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Baio lon Annual Report and Accounts HUMAN FERTILISATION = EMBRYOLOGY Nees) A ws“ (WOU 22502759397 Presented pursuant Section 6(1) of the Human Fertilisation and Embryology Act 1990 | ~Human Fertilisation and ~Embryology Authority Annual Report and Accounts — 2007/08 Ordered by the House of Commons to be printed — 23 June 2008 CORR IRA YBa TN ROT REM bSaR Bas ou ES WiEsL arL iC aeOa e OaM P eeLI CRARY fs. us? S. r CINy iE yBNee G MTToo ESy ty &o*%e SSadSeOP R BCa RIetg ESmTarr dY Pa y 15 JUL 2008 SceDEshao ceem ~HC 611 London: The Stationery Office £18.55 © Crown Copyright 2008 The text in this document (excluding the Royal Arms and other departmental or agency logos) may be reproduced free of charge in any format or medium providing it is reproduced accurately and not used in a misleading context. The material must be acknowledged as Crown copyright and the title of the document specified. Where we have identified any third party copyright material you will need to obtain permission from the copyright holders concerned. For any other use of this material please write to Office of Public Sector Information, Information Policy Team, Kew, Richmond, Surrey TW9 4DU or e-mail: [email protected] Annual Report and Accounts 2007/08 Contents Page 1. Chair’s & Interim Chief Executive’s Foreword 2. Management Commentary 3. Appendices 1. Standing Committee Membership as at 31 March 2008: Appointment Summary of Authority Members as at 31 March 2008: Licence Committee Members as at 31 March 2008: Horizon Scanning Expert Panel Membership as at 31 March 2008: 2, Centres licensed by the HFEA 3. External advisors 4. Research Centres / Projects licensed by the HFEA 5. HFEA peer reviewers 6. Members’ interests 4. Remuneration Report 5. Statement of the Authority’s and Interim Chief Executive’s Responsibilities 6. Statement on Internal Control 7. The Certificate and Report of the Comptroller and Auditor General to the Houses of Parliament 65 8. Financial Accounts 69 ——> A Human Fertilisation and cn 6/ | Embryology Authority : : . | Alan Doran CB - Interim Chief Executive Lisa Jardine CBE - Chair ‘We strive to ensure rigorous safety standards for patients, embryos and children born as a result of Assisted Reproductive Technologies’ Annual Report and |a Accounts 2007/08 Chair's & Interim Chief Executive's Foreword The Human Fertilisation and Embryology Authority The HFEA remains fully committed to the drive operates within a fast-moving, complex and to increase cost effectiveness and to reduce the ethically challenging area of science. The HFEA’s burden of regulation for clinics. We have worked activities attract a consistently high level of public with the Human Tissue Authority (HTA) to promote and media interest, particularly in light of the ongoing joint working across a range of support Human Fertilisation and Embryology (HFE) Bill’s functions, in the interests of more streamlined current passage through Parliament. We strive regulation and support services. We are also to ensure rigorous safety standards for patients, working to ensure that all our regulatory processes embryos and children born as a result of Assisted are risk-based and proportionate. Reproductive Technologies (ART). Maintaining Throughout the year, the HFEA has maintained public confidence in infertility treatment and a robust corporate governance structure, and embryo research remains paramount. we have sustained a high level of activity and The past year has been a period of high activity performance standards during a period of and significant achievement. In addition to change at the senior level of the organisation. our normal range of inspection and licensing A programme of organisational development work, during 2007/08, the HFEA successfully (Programme 2010) was initiated in preparation for implemented the requirements of the European the implementation of the new HFE Act, which is Union Tissue and Cells Directive for existing expected to receive Royal Assent during 2008. Clinics and services new to regulation. The 7th Finally, we would once again like to give our thanks edition of the Code of Practice was issued, to Authority Members and HFEA staff whose offering online access for the first time. We have continued hard work and commitment remain key also worked to continue to improve access to to Our SUCCeSS. a range of reliable and meaningful information and advice available to patients, donors, offspring and the public on the performance of ) services regulated. This work will continue into Professor Lisa Jardine CBE 2008/09 in response to legislative changes. Chair The HFEA remains alert to changes in the external environment. Our policies take into account the (Pie Apres wide-ranging and sometimes conflicting views of the public, as well as those of stakeholders from Mr Alan Doran CB the fertility sector, and beyond. In 2007, the HFEA Interim Chief Executive made important policy decisions on the use of hybrids in research and on multiple births following wide ranging consultations with clinicians, patients and the public. The HFEA also advised the Department of Health on the draft HFE Bill as it took shape and began its passage through Parliament. 02 Management Commentary Ce—“are t ) Human Fertilisation and Embryology Authority Management Commentary About the Human e We consult widely - listening to and learning from those with an interest in what we do Fertilisation and e We keep abreast of scientific and Embryology Authority clinical advances (HFEA) e We exercise our functions consistently, proportionately, openly and fairly The Human Fertilisation and Embryology Statutory Remit Authority (HFEA) is the UK’s independent regulator overseeing the use of gametes Within this context, the HFEA has a number and embryos in infertility treatment and of statutory functions. They are based on two research. The HFEA licenses clinics and specific roles: firstly the licensing and regulation research establishments carrying out In of clinics and research establishments providing Vitro Fertilisation (IVF), donor insemination, treatment, storage and research; and secondly, the other assisted conception procedures and maintenance and publication of information about human embryo research, and provides a donor treatment and assisted conception. range of detailed information for patients, professionals, the public and Government. The current statutory functions are: The HFEA’s aim is to be a leading healthcare e To license and monitor clinics carrying out IVF regulator exercising its functions fairly and and donor insemination proportionately, supplying good quality, relevant e To license and monitor establishments and accessible information to all its stakeholders. undertaking human embryo research The Authority has recently developed the following e To maintain a register of licences held by clinics, statement of its purpose and principles: research establishments and storage centres e To regulate the storage of gametes (eggs and Purpose sperm) and embryos e To implement the requirements of the We are the UK’s independent regulator of European Union Tissue and Cells Directive treatment using eggs and sperm, and of treatment (EUTCD) to relicense IVF clinics and to and research involving human embryos. We set license Intrauterine Insemination (IUl), Gamete standards for, and issue licences to centres. We Intrafallopian Transfer (GIFT) and other services provide authoritative information for the public, in new to regulation (in 2007) particular for people seeking treatment, donor- conceived people and donors. We determine the e To investigate serious adverse incidents policy framework for fertility issues, which are and reactions, and to keep a register of serious sometimes ethically and clinically complex. adverse incidents and serious adverse reactions Principles e To produce and maintain a Code of Practice, providing guidelines to clinics and research ° We treat people and their information with establishments about the proper conduct of sensitivity, respect and confidentiality licensed activities * We observe the highest standards of integrity e To maintain a formal register of information and professionalism about donors, licensed treatments and children born as a result of those treatments