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Human Reproductive Technologies and the Law

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Human Reproductive Technologies and the Law House of Commons Science and Technology Committee Human Reproductive Technologies and the Law Fifth Report of Session 2004–05 Volume I HC 7-I House of Commons Science and Technology Committee Human Reproductive Technologies and the Law Fifth Report of Session 2004–05 Volume I Report, together with formal minutes Ordered by The House of Commons to be printed 14 March 2005 HC 7-I [Incorporating HC 599 i-ix of Session 2003-04] Published on 24 March 2005 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 Technology and its associated public bodies. Current membership Dr Ian Gibson MP (Labour, Norwich North) (Chairman) Paul Farrelly MP (Labour, Newcastle-under-Lyme) Dr Evan Harris MP (Liberal Democrat, Oxford West & Abingdon) Kate Hoey MP (Labour, Vauxhall) Dr Brian Iddon MP (Labour, Bolton South East) Mr Robert Key MP (Conservative, Salisbury) Mr Tony McWalter MP (Labour, Hemel Hempstead) Dr Andrew Murrison MP (Conservative, Westbury) Geraldine Smith MP (Labour, Morecambe and Lunesdale) Bob Spink MP (Conservative, Castle Point) 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 the present Parliament is included at the back of this volume. Committee staff The current staff of the Committee are: Chris Shaw (Clerk); Emily Commander (Second Clerk); Alun Roberts (Committee Specialist); Hayaatun Sillem (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] Human Reproductive Technologies and the Law 1 Contents Report Page 1 Introduction 3 2 Regulation of assisted reproduction 7 Voluntary Licensing Authority/Interim Licensing Authority 7 European Convention for the Protection of Human Rights 11 European Convention on Human Rights and Biomedicine 12 United Nations 12 EU Charter of Fundamental rights 13 3 The embryo 15 Alleviating infertility 17 Spare embryos 23 Research 24 4 Problems with the HFE Act 25 Time limits 28 Animals and human cells 30 Embryos not formed through fertilisation 33 Genetic modification 38 Internet services 40 Sperm sorting 42 Regulation of fresh gametes 42 Artificial gametes 43 Practical issues and the Code of Practice 45 Discrimination 46 Ethical basis for PGD 52 Reasons to undertake PGD 56 Anonymity 67 Regulation of embryo and gamete donation 72 Fertility research 77 Therapeutic research 78 Conclusion 81 Breaches of the HFE Act 82 Breaches of regulation 83 Professional discipline 84 5 Operation of the HFEA 87 Expertise 88 Representation 90 Regulatory and advisory roles 92 Statutory boundaries 96 Policy-making and the Code of Practice 97 Inspection 100 Inspectorate 104 2 Human Reproductive Technologies and the Law Licensing 106 Research function 114 Data collection and analysis 115 Use of evidence 117 Precautionary principle 122 Conclusion 123 Research licence fees 126 Proportional 127 Accountable 127 Consistent 127 Transparent 127 Targeted 128 6 Provision of infertility services 129 International comparisons 131 7 Review of the Act 136 8 Legislative and regulatory models 142 Regulation of other medical practice 143 Research oversight 145 Oversight of treatment 149 National committees 150 Local vs national oversight 153 Policy and advice 157 Policing and accreditation 158 Risk management 159 Harmonisation of legislation 163 Reproductive tourism 164 International science 166 Legislation around the world 167 9 A new approach 169 Status and protection of the embryo and gametes 171 Consent and confidentiality 171 Regulatory agency 171 Conclusions and recommendations 175 Formal minutes 190 Witnesses 209 Written Evidence 212 Human Reproductive Technologies and the Law 3 1 Introduction 1. Louise Brown, born in 1978 in Oldham and District General Hospital, was the first child born in the world as a result of the use of in vitro fertilisation (IVF) techniques. Her birth dramatically expanded the options available to couples unable to conceive naturally and, as a result, a number of centres in the UK started to offer this treatment. The attractiveness of IVF treatments to patients can be observed by the fact that in 1990 a total of 64 licensed centres treated almost 10,000 patients, resulting in the birth of 1,443 children. However, by 2000 the number of centres had increased to 105 with almost 30,000 patients treated and over 8,000 births. Around 1% of births in the UK (8,000 babies) were conceived using IVF and in many European countries the figure is higher. 2. IVF and embryo research are regulated by the Human Fertilisation and Embryology Authority (HFEA), formed as a result of the Human Fertilisation and Embryology Act 1990. While IVF has become commonplace, the pace of medical and scientific advice has been rapid and the public interest and concern has ensured that the HFEA has never been far from controversy. In 24 April 2002, Dame Ruth Deech, outgoing Chair of the Human Fertilisation and Embryology Authority, her successor Ms Suzi Leather, and the Chair of the Human Genetics Commission, Baroness Kennedy of the Shaws, gave evidence to us on some of the issues that faced their organisations. We asked Dame Ruth what areas of the 1990 Human Fertilisation and Embryology Act (HFE Act) needed to be reviewed.1 She responded that “There is nothing that I would like to see changed or tightened. The procedure for appeals needs looking at from a human rights point of view. I would relax the confidentiality provisions but the structure remains pretty good.”.2 In our view this represented a complacent response to developments in fast-moving field, especially at a time when the HFEA had been at the centre of several legal challenges to its jurisdiction. We concluded that it was necessary to “reconnect the Act with modern science”.3 The Department of Health’s limp response was that the Government was keeping the Act “under review”.4 We considered this statement to be inadequate, and on 24 October 2003, we announced our decision to embark on a review of our own.5 On 30 March 2004, we announced the inquiry’s terms of reference (see Table 1). The Department of Health announced a review of the HFE Act on 21 January 2004 and is looking to this Inquiry to inform the review.6 1 Hereafter, we will refer to the Human Fertilisation and Embryology Act 1990 (c. 37) as the “HFE Act”. 2 Fourth Report of the Science and Technology Committee, Session 2001-02, Developments in Human Genetics and Embryology, HC 791, Q 32 3 HC (2001–02) 791, para 20 4 Department of Health, Government Response to the Report from the House of Commons Science and Technology Committee: Developments in Human Genetics and Embryology, November 2002, Cm 5693, para 34 5 Press Release No. 45, Session 2002-2003 6 Q 1301 4 Human Reproductive Technologies and the Law Table 1: Inquiry into Human Reproduction and the Law: Terms of Reference. a) To consider a) the balance between legislation, regulation and reproductive freedom; b) the role of Parliament in the area of human reproductive technologies; and c) the foundation, adequacy and appropriateness of the ethical framework for legislation on reproductive technologies. b) To consider the provisions of the Human To include related legislation such as the EU Fertilisation and Embryology Act 1990 in the human tissue directive, and law covering human context of other national and international rights, surrogacy, adoption and abortion. legislation and regulation of medical practice To include relevant declarations and statements and research by international bodies. To compare the safety and welfare provisions of the Human Fertilisation and Embryology Act 1990 with those that cover other areas of medical practice. c) To consider the challenges to the Human To include new areas of research, treatments and Fertilisation and Embryology Act 1990 from a) interventions, such as cloning, cell nuclear the development of new technologies for transfer, transplants of ovarian and testicular research and treatment, and their ethical and tissue, embryo splitting, selection of genetic societal implications and b) recent changes in characteristics (including sex selection), stem cell ethical and societal attitudes. therapy and the use of immature gametes. d) To consider the composition, expertise and approach of the Human Fertilisation and Embryology Authority, its code of practice, licensing arrangements and the provision of information to patients, the profession and the public. 3. In view of the keen public interest in the many scientific and ethical issues raised by the inquiry, we undertook, as a first step, a public online consultation. The aim of this consultation was to listen to and gauge the public’s views, both to help us frame the inquiry’s terms of reference and to allow new voices to contribute to the debate. We believe that this approach represented a significant innovation in the use of “e-consultations” in the UK. 4. The Human Fertilisation and Embryology Act 1990 contains a revision to the Abortion Act 1967. A key issue for us was to decide how to tackle the abortion issue.
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