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Government Proposals for the Regulation of Hybrid and Chimera Embryos

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Government Proposals for the Regulation of Hybrid and Chimera Embryos House of Commons Science and Technology Committee Government proposals for the regulation of hybrid and chimera embryos Fifth Report of Session 2006–07 HC 272–l House of Commons Science and Technology Committee Government proposals for the regulation of hybrid and chimera embryos Fifth Report of Session 2006–07 Report, together with formal minutes Ordered by The House of Commons to be printed 28 March 2007 HC 272–l Published on 5 April 2007 by authority of the House of Commons London: The Stationery Office Limited £0.00 The Science and Technology Committee The Science and Technology Committee is appointed by the House of Commons to examine the expenditure, administration and policy of the Office of Science and Innovation and its associated public bodies. Current membership Mr Phil Willis MP (Liberal Democrat, Harrogate and Knaresborough)(Chairman) Adam Afriyie MP (Conservative, Windsor) Mr Robert Flello MP (Labour, Stoke-on-Trent South) Linda Gilroy MP (Labour, Plymouth Sutton) Dr Evan Harris MP (Liberal Democrat, Oxford West & Abingdon) Dr Brian Iddon MP (Labour, Bolton South East) Chris Mole MP (Labour/Co-op, Ipswich) Mr Brooks Newmark MP (Conservative, Braintree) Dr Bob Spink MP (Conservative, Castle Point) Graham Stringer MP (Labour, Manchester, Blackley) Dr Desmond Turner MP (Labour, Brighton Kemptown) Powers The Committee is one of the departmental Select Committees, the powers of which are set out in House of Commons Standing Orders, principally in SO No.152. These are available on the Internet via www.parliament.uk Publications The Reports and evidence of the Committee are published by The Stationery Office by Order of the House. All publications of the Committee (including press notices) are on the Internet at www.parliament.uk/s&tcom A list of Reports from the Committee in this Parliament is included at the back of this volume. Committee staff The current staff of the Committee are: Dr Lynn Gardner (Clerk); Dr Celia Blacklock (Second Clerk); Dr Anne Simpson (Committee Specialist); Dr Sarah Bunn (Committee Specialist); Ana Ferreira (Committee Assistant); Robert Long (Senior Office Clerk); and Christine McGrane (Committee Secretary). Contacts All correspondence should be addressed to the Clerk of the Science and Technology Committee, Committee Office, 7 Millbank, London SW1P 3JA. The telephone number for general inquiries is: 020 7219 2793; the Committee’s e- mail address is: [email protected] Government proposals for the regulation of hybrid and chimera embryos 1 Contents Report Page Summary 3 1 Introduction 5 Motivation for this inquiry 5 Terminology 5 The inquiry 6 2 Background 9 Regulation 9 The Human Fertilisation and Embryology (HFE) Act 1990 9 The Human Fertilisation and Embryology Authority (HFEA) 11 The effectiveness of the UK regulatory system 11 Public consultation on review of the HFE Act 12 The outcome of the consultation 13 Stem cell research 14 Previous interest in the area 16 Chronology of relevant reports and developments 16 Previous Science and Technology Select Committee interest 18 3 Human-animal chimera or hybrid embryos and research 19 Chimera and hybrid models in research 19 Cytoplasmic hybrid embryos 22 Are they human? 23 Ethical and moral points of view 23 Is it necessary to use hybrid and chimera embryos in research? 27 Use of human embryos 27 Progress in stem cell research 27 Animal eggs as a replacement for human eggs 28 Potential problems with this research 29 Mixing animal and human material 29 Specific problems potentially associated with cytoplasmic hybrid embryos 30 Scientific opposition to research involving hybrid and chimera embryos 32 Conclusions on the desirability and necessity of hybrid and chimera embryo research 32 4 The HFEA and the current regulatory framework 34 Current applications to the HFEA 34 The role of the HFEA in regulating research 35 Do these applications fall within HFEA remit? 36 The HFEA decision of 10 January 2007 40 Delay on assessment of the applications 42 2 Government proposals for the regulation of hybrid and chimera embryos 5 Future regulation of research involving the creation of human-animal chimera or hybrid embryos 43 The parliamentary process 43 Definitions and terminology in the draft Bill 43 The proposed prohibition 46 Allowing for such research in the future 47 Drawing the line: acceptable research practice 48 The 14-day rule 48 Implantation of human-animal chimera or hybrid embryos into a woman 49 Injecting cells derived from human-animal chimera and hybrid embryos into animal models 49 Development of human-animal chimera or hybrid embryos past the 14 day limit in vivo 50 Legislative and regulatory structure 51 Impact of the legislative structure on UK science 53 6 Public engagement 55 Public confidence 55 Defining public opinion 56 Public understanding 57 7 Conclusion 58 Conclusions and recommendations 59 Glossary 64 Abbreviations used in report 68 Formal minutes 69 Witnesses 70 Written evidence 71 Government proposals for the regulation of hybrid and chimera embryos 3 Summary We have conducted this inquiry in response to the publication of Government proposals to prohibit the creation of human-animal chimera or hybrid embryos for research for the time being. We have also taken account of recent applications from researchers for licences to create human-animal cytoplasmic hybrid embryos for research. There have been significant developments in science and medicine since the passing of the Human Fertilisation and Embryology Act in 1990, and we recognise the need for revised legislation in this area of research. We believe that public confidence in this area of research must be encouraged and that the Government should ensure wider public understanding in this area through increased education and dialogue. We find this of particular importance in respect of the sincere ethical and moral concerns associated with the creation of human-animal chimera or hybrid embryos for research. We find that the creation of human-animal chimera or hybrid embryos, and specifically cytoplasmic hybrid embryos, is necessary for research. However, we maintain the view of the previous Science and Technology Select Committee that development of human- animal chimera or hybrid embryos past the 14-day stage should be prohibited and that a prohibition should be put in place on the implantation of human-animal chimera or hybrid embryos in a woman. We are critical of the Human Fertilisation and Embryology Authority for delaying assessment of applications for licences to create cytoplasmic hybrid embryos for research. It is the role of HFEA to make judgement in areas considered within the spirit of the HFE Act and we find delay of assessment of these applications by HFEA inappropriate once the Authority had established that such research is within its remit. We find the Government proposals prohibitive, notwithstanding the provision of powers to allow future regulation in this area at an unspecified date. Some research practices should be permitted under licence immediately. We recommend that the Government build upon its previous, successful, record through regulation of embryo research and we propose mechanisms for legislation and regulation of the creation of human-animal chimera or hybrid embryos for research. We are critical of the Government for not clearly setting out the areas of research practice intended to fall under the proposed legislation and suggest that greater attention should be paid to implications of the proposals for current research practice and the UK research base. Government proposals for the regulation of hybrid and chimera embryos 5 1 Introduction Motivation for this inquiry 1. On 14 December 2006 the Government published its proposals for revision of the Human Fertilisation and Embryology (HFE) Act (Cm 6989), including proposals aimed at clarifying Government policy on the creation of human-animal hybrid or chimera embryos. The White Paper explained that the Government had found that the current law does not refer to more novel processes of embryo creation that have been developed since the 1990 HFE Act was passed, and which, in theory, could be used to create embryos combining human and animal material. The Government proposed to clarify the extent to which the law applies to such entities, but also to prohibit their creation, whilst leaving the door open at some future unspecified date to regulate for circumstances in which they may be allowed under licence. 2. The Science and Technology Select Committee has long been an involved participant in debates regarding the use of human reproductive technologies in research, as demonstrated by the previous Committee’s 2005 report into Human Reproductive Technologies and the Law.1 We followed up this Report in the current Parliament by taking evidence from the Minister for Public Health, Caroline Flint MP, on how the Government intended to take forward regulation in this area, and were therefore interested in the Government proposals for revision of the HFE Act. The proposed policy on the creation of embryos containing human and animal material for research (human-animal chimera or hybrid embryos) struck us, in particular, as being at odds with the recommendations of the Committee in the last Parliament. 3. Coincidentally, we had been aware for some time that the Human Fertilisation and Embryology Authority (HFEA) was anticipating applications from researchers from King’s College London and Newcastle University for licences covering an area of research which would fall within the remit of the Government’s proposed legislation. Soon after the publication of the Government’s proposals for future legislation, the HFEA decided in mid-January 2007 to defer consideration of the licence applications, pending the outcome of a major public consultation on the creation of human-animal hybrid and chimera embryos for research purposes. It was these two threads – the general Government proposals and the specific research applications – which combined to make a compelling case for an urgent Committee inquiry. Terminology 4. We recognise that it is essential from the outset to be absolutely clear in our use of terminology in discussing these issues.
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