The Legal Structure of UK Biobank: Private Law for Public Goods? By: Jessica Lauren Bell A thesis submitted in partial fulfilment of the requirements for the degree of Doctor of Philosophy The University of Sheffield School of Law February 2016 Abstract Population biobanks hold promise for improving the health of future generations by providing researchers with a resource of both human samples and data to investigate the linkages between genes, lifestyle and environment in population health. Widespread concern has been expressed in academic and policy literature as to the ongoing ethical, legal and social challenges that are raised by population biobanks, by virtue of their longitudinal nature and broadly set research aims. To address these challenges, and to balance private interests of the individuals who donate to biobanks, with the public benefit that is believed to derive from the establishment of biobanks, some countries have specifically legislated to establish national biobanks. Alternatively, UK Biobank has been incorporated as a charitable corporation. Potentially, this private legal structure diminishes the public accountability of the project, as well as the protection of donors from personal harm. This thesis analyses the multi-layered nexus of laws within which UK Biobank is embedded and shows the tensions that are associated with using a private legal structure to secure public objectives. UK Biobank is in unchartered legal territory on a number of levels, and this thesis posits UK Biobank as a timely example of a large- scale organisation whose model straddles the public/private divide in law and invites an eclectic mix of corporate, public, charity, contract and tort lawyers into a conversation with ethicists, scientists, policy experts and the public to consider how to effectively progress population health via biobanking. As such, the experience of UK Biobank raises questions as to how best to balance public and private interests in large-scale, public mission organisations in general. i Acknowledgements This project was supported by the University Of Sheffield School Of Law and the Sheffield Institute of Biotechnology, Law and Ethics (SIBLE). I would especially like to thank Professor Aurora Plomer and Dr Richard Kirkham for encouraging me to pursue this research topic and for their excellent supervision throughout this project. I am particularly indebted Aurora, for your continued enthusiasm and passion for this subject, and for the brilliant opportunities that have shaped this thesis and have been invaluably motivating over the years. Richard, I am enormously appreciative of your patience and direction, which have kept me on track until the end! Together, your sustained support and critical suggestions have ultimately made this thesis possible. Special thanks are owed to Professor Bartha Marie Knoppers and her wonderful team at the McGill University Centre of Genomics and Policy, and Associate Professor David Winickoff for sunny, productive days at the University of Berkley, California. I am overwhelmed and inspired to have been able to spend time working with, and learning from, such esteemed scholars and kind people. During this project I am also fortunate to have spent time at the Brocher Foundation and I am thankful to all the team who run the Foundation for the peace, the thinking space and the views. I am grateful to all attendees of the SIBLE International Workshop, ‘Biobanking Beyond Boundaries: Public and Private Governance Models- Who Benefits?’ for their thoughtful presentations and lively debate, which developed key themes of this thesis. Thanks are also owed to Dr Vicky Chico and Professor Andrew Johnston for your helpful comments on chapters of this thesis. I would also like to take this opportunity to thank Professor Jane Kaye for your kindness and support, and the brilliant team at HeLEX. Special thanks are owed to Harriet, Vic and Colin, for helping me to the finish line in so many ways. Finally, my most heartfelt thanks to my dear family and friends, who have been with me every step of the way. Dad, thank you for assuring me that I could do it and for dedicating everything to getting us where we are. Mum, thank you for helping me do it; burning the midnight oil on countless occasions. Thank you both for your endless belief, support and encouragement. And to my sister and brother, Harriet and George, who are my inspiration, joy and my best friends. In loving memory of Bernice Josephine Jefferson and John Smith, my Nana and Grandad, who passed from cancer before UK Biobank was built, and who we miss every day. They would have donated and they would have asked questions. ii Table of Contents Abstract ......................................................................................................................... i Acknowledgements ...................................................................................................... ii Table of Cases .......................................................................................................... viii Table of Statutes, Conventions and Agreements ....................................................... xv List of Abbreviations.................................................................................................. xx Introduction .................................................................................................................. 1 Background: ‘Public’ and ‘Private’ Biobanking ...................................................... 1 Research questions and aims .................................................................................... 8 Methodology ............................................................................................................ 9 i) Doctrinal approaches ...................................................................................... 9 ii) Socio-legal and comparative approaches .................................................... 12 Contribution to existing scholarship ....................................................................... 14 Thesis outline ......................................................................................................... 16 Chapter 1: Biobanking: Scientific Opportunity and Ethical Challenges ................... 19 1.1 Introduction ...................................................................................................... 19 1.2 Scientific Ambition: Human Genome Project success and a ‘New Generation’ of Biobanking ......................................................................................................... 22 1.3 Population biobanking: Ethical challenges ...................................................... 27 1.3.1 Privacy ....................................................................................................... 28 1.3.2 Consent ...................................................................................................... 31 1.3.3 Data access ................................................................................................. 33 1.3.4 Property, ownership and commercialisation .............................................. 36 1.3.5 Public and private interests in biobanking research ................................... 40 1.4 Global science and biobanks ............................................................................ 41 1.5 Conclusion ........................................................................................................ 43 Chapter 2: Governance of population biobanks: Comparative perspectives and lessons learned from public-private partnerships in Iceland and Estonia .................. 45 2.1 Introduction ...................................................................................................... 45 2.2 Iceland: A global lesson for biobanks and genomics ....................................... 47 2.2.1 Privatising the Icelandic Health Sector Database ...................................... 48 2.2.2 Establishing and dismantling a legal framework: The Health Sector Database Act ....................................................................................................... 51 iii 2.2.3 Regulating and financing deCODE today ................................................. 55 2.3 Estonia .............................................................................................................. 59 2.3.1 Organisational development of the Estonian Genome Project .................. 60 2.3.2 The Human Genes Research Act ............................................................... 62 2.3.3 Public-Private Partnership: The Estonian Genome Project Foundation and EGeen Ltd ........................................................................................................... 64 2.3.4 Protecting participants and securing public trust ....................................... 66 2.4 Conclusion ........................................................................................................ 68 Chapter 3: Origins and development of UK Biobank ................................................ 71 3.1 Introduction ...................................................................................................... 71 3.2 Background ...................................................................................................... 72 3.2.1 The UK and a ‘genetic revolution’ ............................................................ 72 3.2.2 NHS reform and public-private partnerships in the UK ...........................