The Regulation of Research Involving Human Embryos and Cloning in the United Kingdom and Australia Sonia Marie Allan Submitted in total fulfilment of the requirements of the degree of Doctor of Philosophy April, 2009 Faculty of Law University of Melbourne Page i Page ii Abstract This thesis analyses the nature, rationale, and implementation of United Kingdom and Australian regulation of research involving human embryos and cloning using legal materials, other documents and qualitative interviews with researchers, practitioners and regulators. It considers how law-makers have decided upon what to regulate and where to draw the line between permissible and prohibited activities, and the type of regulatory design strategies and enforcement approaches adopted in each jurisdiction (the ‘how to regulate’ question). It is argued that both jurisdictions have effectively decided upon permissible and prohibited activities as a result of thorough public consultation, research, reviews and the parliamentary process, and have appropriately balanced competing rationales for regulation. However, the type of regulation used in relation to those who are licensed to research in this area is unsuitable due to an over-emphasis on deterrence and the authoritarian approach taken by the regulatory bureaucracies. The central thesis is that a responsive regulatory system for licence-holders should be adopted. It is proposed that such a system would maintain the top level ‘command and control’ design strategies and deterrence approaches present in the current regulatory systems for breaches of legislation by non-licence holders and serious breaches by licence holders. However, greater use of co- regulatory design strategies and cooperative, educative and persuasive enforcement approaches should be used for regulating licensed research activities. Page i Page ii Declaration This is to certify that (i) the thesis comprises only my original work towards the PhD except where indicated in the Preface, (ii) due acknowledgement has been made in the text to all other material used, (iii) the thesis is less than 100,000 words in length, exclusive of tables, maps, bibliographies and appendices. Page iii Page iv Acknowledgments Associate Professor Christine Parker. I cannot thank you enough for ‘coming on board’ and being an amazing Supervisor. You facilitated my research trips, and made so many things possible. You kept encouraging me whilst I worked, fell ill, had babies, and lived life’s vicissitudes. You kept pointing me towards relevant material and raising the bar. I have learnt so much and can only thank you again. You are the best!!! Professor Loane Skene. I am grateful for you having accepted me as your PhD student, and being there at the beginning of my journey to welcome me with your very kind, hospitable manner. I thank you for taking the time to read my thesis and giving me valuable advice and feedback about how to improve my arguments, your comments led to greater clarity and a better thesis. Most of all I thank you for encouraging me! Thank you to Professor Gerry Simpson and Associate Professor Jacqueline Peel, my completion seminar assessment panel, who gave very positive feedback and invaluable advice on filling in the gaps and tying up the ‘loose ends’. Thank you to the women who work and have worked in the research office at the University of Melbourne: Margherita Matera, Lucy O’Brien, Sophie Garrett, Mas Generis. You are all stars! (Special thanks to Lucy who lent me her own funds to support a research trip. You are so generous and kind!!!) Associate Professor Carolyn Evans, Associate Dean (Research) for keeping the research higher degree program running at Melbourne Law School, and for introducing initiatives to enhance the quality of Melbourne Law School HDR graduate programme. Dr. Kate Foord (friend and former VLRC colleague) another superstar. University of Melbourne friends and colleagues – especially Michael Bryan, Christian Witting, Ian Malkin, Paula O’Brian, Amir Kordvani, Rachel Carson, Carrie McDougall. University of Melbourne – scholarship, postgraduate association (UMPA). University of Melbourne – My undergraduate, Masters and Juris Doctorate students 2003- 2008. Victorian Law Reform Commission – where my writing and research skills were developed and I learnt many skills working on their reference on Assisted Reproductive Technology. Deakin University School of Law, where as a full-time staff member I was able to work solidly on my PhD in second semester 2008. I am extremely grateful for this block of time, which I believe has enabled me to finish. A special thank you to Professor Anne Rees who made this possible. Page v Page vi This thesis is dedicated to my husband, Geoffrey Damien Allan, my daughter, Mahalia Rose Allan, born 14 May 2007 and my son, Gabriel Jackson Allan, born 14 May 2009: you are so beautiful, and I love you! Page vii The law stated in this thesis is the law at March 2009 Citation style: Melbourne University Law Review Association Inc, Australian Guide to Legal Citation (2002) Page viii TABLE OF CONTENTS Chapter One: INTRODUCTION __________________________________________________ 1 I. Introduction: Technology and the Law, a Call for Regulation ________________________ 1 II. Statement of the Research Problem ____________________________________________ 4 III. The Scope of the Research ____________________________________________________ 4 IV. Summary of Research Methodology ____________________________________________ 6 V. Thesis Outline and Organisation _______________________________________________ 7 VI. Conclusion ________________________________________________________________ 15 Chapter Two: RATIONALES FOR REGULATION: THE BASIS FOR MAKING DECISIONS ABOUT WHAT TO REGULATE AND WHERE TO DRAW THE LINE _________________ 17 I. Introduction ______________________________________________________________ 17 II. Early Philosophical, Religious and Scientific Views of the Embryo and When Life Begins _ 20 A. Hippocrates ____________________________________________________________________ 20 B. Aristotle ______________________________________________________________________ 21 C. Religious Philosophies ___________________________________________________________ 22 D. Developmental Biology and Embryology _____________________________________________ 27 III. Current Scientific Views on the Beginning of Life _________________________________ 30 IV. Formal Regulation of Research Involving Human Embryos _________________________ 32 A. Assisted Reproductive Technologies: Beyond the Moral Status of the Embryo _______________ 32 B. United Kingdom ________________________________________________________________ 32 C. Australia ______________________________________________________________________ 36 V. Reproductive Cloning _______________________________________________________ 42 VI. Stem Cell Research _________________________________________________________ 43 VII. The Use of Cloning Technology in Stem Cell Research _____________________________ 44 VIII. A Shift in the Regulation Debate: Regulating all Research Involving Human Embryos and Cloning __________________________________________________________________ 45 A. Old Debate, New Issues __________________________________________________________ 45 B. Further Rationales for Regulation __________________________________________________ 46 IX. Conclusion ________________________________________________________________ 51 Page ix Chapter Three: AN INTRODUCTION TO REGULATORY THEORY, DESIGN STRATEGIES AND ENFORCEMENT APPROACHES ______________________________________ 53 I. Introduction ______________________________________________________________ 53 II. Introduction to Theories of Punishment ________________________________________ 55 A. Deterrence Theory ______________________________________________________________ 55 B. Incapacitation Theory ____________________________________________________________ 58 C. Rehabilitation Theory ____________________________________________________________ 59 D. Restorative Justice Theory ________________________________________________________ 60 E. Retribution Theory ______________________________________________________________ 63 F. The Five Theories in the Context of Regulating Research Involving Human Embryos and Cloning 64 III. Regulatory Design Strategies _________________________________________________ 65 A. Command and Control ___________________________________________________________ 66 B. Self-Regulation and Enforced Self-Regulation _________________________________________ 71 C. Co-Regulation __________________________________________________________________ 75 IV. Enforcing Regulation _______________________________________________________ 78 A. Deterrence Approach ____________________________________________________________ 79 B. Cooperative, Persuasive and Educative Approach ______________________________________ 82 C. Progression through Various Approaches ____________________________________________ 84 V. Conclusion ________________________________________________________________ 90 Chapter Four: REGULATION OF RESEARCH INVOLVING HUMAN EMBRYOS AND CLONING IN THE UNITED KINGDOM AND AUSTRALIA _____________________________ 92 I. Introduction ______________________________________________________________ 92 II. The United Kingdom: Decisions About What to Regulate and Where to Draw the Line Between Permissible and Prohibited Research __________________________________ 94 A. Research Involving Human Embryos: Delineating