HUMAN FERTILISATION EMBRYOLOGY AUTHORITY Human — fertilisation a Embryology Authority EIGHTH ANNUAL REPORT & ACCOUNTS 1999 22501866754 Human Fertilisation and Embryology Authority EIGHTH ANNUAL REPORT & ACCOUNTS nO eB SE a4 sR a va* H % iN 4a >» <s 3 Human Fertilisation and Embryology Authority Paxton House, 30 Artillery Lane, London El 7LS Telephone: 0207 377 5077 Fax: 0207377 1871 Website: http://www.hfea.gov.uk Published with the permission of the Department of Health on behalf of the Controller of Her Majesty’s Stationery Office. © Crown copyright 1999. Copyright in the typographical arrangement and design is vested in the Crown. Applications for reproduction should be made in writing to The Copyright Unit, Her Majesty’s Stationery Office, St Clements House, 2-16 Colegate, Norwich NR3 1BQ. First published 1999 ISBN 0 11 322290 4 Printed in the United Kingdom for The Stationery Office J98544 C15 11/99 9385 11697 This report covers the year beginning | November 1997 with a forward look for the year beginning 1 November 1998. All information contained was correct as of 31 August 1999. lable of Contents Chairman’s Letter The Human Fertilisation and Embryology Authority The HFEA’s Role The HFEA’s Membership and its Executive Performance Indicators Efficiency Savings The Code of Practice and Enforcement Membership of the HFCA H0Neb0NSem9OO9 Membership of the HFCA Committees and Working Groups Or Licensing and Audit of Licensed Clinics Introduction The Licensing and Inspection Process Breaches and Enforcement The Audit Programme of Licensed Clinics’ Data The Code of Practice Introduction ‘Welfare of the Child’ Fifth Edition of the Code Guidance on Egg-Sharing Collecting and Providing Data Development of the HFEA’s Data Register IVF Data Multiple Births and Two and Three Embryo Transfer Donor Insemination Data Research Background HFEA Remit The Research Licensing Process Current Situation HUMAN FERTILISATION AND EMBRYOLOGY AUTHORITY 1999 ANNUAL REPORT & ACCOUNTS 6 Policy Update and Issues for the Coming Year 28 Payments to Sperm and Egg Donors 28 Cloning 28 Preimplantation Genetic Diagnosis (PGD) 29 Cryopreservation of Sperm and Embryos 30 Storage and use of Testicular and Ovarian Tissue 30 Oncology Patients — Review of Guidelines 30 Department of Health’s Consultations 30 Working Group on New Developments in Reproductive 30 Technology (WGNDRT) Licensing of Novel Applications 31 Laser Assisted Hatching a1 Use of Crytoplasmic Donation in Treatment ol Fertility Drugs and Cancer 31 Guidance for Centres Regarding the Use of Blastocysts in 32 Treatment . Communications 33 Introduction 33 Review of the Patient’s Guide to DI and IVF Clinics 33 and other Patient Literature The HFEA Annual Conference 34 Regional and Other Meetings 34 Information available to the public 34 Annexes: Executive Staff 36 List of Licensed Clinics ce List of HFEA Inspectors 59 eme,e Li st of Research Projects 41 List of Peer Reviewers 42 oeL ist of Members’ Interests 44 Accounts Financial Report 48 1998/99 Accounts 53 Notes to the Accounts 56 Appendix to the Accounts 62 Schedules 1 and 2 63 Chairman’s Letter In the last decade several issues have arisen to challenge society’s view of what is ‘normal’ or ‘acceptable’ in human reproduction. These issues have been difficult for society to accommodate, and have presented serious challenges to conventional ideas. The HFEA has, however, been able to assure both public and legislators that fertility clinics and centres conducting research are acting properly and that there are adequate controls in place. The aims of the HFEA are to regulate licensed clinics in a rigorous but sensitive way; to protect patients who may be vulnerable to exploitation, whether intended or inadvertent; to enable this sensitive area of science and medicine to progress in a responsible way; and to reassure the public that possible excesses are guarded against. The HFEA balances the desire for scientific progress with the need to protect patients and future offspring. No other field of medicine in the UK is regulated as strictly as [VF and embryo research — and no other country in the world regulates these fields as closely as the UK. This year, both areas have seen rapid developments. After discussion and consultation lasting several years, the HFEA decided to continue to allow the payment of up to £15 for egg and sperm donors. It had become increasingly clear that the issue of payment could not be considered as an issue of principle in isolation from others, and that the continued provision of safe donor treatments in the UK would be seriously undermined by the removal of payments. We also decided that it would not be right to ban paid egg sharing, which can be beneficial to both sharer and receiver. We were influenced by the argument that egg sharers are not motivated by money, but by the desire for a baby. It is clear, however, that such schemes needs to be closely controlled and regulated, and we are actively preparing specific guidelines. We are continuing the development of the licensing system, moving towards three year licences for established centres. We are also working towards the redevelopment of our data register system. As part of that process we plan to introduce a process for the direct electronic transfer of treatment data from clinics. We aim to publish detailed, non- identifying data sets of treatments and their outcomes during 2000, possibly on the HFEA website. A key role of the HFEA is to provide information to current and prospective patients finding their way through the maze of infertility HUMAN FERTILISATION AND EMBRYOLOGY AUTHORITY 1999 ANNUAL REPORT & ACCOUNTS clinics and treatments, and who face a bewildering wall of technical terms, statistical probabilities, and often worrying financial decisions. This year we have fundamentally revised our Patients’ Guide to DI and IVF Clinics, which includes detailed, impartial information about all licensed clinics, the treatments they offer and their success rates. In late 1998 the HFEA and the Human Genetics Advisory Commis- sion (HGAC) published a report to Ministers on human cloning. In the report the HFEA repeated its policy that it would not license the use of nuclear replacement for the purpose of reproductive cloning. The Government had also explicitly ruled this out. The HGAC and the HFEA recommended that these safeguards should be recognised as being wholly adequate to forbid human reproductive cloning in the UK. However, we suggested that the Government might wish to consider the possibility of introducing legislation that would explicitly ban human reproductive cloning regardless of the technique used so that this ban would not depend upon the decision of a statutory body (the HFEA), but would itself be enshrined in statute. We also recommended that the Secretary of State for Health should consider specifying in regulations two further purposes for which the HFEA might issue licences for research, so that potential benefits can clearly be explored: firstly, the development of methods of therapy for mitochondrial disease; and, secondly, the development of therapeutic treatments for diseased or damaged tissues or organs. We also recommended that the issues be re-examined in five years’ time in the light of developments and public attitudes towards them. In June of this year the Government announced the creation of a high-level advisory group to consider in more detail the scientific implications of the use of the cloning techniques in embryo research. The HFEA welcomed this move. One must, of course, respect the views of those who believe it is wrong to create embryos outside the body for either treatment or research. Yet we believe that for many years now, a clear majority of both the public and politicians has supported such work, which has enabled many thousands of couples to have children previously denied them. The embryo is the first step to the creation of a human being, and always deserves respect and protection. Both we and the professionals in this field are well aware that we are operating at the outer limits of technology in a field uniquely intimate as well as scientific. In probing the depths of human reproductive biology, decisions and discoveries raise ever more questions. After 30 years of public awareness of embryo research there is more moral and ethical discussion than ever before and a new profession of bio-ethics has emerged. For that reason, and in the light of new vi CHAIRMAN'S LETTER research and treatment that springs from embryo creation, close regulation will continue to be necessary for the foreseeable future. I am extremely grateful to the HFEA Members and staff for coping with the ever-increasing workload. I would particularly like to pay tribute to those Members who have left the Authority since the last Annual Report: Ruth Chambers, Liz Forgan, David Greggains, Martin Johnson, Richard Jones and Anthony Thiselton. I am sure that their successors will carry on their fine work. 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