Published by Nuffield Council on Bioethics 28 Bedford Square London WC1B 3JS Telephone: 020 7681 9619 Email: [email protected] Website: http://www.nuffieldbioethics.org September 2016 © Nuffield Council on Bioethics 2016 All rights reserved. Apart from fair dealing for the purpose of private study, research, criticism or review, no part of the publication may be produced, stored in a retrieval system or transmitted in any form, or by any means, without prior permission of the copyright owners. Web reference throughout this report were accessed September 2016 Nuffield Council on Bioethics Professor Jonathan Montgomery (Chair) Revd Dr Michael Banner Professor Simon Caney Dr Tara Clancy Professor Jeanette Edwards* Professor Ann Gallagher Dr Andy Greenfield Professor Erica Haimes Professor Julian Hughes (Deputy Chair) Sir Roland Jackson Dr David Lawrence Professor Shaun Pattinson Professor Tom Shakespeare Professor Mona Siddiqui Professor Christine Watson Professor Robin A Weiss Professor Heather Widdows Adam Wishart Dr Paquita de Zulueta * co-opted member of the Council while chairing the Working Party on Cosmetic Procedures iii Secretariat Hugh Whittall (Director) Ranveig Svenning Berg Dr Peter Mills Kate Harvey Katharine Wright Carol Perkins Catherine Joynson Dr Bettina Schmietow Sarah Walker-Robson Dr Anna Wilkinson Busayo Oladapo The terms of reference of the Council are: 1. to identify and define ethical questions raised by recent advances in biological and medical research in order to respond to, and to anticipate, public concerns; 2. to make arrangements for examining and reporting on such questions with a view to promoting public understanding and discussion; this may lead, where needed, to the formulation of new guidelines by the appropriate regulatory or other body; 3. in the light of the outcome of its work, to publish reports; and to make representations, as the Council may judge appropriate. The Nuffield Council on Bioethics is funded jointly by the Medical Research Council, the Nuffield Foundation, and the Wellcome Trust iv Members of the Working Group Andy Greenfield (Chair) Council member, Programme Leader in Developmental Genetics at the Medical Research Council’s Harwell Institute, and a member of the Human Fertilisation and Embryology Authority (HFEA) Tony Perry Reader, Laboratory of Mammalian Molecular Embryology, Department of Biology and Biochemistry, University of Bath Christine Watson Council member, Professor of Cell and Cancer Biology in the Department of Pathology, University of Cambridge and Vice-Principal of Newnham College David Lawrence Council member, Chair of the UK Knowledge Transfer Network and Non-Executive Director at Syngenta AG Charis Thompson Professor of Sociology, London School of Economics and Political Science and Chancellor’s Professor of Gender & Women’s Studies, University of California, Berkeley John Dupré Professor of Philosophy of Science, Exeter University and Director of Egenis, the Centre for the Study of Life Sciences Richard Ashcroft Professor of Bioethics, School of Law, Queen Mary University of London Karen Yeung Professor of Law and Director of the Centre for Technology, Ethics & Law in Society (TELOS), King’s College London Y Terms of reference The terms of reference for the working group are: 1. To identify and define ethical questions relating to developments in genome editing research. 2. To review institutional, national and international policies and provisions relevant to genome editing, and to assess their current and likely future significance. 3. To deliberate and to draw conclusions, as appropriate, about the nature of the ethical questions raised and how they might most suitably be addressed. 4. To report on these matters and to make recommendations, as appropriate, for further initiatives by the Council or by other identified bodies, or for the development or revision of policy or legislation. Yi Table of Fontents Nuffield Council on Bioethics...................................................................................................................iii Members of the Working Group ..............................................................................................................Y Terms of reference ..................................................................................................................................Yi Introduction .............................................................................................................................................. 1 Section 1 – Genome editing ..................................................................................... 4 The concept of genome editing ............................................................................................................... 4 Gene, genome and epigenome ............................................................................................................... 5 Techniques of genome editing ................................................................................................................ 7 Section 2 – Science in context .............................................................................. 12 Introduction ............................................................................................................................................ 12 Research and innovation....................................................................................................................... 13 Interpretation and governance............................................................................................................... 19 Section 3 – Moral perspectives ............................................................................. 24 Introduction ............................................................................................................................................ 24 Science as a moral enterprise ............................................................................................................... 24 Intervening in the genome ..................................................................................................................... 25 Responses to the challenge to established norms................................................................................ 26 Governance and democracy ................................................................................................................. 30 Conclusion ............................................................................................................................................. 31 Section 4 – Human health ...................................................................................... 34 Introduction ............................................................................................................................................ 34 Improving understanding of health and disease.................................................................................... 35 Treating disease .................................................................................................................................... 40 Avoiding genetic disease....................................................................................................................... 45 Enhancing biological function and performance.................................................................................... 50 Conclusion ............................................................................................................................................. 52 Section 5 – Food ..................................................................................................... 56 Introduction ............................................................................................................................................ 56 Plants..................................................................................................................................................... 57 Conclusion ............................................................................................................................................. 72 Section 6 – The natural environment .................................................................... 76 Introduction ............................................................................................................................................ 76 Use of genome technologies in the wild................................................................................................ 77 Gene drive ............................................................................................................................................. 79 Converging technologies: CRISPR-enabled gene drive ....................................................................... 81 Yii Law and regulation ................................................................................................................................ 84 Moral and societal questions identified ................................................................................................. 86 Conclusion............................................................................................................................................. 92 6HFWLRQ 7 – Other applications .............................................................................. 96 Introduction...........................................................................................................................................