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HC 7-I House of Commons Science and Technology Committee Human Reproductive Technologies and the Law Fifth Report of Session 2004–05 Volume I 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 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 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: scitechcom@parliament.uk 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 Fertilisation and Embryology Act 1990 in the context of other national and international legislation and regulation of medical practice and research To include related legislation such as the EU human tissue directive, and law covering human rights, surrogacy, adoption and abortion. To include relevant declarations and statements 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 Fertilisation and Embryology Act 1990 from a) the development of new technologies for research and treatment, and their ethical and societal implications and b) recent changes in ethical and societal attitudes. To include new areas of research, treatments and interventions, such as cloning, cell nuclear transfer, transplants of ovarian and testicular tissue, embryo splitting, selection of genetic characteristics (including sex selection), stem cell 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. In view of the complex arguments to be heard in relation to assisted conception and embryo research in what was likely to be our longest inquiry of the Parliament, we decided to limit our deliberations to these issues. A further section of the HFE Act deals with surrogacy arrangements and we make recommendations as to how this topic should be addressed. 5. This inquiry comprised 12 evidence sessions and two UK visits (to visit the assisted conception unit at Guy’s and St Thomas’ Hospital and the Assisted Reproduction and Gynaecology Centre in London and to discuss stem cell research at the Medical Research Council’s National Institute for Medical Research). A further visit was made to Stockholm and Rome, to learn more of the contrasting approaches taken by Sweden and Italy, and also the Vatican. We also took part in a number of meetings. On 29 April 2004, we met with members of the British Medical Association’s Medical Ethics Committee, chaired by Dr Michael Wilks. Also contributing was Baroness Warnock. The Warnock Report is the Human Reproductive Technologies and the Law 5 basis for UK regulation of assisted conception and embryo research and is thus the key reference point for our inquiry. Her participation in our discussions was much valued. On 15 July 2004, a seminar was held in Westminster Hall organised by Progress Educational Trust and Epalan, a consultancy offering services to those working with genetic and reproductive technologies, in association with our Committee. This proved to be a useful opportunity to discuss the issues with a wide range of interested parties and for them to hear about our inquiry. Our online consultation also proved to be a valuable source of views (see Box 1). Box 1: Online consultation Our online consultation on Human Reproductive Technologies and the Law ran from 22 January 2004 for eight weeks at www.tellparliament.net. The aim of the forum was to get the views of a much wider group on the issues involved and to help us shape the terms of reference for the inquiry. The site was designed with a view to encouraging people from all walks of life to take part in the online forum. It provided a glossary and background information about the inquiry with a list of useful resources as well as the main headings with the scenarios in the online forum. Tellparliament.net was publicised through direct mailings, local media coverage, viral emails, web links and word of mouth. The online discussion was structured around four main headings: • Screening and Therapy • Surrogacy and Donation • Consent and Confidentiality • New Fertility Treatments To initiate the debate, the Committee Secretariat provided several scenarios under each of the headings. A section devoted to Human Cloning was added in the third week of the forum following the news story of research in human cloning in Korea. There was also a section for General Comments for participants to raise any additional points and to comment about the site itself. 333 people registered to take part in the online forum at tellparliament.net. 111 individual users logged on to the site and posted a total of 554 messages. Out of those who registered 181 were members of various organisations, including academic institutions and 152 were private individuals. Out of those who actually posted messages on the site 54 were members of organisations, while 52 were members of the public. There was an even split between male and female participants. 6. This has been a long inquiry and we are indebted to our advisers: Dr Gillian Lockwood, Medical Director of Midland Fertility Services; Professor Sheila McLean, Director of the Institute of Law and Ethics in Medicine at Glasgow University; and Professor Derek Morgan, Professor of Health Care Law and Jurisprudence at Cardiff Law School. They have been invaluable in negotiating the many complex technical, legal and ethical issues this inquiry has raised. 7. This report will begin by providing some background to the regulatory framework in the UK (Chapter 2). After that we will discuss the status of the embryo (Chapter 3). Our conclusions on this vital issue will then inform our discussions of the problems with the HFE Act and its implementation by the HFEA (Chapters 4 and 5). Since the HFE Act was passed there have been enormous changes in the provision of assisted reproduction services and the implications for regulation will be discussed in Chapters 6 and 7. We will then discuss some possible approaches to regulation (Chapter 8) and then conclude with 6 Human Reproductive Technologies and the Law our blueprint for a legislative and regulatory system fit for purpose in the 21 st century (Chapter 9). [...]... particular: 14 Human Reproductive Technologies and the Law — the free and informed consent of the person concerned, according to the procedures laid down by law, — the prohibition of eugenic practices, in particular those aiming at the selection of persons, — the prohibition on making the human body and its parts as such a source of financial gain, — the prohibition of the reproductive cloning of human beings... for the purpose of considering the elaboration of an international convention against the reproductive cloning of human beings All countries agree on the need to ban 'reproductive' cloning – the cloning of a human to produce another human One group of more than 40 countries, led by Costa Rica, the United States and the Vatican, wants also to outlaw therapeutic cloning The other group, led by Belgium and. .. Technologies and the Law 15 3 The embryo Status of the embryo 24 At the heart of any review of assisted reproduction legislation is the fundamental question of the status to be accorded to the human embryo There is a range of positions which can be taken on this These fall into three principal views: a) that the embryo is a human life and therefore is entitled to conferral of full human rights; b) that the. .. para 11.17 Human Reproductive Technologies and the Law 17 29 Adopting a gradualist approach, we believe, recognises the special status of the embryo of the human species, while at the same time respects the legitimate interests of intending parents and the wider society It does not, therefore, exclude other considerations such as seeking to provide treatment for the infertile or discovering the causes... make their overriding importance and relevance more visible to the Union’s citizens The Presidents of the European Parliament, the Council and the Commission signed and proclaimed the Charter on behalf of their institutions on 7 December 2000 in Nice The Charter contains the fundamental rights and freedoms as well as basic procedural rights guaranteed by the European Convention for the Protection of Human. .. 26 The gradualist approach is favoured, among religious perspectives, by the Church of England and the Jewish faith Dr Michael Nazir-Ali, the Bishop of Rochester, argued that 18 Ev 318 19 Q 712 16 Human Reproductive Technologies and the Law the gradual emergence of a person was often the approach in Christian tradition until 1869.20 It draws on distinctions between the unformed and formed foetus in the. .. 259, November 1987 8 Human Reproductive Technologies and the Law Human Fertilisation and Embryology Act 1990 11 The Human Fertilisation and Embryology Bill was given a second reading in the House of Lords in December 1989 The debates in Parliament focused on three main issues: embryo research; welfare of the child; and abortion The Bill received Royal Assent on 1 November 1990, with the HFEA taking up... powers of the HFEA This situation was later clarified by the Human Reproductive Cloning Act 2001, which 48 Ev 262 49 Section 3 50 The Act specifies the replacement of an embryo’s nucleus and therefore does not cover the cloning technique developed at the Roslin Institute which used an enucleated egg 28 Human Reproductive Technologies and the Law states “A person who places in a woman a human embryo... a human or animal is prohibited Hybrids can be created but not for the purpose of reproduction or transplanting a hybrid into a human or animal 65 Q 888 32 Human Reproductive Technologies and the Law 65 There is some uncertainty about how hybrids and chimeras are dealt with in UK law The Centre for Bioethics and Public Policy states that the creation of new genetic humananimal chimeric embryos and. .. John Harris, Reproductive Liberty, Disease and Disability, unpublished article, 2004 30 Robin Gill and Gordon Stirrat, Journal of Medical Ethics, in press Human Reproductive Technologies and the Law 19 that in the Warnock report, the idea of protecting the embryo in law arose from the discussion of embryo research rather than assisted reproduction Professor Peter Braude from Guy’s Hospital and a former . 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. abroad. Human Reproductive Technologies and the Law 11 International law and treaties European Convention for the Protection of Human Rights 15. The Council of Europe Convention for the Protection. Baroness Warnock. The Warnock Report is the Human Reproductive Technologies and the Law 5 basis for UK regulation of assisted conception and embryo research and is thus the key reference