HOUSE OF LORDS HOUSE OF COMMONS Joint Committee on the Human Tissue and Embryos (Draft) Bill Session 2006–07 Human Tissue and Embryos (Draft) Bill Volume I: Report Ordered to be printed 24 July 2007 and published 1 August 2007 Published by the Authority of the House of Lords London : The Stationery Office Limited £price HL Paper 169-I HC Paper 630-I Joint Committee on the Human Tissue and Embryos (Draft) Bill The Joint Committee was appointed to consider and report on the Human Tissue and Embryos (Draft) Bill published by the Department for Health on 17 May 2007 (Cm 7087). The Committee was appointed by the House of Commons on 2 May 2007 and the House of Lords on 8 May 2007. Membership The Members of the Committee were: Baroness Deech Mr David Burrowes MP Baroness Hollis of Heigham Ms Katy Clark MP Lord Mackay of Clashfern Dr Ian Gibson MP Lord Jenkin of Roding Robert Key MP Baroness Neuberger Chris Mole MP Bishop of St Albans Dr Doug Naysmith MP Lord Selsdon Geraldine Smith MP Lord Turnberg Ms Dari Taylor MP Lord Winston Phil Willis MP (Chairman) Full lists of Members’ interests are recorded in the Commons Register of Members’ Interests http://pubs1.tso.parliament.uk/pa/cm/cmregmem/041203/memi02.htm and the Lords Register of Interests http://pubs1.tso.parliament.uk/pa/ld/ldreg/reg01.htm General Information General information about the House of Lords, House of Commons and Parliamentary Committees, is on the internet at http://www.parliament.uk Contacts for Joint Committee on the Human Tissue and Embryos (Draft) Bill All correspondence should be addressed to the Clerk, Joint Committee on the Human Tissue and Embryos (Draft) Bill, Committee Office, House of Lords, London SW1A 0PW. The telephone number for general enquiries is 020 7219 8675. The Committee’s email address is [email protected] CONTENTS Paragraph Page ABSTRACT 6 Chapter 1: Introduction 1 7 The Joint Committee 1 7 Scope of our inquiry 2 7 Timing 3 7 Evidence and other views received 4 8 Acknowledgements 5 8 Chapter 2: Policy Background 6 9 Policy history 6 9 Table 1: Chronology of relevant legislation, review and reports 11 Parliamentary involvement 13 12 Chapter 3: Public Opinion and Public Understanding 14 13 Public Opinion 14 13 Public education and public understanding 24 15 Parliament’s role 27 16 Chapter 4: Legislative and Ethical Framework 28 17 The ethical framework 28 17 Warnock and the 1990 framework 28 17 The ethical framework in the draft Bill 32 18 A statement of principles? 34 18 How ethical decisions are currently made 35 19 Ethics within the regulatory framework 37 19 Ethics outside the regulatory framework 41 20 Conclusions 44 21 The regulatory architecture: getting the balance right 49 22 Chapter 5: Part 1 of the Draft Bill—The Regulatory Authority for Tissue and Embryos 57 24 Introduction 57 24 RATE 59 24 RATE: efficiency or more bureaucracy? 65 25 RATE: bringing tissue and embryos together 68 26 HFEA reputation: domestically and internationally 73 27 Breadth of functions 76 28 RATE’s constitution and the Expert Advisory Panel (EAP) model 83 29 The Draft Full Regulatory Impact Assessment: costs and savings 86 30 An alternative to RATE? 90 30 Regulating research and treatment 93 31 (1) The relationship between research and treatment 94 31 (2) The regulation of research 97 32 (3) Regulation of treatment 99 32 (4) The overall regulatory structure 104 34 Conclusion 105 34 Reform of the Human Tissue Act 2004 106 34 Embryo transfer in treatment 115 36 Paying for the regulator 118 37 Paying for regulation 119 37 Research licence fees 122 38 Treatment fees 124 38 NICE guidelines 128 39 Chapter 6: Part 2 of the Draft Bill—Amendments of Human Fertilisation and Embryology Act 1990 130 40 Definitions 130 40 Introduction 130 40 Definitions in clauses 14 and 15 134 41 Secretary of State’s power to extend definitions 139 42 Inter-species embryos 142 42 General points on inter-species embryos 145 44 Government policy 152 45 Section 4A(5)(a): ‘true’ hybrids 156 46 Section 4A(5)(e): the ‘catch-all’ provision and the regulatory gap 162 47 A way forward with definitions 170 49 Box 1: Inter-species embryo: working definition 50 Overall conclusion on inter-species embryos 177 50 Prohibitions in respect of embryos and mitochondrial DNA from two women (artificial gametes) 179 51 Clause 18 and Schedule 2: Licensable activities 190 53 Embryo testing 192 53 Tissue typing and ‘saviour siblings’ 196 54 Sex selection 200 55 Research licences 206 56 Consent to storage and use of gametes and embryos 213 58 Conditions of licence for treatment: ‘Welfare of the child’ and ‘need for a father’ provisions 219 59 Introduction 219 59 Welfare of the child 221 60 The ‘need for a father’ 224 61 Reasons for proposed change 224 61 Research evidence on role of fathers 231 62 HFEA guidance on the welfare of the child and the need for a father 236 64 Alternative proposals 239 64 Storage limits 244 66 Register of Information 251 67 New section 31ZA: access to the register for civil partners 252 67 Section 31ZA (access to identifying information about genetic half-siblings) 257 68 Section 31ZE (voluntary contact register) 259 69 Use of information for research purposes 260 69 Age of access 261 69 Chapter 7: Part 3 (Parenthood in cases involving Assisted Reproduction) and Part 4 (Miscellaneous and General) of the Draft Bill 263 70 Parenthood 263 70 Feelings of donor-conceived people 267 71 The right to know and the need to be told 268 71 Birth certificates 273 72 Counselling/intermediary services 277 73 Sperm sorting kits 279 74 Surrogacy arrangements 285 75 Internet sperm donation 290 76 Chapter 8: Recommendations 293 77 Chapter 3 293 77 Chapter 4 295 77 Chapter 5 297 77 Chapter 6 303 78 Chapter 7 320 80 Appendix 1: Joint Committee on the Draft Human Tissues and Embryos Bill 81 Appendix 2: List of Witnesses 82 Appendix 3: Call for Evidence 86 Appendix 4: List of Acronyms 91 Appendix 5: Report of Evening Forum 92 Appendix 6: Report on the Online Consultation 105 Appendix 7: Memorandum on behalf of the Chairman of the House of Lords Select Committee on Delegated Powers and Regulatory Reform 111 Appendix 8: Letter from the Minister to the Chairman on the Draft Regulatory Impact Assessment 115 Appendix 9: Letter to the Clerk from the Department of Health on the Provisions on Inter-Species Embryos 123 Appendix 10: Formal Minutes 125 NOTE: References in the text of the report are as follows: (Q) refers to a question in oral evidence (Ev) refers to an evidence submission The Report of the Joint Committee is published in Volume I, HC 630-I, HL Paper 169-I. The Evidence of the Committee is published in Volume II, HC 630-II, HL Paper 169-II (published 8 August 2007). ABSTRACT ___________________________________________________________________________________________________________________________________________________________________________________________________________________ The Human Tissue and Embryos (Draft) Bill, published on 17 May, sets out the Government’s proposals to update the law on assisted human reproduction. A Joint Committee of both Houses of Parliament was set up on to undertake pre-legislative scrutiny on the draft Bill and ordered to report by 25 July. Assisted reproductive technology, treatment and research have developed significantly since the Human Fertilisation and Embryology Act was passed in 1990. These developments have raised ethical, scientific, legal and social issues worthy of detailed consideration. We welcome the draft Bill and the opportunity to undertake pre-legislative scrutiny in this important area. However, there are a number of significant areas where we challenge the Government’s approach. First, we reject the Government’s proposals to merge the existing regulators to form RATE—the Regulatory Authority for Tissue and Embryos. The evidence we received on the merger proposal was overwhelmingly against setting up RATE. Retaining the HFEA and the HTA will provide better regulatory oversight and we recommend amending the draft Bill to provide a clear framework of devolved regulation giving greater regulatory freedom and authority to the regulator and clinicians except where there is a good reason to do otherwise. Second, we ask the Government to revisit its approach to inter-species embryos. If Parliament supports the creation and use of inter-species embryos for research—and we believe the issue should be put to a free vote in both Houses—we recommend that legislation should provide a general definition that the regulator can interpret and apply to individual research applications within the principles set out by Parliament. This contrasts with the Government’s approach to try to define now in legislation new types of inter- species embryos that may emerge in the future. Third, the draft Bill proposes to remove the requirement to take into account the need of the child for a father from the current conditions of every licence to provide IVF treatment services. Again, we recommend a free vote on the issue. The balance of view of the Committee is that the provision should be retained but in a form that makes clear (in keeping with other provisions in the draft Bill) that it relates to the need for a second parent. Finally, in relation to both inter-species embryos and the ‘need for a father’ provisions, we have recommended a free vote in Parliament because of the profound nature of the ethical issues involved. If Parliament is being asked to make judgements on such issues, it should have an established mechanism to allow it to do so with input and engagement from those holding views across the ethical spectrum.