how entities should be at the centre. differences and potential implications. J Med Ethics treated, because once the status is assigned 2018;44(11):751–5. we must then make moral judgements Contributors I am the sole author. 2 Colgrove N. Subjects of ectogenesis: are ’gestatelings’ fetuses, newborns or neither? J Med Ethics about whether that status justifies certain Funding I am the recipient of a Wellcome Trust 2019;45:722–5. treatment. This is evident from Colgrove’s Doctoral Studentship in Society and Ethics (grant 3. Maternal Mortality Ratio. In World Health organization: paper, in which despite his conclusions reference 208245/Z/17/Z). health statistics and information systems, 2019, 2019. that a gestateling is morally equivalent to a Competing interests None declared. Available: https://www.who.int/ healthinfo/statistics/ indmaternalmortality/en/ newborn, he concludes this ‘does not imply Patient consent for publication Not required. 4. Romanis EC. Challenging the ’Born Alive’ Threshold: they have a right to life nor does it imply Provenance and peer review Not commissioned; Fetal Surgery, Artificial Wombs, and the English 2 that have a right not to be killed.’ internally peer reviewed. Approach to Legal Personhood. Med Law Rev 2019. Importantly, attempting to reduce the doi:10.1093/medlaw/fwz014. [Epub ahead of print: 01 Jun 2019]. debate about AWs to a question of moral 5. Greasley K. Arguments about abortion: personhood, status frames AWs as something that only morality and law. 1st edn. Oxford University Press: concerns the developing human entity. Oxford, 2017. 6. Usuda H, Watanabe S, Saito M, et al. Successful use However, AWs are not just about gestatel- of an artificial placenta to support extremely preterm ings. The location of a developing human ovine fetuses at the border of viability. Am J Obstet entity matters because when it is located Open access This is an open access article distributed Gynecol 2019;221(1):69.e1–69.e17. in accordance with the Creative Commons Attribution 7. Gelfand S, Shook J. Ectogenesis; Artificial womb inside the womb of a pregnant person, this 4.0 Unported (CC BY 4.0) license, which permits others technology and the future of human reproduction. impacts significantly on that individual. to copy, redistribute, remix, transform and build upon New York: Rodopi, 2006. There can be no uncertainty about the need this work for any purpose, provided the original work 8. Alghrani A, Brazier M. What is it? whose it? Re- to respect the subjective preferences of the is properly cited, a link to the licence is given, and positioning the fetus in the context of research? Camb Law J 2011;70(1):51–82. pregnant person and to allow them to make indication of whether changes were made. See: https:// creativecommons.org/ licenses/by/ 4.0/. 9. Sander-Staudt M. Ectogenesis: Artificial Womb decisions about their body and gestational Technology and the Future of Human Reproduction.. labour. Focusing entirely on the value of the © Author(s) (or their employer(s)) 2019. Re-use In: in Gelfand S, Shook J, eds. Ectogenesis; artificial permitted under CC BY. Published by BMJ. womb technology and the future of human fetus/gestateling neglects this fact that deci- reproduction. New York: Rodopi, 2006: 109–26. sions about gestation impact on a pregnant 10. Steiger E. Not of woman born: how Ectogenesis will Protected by copyright. person’s self. Choosing to opt for an AW change the way we view viability, birth and the status or not, and in what circumstances, is still a To cite Romanis EC. J Med Ethics 2019;45:727–729. of the unborn. JL & Health 2010;23:143–71. xvi 11. MANCHESTER. C and another v S and others [1987] ALL decision that a woman should be entitled Received 19 July 2019 ER 1230 The University of Manchester Library; 1987. Accepted 3 August 2019 12. Swarb.Co.Uk. Rance and Another v Mid-Downs Health Published Online First 31 August 2019 Authority and Another [1991] 1 QB 587; 2019. 13. The births and deaths registration act 1953. xvi It is important to note that pregnancy is a condi- 14. Partridge EA, Davey MG, Hornick MA, et al. An extra- tion that can be experienced by any person with uterine system to physiologically support the extreme the reproductive biology that allows them to premature lamb. Nat Commun 2017;8(1):1–15. become pregnant (female) irrespective of gender 15. Werner R. Abortion: the moral status of the unborn. ►► http://dx. doi. org/ 10. 1136/ medethics- 2019- 105495 identity. In this paper, I generally have referred to Soc Theory Pract 1974;3(2):201–22. http://jme.bmj.com/ pregnant persons rather than pregnant women in 16. Tooley M. Abortion and infanticide. Oxford: Clarendon order to encapsulate this fact. However, here I refer J Med Ethics 2019;45:727–729. Press, 1983. to a choice that women must be allowed to make doi:10.1136/medethics-2019-105723 17. Abecassis M. Artificial Wombs: the third era of human because the vast majority of people who experience reproduction and the likely impact on French and US pregnancy identify as women, and this massively ORCID iD law. Hastings Women's LJ 2016;27:3–28. impacts on the social experience of pregnant people Elizabeth Chloe Romanis http://orcid. org/0000- 0002- 18. R V Iby (2005) 63 NSWLR 278 (New South Wales and the choice to terminate a pregnancy. 8774-4015 Court of criminal appeal). on July 5, 2020 at The University of Manchester Library.
Romanis EC. J Med Ethics November 2019 Vol 45 No 11 729 Appendix 4 – Artificial Womb Technology and Clinical Translation: Innovative Treatment or Medical Research? (2020) 34 Bioethics 392
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Received: 25 April 2019 | Revised: 12 September 2019 | Accepted: 25 October 2019 DOI: 10.1111/bioe.12701
SPECIAL ISSUE: ETHICS OF ECTOGENESIS
Artificial womb technology and clinical translation: Innovative treatment or medical research?
Elizabeth Chloe Romanis
Centre for Social Ethics and Policy, Department of Law, University of Abstract Manchester, Manchester, United Kingdom of In 2017 and 2019, two research teams claimed ‘proof of principle’ for artificial womb Great Britain and Northern Ireland technology (AWT). AWT has long been a subject of speculation in bioethical litera- Correspondence ture, with broad consensus that it is a welcome development. Despite this, little at- Elizabeth Chloe Romanis, Centre for Social Ethics and Policy, School of Law, Williamson tention is afforded to more immediate ethical problems in the development of AWT, Building, University of Manchester, Oxford particularly as an alternative to neonatal intensive care. To start this conversation, I Road, Manchester M13 9PL, U.K. Email: [email protected] consider whether experimental AWT is innovative treatment or medical research. The research–treatment distinction, pervasive in regulation worldwide, is intended to Funding information Wellcome Trust, Grant/Award Number: isolate research activities and subject them to a greater degree of oversight. I argue 208245/Z/17/Z that there is a tendency in the literature to conceptualize AWT for partial ectogen- esis as innovative treatment. However, there are sufficiently serious ethical concerns with experimental AWT that mean that it must not be first used on humans on the basis that it is a ‘beneficial treatment’. First, I outline the prospects for translation of AWT animal studies into treatment for human preterms. Second, I challenge the conceptualizations of experimental AWT as innovative treatment. It must be consid- ered medical research to reflect the investigatory nature of the process and guaran- tee sufficient protections for subjects. Identifying that AWT is research is crucial in formulating further ethico-legal questions regarding the experimental use of AWT. Third, I demonstrate that clinical trials will be a necessary part of the clinical transla- tion of AWT because of requirements laid out by regulators. I consider the justifica- tion for clinical trials and highlight some of the crucial ethical questions about the conditions under which they should proceed.
KEYWORDS artificial wombs, innovative treatment, medical research, neonatal intensive care, partial ectogenesis, research ethics
This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. © 2019 The Authors. Bioethics published by John Wiley & Sons Ltd
.wileyonlinelibrary.com/journal/bioe Bioethics. 2020;34:392–402 | 392 ROMANIS | 393
1 | INTRODUCTION literature,9 and is at the foundation of regulation in many jurisdic- tions.10 The basis of this distinction is that research subjects need Two research teams, in the U.S. and Australia, claim to have estab- more protection than patients receiving medical treatment. Research lished proof of principle for artificial womb technology (AWT).1 Both is directed towards the production of generalizable knowledge in the teams have designed ‘artificial womb devices’ that they claim will interests of future patients/medical science.11 Innovative treatment, revolutionize the treatment of preterm neonates. The devices, the however, aims to treat the patient in their best interests. The subject EVE2 platform and the biobag, are intended to facilitate the process of medical research is more vulnerable than a patient receiving med- of gestation ex utero (ectogenesis), enabling preterms to continue to ical treatment because there is not the same guarantee that the in- develop. When artificial wombs (AWs) are used to continue gestation vestigator is acting in their interests.12 Consequently, research is ex utero this is described as partial ectogenesis.3 Partial ectogenesis subject to a higher level of ethical oversight13 than the normal ethical could significantly reduce mortality and morbidity rates amongst constraints of medical practice (treatment in the patient’s best inter- preterms. Both teams explicitly anticipate the clinical application of ests)14 to protect the research subject. Because of the ethical ten- their device as a treatment for preterms in the near future. Little at- sions innate in the innovative treatment–research distinction, tention has been afforded, however, to how experimental AWs categorizing activities is essential wherever possible. Berkman et al. might be ethically justified as an alternative to existing treatment. advocate that this is the easiest way to ensure that activities are af- Following recent animal studies of the biobag (2017) and EVE forded the appropriate ethical oversight and that investigators/clini- platform (2019), there has been renewed interest in the socio-ethi- cians are aware of their responsibilities to subjects/patients.15 cal implications of AWs.4 This debate treats the development and It is often assumed that AWs are an extension of (but an im- human use of AWs as a foregone conclusion. The focus on future provement on) current methods in neonatal intensive care (NIC).16 implications neglects more immediate ethical problems concerning The assumption implies that partial ectogenesis should be concep- the translation of AWT from concept and animal studies into treat- tualized as innovative medical treatment. The danger with such an ment. Arguments are frequently made that ectogenesis is a moral approach, however, is that it enables experimental AWs to be uti- imperative5 and a welcome development.6 Claims that AWT should lized on an ad hoc basis without objective ethical scrutiny. By fail- be actively sought imply that risks in research are justified to achieve ing to recognize the difference between AWT and NIC, we this end. Often scholars ignore the fact that research on humans, potentially expose pregnant people and preterms to harm. In this both pregnant people and preterms, would be necessary, or they paper, I argue that AWT must be conceptualized as medical re- downplay the risks involved. Work exploring the ethics of experi- search, and be subject to the same strict criteria as all research. mental AWT focuses on full ectogenesis (rather than partial ecto- This paper does not examine all the ethical constraints that should genesis)7 or pre-dates the recent scientific studies8 and is therefore regulate experimental AWT, but instead establishes that there are more abstract. This paper addresses this gap in the literature. How sufficiently serious ethical concerns with experimental AWT that and when might it be ethical to use experimental AWT on humans? means it must not be first used on humans on the basis that it is a These questions are increasingly important as researchers consider ‘beneficial treatment’. translating their devices into treatment for preterms.
In this paper I address these questions by considering whether 9 Beauchamp, T. L., & Saghai, Y. (2012). The historical foundations of the research–prac- AWT is an innovative treatment or medical research. A distinction tice distinction in bioethics. Theoretical Medicine and Bioethics, 33(1), 45–56, p.46. The research–innovative treatment distinction has been criticized: Kass, N. E., Faden, R. R., between innovative treatment and research is pervasive in bioethical Goodman, S. N., Pronovost, P., Tunis, S., & Beauchamp, T. (2013). The research–treat- ment distinction: A problematic approach for determining which activities should have 1 Partridge, E. A., Davey, M. G., Hornick, M. A., McGovern, P. E., Mejaddam, A. Y., ethical oversight. Hastings Center Report, 43(1), S4–S15. However, the distinction remains Vrecenak J. D… Flake, A. W. (2017). An extra-uterine system to physiologically support widely accepted in the literature, and is embedded in law in the U.S.A., U.K. and the extreme premature lamb. Nature Communications, 8, 1–15; Usuda, H., Watanabe, S., Australia. Saito, M., Sato, S., Musk, G., Fee, E… Kemp, M. W. (2019). Successful use of an artificial 10 For example the U.S.A.: The National Commission for the Protection of Human placenta to support extremely preterm ovine fetuses at the border of viability. American Subjects of Biomedical and Behavioural Research. (1979). The Belmont report: Ethical Journal of Obstetrics and Gynecology, 221(69), e1–17. principles and guidelines for the protection of human subjects of research. Retrieved from 2 Ex-vivo environment. https://www.hhs.gov/ohrp/sites/default/files/the-belmont-report-508c_FINAL.pdf and the U.K.: Simms v Simms [2003] 1 Fam 83. 3 Kaczor, C. (2005). The edge of life: Human dignity and contemporary bioethics, philosophy 11 and medicine. Dordrecht, the Netherlands: Springer, p. 113. Lewens, T. (2006). Distinguishing treatment from research: A functional approach. Journal of Medical Ethics 32(7), 424–429, p. 425. 4 Cohen, I. G. (2017). Artificial wombs and abortion rights. Hastings Center Report 47 12 (inside back cover). Menikoff, J. (2006) What the doctor didn’t say: The hidden truth about medical research. New York, NY: Oxford University Press, pp. 17–19. 5 Smajdor, A. (2007). The moral imperative for ectogenesis. Cambridge Quarterly of 13 Healthcare Ethics, 16(3), 336–345. Berkman, B. E., Hull, S. C., & Eckstein, L. (2014). The unintended implications of blurring the line between research and clinical care in a genomic age. Personalized 6 Kendal, E. (2017). The perfect womb: Promoting equality of (fetal) opportunity. Journal Medicine, 11(3), 285–295, p. 286. of Bioethical Inquiry 14(2), 185–194, pp. 185–186. 14 Chan, S. (2018). Research translation and emerging health technologies: Synthetic 7 Raskin, J. M., & Mazor, N. (2006). The artificial womb and human subject research. In S. biology and beyond. Health Care Analysis, 26(4), 310–325, p. 319. Gelfand & J. R Shook, J. R. (Eds.), Ectogenesis: Artificial womb technology and the future of 15 human reproduction (pp. 159–182). New York, NY: Rodopi; Alghrani, A. (2018). Regulating Berkman et al., op. cit. note 13, p. 287. assisted reproductive technologies. Cambridge, U.K.: Cambridge University Press. 16 For example, Singer, P., & Wells, D., (2006). Ectogenesis. In S. Gelfand & J. R Shook 8 Alghrani, A., & Brazier, M. (2011). What is it? Whose it? Re-positioning the fetus in the (Eds.), Ectogenesis: Artificial womb technology and the future of human reproduction (pp. context of research? Cambridge Law Journal, 70(1), 51–82. 9–25). New York, NY: Rodopi, p. 10. 394 | ROMANIS
First, I outline the prospects for experimental AWT with human therapy system to improve outcomes for extremely preterm subjects. Second, I review how AWT has been conceptualized in the infants’.22 bioethical literature, demonstrating why these conceptualizations are These studies are encouraging but have limitations. The devices problematic. I argue that experimental AWT must be considered med- have only been tested on small sample sizes for short durations. ical research to better reflect the investigatory nature of the process, Further validation of results is necessary in repeated, longer studies. and to better guarantee protections for the subjects of experimental Moreover, the outcome of these studies should not be considered suf- AWT. I outline that AWT would be required by regulatory authorities ficiently promising to allow use on human subjects without significant to be the subject of extensive clinical trials before such devices are refinement. The EVE study had a survival rate of 87.5%, there was an approved for more general use. Third, I consider whether and how such incidence of brain damage, and several subjects displayed early signs of clinical trials should be conducted by highlighting some of the critical liver dysfunction. These risks may be no worse than those that rou- ethical questions that must be addressed in designing such trials. tinely occur in NIC. It is important, however, that the specific risks and uncertainties are acknowledged. Finally, lambs have a different physi- ology from humans. Thus, the devices may be less successful when 2 | THE PROSPECTS FOR ARTIFICIAL used on humans. Testing on animals, such as primates, with physiolo- WOMB TECHNOLOGY gies more similar to humans, is necessary to better understand the like- lihood of AWs gestating humans. Significant hurdles must be overcome In 2017, Partridge et al. published the results of their artificial before AWs are ready for human testing. It is clear, however, that re- womb-like device (the biobag) designed to continue gestation ex searchers believe that their preliminary results support the expecta- utero. Catheters imitate umbilical cord access and facilitate water tion that their devices could prolong human gestation ex utero. The and nutrient provision and waste product removal. An oxygenator process of refinement and validation may not be lengthy, as develop- ensures oxygen provision but allows the subject’s heartbeat to con- ment in this area is fast-paced. The EVE team produced a redesign in trol circulation as in utero. The subject is sealed in (synthetic) amni- just two years. There are strong incentives driving this research—re- otic fluid, facilitating sustenance delivery and protecting it from searchers are primarily concerned with improving outcomes for infection.17 The biobag was able to sustain preterm lamb foetuses, preterms and their parents, but are also intrigued by the bioengineer- developmentally equivalent to ‘just-viable’ human preterms, for 28 ing problems and the possible prestige of developing the first ‘artificial days. 100% of the biobag subjects survived and were successfully womb’—and there is available funding.23 In an interview, Dr Flake ‘delivered’. All research subjects appeared healthy and to have de- (biobag study lead) alluded to a future ‘a decade from now’ when veloped (evidencing successfully continued gestation). The biobag preterms are treated with AWT rather than conventional NIC,24 sug- researchers acknowledge that the device needs further refine- gesting we are on the cusp of the technology. It is important that we ment,18 and their results need additional validation. They conclude, start considering some of the ethico-legal issues inherent to experi- however, that their device might soon be ready for human testing, mental AWT before they are considered a clinical option. identify their potential clinical target population, and comment on Identifying how AWT might be translated into a clinically effective the justification for use of experimental AWT on humans.19 device is essential to addressing any ethical issues in the process. Both In 2019, Usuda et al. published the second trial of the EVE plat- research teams declare that the objective of their device is to provide form.20 The EVE device has a similar design, sealing the subject in human preterms with more comprehensive support and to improve clin- a warm amniotic fluid bath in a sterilized plastic bag. The subject’s ical outcomes. The studies, however, might potentially differ in their ap- heartbeat, an oxygenator and catheters maintain circulation. In a proach to future clinical translation. There is a presumption in the 2017 study,21 the EVE platform sustained lamb foetuses for a literature that AWT will be used beyond current conceptions of viabil- shorter period than the biobag study, and had a higher incidence ity.25 The biobag study, however, identifies their clinical population as the of morbidity and mortality. The authors were reserved about the ‘just-viable’ preterm (23–25 weeks) and is explicit that the authors have potential clinical application of EVE therapy and directed their no intention of challenging the viability timeline. Their aim is only to conclusions towards redesign. In 2019, they published the results of a study using their redesign. Usuda et al. reported an improved 22 Usuda, et al., op. cit. note 1, p. e2. survival rate, and posited that, although preliminary, their findings 23 Woolfrey, J. (2006). Ectogenesis: Liberation, technological tyranny or just more of the ‘demonstrate the potential clinical utility of a further refined EVE same? In S. Gelfand & J. R Shook (Eds.), Ectogenesis: Artificial womb technology and the future of human reproduction (pp. 77–89). New York, NY: Rodopi, pp. 130–131. 24 Children’s Hospital of Philadelphia. (2017). Unique womb-like device could reduce 17 Partridge et al., op. cit. note 1, pp. 2–4. mortality and disability for extremely premature babies. Retrieved from https://medicalxpr ess.com/news/2017-04-unique-womb-like-device-mortality-disability.html?utm_sourc 18 Ibid: p. 10. e=TrendMD&utm_mediu m=cpc&utm_campaign=MedicalXpress_TrendMD_1. 19 Ibid: p. 11. 25 Alghrani and Brazier focus on technology designed to lower the viability threshold, 20 Usuda et al., op. cit. note 1. suggesting that they envisaged AWT would be trialled in this way: Alghrani & Brazier, op. 21 Usuda, H., Watanabe, S., Miura, Y., Saito, M., Musk, G. C., Rittenschober-Böhm, J… cit. note 8, p. 53. The bioethical literature focuses on ectogenesis collapsing the viability Kemp, M. (2017). Successful maintenance of key physiological parameters in preterm threshold: Cohen, op. cit. note 4. This is dependent on AWT being used before 24 weeks. lambs treated with ex vivo uterine environment therapy for a period of 1 week. American This is not an explicit claim that AWT should be initially trialled like this, but does Journal of Obstetrics and Gynecology, 217(457), e1–13. envisage experimental use of AWT below the viability threshold at some point. ROMANIS | 395 reduce the incidence of mortality and morbidity amongst those preterms This potentially presents an alternative clinical translation strategy of that we already know have some capacity to survive.26 In this approach initially trialling AWT on preterms that are delivered alive but are so to clinical translation, experimental AWT would involve using a method functionally immature that resuscitation would not typically be at- that is conceptually sound but unproven in humans, in place of the exist- tempted (< 22 weeks).38 These two approaches (using viable, or not yet ing approach (conventional NIC) that has mixed results. Conventional viable preterms) invoke different ethical issues. NIC routinely ensures the survival of preterms.27 Before 26 weeks, how- ever, preterms remain unlikely to survive the common complications as- sociated with prematurity and resulting from NIC.28 Only approximately 3 | EXPERIMENTAL AWT IS MEDICAL 9% of preterms born at 22 weeks survive.29 One study reports that the RESEARCH survival rate increases to 33% at 23 weeks, and to 65% at 24 weeks.30 Complications in NIC include lung damage caused by ventilation, cardiac The conventional account of partial ectogenesis is that it is already failure, and infection.31 Of preterms born at 26 weeks that do survive, a ‘partial reality’,39 and full ectogenesis will come about in the nat- 50% have a severe impairment following complications.32 This increases ural evolution of NIC.40 Singer and Wells argued in 1984 that the to 75% amongst preterms at 23 weeks.33 Despite overall mortality rates ability of modern medicine to ensure the survival of preterms improving in NIC over time, outcomes for extremely preterm infants meant that ectogenesis was already a partial reality.41 Both (< 28 weeks) have not meaningfully changed in the last two decades.34 Cannold42 and Alghrani43 refer to partial ectogenesis as a reality Moreover, conventional care does not consistently produce good out- demonstrated by the ‘gestation of premature babies in incuba- comes, because individual circumstances vary greatly, and thus it is hard tors’.44 Even those who do not expressly claim that partial ec- to predict the outcome in any individual case.35 togenesis is already facilitated by incubators often imply that AWs The EVE authors make no explicit attempts to identify their clinical would be only a slight ‘advancement of’ NIC45—a case of improving population, but note that they envisage the EVE platform aiding current technology to enable it to support younger preterms.46 preterms ‘close to or at the border of viability’.36 The study emphasizes Coleman suggests that ‘if premature new-borns are saved earlier that the lamb subjects on which the device was tested were chosen so and earlier stages of gestation then eventually… ectogenesis may that they, as far as possible, ‘approximated the size and weight of a be discovered by default’.47 Singer and Wells posited that ectogen- human fetus close to the border of viability (21–24 weeks of gesta- esis would be further developed ‘by accident’, not because of ‘re- tion).’37 This implies that the authors anticipate the experimental use of searchers deliberately seeking to make ectogenesis possible but EVE on preterms not yet considered viable (just below that threshold). rather [as a result of] doctors attempting to save… premature ba- bies’.48 Alghrani suggests that efforts to perfect NIC mean that 49 26 Partridge et al., op. cit. note 1, p. 11. ‘ectogenesis may not be as far off as… imagined’. 27 Azad, K., & Matthews, J. (2016). Preventing newborn deaths due to prematurity. Best These conceptualizations of AWT as similar to existing routine Practice & Research: Clinical Obstetrics and Gynaecology, 36, 131–144, p. 132. treatment are an attempt to contextualize claims about the implica- 28 Lissauer, T., & Clayden, G. (eds.) (2012). Illustrated textbook of pediatrics. London, U.K.: tions of AWs by ‘demonstrating’ that AWT is a ‘real, serious technology Mosby Elsevier, p. 159. 50 29 Stoll, B. J., Hansen, N. I., Bell, E. F., Walsh, M. C., Carlo, W. A., Shankaran, S… Higgins, and thus something worthy of ethical debate’. AWT is ‘already here’, R. D. (2015). Trends in care practices, morbidity and mortality of extremely preterm neonates, 1993–2012. Journal of the American Medical Association, 314(10), 1039–1051, p. 1045. 38 Nuffield Council on Bioethics. (2006). Critical care decisions in fetal and neonatal 30 Ibid: p. 1045. medicine: Ethical issues. Plymouth, U.K.: Latimer Trend & Company, p. 21. 31 Lissauer & Clayden, op. cit. note 28, p. 159. 39 Singer & Wells, op. cit. note 16, p. 11. 32 Ibid: p. 159. 40 Alghrani, A. (2007). The legal and ethical ramifications of ectogenesis. Asian Journal of 33 Moore, T., Hennessy, E. M., Myles, J., Johnson, S. J., Draper, E. S., Costeloe, K. L., & WTO & International Health Law and Policy, 2(1), 189–212, p. 193. Marlow, N. (2012). Neurological and developmental outcome in extremely preterm 41 Singer & Wells, op. cit. note 16, p. 10. children born in England in 1995 and 2006: The EPICure Studies. British Medical Journal, 42 345, e7961. Cannold, L. (2006). Women, ectogenesis and ethical theory. In S. Gelfand & J. R Shook (Eds.), Ectogenesis: Artificial womb technology and the future of human reproduction (pp. 34 Stoll, B.J. et al, op. cit. note 29, p. 1045. Glass, H. C., Costarino, A. T., Stayer, S. A., 47–58). New York, NY: Rodopi, p. 47. Brett, C., Cladis, F., & Davis, P. J. (2015) Outcomes for extremely premature infants. 43 Anesthesia & Analgesia, 120(6), 1337–1351. Alghrani op. cit. note 7, p. 146. 44 35 All the data we have about the likelihood of premature infants surviving (based on Cannold, op. cit. note 42, p. 47. factors such as gestational age and weight) are prediction models involving a multitude 45 Steiger, E. (2010). Not of woman born: How ectogenesis will change the way we view of factors. Kipnis argues that whilst there may be generalized data to support the viability, birth and the status of the unborn. Journal of Law and Health, 23(2), 143–171, p. 150. likelihood of a good outcome (assuming a certain weight and gestational age), NIC is a 46 Alghrani, op. cit. note 40, p. 191. unique situation. In providing treatment intended to result in the best outcome (survival 47 Coleman, S. (2004). The ethics of artificial uteruses: Implications for reproduction and with limited deficits), it is also then inevitable that the likelihood of the worst outcome abortion. Aldershot, U.K.: Ashgate, p. 45. (death after suffering or survival with intolerable deficits) simultaneously increases. 48 Kipnis, K. (2007). Harm and uncertainty in newborn intensive care. Theoretical Medicine Singer & Wells, op. cit. note 16, p. 10. and Bioethics, 28, 393–412, p. 404. There is also uncertainty in every individual case, 49 Alghrani, A. (2008). Regulating the reproductive revolution: Ectogenesis – a regulatory because we cannot accurately predict the incidence of every complication, from how minefield. In M. Freeman (Ed.), Law and Bioethics (pp. 303–332). Oxford, U.K.: Oxford developed a particular subject’s lungs are to occurrence of necrotizing encephalitis. University Press, p. 303. 36 Usuda et al., op. cit. note 1, p. e2. 50 Hedgecoe, A. (2010). Bioethics and the reinforcement of socio-technical expectations. 37 Ibid. Social Studies of Science, 40(2), 163–186, p. 172. 396 | ROMANIS so ectogenesis is merely trying more of the same type of intervention know what those risks are and how we can attempt to mitigate them in preterms born earlier. Singer and Wells assert that, as an extension (even if we cannot be certain that this will work); we also anticipate that of current methods, AWT would not be ‘potentially reckless with after 26 weeks there is a reasonable chance that preterms will survive human life’.51 They envisage AWT as technology that builds on already treatment.56 Experimental AWT could involve unknown risks and po- established medical approaches with therapeutic intention in each use. tentially result in subjects experiencing worse outcomes than they This characterization of AWT may not have been intended as a com- might have done if treated by conventional methods. Experimental mentary on the status of these technologies as innovative treatments AWT, therefore, needs justification. rather than research; however, this is the implication of conceiving of Experimental AWT is embroiled in more uncertainty than conven- AWT as merely an extension of NIC. This characterization misleadingly tional NIC. Novel approaches sometimes constitute innovative treat- implies that AWT is a beneficial treatment rather than a novel process ments where there is some clinical basis for believing that the patient embroiled in uncertainty. The conceptualization of AWT as already a will experience a direct benefit.57 If there were a reasonable expecta- partial reality, or as a development of an already established techno- tion that experimental AWT would directly benefit individual preterms, logical approach, is flawed for several reasons. These reasons illustrate it would not need to be considered research. If ‘just viable’ preterms that the clinical translation of AWT is research. were used to trial AWT, it could be argued that there is already evi- First, underlying the supposition that partial ectogenesis is already dence that these ‘just-viable preterms’ are capable of surviving with a partial reality is the flawed assumption that incubation and gestation treatment; therefore, there is a valid clinical basis for treating them are conceptually identical. I have argued that incubation is a bid to ‘res- with AWT. However, knowing that there are instances in which this cue’ a preterm by assisting that preterm with life functions it is at- group can survive with support cannot be equated to a reasonable ex- tempting, or beginning to attempt, to sustain itself independently. The pectation that they will benefit from AWT. In this context, benefit process of gestation, however, is different; it is the process of the cre- would (or should) mean that the preterm experiences a better outcome ation of humans.52 AWT marks a complete shift in approach to the than that anticipated from NIC. The approach envisaged by AWT (con- treatment of underdeveloped human preterms: from ‘rescuing’ a tinuing gestation) is conceptually sound. However, there is uncertainty preterm by intervening to assist in the performance of life functions in translating that theoretical approach into reality. There is prelimi- necessary for independent life, to facilitating the ‘creation’ of the sub- nary data suggesting that ex utero gestation is possible for periods with ject by continuing the process of gestation ex utero. Conventional NIC animals. Current animal data, however, are not sufficient to demon- requires that preterms withstand ventilation53 because oxygen must strate a reasonable expectation of clinical benefit because of the sub- be obtained through use of their lungs (pulmonary gas exchange). stantial differences in physiology. This is why standard research Conventional incubators, therefore, will never be capable of facilitating pathways involve human trials after animal testing before approval. ectogenesis even as they improve because, in requiring a preterm to Until it is tried for the first time, there is no clinical evidence supporting use their lungs, the continued development of the lungs is precluded.54 experimental AWT in humans. The lack of clinical validity gives us good AWT devices are purposefully designed to avoid the subject having to reason to presume that AWT should be considered research. utilize their lungs. Instead, gas exchange is performed using a catheter Second, in research the investigator primarily intends to produce imitating gas exchange through the placenta in utero.55 The intention is generalizable knowledge,58 whereas when providing innovative treat- to try to build an environment in which a subject can behave more like ment the intention is to benefit the individual patient.59 Where gener- a ‘foetus’ than a ‘baby’. AWT is an attempt to artificially replicate and alizable knowledge is the primary goal, objective scrutiny is necessary replace the biological process of gestation and to facilitate the exis- to ensure that health is not ‘unduly sacrificed in experimental design’.60 tence of humans ex utero that do not need to exercise their life func- Dr Flake envisages that AWT ‘could establish a new standard of care tions to survive. The important point in raising this distinction is to for this subset of extremely premature infants’.61 The EVE team ex- highlight that experimental AWT is an advancement of NIC only in the pressly state that their objective is to develop ‘a new therapeutic op- sense that it seems conceptually superior (if successful) in process and tion’ replacing conventional ventilation.62 The researchers clearly outcomes. Furthermore, attempting to use AWT on preterms means completely abandoning all previously established, and proven, treat- 56 Lissauer & Clayden, op. cit. note 28, p. 159. ment methods on a vulnerable population to test an approach with 57 Levine, J. (1979). The boundaries between biomedical or behavioral research and the accepted and routine practice of medicine. In National Commission for the Protection of unknown short- and long-term consequences, thus exposing the sub- Human Subjects of Biomedical and Behavioral Research. Appendix to the Belmont Report: ject to risks. Conventional NIC is certainly not risk-free. However, we Volume I (pp. 1–44). Retrieved from https://videocast.nih.gov/pdf/ohrp_appendix_belmo nt_report_vol_1.pdf, p. 34. 58 National Commission for the Protection of Human Subjects of Biomedical and 51 Singer & Wells, op. cit. note 16, p. 16. Behavioural Research, op. cit. note 12, pp. 2–3; Department of Health. (2005). Research 52 Romanis, E. C. (2018). Artificial womb technology and the frontiers of human governance framework for health and social care. London, U.K.: Central Office of reproduction: Conceptual differences and potential implications. Journal of Medical Information, p. 3. Ethics, 44, 751–755, p. 754. 59 Brody, H., & Miller, F. G. (2013). The research–clinical practice distinction, learning 53 Hendricks, J. (2012). Not of woman born: A scientific fantasy. Case Western Reserve Law health systems, and relationships. Hastings Center Report, 43(5), 41–47, p. 44. Review, 62, 399–445, p. 405. 60 Lewens, op. cit. note 11, p. 425. 54 Romanis, op. cit. note 52, p. 753. 61 Children’s Hospital of Philadelphia, op. cit. note 24. 55 Usuda et al., op. cit. note 1, p. e2. 62 Usuda et al., op. cit. note 1, p. e2. ROMANIS | 397 perceive their devices as different from traditional approaches and circuit flow’.67 Animal studies are unhelpful here because circuit flow/ hope that their research will improve outcomes for preterms. The ob- nutrition will be impacted by the size of the subject. The initial use of jective in developing AWT is that eventually, if the devices work as well experimental AWT on humans may not necessarily benefit the first as anticipated, AWT could more reliably support human preterms and subjects but could benefit preterms in the future.68 Without a reason- reduce the incidence of mortality and morbidity. Ultimately, if re- able expectation of success, and with an understanding of the substan- searchers can prove the validity of their approach, AWT may replace tial risks involved, AWT should not be considered justifiable because it conventional NIC (and associated complications). To do this, evidence is in any individual preterm’s interests. It could, however, be considered is needed to establish that AWs can consistently achieve better out- justifiable because of the potential to revolutionize the future of comes. Thus, the primary objective of experimental AWT is the pro- preterm care. duction of generalizable knowledge establishing that AWT is a Research on developing human beings is controversial, especially replacement for conventional technologies. when of uncertain benefit. The World Medical Association,69 British This objective does not preclude the possibility that physi- Medical Research Council70 and U.S. Department for Health and cian-investigators hope or intend that experimental AWT will ben- Human Services,71 however, all accept that non-therapeutic research efit individual subjects of the device, perhaps by ensuring their in these circumstances can be justifiable where it is intended to benefit survival where it was uncertain or by reducing the incidence of future preterms, and can only be conducted on the identified popula- complications. This intention is, however, secondary to the pro- tion.72 Brazier and Alghrani argue that the potential of AWT to ‘im- duction of generalizable knowledge. Initial clinical translation will prove the care of premature babies provides a strong case for involve trial and error. If researchers intended to provide the best permitting ethically approved research’.73 Thus, experimental AWT treatment available to a preterm (assuming that the preterm was can be justified, although the reality, according to Brazier and Alghrani, ‘just viable’ at 23–25 weeks), the reasonable course of action is that research into ectogenesis being in any initial subject’s best inter- would be to provide conventional therapies known to have some ests is contestable.74 Thus, AWT is research. The functional impor- success rather than to trial a device with uncertain outcomes as an tance of conceptualizing experimental AWT in this way is that research alternative. For example, survival (irrespective of morbidity) rates involves formal protocol, robust study design, and procedures de- of NIC at 25 weeks gestation are around 81%.63 It might be, prima signed to ensure the protection of subjects and to ensure the produc- facie, more justifiable to trial the technology on preterms at the tion of generalizable knowledge.75 If this research were to go ahead, it threshold of this category, for example 22 weeks, where NIC is a would first be in a clinical trial. Regulatory agencies, such as the Food much less reliable option. In any case, experimental AWT involves and Drug Administration (FDA) in the United States or the Therapeutic uncertainty and substantial risks. Attempting to assist any individ- Goods Administration (TGA) in Australia (where this technology is cur- ual preterm is, consequently, not the primary motivation of exper- rently being developed) would require extensive clinical evidence be- imental AWT. Even if AWT resulted in benefit for individual fore these devices could be utilized outside controlled processes. The subjects in every case, this does not render the procedure treat- FDA regulates medical devices by a classification system. ‘High risk ment rather than research.64 devices’ include implanted devices and devices that are ‘life-supporting Finally, the substantial risks assumed by the subject of experimen- or life-sustaining… [or that present] a potential unreasonable risk of tal AWT are unlikely to be justifiable on the basis that the individual illness or injury’.76 AWT is likely to fall into this category. By design, it is subject will benefit. Some risk of harm is innate in all medical practice an advanced life-support system. It is not implanted into the subject, (including innovative treatment) and is considered justifiable where the but arguably the fact that a subject is so encased and intimately con- patient stands to benefit from that treatment.65 Because research is nected to the device means that the degree of support it provides is not primarily aimed at securing a patient’s medical best interests, the similar to an implanted device. Moreover, the uncertainty in the justification offered is consequentialist: that any risk tolerated in the experiment might be justifiable based on contribution to knowledge 67 Partridge et al., op. cit. note 1, p. 10. that will have further good outcomes, such as improving the prospects 68 Alghrani, op. cit. note 7, p. 135. 69 for future patients.66 How risks of treatment are justified is therefore World Medical Association. (2000). Ethical principles for medical research involving human subjects. Retrieved from https://www.wma.net/policies-post/wma-decla useful in distinguishing between innovative treatment and research. ration-of-helsinki-ethic al-principles-for-medical-research-involving-human-subjects/. Substantial risks are involved in experimental AWT, such as cardiac 70 Medical Research Council. (2004). Medical research involving children. Retrieved from failure from circuit overload, liver dysfunction because of improper nu- https://mrc.ukri.org/documents/pdf/medical-research-involving-children/. 71 trient supply, or brain injury. Circuit malfunction is also a significant risk US Department for Health and Human Services. (2018). DHHS regulations. Retrieved f r o m h t t p s ://www.ecfr.gov/cgi-bin/retri e v e E C FR?gp=&SID=83cd0 9 e 1 c 0 f 5 c 6 9 3 7 c d 9 because there is a ‘delicate balance between adequate and excessive d7513160fc3f&pitd=20180719&n=pt45.1.46&r=PART&ty=HTML#se45.1.46_1205. 72 Mason, J. K., & Laurie G. T. (2013) Mason & McCall Smith’s law & medical ethics. Oxford, U.K.: Oxford University Press, pp. 650–651, 687. 63 Stoll et al, op. cit. note 29, p. 1045. 73 Alghrani & Brazier, op. cit. note 8, p. 71. 64 Dickens, B. M. (1975). What is a medical experiment? Canadian Medical Association 74 Ibid: p. 70. Journal, 113(7), 635–639, p. 635. 75 Brody & Miller, op. cit. note 59, p. 45. 65 Berkman et al. op. cit. note 13, p. 286. 76 The definition is found in the U.S. Code of Federal Regulations concerning Food and 66 Brody & Miller, op. cit. note 59, p. 44. Drugs 21 CFR §860.3 (c) (3). High-risk devices are known as Class III devices. 398 | ROMANIS outcome for any individual subject means that there is the potential for I have argued elsewhere that the subject of an AW is a unique en- unreasonable risks of adverse effects. The FDA has the authority to tity. A ‘gestateling’85 in an AW is not a neonate because it is not com- require that high-risk devices secure pre-market approval,77 so pletely born. It is still undergoing the process of gestation (human that they cannot be generally used before clinical investigations78 have creation), and is thus more ontologically similar in behaviour and phys- demonstrated their safety and effectiveness.79 The FDA also has the icality, in terms of exercising no capacity for independent life and hav- authority to approve, require modifications to or disapprove all clinical ing no interaction with others, to a foetus.86 It is also distinct from a trials before they begin.80 Studies with the potential for substantial risk foetus because it is not dependent on another person,87 a fact that will must be approved both by an Institutional Review Board (IRB), and by alter the way we treat it. There is, therefore, room to question whether the FDA.81 Similar hierarchical classification systems, with processes a gestateling should be treated more like a foetus or a preterm. In the requiring extensive evidence for devices considered higher risk, have context of a potentially non-beneficial research trial there are signifi- been established in Australia82 and Europe.83 cant similarities in the way foetuses and preterms are treated, because regulators generally deem it impermissible to expose either to unnec- essary risk and require researchers to maximize potential benefits and 4 | CLINICAL TRIALS AND AWT obtain parental consent. The U.S. Office for Human Research Protections (OHRP) has produced regulations on protecting human It has been generally assumed that non-beneficial research on devel- subjects in research88 that provides guidance for IRBs making deci- oping human beings with the object of devising AWT could be ethically sions. Subpart B provides additional protections for foetuses and neo- permissible.84 Such conclusions, however, should be carefully drawn. nates involved in research. §46.204 details the requirements in relation In this section, I consider the justification for AWT research and posit to foetuses and is explicit that any risk to the foetus must be solely by that the consequentialist justification usually offered in the literature interventions that have some prospect of direct benefit, or if there is would be dependent on certain conditions. This investigation exam- no direct benefit the risk must only be minimal and the purpose of re- ines some of the questions that an IRB or the FDA might consider in search must be the generation of important biomedical knowledge deciding whether to approve an AWT clinical trial. The permissibility of that cannot be otherwise obtained. The informed consent of both par- these trials, I demonstrate, is embroiled in intricate ethical issues of ents must be obtained (so far as they are both available, and the con- research design. Before I engage in this discussion, I will briefly address sent of only the pregnant person is required if the research would also the issue of the status of the subjects in a potential AWT trial. be for their benefit). §46.205 details the requirements for research on neonates of uncertain viability (likely to be those identified for any 77 Following the U.S. Federal Food, Drug and Cosmetic Act, 21 U.S.C. §360e (1976), Class AWT study). This section requires that the research has the prospect III devices (high-risk) are required to secure premarket approval (with only a very limited of enhancing the probability of survival with the least possible risk and number of exceptions). This section details the necessary process, including the information that must be supplied in order to secure approval. Further details about the that the purpose of the research is important biomedical knowledge requirements are provided in the U.S. Premarket Approval of Medical Devices Process that cannot be obtained by other means with no added risk. The in- Code of Federal Regulations: Ibid, §814. formed consent of either parent must be sought, unless the neonate is 78 There are other research designs that can demonstrate the clinical utility of a medical device. There is, however, a general consensus that clinical trials are the best method to thought to be non-viable in which case the consent of both parents is ensure the validity and generalizability of results. The regulatory approval process for a required (dependent on availability). We can see that there are signifi- new medical device in multiple jurisdictions is also written assuming that clinical trials are the appropriate clinical investigation in the case of high-risk devices. cant similarities, therefore, in the practicalities of what IRBs will con- 79 The U.S. Federal Food, Drug and Cosmetic Act, op. cit. note 77, §360e (c) (1) (a) sider irrespective of whether subjects are deemed equivalent in moral specifies that any application for premarket approval must include details about design, status to foetuses or neonates. In this paper I will focus on the practi- production, manufacturing and ‘full reports of all information… concerning investigations which have been made to show whether or not such device is safe and effective’. calities, in determining the permissibility of trials, that IRBs would con- 80 Investigation cannot begin until approval from an IRB and FDA is secured: Premarket sider important, for example what risks any subject is exposed to etc. Approval of Medical Devices Regulations, op. cit. note 76, §812.42. The FDA can approve because the approach taken would likely be similar irrespective of the or disprove an application for investigations if there is reason to believe that risks do not outweigh the anticipated benefits for subjects or knowledge to be gained, there are subject’s moral status. The matter of how the moral status of the sub- issues with the investigational plan or methods, there is reason to believe that the device ject of an AW will determine its treatment in the future should be is/will be ineffective or informed consent is ineffective: §812.30. revisited. 81 U.S. Food & Drug Administration (2019) IDE Approval Process. Retrieved from https:// www.fda.gov/medical-devices/device-advice-investigational-device-exemption-ide/ Some might argue that AWT trials are ethically permissible be- ide-approval-process#sig_risk. cause there is the potential that the subjects may benefit. It might be 82 In Australia, medical devices are also classified on the basis of risk in s.41BD Therapeutic Goods Act 1989, and Regulation 3.2 Therapeutic Goods Regulations 2002. 83 In the European Union, a classification system is established in Article XI Council 85 A gestateling is ‘a human being in the process of ex utero gestation exercising, whether Directive 93/42/EEC (1993). This classification system is implemented in the U.K. in the or not it is capable of doing so, no independent capacity for life’: Romanis, op. cit. note Medical Devices Regulations 2002, SI 2002/618. The Medicines and Healthcare 52, p. 753. Products Regulatory Agency has advised that EU directives governing the classification 86 of new medical devices will remain in force, through the MDR 2002, immediately after Romanis, E. C. (2019). Artificial womb technology and the significance of birth: Why any British exit from the EU. See: The Medical Devices (Amendment etc.) (EU Exit) gestatelings are not newborns (or fetuses). Journal of Medical Ethics, 45(11), 727–729, Regulations 2019. p. 728. 87 84 Alghrani, op. cit. note 7, p. 135; Singer & Wells, op. cit. note 16, p. 16, and Alghrani & Ibid. Brazier, op. cit. note 8, p. 78. 88 HHS Regulations 45 CFR 46 (2018). ROMANIS | 399 claimed that some chance of life (or a life without serious medical com- experiencing dangerous but wanted pregnancies.94 Much good can be plications) is better than no chance at all. I have demonstrated that this generated if AWT can save/improve the prospects for future preterms justification is unlikely to be satisfactory because of uncertainty. I raise and persons experiencing (dangerous) pregnancy and limit the emo- it again, however, to highlight that such a justification would be entirely tional distress experienced by parents. If we do not pursue AWT re- dependent on identifying a particular category of research subject. search, all of this potential could never be realized.95 This There could be an identifiable population of subjects for whom the consequentialist justification, frequently offered in the ethical litera- possible reward of ‘some chance at life’ could outweigh the chance of ture,96 should be approached with caution. significant risks. These subjects are those who have little chance in First, the logical corollary of a purely consequentialist justification NIC. In these cases, AWT could be considered at least as safe as NIC, is that, in order to maximize future good to future persons (especially and there would be no reason to suppose worse outcomes. The ques- on this scale), exposing research subjects to severe risks with little po- tion would be instead how much potential suffering the subject is ex- tential benefit is tolerable. Exposing subjects to considerable suffering, posed to, and how much suffering is considered tolerable when however, would not be compliant with regulatory requirements, which weighed against a chance of life. Further, what gain in terms of ‘life’ is are a reflection of the ethical obligation not to abuse vulnerable popu- sufficient would need to be determined. For some parent(s), any addi- lations. The OHRP Regulations, which contain requirements for IRBs tional time (even days) would be considered a benefit. This would, of making decisions about potential trials, do allow non-beneficial re- course, be harder to justify if the subject were likely to experience search intended to result in important biomedical knowledge that can- heavy burdens in the study. It is difficult to support a claim that more not be obtained by other means, though subject to the caveat that mature preterms (> 24 weeks) benefit in any way by being subject to there will be no added risk caused to the developing human being.97 experimental AWT. Such a claim is dependent on whether researchers Second, a consequentialist justification is dependent upon research make a good case that AWT is as safe as, and potentially able to pro- design, because if the correct research question is not identified and duce a better result than, current NIC. The benchmark is much higher carefully answered (with appropriate methods), the future benefit is for this group because they will have a chance of survival (> 50%) in not possible. There are ethical issues embroiled in these methods that NIC.89 Irrespective of what clinical population is identified, the only need to be addressed as part of any justification. Research subjects in evidence researchers will have to attempt to justify an initial trial would any potential AWT trial would be vulnerable to exploitation because be the results of animal studies. Lamb studies cannot provide sufficient they are not participating in a wholly therapeutic arrangement. How data to demonstrate potential benefit in humans. Therefore, research- can we ensure that a research trial is able to answer its research ques- ers may need to gather data by testing on more comparable animal tion? How do we mitigate concerns about coercion and parent(s) feel- models, such as primates, to justify a human trial in preterms90—espe- ing pressured to consent to experimental procedures? How do we cially if they want to test the technology on subjects already consid- ensure that preterms are not exposed to unnecessary additional risk in ered viable. This will encompass its own ethical issues, but they are the course of experimental procedures? These and other questions will beyond the scope of this paper. require exploration in the process of ethical review before any re- Any potential AWT trial may be high-risk, but could potentially re- search study is begun. sult in high rewards if the devices are proved successful. The general Clinical investigations are the only way that experimental AWT justification offered for these trials is the improved prospects for de- can result in generalizable knowledge. Emanuel et al. argue that to veloping human beings and parent(s) in the future. Around 15 million be ethical, research must be conducted in a methodologically rigor- babies are delivered preterm every year,91 and prematurity remains the ous manner: without ‘validity the research cannot generate the in- leading cause of neonatal death in high-income economies.92 Even tended knowledge, cannot produce any benefit, and cannot justify though there has some increase in the number of preterms surviving exposing subjects to burdens or risks’.98 Reitsma and Moreno explain post-NIC, there has been no improvement for some time in the inci- that doctors struggle to deny parents the newest available technol- dence of long-term illness and complications affecting those who do ogy, regardless of questionable benefits and unknown risks, to facil- survive.93 NIC has some innate limitations, and we have potentially itate parents’ wishes ‘not to give up’.99 If AWT were provided ad hoc reached the limits of the capacities of these rescue technologies to aid to preterms in uncontrolled circumstances, generalizations about preterms. AWT has also been emphasized as a potential aid to persons why and how AWT worked in some cases, and not in others, could
94 Some have argued that it could potentially aid all women who want to reproduce but 89 Glass et al. op. cit. note 34, p. 1338. perceive pregnancy as too dangerous or want to avoid the risks associated with pregnancy: Smajdor, op. cit. note 5. 90 I am grateful to one of the anonymous reviewers for raising this point. 95 Alghrani, op. cit. note 7, p. 136. 91 Lawn, J. E., Davidge, R., Paul, V. K., von Xylander, S., de Graft Johnson, J., Costello, A… 96 Molyneux, L. (2013). Born too soon: Care for the preterm baby. Reproductive Health, Ibid: p. 135; Singer & Wells, op. cit. note 16, p. 16, and Alghrani & Brazier, op. cit. note 10(1), S1–S5. 8, p. 78. 97 92 Azad, K., & Matthews, J. (2016). Preventing newborn deaths due to prematurity. Best HHS Regulations, op. cit. note 88, §46.205. Practice & Research Clinical Obstetrics & Gynaecology, 36, 131–144, p. 132. 98 Emanuel, E. J., Wendler, D., & Grady, C. (2000). What makes clinical research ethical? 93 Costeloe, K. L., Hennessy, E. M, Haider, S., Stacey, F., Marlow, N., & Draper, E. S. (2012) Journal of the American Medical Association, 283(20), 2701–2711, p. 2704. Short term outcomes after extreme preterm birth in England: Comparison of two birth 99 Reitsma, A., & Moreno, J. (2003). Maternal–fetal research and human research cohorts in 1995 and 2006 (the EPICure studies), British Medical Journal, 345, e7976. protections policy. Clinics in Perinatology, 30(1), 141–153, p. 144. 400 | ROMANIS not be made. Collating relevant information and accounting for con- improve with gestational age. Identifying the requisite threshold of founding variables would be impossible. There would be no emerg- uncertainty using prediction models (likely based on prospects for a ing evidence that could establish whether AWT is a viable good outcome) would need to be carefully determined. What chance alternative to (or replacement for) conventional NIC. Clinical trials of survival in NIC would be deemed comparatively uncertain? In ensure suitable research methods capable of producing generaliz- medical practice, the viability threshold is defined as the gestational able knowledge. The Council of International Organisations of age at which the chance of survival with NIC is 50%106 (usually this Medical Sciences advises that ‘scientifically unsound research on point is reached at 24 weeks gestation).107 If we accept that a 50% human subjects is ipso facto unethical in that it may expose subjects chance of survival is a useful threshold, it is the point at which treat- to risks…. to no purpose’.100 Important research methods in a clinical ment in NIC is usually deemed appropriate, preterms below this point trial include randomization,101 blinding, and controls.102 These ele- with a lesser chance of surviving might satisfy a claim that there is ments of research design guarantee that the research results in sta- insufficient evidence to suppose that AWT would result in a worse tistically significant data that can be used to attain that anticipated outcome. The point of sufficient uncertainty, however, is hard to future benefit of improving treatment prospects for preterms. quantify. Identifying when the likelihood of survival (based on pre- Without such data, there can be no guarantee that AWT produces diction models) is comparatively uncertain to the unknowns in AWT any benefit, and it would be unethical to continue to expose future is, ultimately, a subjective matter. It might be argued that a 25% subjects to the associated risks. However, these research methods, chance of survival in NIC is not comparatively uncertain to AWT, and in particular randomization, invoke ethical questions. Because the it equally might be argued that it is. To further complicate things, the AWT research trial would involve comparing the new technology analysis so far is dependent on the assumption that the only relevant against the existing technology, prospective subjects would be ran- consideration in identifying a null hypothesis is survival. Long-term domized to receive either NIC or AW care. Only making this direct morbidity is also considered an important factor in determining the comparison in outcomes under controlled conditions would allow appropriateness of providing or withdrawing current NIC treatment. researchers to conclude whether AWT is/is not effective. How might we determine the point at which a chance of certain mor- The concern with randomization is that some subjects are ‘disad- bidities is deemed sufficient to gamble on the uncertainty in AWT? vantaged’ because they receive an inferior treatment (whether this is Moreover, what kind of complications would be relevant? Gestational NIC or AWT) in a research trial. There is broad consensus, according age probably would still be an important factor in this determination, to Freedman, that to be ethical, clinical research must begin with an because morbidity rates, while still high among all NIC patients, are ‘honest null hypothesis’, meaning that there is a ‘state of genuine un- greater at or below the viability threshold. The critical point is that certainty regarding the comparative merits of treatments A and B for with these necessary research methods, it is more justifiable to enrol population P’.103 Uncertainty means that there is insufficient evi- ‘almost viable’ rather than ‘just viable’ subjects in the study. It is eas- dence to establish that treatment A is better than treatment B (or ier to apply the concept of clinical equipoise to this group because vice versa) for that population, and thus any individual subject is not they are less likely to be exposed to more risk in the study than they disadvantaged by receiving one treatment rather than the other. This would be receiving standard care. uncertainty, where there exists ‘an honest, professional disagree- It is expressly within the remit of an IRB to consider the inclusion ment among expert clinicians about the preferred treatment’ is criteria of a proposed clinical trial.108 Identifying the ‘almost viable’ (as known as clinical equipoise.104 Depending on the clinical population opposed to the ‘just viable’ preterm) as the target population of clinical identified as the potential subjects of an AWT trial, clinical equipoise trials seems prima facie more justifiable. The OHRP Regulations also could offer some resolution to the discomfort surrounding random- direct towards this conclusion, because they require that research holds ization. The best evidence available regarding the efficacy of AWT at out the ‘prospect of enhancing the probability of survival of the [devel- the time of initial trials would be animal studies, and outcomes for oping human entity of uncertain viability]… and any risk is the least pos- human subjects would be innately uncertain. If we accept the impor- sible for achieving that objective’ [emphasis added].109 However, it is not tance of clinical equipoise as an ethical constraint,105 the treatment uncommon for NIC to be withheld or withdrawn from this population for comparison must also be uncertain. Outcomes in NIC markedly because treatment (ventilation, nasogastric feeding etc.) is often thought to be too burdensome for extreme preterms with limited pros- pects for improvement.110 ‘Almost viable’ subjects may be inherently 100 Council for International Organizations of Medical Sciences. (1993). International ethical guidelines for biomedical research involving human subjects. Geneva, Switzerland: more vulnerable because of the greater likelihood of treatment being CIOMS. 101 Berkman et al., op. cit. note 13, p. 286. 106 102 Brody, B. A. (1997). When are placebo-controlled trials no longer appropriate? Glass et al., op. cit. note 34, p. 1338. Controlled Clinical Trials, 18, 602–612, p. 605. 107 Ibid. 103 Freedman, B. (1987). Equipoise and the ethics of clinical research. New England Journal 108 U.S. Food & Drug Administration (2009). FDA 101: Clinical Trials and Institutional of Medicine, 317, 141–145, p. 141. Review Boards. Retrieved from: https://www.fda.gov/consumers/consumer-updates/ 104 Ibid: p. 141. fda-101-clinical-trials-and-institutional-review-boards. 109 105 For arguments defending the concept of clinical equipoise, see Hey, S., London, A. J., HHS Regulations, op. cit. note 88, §46.205 (1) (ii). & Weijer, C. (2017). Is the concept of clinical equipoise still relevant to research? British 110 Lantos, J. D., & Meadow, W. L. (2006) Neonatal bioethics: The moral challenges of Medical Journal, 359, j5787. bioethical innovation. Baltimore: John Hopkins University Press, pp. 109–110. ROMANIS | 401 futile, and therefore potentially an unethical burden.111 How we might stringent consent, involving an understanding of the purpose of the balance the researchers’ interest in gathering useful data against some research, any potential risks or benefits, and the alternatives in- of the ethical considerations in burdensome treatment, in both arms of volved,118 is an important mechanism to ensure that parent(s) are not the trial, would need to be carefully navigated. Moreover, to what ex- coerced. Principal investigators should be able to clearly explain to par- tent is opportunity for survival worth the potential for suffering in that ticipants’ parent(s) what the standard course of care would be, and process (by subjects in both arms of an AWT trail)? Regulatory require- how being in the trial would be different. In the case of AWT, parent(s) ments impose obligations on researchers to minimize risks and maxi- should be counselled about the options regarding not enrolling in the mize potential benefits for subjects.112 We would need to carefully study, and the potential harms and benefits of enrolling (including ran- determine the limits of harm exposure in the experiment. Context is domization). Some scholars have expressed concern about parents’ crucial. Lantos explains that in the setting of NIC, standard care is al- ability to meaningfully consent to research, because of the emotional ready predictably associated with serious risk of morbidity and mortal- challenges involved in decisions about giving their offspring a ‘chance ity.113 We must be careful, therefore, in not judging the study based on of life’.119 Specific aspects of the process, for example randomization, risk in its entirety, but by considering whether there is any attributable can also be distressing to comprehend.120 Uncertainty is hard to com- risk, which Lantos defines as the risk ‘attributed to study participation as municate. The explanation that this process may be unlikely to benefit opposed to being attributed to the clinical condition of… [the subject] this subject, but may be able to help preterms in the future will be a and the known risk of conventional treatments’.114 Those subjects ran- difficult conversation for researchers to navigate. The emotional im- domly assigned to NIC in a potential AWT trial would not be exposed to pact on parent(s) is a factor that IRBs must carefully consider.121 any attributable risk. Presumably, if the parent(s) were willing to consent One of the biggest problems with research is minimizing the effect to the study, they would also be consenting to standard care in NIC. The of ‘therapeutic misconception’ when individuals presume that the ex- group receiving AWT is potentially of more significance, but given the periment in which they are participating (or agreeing their preterm high risk of death/injury in ‘almost viable’ subjects, attributable risk is should participate in) is medical treatment.122 Parent(s) most likely to likely to be minimal. There should also be a consideration of safeguards agree to experimental AWT are those who believe that the experimen- to ensure the safety of research participants. For example, in a recent tal technology provides the best possible chance at life, or potentially study evaluating oxygen saturation targets in preterm neonates, a data of life without complications following NIC. Experimental AWT may safety monitoring board was established that continuously compared benefit some of the first preterms that are subjected to it. There is, the incidence rates of serious adverse events between arms of the however, the danger that parents may not appreciate the real risk that study.115 Thus, if a statistically significant trend emerges demonstrating experimental AWT may not work, or may actively cause harm. Such that either arm of the trial is resulting in more frequent adverse results, expectations about new approaches are best managed in the context the study can be stopped. of a research trial because of a shift in perception. There is increased Finally, we must consider how consent for AWT research should be awareness that the purpose of receiving the treatment is to test the obtained. In neonatal/foetal research, informed consent must be ob- hypothesis about a new approach, with the understanding that good tained from the parent(s) of the subject.116 They will only be able to results are not likely, or not without risk, or that standard care is re- decide to permit participation in a trial if they are provided with ade- ceived because of randomization. If the consent process if designed quate information to make an informed decision. The law (of multiple carefully, it should meaningfully address therapeutic misconception. jurisdictions) requires an even greater degree of risk disclosure to Discussion about treatment in the distressing circumstances that a parent(s) for research as opposed to treatment.117 Requiring a more pregnancy is going to end/has ended prematurely will always be diffi- cult. Lantos and Feudtner emphasize that grappling with painful deci- sions, and the details in the process, will be especially hard for parent(s) 111 Ethical arguments for the withdrawal of NIC treatment thought to be futile, and 123 therefore only likely to prolong suffering, have found strong support in the law. Courts when time is limited—sometimes they may have only minutes —and (in England and Wales) have overwhelmingly supported the conclusion that withdrawing when they feel pressured by a sense of emergency. They argue, how- treatment in these circumstances is in a preterm’s best interests: Bhatia, N. (2015) ever, that meaningful consent can still be carefully procured if pro- Critically impaired infants and end of life decision making: Resource allocation and difficult decisions. Abingdon, U.K.: Routledge, pp. 41. cesses are simplified and parent(s) given ‘key information honestly and 112 Mason & Laurie, op. cit. note 72, p. 659. 113 Lantos, J. D. (2018) Neonatal research ethics after SUPPORT. Seminars in Fetal & 118 Neonatal Medicine, 23, 68–74, p. 71. Mason & Laurie, op. cit. note 72, p. 668. 119 114 Ibid: p. 70. Harrison, H. (2008) The offer they can’t refuse: Parents and perinatal treatment decisions. Seminars in Fetal and Neonatal Medicine, 13(5), 329–334. 115 Ibid: p. 70. 120 Kodish, E., Eder, M., & Noll, R. B. (2004) Communication of randomization in 116 The HHS Regulations, op. cit. note 88, §46.205 (2) stipulate that effective consent to childhood leukemia trials. Journal of the American Medical Association, 291(4), 470–475, p. research on a neonate must be provided by either parent, and, in the case of non-viable 472. neonates, §46.205 (c) (5) is clear that both parents must provide effective consent unless 121 one is unavailable. §46.204(e) is explicit that in the case of research on foetuses where I am grateful to one of my anonymous reviewers for raising this point. there is only the prospect of direct benefit to the foetus (and not the pregnant person), 122 Appelbaum, P. S., Roth, L. H., Lidz, C. W., Benson, P., & Winslade, W. (1987). False the effective consent of both parents must be sought unless the father is unavailable to hopes and best data: Consent to research and the therapeutic misconception. Hastings provide it. Center Report, 17(2), 20–24, p. 20. 117 Biggs, H. (2009). Healthcare research ethics and law: regulation, review and responsibility. 123 Lantos, J. D,. & Feudtner, C. (2015) SUPPORT and the ethics of study implementation. London, U.K.: Routledge-Cavendish, pp. 5–7, 82. Hastings Centre Report, 45(1), 30–40, p. 38. 402 | ROMANIS straightforwardly’.124 Entirely how we determine a sufficient consent hoped that this paper has started the necessary ethico-legal con- process for an AWT trial must be the subject of further discussion. versation about experimental AWT. It is common in the literature for the development and use of AWT in humans to be discussed as a foregone conclusion. However, we should be careful to avoid 5 | CONCLUSION focusing on the potential implications of AWT while neglecting is- sues in the development of the technology. Two research teams have claimed proof of principle for AWT. It is I am grateful to Dr Alexandra Mullock, Professor Bernard plausible that soon there could be calls to test their devices, which Dickens, Professor Rebecca Bennett and fellow students at the might drastically improve the prospects for preterms, on humans. Centre for Social Ethics and Policy for their helpful comments on It is necessary, therefore, to consider how and when we should earlier drafts of this paper. use experimental AWT on humans. Little attention has been paid to the ethical issues in AW research. It is often assumed that AWT CONFLICT OF INTEREST constitutes an innovative, beneficial treatment, and thus would The author declares no conflict of interest. emerge almost ‘by accident’. The tendency to conceptualize ex- perimental uses of AWT as innovative treatment—as extensions ORCID of current NIC—and therefore justifiable in the best interests of Elizabeth Chloe Romanis https://orcid.org/0000-0002-8774-4015 preterms is flawed. In this paper, I demonstrated that AWT is medical research. AUTHOR BIOGRAPHY AWT is conceptually distinct from NIC, and it is unknown if it will produce desirable outcomes. Experimental AWT is not ipso facto Elizabeth Chloe Romanis is a PhD candidate in Bioethics and in any individual preterm’s best interests. Clinical trials will be a Medical Jurisprudence at the University of Manchester. Her necessary part of the clinical translation of these devices because PhD, considering the ethical and legal questions arising from of regulatory processes. Clinical trials are thought to ensure pro- the potential use of artificial womb technology as an alternative tection for research subjects, to produce reliable, generalizable to neonatal intensive care, is supported by a Wellcome Trust knowledge, and to better manage therapeutic misconceptions. Studentship in Society in Ethics. Chloe’s broader research in- However, these benefits are contingent upon the conditions of terests include pregnancy and the law, innovative reproductive the research trials. Moreover, clinical trials would only be justifi- technologies, and the legal meaning of birth and life. able under particular conditions. In this paper, I highlighted some of the important ethical questions that would need to be consid- ered in designing research trials of AWT devices. I considered the appropriate clinical population for such a trial, the ethical issues How to cite this article: Romanis EC. Artificial womb in research methods such as randomization, and the importance technology and clinical translation: Innovative treatment or of carefully addressing consent and therapeutic misconception. medical research? Bioethics. 2020;34:392–402. h t t p s : / / d o i . These identified issues remain in need of further scrutiny, but it is org/10.1111/bioe.12701
124 Ibid: p. 38. Appendix 5 – Artificial Womb Technology and the Choice to Gestate Ex Utero: is Partial Ectogenesis the Business of the Criminal Law? (2020) 28 Medical Law Review 342
304
Medical Law Review, Vol. 28, No. 2, pp. 342–374 doi:10.1093/medlaw/fwz037 Advance Access Publication: December 18, 2019 Downloaded from https://academic.oup.com/medlaw/article-abstract/28/2/342/5680368 by University of Manchester user on 05 July 2020 ARTIFICIAL WOMB TECHNOLOGY AND THE CHOICE TO GESTATE EX UTERO: IS PARTIAL ECTOGENESIS THE BUSINESS OF THE CRIMINAL LAW? ELIZABETH CHLOE ROMANIS*
Department of Law, Centre for Social Ethics and Policy, School of Social Sciences, University of Manchester, Manchester, UK *[email protected]
ABSTRACT It is frequently claimed that artificial wombs (AWs) could alleviate the burdens placed exclusively on women in reproduction. In this article, I demonstrate how AWs used for the partial gestation of preterm neonates could introduce new choices for women by changing perceptions of tolerable risks in gestation. In light of advancing medical tech- nology, it is necessary to consider whether the current legal framework in England and Wales would support increased choice for women about alternative forms of gestation. I examine the ill-defined offence of ‘unlawfully procuring miscarriage’ in the Offences Against the Person Act 1861 and demonstrate that different conclusions about the legal significance of ending a pregnancy are evident, depending on the analytical lens adopted in interpreting ambiguities. Furthermore, I demonstrate that the defences available to pregnancy termination under the Abortion Act 1967 are too narrow to support choices about alternative forms of gestation, even if they become physically and medically possi- ble. Therefore, we should decriminalise termination of pregnancy, or, if it is assumed that gestation is the business of the criminal law, specific reforms to the legal framework are necessary. The offence of unlawfully procuring miscarriage is too uncertain and broad, and the defences available are too restrictive. KEYWORDS: Abortion, Artificial wombs, Ectogenesis, Miscarriage, Pregnancy, Termination of pregnancy
I. INTRODUCTION In 2017 and 2019, two teams of researchers claimed that their prototype artificial womb (AW) devices, successfully tested on animals, might soon be ready for use on
VC The Author(s) 2019. Published by Oxford University Press. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creati- vecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, pro- vided the original work is properly cited. • 342 Artificial Wombs and Terminations of Pregnancy • 343 humans.1 It is thought that AWs can better guarantee that preterm delivery does not necessarily result in death/severe complications. Moreover, because the technology is 2
designed to continue the process of gestation ex utero (this process is known as par- Downloaded from https://academic.oup.com/medlaw/article-abstract/28/2/342/5680368 by University of Manchester user on 05 July 2020 tial ectogenesis),3 AWs could become a reliable alternative to later term pregnancy. There is general consensus that AWs should be welcomed both to aid preterms4 and to alleviate women5 of the burdens placed solely on them in reproduction.6 It has been posited that AWs could reduce the burdens placed exclusively on women in re- production, because the technology might reduce the need for pregnancy.7 In this ar- ticle, I demonstrate how artificial womb technology (AWT) will change how risk is perceived and assessed during pregnancy. AWs could present an empowering choice for some women: enabling them to choose an alternative to pregnancy without risking the loss of their future child. This choice could be sought by women for a variety of reasons, but would be particularly empowering for women experiencing dangerous yet wanted pregnancies. The availability of AWs in place of neonatal intensive care (NIC) would shift perceptions of risk in pregnancy, potentially resulting in an in- crease in terminations of pregnancy that are not intended to result in foetal death. There is, therefore, a need to consider the legalities of opting for ex utero gestation. The clinical translation of prototype AW devices into treatment for human neo- nates is fraught with ethico-legal issues.8 In this article, I do not deal with these ques- tions but rather focus on technical legal questions that AWs will bring. It should be noted, however, that pregnant women will necessarily shoulder any risks associated
1 E Partridge and others, ‘An Extra-uterine System to Physiologically Support the Extreme Premature Lamb’ (2017) 8 Nature Communications 1, 11; H Usuda and others, ‘Successful Use of an Artificial Placenta to Support Extremely Preterm Ovine Fetuses at the Border of Viability’ (2019) American Journal of Obstetrics and Gynecology. doi: https://doi.org/10.1016/j.ajog.2019.03.001. 2 The AWs from recent experiments are designed with the intention of facilitating the continued gestation of developing human entities delivered from a pregnant woman’s uterus prematurely. Usuda and others (n 1) are explicit that the object of their AW device is to provide an environment in which the subject can behave ‘more like a foetus than a baby’. 3 Partial ectogenesis is the development of a human being in an AW for part of the typical gestational period following transfer from the maternal womb. C Kaczor, The Edge of Life: Human Dignity and Contemporary Bioethics, Philosophy and Medicine (1st edn, Springer 2005), 113. 4 EC Romanis, ‘Artificial Womb Technology and the Frontiers of Human Reproduction: Conceptual Differences and Potential Implications’ (2018) 44 Journal of Medical Ethics 751. 5 This burden is placed on any person with the reproductive biology that allows them to become pregnant (female) irrespective of gender identity. In this article, I refer to women and to pregnant women because the vast majority of people who experience pregnancy identify as women, and this massively impacts on the social experience of pregnant people and the social and medical response to them. 6 Hendricks posits that AWs could reduce the risks to health incumbent on women in pregnancy. Smajdor argues that AWs are a moral imperative because they will alleviate women from the burdens and suffering innate in pregnancy. See J Hendricks, ‘Not of Woman Born: A Scientific Fantasy’ (2011) 62 Case Western Reserve Law Review 399, 408–09; A Smajdor, ‘The Moral Imperative for Ectogenesis’ (2007) 16 The Cambridge Quarterly of Healthcare Ethics 336, 337. Kendal posits that AWs are a ‘much needed option for those women who wish to have children without submitting to the physical burdens of gestation and child- birth...’ and to potentially evade some of the ‘social burdens’ associated with gestation. See E Kendal, Equal Opportunity and the Case for State Sponsored Ectogenesis (Palgrave 2015) 8. 7 ibid. 8 These important issues related to clinical translation are explored in EC Romanis, ‘Artificial Womb Technology and Clinical Translation: Innovative Treatment or Medical Research?’ (2019) Bioethics; doi: 10.1111/bioe.12701. 344 • MEDICAL LAW REVIEW with AW development. Thus, that women may not necessarily be as emancipated by AWT as has been suggested,9 because of potential legal restrictions, is all the more
concerning. Examining the extent to which the current legal framework is compatible Downloaded from https://academic.oup.com/medlaw/article-abstract/28/2/342/5680368 by University of Manchester user on 05 July 2020 with future reproductive technologies is essential, because AWs bring new challenges concerning their accessibility and application.10 While aspects of my analysis are un- avoidably speculative, it is important to raise these questions before the first human use of AWs.11 Moreover, this investigation allows for a meaningful critique of current provisions. The Abortion Act 1967 (AA 1967) has frequently been criticised for affording doctors, rather than women, the power to make choices about women’s bodies.12 In light of emerging technologies, it remains important to continue the de- bate about whether the medical monopoly on termination decisions is appropriate. Such analysis can meaningfully add to the contemporary debate about decriminalisation. Scholarship exploring the ethico-legal implications of AWs has been primarily di- rected towards the potential movement of the viability threshold, and thus whether there will be,13 or should be14 more limitations on access to conventional abortion (a termination of pregnancy resulting in foetal death).15 In this article, I do not raise such questions because AWs do not present an alternative to conventional abortion. First, ‘foetal extraction’ for gestation ex utero would be a much more invasive proce- dure than a conventional abortion16 (drug-induced or vacuum/surgical). Secondly, AWT will not be able to sustain embryonic products of conception in the foreseeable future, and most women seeking conventional abortion opt for abortion before 13 weeks.17 Finally, the claim that AWT is an ‘alternative’ to abortion fundamentally mis- understands why abortion is protected in liberal societies,18 including women’s
9 Hendricks (n 6); Smajdor (n 6); Kendal (n 6). 10 A Grubb, ‘Abortion Law in England ‘(1990) 18 Law, Medicine and Healthcare 146, 156. 11 Issues related to speculative discourse are addressed in ongoing co-authored research with Claire Horn at Birkbeck, University of London. 12 Eg S Sheldon, Beyond Control: Medical Power and Abortion Law (Pluto Press 1997); E Jackson, Regulating Reproduction: Law, Technology and Autonomy (1st edn, Hart Publishing 2001) 80; S Sheldon, ‘Abortion Act 1967: A Critical Perspective’ in E Lee (ed), Abortion Law and Politics Today (1st edn, Macmillian Press Ltd 1998). 13 J Dalzell, ‘The Impact of Artificial Womb Technology on Abortion Jurisprudence’ (2019) 25 William & Mary Journal of Race, Gender and Social Justice 327; J Schultz, ‘Development of Ectogenesis: How will Artificial Wombs Affect the Legal Status of a Fetus or Embryo’ (2010) 84 Chicago-Kent Law Review 877; A Alghrani, ‘Viability and Abortion: Lessons from Ectogenesis,’ (2009) 4 Expert Review of Obstetrics and Gynecology 625. 14 C Overall, ‘Rethinking Abortion, Ectogenesis and Foetal Death’ (2015) 46 Journal of Social Philosophy 126; J Ra¨sa¨nen, ‘Ectogenesis, Abortion and a Right to the Death of the Fetus’ (2017) 31 Bioethics 697; P Hendricks, ‘There is No Right to the Death of the Fetus’ (2018) 32 Bioethics 395. 15 I use the term ‘conventional abortion’ to refer to the medical process of terminating a pregnancy that results in foetal death. Conventional abortions include drug-induced abortion and surgical abortion. 16 A Alghrani, ‘Regulating the Reproductive Revolution: Ectogenesis – A Regulatory Minefield?’ in M Freeman (ed), Law and Bioethics: Volume 11 (1st edn, OUP 2008) 316. 17 Department of Health, ‘Abortion Statistics, England and Wales 2017’ (2018) 4
In this article, I argue that partial ectogenesis to allow a woman who might other- Downloaded from https://academic.oup.com/medlaw/article-abstract/28/2/342/5680368 by University of Manchester user on 05 July 2020 wise have to continue a pregnancy experiencing some burden (or have an unwanted conventional abortion) should be lawful. I argue that pregnant women, rather than medical professionals, should be empowered to determine what threshold of risk in their pregnancy justifies foetal transfer to an AW. I demonstrate in this article, how- ever, that present law does not accommodate this possibility. Thus, we should either decriminalise terminations of pregnancy in England and Wales, or reform current le- gal provisions on the grounds that they are too broad, and the circumstances in which terminations are lawful are too restrictive. It is clear that the criminal law, in particular offences so old and out-dated, should not be the basis of medical regulation in this matter. However, since pregnancy termination remains a criminal offence, I offer an account of the problems the current legal framework creates. I limit my discussion to partial ectogenesis20 and to situations in which women21 want to end their pregnan- cies without corresponding foetal death. First, I outline the prospects for, and potential uses for, AWs in place of neonatal intensive care. Secondly, I outline the potential impact of the technology on per- ceptions of risk in pregnancy and demonstrate how AWs have particular utility in minimising the burdens women have to experience in pregnancy, especially in those instances in which pregnancy is, or becomes, dangerous. Thirdly, I outline the criminal law surrounding termination of pregnancy and some of the inadequa- cies in the regulation, particularly with regard to the application of the legal frame- work to emerging biomedical technologies. It may be surprising to many that in 2019 the termination of pregnancy remains a criminal offence in England and Wales.22 The Offences Against the Persons Act 1861 (OAPA 1861)23 established the offence of unlawfully procuring miscarriage that remains the basis of the law to- day, 158 years later. The offence is committed when a pregnant woman, or any other person, takes steps to unlawfully procure miscarriage with the intention of
19 L Cannold, ‘Women, Ectogenesis and Ethical Theory’ (1995) 12 Journal of Applied Philosophy 55. 20 There might be future calls to attempt to use the current prototype AW devices to develop complete ecto- genesis whereby embryos could be gestated entirely ex utero (without the need for a pregnancy). The pros- pects of AWT being realistically used for this process are far less likely. Complete ectogenesis is still decades away, because of the legal and political realities limiting embryo research, and because of the uncertain reali- ties of embryo science. The technology we have, at least for now, is only a viable facilitator of partial ecto- genesis (rather than eliminating the need for all pregnancy). 21 See n 5. 22 The Offences Against the Person Act 1861 also criminalised termination of pregnancy in Northern Ireland. However, a majority of the House of Commons voted to decriminalise termination in Northern Ireland in early July 2019. Abortion has been decriminalised since the repealing of the law in Northern Ireland (Executive Formation) Act 2019, s 9 came into effect on 22 October 2019. The Government has now launched a consultation about what regulatory framework should be put in place concerning abortion provi- sion. See HM Government, ‘A New Legal Framework for Abortion Services in Northern Ireland’
procuring miscarriage irrespective of whether the woman is pregnant. Medical pro- Downloaded from https://academic.oup.com/medlaw/article-abstract/28/2/342/5680368 by University of Manchester user on 05 July 2020 fessionals are afforded a defence in England and Wales under particular circumstan- ces prescribed in the AA 1967. Despite the offences contained in the OAPA 1861 forming the foundations of the law, I demonstrate that the terminology used to de- scribe the offence is vague. There is no definition of ‘miscarriage’ in any criminal stat- ute. Miscarriage was interpreted to mean ‘the termination of an established pregnancy’ in a high court challenge concerning the legality of contraceptives.27 This is so broad, however, that it becomes confusing when applied to decisions made later in pregnancy. The definition does not illuminate whether ‘miscarriage’ encompasses any deliberate ending of a pregnancy, or only those resulting/intending to result in foetal death. I demonstrate that there are plausible different interpretations that might be afforded to ‘unlawful miscarriage’, such that there are different legal conse- quences to opting for ex utero gestation depending on the analytical lens that is adopted in interpreting the OAPA 1861. Moreover, the use of the phrase ‘unlawfully’ in the OAPA 1861 itself means that the parameters of the offence are ill-defined. If a doctor terminates a pregnancy outside of the specific defences granted in the AA 1967, but with the intention of ‘treating’ the delivered foetus in an AW, have they committed the offence of unlawfully procuring a miscarriage?28 Answering this ques- tion is crucial because it establishes whether all medical interventions to end preg- nancy are in need of legal justification, or only a subset of terminations with particular consequences. Finally, I consider the defences available in the AA 1967 for doctors providing terminations of pregnancy with the intention of continuing gesta- tion ex utero. I argue that the AA 1967 does not account for shifting perceptions of risk that AWs could bring because it does not provide permission to end a pregnancy for less severe risks or non-medical reasons, even if the foetus survives the termina- tion. This analysis exposes how restrictive the AA 1967 is.
II. THE PROSPECTS FOR AWT In 2017, a US research team announced the development of the ‘biobag’.29 This proto- type AW had, in early trials, successfully supported lamb foetuses on the viability thresh- old for 4 weeks.30 In 2019, a second research team in Australia published the results of an alternative design named the ‘EVE platform’ with some comparable success.31 These
24 ibid. 25 ibid, s 58. 26 ibid. 27 R (On the Application of Smeaton) v Secretary of State for Health [2002] EWHC 610 (admin) (Munby J) para 17. 28 A Alghrani and M Brazier, ‘What Is It? Whose Is It? Re-positioning the Foetus in the Context of Research?’ (2011) 70 Cambridge Law Journal 51, 75. 29 The biobag has also been referred to as ‘EXTEND’ therapy in more recent publications by this research team. See A Rossidis and others, ‘Premature Lambs Exhibit Normal Mitochondrial Respiration after Long- Term Extrauterine Support’ (2019) Fetal Diagnosis and Therapy. doi: 10.1159/000496232. 30 Partridge and others (n 1). 31 Note that this research group first published results in 2017, but published results of a refined device in 2019: H Usuda and others, ‘Successful Maintenance of Key Physiological Parameters in Preterm Lambs Artificial Wombs and Terminations of Pregnancy • 347 devices are designed to replicate the conditions and function of the human uterus so that the developing human entity subject to the device (the gestateling)32 is able to continue
to gestate. The gestateling is submerged in artificial amniotic fluid in a sealed plastic bag. Downloaded from https://academic.oup.com/medlaw/article-abstract/28/2/342/5680368 by University of Manchester user on 05 July 2020 Circulation is maintained by the gestateling’s own heartbeat (assisted by an oxygenator) and catheters imitating umbilical cord access. These studies signal a change in approach: from assisting a preterm with the necessary bodily functions for survival in the external environment that they are attempting, but struggling, to perform themselves, to continu- ing the process of gestation ex utero.33 Prematurity remains the leading cause of death for infants born at or before 24 weeks,34 because the infant is usually too functionally immature35 to survive, even with assistance. In addition to the innate risks of mortality and morbidity in prematu- rity, the use of conventional NIC technologies also harbours significant risk of serious injury or death due to infection,36 irreversible lung damage,37 and heart failure.38 The biobag demonstrates the opportunity to deal with both of these problems. The lamb subjects in the trial all exhibited organ maturation and growth.39 Moreover, there were no incidences of infection or heart failure during the experiment and, after the experiment, all subjects were delivered from the AW ‘healthy’ with normal heart and lung function.40 Similar results41 were reported with the EVE platform, leading the re- search team to conclude that their findings demonstrate ‘the potential clinical utility of a further refined EVE therapy system to improve outcomes for extremely preterm infants’.42 The biobag team suggests that, following further scientific and safety valida- tion,43 they will soon start preparing for testing on humans.44
Treated with Ex vivo Uterine Environment Therapy for a Period of 1 week’ (2017) 217 American Journal of Obstetrics and Gynaecology 1; Usuda and others (n 1). 32 A gestateling is ‘a human being in the process of ex utero gestation exercising, whether or not it is capable of doing so, no independent capacity for life’: Romanis (n 4) 753. The term gestateling will be used throughout this article to refer to a human being in the process of gestation ex utero. A unique term is used because the subject of an AW is conceptually distinct from both a foetus and a neonate. 33 Romanis (n 4) 753. 34 K Azad and J Matthews, ‘Preventing Newborn Deaths Due to Prematurity’ (2016) 36 Best Practice & Research Clinical Obstetrics and Gynecology 131, 132. 35 In particular infants born at or before 24 weeks often have lungs too immature to withstand pulmonary gas exchange, and thus cannot acquire sufficient oxygen. 36 T Lissauer and G Clayden (eds), Illustrated Textbook of Pediatrics (4th edn, Mosby Elsevier 2012) 164. 37 ibid 159. 38 ibid 167. 39 Partridge and others (n 1) 6. 40 ibid 2, 6. 41 The EVE platform study has a lower survival rate (of 87.5%) and incidences of white matter brain injury and early signs of liver dysfunction amongst trial subjects (lamb foetuses): Usuda and others (n 1). 42 Usuda and others (n 1). 43 ibid 10. 44 J Couzin-Frankel, ‘Fluid-filled ‘biobag’ Allows Premature Lambs to Develop Outside the Womb’ (Science, 25 April 2017)
It is initially anticipated that these AW devices could aid gestatelings removed from the uterus at, or just below, the borderline of viability (23–24 weeks).45
Current methods of NIC have succeeded in pushing back our understanding of via- Downloaded from https://academic.oup.com/medlaw/article-abstract/28/2/342/5680368 by University of Manchester user on 05 July 2020 bility,46 but this appears to have reached a natural limit at 22 weeks.47 Resuscitation, and/or subsequent support provision, is usually not given to pre- terms delivered before 22 weeks,48 because these preterms are thought to be too developmentally immature to benefit.49 In theory, AWs would not be subject to the constraints of gestational maturity.50 Therefore, if AWT is used to sustain ‘just-via- ble’ preterms successfully by imitating gestation, there could eventually be instan- ces where the technology is used to sustain younger preterms. Doctors will have clinical incentives to attempt to use the technology at the request of women51 to support preterms delivered before the current threshold.52 Over time, it is plausible that the technology could increasingly be used to sustain less functionally mature developing human entities, for example, gestatelings removed from the uterus as young as 18 weeks.53 In the animal studies discussed, the subjects were transferred into the AW devices after caesarean delivery. As a result, attempts were made to control the stress experi- enced by the subject in transfer. For example, a drug was administered to the subject to ensure that fluid did not drain from the lungs.54 In addition, the subjects did not ex- perience any of the potential pressures or trauma in a natural birth. For this reason, I envisage these AW devices being most effective in situations where delivery can be managed by caesarean, rather than following spontaneous preterm deliveries. This is not to say that attempts would not be made to utilise AWs as treatment in those cases, only that there is cause for speculation that outcomes might not be as promising. For the purposes of this article, those instances in which preterm delivery is anticipated and is actively undertaken are of more interest.
45 Partridge and others (n 1) 11. 46 Alghrani (n 16) 307. 47 This point is identified because it is the age of the youngest premature neonate that has ever survived. It is notable, however, that lung development will occur at a slightly different rate for different foetuses and so this is not a fixed point. 48 This approach was actually recommended by the Nuffield Council on Bioethics in their 2006 Report. See Nuffield Council on Bioethics, Critical Care Decisions in Fetal and Neonatal Medicine: Ethical Issues (2006)
III. CHANGING CHOICES IN OBSTETRICS AWs could empower women who struggle to make decisions about pregnancies that
have become, could become, or are perceived to be, dangerous. Moreover, AWs could Downloaded from https://academic.oup.com/medlaw/article-abstract/28/2/342/5680368 by University of Manchester user on 05 July 2020 provide women with an increased ability to decide what risks they are willing to as- sume during gestation. In this section, I demonstrate a potential shift in risk percep- tion that occurs with the availability of AWs, and how this might lead to a change in demand (both in nature and frequency) for endings to pregnancy. The choice to end a pregnancy and deliver a foetus preterm (before 37 weeks)55 is a difficult, but not un- common, choice that women and obstetricians must navigate when pregnancies go wrong. This choice (to induce a premature end to the pregnancy) is a response to complications that threaten the life or health of the pregnant woman or her foetus. Examples of cases in which premature ending of pregnancy is considered necessary to manage risks in a pregnancy include: placental abruption,56 severe traumatic injury,57 preeclampsia,58 chronic hypertension,59 diabetes,60 unmanaged uterine infection,61 significant foetal compromise,62 maternal cancer, and foetal growth restriction.63 Combined, these complications in pregnancy are not uncommon, and therefore the induced ending of a pregnancy to manage them is also not uncommon. The decision about whether a pregnancy should be continued, or ended either by a termination likely to result in foetal death, or by ‘premature delivery’ with the inten- tion that the delivered preterm will be sustained with NIC, depends on a number of
55 I Symonds, P Baker and L Kean, Problem Orientated Obstetrics and Gynaecology (1st edn, Arnold Publishers 2002) 302. 56 Where the placenta becomes detached from the uterine wall and compromises the foetal condition: ibid 103. During or following placental abruption, terminating the pregnancy is the only chance to save the life of the pregnant woman, and depending on the duration of gestation, her foetus. 57 If a pregnant woman suffers a severe traumatic injury, their prognosis, and that of the foetus when their vital signs are weak or absent, are often improved by terminating the pregnancy preterm. See C Beckman and others, Obstetrics and Gynaecology (7th edn, Wolters Kluwer 2014) 203. 58 Preeclampsia is a serious condition characterised by high blood pressure, which if unmanaged leads to organ damage, neurological symptoms and fluid in the lungs. Substances being released from the placenta into the maternal blood vessels cause the condition to develop. See C Nierenberg, ‘Preeclampsia: Signs, Symptoms & Treatment’ (Live Science, 01 June 2017)
tional risks increasing with the duration of pregnancy, the risk for the foetus in utero, Downloaded from https://academic.oup.com/medlaw/article-abstract/28/2/342/5680368 by University of Manchester user on 05 July 2020 and the risk to the foetus of being born premature.64 The removal of the foetus before complete gestation is risky because the foetus is underdeveloped65 and usually cannot survive without support. NIC can improve the chances of survival, but there remains a high risk of complications66 causing disability or death.67 As gestation advances, the threshold of risk of early delivery falls,68 because the likelihood of complications resulting from premature birth decreases with gestational age69 and maturity.70 Where the pregnant woman is stable enough and anxious to save her foetus, termination is undertaken as late as possible. Ending the pregnancy is seen as a last resort, because NIC is no guarantee that a delivered preterm can survive. Once a decision is made to end a pregnancy, and the timing decided, the mode of ending the pregnancy must be determined. The mode of termination will determine the outcome. In what are thought of as ‘attempted premature deliveries’, the foetus is extracted from the uterus by caesarean (the surgical opening of the abdomen and womb)71 or drug-induced vaginal delivery.72 These methods of ending pregnancy carry their own risks.73 Deciding if, when, and how to end a pregnancy is a case of bal- ancing the risks affecting the pregnant woman and the foetus in continuing the preg- nancy, versus ending it. In some cases, when continuing the pregnancy endangers both the pregnant woman and the foetus, opting to end the pregnancy (and provide NIC post-birth) can be a clear decision to make in order to attempt to save both. This decision can be difficult in cases where continuing with the pregnancy is danger- ous for the pregnant woman, but would be beneficial for the foetus, and termination carries greater risks for it. In deciding whether to continue or end the pregnancy, such risks can be hard to weigh both for doctors exercising clinical judgement, and for preg- nant women anxious for their own health and well-being, and for their foetuses. This decision-making calculus, however, could become less challenging with AWs.
64 EM Symonds and I Symonds, Essential Obstetrics and Gynaecology (4th edn, Elsevier Science 2002) 107. 65 Common risks associated with premature delivery for the foetus include, but are not limited to, underdevel- oped lungs and respiratory issues, circulatory problems, low blood pressure, and an inability to swallow or suck. See Lissauer and Clayden (n 36) 164, 167. 66 For example infection, see ibid 164. 67 For further discussion of the conceptual differences between AWs and conventional neonatal intensive care, see Romanis (n 4). 68 Symonds, Baker and Kean (n 55) 55. 69 Lissauer and Clayden (n 36) 159. 70 In some instances, when complications and the need for premature termination of pregnancy become evi- dent earlier in the pregnancy, steroids can be administered to accelerate lung maturity to reduce some of the most significant risks associated with preterm birth. See Symonds, Baker and Kean (n 55) 90. 71 National Institute for Health and Care Excellence, ‘Information for the Public; Caesarean Section’ (2011) 3
Used as an alternative to conventional methods of NIC, AWs have the potential to produce better and more consistent outcomes for developing human entities removed
from the uterus before 37 weeks. Current NIC is seen as an unreliable/dangerous al- Downloaded from https://academic.oup.com/medlaw/article-abstract/28/2/342/5680368 by University of Manchester user on 05 July 2020 ternative to remaining pregnant (because of the inherent risks and limitations) for pregnant women who are concerned with not losing their foetuses. Most pregnant women who seek to end their wanted pregnancies before full term do so only because their pregnancies are dangerous, and they seek to remain pregnant for as long as pos- sible because of their concerns about their foetuses and prematurity/conventional NIC. AWs, however, could eliminate much of the concern over the risks of prematu- rity, and the limited success of NIC. This could enable a new kind of decision-making in obstetric practice, shifting the focus to the woman’s experience of pregnancy, rather than the ‘foetus’s interests’ in not being removed from the uterus prematurely. AWs thus have the potential to enhance women’s autonomy by lessening the pressure in- cumbent on them to act in self-sacrificial ways during a wanted pregnancy. This change in focus could result in more ‘endings of pregnancy’ being considered clinically appropriate, and/or endings of pregnancy on medical grounds being advised earlier in gestation. This could then reduce the pressure on women in terms of forcing them to make difficult decisions about termination themselves.74 AWs have the potential to become not just about rescuing developing human entities from the effects of prema- turity, but also about rescuing pregnant women from aspects of pregnancy without re- quiring women to sacrifice or risk their foetuses. There are four ways in which AWs will reframe perceptions of risk in pregnancy. First, taking the case of dangerous pregnancies, it is possible that AWs will shift perceptions of what level of risk would be sufficient to justify an intervention to end a pregnancy on the grounds of a woman’s health. At present, the concerns about prema- turity mean that only the most serious risks to the pregnant woman’s health and life are considered medically sufficient grounds to end pregnancies prematurely. This of- ten results in women making the choice to sacrifice their own health.75 If there were a more reliable alternative to natural gestation than conventional NIC, there is every possibility that the threshold of sufficient risk to justify terminations will be lowered. This might be lowered to include less severe complications (such as the earlier stages of preeclampsia or less serious traumas) that are not thought sufficiently grave to jus- tify risking a woman’s wanted foetus being born premature, but might be thought suf- ficient to justify ending a pregnancy in favour of artificially continued gestation. Pregnant women concerned for their foetuses would consequently no longer have to
74 In instances where a pregnant woman faces a threat to her own health, but wants to give her foetus the best chance of life, this can be a very difficult decision to make: AWT might effectively make it so that pregnant women do not have to actively make a choice between their health and their foetuses. 75 In 2016, Heidi Loughlin was diagnosed with an aggressive cancer whilst pregnant and was forced to choose between life-saving treatment and remaining pregnant. This case caught the attention of the national media. Heidi opted for premature delivery at 28 weeks to receive treatment in the hope that her preterm daughter would be developed enough to successfully be supported by NIC. Waiting this long for treatment was ex- tremely risky for Heidi because the cancer continued to grow and spread during the time she remained pregnant. She fortunately survived, however her neonate, Ally Loughlin, died soon after delivery: P Walker, ‘Baby Delivered Early to Allow Mother’s Cancer Treatment Dies’ The Guardian (London, 20 December 2015)
serious. Downloaded from https://academic.oup.com/medlaw/article-abstract/28/2/342/5680368 by University of Manchester user on 05 July 2020 Secondly, AWs could impact on perceptions of viability and could, therefore, remove the importance placed on gestational maturity in obstetric decision-making. If foetuses are considered ‘viable by virtue of technology’76 earlier in a pregnancy, this could dimin- ish the emphasis placed on the timing of delivery in the decision-making process that obstetricians evoke when considering bringing a high-risk pregnancy to an end. With the concern about foetal viability increasingly removed from the equation, and because lower levels of risk that signal the need for intervention are likely to occur earlier in preg- nancy, there could not only be an increase in premature endings to pregnancy, but these terminations could be more ‘premature’. There might be attempts to transfer foetuses to AWs very early in gestation (18 weeks), but also more routine attempts to end preg- nancies closer to the threshold of viability (22–24 weeks) as opposed to continuing and monitoring the pregnancy to ensure delivery occurs as far along as possible. Thirdly, if AWs become reliable, obstetricians would not have to frame their advice to pregnant women as a ‘balancing act’ in terms of weighing up the risk to their foe- tuses against the risks to their health in remaining pregnant. Presently, even when a woman’s health is at risk due to her pregnancy, she is often advised (by choice) about the severity of the risk to her, in comparison to the severity of the risk to her wanted foetus of terminating early. Often women are advised to end pregnancy only when the threat to their health is serious, because only this is thought to outweigh the risk to the foetus of prematurity/NIC. If AWs were available, and could mitigate the impact of prematurity, less emphasis would be placed on a comparative account of risk. Whilst it could never be guaranteed that there is no risk to the foetus in removal for gestation ex utero, there would not be the same impetus to evaluate risks to the foetus. If the technology were considered reliable, any risks to the foetus would result only from the process of transfer, as opposed to the risks of preterm delivery coupled with the inherent risks of being born premature. With less concern regarding the impact of prematurity on the part of both pregnant women and their obstetricians, it becomes possible for the nature of the discussions regarding management of dangerous preg- nancies to shift. Instead of a comparative account of risk to the pregnant woman and to her foetus, conversations could be directed more towards the pregnant woman’s condition in itself, and the associated risks for her in continuing the pregnancy. The pregnant woman would be free to make decisions predominantly on the basis of her own health with the knowledge (if her concern) that prioritising her health will not al- ways be in direct conflict with the foetus’s welfare. The technology will have the po- tential to change the language used in these circumstances of the ‘maternal-foetal conflict’,77 a common conceptualisation that is the result of the pregnant woman and foetus’s physical interests being understood as in competition with each other.
76 By this phrase I mean to suggest that foetuses could be considered viable if they were placed in a machine able to continue gestation, but they are not ‘naturally viable’ because they have not reached sufficient devel- opmental maturity to survive without gestational support aiding continued organ maturation. 77 The ‘maternal-foetal conflict’ model is a way of conceptualising pregnancy that presents the interests of the pregnant woman and foetus as in contention with each other. Bowden presents a compelling argument, even outside of the possibility of technology like AWT, as to why there is an inherent problem in adopting Artificial Wombs and Terminations of Pregnancy • 353
The decision about whether to end a pregnancy for medical reasons could be re- duced to a case of considering the impact of pregnancy on a woman’s health, and
weighing up the risk to her health of termination against remaining pregnant and de- Downloaded from https://academic.oup.com/medlaw/article-abstract/28/2/342/5680368 by University of Manchester user on 05 July 2020 livering at the end of 37 weeks. In most cases, especially when a woman’s life or health is at risk, these risks are likely easily resolved because the mode of delivery would be the same whether the pregnancy is delivered preterm, or at term (by caesarean). Arguably, a managed elective caesarean is likely to be less risky for women in such cases than an emergency caesarean.78 Even if this were not the case, such a balancing exercise would more often be resolved in favour of termination when there is any risk in remaining pregnant to a woman’s life or health. I will return to the issue of balanc- ing the risk of termination versus the risk of remaining pregnant in legal terms later in this article. Finally, if AWs were a reliable alternative to pregnancy a demand might emerge for endings to pregnancy (in favour of ex utero gestation) in less urgent or in non-medical circumstances. Pregnant women whose pregnancies pose a lesser risk to health may request to opt for an alternative to their gestation. Unpleasant or uncomfortable, but not actively dangerous, experiences during pregnancy might encourage women to seek termination in favour of AWs. Unrelenting morning sickness, mobility issues and swollen limbs, migraines, insomnia, anxiety, fear of developing post-partum depres- sion, and plenty of other side effects can be difficult to endure for some women. Kendal suggests that there could also be women who seek termination in favour of an AW to evade social stigmas associated with pregnancy.79 For example, women con- cerned about the impact on their work and potential discrimination or women strug- gling with addiction.80 There could, in these cases, be innate risks apparent in the preterm extraction of a foetus for ex utero gestation that are not apparent in a woman’s remaining pregnant and delivering after 37 weeks. For these reasons, the use of AWs for social considerations is less likely to be considered medically acceptable than in cir- cumstances involving some clinical justification. In English law, patients are not empowered to demand any particular form of prenatal care81 (including presumably ex utero gestation), and simultaneously, doctors cannot be compelled to perform
this conceptualisation, because the welfare of a pregnant woman and her foetus are frequently intercon- nected. See C Bowden, ‘Are We Justified in Introducing Carbon Monoxide Testing to Encourage Smoking Cessation in Pregnant Women?’ (2019) 27 Health Care Analysis 128, 139. 78 O Keag, J Norman, and S Stock, ‘Long Term Risks and Benefits Associated with Caesarean Delivery for Mother, Baby and Subsequent Pregnancies: Systematic Review and Meta-analysis’ (2018) 15(1) PLOS Medicine e1002494. 79 Kendal (n 6) 12–13. 80 In using these examples, I am not trying to suggest that women in these circumstances should seek AWs in place of conventional termination or remaining pregnant. I only wish to suggest that, in those instances where a woman wants to become a mother or wants to give up her foetus for adoption (rather than pursue abortion for their own reasons), partial ectogenesis could be a favourable option for someone with those preferences in some circumstances. 81 The law is clear that, outside of emergencies, patients do not have the right to demand any particular treat- ment over another following R (Burke) v General Medical Council [2005] EWCA Civ 1003. This is evident in the context of prenatal care: for example, while the law is supportive of choice in childbirth a woman can- not demand one form of childbirth over another, eg an elective caesarean, if their doctor is unwilling to offer that choice. See EC Romanis, ‘Why the Elective Caesarean Lottery is Ethically Impermissible’ (2019) Health Care Analysis. doi: 10.1007/s10728-019-00370-0. 354 • MEDICAL LAW REVIEW medical interventions in non-emergencies.82 It is unlikely, especially in communal health systems, that pregnant women would be routinely enabled to opt for ex utero
gestation without medical cause. However, the possibility of such a demand for an al- Downloaded from https://academic.oup.com/medlaw/article-abstract/28/2/342/5680368 by University of Manchester user on 05 July 2020 ternative to natural gestation to allow women to avoid any (social) risks in order to re- produce is something we should take seriously. This possibility raises new ethico-legal (and socio-political)83 issues. Should the AW be seen as, and used only as, a healthcareresourceorshoulditbewelcomedas a new reproductive choice? Hammond-Browning argues that although partial ecto- genesis provides many benefits to women carrying a pregnancy, ‘foetal welfare’ and ‘uterine experience’84 must be taken into account. She argues, therefore, that an elective foetal transfer would only be justifiable in instances of dangerous preg- nancy and/or where it can be ‘shown to be in the foetus’s best interest’.85 In con- trast, Kendal argues that the AW must be utilised as a reproductive choice in order to afford those of female reproductive biology the potential for equal opportunity, both in terms of enabling them to reproduce with minimal physical risks and to evade what she terms the ‘social burdens’ that she claims inevitably result from pregnancy.86 If women could be enabled to exercise greater choice about what risks they are willing to assume in pregnancy without risking their foetuses, to what ex- tent does the law empower them to opt for partial ex utero gestation? I now pro- ceed to demonstrate that if all foetal extraction before 37 weeks requires legal justification, then it is unlikely that the current legal framework would permit women to end their pregnancies in order to opt for AWT for social reasons. This is because these circumstances fall outside of the AA 1967 and, potentially, the de- fence at common law. Moreover, women may not be able to opt for AWs at lower thresholds of maternal risk, because the AA 1967 is drafted to justify the ending of pregnancy only in instances of severe risk.
IV. THE LEGAL PERMISSIBILITY OF PREGNANCY TERMINATION The AA 1967 specifies that the law regarding termination is contained in sections 58 and 59 of the OAPA 1861. The actus reus of unlawfully procuring miscarriage is com- pleted when an individual takes any unlawful steps to procure miscarriage (by any
82 ibid; also the law is supportive of doctors’ right to conscientiously object to certain treatments in a number of instances. In this context, it is notable that doctors are entitled to object, on the grounds of conscience, to provide pregnancy terminations when the termination is not necessary to save the life of the pregnant woman. See Abortion Act 1967, s 4. 83 There are interesting socio-political implications associated with the increasing availability of AWs—for ex- ample, the negative implications of women feeling the need to opt out of complete pregnancy in order to re- turn to work earlier, or the use of AWs to police pregnancy where women are non-compliant eg drug users. Such issues are beyond the scope of this article. 84 N Hammond-Browning, ‘A New Dawn: Ectogenesis, Future Children and Reproductive Choice’ (2018) 14 Contemporary Issues in Law 349, 365. 85 ibid 362 86 Kendal (n 6) 8, 12–13. I agree that ectogenesis could present an important reproductive choice for women; however, it is inappropriate to label ectogenesis as a solution to social problems since this suggests that there is something inferior about the female body and its role in gestation. The argument has the implication that we should remove gestation from the body to solve discrimination against women, rather than attempt to deconstruct the problematic social reactions to gestation and the female body. Claire Horn and I develop this argument in our ongoing research. Artificial Wombs and Terminations of Pregnancy • 355 means).87 The requisite mens rea is that the object of that individual’s actions is the procurement of miscarriage.88 The offence is committed only in the absence of a de-
fence. Defences are clearly listed in the AA 1967, which I will explore in detail later in Downloaded from https://academic.oup.com/medlaw/article-abstract/28/2/342/5680368 by University of Manchester user on 05 July 2020 this article. The offence of unlawfully procuring miscarriage is broad in its construc- tion and lacks detail. The possibility of prematurely ending a pregnancy without it necessarily resulting in foetal death was not envisaged when the OAPA 1861 was first constructed. Acts of Parliament that have subsequently added and amended defences to the offence of procuring miscarriage (AA 1967, Human Fertilisation and Embryology Act 1990) were also drafted with the reasonable assumption that termi- nation of pregnancy usually results in foetal death, and that other forms of termination later in pregnancy to save a pregnant woman’s life are ‘premature deliveries’ that only occur later in pregnancy, and in circumstances encompassed in the AA 1967. The of- fence of unlawfully procuring miscarriage, therefore, was deliberately designed to be all encompassing due to the limited knowledge of pregnancy and foetal development in 1861, and to include all the various different methods of procuring abortion that could be used by back-street abortionists. The advent of AWs, and other technologies, that have enabled the possibility of prematurely ending a pregnancy without causing foetal death, is a blind spot for many areas of the law. The broad construction of the offence, in light of advancing technol- ogy, causes increasing uncertainty. This is primarily because the offence turns on the definition afforded to miscarriage,89 and subsequently how we might then define an ‘unlawful miscarriage’, as this is somewhat dependent on the meaning of miscarriage itself. The term ‘abortion’ featured in the first British statute to regulate terminations, Lord Ellenborough’s Act of 1803,90 but was subsequently abandoned in other statutes until the AA 1967. The term ‘termination of pregnancy’ was not used in law until the AA 1967.91 Notably, despite the use of these terms in more modern statutory provi- sions, there were no amendments introduced to change, clarify, or supersede the ter- minology of miscarriage in the OAPA 1861. Whilst miscarriage might seem straightforward in meaning, there are two possible interpretations with different con- sequences for how the offence is understood and where it applies, that could be adopted. For the purposes of this article, these interpretations must be explored in the context of terminations later in pregnancy. Dickens noted that ‘one may allege that “miscarriage” is the wider expression covering a removal or discharge of the contents of the uterus before natural birth’, however he also posited that the phrase in its natu- ral meaning should be accepted as a synonym of abortion (a deliberate intervention to end a pregnancy resulting in foetal death).92 There has been limited further explo- ration of this issue, because we tend to think of terminations not intended to result in foetal death as ‘premature deliveries’ accounted for under the AA 1967. In the context of contemporary and future medical developments, however, the uncertainty in the
87 See the text accompanying nn 25 and 26 above. 88 Offences Against the Person Act 1861, ss 58 and 59. 89 Smeaton (n 27) para 338. 90 B Dickens, Abortion and the Law (1st edn, MacGibbon & Kee 1966) 25. 91 V Harpwood, Legal Issues in Obstetrics (1st edn, Dartmouth 1996) 216. 92 Dickens (n 90) 30. 356 • MEDICAL LAW REVIEW meaning of ‘miscarriage’ may become more problematic because of the possibility of ending pregnancy in favour of ex utero gestation if AWs did replace conventional
NIC. Downloaded from https://academic.oup.com/medlaw/article-abstract/28/2/342/5680368 by University of Manchester user on 05 July 2020 Smeaton,93 the only case in which a court has been required to consider the mean- ing of miscarriage in the OAPA 1861, concerned the legality of the morning-after pill. The Society for the Protection of Unborn Children alleged that contraceptives designed to ensure the prevention of a fertilised egg to implant in the uterus amounted to a ‘criminal miscarriage’. Munby J was unsympathetic, holding that ‘what- ever it may or may not have meant in 1861 the word miscarriage today means the ending of an established pregnancy, and there is no established pregnancy prior to implantation...’.94 It was held that miscarriage was ‘the expulsion of the contents of a pregnant uterus’ at any point in pregnancy.95 This interpretation of miscarriage is too broad, because it makes no reference to the outcome of the miscarriage. If this inter- pretation were correct, unlawfully procured miscarriage would be any deliberate cessa- tion of pregnancy in the absence of a defence. There are grounds to believe an alternative definition of miscarriage might be adopted if the question were re-examined, particularly in the context of later term pregnancy. Smeaton96 focused on the beginning of pregnancy. The judgment emphas- ised that an instrument of procuring miscarriage had to have the capacity of ending an established pregnancy. Later in pregnancy, there is no issue regarding the established status of a pregnancy. Instead, the question is a much more explicit one. Does (unlaw- fully) procuring miscarriage necessarily involve intent to cause foetal death? There was a heavy reliance in the Smeaton judgment on medical evidence; many expert wit- nesses were called and medical texts were utilised. Munby J was clear that the defini- tion of miscarriage that he arrived at was also ‘the current understanding of what is meant by miscarriage when used by lay people in the popular sense’.97 This implies that medical and lay opinion of what a miscarriage involves is relevant in understand- ing what it legally encompasses. When the OAPA 1861 was drafted there was no com- prehension that there might be the possibility of ending a pregnancy without foetal death being both a necessary part of, and the intention of, the process. Common understandings of, and some medical definitions98 of, miscarriage include death as in- tegral to the process. The second potential interpretation of miscarriage is, therefore, the ending of an established pregnancy resulting in foetal death. This will be referred to as ‘miscarriage as foetal death’. The difference between the two interpretations is that one is concerned with the condition of the foetus, and the other is not. The actus reus and mens rea of the offence differ wildly depending on which inter- pretation is adopted. If miscarriage means any deliberate cessation of pregnancy (in the absence of a defence) then ending a pregnancy in order to facilitate ex utero gesta- tion would fall within the parameters of procuring miscarriage (and, therefore, a
93 ibid. 94 Smeaton (n 27) para 17 (emphasis added). 95 Harpwood (n 91) 216. 96 Smeaton (n 27). 97 ibid, para 17. 98 E Martin, Concise Medical Dictionary (9th edn, OUP 2015) 480–81; M Page (ed), British Medical Association Illustrated Medical Dictionary (3rd edn, Dorling Kindersley 2013) 370. Artificial Wombs and Terminations of Pregnancy • 357 doctor would need to demonstrate lawfulness in common law or under the AA 1967). However, if miscarriage necessarily includes only terminations that result in
foetal death, ending a pregnancy to opt for ex utero gestation would not be a criminal Downloaded from https://academic.oup.com/medlaw/article-abstract/28/2/342/5680368 by University of Manchester user on 05 July 2020 matter so long as the intention was that the foetus survives the ending of pregnancy. There is an important distinction to be remembered here between endings to preg- nancy where foetal death can be considered deliberate, and those where it can only be considered incidental.99 It is necessary that we ascertain which interpretation is, and should be, adopted in the criminal law. Medical technologies, of which AWs are just one, are increasingly blurring the distinction between those events that we would con- ceptualise as ‘medical premature deliveries’ and the deliberate unlawful ending of pregnancy. These technologies are making it more likely that questions surrounding the parameters of unlawfully procuring miscarriage will become a real issue in obstet- ric practice. Is ending a pregnancy to opt for an AW the unlawful procurement of mis- carriage and thus in need of legal justification? If so, are there available defences in the AW context? This investigation, which I now undertake, involves examining the meaning of ‘miscarriage’ and the meaning of ‘unlawful’, as used in section 58. It should be noted that such an investigation of the law would not be necessary if termination were decriminalised, as questions of criminal liability would become irrelevant.
V. DOES ALL ‘FOETAL EXTRACTION’ AMOUNT TO THE UNLAWFUL PROCUREMENT OF MISCARRIAGE? In this section, I explore the possible interpretations that might be afforded to ‘miscar- riage’ and ‘unlawful miscarriage’ in the OAPA 1861. I consider whether the law could be interpreted to mean that all deliberate endings to a pregnancy are prima facie crimi- nal, or whether only terminations resulting in foetal death are ‘miscarriages’ for the purposes of the criminal law. I consider the possible arguments that might be offered to support each interpretation and I analyse the law from both of these differing per- spectives to show that there would be different conclusions reached about the legal consequences of foetal death depending on the analytical lens adopted. I demonstrate that we cannot be certain how miscarriage would be interpreted if the matter came be- fore a court of law, as there are compelling reasons that mean both are plausible accounts of the law. However, I advocate that (assuming criminalisation is appropri- ate), the most ethically sound operation of the law is dependent on unlawful procure- ment of miscarriage being understood as referring only to those terminations intending to cause foetal death. I argue that law reform is necessary.
A. Are all Deliberate Endings to Pregnancy Presumptively Criminal? By looking at other statutes concerning the law of terminating pregnancy, it could be argued that Parliament did not intend that miscarriage would refer only to deliberate
99 Under this interpretation (miscarriage as termination resulting in foetal death), there would be no offence even where the foetus dies (despite best efforts), so long as there was no intention that it would not survive the ending of the pregnancy, because the mens rea of the offence would be ‘an intention to procure a termi- nation of pregnancy resulting in the death of the foetus’. In some instances, there might be considered to be an oblique or indirect intention if it could be demonstrated that the doctor ending the pregnancy was ‘virtu- ally certain’ that the foetus would die as a result of their actions, to such an extent that they can be said to have intended that outcome. 358 • MEDICAL LAW REVIEW interferences to end a pregnancy that is intended to result in foetal death. There is sig- nificant overlap between the offence of child destruction contained in the Infant Life 100
(Preservation) Act 1929 (ILPA 1929) and the offence of procuring miscarriage in Downloaded from https://academic.oup.com/medlaw/article-abstract/28/2/342/5680368 by University of Manchester user on 05 July 2020 the OAPA 1861. Terminating a pregnancy that results in the death of a foetus ‘capable of being born alive’101 would amount to an offence under both provisions.102 Grubb posits that the only distinction between the two statutes is that the offence of procur- ing miscarriage can be committed before the 24-week viability threshold.103 There is, however, a further distinction Grubb did not account for. The ILPA 1929 is explicit that the actus reus of child destruction is complete only when action results in foetal death, whereas the OAPA 1861 is too vague to be explicit to this effect. Brazier and Harris posit that the language used to construct the OAPA 1861 and AA 1967 imply that ending pregnancy and foetal death are ‘one and the same’.104 Alghrani and Brazier expand on this, arguing that ‘s.58 envisages [and criminalises] a process inevitably designed to kill the foetus’.105 The offence does imply that there is usually some ac- tion in procuring a miscarriage that is associated with the causing of death. The provi- sion makes references to some methods of procuring miscarriage that might cause damage to a foetus: ‘any poison or other noxious things’.106 The offence is not ex- plicit, however, that only those methods of procuring miscarriage that would have noxious effect, are criminal. It could be argued that the offence is specific to the con- trary because it states that ‘any other method whatsoever’107 of ending a pregnancy is criminal. Any other method could have been a direct reference to action that was not in any way designed to cause immediate harm to the foetus. It certainly encompasses that possibility in its plain meaning. Moreover, the offence of unlawfully procuring miscarriage was constructed as an offence committed against the pregnant woman’s body, not against an unborn foetus. The offence first appears in the OAPA 1861, and the law has always been clear, even in 1861,108 that the foetus is not a person in law.109 As already noted, where it is a per- son other than the pregnant woman accused of unlawfully procuring miscarriage, there is no requirement that the woman is actually pregnant when an attempt is made to procure miscarriage.110 This suggests that the condition of the foetus is not the pri- mary concern of the offence, because there need not be any foetus at all for the of- fence to be committed. In either case, no reference is made at all to the foetal body, its condition, or its experience. It seems, therefore, almost counter-intuitive, to read any meaning into ‘miscarriage’ that involves the condition of the foetus.
100 Infant Life (Preservation) Act 1929, s 1. 101 ibid. 102 Grubb (n 10) 149. 103 ibid 149. 104 M Brazier and J Harris, ‘"Fetal Infants:” At the Edge of Life’ in P Ferguson and G Laurie (eds), Inspiring a Medico-Legal Revolution; Essays in Honour of Sheila McLean (1st edn, Ashgate Publishing 2015) 55. 105 Alghrani and Brazier (n 28) 75. 106 Offences Against the Person Act 1861, s 59. 107 ibid, ss 58 and 59. 108 An unborn foetus has never been considered a person for the purposes of the law of homicide see: Rv Senior (1832) 1 Mood. C.C. 346. 109 Paton v British Pregnancy Advisory Service [1979] QB 276. 110 See the text accompanying n 26. Artificial Wombs and Terminations of Pregnancy • 359
Finally, the AA 1967 provides a defence to terminations of pregnancy on a medical model in limited instances. It is interesting that defences were provided expressly to
cover those cases that would conventionally be termed ‘premature deliveries’: the end- Downloaded from https://academic.oup.com/medlaw/article-abstract/28/2/342/5680368 by University of Manchester user on 05 July 2020 ing of a (later term) pregnancy to save a woman’s life with attempts to ‘save’ the pre- term neonate pre-empted and engaged. The fact that explicit legal authority for such actions was deemed to be necessary in the form of a defence in the AA 1967 (to the extent that implicit common law defences were codified for this context), strongly implies that the ending of the pregnancy is always prima facie criminally relevant, be- cause even those instances where there is an attempt to save the foetus are encom- passed in the AA 1967.
B. Is it Only Terminations Intended to Cause Foetal Death that are Criminal? There are, however, also compelling reasons to suggest that miscarriage would be inter- preted more narrowly. Criminal statutes are generally interpreted narrowly, in favour of an accused person,111 as part of the principle of fair warning.112 It is unlikely that when first drafted Parliament intended the offence to cover instances where individuals had not attempted to undertake a termination resulting in foetal death (irrespective of whether this was the result). This is because there was no such thing as induced prema- ture delivery in 1861. Knowledge of obstetric complications was limited. Deliveries could not be chemically induced.113 Caesareans, while possible, were not yet routinely available or safe (and mortality rates were high).114 There was no NIC to support pre- mature babies.115 Premature labours were only spontaneous occurrences116 dangerous for the pregnant woman and foetus. These factors combined meant doctors had no incentives to attempt ‘premature deliveries’. It could be argued, therefore, that since Parliament could not have intended to render these circumstances the concern of the criminal law, miscarriage should not be interpreted to have this effect. There are clues in language elsewhere in the offence that might be used to argue that only conduct intended to cause foetal death should be considered criminal. It is not to be ignored, as Alghrani and Brazier, and Brazier and Harris suggest (discussed above), that Parliament specified only the language of ‘violence’ in the offence. The fact that non-violent methods of ending a pregnancy were not explicitly excluded does not mean the offence meant to encompass those situations. The non-exclusion
111 As in R v Bourne [1939] 1 KB 687. 112 W Chan and AP Simester, ‘Four Functions of Mens Rea’ (2011) 70 Cambridge Law Journal 381. 113 Some of the most common pharmaceuticals inducing delivery, prostaglandins, were not discovered until 1976. 114 United States National Library of Medicine, ‘Cesarean Section – A Brief History’ (2018)
before the end of gestation and, being underdeveloped, it died ‘naturally’ ex utero. Downloaded from https://academic.oup.com/medlaw/article-abstract/28/2/342/5680368 by University of Manchester user on 05 July 2020 Such arguments, however, are likely to be insufficient without creative judicial inter- pretation. Principles of statutory interpretation could direct us to the conclusion that the term miscarriage encompasses only the deliberate ending of pregnancy intended to result in foetal death. Smeaton was an instance in which the law was faced with an unanticipated medical development.117 In 1861, contraception as efficient as the morning-after pill would have been equally as unimaginable as partial ectogenesis. Parliament was not intending when legislating on abortion ‘to ban abortion whilst per- mitting contraception. It was simply legislating to punish abortion’.118 The same is true in this instance; Parliament was not attempting to ban ‘premature deliveries’. It was making rules about abortion. How should a term used in ignorance of future med- ical developments be interpreted? In Smeaton, Munby J approached the issue using the principle of updating construction.119 The language, and the parameters of the language, used in the 1861 Act cannot be abandoned because this is how Parliament chose to legislate,120 and thus the question of interpreting the boundaries of the of- fence of procuring miscarriage in the context of AWs must be determined using the given language. This does not mean, however, that the language used in the OAPA 1861 should convey only the meaning it had at the time it was written. In Smeaton, Munby J held that the 1861 Act was an ‘always speaking Act’ and there was significance in Parliament having left the word ‘miscarriage’, so central to the of- fence, undefined. There have been plenty of opportunities even following this judg- ment for Parliament to intervene and yet a definition has not materialised. Accordingly, Munby J observed that miscarriage should be ‘interpreted as it would be currently understood and it should be interpreted in light of the best scientific and medical knowledge that is available to the court’.121 In advancing this conclusion, Munby J was relying on the approach adopted by the House of Lords in Rv Ireland.122 Lord Steyn was explicit that in interpretation exercises ‘courts of law must act on the best medical insight of the day’.123 The judiciary are likely, and entitled, to use medical evidence and medical definitions as an external aid to interpreting124 the OAPA 1861. This was an important exercise in the Smeaton judgment, in which expert advice was sought as to the meaning of an established pregnancy that could be ‘mis- carried’. The same approach is likely to be taken to determining the modern meaning of miscarriage and whether this is intended to refer only to endings of pregnancy intended to result in foetal death. There has consistently been deference to medical opinion on the part of the judiciary in the realm of abortion law.125
117 Smeaton (n 27) para 337. 118 ibid. 119 ibid, para 329. 120 ibid, para 334. 121 ibid, para 350. 122 [1998] AC 147. 123 ibid (Lord Steyn) 156. 124 G Slapper and D Kelly, The English Legal System (13th edn, Routledge 2012) 103. 125 See deference to medical opinion in the judgments of: Paton (n 109), and Bourne (n 111). Artificial Wombs and Terminations of Pregnancy • 361
There are varying medical definitions of miscarriage. There is no uniformity in defi- nitions in explicitly referring to foetal death. Miscarriage is often defined in medical 126
dictionaries as ‘the spontaneous loss of pregnancy before 24 weeks’. Such defini- Downloaded from https://academic.oup.com/medlaw/article-abstract/28/2/342/5680368 by University of Manchester user on 05 July 2020 tions are confusing because they refer to the loss of a pregnancy as opposed to the de- liberate ending of a pregnancy. They are still, however, helpful in demonstrating that the term miscarriage is most often used in situations in which foetal death has oc- curred or is inevitable. Other medical dictionaries define miscarriage as ‘the loss of the foetus’,127 more explicitly indicating that foetal death is the consequence of a miscar- riage. Others, however, vaguely refer to miscarriage as only the ‘induced expulsion of a human fetus’.128 Medical opinion would be likely, on balance, to support the opin- ion that procurement of miscarriage encompasses only endings to a pregnancy that re- sult in foetal death. Medical books mentioned in the Smeaton judgment were implicit that this was the case, and even defined a spontaneous miscarriage earlier in gestation in juxtaposition to a spontaneous premature labour later in gestation.129 Moreover, management of difficult complications in pregnancy by its premature ending is com- mon professional practice. The methods undertaken to end a pregnancy are often intended to ensure the foetus survives delivery. In the chosen methods of termination, the juxtaposition between induced loss of pregnancy resulting in foetal death and in- duced delivery of pregnancy is easy to see. In interpreting the relevant provisions, beyond only taking a literal approach exam- ining language, the judiciary are empowered to interpret terms in light of what their use in the provision was attempting to achieve.130 The two ‘purposes of the ... [OAPA 1861] were plainly the protection of women and the protection of the un- born’.131 The Act intended primarily to limit abortion, and to protect women from the dangers of termination (inevitable in 1861 because even terminations performed by doctors were unsafe) and, in particular, from back-street abortion. The danger posed by all premature endings of pregnancies is now minimal in medical settings, and the concern regarding back-street abortion almost eliminated. It is believed that there has not been a death resulting from back-street abortion in England and Wales since 1982.132 Thus, in placing limitations on access, the OAPA 1861 serves the pur- pose of enforcing some protection for foetuses. This raises the important issue, how- ever, of how far that protection was intended to extend. This issue of quantifying protection was explicitly acknowledged but dismissed as irrelevant to the issue before the court in Smeaton.133 Munby J asked ‘how far back [in pregnancy] does the protec- tion afforded by the Act extend?’134 In the case of ending a pregnancy in order to facil- itate gestation ex utero, we need to be asking a similar question about what the protection afforded to the foetus in the law substantively entails. Specifically, how late
126 Martin, Concise Colour Medical Dictionary (6th edn, OUP 2015) 480. 127 R Pease (ed), Merriam-Webster’s Medical Dictionary (1st edn, Merriam-Webster 1995) 2. 128 H Marcovitch (ed), Black’s Medical Dictionary (43rd edn, Bloomsbury 2017). 129 Smeaton (n 27) para 157; Burns (n 116). 130 See Heydon’s case (1584) EWHC Exch J36. 131 Smeaton (n 27) para 354. 132 Symonds and Symonds (n 64) 303. 133 Smeaton (n 27) para 354. 134 ibid, para 354. 362 • MEDICAL LAW REVIEW in pregnancy is this protection extended? I argue that unlawful procurement of mis- carriage should be interpreted to refer only to those incidents intending to cause foetal
death, however, this is by no means a concretely established interpretation of the law; Downloaded from https://academic.oup.com/medlaw/article-abstract/28/2/342/5680368 by University of Manchester user on 05 July 2020 there are equally compelling reasons to believe that the law as it is currently written necessitates that, legally, miscarriage encompasses any deliberate cessation of preg- nancy. Reform of the law for clarity (provided decriminalisation is not possible),135 is necessary. If the legal definition of ‘miscarriage’ necessarily included foetal death, this would result in the most ethically sound operation of the law (again, making the question- able assumption that criminalisation is appropriate)136 because it would not require doctors, acting on behalf of women, to justify the ending of a pregnancy in favour of ex utero gestation. Intuitively, if we accept the legitimacy of a criminal, and medical, model of termination provision, there is a meaningful distinction between procure- ment of miscarriages later in pregnancy that should be considered criminal, and thus in need of some justification,137 and endings to pregnancy that are in need of no such explanation. That distinction would be the intention of the doctor in bringing the pregnancy to an end. In reality, when it is decided that a later term pregnancy should be ended, what efforts are made to preserve the foetus are influenced by viability, and determined by the approach and subsequent actions adopted by attending doctors, influenced by the wishes of the parent(s). Grubb observes that often, ‘providing it is not inconsistent with saving the mother, saving the foetus and producing a live birth will be desired by the mother. Therefore, these abortions amount to induced labour... A late abortion in these circumstances is consistent with foetal survival’.138 If decisions regarding mode and timing of ending pregnancy are made with the inten- tion that a foetus will survive, this seems like a ‘premature delivery’. This ending of a pregnancy would be hard to criticise as ‘unethical’ because it encompasses action be- ing taken to preserve a woman’s life and health, while simultaneously respecting their desire to protect their foetus. With the direction of the pregnant woman, thought is being directed to the foetus, and action can be taken to promote its survival. A ‘prema- ture delivery’, in an intuitive sense, implies an intention to ‘birth’ the developing hu- man entity to the world. The term ‘delivery’ implies the conveyance of a good and the connotation is that the usual outcome of pregnancy (a baby) would be that good. Conversely, miscarriage implies that the conveyance of the usual good of preg- nancy (the baby) has failed or is intentionally prevented. If decisions regarding mode
135 There are political complications to the decriminalisation debate; however, the developments referred to in n 22 do demonstrate that it is politically possible. 136 There are good reasons to question the legitimacy and ethics of criminalisation: E Jackson, ‘Abortion, Autonomy and Prenatal Diagnosis’ (2000) 9 Social & Legal Studies 467. For the current campaign for decriminalisation of abortion in the UK, see ‘We Trust Women’
riage the criminal law was intending to regulate. The distinction is not based on when Downloaded from https://academic.oup.com/medlaw/article-abstract/28/2/342/5680368 by University of Manchester user on 05 July 2020 an attempt is made to end pregnancy, making assumptions about likely outcomes, but on a combination of why, how, and when the deliberate intervention into pregnancy is undertaken. This distinction is easily read into the law if, first, miscarriage is defined as the termination of pregnancy resulting in foetal death (thereby requiring a mens rea of intent to cause foetal death), and/or, secondly, if the word ‘unlawful’ in section 58 were, by definition, to exclude those instances in which there was no foetal death. Making the mens rea the distinction—considering the object of the ending of the pregnancy and/or intentions of the person ending the pregnancy—provides a consis- tent approach to determining what endings to a pregnancy are ‘in need of justification’ that would match common intuitions about the purpose of the criminal law. Moreover, considering intention is future-proof, in that it could continue to isolate ac- tivities for regulation, even with the introduction of technologies like AWT. It is possible that I have overestimated the extent to which Parliament was, in legis- lating to prohibit procurement of miscarriage, concerned with the protection of foetal welfare. It is certainly plausible that the OAPA 1861 was intended to be broadly inter- preted and is interested in reinforcing the heteronormative regulation of female bod- ies. If miscarriage is interpreted broadly to mean any unlawful deliberate cessation of pregnancy, regardless of outcome, this effectively prioritises the protection of foetuses over the interests of women (and thus does not protect women). This is because it places a burden on women to provide some legal justification for their decision to opt for artificial gestation. The criminalisation of opting for ex utero gestation would have very negative, emotional, and moralistic connotations, such that, even if it was prima facie defensible, it would have real consequences for women. The construction of ‘criminal abortion’ in the law is used to implicate activities deemed to be ‘deviant’.139 Requiring some justification to avoid criminal sanction, even if it is easily done, still has the impact of stigmatising that decision, categorising it as ‘in need of explanation’, and labelling women who want to escape some of the burdens of pregnancy as mak- ing a prima facie ‘bad’ choice. Moreover, if all endings to a pregnancy were unlawful outside of the applicable defences in the AA 1967,140 this could place a legal obligation to undertake gestational work (remaining pregnant) in place of alternative forms of gestation on pregnant women who are not facing an immediate serious risk to health or any risk to life.141 Was the Act intended to place such an onerous requirement on women and entirely subjugate their right to bodily autonomy and integrity to privilege foetuses? In 1861, the answer would have been ‘yes’ because ending a pregnancy was unlawful in any cir- cumstances, save where necessary to save a pregnant woman’s life.142 However, would
139 The stigma automatically attached to ‘criminal termination of pregnancy’ is another good reason to support decriminalisation of abortion. See R Cook, ‘Stigmatized Meanings of Criminal Abortion Law,’ in R Cook, J Erdman and B Dickens (eds), Abortion Law in Transnational Perspective: Cases and Controversies (1st edn, University of Philadelphia Press 2014). 140 Abortion Act 1967, s 1 (1), as amended by Human Fertilisation and Embryology Act 1990, s 37. 141 ibid, s 1 (1) (b) and (c), as amended by Human Fertilisation and Embryology Act 1990, s 37. 142 The defence of necessity is likely to have applied. See Bourne (n 111). 364 • MEDICAL LAW REVIEW
Parliament have intended to place this onerous obligation on women in a world in which AWs were available to free women of pregnancy without corresponding foetal
death? In interpreting the meaning of miscarriage, the impact of an all-encompassing Downloaded from https://academic.oup.com/medlaw/article-abstract/28/2/342/5680368 by University of Manchester user on 05 July 2020 definition of termination on the rights of women should be considered. Bodily auton- omy is afforded the highest respect in law.143 Today, interference with women’s choices about their body regarding remaining pregnant is only arguably justifiable be- cause of the state’s interest in the foetus.144 There are good reasons to believe this is not the case, but for the purposes of the current discussion this is assumed. If gesta- tion can be continued without the use of a woman’s body, there should be no legal re- quirement that she remain pregnant for any reason.145 If miscarriage encompasses only termination resulting in foetal death, the state is still able to enforce its ‘interest’ in foetuses. The OAPA 1861 would penalise only individuals who attempt to procure termination resulting in foetal death without an applicable defence. This aspect of the criminal law would not concern itself with attempts to extract foetuses for continued gestation ex utero. For this reason alone, if criminalisation is thought appropriate, ‘mis- carriage as foetal death’ should be adopted as the definition of miscarriage in criminal law. Another important point to be made about the parameters of the offence is the use of the term ‘unlawful’, further qualifying the meaning of miscarriage in the 1861 Act. In RvBourne,146 Macnaghten J held that the explicit use of the term ‘un- lawful’ in the offence of procuring a miscarriage was not ‘meaningless,’ and thus imported the defence that had always been in the common law. According to this judgment, a doctor ending pregnancy in good faith and to preserve a pregnant woman’s life or health does not act unlawfully.147 Whilst this can be conceptualised as a defence, and one that is now incorporated into the AA 1967,148 this case dem- onstrates that the use of the term ‘unlawful’ in the construction of the offence is thought to be crucial. The fact that the word features no less than four times in sec- tion 58 means it is central to the actus reus of ‘unlawful miscarriage’. It is arguable that foetal extraction with the intent of completing gestation would not be consid- ered unlawful and, in not satisfying an actus reus requirement, there would be no need to consider defences. The 1909 Re McCready judgment149 in the Supreme Court of Saskatchewan (Canada) came to such a conclusion. The Canadian Criminal Code (at that time) closely mirrored the provision in the 1861 Act, speci- fying that the offence was committed when the action to procure miscarriage un- dertaken with intent to procure miscarriage was unlawful.150 Lemont J held that,
143 Re T (Adult: Refusal of Treatment) [1993] Fam 95 (Lord Donaldson) 102. 144 The language of ‘state interest in fetal life’ is explicit in US law following Roe v Wade (1973) 410 US 113 (United States Supreme Court). In the UK a similar approach is adopted (though less explicitly justified in terms of ‘state interest’), because a foetus is afforded more protection in law from 24 weeks gestation when it is deemed ‘capable of being born alive’: Infant Life (Preservation) Act 1929, s 1 (1). 145 Abortion Act 1967, s 1 (1) (a), as amended by Human Fertilisation and Embryology Act 1990, s 37. 146 Bourne (n 111). 147 ibid (Macnaghten J) 691. 148 Abortion Act 1967, s 1 (1) (c), as amended by Human Fertilisation and Embryology Act 1990, s 37. 149 [1909] 2 Sask LR 46 (Supreme Court of Saskatchewan). 150 The Criminal Code 1892, s 303 (Canada). This version of the Criminal Code has since been repealed and replaced. Artificial Wombs and Terminations of Pregnancy • 365 on the facts, it was not possible to confirm that the miscarriage was not necessary to preserve the woman’s life, ‘in which case it is not unlawful’.151 He posited that ...152 ‘every miscarriage brought on by a physician is not unlawful ’ and, despite the Downloaded from https://academic.oup.com/medlaw/article-abstract/28/2/342/5680368 by University of Manchester user on 05 July 2020 evidence that the defendant was involved in the procurement of miscarriage, he found no reason to believe it was an unlawful one and, therefore, discharged the de- fendant.153 This case strongly suggests that the actus reus of the offence centres on unlawful miscarriage. The Bourne154 judgment is also good law supporting the same conclusion in the English context. Just as it was held in this case that saving the life of, or preserving the mental health of, the pregnant women was lawful under section 58, it might be that ending a pregnancy whilst preserving the foetus would also be a ‘lawful miscarriage’. As Dickens points out, however, ‘one may question historically whether the word was intended or realised by the legislature to imply what Macnaghten J saw in it’.155 The significant legal developments since Bourne—the passing of the AA 1967 and subse- quent parliamentary debate about those circumstances in which the ending of preg- nancies is thought to be lawful—raise the question of whether a different approach would be taken to deny that such importance be placed on ‘unlawful’ in circumstances not proscribed by that Act. It remains to be seen how this turn of phrase would be interpreted, and whether there would be any need to look to the AA 1967. For the sake of thoroughness, it is important that we consider the circumstances in which there would be a defence to unlawfully procuring miscarriage if all deliberate endings of pregnancy (including those instances where the intention is to continue gestation ex utero for medical or social reasons) were prima facie criminal. If a defence can be successfully raised in situations where a doctor terminates a pregnancy intending that the foetus will continue gestation ex utero, then their conduct would not be unlawful.
VI. ARE THERE AVAILABLE DEFENCES TO UNLAWFULLY PROCURING MISCARRIAGE? For all terminations before 24 weeks’ gestation, there is a defence available to medical practitioners under the AA 1967.156 Access to conventional terminations of pregnancy is relatively liberal before 24 weeks because section 1 (1) (a) of the AA 1967, the de- fence under which the majority of abortions are performed,157 is so broad that it ren- ders ‘every pregnancy legally terminable within the first 24 weeks’.158 In practice, doctors do not tend to justify their decision to perform termination before 24 weeks
151 Re McCready (n 149) (Lamont J) para 9. 152 ibid, para 9. 153 ibid, para 10. 154 Bourne (n 111). 155 Dickens (n 90) 39. 156 The ‘social’ ground for abortion in Abortion Act 1967, s 1 (1) (a), as amended by Human Fertilisation and Embryology Act 1990, s 37, provides a defence for all terminations carried out before 24 weeks where the risk of continuing the pregnancy is greater than the risk of terminating the pregnancy. This is easily estab- lished today in the vast majority of pregnancies, given the availability of abortifacient drugs carrying far fewer risks than surgical abortions and than remaining pregnant. See M Brazier and E Cave, Medicine, Patient’s and the Law (6th edn, Manchester UP 2016) 404. 157 J Mason and G Laurie, Mason and McCall Smith’s Law and Medical Ethics (9th edn, OUP 2013) 336. 158 Jackson (n 12) 80. 366 • MEDICAL LAW REVIEW on clinical grounds. However, this does not mean that it is necessarily lawful for doc- tors to provide terminations (even to allow for ex utero gestation) before 24 weeks for
any non-medical or social reason. This is because the so-called ‘social ground’ for Downloaded from https://academic.oup.com/medlaw/article-abstract/28/2/342/5680368 by University of Manchester user on 05 July 2020 abortion is still framed in medical terms; it provides a defence before 24 weeks where the risk of continuing the pregnancy is greater than the risk of ending pregnancy. Methods of conventional abortion have now developed to the point that it is seem- ingly statistically always the case that performing an abortion (usually drug induced) within the time frame that most are requested is less risky than continuing preg- nancy.159 It seems unlikely that the foetal extraction procedure necessary for transferal to an AW would be less risky for a pregnant woman than remaining pregnant (or hav- ing a conventional termination) in the vast majority of circumstances. Of course, all pregnancy is inherently risky, but if the process of foetal transfer were to involve an in- tricate caesarean procedure,160 it might be argued that this is far riskier than continu- ing the pregnancy if the pregnant woman is healthy and a natural delivery is anticipated. Moreover, this provision of the AA 1967 does not mean that all women are legally entitled to a termination of pregnancy (by any method, with any outcome). The AA 1967 has effectively ‘transferred’ the right to self-determination, specifically regarding decisions about whether to remain pregnant, from women to the medical profession.161 The way that the law is framed means women have no positive right to end their pregnancy. Women must convince a doctor that they require intervention into their pregnancy, and that they are entitled to it because their circumstances fit within the medical model. Furthermore even where it may be lawful for doctors to perform interventions to end a pregnancy, they are under no obligation to do so unless it is an emergency.162 As already noted, the law is clear that patients are not entitled to demand any particu- lar treatment, and doctors cannot be compelled to provide treatments they are un- comfortable with.163 Women are effectively subjected to an enormous constraint on their decision-making, because they are empowered only to make decisions about ending pregnancies for reasons that satisfy medical practitioners. This is even assum- ing that medical practitioners would be willing to end pregnancies in favour of ex utero gestation before 24 weeks for less urgent medical considerations, or non-medical rea- sons. This raises some ethical issues for exploration about the role of medicine in re- production, the parameters of what treatment is, and when it can be demanded. This discussion is important to revisit, but is beyond the scope of this article. For women experiencing high-risk or dangerous pregnancies, it would potentially be lawful for them to end their pregnancies in favour of ex utero gestation before 24 weeks gestation. After 24 weeks, a lawful defence to a deliberate ending of a preg- nancy becomes much harder to establish. The two relevant grounds of the AA 1967 that could be invoked as a defence to the circumstances of potentially dangerous/
159 Brazier and Cave (n 156) 404. 160 J Murphy, ‘Is Pregnancy Necessary? Feminist Concerns about Ectogenesis’ in S Gelfand and J Shook (eds), Ectogenesis: Artificial Womb Technology and the Future of Human Reproduction (1st edn, Rodopi 2006) 34; Schultz (n 13) 880. 161 J Mason, The Troubled Pregnancy (1st edn, CUP 2007) 25. 162 Abortion Act 1967, s 4. 163 Burke (n 81). Artificial Wombs and Terminations of Pregnancy • 367 high-risk pregnancies are risk to the pregnant woman’s life164 and risk of grave, perma- nent injury to the physical or mental health of the pregnant woman.165 These defen- 166
ces are available when two medical practitioners form the opinion, in good faith, Downloaded from https://academic.oup.com/medlaw/article-abstract/28/2/342/5680368 by University of Manchester user on 05 July 2020 that a pregnant woman’s circumstances fall within these grounds. There is no time limit imposed on these grounds for termination. They are, therefore, harder to estab- lish and require ‘clear proof of the more serious danger specified’.167 The separation of these two grounds related to the pregnant woman’s condition in the statute, which distinguishes life from health, is an attempt to demark that the ground of risk to health requires more substantial proof than risk to life.168 In the following sub-sections, I consider what level of risk is sufficient to justify deliberately ending pregnancy, and whether these legal requirements satisfactorily account for the change in risk percep- tion that might follow AWs.
A. Risk to Life Doctors need not wait until a pregnant woman is in peril of immediate death to end a pregnancy169 since, as noted, there is a defence to unlawfully procuring miscarriage when pregnancy poses a risk to the pregnant woman’s life that is greater than the risk of termination.170 The risk to life and risks of termination must be weighed against each other.171 Most premature deliveries that are currently undertaken are attempted because the pregnancy poses specific risks to the pregnant woman’s life.172 The method by which the pregnancy is ended often carries the same risks as delivery at the end of the normal gestational period when a pregnancy has to be managed.173 The risk of termination will have to be assumed at some point in order for the pregnancy to end, whether before, or at the end of, the normal period of pregnancy. Therefore, when there is risk, it is often easy to demonstrate that the
164 Abortion Act 1967, s 1 (1) (c), as amended by Human Fertilisation and Embryology Act 1990, s 37. 165 ibid, s 1 (1) (b). 166 ibid, s 1 requires that two medical professionals form this opinion; however, if a medical professional forms the opinion in good faith that termination of pregnancy is immediately necessary to save the pregnant wom- an’s life or to prevent serious injury to their health, the medical practitioner may act alone. See Brazier and Cave (n 156) 404. 167 Grubb (n 138) 661. 168 This will be explored in detail later in this article. For now, it is sufficient to note that if doctors are con- cerned that pregnancy poses a risk to life, they can act when that risk is greater than the risk of termination. Yet when doctors are concerned only about the impact of pregnancy to health (but not life), that impact on health must be ‘grave’ or ‘permanent’. Thus, there are more qualifications on the risk to health than poten- tial risks to life. 169 This was established in Bourne (n 111), a case that considered the legality of termination of pregnancy be- fore the AA 1967; D Morgan and RG Lee, Blackstone’s Guide to the Human Fertilisation and Embryology Act 1990 (1st edn, Blackstone Press 1990) 51. 170 Abortion Act 1967, s 1 (1) (c), as amended by Human Fertilisation and Embryology Act 1990, s 37. 171 Harpwood (n 91), 231. 172 For example, when a woman is suffering from a severe traumatic injury, preeclampsia, or gestational diabetes. 173 If a woman has preeclampsia, for example, regardless of when the ending of the pregnancy takes place, it is safest for the product of pregnancy to be removed by caesarean section. Therefore, the risks of a caesarean are inherent to that pregnancy whenever it is ended. These risks thus become almost irrelevant for the pur- poses of the defence in Abortion Act 1967, s 1 (1) (a), as amended by Human Fertilisation and Embryology Act 1990, s 37. 368 • MEDICAL LAW REVIEW risk of remaining pregnant is greater than the risk of inducing the end of the pregnancy by vaginal expulsion or caesarean. This defence encompasses the decision- 174
making calculus currently adopted in obstetric practice. However, if AWs shift per- Downloaded from https://academic.oup.com/medlaw/article-abstract/28/2/342/5680368 by University of Manchester user on 05 July 2020 ceptions about which pregnancies are risky, what does this mean for the interpretation of ‘risk to life?’ The explicit balancing exercise that the defence requires means a lower threshold of risk to life is not easily read into the provision. Even if a doctor believes a lower level of risk earlier in a pregnancy justifies ending the pregnancy (because they no lon- ger concern themselves with balancing risk against the impact of foetal immaturity), it will not necessarily mean they can form the opinion in good faith that ending the pregnancy carries a lesser risk to life than remaining pregnant. The serious conditions that termination is necessary to manage at present will fit within the defence in milder forms and perhaps earlier in their onset. Conditions that do, or will, pose some risk to life, can be balanced against the risks of the method of ending the pregnancy accordingly. AWs, however, could result in pregnant women with a broader range of medical complications, some of lesser severity, wanting to end their pregnancies because there is a better guarantee that this will not result in foetal loss. Consider a preg- nant woman struggling to manage unrelenting nausea. Her symptoms may not pose an obvious risk to life,175 and would certainly not constitute such a risk that continuing pregnancy could be described, in good faith, as more of a threat than the risk of complications in a medically induced ending of pregnancy. This is partic- ularly evident in circumstances where a routine vaginal birth at the end of the nor- mal gestational period is anticipated. The question is ultimately whether a doctor could, in good faith, come to the opinion that her patient’s circumstances are encompassed under the defence.176 It is notoriously difficult to prove a doctor did not form their opinion in good faith.177 There seems to be scope, however, to ques- tion the opinion of a doctor who believes sickness, swelling limbs or limited mobil- ity during pregnancy is a threat to life, or a greater threat than induction or caesarean. It appears that a ‘foetal extraction’ for gestation ex utero in an AW before the end of the usual gestational period would only be lawful by virtue of section 1 (1) (c) of the AA 1967178 outside of conventionally serious circumstances in which the threat to the woman’s life is easily observable.
B. Risk of Grave, Permanent Injury to Physical or Mental Health For a doctor to avail herself of the defence related to preventing a grave and perma- nent injury to a pregnant woman’s physical or mental health, she must believe that
174 There might be questions about whether this defence technically applies in some instances in which ‘prema- ture delivery’ is routinely performed—for example, when termination is performed to extract a foetus with stunted growth. 175 This is obviously dependent on the pregnant woman’s particular circumstances. A pregnant woman with very severe nausea who risks developing kidney problems, for example, could argue there could be some risk to their life. 176 Jackson (n 12) 78. 177 Harpwood (n 91) 228. 178 As amended by Human Fertilisation and Embryology Act 1990, s 37. Artificial Wombs and Terminations of Pregnancy • 369 the termination is necessary to prevent the injury, but it need not be immediately nec- essary.179 The doctor can act where permanent and grave injury is foreseen.180 There
is no further statutory guidance as to the meaning of ‘grave’ and ‘permanent’ and what Downloaded from https://academic.oup.com/medlaw/article-abstract/28/2/342/5680368 by University of Manchester user on 05 July 2020 conditions would be severe enough to establish this defence. This is open to the inter- pretation of doctors forming their opinion in good faith, though it is clear that only se- rious and long-term illnesses resulting directly from the continuation of pregnancy would be sufficient.181 There is no balancing exercise; the defence is not a question of whether there is a risk of injury from remaining pregnant greater than the risks associ- ated with early ending of pregnancy.182 The doctor must be of the opinion that grave, permanent injury is ‘reasonably certain to occur if pregnancy [is] continued’.183 This reinforces the notion that the defence is extended to serious injury only. In the 1990 House of Lords debates about amendments to the AA 1967, the Lord Chancellor stipulated that the terms ‘grave’ and ‘permanent’ were deliberately used to create a stiff legal test. He suggested examples of sufficiently serious injury included ‘where [the pregnant woman] has severe hypertension and continuation of the pregnancy might result in permanent kidney, brain or possibly heart dam- age’.184 Morgan and Lee suggest further examples; ‘mild preeclampsia; breast or cervical cancer.... uncontrolled diabetes; [and] conditions which may improve or deteriorate during pregnancy, such as asthma or epilepsy...’.185 It is interesting that the debate focused on women’s physical, rather than mental, health. This de- fence was clearly designed to encompass the kinds of decisions currently made in practice. In the House of Lords, there was implicit acknowledgement that the de- fence was designed with ‘premature deliveries,’ rather than terminations resulting in foetal death, in mind. There was explicit reference made to the bond that devel- ops between woman and foetus throughout pregnancy,186 and Lord Mackay remarked that later in pregnancy he expected that ‘the method of termination would be selected in the best interests of the woman, but the intention would be to deliver a living baby where possible’.187 It was anticipated that terminations neces- sarily resulting in foetal death would usually only be carried out when this was the only possible method of ending pregnancy that would spare or significantly reduce the likelihood of injury to the pregnant woman. An example would be those instan- ces where there is a birth canal obstruction that requires cranial crushing of the foe- tus in order to extract it.188 The AA 1967, however, still provides a defence to unlawfully procuring miscarriage when the pregnancy threatens serious injury and
179 Morgan and Lee (n 169) 50. 180 ibid 52. 181 Harpwood (n 91) 231. 182 Morgan and Lee (n 169) 50. 183 E Jackson, ‘Abortion’ in I Kennedy and others (eds), Principles of Medical Law (4th edn, OUP 2017) 867. 184 HL Vol 522 Col 1039. 185 Morgan and Lee (n 169) 51. 186 HL Vol 522 Col 1039. 187 ibid. 188 In these instances a caesarean delivery cannot be performed as, once the foetus is not fully in the uterus, it is too late to perform the procedure, and the foetus is stuck in the birth canal. 370 • MEDICAL LAW REVIEW a miscarriage resulting in foetal death is chosen for any reason.189 In practice, it is most often the case that when pregnancies are ended early by interference, the
pregnant woman wants her foetus to have the best chance of surviving and deci- Downloaded from https://academic.oup.com/medlaw/article-abstract/28/2/342/5680368 by University of Manchester user on 05 July 2020 sions are made regarding the timing and method of delivery accordingly. If the decision-making calculus regarding ending pregnancies starts to shift because of AWs, there may be instances when the ending of a pregnancy might be medically advantageous to a woman (given the reliable alternative form of gestation), but where pregnancy is not anticipated to cause a ‘grave permanent injury’ to her health. The se- rious conditions for which intervention to end pregnancy is currently recommended, even earlier in their onset, would still be encompassed under this defence. There are compelling arguments that all pregnancies cause grave and permanent injury to wom- en’s bodies.190 However, the defence is constructed in such a way as to prevent such an argument being legally entertained. Many women’s experiences of comparatively milder complications or ‘side effects’ during gestation make their pregnancies difficult. For some women, it would be better for their physical and mental health not to experience these symptoms. However, these side effects are unlikely to be considered ‘grave,’ a threat to long-term health, or likely to cause serious and/or long-term damage to health. Morning sickness, limited mobility and swollen limbs are temporary hindrances to health that will end with the pregnancy; therefore, they could not be described as long-term injuries. There will be a huge difference of opinion as to how grave these symptoms are to experience. Many women who desire to remain pregnant despite these side effects do so because they want a future child, not because they enjoy pregnancy. If AWs were available as a reli- able alternative to pregnancy, continuing gestation and better guaranteeing the desired outcome, it is plausible that some women would want to end their pregnancies, opting for AWs. Continuing a pregnancy that encompasses difficult symptoms that pose a hindrance to short-term health or quality of life would not be in these women’s inter- ests. However, the AA 1967 provides no express permission for a doctor to procure the ending of a pregnancy to improve a woman’s short-term heath, or (what might be perceived as), quality of life after 24 weeks. Notably, this ground of the AA 1967 also provides a defence if a doctor believes that termination would prevent grave and permanent injury to a woman’s mental health. In Bourne, the judge stressed that termination would be lawful if a doctor was of the reasonable opinion ‘that the probable consequence of the continuance of
189 An explicit attempted amendment in the House of Lords to stipulate that later terminations when the foetus may be ‘capable of being born alive’ should mean that the medical practitioner is required to take ‘all reason- able steps to procure that the child is born alive’ was defeated in a vote. See HL Vol 522 Cols 1043–1087. 190 Pregnancy forces a woman to share her bodily resources, literally stripping her of nutrients and draining her of the energy needed to conduct daily activities. The occupation of her body causes her to experience severe hormonal and chemical changes that affect how she feels, behaves, and perceives the world. Changes to physical appearance necessarily affect how a pregnant woman is treated. Lots of this cannot be undone. After 9 months her body is (often) torn apart by the process of childbirth and there will be permanent scars, and even damage. Even following the pregnancy, she faces serious risks associated with it: for example, there is the risk of experiencing post-partum depression and suicide. This is, of course, not to say that all experien- ces of pregnancy are negative, but it is important that we acknowledge some of the negative experiences of- ten innate to an individual pregnancy. Artificial Wombs and Terminations of Pregnancy • 371 pregnancy would be to make the woman a physical or mental wreck’.191 In this judg- ment, recognition was afforded to the inevitable emotional and psychological trauma
if a young girl was forced to carry a foetus conceived by violent rape. Quite what other Downloaded from https://academic.oup.com/medlaw/article-abstract/28/2/342/5680368 by University of Manchester user on 05 July 2020 circumstances would be considered legally sufficient here, or under the AA 1967, is uncertain. In short, without amendment to the AA 1967, there is mismatch between the law and the decision-making calculus based on AWs that obstetricians would want to de- ploy in women’s interests. Current statutory provisions potentially require women to sustain their foetuses by remaining pregnant, rather than opting for artificial gestation. This framing of the law, even if only symbolically, subjugates the female body for the purposes of reproduction. This seems particularly callous if the female body is not necessary for gestation. This is an ethical issue deserving of more attention in the legal discourse surrounding AWs.
C. Doctors’ Discretion? The defences in the AA 1967 can be interpreted broadly. The legality of ending preg- nancy is dependent on whether doctors acting in good faith perceive that a pregnant woman’s circumstances meet the grounds in the AA 1967, not on whether their cir- cumstances actually do.192 Furthermore, the defences in the AA 1967 were not the first available for doctors procuring miscarriage. The common law implicitly provided doctors with a defence to unlawful procurement of miscarriage long before 1967. In 1938, R v Bourne193 highlighted that doctors could lawfully end pregnancies where their object was to save the life of the mother or prevent permanent damage to their health.194 This case demonstrates that the use of the term ‘unlawful’ in the construc- tion of the offence of procuring miscarriage means that there is significant judicial dis- cretion in determining which procurements of miscarriage are ‘unlawful’. There are several reasons, therefore, to believe that the power to determine the legality of pro- curing miscarriages has been placed firmly in the hands of the medical profession. It seems unlikely that any decision-making process regarding ending pregnancy that is not intended to harm the pregnant woman or foetus, therefore, would be treated as criminal. First, judges are likely to direct juries in such a way that encourages acquittal on charges of procurement of miscarriage where a doctor did not cause foetal death, or intend for miscarriage to result in foetal death. On these charges in the past, judges (even before public opinion about abortion liberalised, and in circumstances where termination inevitably would result in foetal death) have been keen to emphasise the difference between a medicalised ending of pregnancy and the illegal actions of ‘back- street abortionists’. In Bourne,195 MacNaughten J emphasised on three separate occa- sions in his jury direction how the actions of the doctor procuring a miscarriage for a woman following his perceived belief that it was in her interests was different to what
191 Bourne (n 111) (Macnaghten J) 694. 192 Jackson (n 12) 78. 193 Bourne (n 111). 194 ibid (MacNaughten J) 694. 195 ibid. 372 • MEDICAL LAW REVIEW is normally understood as ‘illegal abortion’.196 A similar emphasis might be attached to a medical decision to procure miscarriage based on a decision-making calculus with
medical merit, even if focused on a lower level of risk. Downloaded from https://academic.oup.com/medlaw/article-abstract/28/2/342/5680368 by University of Manchester user on 05 July 2020 Secondly, a jury is unlikely to convict a doctor197 unless there is evidence that the doctor was behaving with blatant disregard for the purpose of the law. If the intention of a doctor in ending a pregnancy was not to cause foetal death and to best protect the pregnant woman’s health, it is hard to imagine any jury questioning the decision- making process unless things go wrong and/or the doctor is shown to be acting in bad faith. Thirdly, judges are likely to quash convictions that they feel may be unsafe. In the Paton198 judgment, Baker P was explicit that a judge who sought to interfere with the discretion of doctors under the AA 1967 would be both bold and foolish, ‘un- less, possibly, where there is clear bad faith and an obvious attempt to perpetrate a criminal offence’.199 It is unlikely that a doctor who sought to preserve the life of both the pregnant woman and her foetus would be seen as making an obvious attempt to behave criminally. Even before the advent of AWs, and before a doctor undertaking an earlier termination could claim they explicitly intended that the foetus would con- tinue gestation ex utero, the judiciary have been unwilling to question doctors decision-making in this arena. In R v Smith (John)200 the Court of Appeal, overturning a doctor’s conviction of criminally procuring miscarriage, posited that without clear evidence that behaviour was not within the reasonable bounds of professional practice and medical probabilities, ‘a verdict against a doctor is often unlikely to be unsafe’.201 And Keown has argued that ‘medical control of pregnancy and childbirth has long been established as has the termination of pregnancies’.202 It is thus unlikely that, whatever the legal definition of miscarriage, there will be a charge or a conviction for unlawful procurement of miscarriage upheld against a doc- tor who ends a pregnancy intending that gestation is completed ex utero. Despite this, the legal uncertainty that I have examined is problematic, because ambiguity violates the human rights of those subject to the law.203 Legal uncertainty has the potential to foster moral uncertainty amongst the medical profession,204 and potentially restrict the use of future medical technologies that might help reduce the physical burdens placed on women during pregnancy. It has long been observed that the AA 1967 firmly placed decisions about ending pregnancies into the ambit of the medical profes- sion; however, as more avenues of potential choice open to women, it is important
196 Macnaghten J commented that the doctor’s decision, ‘you will observe ...has nothing to do with the ordi- nary case of procuring abortion to which I have already referred’. ibid (Macnaghten J) 691. 197 J Montgomery, ‘Medicine, Accountability and Professionalism’ (1989) 16 Journal of Law and Society 319, 325. 198 Paton (n 109). 199 ibid (Baker P) 282. 200 [1973] 1 WLR 1510. 201 ibid (Scarman LJ) 1516. 202 J Keown, Abortion, Doctors and the Law: Some Aspects of the Legal Regulation of Abortion in England and Wales from 1803 to 1982 (1st edn, CUP 1988) 165. 203 R v Misra and Srivastava [2005] 1 Cr App R 328. 204 EC Romanis, ‘Challenging the ‘Born Alive’ Threshold: Foetal Surgery, Artificial Wombs and the English Approach to Legal Personhood’ (2019) Medical Law Review, online first doi: https://doi.org/10.1093/med law/fwz014. Artificial Wombs and Terminations of Pregnancy • 373 that the degree of medical control over those choices is re-examined. This degree of medical control over women’s decisions to end their pregnancy in favour of ex utero
gestation is not justifiable for the reasons reflected in the termination jurisprudence Downloaded from https://academic.oup.com/medlaw/article-abstract/28/2/342/5680368 by University of Manchester user on 05 July 2020 thus far. This reasoning has focused on the ‘state interest’ in preserving a foetus’s lim- ited right to be gestated and the state’s interest in life, and this does not apply in these circumstances. Women should be permitted to decide how long they wish to be preg- nant. In this article, I have considered the case of dangerous pregnancies; however, some of my arguments may equally apply to those instances in which women want to opt out of undertaking gestational work in favour of an AW in a broader range of cir- cumstances. In considering whether the law should interfere with a choice to gestate ex utero, there can be no objections from those who believe that foetal welfare should prevent (conventional) termination because foetal death is not at issue here. The fact that women are unlikely to gain greater control over their pregnancies even if/when future technologies enable greater choice, is an important problem that should be addressed. Sheldon observes that the medicalisation of termination decisions in the AA 1967 was useful to aid the partial de-politicisation of abortion, and to liberalise ac- cess to terminations for women in England and Wales. However, the framing of the AA 1967 has limited utility in ‘defending and furthering women’s reproductive rights...’.205 There are two reasons for this: first, because women both have no formal legal right to demand termination and, secondly, because ‘clinically unsupported restrictions on abortion provision have been retained as part of a system of tight medi- calised control’.206 It is time to decriminalise all methods of pregnancy termination re- gardless of their intended outcome.207 In other words, it is time that we trust women to make pregnancy termination decisions.
VII. CONCLUSION In this article, I have considered the claim that AWT could relieve some of the physi- cal burdens placed on women during pregnancy. I argued that AWT, with the capabil- ity to continue gestation, has the capacity to empower women to escape potentially dangerous pregnancies without risking their wanted foetuses (if this is their concern). Given the capacity of AWT to shift the focus of decision-making in obstetrics to em- power women, it is important to consider whether those choices would be accessible to women under current legal provisions. The legality of ending pregnancy in English law still turns on the offence of ‘unlawfully procuring miscarriage’, to which doctors have a defence if they can demonstrate that the termination they provide is ‘lawful’ by virtue of the circumstances contained in the AA 1967, or potentially the more implicit necessity defence from Bourne.208 How the present legality of ending pregnancy to opt for gestation ex utero is determined depends on whether ‘miscarriage’ and specifi- cally ‘unlawful miscarriage’, neither of which are usefully defined in any statute or case
205 S Sheldon, ‘The Medical Framework and Early Abortion in the UK: How Can a State Control Swallowing?’ in R Cook, J Erdman and B Dickens (eds), Abortion Law in Transnational Perspective (University of Pennsylvania Press 2014) 207 206 ibid 207. 207 Unfortunately, there has only been limited scope in this article to explain why this argument should also ap- ply to conventional abortion. 208 Bourne (n 111). 374 • MEDICAL LAW REVIEW law, means the deliberate cessation of any pregnancy, or only those attempts to end a pregnancy in such a way that results in foetal death. I have demonstrated that there is
ambiguity here; whilst an interpretation of ‘miscarriage’ as only encompassing those Downloaded from https://academic.oup.com/medlaw/article-abstract/28/2/342/5680368 by University of Manchester user on 05 July 2020 instances where there is intent to cause foetal death is the most ethically justifiable (if we accept that criminalisation is appropriate), such an interpretation involves judicial creativity. It is important to determine what miscarriage means, because if miscarriage includes ending pregnancy to opt for ex utero gestation, this action would be prima fa- cie criminal unless ‘lawful’ or unless a doctor could raise a defence. I demonstrated that it was unlikely that a doctor would be found guilty of unlawfully procuring mis- carriage in instances where there was no attempt to procure foetal death in the pro- cess. However, women’s access to a choice to end pregnancy in favour of an AW could be based entirely on medical perceptions of risk. A question for further consid- eration remains: is it appropriate for doctors to remain in control of decisions about ending pregnancies in light of AWs? AWT has the potential to alleviate women of the burdens placed solely on them in reproduction, but this is only possible if women are empowered to decide which risks are tolerable. It is possible that healthcare policy might still present high hurdles in terms of access to this technology in future; how- ever, it is not appropriate for the criminal law to impose heteronormative conceptions of the female body and its role in gestation.
ACKNOWLEDGEMENTS I am grateful to Dr Alexandra Mullock, Professor Margot Brazier, and Professor Bernard Dickens for their insightful comments on earlier drafts of this paper. I am thankful to fellow students at the School of Law at Manchester, Dunja Begovi c and Victoria Hooton, for helpful comments. I would also like to thank the two anonymous reviewers for their kind and constructive feedback. I am grateful to the Wellcome Trust for funding my research.
FUNDING I am the recipient of a Wellcome Trust Doctoral Studentship in Society and Ethics [grant reference 208245/Z/ 17/Z].
Conflict of interest statement. None declared. Appendix 6 – Partial Ectogenesis: Freedom, Equality and Political Perspective (2020) 46 Journal of Medical Ethics 89
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likely to place doctors in the position of gate- Partial ectogenesis: freedom, equality keepers to partial ectogenesis as well.5 The suggestion that persons with female biology, and political perspective predominantly women, will be subject to a lesser burden in pregnancy because of partial Elizabeth Chloe Romanis ectogenesis has little merit, unless there is legal reform to address the fact that pregnant people themselves are not legally empow- 3 Abstract than as an alternative to pregnancy. Further- ered to determine the level of tolerable risk In this commentary, I consider how Giulia more, in partial ectogenesis there necessarily in pregnancy.5 Legal reform is also necessary Cavaliere’s arguments about the limited reach remains a pregnant person whose rights to mitigate how social circumstances may of the current justifications offered for full and freedoms are impacted by the use of, limit women’s freedom to make the choice ectogenesis in the bioethical literature apply in and by narratives surrounding, the artificial to opt for assistance with late-term gestation. the context of partial ectogenesis. I suggest that womb. The justifications for ectogenesis that It may be that pregnant people wanting to considering the extent to which partial ectogenesis Cavaliere labels as ‘freedom-promoting’ and opt for extra uterum gestation for health is freedom or equality promoting is more urgent ‘equality-promoting’ have been, or plau- reasons would be subject to the same stigma because of the more realistic prospect of artificial sibly could be, advocated in the context of as women who request a caesarean (in place womb technology being utilised to facilitate partial partial ectogenesis. In this commentary, I of vaginal delivery). These women are often gestation extra uterum as opposed to facilitating highlight concerns about potentially harmful labelled selfish, or ‘too posh to push’iii6 complete gestation from conception to term. I narratives about pregnancy that might result despite the reality that those who make this highlight concerns about potentially harmful social from partial ectogenesis, and about limited decision do so because they believe it is best narratives surrounding pregnancy and about the or unequal access to technology enabling for their well-being. 7 Social conditions can current legal framework surrounding gestation a choice about the duration of pregnancy. make decisions about a pregnancy much limiting access to technology in the advent of Like Cavaliere, I do not advocate that these harder for pregnant people to access and this partial ectogenesis. I do not advocate that these concerns mean we should not develop arti- will be no less true for people considering concerns mean that we ought not develop ficial wombs, but in the introduction of ectogenesis (full or partial). The law perpet- artificial wombs, but like Cavaliere I suggest that this technology we must be mindful of its uates harmful social conditions by label- we must be mindful of these concerns, and I posit capacity to perpetuate stigma and inequality ling decisions about pregnancy as requiring Protected by copyright. that legal reform must accompany technological and take steps to mitigate this. explanation and supervision, thus subjecting developments. Ectogenesis as a political pregnant people to unwarranted stigma.8 perspective, through which we consider the It is also possible that constructing the Freedom value in social reproduction and the experiences artificial womb as an ‘alternative’ to later- It has been argued that partial ectogenesis of pregnant people, is useful to prevent political term gestation may come to limit pregnant offers pregnant people an increasing range of capture of this technology for regressive policies. people’s freedom. Cavaliere highlights choices about pregnancy, and thus is freedom Using this perspective to examine the law is also the risk that ‘certain women, especially promoting. With the availability of artificial a useful tool to expose just how restrictive the law from disadvantaged groups, would be wombs people experiencing pregnancies that is in relation to gestation and female reproductive regarded as substandard gestators’ and are, or are perceived as, dangerous might http://jme.bmj.com/ health. notes the potential for ‘increased control welcome the opportunity to opt to end their and pressure to use ectogenesis to secure pregnancy (opting out of gestation) without the safety of the fetus’.1 Ectogenesis is Introduction necessarily having to make the decision not frequently cited as a welcome develop- While Cavaliere narrows her focus in ‘Gesta- to reproduce.4 5 These arguments assume the ment to provide a more secure ‘uterine tion, equality and freedom: ectogenesis as availability of such choices both legally and experience’9 for a fetus when maternal a political perspective’, to considering the socially. Access to technology during preg- behaviour is thought to be concerning, for justifications offered for full ectogenesis,1 it is nancy is strictly medically controlled (and on July 5, 2020 at The University of Manchester Library. example because of substance misuse.9 10 notable that her arguments about the limited equally dictated). Doctors are installed by the The narrative of an accessible ‘alternative’ reach of these justifications could have even law as gatekeepers to decisions about ending can be mechanised as a powerful tool for greater implications in the context of partial pregnancy.i and childbirth,ii and the law is increased monitoring of pregnant women. ectogenesis (the continued gestation of a fetus In the context of pregnancy false alterna- after it has been removed from a pregnant i In English law there is no right to preg- tives are frequently deployed to regulate person’s womb). There is greater urgency nancy termination (potentially inclusive of behaviour; pregnant people are system- in considering these issues in this context ending to a pregnancy in order to opt for 5 atically denied access to abortion after because partial ectogenesis will be possible gestation extra uterum ) outside of emer- gency circumstances. A doctor merely has ‘viability’ because it is advocated that the long before complete ectogenesis. Recent 2 a defence to the crime of procurement of fetus could survive in an alternate space studies have demonstrated some proof miscarriage under the Offences Against the of principle for gestation ex utero but are Person Act 1861 and/ or child destruction being designed as a replacement for neonatal under the Infant Life (Preservation) Act Civ 1003, that a doctor is not legally intensive care (for partial ectogenesis), rather 1929 in a list of prescribed, and heavily required to provide any particular medical medicalized, circumstances that are listed intervention in the absence of an emer- in s.1 of the Abortion Act 1967. gency. A doctor cannot be compelled to Centre for Social Ethics and Policy, Department of Law, ii National Institute of Health and Care comply with a pregnant person’s choice, University of Manchester, Manchester M13 9PL, UK 14 for example, to opt for caesarean in place Excellence guidelines currently recom- 7 Correspondence to Elizabeth Chloe Romanis, Centre mend that it is good practice for doctors of vaginal delivery. for Social Ethics and Policy, University of Manchester to offer a choice in childbirth,15 but iii Women frequently report being ‘shamed’ Manchester School of Law, Manchester M13 9PL, UK; English law is clear, following R(Burke) by medical staff for wanting a caesarean elizabeth. romanis@manchester. ac.uk v General Medical Council (2005) EWCA birth.15
Romanis EC. J Med Ethics February 2020 Vol 46 No 2 89 Commentary J Med Ethics: first published as 10.1136/medethics-2019-105968 on 3 February 2020. Downloaded from
(and this is enshrined in law),iv and perni- interesting theoretical perspective to high- cious narratives persist about birth control light how present conditions (including and the necessity of abortion. gestation taking place inside a person of To cite Romanis EC. J Med Ethics 2020;46:89–90. Legal reform must accompany tech- female biology) have resulted in some nological developments. A repro- structural inequalities. Examining the law Received 18 December 2019 ductive agenda that is genuinely surrounding partial ectogenesis is useful Accepted 13 January 2020 Published Online First 3 February 2020 freedom-promoting must place emphasis to demonstrate quite how restrictive the on scaling back excessive medical control law is in relation to gestation and female over, and legislative interference into, reproductive health.5 Historically, tech- female reproductive health, and foster nology has been politically captured to trust in women and pregnant people to afford increased legitimacy for measures ►► http://dx. doi. org/ 10. 1136/ medethics- 2019- 105691 ► http://dx. doi. org/ 10. 1136/ medethics- 2020- 106099 make decisions for themselves. that subject pregnant people to greater ► control. Better neonatal intensive care has J Med Ethics 2020;46:89–90. resulted in increased legal restrictions on doi:10.1136/medethics-2019-105968 Equality abortion,v and birth control has resulted ORCID iD Cavaliere explains that the proposals for in legal and political manoeuvres to deter- 3 Elizabeth Chloe Romanis http://orcid. org/0000- 0002- ‘state sponsored ectogenesis’ by Kendal 12 mine who is allowed to reproduce. In 8774-4015 and others are infeasible, and thus there the literature, as well as those writing are likely to be financial barriers to from the perspective that ectogenesis accessing ectogenesis.1 Such concerns References presents a possible tool for female libera- 1 Cavaliere G. Gestation, equality and freedom: 3 are also evident in the context of partial tion, there are equally those claiming that ectogenesis as a political perspective. J Med Ethics ectogenesis, because if the technology has ectogenesis is a justification for restricting 2020;46:76–82. the capacity to be revolutionary in mini- 2 Partridge EA, Davey MG, Hornick MA, et al. An extra- access to reproductive healthcare (namely, uterine system to physiologically support the extreme mising the risks that pregnant people have abortion).13 Carefully framed political 5 premature lamb. Nat Commun 2017;8(1):15112. to tolerate in gestation, or the likelihood provocation, analysing ‘the risks and 3 Romanis EC, Horn C. Artificial Wombs and the of human entities dying after delivery burdens of pregnancy and childbirth, as Ectogenesis conversation: a misplaced focus? due to prematurity, equal access to such Technology, abortion and reproductive freedom. IJFAB well as the unfair distribution of child- 2020, forthcoming. technology must be ensured. In public bearing responsibilities between men and 4 Kendal E. Equal opportunity and the case for state Protected by copyright. and private health systems alike, there women’1 through the prism of value in sponsored ectogenesis. Basingstoke, UK: Palgrave, 2015. are already significant inequities in access 5 Romanis EC. Artificial womb technology and the choice social reproduction, can prevent political to gestate ex utero: is partial ectogenesis the business to prenatal and postnatal care, as well as capture of technology. Focusing on the 11 of the criminal law? Med Law Rev 2019. neonatal intensive care. Horn and I have extent to which society’s treatment of the 6 Ellen B. It’s time to debunk the myth of too posh to argued that these disparities risk wors- (potentially) gestating person, both before, push, 2016. Available: https://www.theguardian.com/ ening if some pregnant people have the commentisfree/2010/ nov/ 21/ childbirth- nhs [Accessed 9 during and after gestation, has resulted in Dec 2019]. means to opt out of full-term pregnancy structural inequality in the labour market 7 Romanis EC. Why the elective caesarean lottery 11 and others do not. and beyond, emphasises the importance is ethically impermissible. Health Care Anal 2019;27(4):249–68. of good reproductive healthcare to better
8 Cook R. Stigmatized Meanings of Criminal Law. In: http://jme.bmj.com/ guarantee equality and freedom. Abortion law in transnational perspective: cases Political perspective and controversies. Philadelphia, US: University of Cavaliere concludes that ‘ectogenesis Twitter Elizabeth Chloe Romanis @ECRomanis Philadelphia Press, 2014: 347–70. should be defended as a provocation, 9 Hammond-Browning N. A new dawn: ectogenesis, one that demands: better medical and Contributors ECR is the sole author. future children and reproductive choice. Contemporary Funding This study was funded by Wellcome Trust Issues in Law 2018;14(4):349–73. social services for gestating women; a 10 Pence G. What’s so good about natural motherhood? (208245/Z/17/Z). decrease in the medical hazards associ- (In praise of unnatural motherhood). In: Ectogenesis. ated with gestation and childbirth; better Competing interests None declared. Artificial womb technology and the future of human on July 5, 2020 at The University of Manchester Library. reproduction. Amsterdam, NL: Rodopi, 2006: 77–88. working … conditions for future mothers, Patient consent for publication Not required. 11 Horn C, Romanis EC. Establishing Boundaries for gestating mothers, mothers and women Provenance and peer review Commissioned; Speculation about Artificial Wombs, Ectogenesis, more generally; and a true redistribution internally peer reviewed. Gender and the Gestating Body. In: Jurisprudence of the Body, 2020, forthcoming. of the burdens of responsibilities of social © Author(s) (or their employer(s)) 2020. No commercial 1 12 Ross L. Reproductive justice: an introduction. reproduction’. Ectogenesis makes for an re-use . See rights and permissions. Published by BMJ. California, US: University of California Press, 2017. 13 Kaczor K. Ectogenesis and a right to the death of the prenatal human being: a reply to Räsänen. Bioethics 2018;32(9):634–8. iv The use of viability to regulate abor- v For example, the British Parliament 14 National Institute for Health and Care Excellence. tion is prevalent of the law of multiple explicitly chose to amend the viability Caesarean Section: Clinical Guideline [CG132], 2011. jurisdictions, including the US following threshold in English law from 28 weeks in Available: http://www.nice. org.uk/ guidance/ cg132/chapter/ the explicit Supreme Court ruling in Roe the Infant Life (Preservation) Act 1929 to 1-Guidance# planned- cs [Accessed 9 Dec 2019]. v Wade 410 U.S. 113. 1973. An implicit 24 weeks in the 1990 amendments (s.37 of 15 Winston N. I was C-Section shamed by a midwife after viability threshold is also installed in the Human Fertilisation and Embryology delivering at 32 weeks., 2019. Available: https://www. English law because of the much-narrowed Act 1990) to s.1 of the Abortion Act 1967 whimn.com. au/ strength/health/ i-was- csection- shamed- grounds for legally permissible abortion because developments in neonatal inten- by-a-midwife-after-delivering- at-32-weeks/news-story/ after 24 weeks in s.1 of the Abortion Act sive care meant an increased likelihood of cd395bd2361978b3f67436a2e56ed50d [Accessed 9 Dec 1967. survival at an earlier point in gestation. 2019].
90 Romanis EC. J Med Ethics February 2020 Vol 46 No 2 Additional Relevant Publications
Appendix 7 - Re-viewing the Womb (2020) Journal of Medical Ethics (forthcoming)
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Extended essay J Med Ethics: first published as 10.1136/medethics-2020-106160 on 29 July 2020. Downloaded from Reviewing the womb Elizabeth Chloe Romanis , Dunja Begović, Margot R Brazier, Alexandra Katherine Mullock
Centre for Social Ethics and ABSTRACT from their view. Pernicious narratives about conflict Policy, Department of Law, Throughout most of human history women have and danger, born from ignorance, have endured University of Manchester, and transmuted into modern, medicalised tropes. Manchester, UK been defined by their biological role in reproduction, seen first and foremost as gestators, which has led to New reproductive technologies, heralded as Correspondence to the reproductive system being subjected to outside increasing reproductive choice for women, equally Elizabeth Chloe Romanis, interference. The womb was perceived as dangerous foreshadow exacerbation of maternal–fetal conflict Centre for Social Ethics and and an object which husbands, doctors and the state and medical hegemony over women’s choices. We Policy, University of Manchester had a legitimate interest in controlling. In this article, we illuminate this problem and argue that such atti- Manchester School of Law, tudes must not be permitted to direct ethico-legal Manchester M13 9PL, UK; consider how notions of conflict surrounding the womb elizabeth. romanis@manchester. have endured over time. We demonstrate how concerns approaches to emerging technology. ac.uk seemingly generated by the invisibility of reproduction Until recently, the womb was an exclusively and the inaccessibility of the womb have translated into natural, static female organ, but medical science Received 27 February 2020 similar arguments for controlling women, as technology is now delivering opportunities to transplantii or Revised 19 May 2020 iii Accepted 8 June 2020 increases the accessibility of the female body and the emulate the function of the womb. Women who womb. Developments in reproductive medicine, from in suffer from uterine factor infertility can now receive vitro fertilisation (IVF) to surrogacy, have enabled women a uterus transplant, and it seems feasible that soon and men who would otherwise have been childless trans women and cis men wanting to gestate their to become parents. Uterus transplants and ’artificial own child could too.iv Such advances may poten- wombs’ could provide additional alternatives to natural tially degenderv gestation. On the horizon, there gestation. An era of ’womb technology’ dawns. Some is the promise of ‘artificial wombs’vi creating
argue that such technology providing an alternative to further options for the wombless and those who Protected by copyright. ’natural’ gestation could be a source of liberation for want a child but not to gestate. More choices for female persons because reproduction will no longer all putative parents and better healthcare for the be something necessarily confined to the female body. fetus, whether in a parent’s biological uterus or ’Womb technology’, however, also has the potential to a ‘machine,’ appear to represent progress which exacerbate the labelling of the female body as a source should be welcomed. of danger and an ’imperfect’ site of gestation, thus History, however, suggests that a note of replaying rudimentary and regressive arguments about caution must be voiced about the impact of such
controlling female behaviour. We argue that pernicious http://jme.bmj.com/ narratives about control, conflict and the womb ii In December 2014 the first baby was born from a must be addressed in the face of these technological transplanted uterus in Sweden.99 developments. iii In 2017 a team of fetal scientists and surgeons in Philadelphia revealed an AW prototype that had ‘As all historians know, the past is a great darkness, yielded promising results in animal testing (the and filled with echoes.’ Biobag). Another research team, based in Western
― Margaret Atwood, The Handmaid's Tale Australia/Japan, has reported similar results from on October 5, 2020 at The University of Manchester Library. testing their prototype AW, the EVE platform. In 2019 a third research team in the Netherlands announced they had received Horizon 2020 funding INTRODUCTION to build their AW prototype.71–73 This article traces how attitudes to female repro- iv Medical objections to uterus transplantation duction, shaped by historical misunderstandings of in non-biologically female persons (that formed procreation and the female body, have perpetuated the basis of the Montreal Criteria about ethical an approach that continues to subjugate and ‘other’ uterus transplantation) do not appear to be well-founded.100 women,i especially as they gestate and bear children. v Claims that artificial wombs will de-gender gesta- From classical times, the womb garnered suspicion tion are frequently made in the literature.96 98 101 102 and fear among ‘medical men’, theologians and For an explanation of why these claims are inaccu- ordinary people partly because it was obscured rate see.103 vi © Author(s) (or their Kingma and Finn note that it is more appropriate employer(s)) 2020. Re-use to refer to ectogestation and the specific names of i It is important to acknowledge that it is persons designed prototypes because describing the technol- permitted under CC BY. 58 Published by BMJ. of female biology, regardless of the gender they ogies as ‘artificial wombs’ is inaccurate, and as we live in or identify as, that can become pregnant. will demonstrate the notion of an ‘artificial’ womb To cite: Romanis EC, In this article, we refer to women and pregnant might perpetuate harmful narratives about the need Begović D, Brazier MR, et al. women because throughout history the fact that the to control gestation. Here, we use the term ‘artifi- J Med Ethics Epub ahead of majority of pregnant people identified as, or were cial womb’ because this is how they are popularly print: [please include Day assumed to be, women because of their biology referred to and understood, and because this term Month Year]. doi:10.1136/ has impacted on how pregnancy has been and is is an important part of our argument about how medethics-2020-106160 conceptualised and how pregnant people were and language is used in this context to create narratives are treated. about women.
Romanis EC, et al. J Med Ethics 2020;0:1–10. doi:10.1136/medethics-2020-106160 1 Extended essay J Med Ethics: first published as 10.1136/medethics-2020-106160 on 29 July 2020. Downloaded from developments on women’s rights and role in society more gener- 1991,4 husbands enjoyed something akin to what we might clas- ally. Fascination with the womb, coupled with the capacity for sify today as a right to procreate, and wives a duty to provide the others to intervene for the benefit of the fetus, has culminated means by which he might do so.vii in the notion of ‘maternal–fetal’ conflict, in which the interests A husband’s interest in the child was magnified by the firm of pregnant woman and the fetus are presented as incompat- belief that the child was ‘his’, the product of his body; he had the ible with, or in competition with, each other. While advances in strongest of interests in ensuring that no other man’s ‘animal- reproductive technologies offer hope and important solutions cule’ was carried in the wife’s womb and passed off as his. He for putative parents, there may be unintended side effects that had a further strong interest in ensuring that the behaviour of negatively affect pregnant women because of prevailing narra- the ‘gestational carrier’ did not compromise his reproductive tives within healthcare, maternity care and wider society. enterprise. That sadly did not mean that all husbands acted posi- In this paper, we recall how frameworks based on the womb as tively to promote the health of the wife. The high rates of child a site of conflict, and concerns about the need to control women mortality and at many times in history the surplus of women because of their wombs, are evident in medical practice and law over men might mean that quantity in reproduction was the throughout history. We then consider how these narratives have primary objective, to generate as many children as possible and prevailed as advances in medical technologies have provided us replace ‘worn out wombs’ with fresh stock. The desire for sons with a ‘view into the womb’, and demonstrate why the conflict and primogeniture begin to make sense. If you accepted animal- framework is not only conceptually and evidentially unjustified, culism, a son when he reproduced begat a grandson who shared but also potentially harmful. Finally, we examine this danger your blood. Daughters will bear a child formed by her husband’s in connection with future reproductive technology, focusing ‘animalcule’, unrelated to its maternal grandfather. on ‘artificial womb’ technology, to interrogate these issues in a A working womb did not necessarily benefit the woman, contemporary context. We consider the development of ecto- but to be barren might have been a worse fate. From classical gestation and argue that such technology exemplifies further times, theologians and physicians declared barren women to be why we need a wholescale shift in medicine, ethics and law away monstrous. In Ancient Greek myth, the grisly Gorgon queen from narratives that consider pregnancy and the womb as a site Medusa, whose gaze turned men to stone, was said by some of danger. to be barren. The empty womb was dangerous, but so was any womb, dangerous to the woman and to others. Secreted far from public view, wombs were judged the cause of many female ills, or
HIDDEN FROM VIEW rather conditions styled ‘ills’ by men. Protected by copyright. Possession of a womb has not always been a blessing. In the past, Women, learnt men declared, were defective creatures the woman who successfully gestated children faced an agonising possessing weak intellectual capacity and unregulated emotions. labour and risk of death. Her pain was to expiate the sin of Eve Christian theology was supported by so-called science. The in tempting Adam with that apple. The book of Genesis declares ‘scientific’ grounds for female defects were various, contradic- ‘I will greatly multiply your pain in childbirth, in pain shall you tory and changed over time. When it came to female physiology bring forth children yet your desire shall be for your husband’ ‘medical men’, anatomists, the law, the Church et al resembled (Genesis 3.7). John McKeown cites Martin Luther: Alice in Wonderland trying ‘to believe as many as six impossible
[W]e see how weak and sickly barren women are. And those things before breakfast.’ The female body was declared to be http://jme.bmj.com/ who are fruitful are healthier cleanlier and happier and even defective compared with male perfection, yet when anatomists if they bear themselves weary—or ultimately bear themselves were able to examine the interior of female corpses, they argued out— that does not hurt let them bear themselves out this is the that female organs could be seen as inversion of the male.5 So, it purpose for which they exist.1 was said that the ‘neck of uterus is like the penis, and its recep- For Luther, women were ‘not created for any other purpose tacle with testicles and vessels is like the scrotum’.2 Wombs, than to serve man and be his assistant in bearing children.’1 however, were accorded dark powers not shared by the perfect
However, even if a woman’s purpose was thought to be to male genitalia. The ‘wandering womb’ which was not fixed in on October 5, 2020 at The University of Manchester Library. gestate her husband’s children, her contribution to the creation its proper place but wandered around the body pressing on of the child was judged by many learnt men across the ages to heart and lungs endangered the woman’s life resulting in ‘suffo- be simply a ‘seed bed’ for the embryo.2 Wombs were no more cation of the mother’.6 The wandering womb was described as than a necessary medium in which the father’s seed could grow. ‘a migratory uterus prowling about the body like a wild animal Aristotle argued that the embryo was formed when the male pressing on the chest.7 The uterus emitted noxious fumes; not seed interacted with menstrual blood. The woman nourished a desirable commodity. By no means all eminent physicians the seed.2 Galen disagreed, contending that women produced agreed that such a condition existed. The Trotula, a medieval seeds, although ‘weaker in nature’ than the male seed. In the compendium on women’s medicine, rejected the notion of 17th century, anatomists examining semen under the microscope ‘suffocation of the mother’.8 Popular opinion on science then as discovered sperm, originally described as ‘animalcules.’ The now influenced society, as Edward Shorter explained ‘through view (described as preformationism) grew that the fully formed popular culture as well rode a visceral male fear of women’s’ child was present in the sperm. magical powers’.9 Wandering wombs made a good story. A Animalculism obviously proved inaccurate, but for those who cure for wandering wombs and later hysteria recommended by believed that mothers only contributed an environment in which some medical men was sexual intercourse—within marriage of the father’s child could grow and be nurtured, the woman was course. Writers warned of the libidinous nature of imperfect in effect a ‘gestational carrier’. From this (mistaken) premise, the legal incapacities which English law imposed on married women vii begin to make some sort of sense.3 The marriage contract obliged The right to sexual intercourse was not solely linked to the right to reproduce but theological suspicions of sexual plea- a wife to make her womb available to nourish her husband’s s sure even in marriage, the notion that the primary purpose of children. Coupled with the myth that a wife could not refuse marriage was the procreation of children in theory demoted the consent to marital intercourse, perpetuated in English law until non-procreative role of marital intercourse to a subordinate role.
2 Romanis EC, et al. J Med Ethics 2020;0:1–10. doi:10.1136/medethics-2020-106160 Extended essay J Med Ethics: first published as 10.1136/medethics-2020-106160 on 29 July 2020. Downloaded from women, seeking in sexual relations with a man to be completed. an increasingly more difficult dilemma for health professionals. As Rawcliffe notes, male writers seemed to see no contradiction Who is their patient, the mother or the fetus?… But in the event in depicting the womb as both ‘a passive empty vessel and a of a conflict of interests who should take priority?’.15 Technology voracious animal’.7 has arguably oriented the focus away from the pregnant person If the danger of the womb was not enough, its monthly func- towards gathering as much information as possible about the tion testified further to the evidence of female defect. Menstru- fetus, potentially becoming a form of coercive control. Douglas ating women were ‘venomous during the time of their flowers concludes that ‘the main focus of attention these days [with all and so dangerous that they poison beasts with their glance and of contemporary obstetric technology] has moved away from the little children in their cots.’ Should a man have intercourse with pregnant women and towards the fetus within her… [and this] a menstruating woman, a child conceived might interalia be born enables supervision to be maintained over the woman and to leprous or blind, hunch backed or malformed.’ Any child born some extent her lifestyle’.15 in defiance of such a taboo ‘would bear some mark of ignominy, Developments in fetal medicine, from heart rate monitoring 7 if only red hair’. to three-dimensional imaging and prenatal surgery, have made Once human dissection showed plainly that wombs were not the journey from zygote to child, once hidden from view, apt literally to suffocate or wander around the body, Victorian accessible not only to pregnant women, but also their families, 10 doctors recast the womb as the cause of hysteria. The womb doctors and society. We are increasingly afforded a ‘view into disordered the female brain. We hear a great deal about ‘baby the womb,’ leading to the perception of the fetus as a distinct brain’ today and cognitive impairment in the menopause. It has being. Taylor notes that ultrasound has had the effect of bringing been reported that women having a heart attack with exactly fetuses ‘to life’ in that ‘it necessarily involves making visible the the same symptoms as men are often sent home told they are invisible and unmasking what has been hidden and obscured, 11 suffering from panic or stress —hysteria by any other name? [and] inevitably draws us into a rhetoric and politics of vision.’16 Arcane beliefs about the womb, which underpinned laws The fetus appears as something that can be watched and ‘inter- adverse to women and especially pregnant women, no longer acted with’.17 Technology has afforded the means ‘to monitor, to hold sway. The womb is no longer mysterious and yet misog- control and possibly intervene.’18 ynistic attitudes, which define women by their biology, persist. However, an important boundary remains in the form of the Look at contemporary social media abuse of female MPs. pregnant woman, whose consent is essential for any kind of See how some US states have passed regressive laws on abor- intervention to be performed: ‘literally, if not conceptually, the Protected by copyright. tion, contra to Constitutional Rights, to police every woman’s pregnant woman incorporates the foetus, so direct medical access viii womb. As we now examine, technological advances, while to the fetal patient is as remote as ever’.19 Laws in many coun- potentially benefiting women, might also invite opportunities tries appear to recognise the interests of the pregnant woman as to interfere with female autonomy, increasing the potential for primary, and the fetus is usually not considered a being with its conflict between the interests of women and fetal welfare and own rights and interests.20 Respecting the autonomy of the preg- the continued pathologisation of aspects of female physiology. nant patient is given ethical primacy even by those who would accept a limited notion of fetal patienthood.21 Yet it is necessary
to be vigilant as personal and social perceptions of fetal status http://jme.bmj.com/ A VIEW INTO THE WOMB and interests have and are likely to continue to evolve, even as The previous section outlined the ways in which the ‘inaccessi- legal and ethical codes maintain the autonomy of the pregnant 22 bility’ of the womb was a source of rampant speculation about woman as central. The medicalisation of pregnancy has already women and their pregnancies. Twentieth century advances in led to a change in how women perceive their responsibilities to 23 24 medical technology have drastically changed how we engage the unborn child, and technological developments, such as with women and the fetus during pregnancy, though as we will more sophisticated prenatal imaging or pregnancy apps moni- on October 5, 2020 at The University of Manchester Library. demonstrate, these have not necessarily quashed some of the toring fetal well-being, could further encourage this thinking. backward thinking about needing to control gestation. X-ray Empirical studies of pregnant women preparing for prenatal technology initially allowed obstetricians to diagnose poten- therapy suggest that the fetus is commonly seen by them as a 25 tial health problems prenatally, and the later development of distinct entity with its own needs and interests. Further tech- obstetric ultrasound provided a safer way of gaining insight into nological development may increase the potential for tension fetal health, ultimately becoming a routine part of prenatal care. between the perceived interests of the woman and her fetus. In the second half of the century, various forms of prenatal testing Consequently, it is important to interrogate the ways in which we and treatment procedures were pioneered, including complex imagine the maternal–fetal relationship as technology increases prenatal surgeries for conditions like spina bifida.12 Many of access to the womb. these relatively recent developments are now used routinely, There is an urgent need to avoid perceptions of the womb and some previously experimental and risky procedures have as a site of conflict, in order to ensure that pregnant women’s been made safer and less invasive, allowing their gradual intro- bodies are not treated as a dangerous environment for the fetus, duction into healthcare.13 These developments have placed the rather than an essential part of the maternal–fetal unit. Pregnant fetus firmly at the centre of the gestation process. Some worry women’s interests and autonomous choices must not be erased that this shifts the maternal–fetal relationship to be potentially and ignored in favour of promoting fetal well-being, and the adversarial and may also lead to the woman’s interests being side conflict view of the maternal–fetal unit seems to play a crucial lined.14 Douglas explains that ‘the perception of childbearing as role in this framing. In the next two sections, we present the primarily, rather than coincidentally, a health matter has led to notion of maternal–fetal conflict as it is often used in the ethical and legal literature, and demonstrate why this notion is unsub- viii For example: Alabama, Georgia, Kentucky, Louisiana, Missis- stantiated, incoherent and possibly dangerous, and should there- sippi, Missouri and Ohio. fore be rejected.
Romanis EC, et al. J Med Ethics 2020;0:1–10. doi:10.1136/medethics-2020-106160 3 Extended essay J Med Ethics: first published as 10.1136/medethics-2020-106160 on 29 July 2020. Downloaded from
REVIEWING CONFLICT number of possible situations’.43 There are several legal princi- Maternal–fetal conflict is said to occur when a pregnant woman ples which afford recognition to fetuses in ways influenced by behaves in ways that may be harmful to the fetus, such as drinking conflict framing. Alghrani notes that ‘many of the cases that have excessive alcohol or refusing a caesarean that is medically indi- generated legal rules and principles on the status of the unborn cated.26 27 This is seen in definitions like: ‘maternal–fetal conflict have developed in the context of the abortion debate and cases has been defined as the situation in which the intent or actions of maternal–fetal conflict’44 Thus, they have some notion of of the pregnant woman do not coincide with the needs, inter- inherent conflict at their root. ests, or rights of her fetus as perceived by her obstetric care- In England and Wales, it has been established by the courts givers’.28 This posits the main ethical dilemma for doctors as that the fetus does not have legal personality until birth, and being how to balance the interests of the pregnant woman in therefore, it does not (and probably never did) have any claim having her autonomy respected and the fetus in having its ‘inter- to human rights protection.45 Moreover, an unborn child cannot ests’ or welfare protected, leading back to the problematic issue be the victim of murder, and manslaughter may only apply if it is of recognising the fetus as a separate patient. delivered alive before subsequently succumbing to its injuries.ix 46 Sometimes it is not the pregnant woman who is considered The fetus cannot be a victim of a non-fatal offence against the 47 to be the ‘perpetrator’ of the conflict—her well-being might be person irrespective of whether it survives the injury. A fetus can jeopardised by interventions aimed at ensuring the well-being of be, however, the victim of child destruction once it has reached the fetus29—for example, more invasive maternal–fetal surgeries the gestational stage of being capable of life outside its mother’s 48 that may present long-term risks to the woman’s health and well- body. The offence of procuring a miscarriage also safeguards being, and sometimes caesareans performed for fetal benefit. The fetal life unless one of the grounds specified in the Abortion Act 49 x 45 definition above more clearly paints the pregnant woman and 1967 applied. While the case of Paton, which involved an fetus as adversaries, rather than acknowledging that the well- unsuccessful claim by a putative father seeking to prevent abor- being of the fetus ultimately depends on respecting the autonomy tion, confirmed that the fetus has no right to life under Article 2 xi of the pregnant woman, who is usually the one most invested of the European Convention on Human Rights, abortion law in ensuring good outcomes for the future child.30 31 However, does provide certain protections for fetal life. Section 1 (1)(a) any conception of clashing interests rests on the assumption that Abortion Act 1967 can be seen to provide little, if any, protec- pregnancy involves two separate parties, between whom conflict tion for fetal interests up to 24 weeks gestation, but it is possible might occur, rather than a necessarily interdependent biological for doctors—as gate-keepers—to exercise professional discre- unit. We argue instead that this interdependence must be taken tion in seeking to discourage abortion, or indeed to refuse to Protected by copyright. 46 as a starting point when examining ethical issues in prenatal care participate as a matter of conscience. It also might be argued and application of reproductive technology. that the first ground in the Abortion Act provides real protection The notion of ‘maternal–fetal conflict’ is so pervasive it is to a non-viable fetus because it requires women to justify their often the starting point of discussions related to ethical issues in terminations in medical terms (though in reference to their own pregnancy. Bioethical discussion often takes this framework, and bodies). It remains unlawful for a pregnant person in English law 51 examples of conflict, as the default assumption32 33 or a problem to access termination ‘for any reason or no reason’. After 24 to be addressed,34 thus generating the false perception that such weeks the potential for maternal–fetal conflict within the Abor-
conflict is widespread. Medical research also adopts this termi- tion Act 1967 is more significant. We see, therefore, that abor- http://jme.bmj.com/ nology at times, which inevitably frames the presentation and tion law and the Infant Life Preservation Act 1929, in offering discussion of findings.35 36 Most notably, maternal–fetal conflict greater protection once there is the potential for the fetus to is arguably one of the key concepts in the area of obstetric survive ex utero, convey the message that the mature fetus has ethics,21 37 38 including a large body of work on balancing the interests worthy of protection. doctor’s obligations towards the pregnant woman and those For women who have chosen to carry a pregnancy to term, owed to the fetus.39–41 Some have suggested that the difference other points of conflict arise. The shift towards greater respect of opinion between medical professionals and pregnant woman for patient autonomy in medical matters has been slow to on October 5, 2020 at The University of Manchester Library. materialise in disputes involving pregnant women. The forced about what to do in a particular situation is the true source of 52–54 conflict: the term ‘maternal–fetal conflict’ ‘misdirects attention caesarean cases illustrate this problem. Although the rights of pregnant women to refuse interventions intended to benefit away from the conflict that needs to be addressed: namely the 52 53 conflict between the pregnant woman and others (such as child their fetus are routinely declared in judgements, implemen- welfare agencies, physicians and other healthcare providers) tation of these principles is hard to evidence since the majority who believe they know best how to protect the fetus’.26 42 This of these cases involve compulsory treatment being ordered on is reminiscent of the imagery conjured by pre-Victorian doctors the grounds that the woman does not have capacity. Some of the ways in which women are found to be lacking in decision- treating the female body as an innate source of danger. We can xii see echoes of suspicion and mistrust towards women where making capacity are questionable. Conversely, professional risk is calculated by doctors who seem to be advocating for the ix fetus, as if the default assumption is that women’s behaviour will This is also the case in several other common-law jurisdictions; somehow endanger it. the Born-Alive rule is enshrined in the Canadian Criminal Code, for example. x There are compelling calls to decriminalise abortion in England Conflict enshrined in the law: the example of England and and Wales in order to afford proper weight to the bodily 51 Wales autonomy of pregnant women. xi The law is often the mechanism through which ethical and This was also confirmed in the European Court of Human Rights Decision in Vo v France.104 medical ideas about conflict in pregnancy have been trans- xii 53 lated into a substantial impact on women’s bodies and choices. Re MB left the door open to problematic findings of inca- pacity. In finding that panic and a phobia of needles incapaci- McLean explains that ‘the attribution of rights to embryos and tated a pregnant woman, this judgment left open the possibility fetuses places the mother and conceptus in direct conflict in a of using terms like ‘panic’ and ‘pain’ generally to establish a
4 Romanis EC, et al. J Med Ethics 2020;0:1–10. doi:10.1136/medethics-2020-106160 Extended essay J Med Ethics: first published as 10.1136/medethics-2020-106160 on 29 July 2020. Downloaded from reluctance to allow women to choose to give birth by caesarean, problematic assumption that ethical dilemmas in pregnancy are illustrated in Montgomery v Lanarkshire,55 56 suggests that the a matter of clashing rights between the woman and the fetus,26 autonomy of pregnant women is often not prioritised. Women when it is not determined in either ethics or law that fetal rights seeking to avoid medical interference in childbirth altogether are a coherent concept.20 60 Also, the ‘maternal’ in maternal–fetal will also find their choices constrained. Article 45 of the Nursing conflict implies that the pregnant woman already has parental and Midwifery Order 2001 makes it a summary offence for a responsibilities towards the fetus while it is still in the womb, person other than a registered midwife or medical practitioner which may then conflict with her other desires and actions. This to attend a woman in childbirth, unless there is sudden or urgent is also (rightfully) contested,26 with some authors arguing that necessity. This is a formalised attempt to medicalise pregnancy fetuses cannot be the proper object of parental responsibilities.61 and childbirth and take away control from the labouring woman. Second, the outcomes for maternal and fetal health are worse As such it is reminiscent of the medical comment repeatedly when women are perceived as a potential threat to their own made of female physiology throughout history. Such instances pregnancy. As the fetus is increasingly visualised and subject to of conflict in childbirth seem to support the view that the true 26 clinical recognition as a ‘patient’, and even some legal recogni- conflict lies between women and the medical profession, and xiii that the presence of the fetus still means that a woman is less tion, this strengthens the perception that there is a need to likely to be afforded full agency in situations where her views interfere with the choices women can make about their preg- conflict with accepted ideals about what is ‘best for baby’. Even nancies, either by failing to disclose information (as in Mont- 55 more extreme examples are found in the USA where a pregnant gomery ) or in the framing of childbirth as an emergency when 62 woman’s status as an aggressor is embedded in a wide range of this may not necessarily be appropriate. However, empirical criminal laws including the Federal Partial-Birth Abortion ban studies have demonstrated that fetal outcomes are better when and fetal homicide laws at State level.57 women are enabled to take a more directive role in their own care.30 63 64 Respecting women’s autonomy is important in allowing them, the people most familiar with their own body, REFRAMING CONFLICT underlying health needs and values, to make the decisions they The prevalent framing of pregnancy as a site of conflict in medi- feel best promote their own and their fetus’s welfare. cine, ethics and law has been challenged, especially by authors The notion of conflict is deeply rooted in a historical tradi- writing from a feminist standpoint. Bowden argues that the tion of thinking about women and wombs. The origins of our
pervasive maternal–fetal conflict conceptualisation of pregnancy Protected by copyright. 30 social and medical attitudes can be found in early mistaken is both innately problematic and empirically unfounded. She explains that this model ‘presents the interests of the pregnant beliefs about procreation and the mother’s gestational role. woman as conflicting with those of the future child and there- These ideas however, when applied in medical practice, fore, the pregnant woman as a threat to her future child rather encourage dysfunctional relationships between clinicians than the person who is most invested in its welfare’.30 This can and pregnant women, as observed in forced caesarean cases lead to the ignoring of women’s autonomous choices as well where doctors often seek court approval in cases involving 65 as the erosion of trust between pregnant women and medical women with mental health conditions. The presentation professionals, likely leading to further negative outcomes. In this of a woman’s health interests and personal well-being as http://jme.bmj.com/ section, we demonstrate that there are conceptual, outcome- detrimental to her fetus can also dissuade some, particularly based, and political and social reasons why framing pregnancy vulnerable women, from accessing prenatal care.30 66 Pregnant as a site of conflict is both unfounded and harmful, and must be women are more likely to engage in prenatal care when they do abandoned. not fear legal consequences67 or being made to feel judged by First, the notion of maternal–fetal conflict is arguably concep- care providers.30 There is substantial evidence that outcomes tually unsound. This has been explored extensively within are better for both woman and fetus when pregnant women are 68 69 bioethical and philosophical literature. There are metaphysical engaged and receive routine prenatal care, so to guarantee on October 5, 2020 at The University of Manchester Library. arguments about the status of the pregnant woman positing that this autonomy in pregnancy must be protected. Furthermore, it is mistaken to consider a pregnancy as involving two distinct as Bowden observes, women choosing pregnancy are almost entities.58 59 Some argue that considering the fetus as a part of always invested in the outcome and so treating women as a the pregnant woman59 or considering the fetus-pregnant woman source of danger is usually spurious.30 as a unit/dyad view19 is more accurate. Some of these authors do Finally, there are significant political and social ramifications not attempt to draw any normative claims from such argumen- 59 of the framing of the womb as a hostile environment. Some of tation. Still, their conclusions could be used as support for the idea that the pregnant woman and the fetus are intertwined such these are already evident in practice. A worrying trend of pros- that the concept of there being separate interests cannot make ecuting ‘pregnancy-related offences’ in some US states under sense. so-called ‘fetal protection laws’ shows a perception of women The terminology around this concept is also highly sugges- as dangerous, leading to apprehension and all the conse- tive and value-laden. Using the term ‘conflict’ perpetuates the quences of life after imprisonment. These cases involve an over-representation of poor women/women of colour, showing how certain groups are disproportionately affected by conflict person is incapable of making decisions. Since panic and pain are framing, depending on the overall political context.70 Such very common, normal and temporary states they might easily be attributed to a pregnant woman and used to conclude she does thinking also encourages the view of women as ‘dangerous crea- not have capacity by virtue of the fact she is in childbirth. This tures’ that threaten a man’s procreative interests, again echoing may ‘tempt’ a concerned judge to ‘err on the side of finding incompetence’ especially when pregnant women are in disagree- ment with their doctors, but pain prevents clear, reasoned expla- xiii Even if not legally recognised as a person the fetus does have nation.54 There are similar concerns about forced caesareans in some legally protected interests, for example in the Abortion the United States.67 Act.51 66 105
Romanis EC, et al. J Med Ethics 2020;0:1–10. doi:10.1136/medethics-2020-106160 5 Extended essay J Med Ethics: first published as 10.1136/medethics-2020-106160 on 29 July 2020. Downloaded from the themes evident in the historical background provided earlier Boix assert that ‘medical practices have historically maintained a in this paper. Furthermore, we have demonstrated that it is not form of male control over women, and that reproductive tech- constructive, nor pertinent to the achievement of the best clinical nologies have been oriented towards the male help in detriment outcomes, to routinely place blame at women’s feet for failing in of women’s welfare’82 and thus the introduction of ectogestation gestation when there are other factors that need to be addressed. would likely be no different. There are broader socioeconomic factors that are more respon- In this section, we place the (potential) development of the sible for poor prenatal outcomes, including access to care, than artificial womb into historical and contemporary context by any individual women’s behaviour. demonstrating how prevailing narratives of maternal–fetal We argue that the above considerations show we must ‘move conflict—if not addressed—will limit the capacity of technology away from presenting the needs of a developing fetus as being capable of ectogestation from benefiting women and pregnant in conflict with those of the pregnant woman’.30 One way to people. First, artificial wombs might escalate the pathologisation do this is by adopting a more holistic view, which regard the of gestation, and second, they might fuel excessive control over pregnant woman and the fetus as ‘an inseparable whole whose natural pregnancy by creating a ‘narrative of alternative.’ The well-being needs to be fostered before, during and after the preg- purpose of this examination is not to advocate that we should nancy’.28 Focusing on this maternal–fetal ‘dyad’19 as an interde- ban research into ectogestation, because we see the potential pendent biological unit is a better approach to providing ethical benefits it will bring. Rather we seek to contextualise any poten- prenatal care than trying to balance the distinct interests of two tial development in the prevailing and enduring norms about (seemingly opposed) parties, especially since the fetus is fully pregnancy to illuminate the concerns that should be considered dependent on the pregnant woman for its health and survival.19 before ectogestation is used in humans. While this investigation This also ensures that women are affirmed as persons, with their is inevitably speculative, it helps highlight some of the contem- autonomy and bodily integrity respected. Rejecting the notion of porary concerns about harmful conceptualisations of maternal– ‘conflict’ reduces the risk of stigmatising pregnant women for a fetal conflict. multitude of decisions about their gestation, from diet to child- birth. As future reproductive technologies emerge, it is partic- Pathologising gestation ularly important that we reframe thinking about pregnancy to Limon notes that liberal feminists often adopt pathological determine appropriate ethical and legal parameters for their use. language in explaining the necessity or desirability of ectogesta- tion.83 Firestone described pregnancy as ‘barbaric’ and childbirth 75 as like ‘shitting a pumpkin’. Smajdor refers in detail to the pain Protected by copyright. WOMB WITH A VIEW and suffering gestation causes women and explicitly claims it is One of the most anticipated developments in assisted repro- a ‘conceptual failure in medicine and social and ethical terms to duction is ‘assisted gestation’; the ‘artificial womb.’ Ectogesta- address the pathological nature of gestation and childbirth’.77 tion58 is the process of gestation undertaken ex utero in a device While Kendal advocates for ectogestation as a reproductive attempting to emulate the conditions of the human womb. choice (and is explicit that she does not seek to devalue natural Complete ectogestation is the growing of babies entirely from pregnancy and childbirth), she nevertheless describes pregnancy scratch in an artificial womb; partial ectogestation is the use of as ‘temporary incapacitation,’ as an illness or cause of injury, and
‘artificial womb’ devices to facilitate the continued gestation suggests it is ‘only logical for someone to actively avoid devel- http://jme.bmj.com/ of human entities that are removed from a woman’s womb oping a physical condition that is guaranteed to cause significant, prematurely. Recent animal experiments with artificial womb prolonged discomfort, especially if it also carries the risk, no prototypes have demonstrated it is possible to facilitate partial matter how small, of sustaining some severe injury or death’.76 ectogestation in lambs,71–73 fuelling speculation about the devel- We do not disagree that pregnancy can be difficult, harmful opment of this technology and its impact. and in some cases dangerous. It remains true that gestating and Artificial wombs are often heralded as a source of potential birthing can have serious, long term, even fatal, consequences liberation for women. Simonstein and Mashiach-Eizenberg for women. However, pathologising all pregnancy could exac- on October 5, 2020 at The University of Manchester Library. explain that ‘reproductive hazards have traditionally been erbate notions of maternal–fetal conflict by explicitly locating a viewed as women’s fate, and therefore, have been taken for normal pregnancy as a source of danger and providing justifica- granted’.74 Firestone,75 Kendal76 and Smajdor77 echo concerns tion for medical intervention. about the physical burdens of gestation and pregnancy being This pathologisation lends itself to the way the female body placed exclusively on female people and posit that entirely has always been ‘othered.’ Earlier, we demonstrated how the removing gestation from the body offers women, finally, equal female body and particularly the womb has always been consid- opportunity. Smajdor explains that with complete ectogesta- ered oppositional to and defective compared with the male body, tion available, women would be able to ‘reproduce as men do, pathologised in its ability to gestate, its inability to gestate and without risking their physical and mental health, economic and its capacity to menstruate. These female attributes were thus social well-being, and crucially—their bodily integrity’.77 Partial seen as medical matters worthy of medical supervision and patri- ectogestation has also been advocated as beneficial for women archal interference. The language of pathology that has been as a way of alleviating some of the burdens of pregnancy by used by some scholars in explaining why some women might offering, for example, an alternative if pregnancy is dangerous opt for ectogestation unintentionally implies that the fact that (or potentially undesirable) in the later stages.78 The problem females carry pregnancies (and thus potentially subject to this with the arguments about how ectogestation might assist women ‘incapacity’ at some point or multiple times in their lifespan) in taking more control of their reproduction is that they are renders them inferior. There are parallels between historical atti- often advanced in a vacuum, seemingly ignorant of contempo- tudes and the imagined ‘artificial womb’ utopia. Importantly, to rary sociolegal conditions and importantly, women’s histories. pathologise and medicalise is to direct to the necessity of inter- Some of our concerns about the capacity of the technology to vention and this can have material impacts. This is evident today liberate women of the burdens placed exclusively on the female in the stark increase in interference in childbirth, as the female body are shared by other feminist scholars.79–81 Vallerdu and body and its capacities, Wolf and Charles explain, are treated
6 Romanis EC, et al. J Med Ethics 2020;0:1–10. doi:10.1136/medethics-2020-106160 Extended essay J Med Ethics: first published as 10.1136/medethics-2020-106160 on 29 July 2020. Downloaded from as an ‘inherently dangerous, unpredictable process that must abortion for three principal reasons. First, because the proce- be controlled to remove its dangers and lack of predictability’ dure to extract a fetus for ex uterum gestation is far more inva- because ‘serious complications can arise at any moment and sive than the procedures of medical or surgical abortion.78 79 create an emergency’.62 Burrow suggests that there is an opera- Second, because women want access to abortion care as early as tive technological imperative in obstetrics,84 which increasingly possible; most care is provided before 13 weeks,95 and there is encourages individual clinicians to ‘rationalise surgical [or tech- not yet evidence to suggest that artificial womb technology will nological] intervention to gain as much control as possible’.85 be capable of gestating embryos since current prototype models Furthermore, pathologising pregnancy treats all pregnancies are reliant on fetal physiology.81 xvi Finally, several scholars have as homogeneous. Many women enjoy being pregnant,xiv so we highlighted that abortion is meaningful not only a right not to be must be mindful of how using language that describes pregnancy pregnant, but to encompass the broader harmful social realities as ‘an illness,’ analogising it to a disease or referring to it as for women if forced to accept the consequences of unwanted ‘temporary incapacitation’ feeds into old-fashioned claims about pregnancy.79 81 83 Romani and Horn argue that it is important to the inherent pathology of female biology. This is to denigrate reground conversation about ectogenesis in the realities of this natural pregnancy and the women who value the experiences of technology and its unsuitability as an ‘alternative to abortion’ pregnancy and labour. Moreover, it paints the female body as a calling for scholars to consider the ramifications of neglecting to dangerous place and feeds into claims that fetuses might be safer understand abortion as healthcare.81 gestating ex utero. A woman’s body is perceived as a conflict It is also harmful (and likely always going to be factually inac- zone to be avoided in favour of ectogestation. curate)xvii to label ectogestation as an alternative to pregnancy. Pence94 and Hammond-Browning93 both advocate that ectoges- Narrative of alternative tation might be beneficial in those instances in which a preg- We have examined how the womb being both invisible within nant woman is behaving ‘inappropriately’, for example, abusing the pregnant body, yet increasingly visible with a wide variety substances. It is thought that ectogestation brings the possibility of technologies has led to the conceptualising of the pregnant of ‘safeguarding’ fetuses and embryos without interfering with body as an environment in need of supervision. The visibility of women’s rights.96 It is not difficult to extrapolate from this argu- the fetus has potentially increased the prevalence of conceptu- ment that there is seemingly frustration that maternal rights are alising pregnancy as a conflict-zone of competing interests. The seen to be interfering with the goal of protecting a fetus (clearly possibility of a fetus being gestated externally further increases placing the pregnant person, even if unintentionally, second in the visibility of the fetus and could potentially impact on how the pecking order) and ectogestation is thus seen as a tool to Protected by copyright. a fetus in a pregnancy is conceptualised. Sander-Saudt posits ensure these interests can be superseded. What is concerning that ‘conflicts between the rights of women and fetuses will be about these arguments concerning the welfare of fetuses (and/ heightened greatly as a result of this technology’.86 The view, or potential ‘ecto-children’xviii 93), is that they invite the poten- even sometimes expressed in the courtroom, that the fetus is tial for ‘increased control and pressure to use ectogenesis to ‘a fully formed child, capable of a normal life if only it could secure the fetus’,80 or to encourage compliance in a multitude of be delivered from the mother’87 is potentially emboldened by different ways with medical recommendations about behaviour technology that allows us to see, control and visualise gestation during pregnancy.96 Welin posits that, if ectogestation were to
in every material way. If there is an alternative space for gesta- come to fruition, ‘women who choose to have a natural preg- http://jme.bmj.com/ tion there may be an increased tendency, as this view is already nancy [in its place] will have to face restriction on lifestyles. At prevalent to some extent, to view the pregnant woman as a least, I believe it will be very hard to argue against such restric- ‘temporary fetal container’.79 These concerns reflect aspects of tion in order to protect the fetus…’.96 This kind of argumenta- Aristotle’s view of the woman as the mere ‘seed bed’.2 tion is maternal–fetal conflict rearing its ugly head once more The idea of there being an alternative to the pregnancy for and it is reminiscent of animalculism and the view of a woman the fetus is consistently used inappropriately in the context of as her husband’s ‘gestational carrier.’ 88 gestation to control the behaviour of pregnant women. The on October 5, 2020 at The University of Manchester Library. fact that a fetus if delivered prematurely might be able to survive Situating gestation and pregnancy in neonatal intensive care at a given fixed point (usually identi- Petchesky wrote of ultrasound imagery that women must be fied as 24 weeks) is repeatedly used as justification to control re-centred in discussions of pregnancy with attention to context; a woman’s body. After this point she is not allowed to end her placing the fetus ‘back into the uterus, and the uterus back into pregnancy unless a fetal abnormality is present, or her health the woman’s body and her body back into its social space’.18 is seriously threatened. The fact that the fetus could perhaps In discussions of ectogestation, there is an abject failure to survive ex utero—though it remains unlikely until 26 weeks89— recognise the realities of the technology that scholars are refer- prevents abortion on all but serious medical grounds. Simul- ring to. Arguments made about moral obligations of pregnant taneously, she is not allowed to prematurely deliver that fetus women or about the experience of pregnancy in the event of this intending for it to receive neonatal intensive care unless there is xv medical justification. The artificial womb is frequently posited xvi 90–92 78 93 94 Model AW prototypes currently being tested on animals are as both an alternative to abortion, and to pregnancy. reliant on the subject being developed beyond an embryo; for It is inappropriate to consider ectogestation as an alternative to example, it must have a primitive heartbeat to enable circula- tion.71 97 xvii It is hard to imagine a technology that could emulate natural xiv There are many women (and non-women) campaigning for a pregnancy so well that it was literally a direct alternative to right to gestate. For example, those who want to receive a womb pregnancy. transplant in order to be able to carry a pregnancy or women xviii Inevitably referring to the subject of an artificial womb as an who campaign for access to IVF treatment. ‘ecto-child’93 uses emotive language to describe the entity that xv For example, her life is threatened by a condition like can be potentially used to compel behaviour during pregnancy. preeclampsia or the fetus is displaying signs of intrauterine This is one of the reasons why the term ‘gestateling’ [105] for growth restriction. the subject of the artificial womb is thought to be important.
Romanis EC, et al. J Med Ethics 2020;0:1–10. doi:10.1136/medethics-2020-106160 7 Extended essay J Med Ethics: first published as 10.1136/medethics-2020-106160 on 29 July 2020. Downloaded from technology are based on unhelpful generalisations. What is most as a potential ‘second patient.’ Historical suspicion of the womb important to highlight is that in any event the capacities of the when obscured from view has equally endured, despite increasing technology mean that, first and foremost, gestation takes place visibility resulting from technologies routinely used in obstetric inside the female body. Any claims made directly about uses of care, as the womb, pregnancy and childbirth have institutionally or conditions following the development of the artificial womb been rendered an ‘emergency’62 warranting medical interven- inevitably impact on the female body and experiences of preg- tion. We must be mindful of these trends when speculating about nancy. Even where gestation can take place partially ex utero, it future technologies and in order to minimise notions of conflict is a process that originates from and remains partially unique to compromising care today. the female body. Placing this reality at the centre of argumenta- It is frequently posited that a wide variety of technologies, tion can prevent the subjugation of the gestating body and their from fetal heart rate monitoring in childbirth to ultrasound, have autonomy. enabled more intervention in pregnancy.62 This has strength- Furthermore, appropriate language must be used to describe ened the perception that the fetus has distinct interests that are pregnancy and gestation that is inclusive of diverse reproduc- directly impacted on by the pregnant woman’s behaviour, which tive experiences that differ person to person based on social is perceived as a potential threat to those interests. We demon- factors, lived realities and reproductive preferences. Reproduc- strated that this conception of conflict is erroneous in several tive consciousness is individual, complex and corporeal and thus ways, both conceptually and factually. It is additionally problem- 18 is difficult to generalise. It is crucial that natural pregnancy atic in that it fails to encompass the social context of pregnancy is not denigrated in discussions about the potential benefits of and the maternal–fetal unit. As Bowden explains, by ‘focussing the technology. While describing the extent to which artificial on the behaviour of pregnant women other more significant womb technology can alleviate some burdens in later-term preg- causes of prenatal harm such as poverty and poor prenatal care 75 nancy for women who may need or choose relief, Firestone are obscured and overlooked’.30 In order to ensure we respect 77 76 and Smajdor explicitly and Kendal implicitly use language women’s reproductive autonomy in a meaningful way, especially that devalues the capacities of the female body and the empow- in view of a future that may bring even more innovative tech- ering experiences of some pregnant women. Adopting language nologies and possibilities for intervention in pregnancy, we must that is inclusive of a range of reproductive experiences can help abandon this overly simplistic and biased concept. prevent the pathologisation of gestation and assist in the concep- Future reproductive technologies may have emancipatory tual understanding that the artificial womb is not a ‘direct’ alter- potential for women, but they may equally end up entrenching native to a natural pregnancy that can be used to dictate the problematic patriarchal notions and gender roles. Jackson warns Protected by copyright. conditions of pregnancy and the behaviours of pregnant women. that advocating for ectogestation as a safer alternative for fetuses Artificial wombs might be thought of, for some women, as would be extremely harmful ‘since it carries the implication that an alternative to continuing their pregnancy at some risk to the maternal body is a source of danger for the developing fetus their life or health. However, the artificial womb ought not to when this is of course very seldom the case’.79 The possibility be discussed as an ‘alternative’ in general terms to either abor- of advocating for ectogestation in place of pregnancy demon- 81 tion (because this claim is false ) or gestation. Gestation is the strates how the artificial womb might be preferred in order to process of genesis of a human entity in the womb; pregnancy is exert control over the process of gestation. The evident enthu- the task performed by the womb and female body in sustaining siasm for the idea that the power of creation would no longer be http://jme.bmj.com/ gestation. An ‘artificial womb’ may be an alternative form of the contained exclusively in the female body, reveals the power of process of gestation, but it is not an alternative womb (organ of the maternal–fetal conflict narrative. We can see this in the multi- the female body) or pregnancy. tude of authors who have made confident claims about a man’s Petchesky also contends that we must ‘separate the power rela- entitlement to equal control over ex utero gestation.96 98 These tions within which reproductive technologies, including ultra- seemingly echo the historical calls of medical men and putative sound imaging, are applied from the technologies themselves. fathers in their attempts to assert control over reproduction.
If women were truly empowered in the clinic setting, as practi- on October 5, 2020 at The University of Manchester Library. 18 We; therefore, should be mindful of these concerns in the devel- tioners and patients, would we discard the technologies?’ It is opment of technology that, in attempting to emulate gestation, clear that ectogestation has the potential to be an incredible tool has promising benefits for the care of preterm neonates and for to assist pregnant women and potential parent(s) where used as 97 women experiencing dangerous pregnancies. Reorienting our an alternative to neonatal intensive care and in the absence of understanding of pregnancy away from maternal–fetal conflict the concerning power dynamics outlined should be welcomed. will ensure that potential benefits from future assistive technolo- Our task then is to mediate how such technology can come to gies like ectogestation can be realised, but also will benefit preg- fruition without exacerbating problematic notions of pregnancy nant women experiencing problems resulting from conflict in and fetal welfare as oppositional to pregnant women; this is contemporary prenatal care. best done by demanding that the maternal–fetal framework is abandoned. Twitter Elizabeth Chloe Romanis @ECRomanis and Dunja Begović @begovic_dunja Acknowledgements We are grateful to the Institute of Medical Ethics for funding our symposium ’Reconceiving the Womb in Medicine, Law and Society.’ This article is CONCLUSION based on one of the themes that emerged at this event. We are also thankful to all Examining historical medical and social attitudes to women, of the participants who attended this event, and in particular to all of the presenters and particularly pregnant women, helps us understand how and panellists: Sarah Fox, Caroline Henaghan, Stephen Wilkinson, Nicola Williams, and why misogynist tropes and damaging narratives about Emily Jackson, Professor Susan Bewley, Emma Cave, Becki Bennett, Laura O’Donovan and Catherine Bowden. We would also like to thank the two anonymous reviewers maternal–fetal conflict endure over time, influencing the (mis) for their kind and constructive comments on an earlier draft of this paper. treatment of pregnant women now and potentially in the future. Contributors All authors contributed to the conception, planning and writing of We explored how historical narratives of the woman’s purpose this article. MRB wrote the section on historical background, DB and ECR wrote as ‘gestational carrier’ have persisted as increasing access to the the section concerning contemporary technologies and ethical issues, AKM and womb has influenced the perception of the fetus and its status ECR wrote the section on legal issues, DB and ECR wrote the section on reframing
8 Romanis EC, et al. J Med Ethics 2020;0:1–10. doi:10.1136/medethics-2020-106160 Extended essay J Med Ethics: first published as 10.1136/medethics-2020-106160 on 29 July 2020. Downloaded from conflict and ECR wrote the section on ectogestation. 30 Bowden C. Are we justified in introducing carbon monoxide testing to encourage smoking cessation in pregnant women? Health Care Anal 2019;27(2):128–45. Funding This article is based on themes emerging at a symposium that was funded 31 Harris LH. Rethinking maternal-fetal conflict: gender and equality in perinatal ethics. by the Institute of Medical Ethics. Work on artificial wombs by Elizabeth Chloe Obstet Gynecol 2000;96(5 Pt 1):786–91. Romanis is supported by a Wellcome Trust Studentship in Society and Ethics (grant 32 Post LF, Farber Post L. Bioethical consideration of Maternal-Fetal issues. Fordham reference 208245/Z/17/Z). Urban Law J 1997;24(4):757–76. Competing interests None declared. 33 Steinbock B. Maternal-Fetal conflict and in utero fetal therapy. Albany Law Rev 1994;57(3):781–94. Patient consent for publication Not required. 34 Wilkinson D, Skene L, De Crespigny L, et al. Protecting future children from in-utero Provenance and peer review Not commissioned; externally peer reviewed. harm. Bioethics 2016;30(6):425–32. 35 Oduncu FS, Kimmig R, Hepp H, et al. Cancer in pregnancy: maternal-fetal conflict. J Open access This is an open access article distributed in accordance with the Cancer Res Clin Oncol 2003;129(3):133–46. Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits 36 Ohel I, Levy A, Mazor M, et al. Refusal of treatment in obstetrics – a maternal-fetal others to copy, redistribute, remix, transform and build upon this work for any conflict. J Matern. -Fetal Neonatal Med 2008;22:612–5. purpose, provided the original work is properly cited, a link to the licence is given, 37 Pinkerton JV, Finnerty JJ. Resolving the clinical and ethical dilemma involved in fetal- and indication of whether changes were made. See: https://creativecommons.org/ maternal conflicts. Am J Obstet Gynecol 1996;175(2):289–95. licenses/by/ 4.0/. 38 Fasouliotis SJ, Schenker JG. Maternal–fetal conflict. Eur J Obstet Gynecol Reprod Biol 2000;89(1):101–7. ORCID iD 39 McCullough L, Chervenak F. Ethics in obstetrics and gynecology. Oxford University Elizabeth Chloe Romanis http://orcid. org/0000- 0002-8774- 4015 Press: Oxford, 1994. 40 Fleischman AR, Chervenak FA, McCullough LB. The physician’s moral obligations to the pregnant woman, the fetus, and the child. Semin Perinatol 1998;22(3):184–8. 41 Chervenak FA, McCullough LB, Skupski D, et al. Ethical issues in the management of pregnancies complicated by fetal anomalies. Obstet Gynecol Surv REFERENCES 2003;58(7):473–83. 1 McKeown J. God’s babies: Natalism and Bible interpretation in modern America, 42 Hollander M, van Dillen J, Lagro-Janssen T. Women refusing standard obstetric care: Cambridge. Open Book Publishers 2014. maternal fetal conflict or Doctorpatient conflict? J Preg Child Health 2016;03(02). 2 De Renzi S. Women and medicine in Elmer P (ED). The healing arts: health medicine 43 McLean SAM. Abortion law: is Consensual reform possible? J Law Soc and society in Europe 1500-1800. Manchester: Manchester University Press, 1990;17(1):106–23. 2004: 198–227. 44 Alghrani A. Regulating the Reproductive Revolution: Ectogenesis – A Regulatory 3 Brazier M. The body in time. Law, Innovation and Technology 2015;7(2):161–86. Minefield? In: Freeman M, ed. Law and bioethics. Oxford: Oxford University Press, 4 v R R. 1 AC 599, H.L 1991. 2008: Volume 11. 303–32. 5 Vesalius A. De Humani corporis Fabrica. 1543. Italy. 45 Patonv. British pregnancy Advisory service trustees and another 1978. 6 Merskey H, Merskey FJ. Hysteria, or “suffocation of the mother.. CMAJ 46 Attorney General’s Reference (No. 3 of 1994) 1997. 1993;148:395–405. 47 Cp (a child) V criminal injuries compensation authority 2015.
7 Rawcliffe C. Medicine and society in later medieval England. London: Sandpiper Protected by copyright. 48 Section 1 infant life preservation act 1929. Books, 1999. 8 Green M. The Trotula: An English Compendium of Women’s Medicine. Philadelphia: 49 Sections 58 and 59 offences against the person act 1861. University of Pennsylvania Press, 2002. 50 Section 4 abortion act 1967. 9 Shorter E. A History of Women’s Bodies. London: Penguin Books, 1984. 51 Jackson E. Abortion, autonomy and prenatal diagnosis. Soc Leg Stud 10 Abbott EC. The wicked womb. CMAJ 1993;148(3):381–2. 2000;9(4):467–94. 11 Pelletier R, Humphries KH, Shimony A, et al. Sex-Related differences in access 52 Re MB (medical treatment) 1997. to care among patients with premature acute coronary syndrome. CMAJ 53 St. George’s Healthcare NHS Trust v S 1998. 2014;186(7):497–504. 54 Francis R. Compulsory caesarean sections: an English perspective. J Contemp Health 12 Howe D. Ethics of prenatal ultrasound. Best Pract Res Clin Obstet Gynaecol Law and Policy 1997;14:365–89. 2014;28(3):443–51. 55 Montgomery V Lanarkshire health board 2015. UKSC 11.
13 Adzick NS. Fetal surgery for spina bifida: past, present, future. Semin Pediatr Surg 56 Romanis EC. Why the elective caesarean lottery is ethically impermissible. Health http://jme.bmj.com/ 2013;22(1):10–17. Care Anal 2019;27(4):249–68. 14 Lyerly AD, Little MO, Faden RR. A critique of the ’fetus as patient’. Am J Bioeth 57 Paltrow LM, Flavin J. Arrests of and forced interventions on pregnant women in the 2008;8(7):42–4. United States, 1973-2005: implications for women’s legal status and public health. J 15 Douglas G. Law, fertility and assisted reproduction. London: Sweet & Maxwell, 1991. Health Polit Policy Law 2013;38(2):299–343. 16 Taylor J. The public life of the fetal Sonogram: technology, consumption and the 58 Kingma E, Finn S. Neonatal incubator or artificial womb? distinguishing politics of reproduction. New Brunswick, Rutgers University Press, 2008. ectogestation and ectogenesis using the metaphysics of pregnancy. Bioethics 17 Tropp L. A Womb with a View: America’s Growing Public Interest in Pregnancy. ’ 2020;34(4):354–63. Santa Barbara, Praeger 2013. 59 Kingma E. Were you a part of your mother? Mind 2019;128(511):609–46. 18 Petchesky RP, Pollack Petchesky R. Fetal images: the power of visual culture in the 60 Singer P. Practical ethics. Cambridge: Cambridge University Press, 1993. on October 5, 2020 at The University of Manchester Library. politics of reproduction. Feminist Studies 1987;13(2):263–92. 61 Singh P. Fetuses, newborns, & parental responsibility. J Med Ethics 19 Mattingly SS. The maternal-fetal dyad. exploring the two-patient obstetric model. 2020;46(3):188–93. Hastings Cent Rep 1992;22(1):13–18. 62 Wolf AB, Charles S. Childbirth is not an emergency: informed consent in labor 20 Cao KX, Booth A, Ourselin S, et al. The legal frameworks that govern fetal surgery and delivery. IJFAB: International Journal of Feminist Approaches to Bioethics in the United Kingdom, European Union, and the United States. Prenat Diagn 2018;11(1):23–43. 2018;38(7):475–81. 63 Adhikari R, Sawangdee Y. Influence of women’s autonomy on infant mortality in 21 Chervenak FA, McCullough LB. The fetus as a patient: an essential ethical concept Nepal. Reprod Health 2011;8:7. for Maternal-Fetal medicine. J Matern Fetal Med 1996;5(3):115–9. 64 Sharma A, Kader M. Effect of women’s decision-making autonomy on infant’s birth 22 McLean SAM. The moral and legal boundaries of fetal intervention: whose right/ weight in rural. Bangladesh: ISRN Pediatr, 2013. whose duty. Seminars in Neonatology 1998;3(4):249–54. 65 GSTT & SLAM v R 2020. 23 Markens S, Browner CH, Press N. Feeding the fetus: on interrogating the notion of 66 Romanis EC. Pregnant Women May Have Moral Obligations to Foetuses They Have Maternal-Fetal conflict. Fem Stud 1997;23(2):351–72. Chosen to Carry to Term, But the Law Should Never Interfere in a Woman’s Choices 24 Isaacson N. The “fetus-infant”: Changing classifications ofIn Utero development in During Pregnancy. Manchester Rev. L. Crime & Ethics 2017;6:69–85. medical texts. Sociol Forum 1996;11(3):457–80. 67 Morris T, Robinson JH. Forced and Coerced cesarean sections in the United States. 25 Harvey ME, David AL, Dyer J, et al. Pregnant women’s experiences and perceptions Contexts 2017;16(2):24–9. of participating in the EVERREST prospective study; a qualitative study. BMC 68 Chazotte C, Youchah J, Freda MC. Cocaine using during pregnancy and low Pregnancy Childbirth 2019;19(1):144. birth weight: the impact of prenatal care and drug treatment. Semin Perinatol 26 Baylis F, Rogers S, Young D. Ethical Dilemmas in the Care of Pregnant Women: 1995;19(4):293–300. Rethinking ’’Maternal–Fetal Conflicts. In: Singer P, Viens A, eds. The Cambridge 69 El-Mohandes A, Herman AA, Nabil El-Khorazaty M, et al. Prenatal care reduces the textbook of bioethics. Cambridge: Cambridge University Press, 2008: 97–103. impact of illicit drug use on perinatal outcomes. J Perinatol 2003;23(5):354–60. 27 Steinbock B. Mother-Fetus Conflict. In: Kuhse H, Singer P, eds. A companion to 70 Goodwin M. How the Criminalization of pregnancy Robs women of reproductive bioethics. Oxford. Blackwell Publishing, 2009: 149–60. autonomy. Hastings Cent Rep 2017;47 Suppl 3:S19–27. 28 Chavkin W, Bernstein P. Maternal-fetal conflict is not a useful construct. In: 71 Partridge EA, Davey MG, Hornick MA, et al. An extra-uterine system to McCormick M, Siegel J, eds. Prenatal care: effectiveness and implementation. physiologically support the extreme premature lamb. Nat Commun 2017;8(1):1–15. Cambridge: Cambridge University Press, 1995: 285–300. 72 Usuda H, Watanabe S, Miura Y, et al. Successful maintenance of key physiological 29 Townsend SF. Ethics for the pediatrician: obstetric conflict: when fetal and maternal parameters in preterm lambs treated with ex vivo uterine environment therapy for a interests are at odds. Pediatr Rev 2012;33(1):33–7. period of 1 week. Am J Obstet Gynecol 2017;217(4):457.e1–457.e13.
Romanis EC, et al. J Med Ethics 2020;0:1–10. doi:10.1136/medethics-2020-106160 9 Extended essay J Med Ethics: first published as 10.1136/medethics-2020-106160 on 29 July 2020. Downloaded from
73 Davis N. Artificial womb: Dutch researchers given €2.9m to develop prototype. 90 Colgrove N. Subjects of ectogenesis: are ’gestatelings’ fetuses. newborns or neither? Guardian, 2019. Available: https://www.theguardian.com/ society/2019/ oct/08/ J Med Ethics 2019;45:723–6. artificial-womb- dutch-researchers- given-29m- to-develop- prototype [Accessed 17 91 Kaczor C. Ectogenesis and a right to the death of the prenatal human being: a reply Feb 2020]. to Räsänen. Bioethics 2018;32(9):634–8. 74 Simonstein F, Mashiach-Eizenberg M. The artificial womb: a pilot study considering 92 Simkulet W. Abortion and Ectogenesis: moral compromise. J Med Ethics people’s views on the artificial womb and ectogenesis in Israel. Camb Q Healthc 2020;46(2):93–8. Ethics 2009;18(1):87–94. 93 Hammond-Browning N. A new dawn: ectogenesis, future children and reproductive 75 Firestone S. The dialectic of sex: the case for feminist revolution. New York: William choice. Contemporary Issues in Law 2018;14(4):349–73. Morrow and Company, 1970. 94 Pence G. What’s so good about natural motherhood? (In praise of unnatural 76 Kendal K. Equal opportunity and the case for state sponsored Ectogenesis. London: motherhood). In: Gelfand S, Shook J, eds. Ectogenesis. artificial womb technology Palgrave, 2015. and the future of human reproduction. Amsterdam, Rodopi, 2006: 77–88. 77 Smajdor A. In defense of ectogenesis. Camb Q Healthc Ethics 2012;21(1):90–103. 95 Department of Health. Abortion statistics, England and Wales, 2018. Available: 78 Romanis EC. Artificial womb technology and the choice to Gestate ex utero: is https://assets. publishing.service. gov.uk/ government/uploads/ system/uploads/ partial Ectogenesis the business of the criminal law? Med Law Rev 2019. attachment_data/ file/808556/ Abortion_Statistics__ England_and_ Wales_2018__ 79 Jackson E. Degendering reproduction? Med Law Rev 2008;16(3):346–68. 1_.pdf [Accessed 12 Apr 2020]. 80 Cavaliere G. Gestation, equality and freedom: ectogenesis as a political perspective. 96 Welin S. Reproductive ectogenesis: the third era of human reproduction and some J Med Ethics 2020;46(2):76–82. moral consequences. Sci Eng Ethics 2004;10(4):615–26. 81 Romanis EC, Horn C. Artificial Wombs and the Ectogenesis conversation: a misplaced 97 Romanis EC. Artificial womb technology and the frontiers of human reproduction: focus? technology, abortion and reproductive freedom. IJFAB 2020. forthcoming. conceptual differences and potential implications. J Med Ethics 2018;44(11):751–5. 82 Vallerdú J, Boix S. Ectogenesis as the Dilution of Sex or the End of Females? In: Loh 98 Brassington I. The glass womb in Simonstein F (ED). Reprogen-ethics and the future J, Coeckelbergh M, eds. Feminist philosophy of technology. Stuttgart: J.B. Metzler, of gender. Dordrecht, Springer: 197–209. 2020: 2. 105–22. 99 Gallagher J. First womb-transplant baby born. BBC 4, 2014. Available: https://www. 83 Limon C. From surrogacy to Ectogenesis: reproductive justice and equal opportunity bbc.co. uk/news/ health-29485996 [Accessed 22 Oct 2019]. in neoliberal times. Australian Feminist Studies 2016;31(88):203–19. 100 Jones BP, Williams NJ, Saso S, et al. Uterine transplantation in transgender women. 84 Burrow S. On the cutting edge: ethical responsiveness to cesarean rates. Am J Bioeth BJOG 2019;126(2):152–6. 2012;12(7):44–52. 101 Schultz J. Development of Ectogenesis: how will artificial Wombs affect the legal 85 Romanis EC. Addressing rising caesarean rates: elective Caesareans, defensive status of a fetus or embryo. Chic-Kent Law Rev 2010;84:877–906. practice and the power of choice in childbirth. IJFAB 2020;13(1):1–26. 102 Gelfand S. Ectogenesis and the Ethics of Care. In: Gelfand S, Shook J, eds. 86 Sander-Saudt M. Of Machine Born? A Feminist Assessment of Ectogenesis and Ectogenesis. artificial womb technology and the future of human reproduction. Artificial Wombs. In: Gelfand S, Shook J, eds. Ectogenesis. artificial womb technology Amsterdam: Rodopi, 2006: 89–108. and the future of human reproduction. Amsterdam, Rodopi, 2006: 109–28. 103 Horn C, Romanis EC. Establishing Boundaries for Speculation about Artificial 87 Norfolk and Norwich Healthcare (NHS) Trust v W 1997. Wombs, Ectogenesis, Gender and the Gestating Body. In: Jurisprudence of the body, 88 Romanis EC. Partial ectogenesis: freedom, equality and political perspective. J Med 2020. Ethics 2020;46(2):89–90. 104 Vo V France 2004. 89 Lissauer T, Clayden G. Illustrated textbook of pediatrics. London: Mosby Elsevier, 105 McGuinness S. Law, reproduction, and disability: fatally ’handicapped’? Med Law
2012. Rev 2013;21(2):213–42. Protected by copyright. http://jme.bmj.com/ on October 5, 2020 at The University of Manchester Library.
10 Romanis EC, et al. J Med Ethics 2020;0:1–10. doi:10.1136/medethics-2020-106160
Appendix 8 – Is ‘Viability’ Viable? Abortion, Conceptual Confusion and the Law in England and Wales and the United States (2020) Journal of Law and the Biosciences (forthcoming)
352
IS ‘VIABILITY’ VIABLE? ABORTION, CONCEPTUAL CONFUSION AND THE LAW IN ENGLAND AND WALES AND THE UNITED STATES
ORIGINAL ARTICLE (Accepted Manuscript)
Research conducted at the University of Manchester and the University of Toronto.
Ms. Elizabeth Chloe Romanis Centre for Social Ethics and Policy Department of Law University of Manchester Manchester M13 9PL [email protected]
ABSTRACT In this paper I explore how viability, meaning the ability of the fetus to survive post-delivery, features in the law regulating abortion provision in England and Wales and the United States. I demonstrate that viability is formalised differently in the criminal law in England and Wales and the US; such that it is quantified and defined differently. In this paper I consider how the law might be applied to the examples of artificial wombs and anencephalic fetuses. I conclude that there is incoherence in the meaning of viability and argue that it is thus a conceptually illegitimate basis on which to ground abortion regulation. This is both because of the fluidity of the concept and because how it has been thus far understood in the law is unsupported by medical realities. Furthermore, it has the effect of heavily diluting pregnant people’s rights with overly moralistic limitations on access to healthcare.
KEYWORDS Abortion, Artificial Wombs, Comparative Law, Criminal Law, Reproductive Health, Viability
1
INTRODUCTION The status of human entities before birth has been a subject of debate for centuries and remains highly contested. In need of a pragmatic answer, the law in many jurisdictions has adopted a gradualist approach to abortion regulation and provision. Viability has, thus, become an important feature of the law. Viability is ‘the ability [of a developing fetus] to survive independent of a pregnant woman’s womb’.1 In jurisdictions adopting this approach, abortion is lawful, or accessed with less difficulty, before the point that a fetus is deemed viable. After viability, abortion is lawful in a narrower set of circumstances and/or harder to access. Gradualism as grounds for determining the moral permissibility of abortion has been subject to heavy challenge in philosophical literature. Viability remains, however, enshrined as a legal concept in multiple jurisdictions, perhaps exemplifying the gap between moral reasoning and the law (which is inevitably more arbitrary). Lawmakers often paint viability as a workable position somewhere between the demands of the anti-choice and the pro-choice campaigns found in the political landscape of England and Wales and the United States (US). The politicised labelling of viability as a compromise is misplaced, however, because viability limits access to healthcare. The meaning afforded to the concept of viability in the law is therefore hugely impactful.
In this paper, I consider how viability features, is defined and is utilised in the law in England and Wales and the US, and whether these conceptions of viability are legally coherent. The impact of viability as a tool in legal regulation that limits access has been well explored. It is often argued that viability should not be utilised as a legal metric to ground abortion rights.2 In this paper, I consider the parameters of viability as a legal concept, specifically how it has been both defined and quantified and its conceptual grounding. Most literature that criticises the concept has not considered the mechanics of the concept in terms of how it is defined and instrumentalised. Since viability is so entrenched in the law, we should have a clear understanding of its meaning that can be consistently articulated and be able to justify its inclusion as a legal standard. In this paper, I demonstrate that while viability is often described in a simple account of ‘the ability of a fetus to survive after pregnancy’ the concept has been deployed, understood and defined in vastly different ways in the US and England and Wales. I argue that for viability to be considered a coherent concept, it must have a rational and cogent basis that is consistent about what kind of life ex utero matters legally and can be consistently applied in different circumstances. I echo calls made by other scholars that it is inappropriate to ground regulation by reference to viability, however, I do so by considering by what logics the particular legal regimes identified recognise viability as a justifiable concept and standard of compromise in abortion law.
I compare the law in these two jurisdictions because, despite some economic and cultural similarities between them, they have different modern histories of abortion law, abortion politics and systems of provision.3 In the US abortion provision is in the hands of State legislatures that are subject to some restrictions by the Supreme Court, which has interpreted the Constitution, most notably in Roe v Wade4 and Planned Parenthood v Casey,5 to
1 J. GLOVER, CAUSING DEATH AND SAVING LIVES, 124 (Penguin, 1990). 2 E.g. Joanna Erdman, Theorizing Time in Abortion Law and Human Rights, 19 Health and Human Rights 31, 35 (2017). 3 D. HALFMANN, DOCTORS AND DEMONSTRATORS: HOW POLITICAL INSTITUTIONS SHAPE ABORTION LAW IN THE UNITED STATES, BRITAIN AND CANADA 4 (Chicago University Press, 2011). 4 Roe v Wade US 113 (1973). 5 Planned Parenthood v Casey 112 US 2791 (1992). 2
recognise that abortion is encompassed in the right to privacy. In England and Wales, no right to abortion is recognised, but Parliament has legislated to ensure medicalised access under certain circumstances.6 Viability features in both these frameworks to differing degrees. The US Supreme Court has been explicit that the right to abortion is limited by foetal viability. In England and Wales, the statutory framework has, both directly and indirectly, the effect of ensuring access becomes more limited after foetal viability. These jurisdictions are therefore useful points of comparison for examining the coherence of viability because it is featured, defined, and quantified differently in both.7
First, I demonstrate the extent to which viability determines the legality, or provision, of abortion in both jurisdictions. Second, I test the concept of viability that is contained in the law of each jurisdiction by considering its application to two specific cases: the development of artificial womb technology and anencephaly. Artificial womb technology is of interest because such a development might challenge the viability timeline by enabling the support of fetuses ex utero much earlier in gestation.8 Fetuses with conditions incompatible with life such as anencephaly are of interest because they allow investigation of the possibility that viability is a rebuttable presumption later in gestation. I demonstrate that there are internal inconsistencies in the application of the law in these jurisdictions in how the law is applied to these two case studies. There are, therefore, problems in how viability has been legally conceptualised and in implementing viability as a feature of the law, resulting in inconsistency in the legal recognition afforded to fetuses and in determining what kind of life matters ex utero. Finally, I argue that viability is not a conceptually legitimate basis for abortion regulation.
THE ORIGINS OF VIABILITY Before delving into the particularities of how viability is both featured and articulated in the law in the US and England and Wales, it is necessary to first explore the conceptual foundations of viability as a concept.
The central role of gradualism in theorising about the fetus has long been evident. Based on the work of physicians such as Hippocrates, who advanced a gradualist account of fetal formation and development,9 Aristotle considered the moral significance of a fetus as increasing with its development. His theory, centred on ‘ensoulment,’ suggested that the embryo is a ‘vegetative soul’ potentially equivalent to that of plant life, but it attains a more
6 Abortion Act 1967, s.1 (1) (a) as amended by s.37 Human Fertilisation and Embryology Act 1990, s.37. 7 The author notes the choice of jurisdiction is also the result of their expertise in English law and the prominence of American conceptions of viability in the discourse on abortion law. This work was completed during a research visit at the University of Toronto. 8 For a thorough comparative account of how the invention of artificial womb technology (both capable of partially or completely capable of facilitating gestation extra uterum) would affect both the legality of and access to abortion in the United Kingdom, the United States and Canada see: C. HORN, GESTATION BEYOND MOTHER/MACHINE: LEGAL FRAMEWORKS FOR ARTIFICIAL WOMBS, ABORTION AND CARE (PhD Thesis, Birkbeck University of London, 2020). This thesis more thoroughly addresses concerns related to the regulation of artificial wombs in these jurisdictions. The concern of this paper is not the regulation of artificial womb technology, but the coherency of viability as a legal construct and artificial womb technology is utilised as an example to illustrate some of the problems with the concept of viability. 9 For a full account of the earliest medical theories of fetal growth (and concepts of ensoulment) see: Véronique Dasen, Becoming Human: From the Embryo to the Newborn Child, in THE OXFORD HANDBOOK OF CHILDHOOD AND EDUCATION IN THE CLASSICAL WORLD, 18 (Judith Evans Grubbs and Tim Parkin eds., 2013). 3
sentient existence and soul as it attains a human shape - when the fetal body is formed and movement can be perceived.10 The theory that ‘quickening,’ the moment that fetal movement is first perceived, marked a morally significant moment in fetal development persisted throughout the centuries featuring in the work of Thomas Aquinas11 amongst others. These accounts focus, much like the modern conception of viability, on identifying a particular feature of the fetus’s capacities in order to isolate the point at which it can be thought of as a ‘living being.’ The focus began shifting away from quickening to viability in the late nineteenth century with advancing medical technology and increasing obstetrical knowledge. Viability as a concept has its origins in the emergence of contemporary prenatal care. With the revelation of a design of a neonatal incubator at the World Exposition in 1896,12 viability became an increasingly important indicator as a matter of medical ‘pragmatic concern’13 in the context of prenatal care. Viability is, in a medical sense, the point at which there is a reasonable probability that a fetus could survive ex utero when provided with care. Primarily, the concept is utilised by clinicians in the context of spontaneous preterm delivery to determine whether the provision of intensive care is appropriate.14
There is some extent to which the theory that viability as the point at which the fetus becomes deserving of some protection as a ‘living being’ and thus is a relevant consideration in the regulation of abortion came to fruition as a form of political compromise. Lavi explains that this is often because the concept is often presented as a ‘plain reality and a non-controversial development stage that any reasonable person would acknowledge.’15 The logic being that ‘once the fetus is viable, its status as a full-human being seems to be a self-evident truth. The viable fetus no longer needs to become a full-human being, it is ready to begin to live an independent life.’16 It therefore, seemingly, presents a position based on an exercise of logic, but that also allows pregnant people the chance to access abortion care up to a certain point, after which the fetus is ‘entitled’ to certain protections. Later in this paper, I will review the significant criticism that is deployed against viability as a morally significant moment in fetal development and criticise the extent to which viability can be understood as a compromise in abortion regulation.
VIABILITY IN THE LAW This section outlines how abortion provision is dependent upon determinations about viability in England and Wales and the US and makes some preliminary comparative observations.
10 ARISTOTLE, DE ANIMA (ON THE SOUL), (Penguin Books, 1986). 11 T. AQUINAS, ON HUMAN NATURE, (Hackett Publishing, 1999). 12 William Silverman, Incubator-Baby Side Shows, 64 Pediatrics 127, 129 (1979). 13 Shai Lavi, Beyond Natural Potentiality: Brain Death Pregnancy, Viable Fetuses, and Pre-Implanted Embryos, 11 LEHR 161, 182 (2017). 14 E.g. Nuffield Council on Bioethics, Critical Care Decisions in Fetal and Neonatal Medicine: Ethical Issues (2006) http://nuffieldbioethics.org/wp-content/uploads/2014/07/CCD-web-version-22-June-07- updated.pdf accessed Jul 27 2019. 15 Lavi supra note 13 at 182. 16 Id. 4
A. England and Wales Under S.58 and 59 of the Offences Against the Persons Act 1861, it is a crime for any person (including the pregnant person) to unlawfully procure a miscarriage. This crime can be committed at any point in gestation, irrespective of any perceived (in)capacities of the fetus to survive ex utero.17 The Infant Life (Preservation) Act 1929 created the offence of child destruction, committed when a person wilfully acts to intentionally destroy a fetus capable of being born alive.18 The Abortion Act 1967 (AA 1967) provides medical practitioners with a defence to these criminal offences in a proscriptive list of circumstances, the first of which is termed the ‘social ground for abortion’ and stipulates that termination is lawful if two doctors agree that ‘the pregnancy has not exceeded its twenty-fourth week and continuing the pregnancy would involve risk (greater than if the pregnancy were terminated) of injury to the physical or mental health of the pregnant woman or any existing children of her family’.19 This does not provide pregnant persons with any right to pregnancy termination, because the AA 1967 is still framed in medical terms; termination can be provided before 24 weeks provided that the risk of continuing the pregnancy is greater than the risks of termination. However, this provision is so broad it renders ‘every pregnancy legally terminable within the first 24 weeks’.20 This defence in the AA 1967 has installed an implicit viability threshold. There are defences available for doctors performing abortion after 24 weeks, however, they are harder to establish and require ‘clear proof of the more serious danger specified’.21 These grounds consist only of where the termination is necessary to prevent ‘grave permanent injury’ to the physical or mental health of the pregnant woman, where pregnancy is a greater risk to the woman’s life than termination, or where there is a substantial risk that the fetus has serious abnormalities.22 Because the defences available to a doctor to avoid criminal sanction after 24 weeks are narrower, and framed in terms of greater severity, the AA 1967 appears to grant a limited ‘right to be gestated’ to fetuses from 24 weeks. This is, of course, subordinate to pregnant people’s life and health, but notably the law distinguishes between the justifications for abortion before and after this point.
There is a more explicit reference to viability in the offence of child destruction criminalising the abortion of fetuses capable of being born alive. The Infant Life (Preservation) Act 1929 (ILPA 1929) provides limited guidance on the meaning of capable of being born alive, other than to stipulate that reaching 28 weeks’ gestation was prima facie proof. This minimum threshold was subsequently lowered to 24 weeks.23 Section 5 of the AA 1967 was amended in 199024 to specify that this offence is not committed when a medical practitioner conducts abortion in the circumstances outlined by the Abortion Act. It remains unclear whether the Abortion Act offers the more stringent protection to fetuses only at 24 weeks and beyond, or whether fetuses before 24 weeks are also encompassed if proof can be if they are capable of being born alive. It is possible to view the 24-week threshold as either fixing legal viability to
17 Andrew Grubb, Abortion Law in England: The Medicilization of a Crime, 18. Law, Med. Healthcare., 146, 149 (1990). 18 Infant Life Preservation Act 1929, s.1 (1). 19 Abortion Act 1967, s.1 (1) as amended by Human Fertilisation and Embryology Act 1990, s.37. 20 E. JACKSON, REGULATING REPRODUCTION: LAW, TECHNOLOGY AND AUTONOMY 80 (Hart Publishing 2011). While it may be true that the law only imposes stricter restrictions on access to abortion after 24 weeks, it is difficult, in reality, for women in the UK to access abortion after 16-18 weeks. This is because there are relatively few providers that offer late second trimester abortions. I am grateful to an anonymous reviewer for raising this point. 21 Andrew Grubb, The new law of abortion: clarification or ambiguity? Crim LR 659, 661 (1991). 22 Abortion Act 1967, s.1 (1) (b) – (d) as amended by s.37 Human Fertilisation and Embryology Act 1990, s.37. 23 Id, s.1 (1) (a). 24 Human Fertilisation and Embryology Act 1990, s.37. 5
this point (regardless of whether this matches medical reality/ opinion) or as a guideline marking the point from which viability is legally assumed, but not necessarily precluding the recognition of younger fetuses as viable.
The language used in the AA 1967 and ILPA 1929 is significant. There were ample opportunities for Parliament when drafting the AA 1967 or amending it in 1990 to specify that the AA 1967 24-week threshold was superseding a ‘capable of being born alive’ standard. It plausible, therefore, that capable of being born alive was intended to afford protection to some fetuses before 24 weeks; preventing termination unless the grounds under the AA 1967 were met. Judges have interpreted capable of being born alive in this way. In C v S25 the Court of Appeal judgment afforded considerable time to considering medical evidence to ascertain whether an 18-week fetus was capable of being born alive under the ILPA 1929. The legislative threshold is thus ‘only a presumption which relieves the prosecution of the burden of proving viability’ after that point and ‘does not prevent proof that a particular fetus is viable at an earlier stage in development’.26 C v S was decided before the 1990 amendments to the AA 1967 but demonstrates that there is potential for the viability timeline to be shifted, increasing the scope for liability if there is not strict adherence to the defences in the AA 1967.
What is encompassed in the capacity to be born alive? In C v S, Donaldson MR stipulated that a fetus was capable of being born alive only if it could breathe after birth, with or without a ventilator.27 In Rance,28 Brooke J suggested a fetus would be viable only when capable of ‘living through its own lungs alone, without deriving any of its living or power of living through any connection with its mother’.29 English law clearly focuses on the capacity to breathe to establish viability. In C v S, Mr C claimed that capable of being born alive was a more restrictive legal concept than viability; it need only be established that the fetus could survive no more than birth.30 It was held that being born at 18 weeks would result in little hope of survival, because there would be no capacity to breathe. This did not resolve the issue of whether the capacity to breathe only for a short time after birth would be sufficient, or whether the capacity would have to be more substantial (such as longer-term use of the lungs). Intuitively, capable of being born alive is intended to convey a capacity to breathe for some reasonable time after birth.31 The wording of the ILPA 1929 implies the offence would be committed when a fetus is delivered alive and breathes but does not live long after that. The presumption in the AA 1967 that a fetus is capable of being born alive from 24 weeks gestation demonstrates Parliament’s intention to include fetuses that once born may not survive in the longer term, given the usual prognosis of neonates born at this point in gestation, that would have been even worse 20 years ago when the threshold was made law.32 Viability in English law means capable of being born alive and surviving for a time by breathing, rather than being born alive and surviving in the longer term.
25 C v S [1987] 1 All ER 1230. 26 Grubb, supra note 17 at 150. 27 C v S, supra note 25 at 151 per Donaldson MR. 28 Rance and Another v Mid-Downs Health Authority and Another [1991] 1 QB 587. 29 Id. at 620-621 per Brooke J. 30 C v S, supra note 25. 31 J. MASON, THE TROUBLED PREGNANCY: LEGAL RIGHTS AND WRONGS IN REPRODUCTION, 21 (Cambridge University Press, 2007); Abortion Act 1967, s.1 (1) (a) as amended by Human and Fertilisation Embryology Act 1990, s.37. 32 Elizabeth Chloe Romanis, Challenging the ‘Born Alive’ Threshold: Fetal Surgery, Artificial Wombs, and the English Approach to Legal Personhood, 28 Med Law Rev. 99, 110 (2020). 6
B. The United States In Roe v Wade, the Supreme Court recognized that the constitutional right to privacy encompasses the right to terminate a pregnancy, but this right could be qualified by the state’s interest in potential life at fetal viability. The right to abortion continues until the point a fetus becomes ‘potentially able to live outside the mother’s womb, albeit with artificial aid’.33 Blackmun J advanced a ‘trimester framework’ to separate different developmental phases in gestation and illustrate the differing levels of state interference that could be lawfully justified in each. Roe holds that ‘with respect to the State’s important and legitimate interest in potential life, the ‘compelling’ point is at viability… if the State is interested in protecting fetal life after viability, it may go so far as to proscribe abortion during that period, except when it is necessary to preserve the life or health of the mother’.34 This point was identified as the third trimester of pregnancy. 19 years later in Casey35 the Supreme Court, while abandoning Blackmun’s trimester framework, reaffirmed ‘that viability marks the earliest point at which the state’s interest in fetal life is constitutionally adequate to justify a legislative ban on non therapeutic abortions’ emphasising that ‘the attainment of viability may continue to serve as the critical fact…’.36 The Court replaced the trimester framework with the ‘undue burden’ test; holding that a law is unconstitutional if its ‘purpose or effect is to place substantial obstacles in the path of a woman seeking an abortion before the fetus attains viability’.37
Pregnant people have the right to terminate pregnancy, as part of the constitutional right to privacy, until foetal viability. Individual states must refrain from passing laws that unduly interfere with access to abortion until viability. After viability, States can pass whatever restrictions on abortion they see fit, expect that a pregnant person must still be able to access abortion if their pregnancy poses a serious risk to their health or life. This clear delineation by viability begs the question about its definition. In Casey viability was defined as ‘the time at which there is a realistic possibility of maintaining and nourishing a life outside the womb, so that the independent existence of the second life can in reason and all fairness be the object of state protection’.38 It was observed that the precise point of viability is dependent on medical technologies, and medical developments would come to re-determine the concept.39 In Roe fetal viability was estimated at 28 weeks, though it was acknowledged viability could occur earlier.40 Casey found that States could restrict abortion access from 23-24 weeks ‘or some moment even slightly earlier in a pregnancy’.41 In Planned Parenthood v Danforth42 the Supreme Court considered the constitutionality of a Missouri abortion statute, including its definition of viability as “that state of fetal development when life of the unborn child may be continued indefinitely outside the womb by natural or artificial life supportive systems.”43 This definition was found to be consistent with Roe because when a fetus is viable it would presumably be capable of ‘meaningful life outside the mother’s womb’ flexibly understood.44 The Supreme Court resisted the claim that viability was a concept that could be fixed to a
33 Roe, supra note 4 at 160 per Blackmun J. 34 Id. at 163-164. 35 Casey, supra note 5 at 860 per O’Connor J, Kennedy J and Souter J. 36 Id. 37 Id. at 878. 38 Id. at 870. 39 Id. 40 Roe, supra note 4. 41 Casey, supra note 5 at 861 per O’Connor J, Kennedy J and Souter J. 42 Planned Parenthood of Central Missouri v Danforth 1976 428 US 52. 43 The 1969 Missouri Statute, § 2(2). 44 Danforth, supra note 32 at 63 per Blackmun J. 7
particular point in gestation because, ‘viability was a matter of medical judgment, skill and technical ability and [in Roe] we preserved the flexibility of the term…. It is not the proper function of the legislature or the courts to place viability, which essentially is a medical concept, at a specific point in the gestation period’.45 The viability threshold is thus seemingly dependent on technology, but ultimately on medical evidence and opinion with no discrete definition concerning the kind of independent existence of which a fetus must be capable. Viability is strongly tied to the notion of foetal independence from a pregnant person. Swyers warns that ‘assuming that medical science continues with the same momentum seen over the past two decades of advances in… postnatal care, a woman’s right to terminate her pregnancy under the current viability standard may soon disappear’.46
The Supreme Court’s refusal to quantify viability means States have been left to define viability as they see fit, which has resulted in a multitude of approaches. Most State laws have ultimately followed the Supreme Court’s reasoning and maintained that viability is a medical concept, deferring judgement to medical professionals. Despite this, most States place limitations on that medical judgement by implementing some quantification of viability, either by reference to gestational age or the capacities of a fetus. Regulations at State level largely fit into three categories: those that define viability as a matter of medical judgment; those that define viability by referencing the capacities or features of the fetus and those that define viability as a fixed point in gestation.
Some States define viability only by referencing the capacities or features of the fetus. Wyoming defines viability as ‘that stage of human development when the embryo or fetus is able to live by natural or life-supportive systems outside the womb of the mother according to appropriate medical judgment.’47 Utah defines viability as the point when an ‘unborn child’ is potentially able to live outside the womb as determined by a doctor to a reasonable degree of medical certainty.48 Among States that provide a definition of viability, the vast majority explicitly include those fetuses that can only survive ex utero with artificial support. As recently as 2006, Kansas defined viability as the capacity to survive after birth, ‘without the use of extraordinary measures,’49 placing stricter limits on the kind of ex utero existence considered sufficient. The law in Kansas, however, now defines ‘viable’ as the stage of fetal development when ‘it is in the physician’s judgment according to accepted obstetrical or neonatal standards of care and practice applied by physicians in the same or similar circumstances that there is a reasonable probability that the life of the child can be continued indefinitely outside the mother’s womb with natural or artificial life-supportive measures.’50
Interestingly, there are inconsistencies between States regarding how long after being born a fetus would have to be physically able or likely to survive to be considered viable. There are limited references to this in the legislation of most States (adopting similar language to the English model), but there are some notable exceptions. Maryland specifies that viability entails a ‘reasonable likelihood of the fetus’s sustained survival outside the womb.’51 Kansas also, as indicated, stipulates a ‘reasonable probability that the child can be continued
45 Id. at 64. 46 Matthew Swyers, Abortion and its Viability Standard: The Woman’s Diminishing Right to Choose, 8 Geo. Mason U. Civ. R. L. J. 87, 104 (1997). 47 WY Stat § 35-6-101 (2019). 48 Utah Code §76-7-301.5 (2019) 49 Kan. Stat. §65-6701 (2006). 50 Kan. Stat. §65-6701 (2018). 51 MD Code Health, §20-207 (2018). [emphasis added] 8
indefinitely outside the womb’.52 Such definitions, while uncommon in State Codes, are interesting in that they, in specifying the period of time that a fetus would have to survive after birth, set a more stringent requirement on life after birth. These definitions seemingly exclude those fetuses that might be delivered alive and survive only for a few seconds of independent life.
Other States have only implicit definitions of viability. These States have statutes limiting abortion after a particular point in gestation. There is much variance on the identified point of viability from 2053 to 25 weeks.54 Some States still adopt the trimester framework, limiting abortion from the second55 trimester. Despite the Supreme Court having affirmed a constitutional right to abortion until viability, by having left viability abstract without careful quantification, pregnant people have been rendered vulnerable. There is extreme inequity in access to reproductive healthcare (including termination) across the Country. It is bizarre that the Supreme Court would affirm a right but leave that right with absent parameters enabling States to construct their own criteria to accessing it. There are several plausible reasons that might account for the significant discretion left to States on the content of this right. The viability threshold is broadly enunciated in law with significant scope for political interpretation.56
It is important to note here that in 2019 there was a trend of State legislatures attempting to abandon the viability framework entirely. A swarm of ‘foetal heartbeat laws’ have been passed in Alabama,57 Arkansas,58 Mississippi59 and Louisiana.60 These laws attempt to prohibit abortion after a foetal heartbeat can be detected – around 6-8 weeks from conception ‘regardless of viability’61 (except in emergencies). These Acts have all, at the time of writing, been blocked by Federal Courts,62 but they demonstrate a political determination amongst some legislatures to challenge Roe v Wade.
PRELIMINARY OBSERVATIONS There is some legal recognition that there is a state interest in potential life in both the US and England and Wales, which has resulted in some legislative protection for unborn fetuses. The law of each jurisdiction has also recognised that this state interest becomes ‘compelling’ later in pregnancy, so that restrictions can justifiably be enacted on abortion. There is incongruity, however, in ascertaining what viability means and the point at which viability occurs. This inconsistency demonstrates that different kinds of life ex utero are meaningful enough to command ‘state interest’ in each jurisdiction.
52 Supra note 50 [emphasis added]. 53 A significant number of states have a 20-week threshold e.g. North Carolina, N. C. Gen. Stat. §14-45.1 (2019). 54 Virginia did have a 28-week limit, but this was revised to 25 weeks in May 2019. 55 E.g. South Carolina; C Code § 44-41-10 (2019). 56 I am grateful to one of the anonymous reviewers for raising this point. 57 Alabama Human Life Protection Act 2019, s.2 (c). 58 Arkansas SB 134. 59 Mississippi SB 2116. 60 Louisiana SB 184 61 Mississippi SB 2116. 62 The Louisiana law has not been blocked directly, but it contained an express provision that it would only take effect if Mississippi’s law was upheld in federal courts. 9
First, exactly how a viability threshold has been established in law is different in each jurisdiction. While the term viability is used explicitly in the US legal framework established in Roe v Wade, it does not feature in the criminal law in England and Wales at all. Despite this, it is clear that abortion regulation constructs a gestational time limit that intersects with a fixed point in gestation that is often cited as the point of fetal viability, and the offence of child destruction affords some protections to fetuses who are ‘capable of being born alive;’ which adopts the similar logics to the concept of viability in being concerned with the fetus’s potential.
Second, there are potential differences in these jurisdictions as to whether viability as a legal concept is considered distinct from medical conceptions of viability. The US Supreme Court has been clear that viability is a term intended to reflect medical possibility, and most States have legislated along these lines, though this approach is not adopted by all State legislatures. In England and Wales, there remains debate as to whether viability is a strict legislative threshold or an ill-defined legal construction63 that might therefore reflect medical opinion.
Third, there is significant inconsistency in the gestational age of presumed viability. In England and Wales, 24 weeks is used as ‘prima facie proof.’ The US Supreme Court emphasises that viability is a medical question, though judgments have posited fetuses are viable from 23 weeks. There is also significant variation in gestational limits at State level, including several US States with limits below 22 weeks. It remains to be seen how the US Supreme Court would rule on the constitutionality of these fixed points if specifically challenged. While there is inconsistency in terms of gestational age between and within jurisdictions, there is a common problem with all of these approaches; they all label fetuses as viable at a point in development when the data does not reflect a substantial likelihood of survival. Myrhaug and others note that since ‘proactive life support for infants born at 22 to 24 weeks’ gestational age (GA) is a relatively new phenomenon, and we have limited knowledge [therefore] on the chance of survival and survival without significant impairments.’64 Their systematic review concludes however, concludes that existing data suggests that the survival rate of neonates at 22 weeks was 7.3% when calculated in proportion of all live births, and 24.1% as a proportion of infants transferred to neonatal intensive care for treatment.65 At 24 weeks the survival rate is around 29.9% when calculated as a proportion of all live births and 59.7% as a proportion of those transferred to neonatal intensive care. Even at 24 weeks, the likelihood of survival is dependent on access to the best medical care.66 Some cohort studies included in the review placed the likelihood of survival much lower.67 It is puzzling that the law, and medical profession, sets the viability standard with reference to, effectively, some chance of survival, rather than a reasonable chance of survival.
Moreover, there is no evidence that a fetus could ever survive ex utero at some of the points that legislatures have identified (less than 22 weeks) even with intensive care, because the lungs would not yet be formed. Survival with the aid of intensive care is dependent on a
63 Romanis, supra note 32 at 115-116. 64 Hilde Myrhaug et al, Survival and Impairment of Extremely Premature Infants: A Meta-analysis, 143 Pediatrics e20180933 (2019). 65 Id. 66 Hannah Glass et al, Outcomes for Extremely Premature Infants, 120 Anesth & Analg 1337 (2015). 67 Myrhaug et al, supra note 64. 10
neonate having sufficiently formed lungs to tolerate artificial ventilation.68 The way these thresholds (at a specific gestational age) have been constructed suggests that viability is concerned with a chance of survival, rather than the likelihood of survival or meaningful life after birth. Intuitively, however, it seems that a ‘state interest’ in an entity would be more defensible if there were some longevity to life.
In the following sections I explore the coherency of viability in the law, by examining what kind of life ex utero the legal frameworks of England and Wales and the US consider valuable. This turns on whether viability is constructed as a rebuttable presumption, or an evidential rule. In both jurisdictions an isolated point in gestation is identified, formally or informally, as the point a fetus is (assumed) viable. Does this preclude fetuses younger than this point from being recognised as viable? Does the law allow for the recognition that an individual fetus is not viable later in gestation? A consistent and coherent account of viability, that is carefully quantified, is not provided in English or US jurisprudence.
VIABILITY EARLIER IN GESTATION In England and Wales, the law has constructed viability as a rebuttable presumption, because a fetus before the 24-week threshold is not precluded from being determined ‘viable.’ The C v S69 judgment demonstrates the willingness of English judges to examine evidence regarding the viability of fetuses before the 24-week threshold.70 However, the standard remains ‘capable of being born alive,’ suggesting that the fetus must be capable of displaying some legally recognisable life signs after being born. A newborn capable of only surviving with the aid of intensive care is considered viable in English law. There has been limited further clarification about what likely duration of life after birth is sufficient to establish that a fetus is viable. Viability is even less fixed in US law since the Supreme Court has refused to fix a point in gestation from which a fetus is presumed viable. Individual States have thus been free to define viability and the point from which they will assume that fetuses are viable. Some states set a low threshold of presumed viability.
Anti-choice campaigns often attempt to validate arguments about reducing abortion time limits by referencing advances in medical technology and their impact on the viability timeline.71 The argument is that if a fetus can survive earlier in gestation ex utero, then abortion legislation should reflect that medical possibility. Prematurity remains the leading cause of death for preterms born at or before 26 weeks’ gestation,72 because before this point the infant risks being too functionally immature to survive. The likelihood of survival, and without serious complications resulting from care complications or developmental limitation, increases with gestational age. There is considerable variation in studies investigating survival rates for neonates born preterm and extremely premature that is usually, as the British Association of Perinatal Medicine note, because results are influenced greatly by
68 Emily Partridge and Alan Flake, The Artificial Womb, in FETAL THERAPY: SCIENTIFIC BASIS AND CRITICAL APPRAISAL OF CLINICAL BENEFITS, 83 (M Kilby et al eds., 2020). 69 C v S, supra note 25. 70 Romanis supra note 32 at 115. 71 Sheila Mclean, Abortion Law: is Consensual Reform Possible? 17 J. Law Soc 106, 113 (1990); Leah Eades, Social realities, biological realities: The 24-week fetus in contemporary English abortion activism, 74 Women’s Studies International Forum 20 (2019). 72 Kishwar Azad and Jiji Matthews, Preventing newborn deaths due to prematurity, 36 Best Pract Res Clin Obstet Gynaecol 131, 132 (2016). 11
‘cohort selection, place of birth and variation in the provision of active and obstetric and neonatal management.’73 However, a recent systematic review notes that chance of survival, among those who receive intensive treatment, increases from 24.1% at 22 weeks to 90% at 27 weeks.74 Only 23% of surviving children delivered at 22 weeks are without an impairment, this rises to 39.3% of those born at 24 weeks and to 70.8% at 27 weeks.75 In the medical literature, there is generally some consensus that a realistic threshold based on some chance of survival (as explained) can be placed at 24 weeks.76 However, notable exceptions of preterms surviving exceptionally young and the wishes of parents to attempt resuscitation on preterm neonates serve to reinforce the notion of a viability threshold accounting for outside possibilities. The Nuffield Council of Bioethics guidelines regarding resuscitation decisions specifies that resuscitation attempts on newborns below 22 weeks should not be attempted outside of recognised clinical trials.77 This raises questions about the kind of life the law is recognising ex utero. Is some possibility of survival ex utero sufficient, or some possibility of a healthy life with longer-term survival prospects? Or even a reasonable likelihood of survival with good prospects for a healthy life? In both jurisdictions, law and medical guidelines do not set their sights as high as a reasonable likelihood of survival and/ or long- term prospects.
Artificial Wombs; Artificial Amnion and Placenta Technology (AAPT)78 There has been little change in the data regarding premature survival in recent years, as it appears that the clinical possibilities of conventional care to aid survival have been exhausted.79 Interventions can only do so much for preterms born without the functional capacities for independent life; e.g. insufficiently formed organs. There is, however, technology on the horizon thought capable of shifting the viability timeline earlier in gestation. Two research teams, in the US and Australia/Japan, have claimed ‘proof of principle’ for artificial amnion and placenta technology80 (AAPT) and speculate that their devices might replace conventional neonatal intensive care in the future.81 These devices are designed to mimic the function of the placenta and environment of the human uterus such that they are capable of continuing the process of gestation (known as partial ectogestation82); ‘the central principle underlying the iterative development of [the EVE] platform is to treat
73 British Association of Perinatal Medicine, Perinatal Management of Extreme Preterm Birth before 27 weeks of gestation,’ https://hubble-live-assets.s3.amazonaws.com/bapm/attachment/file/182/Extreme_Preterm_28-11- 19_FINAL.pdf accessed Apr. 21 2020, 18. 74 Myrhaug et al supra note 64. 75 Id. 76 Glass et al, supra note 66 at 1338. 77 Nuffield Council on Bioethics supra note 14 at para 8.13. 78 Kingma and Finn explain that the term artificial womb is misleading because the womb is not ‘replaced’ by these devices – rather they are an artificial amnion and placenta. See: Elselijn Kingma and Suki Finn, Neonatal incubator or artificial womb? Distinguishing ectogestation and ectogenesis using the metaphysics of pregnancy, 34 Bioethics 254 (2020). 79 Jennifer Hendricks, ‘Not of Woman Born: A Scientific Fantasy,’ Case W. Res. L. Rev. 399 (2011); Elizabeth Chloe Romanis, Artificial womb technology and the frontiers of human reproduction: conceptual differences and potential implications, 44 Journal of Medical Ethics 751 (2018). 80 Supra note 78. 81 Emily Partridge et al, An extra-uterine system to physiologically support the extreme premature lamb, 8 Nat Commun. 15112 (2017); Harou Usuda et al, Successful use of an artificial placenta to support extremely preterm ovine fetuses at the border of viability. 221 Am J Obstet Gynecol. 69.e1 (2019). 82 The term partial ectogenesis has been more commonly used in the literature. However, Kingma and Finn explain that ectogestation is a more accurate descriptor for the process of gestation ex utero. See Kingma and Finn, supra note 78. 12
extremely preterm infants as fetuses, rather than as small babies… to avoid the use of pulmonary gas exchange.’83 Therefore, AAPT would not be subject to the same limitations of gestational maturity, as they can facilitate continued organ maturation and growth and so could shift perceptions of the viability timeline.84
Research scientists are explicit that they intend to mitigate the impact of being born premature rather than challenge current conceptions of viability. They identify their clinical target population at 23-25 weeks,85 as those who would already be subject to treatment in intensive care. I have argued elsewhere that in the initial stages of testing this technology it should be used on those preterms that we would not consider viable, because to test it on preterms potentially able to survive in intensive care is to deny them medical treatment for potentially no benefit.86 There is thus the possibility that clinical trials of AAPT will necessarily demonstrate the clinical utility of the technology in aiding developing human entities not currently considered viable. Moreover, if AAPT can better promote the survival of preterms on this current viability threshold, there will be calls to use the technology to aid those preterms born not far behind it.87 Gradual use of technology, primarily to aid individual patients and eventually informing general practice, is how the medical conception of viability has arrived at the 22-24-week point. It is hard to speculate about how far AAPT may be able to stretch the viability timeline, as there will be other natural limitations. The developing human entity must survive a form of birth to be placed in an ‘artificial womb’ (AAPT). The developing human entity must also have some kind of fetal physiology to be supported by the current models being developed by researchers in the US, Australia/Japan and the Netherlands.88 In the future, odds in the AAPT might be improved if caesarean sections are scheduled and exposure time and stress for developing entities limited. Future models may (a long way in the future) also be capable of sustaining even more primitive human entities. While AAPT is a speculative development, the technology is an interesting example to examine the coherence of viability in the law.
AAPT is conceptually distinct from other forms of preterm care because it is continuing the process of creating, rather than rescuing, developing human entities. Thus, the subject of an artificial womb (AAPT), termed the ‘gestateling’,89 is a unique entity because it is neither a fetus nor a neonate. A fetus is a developing human entity undergoing the process of gestation dependent upon a pregnant person. A neonate, while developing still, is no longer undergoing a process of creation and must be capable of partially self-sustaining in the external environment. A gestateling is undergoing the process of gestation, and is not ex utero in a
83 Usuda et al, supra note 81. 84 These studies demonstrate that continued gestation with no complications is at least in theory possible, though they have thus far only tested their prototype AW on lambs. These studies therefore have obvious limitations. Researchers believe their results are sufficient, however, to justify experimental application in humans in the near future. Partridge et al, supra note 81 at 11. 85 Partridge et al, supra note 81. 86 Id. 87 Romanis, supra note 79 at 752. 88 In late 2019 a third research team based in the Netherlands announced that they had received a grant to begin working on developing their artificial womb prototype. See: Nicola Davies, Artificial Womb: Dutch researchers given €2.9m to develop prototype,
meaningful sense, but is not dependent upon a pregnant person.90 Viability is generally thought of as the capacity to exist ex utero (conventionally the uterus being a part of a pregnant person). There is the potential to describe some fetuses as ‘viable’ in the sense that they can be sustained outside the body of a pregnant person, but they are not in any way capable of an independent post-gestation existence. Should we consider these fetuses ‘viable?’ Or not, because they are capable only of being transferred to an ‘artificial womb’?
Insofar as any legal concept of viability has any utility, it would distinguish between those fetuses capable of independent existence after gestation and those that cannot. A fetus becomes ‘viable’ only when they can survive ex-gestation irrespective of where that gestation is taking place. A fetus should only be described as ‘viable’ only when able to take on some of the burden of sustaining themselves independently. Emergence from gestation involves the developing human entity undergoing meaningful biological adaptations enabling self- sufficiency, interaction with and survival in the ex utero environment (even if they were dependent on rescue technologies in neonatal intensive care).91 There are substantive reasons to believe that a fetus gestating in a pregnant person that would only be able to continue any biological life ex utero if the process of gestation were continued is different in nature to the fetus capable of making the biological state changes for independent living. If the purpose of the viability timeline is to identify potential life that the state has a meaningful interest in preserving, the state has a greater interest in the preservation of a life able to survive ex utero rather than an entity that can only ‘continue to be gestated ex utero.’92 The entity that can make a meaningful adaptation to the external environment is a life has the potential of being realised, rather than having potential only in a removed sense.
Is the existing the law of England and Wales and the US nuanced enough to account for this difference? Doctrinal lawyers are often criticised for considering the application of contemporary legal frameworks in different contexts – for example, the development of a future reproductive technology. However, it is only by speculating about how a potential future event (the development of AAPT or ‘artificial wombs’) might be treated in contemporary legal frameworks that we can expose any potential conceptual flaws in the existing legal framework93 and consider the necessary changes for a better legal future. In such an exercise, therefore, we can consider how the law and the logics that underlie it need reform in line with technological developments.
While English law does, to some extent, entrench a moveable concept of viability, it makes explicit reference to being capable of ‘being born alive’ rather than just existing ex utero. The gestateling (subject of AAPT) would likely not be capable of satisfying the legal definition of ‘born alive’ in English law because it does not breathe or perform any exertive activities that demonstrate any independence or self-sufficiency.94 Because it remains in the process of gestation, it is not ‘born alive.’ Thus, fetuses should only be considered viable when capable
90 For further defence of the conceptual distinction between the fetus, neonate and gestateling see: Romanis supra note 79, Elizabeth Chloe Romanis, Artificial womb technology and the significance of birth: why gestatelings are not newborns (or fetuses), 45 Journal of Medical Ethics 728 (2019), Romanis supra note 32 and Elselijn Kingma and Suki Finn, supra note 78. 91 K GREASLEY, ARGUMENTS ABOUT ABORTION: PERSONHOOD, MORALITY AND THE LAW 191 (Oxford University Press, 2017). 92 Swyers, supra note 46 at 105. 93 Claire Horn and Elizabeth Chloe Romanis, Establishing Boundaries for Speculation about Artificial Wombs, Ectogenesis, Gender and the Gestating Body, in A JURISPRUDENCE OF THE BODY (C Dietz et al eds., 2020). 94 Romanis, supra note 32 at 112. 14
of maintaining some kind of (supported) independent existence following the biological state changes encompassed in birth. In the US, scholars frequently explain that the Supreme Court quantified viability as a standard of only ‘independent existence’ from a pregnant person.95 Horn, in her comparative account of abortion and the law in England and Wales, the US and Canada after the development of artificial womb technology, stresses that the viability timeline in US law does mean that the development of the technology could result in significant restrictions on abortion access.96 The explicit references to medical advancements and the likelihood that viability will shift with future medical developments in Roe and Casey are highlighted as support for the suggestion that a fetus would be considered viable for legal purposes earlier and earlier in gestation.97
English and US law thus have different approaches: English law is concerned with fetuses capable of being born and maintaining some independent life function, whereas in US law the standard is stipulated in a way that sets the threshold lower; at just independence from a pregnant person. English law is concerned with the capacities of the developing human entity, whereas US law is not. Some US States have passed legislation conceptually similar to the English approach – making specific reference to the capacities of the fetus – even though they are not required to set such specific standards. The reasons for the difference can be elucidated in the origins of the law in each jurisdiction. In England and Wales, the focus on the ‘capacity to be born alive’ standard originates from the ‘born alive’ rule in criminal law. A human entity only has legal personality, and can therefore be the victim of homicide, if it is born alive.98 Such a rule has been long established in English law, in the 17th century Sir Edward Coke wrote that:
if a woman be quick with childe and by potion or otherwise killeth it in her wombe, or if a man beat her, whereby the child dieth in her body, and she is delivered of a dead childe, this is great misprison, and no murder: but if the childe be born alive, and dieth of the potion, battery, or other cause, this is murder; for in law it is accounted a reasonable creature, in rerum natura, when it born alive.99
A human entity that is killed before being born alive cannot be recognised as a victim of homicide, but its death is recognised in the crime of child destruction.100 The offence of child destruction was constructed with reference to the ‘born alive’ rule – and therefore places emphasis on the potentiality to be alive (i.e. exercising some independent function), since
95 Hyun Son, Artificial Wombs, Frozen Embryos and Abortion: Reconciling Viability’s Doctrinal Ambiguity, 14 UCLA Women’s L. J. 213, 214 (2005). 96 Horn, supra note 8, also emphasises that the development of artificial wombs is likely to impact on the availability of abortion in ways more nuanced that the shifting of the viability threshold with the development of artificial womb technology as she explains that ‘at both the federal level the ‘undue burden’ standard could allow for significant infringement on the privacy right applied in abortion both before and after viability…. Even if the ectogenic fetus was not considered viable, the state may be able to ban abortion procedures that resulted in the death of the fetus (allowing extraction to an artificial womb instead) without this being considered an undue burden on the privacy right’ at 64. 97 Robert Favole, Artificial Gestation: New Meaning for the Right to Terminate Pregnancy, 21 Ariz. L. Rev. 755, 764 (1979); I. Glenn Cohen, Artificial Wombs and Abortion Rights, 47 Hastings Cent. Rep (2017); Julia Dalzell, The Impact of Artificial Womb Technology on Abortion Jurisprudence, 25 Wm & Mary J. Women & L. 327, 332 (2019). 98 Attorney-General’s Reference no 3 of 1994 [1997] UKHL 31. 99 E COKE, THE THIRD PART OF THE INSTITUTES OF THE LAWS OF ENGLAND: CONCERNING HIGH TREASON AND OTHER PLEASE OF THE CROWN AND CRIMINAL CAUSES, 50 (E. and R. Brooke, 1797). 100 Infant Life Preservation Act 1929, s.1 (1). 15
being alive at birth is the relevant fact in the law.101 In contrast, US law has focused on the capacity for an independent existence because the law as it was conceptualised was not attempting to construct a coherent distinction between infanticide and homicide, but to establish an object of legitimate state interference – thus, it focuses solely on the circumstance in which a human entity’s existence no longer infringes on the right to privacy of a pregnant person by virtue of its location – independence from the pregnant person.
It is interesting that in both jurisdictions there remains some extent to which the determination of viability (even for the purposes of the law) is a medical question. The US Supreme Court is, as explored, explicit that this is the case, and in England and Wales the ‘capacity to be born alive’ may be open to medical interpretation. It remains to be seen how the medical profession will respond to AAPT and whether the technology will be considered conceptually distinct from rescue technologies in practice, and its impact on the viability timeline. For obvious reasons, there is yet little qualitative or quantitative data available about the attitudes of doctors towards viability and abortion provision in light of AAPT. In a 2020 study, 91 Australian doctors were asked closed questions about their conception of viability in the advent of such technology and its capacity to continue gestation of fetuses at 22 weeks. The study reported that 88% of respondents believed that, in light of the technology, if a fetus were delivered at this point it should be considered ‘viable.’102 Interestingly, 41% of respondents indicated that the availability of such technology would influence their opinion of abortion being performed at this gestational age.103
If viability is a concept intended to meaningfully convey some notion of the potentiality of life, English law currently adopts the more coherent account of viability as applied earlier in gestation. There is a meaningful developmental difference between a fetus no longer necessarily in need of being created because it could survive after gestation with conventional care and a fetus that cannot be sustained outside of gestation. Though questionable, if the state has an interest in potential life, it seems intuitive that this interest would be directed only towards those fetuses that could live in the external environment rather than those human entities still dependent on being created (whether in utero or an ‘artificial womb’). The approach of the US Supreme Court is vague and encompassing of fetuses incapable of making the necessary biological state changes to demonstrate a completed birth.
VIABILITY LATER IN GESTATION The legal framework of these jurisdictions considers viability a rebuttable presumption earlier in gestation, but what about those cases where the viability of a fetus later in gestation (passed the point the law might presumes viability) is questionable? Examining to what extent the law is sensitive to the capacities of an individual fetus is an important aspect of ascertaining the substance of viability and what it intends to protect. If viability is about establishing the point a fetus becomes a ‘potential life’ this will always be specific to an individual fetus and its capacities. If viability operates as a rebuttable presumption in one direction, to allow for recognition that a fetus earlier in gestation might be viable, it would be inconsistent not to recognise that some fetuses may not be viable later in gestation. It is
101 See: Romanis, supra note 32. 102 Lydia Di Stefano et al, Ectogestation ethics: The implications of artificially extending gestation for viability, newborn resuscitation and abortion, 34 Bioethics 371, 377 (2020) 103 Id. 16
potentially possible to generalise that most fetuses will be sufficiently developed to survive with some assistance after a specific point in gestation; however, this will always depend on the particular circumstances. The medical standard of viability is based on the ‘human interpretation of statistical probabilities’ applied to fetuses as a class.104 There will be variances between fetuses at the same point in the gestational period, such that we could describe one fetus as ‘viable’ at 25 weeks and another not based on their stage of development.
Anencephaly Anencephalic fetuses have a congenital absence of the brain, parts of the skull and scalp105 and are inherently non-viable because the absence of a brain is lethal and irreversible in all cases.106 Stillbirth is a common outcome of an anencephalic pregnancy.107 When the fetus can be delivered biologically alive it does not survive long post-delivery.108 Anencephaly is usually detected during prenatal ultrasounds; though sometimes not until later in pregnancy.109 Applying the law to anencephaly allows consideration of whether viability is individualised to a fetus and its capacities, or is a rigid concept strictly applied later in gestation.
In English law, there is provision for the termination of an anencephalic fetus even after 24 weeks (the implicit viability threshold). The Abortion Act 1967110 provides a defence to a doctor performing a later-term abortion in the case of ‘a substantial risk that if the child were born… it would be seriously handicapped.’ There has been little clarification of the necessary severity of the handicap in these circumstances,111 however it is clear that given the severity of anencephaly that abortion would be lawful here. This does not answer the question as to whether such a fetus would be considered ‘viable’ and whether the prima facie assumption of viability from 24 weeks can be rebutted. An English Court has not addressed this issue, because the AA 1967 does allow termination after 24 weeks in all the circumstances it is usually sought after on the grounds that the foetus is non-viable (without needing to consider viability). The AA 1967 is clear that even after a fetus is prima facie viable, the pregnant person’s interests in health and life remain paramount; allowing them to terminate their pregnancy if necessary. The handicap provision does not mandate that the fetus must have an abnormality that would be life-limiting after gestation.112 It is therefore unknown whether there is any requirement in English law that to be capable of being born alive the fetus need
104 I. Glenn Cohen and Sadath Sayeed, Fetal Pain, Abortion, Viability and the Constitution, 39 J Law Med Ethics. 235, 237 (2011). 105 Rebecca Cook et al, Prenatal Management of Anencephaly, 102 Int. J. Gynecol. Obstet. 304, 304 (2008). 106 A public hearing in the Supreme Court of Brazil found that anencephaly ought not be confused with disability because it was a condition ‘incompatible with life, and because of that, there are no children or adults with anencephaly.’ See: L Roberto Barroso, Bringing Abortion into the Brazilian Debate, in ABORTION LAW IN TRANSNATIONAL PERSPECTIVE: CASES AND CONTROVERSIES, 365 (R Cook et al eds., 2014). 107 Stillbirth occurs in 32% of cases where anencephalic pregnancies were carried. M Jaquier et al, Spontaneous pregnancy outcome after prenatal diagnosis of anencephaly, 113 BJOC 951 (2006). 108 How long the anencephalic newborn survives depends on how much of the brain is missing. Those delivered alive usually do not survive longer than a day. Id, 951. 109 Almost all cases are diagnosed by ultrasound before 14 weeks. There is a 100% detection rate during second trimester sonography: Emre Ekmekci and Servet Gencdal, What’s Happening When the Pregnancies Are Not Terminated in Case of Anencephalic Fetuses? 11 J Clin Med Res 332, 334 (2019). 110 Abortion Act 1967, s.1 (1) (d) as amended by Human Fertilisation and Embryology Act 1990, s.37. 111 Rosamund Scott, Interpreting the disability ground of the Abortion Act, 64 Cambridge Law Journal 388, 391 (2005). 112 Jepson v Chief Constable of the West Mercia Police Constabulary [2003] EWHC 3318. 17
be capable of longer-term survival. English legislation was likely intended to afford legal protection to any human entity that survived birth, irrespective of prospects for longer-term survival.113 Viability is not a coherent concept if it does not proscribe more than surviving birth. C v S established that a prima facie assumption of viability at a particular point in gestation is intended to shift the burden of proof in establishing viability away from a prosecutor. If the Court is willing to accept that a party can claim that viability is evident earlier in gestation if compelling evidence is presented,114 equally then should not the ‘prima facie proof’ of viability be challengeable with evidence? An anencephalic fetus, regardless of gestational age, would patently never be capable of surviving for a meaningful amount of time after birth. Most fetuses with anencephaly are absent a cerebral cortex, and thus will never be capable of consciousness, and only capable of sustaining very limited signs of life for a short period.115 While such a fetus might be considered biologically alive on delivery because of these basic signs of life, it might also satisfy the legal definition of death in English law, that is, brain death.116 Thus, describing it as ‘capable of being born alive’ seems counter-intuitive. If a fetus were never likely to have an independent life or consciousness– why should it be afforded comparable protection to fetuses with potentiality? Arguably, the AA 1967 is intended to ensure exactly this by providing explicit grounds for the termination of those fetuses unlikely to survive as a result of a severe congenital impairment.
The US Supreme Court is clear that the viability threshold intends to protect the ‘potential for independent life.’ Little further clarification has been offered about what kind of life meets this standard. Thus, it remains unclear whether viability later in gestation is a rebuttable presumption in US law. Some States have chosen to be more specific in legislation about what kind of ex utero existence is sufficient to establish viability. While most refer to artificial life support to denote fetuses that can survive with the assistance of intensive care as potentially viable, few qualify that further with reference to the duration of life after birth. In Florida, viability means ‘the stage of fetal development when the life of the fetus is sustainable outside the womb through standard medical measures.’117 In Maine, viability is defined as ‘the state of fetal development when the life of the fetus may be continued indefinitely outside the womb by natural or artificial life supportive means.’118 Maryland defines viability as a ‘reasonable likelihood of the fetus’s sustained survival outside the womb.’ The American College of Obstetricians and Gynecologists echo this approach, advising that abortions performed later in pregnancy are usually those involving risk to the pregnant woman or foetal ‘anomalies incompatible with life, such as anencephaly…’ .119 In some States a fetus would be described as viable if there were only the possibility of it surviving birth and no longer, for example States that consider a fetus viable from a specific point in gestation at which the data would not predict a reasonable likelihood of either long- term survival, or even any survival after birth.120 The recognition afforded to these fetuses
113 Romanis, supra note 32 at 109. 114 Grubb, supra note 21 at 663. 115 D. Alan Shewmon, Anencephaly: Selected Medical Aspects, 18 Hastings Cent. Rep 11, 14-15 (1988). 116 Death is not defined in any Statute in English law but is usually legally determined by a medical diagnosis of brain death: Re A [1992] 3 Med LR 303; Airedale NHS Trust v Bland [1993] 1 All ER 821. 117 FL Stat § 390.011 (2019). 118 22 ME Rev Stat § 1598 (2019). 119 The American College of Obstetricians and Gynecologists, Facts are Important: Abortion Care Later in Pregnancy is Important for Women’s Health, https://www.acog.org/About-ACOG/ACOG- Departments/Government-Relations-and-Outreach/Facts-are-Important-Abortion-Care-Later-in-Pregnancy-is- Important-to-Womens-Health?IsMobileSet=false (accessed Oct 12 2019). 120 E.g. those states that place limitations on abortion from 20 weeks gestation: Kansas, North Carolina, Texas and Wisconsin. 18
with conditions incompatible with life is not only incoherent but actively harmful to pregnant people carrying an anencephalic pregnancy. A recent anonymous testimonial by an American physician describes the agony of attempting to support patients carrying pregnancies with no chance it results in a child while being legally, professionally and politically, restricted from offering the option of ending the pregnancy.121 The legality of an abortion based on foetal abnormality is dependent upon the law of individual States.
The rigidity of homicide law in both jurisdictions means that the live birth of a non-viable neonate that is subsequently killed would trigger homicide culpability. In the US, the Born- Alive Infants Protection Act 2002 extended federal protection afforded to infants ‘born alive’ at any stage of development. The Act defines ‘born alive’ as breathing or ‘has a beating heart, pulsation of the umbilical cord or definite movement of voluntary muscles…. Regardless of whether the expulsion… occurs as a result of natural or induced labor, cesarean section, or induced abortion.’122 It is possible for a fetus without the capacity for life; even those absent a brain, to be born bearing these signs of life, and protected by the law of homicide.
The ‘born alive’ rule also applies in England and Wales. Any human entity born alive is a person for the law of homicide. English law dictates that a child is born alive if it breathes or demonstrates ‘any other signs of life.’123 There was little further clarification in the relevant legislation about what signs of life are sufficient to demonstrate life. It is clear, however, that a fetus need only survive the process of birth and display signs of life for a short time after to be a potential victim of homicide if action is taken to end its life.124 In both jurisdictions, the live birth of a non-viable neonate that is then killed would trigger homicide culpability, yet termination of the same entity when a non-viable fetus (whether it is non-viable inherently because it is absent a brain, or because it is too immature to survive) might not be an unlawful abortion. This appears initially incoherent and confusing and is an inconsistency that anti-choice advocates often attempt to monopolise on by analogising the unborn with the neonate. In the US, this has culminated in several States adopting ‘foetal personhood’ laws to recognise that a fetus can be the victim of a homicide with the effect of undermining abortion provision.125 There has been no positive case advanced for non-viable or never-viable fetuses being afforded the protection of homicide law. It is illogical to use a fetus that was never capable of living long post-birth to reason that a fetus also not capable of, or even never capable of, living if it were born should have an equivalent protection. This was the conclusion reached on this subject in the Supreme Court of Brazil which held that, ‘abortion is a crime against life. The potentiality of life is what is protected. In the case of anencephalic fetuses.... there is no life possible’ thus, there can be no crime.’126 In any event, we expose more incoherence in the meaning afforded to viability in the law when we consider examples later in gestation, both within and between the US and England and Wales.
121 Anonymous, The Myth of Choice, 170 Ann Intern Med. 809 (2019). 122 Born-Alive Infants Protection Act 1 U.S.C. §8 (b). 123 Births and Deaths Registration Act 1953, s.1(1) as amended by the Still-Birth Definition Act 1992, s.41. 124 Attorney-General’s Reference no 3 of 1994, supra note 93. A person is still guilty of homicide if they cause injury to a fetus that is born alive before subsequently dying of the injuries sustained. 125 There are (at least) 38 states in which fetal homicide laws have been passed and a number in which women who have experienced the death of their baby are charged with feticide. See: Lynn M Paltrow and Jeanne Flavin, Arrests of and Forced Interventions on Pregnant Women in the United States 1973-2005: Implications for Women’s Legal Status and Public Health, 38 J Health Polit Policy Law 299 (2013). 126 Supremo Tribunal Federal [Supreme Court] April 12, 2012, ADPF 54/DF at 147. 19
It is useful here to highlight that there is no moral continuity between an entity that has actually been delivered alive and an entity that could be delivered alive.127 The rigidity of homicide law in this area is potentially necessary as a way of ensuring that there is no discrimination between human entities. Greasley explains that ‘interpersonal variations in person-relevant capacities should not affect the equal moral status of individuals within the range… [this is] morally essential for maintaining the kind of relations between persons that we deem valuable.’128 As such, a human entity delivered alive129 is afforded the protection of the law of homicide because they have been born alive, even if they cannot survive in the longer term. It is clear, however, that a fetus who has the capacity to be born alive (whether that survival would be short- or longer-term) need not be treated with a comparable level of respect. The reality is that capacity to be born alive is not the same as having been born alive.
Any recognition given to the ‘capacity to be born alive’ is an argument based on potential – and we do not treat entities on the basis of what they might be, but on what they are.130 Any equivalence drawn between the capacity to be born and having been born is ‘in itself misleading, for it is often taken to suggest that an X that is potentially a Y in some mysterious fashion already possesses the being and significance of Y.’131 There are meaningful differences between these two entities – one capable of being born alive and one born alive – most notably, that the entity capable of being born alive is still located inside a gestating person,132 or dependent on an artificial placenta. In contrast, however, the entity born alive is ‘natal’ and has ‘come into the world with and as a specific body, in a given place, set of relationships, situation in society, culture and history…’ and is dependent in ways that specifically flow out of their birth133 including interaction and physical contact with others. Entities with the potential to be born alive may well become natal in this meaningful sense, however, significant changes in physicality (the process of birth), in the case of entities located inside a gestating person, and physiology (adaptation to the external environment) must take place before they do. These are substantial prerequisites to being born alive: a human entity must survive delivery and must adapt to the external environment.
THE CONCEPTUAL ILLEGITIMACY OF VIABILITY THRESHOLDS Horn argues that ‘that Canadian law does not set a viability timeline for abortion demonstrates that legal ‘viability’ is not a quality naturally vested in some fetuses, but a fictive construct designed to act as a limitation on abortion.’134 She makes this argument as a basis for decriminalisation as a model for protecting abortion provision with the advent of artificial womb technology in the United Kingdom (where the AA 1967 applies) and the United States like, as she demonstrates, the right to abortion would be in Canadian law even
127 I argue elsewhere that there is no moral continuity between a fetus and gestateling because each entity’s relationship with the female body is different. The same might be said here. Moreover, there are substantial differences in physiology between an entity that is still gestating and one that has been completely born: Romanis, supra note 32 at 115. 128 Greasley, supra note 86 at 187. 129 To clear, by delivered alive here I mean an entity that has been delivered from a pregnant person and has made the biological state changes associated with a complete birth. See Romanis supra note 90. 130 This is an argument most often made in response to claims about the potential of the embryo. 131 H. TRISTRAM ENGELHARDT, THE FOUNDATIONS OF BIOETHICS 111 (Oxford University Press 1986). 132 Romanis, supra note 32, at 118. 133 A. STONE, BEING BORN: BIRTH AND PHILOSOPHY 3 (Oxford University Press 2019). 134 Horn supra note 8 at 86. 20
with such technology available.135 The traditional viability analysis, evident in the law in English and US law, assumes that foetal viability is a legitimate foundation for regulation. Horn concludes that a framework ‘based on fetal viability regardless of how it is defined, fails to sufficiently account for relationality and care for the pregnant person’ by decentralizing the pregnant person.136 In this paper, I sought to add meaningfully to her call – firstly, by demonstrating the doctrinal incoherence in the concept of viability as it both currently quantified and deployed in English and US law. This investigation was necessary to illustrate how the ‘self-evident logic’ that is sometimes claimed of the viability threshold does not stand up, especially if we examine how viability is defined and utilised in the law. Secondly, my work adds to this call by demonstrating the inadequacy of viability in regulating abortion provision in contexts beyond that of AAPT; most notably, by comparing how the concept applies to fetuses with conditions incompatible with life. In the following section, I make the case that using a viability threshold to regulate abortion provision is not an effective standard of compromise in the law, nor conceptually legitimate.
The entrenched reference to viability in the law assumes that it is necessary to strike a balance between a state’s interest in potential life and a woman’s right to bodily autonomy and equality. Frequently, the viability threshold is conceptualised as a ‘compromise’ between these two interests, but it performs no such function. Despite the regulation of abortion by criminal statute in England and Wales and the US, it is notable that the state interest in abortion policy has not been elaborated upon in any of these jurisdictions. Dalzell explains that in Roe and Casey there is no exploration of the ‘state interest in potential life’ by quantifying or defining this interest, effectively ‘stripping the state from the duty of proving its interest.’137 The interest in potential life has been interpreted broadly in the US, as always present but ‘compelling’ only after viability in Roe,138 and in England and Wales there has been little exploration of the justification for state rationale in legislating to make abortion harder to access after a viability threshold. Abortion legislation was introduced in England and Wales ‘to clarify the law for doctors and to stem the misery and injury from unhygienic, risky illegal abortions.’139 In the 1990 Commons debate regarding the time limit for ‘social abortion’ discussion centred around preventing later-term abortion, and a lack of public support for abortion ‘on demand’140 rather than explaining why abortion was a public, rather than a private, matter. What is the justification for abortion being anything other than a person’s private choice? All sorts of ‘moral matters’ that were at one time thought the business of the state have since been rightfully recognised as private choices. The onus in thinking about abortion must be flipped; claims that the state has an interest in preventing abortions must be fully justified, rather than it being women and pregnant people who are routinely forced to defend their privacy, autonomy and equality.
If the justification for state interest is based on preserving life, or potential life, in any real sense, the law would only provide legal protection for a developing human entity from the point of birth. This is the point at which there is a human being existing independently of another person demonstrating any potentiality for independent life. This is just not true in any
135 Claire Horn, Ectogenesis is for Feminists: Reclaiming Artificial Wombs from Anti-Abortion Discourse,’ 6 Catalyst: Feminism, Theory, Technoscience 2 (2020). 136 Horn, supra note 8 at 113. 137 Dalzell, supra note 95 at 341. 138 Roe, supra note 4.7 139 MARGARET BRAZIER AND EMMA CAVE, MEDICINE, PATIENTS AND THE LAW, 403 (Manchester University Press, 2016). 140 HL Vol 522 Col 1137-114 (1990). 21
way at the point at which an unborn entity is dependent upon a pregnant person. There is compelling evidence to suggest that only fetuses near to or at the end of the gestational period can be described as ‘naturally viable.’141 The gestational period is around 36 weeks, and a fetus is only likely to have sufficiently developed lungs, allowing for breathing ex utero without assistance, at around 30 weeks.142 There might be an attempt to argue that the State has an interest in life in a symbolic sense – in setting a standard of protecting life that might come to fruition as a way of recognising the value of life. This cannot be the case, however, as a State that professed such a position would surely pass rules limiting the use of birth control, or requiring that ‘spare’ embryos left over from IVF be implanted, as these examples are instances where there is interference with ‘life’ in a symbolic sense.
The balance in the ‘viability compromise’ is not appropriate because it pits women and pregnant people’s rights against unarticulated state interests. As Jackson highlights ‘the logical corollary of an abortion law that sets limits upon women’s access to abortion is that, in certain circumstances, a woman can be obliged to carry her unwanted pregnancy to term.’143 The purpose of a viability threshold limiting abortion access, therefore, will always be to place some (symbolic or real) limits on pregnant people’s rights. The argument could be made that, even if AAPT were available tomorrow, a shift in the viability threshold is unlikely to be so drastic to restrict access to conventional abortion. The vast majority of abortions take place before 13 weeks in England and Wales144 and the US.145 Thus, most pregnant people would not be prevented from accessing abortion. However, as Eades explains those who face difficulty are likely to be the most vulnerable; pregnant people who experienced delayed seeking abortion because they live in an area where access is difficult, they have experienced domestic violence, or are younger or older persons who did not recognise their symptoms as pregnancy.146 These people are equally entitled to access healthcare, and should not have to face the stigmatising effects of being labelled as an ‘exception to the rule’ for having a post-‘viability’ abortion. Even if few pregnant people are denied an abortion, the impact of singling out more vulnerable people in difficult situations for the stigmatising process of proving the necessity of their abortion, or face losing the option, is substantial.
Regulating abortion by reference to a viability threshold is not a compromise because it fails to recognise the importance of the right to meaningful equality for women, penalises pregnant people likely to submit for abortion later because of circumstances that have already marginalised them, and labels women and pregnant people as ‘in need of regulation’ to prevent them making ‘bad’ choices. Cook explains that;
criminal abortion, like crime generally, is a legal and social construct … the criminal essence of abortion then implicates the social construction of those who actually and potentially seek abortion
141 Son supra note 95 at 223. 142 TOM LISSAUER AND GRAHAM CLAYDEN, ILLUSTRATED TEXTBOOK OF PAEDIATRICS, 159 (Mosby Elsevier 2012). 143 Jackson supra note 20 at 74. 144 Department of Health, Abortion Statistics, England and Wales 2017, https://www.gov.uk/government/statistics/abortion-statistics-for-england-and-wales-2017 accessed Oct 31 2019. 145 Tara Jatlaoui et al, Abortion Surveillance – United States, 2015, https:/dx.doi.org/10.15585/mmwr.ss6713a1 accessed Nov 1 2019. 146 Eades, supra note 71 at 24. 22
and those who provide and assist in its provision. By framing abortion as a crime societies ascribe deviance to those seeking and providing it…147
The framing of all abortion as a crime in England and Wales ‘in need of a medical explanation’ has a similar effect of stigmatising the choice to end a pregnancy148 and constructing those pregnant people who access treatment as deviant and as failing to perform the role expected of the female body. This will necessarily affect how doctors perceive the procedure, those seeking it and the advice that they give. This is inappropriate because it limits access to a service that is necessary both to ensure female health, and to ensure that women have access to social equality. Cornell argues that there can be no meaningful equality for female people without access to abortion because denying access ‘prevents the minimum conditions of individuation necessary for any meaningful concept of selfhood.’149 She posits that denying access to abortion ‘should be understood as a serious symbolic assault on a woman’s self of self precisely because it thwarts the projection of bodily integration and places the woman’s body in the hands and imagings of others who would deny her coherence by separating her womb from herself.’150 This harm is broad, experienced not only by female people at the time of unwanted pregnancy, but constantly by all people with the physiology to get pregnant. Without abortion all people with the physiology to get pregnant are denied that their womb (and their body) are theirs to imagine into the future. Cornell explains that ‘the fear of unwanted pregnancies and illegal abortions haunted women’s sense of themselves long before the women themselves actually became pregnant’ and thus to deny a right to abortion is to label the female body as not individual (and its function to be subjectively determined), but as limited to a maternal function.151 A person cannot perceive themselves as equal to others in the course of social life if they are not able to engage in social activity without feeling defined by their sex or physiology, thus limiting their free choices (particularly with regards to sexual activity). Interference in choices about abortion in the law, that are also based on archaic assumptions about pregnancy and female behaviour, attempt to enforce notions of the female body as inevitably constrained to the maternal function by biology, and thus reinforce problematic notions of female function. Viability is not a compromise at all.
There are also pragmatic problems with using a viability threshold to regulate because it is innately arbitrary. Viability is wholly dependent on geography and resources.152 Moreover, it is moveable and uncertain.153 The standard of viability in medicine is based on the ‘human interpretation of statistical probabilities’ applied to fetuses as a class.154 There is disagreement about the likelihood of survival at different points in the gestational period. There is, for example, significant dissenting medical opinion about the appropriate point to
147 Rebecca Cook, Stigmatized Meanings of Criminal Law, in ABORTION LAW IN TRANSNATIONAL PERSPECTIVE: CASES AND CONTROVERSIES, 348 (R Cook et al eds., 2014). 148 Elizabeth Chloe Romanis, Artificial Womb Technology and the Choice to Gestate Ex Utero: Is Partial Ectogenesis the Business of the Criminal Law? Med Law Rev. https://academic.oup.com/medlaw/advance- article/doi/10.1093/medlaw/fwz037/5680368 accessed Dec 18 2019. 149 DRUCILLA CORNELL, THE IMAGINARY DOMAIN: ABORTION, PORNOGRAPHY AND SEXUAL HARASSMENT, 33 (Routledge 1995). 150 Id at 38. 151 Id at 53 152 P SINGER, PRACTICAL ETHICS, 126 (Cambridge University Press 1993) Joel Feinberg, Abortion, in MATTERS OF LIFE AND DEATH: NEW INTRODUCTORY ESSAYS IN MORAL PHILOSOPHY, 185 (Tom Regan ed., 1980). 153 Id. 154 Cohen and Sayeed, supra note 104 at 237. 23
rule out ‘newborn rescue’ after birth.155 There is also variance between individual fetuses at the same point in the gestational period. The US Supreme Court, in both Casey156 and Roe,157 explained that legislatures and Courts are entitled to draw arbitrary lines so long as they produce fair outcomes. Limiting abortion access based on viability always perpetuates unfairness, because it forces clinicians to engage with the concept of viability and, as Horn explains, thus think more about gestational age and the fetus than the pregnant person and their needs.158 Thus, again the focus on viability is not an ‘effective compromise’ between abortion rights and state interest in fetal life. It might be, however, argued that such considerations are relevant from the perspective of the pregnant persons health because there are material risks associated with intervention later in gestation. Erdman demonstrates, however, that abortion is
often targeted for excessive regulation due to falsehoods about its inherent risks or dangerousness, [which is simply] a function of abortion stigma. The over-regulation of abortion throughout pregnancy on grounds of medical need or safety is another instance of boundary crossing, where moral and material hazards merge.159
Restrictions based on these grounds, Erdman explains, overstay the available evidence, and thus prevent the safe delivery of healthcare services to pregnant people.160 The construction of ‘absolute gestational cutoffs’161 prevents the (what should be undisrupted) human rights of the pregnant person to make decisions about their own healthcare.162 This right of pregnant persons is well recognised in the law,163 and yet seems to go completely ignored in this context. Moreover, the arbitrariness of viability in some legal instruments constructs an imprecise gestational cut off, which even further harms pregnant persons, by actively fostering moral uncertainty amongst providers that has come, and will continue, to limit pregnant people’s access to care from their doctors.164
Furthermore, because viability is innately variable, it has been utilised by the anti-choice lobby and US State legislatures to justify restrictive definitions only loosely related to the capacity to be born alive. ‘Foetal pain’ has been related to viability in attempts to embed further restrictions in federal law.165 It is hard to see why the state has an interest in a fetus just because it has a primitive ability to feel pain (rather than the complex emotions associated with pain only experienced when one has the ability to subjectively interpret
155 Id. 156 Roe, supra note 4. 157 Casey, supra note 5. 158 Horn, supra note 8 at 106 explains that ‘by constructing abortion rights around scientific research on the fetus’s development and increasing potential for personhood, the use of viability timelines for abortion decentralize the health, needs and desires of the pregnant woman.’ 159 Erdman, supra note 2 at 35. 160 Id at 35. 161 Id at 36. 162 Id at 36. 163 In English law a pregnant person is entitled to refuse any unwanted healthcare intervention even if that intervention were likely to benefit the foetus e.g. St George’s Healthcare NHS Trust v S [1998] 3 WLR 936; Re MB (An adult: medical treatment) [1997] EWCA Civ 3093; Tameside and Glossop Acute Services Trust v Ch (A Patient) [1996] 1 FCR 753; Royal Free NHS Foundation Trust v AB [2014] EWCOP 50; Re AA (Compulsorily Detained Patient: Elective Caesarean) [2012] EWHC 4378. In the United States a pregnant person’s right to bodily integrity was recognised in Re A.C., 573 A.2d 1235 (D.C.1990). 164 Romanis, supra note 32. 165 The Pain Capable Unborn Child Protection Act attempted to restrict abortion access from 20 weeks on the grounds that the fetus can feel pain at this point. The Bill received congressional support on four occasions, including 2019, but has yet to receive Senate support. Similar provisions have been enacted at State level. 24
experiences such that pain becomes suffering). Or, why the state has an interest in a fetus that can be gestated ex utero, or even survive ex utero, when this entity is not a fully formed human being and, at the time of making these assertions of interest, is located inside a person. The viability timeline is primarily useful for aiding doctors and parent(s) in making decisions about the intensive care that should be provided to preterm neonates based on their functional capacities to survive in the external environment. This is an entirely different situation from people making decisions about pregnancy termination – so why should the two influence each other?166 The viability threshold assumes that legislation is necessary to prevent a surge in late-term abortions when this is unlikely. The data in countries where abortion has been deregulated suggests, however, that there has been no quantum leap in abortion (or late-term abortion) provision in the absence of law.167 Pregnant people seeking abortion, for a variety of reasons, tend to access treatment as early as possible. Thus, without explaining what the state interest is in the viability threshold, it becomes easy to presume that it is intended to do nothing other than control both literally and symbolically the female body, women and pregnant people’s choices.
Jackson advocates that English ‘abortion law should no longer consist in a set of defences to the crime of abortion, but rather should, like the rest of British medical law, be informed by the guiding principle of self-determination.’168 If abortion is recognised in England and Wales as a healthcare resource, meaningful conversations can be had to protect access to preserve pregnant people’s bodily integrity, healthcare interests and women’s equality and, agreeing with Horn, even if medical technology advanced to the point of AWs.
The AA 1967 does not apply in Northern Ireland, which meant that (until recently) abortion under the Offences Against the Person Act 1861 was criminal except where necessary to save the pregnant person’s life. In 2019, abortion was finally decriminalised in Northern Ireland.169 This step signalled progress in the United Kingdom and an opportunity to consider how abortion might be regulated without over-medicalisation or unnecessary gestational time limits. However, on the 31st March 2020, the Abortion (Northern Ireland) Regulations 2020 came into effect170 and this new regulatory framework still entrenches abortion provision by reference to gestational limits. Regulation 3 stipulates that a medical professional can terminate a pregnancy where they are of the opinion, formed in good faith, that the pregnancy has not exceeded its 12th week. This provision is more progressive than section 1 of the Abortion Act 1967 because it does not require that an abortion before 12 weeks be justified in clinical terms. An abortion can be performed for any reason or no reason at all. However, that this is limited to 12 weeks is unfortunate. Regulation 4 effectively mirrors s.1 (1) (a) of the AA 1967 and stipulates that where a pregnancy has not exceeded 24 weeks termination may be provided where the continuance of pregnancy involves risk to the physical or mental health of the pregnant person greater than termination.171 After this point, pregnancy may
166 British Pregnancy Advisory Service, Viability of extremely premature babies, http://bpas.org/get- involved/campaigns/briefings/premature-babies/ accessed Sept 21 2019. 167 For example, if we look to Canada, where there is no abortion law since the Supreme Court struck down the 1969 abortion law as incompatible with the Canadian Charter of Rights and Freedoms in R v Morgentaler 1 SCR 30 (1988), abortion rates appear to be decreasing: Jeanelle Sabourin and Margaret Burnett, A Review of Therapeutic Abortions and Related Areas of Concern in Canada, 34 J Obstet Gynaecol Can 532, 533 (2012), 537-538. 168 Jackson, supra note 20 at 72. 169 Northern Ireland (Executive Formation etc) Act 2019, S.9 (2). 170 This framework passed its final legislative hurdle in Westminster when the Abortion (Northern Ireland) (No. 2) Regulations 2020 was passed on 17th June 2020. 171 the Abortion (Northern Ireland) Regulations 2020, regulation 4. 25
only be terminated where there is some immediate necessity to save the life of the pregnant person,172 where there is risk to life or grave permanent injury of the pregnant person173 or in cases of severe fetal impairment.174 These regulations are to be welcomed as a step towards finally enabling the provision of essential care in Northern Ireland, however it is unfortunate that the framework still entrenches the provision of care based on gestational limits.
The advocated shift in abortion law away from rights contingent on viability advocated by Jackson,175 Sheldon,176 Erdman,177 Horn178 and others, and the policy that would follow, might be more difficult to achieve in the US since abortion politics are far more visceral. Thomson-Philbrook explains that abortion has become such a prominent political issue in the US, simply because it was declared a right to be accessed by women.179 This illustrates an important point about how the substance of the law is in how it is socially implemented. It seems less important to have a formally declared constitutional right to services than it does to have access to them. It is beyond the scope of this paper to postulate about how a shift in abortion politics towards recognition of abortion as routine healthcare in the US might be achieved without emboldening anti-choice strategy and jeopardising access. Some States are already thinking about this; in 2019 Vermont passed a law guaranteeing the right to abortion with no restrictions based on timing or gestational age. The law is explicit that no public authority can ‘deprive a consenting individual of the choice of terminating the individual’s pregnancy; interfere with or restrict… the choice of a consenting individual to terminate the individual’s pregnancy [or] prohibit a health care provider… from terminating or assisting in the termination of a patient’s pregnancy.’180 The law makes no reference to gestational age.
CONCLUSION Viability is an incoherent legal concept as it is currently featured in US law and in the legal framework in England and Wales. Viability is frequently ill-defined and presumed from a point in gestation before the fetus has a reasonable chance of survival, thus undermining the (limited) logic behind the use of viability in determining the protection afforded to unborn entities. Furthermore, viability appears to be a rebuttable presumption based on the capacities of a fetus and the technology that might be available to support it in one direction (earlier in gestation), but not in the other (later in gestation) even when the fetus is completely non- viable. I demonstrated that there is, therefore, little clarity or consistency in determining what kind of life extra uterum matters using the examples of AAPT (‘artificial womb’ technology) and unborn human entities with life-limiting conditions. There remain significant ambiguities
172 Id, regulation 5. 173 Id, regulation 6; this mirrors s.1 (1) (b) of the Abortion Act 1967. 174 Id, regulation 7. While this ground for abortion is similar to that contained in s.1 (1) (d) of the Abortion Act 1967, this regulation is far more qualified about what kind of impairment is sufficient to justify termination. It specifies that there must be a ‘substantial risk that the condition of the fetus is such that – a) the death of the fetus is likely before, during or shortly after birth, or b) if the child were born, it would suffer from such physical or mental impairment as to be seriously disabled.’ The Abortion Act 1967, in comparison, specifies only that there must be a substantial risk that the child, if born, would be seriously handicapped. 175 Emily Jackson, Degendering Reproduction? 16 Med LR 346, 366 (2008). 176 Sally Sheldon, The Decriminalisation of Abortion: An Argument for Modernisation, 36 Oxford Journal of Legal Studies 334, 362 (2016). 177 Erdman, supra note 2 at 35. 178 Horn, supra note 135 at 8. 179 Julia Thomson-Philbrook, Doctor Knows Best: The Illusion of Reproductive Freedom in Canada, in FERTILE GROUND: EXPLORING REPRODUCTION IN CANADA, 240 (Stephanie Paterson et al eds., 2014). 180 18 V.S.A. § 9497 (2019). 26
in the law in England and Wales and the US because of a failure to quantify what kind of extra uterum existence is meaningful. In this paper, following other feminist scholars, I argued that viability was a conceptually illegitimate basis for abortion regulation.
AUTHOR BIOGRAPHY Elizabeth Chloe Romanis holds a LLB (Hons) in Law and LLM in Healthcare Ethics and Law, both from the University of Manchester. Chloe is a final-year PhD Candidate at the University of Manchester supported by a Wellcome Trust Studentship in Society in Ethics. Chloe’s research focuses on the ethical and legal questions arising from the potential use of artificial womb technology as an experimental alternative to neonatal intensive care. Her broader research interests include pregnancy, childbirth and the law, assisted reproduction, innovative reproductive technologies and the legal significance of birth.
ACKNOWLEDGEMENTS I am grateful to Professor Bernard Dickens at the Faculty of Law at the University of Toronto for hosting me in Toronto to undertake this research and for his helpful comments on earlier drafts of this work. I am also thankful to the Wellcome Trust for funding my research and to the University of Manchester Faculty of Humanities for awarding additional funding for this visit. I would also like to thank Victoria Hooton, Dunja Begović, Anna Nelson and the two anonymous reviewers and editors at the Journal of Law and Biosciences for their comments on earlier drafts.
CONFLICT OF INTEREST None to declare.
FUNDING I am the recipient of a Wellcome Trust Doctoral Studentship in Society and Ethics (grant reference 208245/Z/17/Z).
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