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Human Fertilisation and Embryology Authority Human Fertilisation and Embryology Authority Human Fertilisation and Embryology Authority Published by TSO (The Stationery Of ce) Annual Report and Accounts 2009/10 and available from: Online www.tsoshop.co.uk Mail, Telephone, Fax & Email TSO PO Box 29, Norwich, NR3 1GN Telephone orders/General enquiries 0870 600 5522 Order through the Parliamentary Hotline Lo-Call 0845 7 023474 Fax orders: 0870 600 55 33 Annual Report and Accounts 2009/10 Email: [email protected] Textphone: 0870 240 3701 The Parliamentary Bookshop 12 Bridge Street, Parliament Square, London SW1A 2JX Telephone orders/General enquiries: 020 7219 3890 Fax orders: 020 7219 3866 Email: [email protected] Internet: http://www.bookshop.parliament.uk TSO@Blackwell and other Accredited Agents Customers can also order publications from TSO Ireland 16 Arthur Street, Belfast BT1 4GD Telephone: 028 9023 8451 Fax: 028 9023 5401 Annual Report 2010 - Cover Final.indd 1 5/7/10 15:28:54 Presented to Parliament pursuant to Section 6 and 7 of the Human Fertilisation and Embryology Act 1990 as amended by Paragraph 3 of Schedule 7 of the Human Fertilisation and Embryology Act 2008 Human Fertilisation and Embryology Authority Annual Report and Accounts 2009/10 Ordered by the House of Commons to be printed 14 July 2010 HC 32 London: The Stationery Office £15.50 © Crown Copyright 2010 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. ISBN: 9780102964561 Printed in the UK by The Stationery Office Limited on behalf of the Controller of Her Majesty’s Stationery Office ID P002359597 06/10 Printed on paper containing 75% recycled fibre content minimum. Content 1. Chair & Chief Executive’s Foreword 5 2. Management Commentary 7 3. Appendices 23 I. Committee Membership as at 31 March 2010 24 Appointment Summary of Authority Members as at 31 March 2010 25 Horizon Scanning Expert Panel Membership as at 31 March 2010 26 II. Centres Licensed by the HFEA as at 31 March 2010 27 III. External Advisors as at 31 March 2010 32 IV. Research Projects licensed by the HFEA 34 Conditions Licensed for PGD as at 31 March 2010 36 V. HFEA Peer Reviewers as at 31 March 2010 37 VI. Members’ Interests as at 31 March 2010 41 4. Remuneration Report 47 5. Statement of the Responsibility of the Authority 57 and Chief Executive 6. Statement on Internal Control 59 7. The Certificate and Report of the Comptroller 67 and Auditor General to the Houses of Parliament 8. Financial Accounts 71 Annual Report and Accounts 2009/10 3 Mr Alan Doran CB Professor Lisa Jardine CBE Chief Executive Chair Safety and quality of care are first on our list of priorities. 4 Human Fertilisation and Embryology Authority Chair & Chief Executive’s Foreword The Human Fertilisation and Embryology Authority We have made significant improvements to our (HFEA) regulates areas of science and medicine which own systems, revising and streamlining many of are always subject to rapid change, but this year has our procedures. We have taken great care to ensure been much busier than usual for our staff and for the that safety and quality of care are first on our list centres we regulate. of priorities. We have continued our work to reduce the number of multiple pregnancies following fertility Our main challenge has been to develop a raft of new treatment, and we have embarked on a review of policies to support the revised regulatory framework donation policies. These will lead to further benefits introduced by new HFE legislation. We introduced our in the year ahead. 8th Code of Practice, alongside new consent forms and guidance. We developed a new approach to inspection and licensing. We overhauled the data that we publish on our website to provide more in depth information about treatments for patients, clinicians and researchers. HFEA staff met these challenges with energy and skill, setting high standards for themselves Mr Alan Doran CB and those we regulate. Chief Executive The new legislation also brought significant challenges for the fertility sector and we are developing a more mature and purposeful dialogue with our stakeholders about the benefits of regulation and the practicalities of implementing new policies. We have made great efforts to ensure that our Professor Lisa Jardine CBE stakeholders understand the new requirements and Chair we have supported clinics in their efforts to make changes to the way they operate. We held a series of workshops around the country where clinicians and other clinic staff had the opportunity to find out more about the changes they needed to make. Annual Report and Accounts 2009/10 5 6 Human Fertilisation and Embryology Authority 02 Management Commentary Management Commentary About the Human Fertilisation and Embryology Authority (HFEA) Purpose Functions We are the UK’s independent regulator of treatment In November 2008, the Human Fertilisation and using eggs and sperm, and of treatment and research Embryology Bill received Royal Assent. The majority involving human embryos. We set standards for, and of the resulting Act came into force in October 2009. issue licences to, centres. We provide authoritative information for the public, in particular for people Since then, the HFEA has been required to have regard seeking treatment, donor-conceived people to two primary sets of legislation: and donors. We determine the policy framework for fertility issues, which are sometimes ethically and • The Human Fertilisation and Embryology Act 1990 clinically complex. (as amended) – we generally refer to this as “the 1990 Act (as amended)”; and • The Human Fertilisation and Embryology Act 2008 Principles (“the 2008 Act”). 1. We treat people and their information with Primarily, the 2008 Act is amending legislation. sensitivity, respect and confidentiality It extensively amends the provisions of the 1990 Act, which will continue to form the main framework 2. We observe the highest standards of integrity and governing the duties and responsibilities of the HFEA. professionalism in putting into effect the law as it However, the 2008 Act also contains new provisions governs our sector1 which were not originally in, and have not been inserted into, the 1990 Act. In particular, these include 3. We consult widely - listening to and learning from provisions relating to legal parenthood. those with an interest in what we do The 1990 Act (as amended) gives the HFEA a number 4. We keep abreast of scientific and of statutory functions: clinical advances • To keep a formal register of information about 5. We exercise our functions consistently, donors, treatments and children born as a result proportionately, openly and fairly. of those treatments • To license and inspect clinics carrying out in vitro fertilisation and donor insemination treatment • To license and inspect establishments undertaking human embryo research 1. The ‘sector’ refers to the assisted reproduction/fertility sector and all the treatment clinics, storage centres and research establishments within it. 8 Human Fertilisation and Embryology Authority • To license and inspect the storage of gametes • Carrying out its functions effectively, efficiently (eggs and sperm) and embryos and economically • To maintain a formal register of licences granted • Reviewing information about: • To produce and maintain a Code of Practice, – Human embryos and developments in research providing guidance to clinics and research involving human embryos establishments about the proper conduct of licensed activities – The provision of treatment services and activities governed by the 1990 Act • To maintain a register of certain serious adverse (as amended) events or reactions (this relates to certain specific activities, which are set out in the amended Act) – Advising the Secretary of State for Health on developments in the above fields, upon request. • To investigate serious adverse events and serious adverse reactions, and to take appropriate The HFEA also functions as the competent authority control measures for the European Union Tissues and Cells Directive, regulating the donation, procurement, testing, • To respond to any request from a competent processing, preservation and distribution of human authority in another European Economic Area tissue and cells for human application. (EEA) state to carry out an inspection relating to a serious adverse event or reaction, and to take any appropriate control measures • To collaborate with the competent authorities of other EEA states. In addition to these specific statutory functions, the legislation also gives the HFEA some more general functions, including: • Publicising the HFEA’s role and providing relevant advice and information to the donor-conceived, donors, clinics, research establishments and patients • Promoting compliance with the requirements of the 1990 Act (as amended), the 2008 Act and the Code of Practice • Maintaining a statement of the general principles that should be followed by the HFEA when conducting its functions, and by others when carrying out licensed activities • Observing the principles of best regulatory practice, including transparency, accountability, consistency, and targeting regulatory action where it is needed Annual Report and Accounts 2009/10 9 Current Operating Context In the 2009/10 business year we completed a programme of organisational development, aimed at embedding the legislative changes which came into force during the year and instilling best practice into our business processes to support this. The HFEA commenced its change management programme, called Programme 2010, in the previous business year (2008/09). This was designed to lead the organisation through the changes needed in order to establish the right structures, behaviours and processes to deliver an effective regulatory system under the 1990 Act (as amended).
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