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4-2020

Geneva Statement on Heritable Human Genome Editing: The Need for Course Correction

Roberto Andorno University of Zurich

Françoise Baylis Dalhousie University

Marcy Darnovsky Center for Genetics and

Donna Dickenson University of London

Hille Haker FLoollowyola thisUniv andersity additional Chicago ,works [email protected] at: https://ecommons.luc.edu/theology_facpubs

Part of the Religious Thought, Theology and Philosophy of Religion Commons See next page for additional authors Recommended Citation Andorno, Roberto; Baylis, Françoise; Darnovsky, Marcy; Dickenson, Donna; Haker, Hille; Hasson, Katie; Lowthorp, Leah; Annas, George J.; Bourgain, Catherine; Drabiak, Katherine; Graumann, Sigrid; Grüber, Katrin; Kaiser, Matthias; King, David; Kollek, Regine; MacKellar, Calum; Nie, Jing-Bao; Obasogie, Osagie K.; Tyebally Fang, Mirriam; Werner-Felmayer, Gabriele; and Zuscinova, Jana. Geneva Statement on Heritable Human Genome Editing: The Need for Course Correction. Trends in Biotechnology, 38, 4: 351-354, 2020. Retrieved from Loyola eCommons, Theology: Faculty Publications and Other Works, http://dx.doi.org/ 10.1016/j.tibtech.2019.12.022

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This work is licensed under a Creative Commons Attribution 4.0 License. © The Authors, 2020. Authors Roberto Andorno, Françoise Baylis, Marcy Darnovsky, Donna Dickenson, Hille Haker, Katie Hasson, Leah Lowthorp, George J. Annas, Catherine Bourgain, Katherine Drabiak, Sigrid Graumann, Katrin Grüber, Matthias Kaiser, David King, Regine Kollek, Calum MacKellar, Jing-Bao Nie, Osagie K. Obasogie, Mirriam Tyebally Fang, Gabriele Werner-Felmayer, and Jana Zuscinova

This article is available at Loyola eCommons: https://ecommons.luc.edu/theology_facpubs/114 Trends in Biotechnology

8 governance in the EU, realize the sub- Division Agroecology and Environment, Agroscope, & Society Reckenholzstrasse 191, 8046 Zurich, sidiarity principle as strengthened by 9Institute for Biosafety in Plant Biotechnology, Julius the Lisbon Treatyii, and focus on regu- Kühn-Institut (JKI), 06484 Quedlinburg, Geneva Statement on 10Institute of - Theology - Natural at the lating issues where there is consensus Ludwig-Maximilians-Universität München, 80539 München, Heritable Human across the EU. Therefore, we propose Germany 11Institute of Political Science, , that the EC initiates an investigation of Bergheimer Strasse 58, 69115 Heidelberg, Germany Genome Editing: The 12 this model. The approach towards co- Heidelberg Center for the Environment, Heidelberg University, Im Neuenheimer Feld 229, 69120 Heidelberg, Germany Need for Course existence policies in the EU may serve 13Plant Breeding, Wageningen University & Research, PO Box as an example. 386, 6700AJ Wageningen, The Netherlands Correction 1 *Correspondence: Roberto Andorno, In the third of our articles [14], we [email protected] (D. Eriksson). 2,@ @Twitter: @cultivision Françoise Baylis, present certain reform details regard- 3,@ https://doi.org/10.1016/j.tibtech.2019.12.016 Marcy Darnovsky, ing the postauthorization require- 4,22 © 2020 Elsevier Ltd. All rights reserved. Donna Dickenson, ments as well as discuss the current 5,@ 3, ,@ political landscape in the EU and Hille Haker, Katie Hasson, * References 6 whether any regulatory reform is cur- Leah Lowthorp, 1. Eriksson, D. (2020) Options to reform the European Union 7,@ rently feasible. legislationonGMOs:scopeanddefinitions. Trends George J. Annas, Biotechnol 38, 231–234 Catherine Bourgain,8 2. Eriksson, D. (2018) Recovering the original intentions of 9 Author Contributions risk assessment and management of genetically modified Katherine Drabiak, D.E. took the initiative and prepared the first draft of the organisms in the European Union. Front. Bioeng. 10 Biotechnol. 6, 52 Sigrid Graumann, manuscript. All other co-authors each contributed a 3. Casacuberta, J.M. and Puigdomenech, P. (2018) Katrin Grüber,11 fi fi section to the manuscript and were involved in naliz- Proportionate and scienti cally sound risk assessment of 12,@ 13 ing the manuscript. gene-edited plants. EMBO Rep. 19, e46907 Matthias Kaiser, David King, 4. Steinberg, P. et al. (2019) Lack of adverse effects in 14 subchronic and chronic toxicity/carcinogenicity studies Regine Kollek, 15 Acknowledgments on the glyphosate-resistant genetically modified maize Calum MacKellar, NK603 in Wistar Han RCC rats. Arch. Toxicol. 93, This work was supported by the Swedish Founda- 16,17 1095–1139 Jing-Bao Nie, tion for Strategic Environmental Research (Mistra) 5. Sanvido, O. et al. (2012) Evaluating environmental risks of Osagie K. Obasogie,3,18,22 through the Mistra Biotech research program; and genetically modified crops: ecological harm criteria for reg- – 19 the German Federal Ministry of Education and Re- ulatory decision-making. Environ. Sci. Policy 15, 82 91 Mirriam Tyebally Fang, 6. Herman, R.A. et al. (2013) Bringing policy relevance and 20 ‘ search through the project Ethical, Legal scientific discipline to environmental risk assessment Gabriele Werner-Felmayer, and and Socio-economic Aspects of Genome Editing for genetically modified crops. Trends Biotechnol. 31, 21 – Jana Zuscinova in Agriculture’ (grant reference number: 493 496 7. Devos, Y. et al. (2015) Optimising environmental risk 01GP1613C). assessments. Accounting for ecosystem services helps to translate broad policy protection goals into specific operational ones for environmental risk assessments. As public interest advocates, policy Resources EMBO Rep. 16, 1060–1063 iwww.g-twyst.eu/files/Conclusions- 8. Smart, R.D. et al. (2015) EU Member States' voting for experts, bioethicists, and scientists, Recommendations/G-TwYSTandGRACEPolicyBrief- authorizing genetically engineered crops: a regulatory we call for a course correction in gridlock. Ger. J. Agr. Econ. 64, 244–262 Def.pdf 9. Purnhagen, K.P. et al. (2018) The European Union Court's public discussions about heritable ii www.europarl.europa.eu/factsheets/en/sheet/5/ Advocate General's Opinion and new plant breeding human genome editing. Clarifying the-treaty-of-lisbon techniques. Nat. Biotechnol. 36, 573–575 10. Raybould, A. and Macdonald, P. (2018) Policy-led com- misrepresentations, centering socie- parative environmental risk assessment of genetically modified crops: testing for increased risk rather than profil- tal consequences and concerns, 1 ing phenotypes leads to predictable and transparent Department of Plant Breeding, Swedish University of and fostering public empowerment Agricultural Sciences, 23053 Alnarp, Sweden decision-making. Front. Bioeng. Biotech. 6, 43 2 11. Faure, M. (2018) The of harmonization of VIB, Rijvisschestraat 120, Ghent BE-9052, Belgium will support robust, global public en- 3Division of Philosophy, KTH Royal Institute of Technology, food in the EU. In Regulating and Managing Food Safety in the EU (Bremmers, H. and Purnhagen, K., eds), gagement and meaningful delibera- Teknikringen 76, 100 44 Stockholm, Sweden 4 pp. 263–290, Springer Department of Crop Production Ecology, Swedish University of tion about altering the genes of Agricultural Sciences, Uppsala, Sweden 12. Eriksson, D. et al. (2018) Why the European Union needs a na- 5 tional GMO opt-in mechanism. Nat. Biotechnol. 36, 18–19 Law Group, Department of Social Sciences, Wageningen future generations. University, Hollandseweg 1, 6706, KN, Wageningen, The 13. Eriksson, D. et al. (2019) Implementing an EU opt-in mechanism for GM crop cultivation. EMBO Rep. 20, Netherlands 6Rotterdam Institute of Law and Economics, Law School, e48036 Heritable Human Genome Editing: Erasmus University of Rotterdam, Burg. Oudlaan, 50 3062, PA, 14. Eriksson, D. et al. (2020) Options to reform the European Nearing a Critical Juncture Rotterdam, The Netherlands Union legislation on GMOs: post-authorization and The impending decision about whether to 7Department of Agricultural Economics and Rural Development, beyond. Trends Biotechnol 38. https://doi.org/10.1016/j. University of Goettingen, 37073 Goettingen, Germany tibtech.2019.12.015 develop and use heritable human genome

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Box 1. Why Another Statement? human genome editing is needed to treat We write as a group of public interest advocates, social science and humanities scholars, ethicists, policy experts, or prevent serious genetic diseases. Deliber- and life scientists who share a commitment to social justice, human rights, and democratic governance of science ations about heritable human genome and technology. In January 2019, we met at the Brocher Foundation near Geneva, Switzerland to assess and dis- cuss public engagement and the governance of heritable human genome editing. As an international group including editing should hence acknowledge these both academic experts and civil society representatives, we necessarily produced a different kind of statement. basic points: • Nearly all previous statements on heritable human genome editing have been authored by groups dominated by Heritable human genome editing scientists and professionals and based in scientific and medical perspectives. By contrast, this state- would not treat, cure, or prevent dis- ment foregrounds social justice, human rights, and civil society perspectives. Its aim is to reorient the conversa- ease in any existing person. Instead, tion around heritable human genome editing by identifying misrepresentations and misunderstandings that it would modify the genes of future muddy the discourse and by encouraging a robust consideration of the social, historical, and commercial con- texts that would influence the development of heritable human genome editing and shape its societal effects. children and generations through the intentional creation of embryos with altered genomes. This fact makes it categorically distinct from somatic fi modi cation carries high stakes for our consensus before any decision about gene therapies. Heritable human ge- shared future. Deciding to proceed with al- whether to proceed is made. We insist nome editing should be understood tering the genes of future children and on the need for genuine public engage- not as a medical intervention, but as generations would mean abandoning the ment that is inclusive, global, transparent, a way to satisfy parental desires for restraint urged by the United Nations informed, open in scope, supported by re- genetically related children or for chil- ’ (UN) General Assembly s formal endorse- sources, and given adequate time. dren with specific genetic traits. ment of the Universal Declaration on the • Modifying genes in early embryos, Human Genome and Human Rights [1] Toward that end, we call for an urgently gametes, or gamete precursor cells and required by the and regulations needed course correction (Box 2)along could produce unanticipated biological of more than 50 nations (F. Baylis et al., three dimensions. effects in resulting children and in their in preparation), including 29 that have offspring, creating harm rather than fi rati ed the Oviedo Convention, a binding First, we need to address and clarify several preventing it. Heritable human genome international treaty [2]. Policymakers put misrepresentations that have distorted pub- editing would also require and nor- these prohibitions in place to protect lic understanding of heritable human ge- malize the use of in vitro fertilization fi human rights and the fundamental equality nome modi cation. (IVF), exposing healthy women to sig- of all people; to safeguard the physical, nificant health burdens [4]. psychological, and social wellbeing of chil- Second, we must reorient the conversation • Prospective parents at risk of trans- dren; and to avert the emergence of a new by foregrounding societal consequences mitting a genetic condition already eugenics. and undertaking a thorough analysis of have several options to avoid doing threats to equality. so, should they find them acceptable. Despite the persistence of these funda- For example, prospective parents ‘ mental and widely shared concerns, a Third, we need criteria for public empower- may seek to have unaffected children ’ small but vocal group of scientists and bio- ment : robust public engagement that via third-party gametes or adoption. ethicists now endorse moving forward promotes democratic governance through • In nearly every case, prospective par- i,ii with heritable human genome editing shared decision-making [4]. ents at risk of transmitting a genetic [3]. They have taken it as their task to de- condition who wish to avoid doing so cide how we might proceed toward alter- Clarifying Misconceptions and to have genetically related chil- ing the genes of future children and Informed deliberations will require setting dren can accomplish this with the generations. In fact, the question at hand the record straight on key points about existing embryo screening technique is whether to proceed at all. Neither the re- heritable human genome editing that have preimplantation genetic diagnosis sponsibility for answering that question repeatedly been presented in a confusing (PGD) [5]. While PGD also raises trou- nor the authority to answer it can be theirs or inaccurate way, distorting understand- bling ethical questions about what alone (Box 1). ing and creating barriers to meaningful kind of lives we welcome into the public engagement. world, modifying or introducing traits We contest moves toward reproductive through genome editing would vastly use of human genome modification and Perhaps the most fundamental and wide- intensify these concerns. Genome affirm the need for broad societal spread misrepresentation is that heritable editing cannot be considered an

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Box 2. The Need for Course Correction reinvigorated by the availability of herita- The organizing committee of the 2015 International Summit on Human Gene Editing asserted that clinical ble human genome editingiv [6,7]. These ‘ ’v use of germline editing should not proceed without broad societal consensus .Insteadofsustainedcom- pernicious ideas increase stigma and mitment and the allocation of significant resources toward this prerequisite, we have seen steady efforts to weaken it. Perhaps the clearest example came from the organizing committee of the 2018 International discrimination against those Summit on Human Genome Editing. Meeting in the shadow of He Jiankui’s utterly unethical experiments, considered genetically disadvantaged, this group issued a call for a ‘translational pathway to germline editing’,withonlyacursorymentionof including disabled people and communi- ‘ ’vi attention to societal effects . ties, and undermine the fundamental More recently, the need for broad societal consensus was reaffirmed in the call for a global moratorium on equality of all people. heritable human genome editing by an international group of scientists and ethicists, including two of the three • Outcomes in related biotechnological vii–ix scientists most often recognized as CRISPR pioneers [5]. Subsequent endorsements of their statement spheres provide examples of the likely [10] and additional calls for a moratorium from scientists, bioethicists, and biotechnology executivesx [11] pro- vide a welcome reminder that enthusiasm for heritable human genome editing is far from universally shared in trajectory of heritable human genome scientific and industry circles. The proposed moratorium would allow time to develop the more substantive, editing if commercialized. These include inclusive, and empowering forms of public engagement needed in deliberations about heritable human the promotion of social sex selection by genome editing. fertility clinics and of unproven and risky ‘treatments’ by commercial alternative to PGD, because PGD because their genetic underpinnings are clinics. would remain a necessary step in any too complexiii. This point is important but embryo editing procedure. not decisive. Some prospective parents Public engagement and empowerment are likely to find fertility clinics’ marketing are likely to reveal additional concerns Centering Societal appeals compelling even when the genetic that have not yet surfaced, particularly if Consequences and Concerns modifications offered are dubious. It is we commit to including and listening to a To date, most conversations about herita- clear that social inequality and discrimina- broad range of voices and perspectives. ble human genome editing have neither tion can be spurred by the mere percep- adequately analyzed its societal context tion that some humans are biologically Fostering Public Empowerment nor meaningfully explored its social justice ‘better’ than others. Despite widespread recognition that deci- and human rights implications, despite sions about this powerful technology their seriousness. Deliberations about heritable human ge- cannot be made by scientists alone, nome modification must seriously investi- public involvement is often devalued, We share widespread concerns that the ac- gate the implications of social and undermined, or limited to predetermined cumulation of individual choices shaped by historical dynamics such as these: issues (e.g., selecting conditions for cultural and market forces could result which germline editing should be avail- • Competitive pressures to ‘get ahead’, in heritable human genome modification able). What is often proposed in lieu of coupled with commercial incentives in ushering in a new form of eugenics. Particu- genuine public engagement is a top- larly troubling is the prospect that heritable the fertility industry (especially where it down project of educating the uninformed human genome editing would be used in operates in the private sector), could public with the explicit goal of engineering efforts to alter a wide range of human foster the adoption of heritable human acceptance. A related approach sidelines traits. Although several recent proposals genome editing by those able to afford public engagement by framing heritable would limit it to genes associated with it. Unequal access to perceived genetic human genome modification as inevitable medical conditions, none adequately ‘upgrades’ could then exacerbate the while ignoring social and medical alterna- grapples with how the tenuous distinc- recent dramatic rise in socioeconomic tives, as well as the numerous policies tion between ‘therapy’ and ‘enhancement’ inequality. prohibiting it. uses would be defined or enforced. Even • Racism and xenophobia are resurgent well-intentioned efforts to restrict its use to around the world, fueled by discredited Public empowerment requires that partici- specified conditions would be unlikely to scientific and popular assumptions pants set the scope and framework of hold, especially under the self-regulatory about biological differences among ra- assessment. All facets of the question – arrangements often envisioned. cially categorized populations. Eugenic especially whether heritable human ge- thinking, which aims to ‘improve’ human- nome modification should be pursued Some dismiss such concerns, saying that ity through genetic and reproductive at all – must remain open to debate. De- it will not be possible to genetically en- and practices, persists liberations must proceed with a clear, hance traits like intelligence or appearance in popular discourse and could be shared understanding of what is in

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19 question and at stake and with transpar- wise, democratic decisions about the Institute of Biomedical and History of , University of Zurich, Zurich, Switzerland ency about financial or other interests shared future we aspire to build. 20Institute of Biological Chemistry and Bioethics Network shaping the conversations. Further, the Ethucation, Medical University of Innsbruck, Innsbruck, outcomes of public deliberations need Acknowledgments 21EPP Working Group on Bioethics and Human , to be taken into account by policymakers The authors gratefully acknowledge the Brocher European , Brussels, Belgium 22These authors were unable to attend the workshop at and integrated into formal decision-making Foundation (www.brocher.ch), Geneva, Switzer- the Brocher Foundation in Geneva but were involved with processes. land, for hosting the workshop that initiated this the planning and preparation of the meeting and statement and for generously providing financial manuscript. support for Open Access publication. We also Robust public engagement must also be *Correspondence: thank Kathrin Martin for her assistance. [email protected] (K. Hasson). global and inclusive, involving a range of @Twitter: @FrancoiseBaylis (F. Baylis), publics whose voices have, to date, been @C_G_S (M. Darnovsky and K. Hasson), @hillehaker (H. Haker), Resources @georgejannas (G.J. Annas), and @matthiaskaise14 (M. Kaiser). overlooked or minimized [8]. While scien- i www8.nationalacademies.org/onpinews/newsitem. https://doi.org/10.1016/j.tibtech.2019.12.022 tists’ contributions are important, their aspx?RecordID=11282018b voices should not dominate; social values ii fi © 2020 The Author(s). Published by Elsevier Ltd. This is an http://nuf eldbioethics.org/project/genome-editing- open access article under the CC BY license and implications must be at the center. human-reproduction (http://creativecommons.org/licenses/by/4.0/). iii Thus, in addition to scholars in the social www.nytimes.com/2017/08/04/science/gene- sciences and humanities, legal and policy editing-embryos-designer-babies.html References ivwww.washingtonpost.com/opinions/if-we-start- 1. UNESCO (1997) In Universal Declaration on the Human specialists, and other experts, delibera- editing-genes-people-like-me-might-not-exist/2017/ Genome and Human Rights (UNESCO, , ed.) tions must include a broad swath of orga- 2. Council of Europe (1997) Convention for the Protection 08/10/e9adf206-7d27-11e7-a669-b400c5c7e1cc_ of Human Rights and Dignity of the Human Being with nized civil society, with special attention story.html Regard to the Application of Biology and Medicine: to public interest organizations focused vwww8.nationalacademies.org/onpinews/newsitem. Convention on Human Rights and Biomedicine (Oviedo Convention),CouncilofEurope aspx?RecordID=12032015a on women’s health, reproductive rights 3. National Academies of Sciences, Engineering, and vi and justice, racial justice, environmental www8.nationalacademies.org/onpinews/newsitem. Medicine (2017) Human Genome Editing: Science, Ethics, aspx?RecordID=11282018b and Governance, National Academies Press justice, gender equality, disability rights, viiwww.eshg.org/index.php?id=910&tx_news_pi1 4. Baylis, F. (2019) Altered Inheritance: CRISPR and the Ethics and human rights. of Human Genome Editing, Harvard University Press [news]=16&tx_news_pi1[controller]=News&tx_news_ 5. Lander, E. et al. (2019) Adopt a moratorium on heritable pi1[action]=detail&cHash= genome editing. Nature 567, 165–168 50d16c4b8e5abef5e2693e7864b7e2e5 6. Stern, A.M. (2019) Proud Boys and the White Ethnostate: How the Alt-Right is Warping the American Imagination, Beacon Press viiiwww.eshre.eu/Press-Room/ESHRE-News Concluding Remarks 7. Roberts, D. (2011) Fatal Invention: How Science, , ix No decision about whether to pursue herita- www.irdirc.org/irdirc-supports-the-call-for-a- and Big Business Re-Create Race in the Twenty-First fi moratorium-on-hereditary-genome-editing/ Century, New Press ble human genome modi cation can be 8. Hurlbut, J.B. et al. (2018) Building capacity for global xwww.asgct.org/research/news/april-2019/scientific- legitimate without broadly inclusive and genome editing observatory: conceptual challenges. leaders-call-for-global-moratorium-on-g) Trends Biotechnol. 36, 639–641 substantively meaningful public engage- 9. Saha, K. et al. (2018) Building capacity for a global ment and empowerment. Such delibera- genome editing observatory: institutional design. Trends 1School of Law of the University of Zurich, Zurich, Switzerland Biotechnol. 36, 741–743 tions may be challenging and messy. They 2Dalhousie University, Halifax, NS, Canada 10. Wollinetz, C. and Collins, F. (2019) NIH supports call 3Center for Genetics and Society, Berkeley, CA, USA for moratorium on clinical uses of germline gene editing. will take time and organizing them will ne- 4 fi Medical Ethics and Humanities, University of London, London, Nature 567, 175 cessitate creativity, hard work, and signi - UK 11. German Ethics Council (2019) Intervening in the Human cant human and financial resources [9]. 5Loyola University Chicago, Chicago, IL, USA Germline, German Ethics Council 6University of Oregon, Eugene, OR, USA The course correction proposed here is es- 7Center for Health Law, Ethics and Human Rights, Boston sential to these efforts. University School of Public Health, Boston, MA, USA 8Center for Research in Medicine, Science, Health, Mental Health, and Society, National Institute of Health and Medical Forum We must in the meantime respect the pre- Research (INSERM), Paris, 9College of Public Health and College of Medicine, University of dominant policy position against pursuing South Florida, Tampa, FL, USA Synthetic Rewiring of heritable human genome modification, if 10Protestant University of Applied Sciences, Bochum, Germany 11Institut Mensch, Ethik und Wissenschaft, , Germany Plant CO2 Sequestration we are to prevent individual scientists or 12Centre for the Study of the Sciences and Humanities (SVT), small committees from making this mo- University of Bergen, Bergen, Norway Galvanizes Plant 13Human Genetics Alert, London, UK mentous decision for us all. This will pre- 14Hamburg University, Hamburg, Germany Biomass Production serve time to cultivate an informed and 15Scottish Council on Human Bioethics, Edinburgh, UK 16Bioethics Centre, Dunedin School of Medicine, University of 1,3, engaged public that can consider and dis- Otago, Dunedin, New Zealand Muhammad Naseem, * 17Peking University Health Science Center, Beijing, China 2,3 cuss the societal consequences of altering 18 Özge Osmanoglu, and University of California, Berkeley, Joint Medical Program, 2, the genes of future generations and make School of Public Health, Berkeley, CA, USA Thomas Dandekar *

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