“A fine conception—the experience of the Human Fertilisation and Embryology Authority (HFEA)”

“A fine conception—the experience of the Human Fertilisation and Embryology Authority (HFEA)”

European Journal of Obstetrics & Gynecology and Reproductive Biology 85 (1999) 3–5 ‘‘A fine conception—the experience of the Human Fertilisation and ...

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European Journal of Obstetrics & Gynecology and Reproductive Biology 85 (1999) 3–5

‘‘A fine conception—the experience of the Human Fertilisation and Embryology Authority (HFEA)’’ Speech to the 13 th Congress of the European Association of Gynaecologists and Obstetricians (EAGO), Jerusalem, 11 May 1998 Ruth Deech* Human Fertilisation and Embryology Authority, Paxton House, 30 Artillery Lane, London E1 7 LS, UK

1. Introduction Assisted reproduction technology by its very nature challenges conventional notions. We read in the paper daily of biological ‘‘miracles’’—women past menopause having children; infertile men becoming fathers; homosexuals having babies. Frequently such developments are exciting. Sometimes it can be frightening. Often the public reaction is ambivalent. Sometimes it is down right fearful. Think back to 1978 and the birth of Louise Brown and in America to the case of Doris Del Zio. Now the story is Dolly, Polly, Megan and Morag, the quartet of Scottish sheep bringing with them the shadow of human cloning. It is understandable that governments, pressured by public opinion and stirred by the press, act. Or should I say react. The quickest and cleanest, and probably most natural response, is to prohibit. It is also the least reflective and most repressive, preventing or pushing underground much desired research and potential treatment. The initial kneejerk of governments around the world to Dolly’s appearance was an example of this behaviour. It is understandable, but it is not commendable if done without suitable reflection. When Mrs Brown gave birth to baby Louise it was more than just a child she delivered. Probably because she was British the UK government felt that it had to do something about this novel procedure. Over the period 1978 to 1991 the UK tried out all the possibilities—do nothing; professional self-regulation and finally a statutory authority. Up till 1985 there was no ART regulation in the UK. Some would have liked it to have remained like that. Patients can avail themselves of whatever treatments are available. The sky, or price tag, is the limit. So are the *Tel.: 144-171-377-5077; fax: 144-171-377-1871.

dangers. These are controlled to some extent by the threat of litigation. But can money paid after the event ever fully compensate a damaged couple or baby? What use is the ability to get compensation if the clinician is a man of straw? How safe is the reputation or the freedom of a profession when mavericks or charlatans can besmirch it with foul deeds? Between 1985 to 1991 the UK tried a halfway house, professional self regulation. The Voluntary Licensing Authority was created jointly by the Medical Research Council and the Royal College of Obstetricians and Gynaecologists. In 1982 the Government set up the Inquiry into Human Fertilisation and Embryology, chaired by Mary Warnock. The ‘‘Warnock Report’’ was published in 1984 and, whilst essentially liberal in its recommendations, called for a national statutory regulatory authority to oversee the area of assisted conception involving the creation of embryos outside the body, and embryo research. In 1989 the Government incorporated almost all of the Warnock committee’s recommendations in its proposed bill, which after a huge amount of discussion and debate became the Human Fertilisation and Embryology Act 1990. The Human Fertilisation and Embryology Authority (HFEA) opened its doors to the world on 1 st August 1991. The 1990 Act gives careful directions to the Secretary of State for Health about how the HFEA should be constituted. The intention was to create a body which represented the views of both genders and could understand and appreciate the interests of medical science while not being dominated by it. The 21 Members are not selected as delegates of particular interest groups, but rather appointed as individuals for their experience or expertise. More than a third, but less than half of the membership, must be doctors or scientists involved in the field of ART or human embryo research. Neither the Chairman nor Deputy Chair-

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man can be in this group. While not legally required, the membership has included people who themselves have had infertility problems. There has always been ethnic minority representation. Among the fields currently represented are law, accountancy, management, counselling, psychology and education. The 21 Members of the HFEA were charged with responsibility for making policy and licensing decisions in respect of any treatment or research involving the creation, keeping or using of human embryos outside the body or storage or donation of human eggs and sperm. Essentially the HFEA is a regulatory body operating a licensing system with both advisory and executive functions. In addition it has statutory obligations to keep patients, potential patients, clinicians and the general public informed, to keep data and to advise the government on developments. It does all this on a modest budget of some £1.6 million of which 70% is raised from licence fees and 30% from government grant. While accountable to the Department of Health, and through it to Parliament, the HFEA stands separate and apart from government. The HFEA is sensitive to political realities, and, like all other Non-Departmental Bodies (commonly known as quangos), it understands that it must work in harmony with the government of the day. But accountability and compatibility does not mean subservience, and the HFEA exercises control over its own policies. The corollary of this is that it must accept full responsibility for its decisions and be prepared to defend them. As one US President said, if you don’t like the heat get out of the kitchen. Often the HFEA feels like it is surrounded by hellfire, but the kitchen was where it was placed and over time it has got use to the fire and brimstone hurled at it from many quarters. The HFEA was created partly to reassure the public that science and medicine would proceed in a responsible and cautious manner and as a forum for ethical debate. The recognition that the UK is a pluralistic democracy has been the starting point of most of the HFEA’s work in this area. The 1990 Act is not dogmatic, but a framework within which different views can be accommodated. There are, however, certain fundamental values which are sacrosanct—the autonomy and integrity of individuals, noncommercialism of the human body and non-exploitation of people. Legislation is never a perfect solution, and no more so than in a fast moving area of medical science like fertility treatments. It is highly likely that at some future date the 1990 Act will need to be amended. The Act’s drafters did, however, successfully include a number of mechanisms which keep the legislation supple, resilient and elastic. This is done in a number of ways: • avoiding for the most part specific and absolute prohibitions, but instead relying on interpretative words such as ‘‘suitable’’, ‘‘proper’’, ‘‘necessary’’ and ‘‘desirable’’;

• using a fundamentally permissive and clearly understood licensing system which allows for flexible, clinical judgements; and • giving the Secretary of State power to make secondary regulations including the categories for which licences can be granted. By having such overarching legislation and creating a body to enforce it, successive UK governments have been able to avoid the risk of enacting piecemeal legislation or being forced to overreact to sensational cases. But any government considering establishing such a body must be careful of duplicating without thought a direct copy of the HFEA. Such transplants rarely work as well as the original because often not enough thought is given to the transplants’ political environment. The HFEA functions as a national institution, and this is expected to continue if constitutional changes currently proposed for Scotland and Wales are enacted. Over 29 000 patients received licensed ART (Assisted Reproductive Technology) treatments in 1995 in the UK alone. These people have had to tread their way carefully through a maze of infertility clinics offering a bewildering array of treatments, to absorb complicated scientific terms and to understand a mass of statistical probabilities. All this must be accomplished while often coping with making significant financial decisions. The HFEA aims to ensure that patients feel secure about the safety and efficacy of their treatments and sufficiently empowered to participate fully in deciding what treatment is right for them. To achieve this the HFEA supports patients in various ways:

2. The licensing process. While some clinicians may see the HFEA’s licensing system, based as it is on a programme of annual inspections, as bureaucratic and unnecessarily invasive, it has positive benefits both for patients and clinics alike. Essentially clinics must demonstrate that they have the necessary personnel and experience, the premises and equipment and the practices and procedures in place. Through the licensing process the HFEA aims to work with, and not against, clinics. Having said that, it does have teeth and, if required, will use them by imposing conditions, suspending licences and, if necessary, revoking or not renewing them. Practising licensable treatments or conducting research using human embryos without a licence is a criminal offence. Applying the 1990 Act and the HFEA’s Code of Practice, the HFEA is able to ensure that every clinic which provides in vitro fertilisation (IVF) or donor insemination (DI) treatments, whether big or small, public or private, reaches and maintains the same high medical and professional standard. The Code’s objective is to translate the Act’s requirements, such as the need for effective consent and the welfare of the child, into practical and

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achievable standards. The Code covers such matters as staff and facilities, standards of clinical practice, screening of donated gametes, storage, handling and use of gametes and embryos, record keeping, screening, counselling and welfare of the child guidance. The HFEA keeps the Code under continual review.

3. Information The 1990 Act requires that, before people can consent to storage or use of their gametes or embryos, they must be given ‘‘relevant and proper’’ information. In this area of medicine it is vital that patients understand the implications of their treatments, the ethical and emotional sensitivities, the technical aspects and the still low success rate. The Code of Practice requires clinics to give such information to patients. In addition, the HFEA publishes a variety of free literature including leaflets and a Patients’ Guide to all licensed IVF and DI clinics. As it has become concerned that the Guide is not as ‘‘user friendly’’ as it might be, the HFEA is reviewing both the Guide’s content and structure during 1998.

4. Data recording The HFEA has a statutory duty to collect data on all licensed treatments including their outcomes and the use made of donated sperm and eggs. Over 65 000 data forms are received each year. Data are inputted onto the HFEA’s register under strict conditions of confidentiality. One of the principal reasons for having such a register is for it to act as a repository of information for children born of such treatments. These children will be able to access information about their genetic background when they reach the age of 18, or 16 if they intend to marry. In addition, this information helps the HFEA monitor clinics’ practices and performance, both individually and collectively, and allows it to produce aggregated data. The HFEA does not have responsibility for regulating all infertility practices. Its role is clearly, and to some extent narrowly, defined by the legislation. Thus it does not cover surrogacy unless achieved through IVF, assisted insemination using a husband’s or partner’s sperm or the prescribing of infertility drugs by doctors in general practice. Further, the HFEA is not an ombudsman commissioned to deal with individual complaints. Its role is to ensure that clinics have, and follow, their own complaint procedures. It is important for any regulatory body to know where its boundaries of responsibility lie as it is all too easy for it to try to assume, and for others to want it to assume, total responsibility. Much of what the HFEA does benefits clinics as much as it does patients, and it is only with the co-operation of clinicians that the HFEA is able to operate. The licensing process is the most common meeting point between the

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HFEA and the almost 120 licensed treatment clinics. The HFEA has always seen the annual inspection as a two-way process where ideas and views on good practice can be shared and discussed. When making policy the HFEA strives towards consultation with clinicians and other interested professionals. As explained above, the HFEA’s intention is to work with, not against, clinics. That is not to say that the HFEA has not taken decisions unpopular with clinicians and the bodies which represent them. But, while saying that, it has to be remembered that the HFEA’s existence also protects clinics and shields them from the public outrage which may greet their choices as to whom to treat and how. For example, the HFEA has continually refused to condemn clinics for treating lesbians or older women as long as proper account has been taken of the welfare of the child. Further, UK clinics have also benefited from the legitimacy that being licensed gives. HFEA’s policy of public consultation when faced with difficult social and ethical decisions has earned it respect and approval, if not always agreement, in most quarters. Particular difficulties have arisen with the licensing of new treatments such as ICSI (Intracytoplasmic Sperm Injection), the implications of cloning, the use without written consent of a man’s sperm after his death, and the treatment of older women. One general and frequently muttered criticism made by practitioners is that the HFEA is a barrier to progress. This may be a justified opinion driven partly by professional or scientific eagerness and perhaps also by commercial pressures. At the same time the HFEA’s position has to be appreciated. The 1990 Act embraces the philosophical premise that human life at all stages deserves respect, and does not allow for clinical treatment licences to be issued. Further, the Act only allows the HFEA to licence research involving human embryos where such research is ‘‘necessary or desirable’’. The HFEA works on the presumption that patients should not be subject to experimental procedures at too early a stage, and that centres should first undertake research and sufficient training before treating patients with a new technique. Its existence probably ensured that the UK did not go down the road of banning all human embryo research. The world of IVF will never be mundane. Governments and parliamentarians must tackle how they wish science to work with society. Solutions may vary between jurisdictions, but it has to be recognised that medical science knows no national boundaries. The challenge is for both the narrow state and wider international dimensions to be considered, debated and maybe even met. The experience of the HFEA is that it is possible to provide effective controls, as long as close co-operation is maintained with licensed clinics, professional and patient groups. At the same time, of course, we cannot forget that we do have responsibilities to a wider public, which does not always endear us with those in the field!