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The Changing Governance of Genetic Intervention Technologies

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The Changing Governance of Genetic Intervention Technologies The Changing Governance of Genetic Intervention Technologies An Analysis of Legal Change Patterns, Drivers, Impacts, and a Proposed Reform Neil Harrel Thesis submitted to the University of Ottawa in partial fulfillment of the requirements for the Doctorate in Philosophy (Ph.D.) degree in Law Faculty of Law University of Ottawa © Neil Harrel, Ottawa, Canada, 2021 . Abstract Major breakthroughs in biotechnology are leading to the emergence of novel methods to select and alter future individuals’ genomes. Genetic intervention technology is evolving from the medical practice of screening for life-threatening congenital malformations to the selection against embryos that might develop mild disabilities. Scientific research suggests that heritable genome-editing technology would enable the custom alteration and the enhancement of human biological characteristics, including appearance, athletic and intellectual abilities. These novel developments and their potential long-term impacts raise the question of how effective are the laws on genetic interventions in setting limits to rapidly evolving biotechnologies. This thesis examines genetic intervention laws in the United Kingdom and France and shows it exhibits a pattern of continuous legal changes over the past several years to permit a broadening range of genetic interventions that were previously prohibited. This pattern is characterized by the regulatory licensing of genetic interventions that specific legal restrictions have sought to disallow, such as screening against conditions that are mild, treatable and not predominantly determined by genes. Moreover, governments are currently considering replacing their bans on inheritable human genetic modification with regulations that will allow the alteration of genes linked to conditions deemed “serious” and for “therapeutic” purposes. This proposed regulatory model would enable licensing the very same type of genomic alterations intended to be prohibited – genetic enhancements of human physiological and cognitive capabilities. This legal change pattern is prima facie inconsistent with the key legislative objectives and relevant international instruments, which seek to restrict these particular genetic interventions. The overarching objectives underpinning the restrictions are to prevent a pattern in which the legal boundaries would become gradually laxer, attempts to improve human heredity and the associated human rights, societal and medical impacts. Furthermore, the pattern in which the legal boundaries are becoming laxer over time stems from drawing the lines between permissible and impermissible genetic interventions using language that is vague, subjective and places few limits on the rules’ scope. A law reform can address the current limit-setting challenges by employing clearer conceptual and normative distinctions and by articulating them using language that gives greater attention to clarity, reduced subjectivity, and explicitly delimits the rules’ scope. The thesis offers a blueprint for such a reform, which includes suggestions for specific legislative amendments, clearer conceptual distinctions and newly developed legal tests. The proposed law reform aims to offer a new avenue to advance towards the key policy goal of preventing the misuse of genetic intervention technologies by strengthening its governance. II Dedication This thesis is dedicated to the memory of the late Dr. Ian Kerr. Dr. Kerr was the Canada Research Chair in Ethics, Law and Technology, a world-class scholar and a true visionary in the field. I had the great honour of having Dr. Kerr as a member of my doctoral committee. He had immensely contributed to this project. Dr. Kerr was an inspirational figure, intellectually, professionally and personally. Acknowledgements My deepest thanks and appreciation goes to the members of my doctoral committee for their remarkable guidance and advice. I have a great privilege of working with an outstanding team of academics whom their intellect, wealth of experience and kind personalities shone a great light and illuminated my path. Their insights and advice greatly contributed to the success of this project. I wish to express my gratitude and deep appreciation to the person who supported me during the process of this project, my beloved wife. I am remarkably fortunate to have a wife with a very kind heart and a unique and great mind. My wife’s love, unwavering support and care have given me enormous strength, inspiration and energy. I wish to acknowledge and extend my thanks to the Canadian Institute of Health Research (CIHR) and the University of Ottawa for their financial support, professional networks and for establishing vibrant intellectual communities. Finally, I would also like to thank the University of Ottawa, Faculty of Law. I wish to thank the various faculty members and the staff for all their support, assistance and for the remarkable quality of scholarly work, which enriched so many minds. III Table of Contents Abstract ......................................................................................................................................................................................... II Acknowledgements ................................................................................................................................................................. III Chapter 1: Introduction – Greater Choices in Child Genetics, Fewer Limitations .................................... 1 Background and Problem .................................................................................................................................................. 2 The Literature on Genetic Intervention Technologies Has Drawn Unclear, Ambiguous Lines .................. 4 Have Laws Set Robust Safeguards?................................................................................................................................. 5 Thesis ....................................................................................................................................................................................... 8 The Issues and Potential Ramifications of Genetic Intervention Laws’ Shortcomings in Setting Limits ...... 8 Challenges with Slippery Slope Arguments................................................................................................................ 14 A Method to Re-Examine the Problem— Legal Change Analysis .................................................................... 16 Original Contributions ..................................................................................................................................................... 18 The Scope of the Study .................................................................................................................................................... 25 Theory ................................................................................................................................................................................... 30 Conclusion ........................................................................................................................................................................... 35 Chapter 2: Background - Prenatal Genetic Interventions: Technologies, Markets, and Political Ideologies ........................................................................................................................................................................... 37 I) Genetic Intervention Technologies’ Growing Capabilities of Shaping Reproductive Outcomes ........................................................................................................................................................................... 38 II) Eugenics and Transhumanism – The Ideologies of Directing Human Evolution ................................. 53 III) Neo-Eugenic Ideology and the Pressures to Genetically Intervene ........................................................... 66 IV) The Risk of Future State Involvement in Market-Driven, Neo-Eugenic Practices ...................................... 74 Conclusion ........................................................................................................................................................................... 85 Chapter 3: The Origins and Objectives of Genetic Intervention Laws........................................................ 87 I) The Historical Origins of Genetic Intervention Laws........................................................................................ 87 II) The Passage of the Governing Acts in France and the UK ........................................................................... 99 III) The Establishment of the Regulatory Requirements under the Acts ....................................................... 100 Conclusion ......................................................................................................................................................................... 102 Chapter 4: “To Treat or Not to Treat?” Legal Change Concerning Treatable Conditions ............. 103 I) The Normative Considerations Behind Restricting Screening to Untreatable Conditions ............... 103 II) The Early Application of the Untreatable Condition Rule............................................................................ 107 III) An Overview of the Legal Change of the Untreatability Requirement .................................................... 107 IV) Change in
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