-
7 Regulating Reprogenetics in the United Kingdom
- Johns Hopkins University Press
- Chapter
- Additional Information
Regulating Reprogenetics in the United Kingdom C H A P T E R S E V E N In 1978 the first test-tube baby, Louise Brown, was born in the United Kingdom . At that time there was no regulation or control of assisted reproductive technologies (ARTs) or embryo research in the United Kingdom. The technology was in its infancy, but it was clear that in vitro fertilization (IVF) and future developments in the technology would present challenges for established social and ethical thinking. State control and regulation of ART and embryo research seemed inevitable, but until 1991 and the coming into force of the Human Fertilisation and Embryology Act of 1990, no formal, statutory regulation existed. Between 1985 and 1991, professional self-regulation existed through a body set up jointly by the Medical Research Council and the Royal College of Obstetricians and Gynaecologists. Known at first as the Voluntary Licensing Authority and subsequently as the Interim Licensing Authority, this body issued licenses for embryo research and ART procedures. It had no teeth, and its only sanction in removing a license was to shame (or generate peer pressure on) clinicians and scientists into conforming with its licensing requirements. In the light of public concerns about the new technologies, in particular embryo experimentation, the British government was not complacent in pursing public policy formation, but it was undoubtedly cautious in moving forward , as the subsequent history of the resulting legislation shows. In 1982, it set up a multidisciplinary Committee of Inquiry chaired by Baroness Warnock, a distinguished moral philosopher. In 1984, a document that came to be A N D R E W G R U B B known as the Warnock Report (Report of the Committee of Inquiry into Human Fertilisation and Embryology) recommended a statutory framework for the regulation of ART and embryo research in the United Kingdom. In 1986 the government produced a consultative document entitled Legislation on Human Infertility Services and Embryo Research. This was followed in 1987 by a white paper, Human Fertilisation and Embryology: A Framework for Legislation , which set out the government’s proposals for future legislation and in large part enacted the recommendations of the Warnock Committee. At the center of these proposals was the creation of a statutory licensing authority with powers to license ART and embryo research. In 1989, the government introduced the Human Fertilisation and Embryology Bill, which, after protracted and sometimes acrimonious parliamentary debate, became an Act of Parliament on November 1, 1990. The Human Fertilisation and Embryology Act of 1990 came fully into force on August 1, 1991. It covers ART and embryo research in the United Kingdom as a whole.1 THE HUMAN FERTILISATION AND EMBRYOLOGY ACT OF 1990 The 1990 act created a complex regulatory framework dealing with licensing of ART procedures (section 11 and schedule 2), control over embryos and gametes (section 12(c) and schedule 3), disclosure of information (sections 33–35), and parentage of children (sections 27–29).2 The regulation is intrusive and the scheme is virtually comprehensive, covering everything except research on gametes or treatment with gametes that are not donated. Surrogacy is also not directly regulated, except to the extent that IVF procedures are used. At the focus of the legislative framework is the Human Fertilisation and Embryology Authority (HFEA). The principal functions of the HFEA are: • To license treatment services and the storage of gametes and embryos (sections 11–14); • To license research on embryos (sections 11–12 and 15 and schedule 2); • To monitor and inspect premises and activities carried out under a license (section 9); • To maintain a register of information about donors, treatments, and children born from those treatments (section 31); • To produce a “Code of Practice” as guidance for clinics about the conduct of licensed activities (section 25); R E G U L AT I N G R E P R O G E N E T I C S I N T H E U N I T E D K I N G D O M 1 4 5 [3.83.187.36] Project MUSE (2024-03-29 08:18 GMT) • To publicize its role and provide relevant advice and information to patients, donors, and clinics (section 8); and • To submit an annual report to the secretary of state on its activities (section 7). The 1990 act divides ART into three categories, according to whether those procedures are (1) illegal, as with keeping or using embryos after fourteen days (sections 3(3)(a...