Hum. Reprod. Advance Access originally published online on August 2, 2006
Human Reproduction 2006 21(12):3044-3049; doi:10.1093/humrep/del308
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OPINION |
Autonomy versus protection—who benefits from the regulation of IVF?*
Deputy Head of Medical Ethics, British Medical Association, BMA House, Tavistock Square, London WC1H 9JP
E-mail: venglish{at}bma.org.uk
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Abstract |
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Parliament will soon be asked to decide about the future regulation of IVF in the United Kingdom. Given that IVF is now considered to be a routine clinical procedure and the fact that we live in an age of unprecedented emphasis on autonomy and patient rights, the justification for continuing to regulate this form of treatment will undoubtedly be challenged. This article considers the four key reasons why the Human Fertilisation and Embryology Authority (HFEA) was originally established—to protect patients and their children, to allay public concerns, to protect scientific freedom and to protect IVF practitioners from claims of unethical behaviour—and asks to what extent these reasons are still valid today. Acknowledging that there are difficulties and frustrations with the HFEA, the article warns that all parties—patients, researchers, IVF practitioners and society—have a lot to lose by limiting the scope of regulation. It concludes that before moving too quickly to get rid of the HFEA as we know it, we need to think carefully about whether the burdens and restrictions imposed by regulation are sufficiently onerous to justify this loss.
Key words: HFEA/IVF/protection/regulation/reproductive autonomy
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Should we continue to regulate assisted reproduction? |
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What is so special about assisted reproduction? That is the question that Parliamentarians must consider in the coming months as the Government prepares to introduce new legislation in this area. The United Kingdom has one of the most comprehensive regulatory mechanisms for assisted reproduction in the world. The ongoing debate about whether to retain this model of regulation or to opt for a lighter touch, or even to extend the regulation to include treatments such as gamete intra-fallopian transfer (GIFT) and intrauterine insemination (IUI), is one that will be central to those involved in this field in the United Kingdom. There is also an international dimension, as the UK debate will be watched with interest by those in other countries, particularly those that have recently introduced (Assisted Human Reproduction Act, 2004
) or proposed (Commission on Assisted Human Reproduction, 2005) legislation along similar lines. Even those jurisdictions that do not currently have legislation in this area probably need to address this issue at some time in the future and will wish to assess the relative merits of various different models of regulation. Although there seems to be general support in the United Kingdom for continuing some form of regulation of embryo research and the use of donor gametes, opinions are more divided about the continuing regulation of clinical practice, and it is the latter point that is the main focus of this article. After nearly 30 years, IVF is no longer considered unusual or exceptional but is a routine clinical procedure, to the extent that between 1 and 2% of all births in the United Kingdom each year are the result of IVF treatment. In an age of unprecedented emphasis on autonomy and patient rights, when any restrictions on individuals’ reproductive freedom are increasingly challenged, the question that needs to be addressed is whether there is really any justification for continuing to regulate IVF.
The House of Commons Science and Technology Committee (2005a: 169–174), in its recent review of the law, was sceptical about the need to continue the current level of regulation, preferring instead a regulatory body with a minimal role of policing technical standards set by professional bodies. The monitoring of practice was, it argued, a role for generic professional regulation, using the same mechanisms as exist for other areas of clinical practice. Although some people have gone further and called for the Human Fertilisation and Embryology Authority (HFEA) to be scrapped completely (Reynolds, 2004), this is unlikely to happen. Under the European Tissues and Cells Directive, the United Kingdom is required to have a ‘competent authority’ to oversee the therapeutic use of human tissues and cells, including gametes (The European Parliament Council of the European Union, 2004). The Department of Health’s (2004) current proposal to merge the HFEA with the Human Tissue Authority could accommodate either a narrow or a broad role for the regulator, but this proposal is, in itself, controversial. While it may succeed in meeting political imperatives, it is far from clear that generating a single body with such a wide and diverse remit represents the best approach to addressing the increasingly complex and sensitive issues around reproduction. So, although having no regulation is not an option, the model, scale and scope of that regulation are now very much open for debate. The type of structure proposed by the Science and Technology Committee, with a very narrow role for the regulator, is possible but is it desirable?
The current model of regulation was the result of public and professional debate lasting more than a decade. Much of that debate focused on the central theme of the moral status of the embryo and what, if any, protection it should be afforded. Out of this debate, four key reasons emerged for establishing the HFEA:
- to protect patients and their offspring by monitoring the safety and efficacy of a new therapeutic technique
- to allay public concerns about the creation, manipulation and appropriate uses of human embryos by erecting barriers and having visible regulation
- to protect scientific freedom by reassuring the public that the work was subject to monitoring and proper control and
- to protect those working in the field from criticism and claims of unethical behaviour.
The emphasis at that time was very much on protection, but, 20 years on, in a society seemingly obsessed with individual rights, we need to consider whether that focus remains appropriate. In today’s society, are there still grounds for choosing protection over autonomy?
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The HFEA’s role in ensuring standards and safety |
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In the early 1980s, IVF was essentially an experimental procedure. Although there had been a number of healthy live births, and there appeared to be no harm to the women who had undergone the procedure, the long-term effects on both the women and the children were unknown. We now have nearly 30 years’ experience of IVF, and there have been more than one and a half million babies born worldwide. So, why should IVF continue to be subjected to regulation?
An argument can be made that there are sufficient differences between IVF and most other forms of treatment to justify regulation, based on a combination of factors such as the high failure rate, the lack of NHS provision, the lack of evidence on the long-term effects of treatment, the extent to which unproven tests or techniques are offered to patients who are in a very vulnerable position and the public and personal sensitivities about issues around human reproduction. This is not however the central proposition of this article, and its main line of reasoning is not reliant on this somewhat controversial point being accepted. Rather, the main question in this article is whether the benefits of regulation to all parties outweigh the burdens. The fact that this level of protection is not available for other forms of treatment is not, in itself, a good reason to remove that protection where it already exists and, perhaps, raises questions about whether other defined forms of practice would benefit from similar provision. So, what are the benefits of regulation to patients?
All women go into IVF with the hope that they will end up with a baby but with the knowledge that even the best clinics are unable to achieve this in a large number of cases. (Although the ‘take home baby rate’ is not the only measure of a clinic’s success, from the patient’s perspective, this is undoubtedly the principal indicator of a ‘successful’ outcome from IVF treatment.) Patients find choosing a clinic very difficult, but without the safeguards provided by the HFEA, this would be far more problematic. With IVF, the procedure may be carried out competently but still, in a large number of cases, be unsuccessful, and so a woman may have repeated unsuccessful attempts at IVF and simply consider herself unlucky without knowing that the clinic lacks the necessary expertise to achieve a pregnancy. A regulatory body that inspects clinics and checks the qualifications and experience of the staff, the adequacy of the facilities, the acceptability of the clinical protocols and monitors success rates gives reassurance to patients that they will receive a good standard of treatment at any licensed clinic. The publication of individual clinics’ success rates by the regulatory body also ensures accuracy and consistency, promoting informed decision making.
Although it may sound patronizing to refer to the vulnerability of women undergoing IVF, there is no doubt that such women are in a vulnerable position. Women who want to have children invest a considerable amount, physically, emotionally and financially, in IVF treatment in an attempt to achieve that aim. Although IVF itself is well-established, the success rates are still relatively low, and there are always new tests and modifications or additions to the treatment that might, or might not, improve the success rate, at varying costs: taking low-dose aspirin, blood tests for natural killer cells, endometrial biopsy, assisted hatching of embryos and intravenous immune globulin to name a few. The evidence supporting some of these interventions is at best equivocal (Royal College of Obstetricians and Gynaecologists, 2003), and women need to know that. The minority who receive NHS-funded treatment are unlikely to be offered tests or treatments that have not been supported by independent clinical evaluation. The large majority who self-fund, however, may be offered a barrage of tests, procedures, food supplements, additional medication—such as Viagra—and alternative therapies. Understandably, those who are having IVF are very often reluctant to reject any suggestion made by their clinic if there is a chance that it might help them to achieve that elusive pregnancy, and this can make what is already expensive treatment, very expensive indeed. A regulatory body that inspects the information given to patients (and itself provides information about new developments) gives women confidence that the way information about efficacy is presented is not unduly influenced by a clinic’s enthusiasm for the procedure or any financial interest the clinic has in increasing its take-up rates.
It is also reassuring for patients that there is some objective assessment of the efficacy and safety of new techniques before they are introduced into clinical practice and established methods for ensuring that those who wish to offer new treatments have not only the knowledge but also the necessary skills to carry them out safely. Having a regulatory body that goes beyond merely assessing technical standards provides this important protection for patients. Another element of this protective role is the ability of the regulator to insist upon certain safeguards—such as the requirement on clinics to offer counselling—and to instigate double-witnessing systems to reduce the risk of error and alert systems to allow clinics to learn from the experiences of others. While putting such safeguards in place is undoubtedly good practice, unless they are mandatory, funding such practices (whether in the NHS or the private sector) may not rate highly against competing demands.
There are also unresolved questions about the long-term safety of IVF for both women and their children that urgently need to be addressed (Medical Research Council, 2004) This is an area that the HFEA has not properly exploited, but it is something that could, and should, be pursued if data continue to be collected by a central body. One of the known risks for women and children, however, is complications arising from multiple births. The surest way to avoid higher order multiple pregnancies is to reduce the number of embryos to be replaced in a single cycle of IVF treatment. Yet, despite guidance from professional bodies, there is reluctance by some clinics to accept any such curtailment of their clinical freedom to decide, with their patients, on this aspect of treatment. While the desire to improve success rates for patients is admirable (and, more cynically, financially beneficial to those who subsequently increase their number of paying patients), this comes at a high cost when it is achieved by increasing the number of embryos replaced. In 2004, the HFEA took action and reduced the number of embryos that could be replaced to a maximum of two in women under 40 (Human Fertilisation and Embryology Authority, 2003). Preliminary data provided by the HFEA appear to show that this has led to a significant decline in the number of triplet pregnancies in that group of patients, from 33 in 2003–4 (plus a further four in those aged 40+) to only 12 in 2004–5 (plus one in patients aged 40+) (HFEA, personal communication, June 2006). This compares with 69 sets of triplets and one set of quads in 1990 before the HFEA took up its role (Human Fertilisation and Embryology Authority, 1992: 10). The problem of multiple pregnancies has not been solved, however, and the rates, particularly of twin pregnancies, are still too high. If we are concerned about this, then having a regulatory body that can require clinics to take steps to reduce their multiple pregnancy rate is probably the most effective way of addressing the problem.
Of course, there is a legitimate debate about whether it is an appropriate role of a regulator to limit the freedom of patients and their doctors to decide together on these clinical issues. But given the growing evidence of the level and nature of risks associated with higher order multiple pregnancies and the costs to parents—both emotional and financial—from these ‘successful’ IVF cycles, intervention in this area seems not only desirable but also necessary if the regulator is charged with protecting patients and their offspring. It is also questionable whether this is a purely private matter, when it is the NHS that takes on the financial burden of coping with the aftermath of such treatments. If, for these reasons, restrictions on this area of clinical practice are justified, two examples illustrate very clearly why this needs to have the force of the law. First, the HFEA’s decision in 2001 to limit to three the number of embryos that could be replaced in a single cycle of treatment was judicially reviewed by one of the clinics [R (on the application of Assisted Reproduction and Gynaecology Centre) v Human Fertilisation and Embryology Authority, 2002]. Although unsuccessful, this illustrates the strength of feeling aroused by attempting to limit clinical discretion in this area. Second, the risk of relying solely on professional guidance is clear from American data collected by the Society for Assisted Reproductive Technology (SART) showing that, in 2003, six or more embryos were replaced in 2.8% of treatment cycles (Centers for Disease Control and Prevention, American Society for Reproductive Medicine and Society for Assisted Reproductive Technology, 2005; Figure 27).
The HFEA was not set up to be the patient’s advocate, but it does play an important role in protecting IVF patients and children born following treatment. Although IVF is now an accepted and standard form of treatment, there are still good reasons for patients with sub-fertility to support the regulation of IVF. The level of protection that is afforded to patients would undoubtedly be significantly reduced if the regulator simply monitored technical standards. Patients need to consider whether the burdens and restrictions that regulation imposes on them are sufficiently onerous to justify that loss.
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The HFEA’s role in allaying public concerns |
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One of the principal reasons given by the Warnock Committee for recommending the establishment of a statutory regulatory body was to allay public concerns about the uncertainty involved in this new form of treatment and to meet society’s perceived need for reassurance that certain barriers would not be crossed (Warnock, 1984
). Public opinion, however, is not static. The type of concerns that were widely expressed about IVF and embryo research in the early 1980s no longer represent the majority view. But does that mean that, from the public’s perspective, there is no need for continued regulation?
Although public opinion polls illustrate a diverse response to questions about both IVF and embryo research (Human Fertilisation and Embryology Authority, 2005), it is probably true to say that the UK public is now broadly supportive of IVF and embryo research. But, this support is given in the context of a society in which there is, and has been for many years, a statutory body to regulate IVF and to ensure that practice remains within the boundaries of what is broadly considered to be acceptable. It is not evident that the public would still be confident in future developments if the monitoring and regulatory system were to be removed.
When stories hit the media about a 66-year-old Romanian woman giving birth to a child using donor gametes (Mutler, 2005), or of models’ gametes being sold to the highest bidder in the United States (Carter, 1999) or attempts to clone human beings by maverick scientists in other countries (Borger, 2001), reports in the UK press are usually tempered with the relief-inducing statement that ‘of course, it couldn’t happen here because we have regulation’. In relation to the older mother, for example, The Telegraph reassured readers that ‘The Human Fertilisation and Embryology Authority (HFEA), which regulates the UK’s IVF clinics, said ... "A woman in this person’s circumstances would almost certainly not be treated [in the UK]" ’(Anon, 2005). Similarly, commenting on the case of Mr and Mrs Hashmi—who wanted to select embryos on the basis of tissue type, so that stem cells from the umbilical cord blood could be used to treat their existing child—Dr Simon Fishel said: ‘From the public’s point of view they should have no fear because cases such as the Hashmis and the procedures involved will remain highly regulated by the HFEA and strict conditions will apply to all couples seeking this treatment on a case by case basis’ (Anon, 2003). The fact that the HFEA is widely considered by the public to be a ‘safe pair of hands’ and, if anything, rather conservative in its decision making [as its refusal to allow selection on the basis of tissue type for the Whitaker family in 2002 illustrated (Human Fertilisation and Embryology Authority, 2002; Wright, 2003)] gives the public confidence in its decisions to allow treatment or research to proceed.
The fact that it is important to be mindful of public opinion does not, however, mean that it is appropriate always to bow to public pressure or that policy making involves merely taking a simple poll of people’s views. When considering the role of the regulator in addressing the public’s concerns, we need to consider the extent to which the views of ‘the public’ should restrict the freedom of those who have a direct interest in seeking treatment. If a woman has three sons and wants to select for replacement only female embryos, is the fact that public opinion disapproves adequate grounds for the regulator to prevent her from doing so?
In practice, the extent to which the public’s opinion should sway policy depends not upon the strength of opinion but on the strength of the argument. So, an informed public with reasonable arguments to limit the treatments available would and should influence the views of the HFEA. The regulator is not in place simply to reflect public opinion, which is often based on fear caused by uncertainty or misunderstanding or which may be based on prejudice. Rather, the regulator should facilitate informed debate and, in many cases, inform and shape public opinion through the provision of information and identifying legitimate areas of disagreement. A perennial question in the debate about the legitimacy of interfering with reproductive autonomy is whether it is for those who would seek to restrict the freedom of others to provide evidence of harm or it is for those who want to use new procedures to demonstrate their safety. A clear mandate to follow one of these rules throughout all policy decisions would make the HFEA’s task of ruling on legitimate boundaries far easier, but in reality, the type of assessment required is more sophisticated than this. For each technique, the HFEA must consider the likelihood, nature and severity of the possible harms to all parties and balance these against the benefits that would accrue before deciding whether and, if so, how quickly to move forward. If the regulator was simply tasked with assessing technical standards, it is not clear who has the necessary range of experience and knowledge of the implications to take on this role in a way that would maintain public support and would balance the, often competing, interests of the various parties involved.
Of course, it could be argued that in this modern day world of emphasis on human rights and, in particular, reproductive autonomy, there should be no restrictions on treatment for ‘public policy reasons’ provided patients are properly informed and are willing to take any risks. With IVF, however, there is another person, or at least a potential person, whose interests need to be considered. This fact, in itself, legitimises the state having some say in where the limits should be set.
As the UK public has grown more familiar with issues related to reproduction and has been encouraged to participate in debates about public policy, there is far greater support for this area of practice. But how sure can we be sure that this support is sustainable and is not conditional upon the existence of a respected and trusted regulatory body?
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The HFEA’s role as facilitator of scientific progress |
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In 1968—10 years before the birth of Louise Brown—Robert Edwards called for the establishment of an organization to advise those working in the field of human reproduction to frame public debate and to act as a watchdog (Edwards and Sharpe, 1971
). He expressed the view that by engaging with the public and providing reassurance that their worst fears would not be realized, scientific freedom was more likely to be protected and fewer restrictions would be imposed on their work. This insightful comment has certainly proved to be true. The United Kingdom has one of the most liberal laws relating to stem cell research in the world and has been able to forge ahead in a way that other countries have not. Professor Alison Murdoch, in her evidence to the Science and Technology Committee, was unequivocal when she said ‘I think the fact that we have an Act that regulates IVF treatment and research in [sic] embryos in the UK is the single most important reason why we have taken a lead worldwide in terms of stem cells’ (House of Commons Science and Technology Committee, 2005b: Ev 155). It is not the Act alone that provides this environment that is supportive of research but the fact that the HFEA is trusted to regulate compliance with the law. The House of Lords Select Committee (2002: 47) on Stem Cells highlighted this point, saying: ‘The HFEA’s role is crucial to the effective regulation of research on human embryos and the maintenance of public confidence in the regulatory regime’. Whilst the debate around the use of embryonic stem cells clearly illustrates the way in which regulation can protect and facilitate research, it is perhaps less clear that regulation protects rather than limits the freedom of clinicians to treat their patients using innovative procedures. Under the current regime, the introduction of new techniques is closely monitored, and restrictions are sometimes imposed on clinical practice. A doctor cannot offer a patient PGD with tissue typing, for example, without seeking prior approval from the HFEA. This may seem unnecessarily bureaucratic, but, arguably, this cautious approach by the HFEA has helped to ease the public’s concerns—and those of Parliamentarians who ultimately decide what restrictions should be imposed—and help to engender an environment within which scientific progress can flourish. Despite the regulation and the fact that we live in a far more risk-averse and litigious society than we did in the 1980s which inevitably affects the speed of transition from research to clinical practice, developments in treatment have continued to occur. ICSI, the use of frozen-thawed oocytes in treatment and aneuploidy screening, are just a few examples of treatments that have been introduced since the legislation was passed. These new treatments have not only been developed and introduced into clinical practice but have also been introduced with a minimal amount of public concern.
The HFEA’s role in facilitating scientific progress also stems from the way the legislation is drafted. By giving the HFEA responsibility for overseeing practice within the broad framework established by Parliament, the legislation allows sufficient flexibility to respond to new developments. If the HFEA’s role was restricted to inspector of standards, and so there was no intermediary between the legislation and the clinics, it is not clear how the law would deal with innovative therapies and currently unforeseen future practices. It seems unlikely that Parliament would be willing to give complete freedom to clinics to pursue research and innovative therapies, and the alternative is for more specific rules to be included on the face of the Act or in secondary legislation. Although there have been complaints about the time taken for the HFEA to assess and approve research and innovative practice, the alternative—which could involve seeking changes in legislation—is likely to be even worse. Clinics clearly have an interest in progressing research and in the smooth and rapid transition from research to clinical practice, and there are good reasons for believing that the current model, though not perfect, may be better than the alternatives.
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The HFEA’s role in protecting clinics |
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In the late 1980s, there was a desire among practitioners to be seen as responsible, sensible and sensitive to the broader implications of their work. Undoubtedly, at that time, guidance issued by the Voluntary Licensing Authority (Gunning and English, 1992
) gave those working in this new and controversial area a degree of security and protection. But do clinics still need this level of protection? Although the public is now more at ease with work in this area, it is certainly not uncontroversial or beyond criticism. The creation and, in some cases, the destruction of human life and the ability to influence and choose what type of people are born will always raise controversy, and decisions will always be open to challenge. The public and the media often fear what they do not know, and those who push the boundaries can find themselves the subject of vitriolic headlines. Working within a regulatory framework—whereby it is the HFEA rather than individual practitioners who attract the main attention of the media—protects individuals from this type of bad publicity that can unfairly damage a practitioner’s reputation or question his or her moral integrity. Such publicity is harmful not only to those directly concerned but also potentially to others working in the field. If public confidence in this work is threatened, it could lead to a shortening of the reins given to the HFEA by Parliament and further restrictions on the type of work that can be undertaken. There is a delicate balance to be achieved between the legitimate desire to pursue scientific progress and the need to maintain public support and confidence. The fact that the HFEA is seen to be responsible for maintaining that balance, and the practitioner concerned is complying with the appropriate regulatory procedures, helps to protect practitioners from criticism.
The number of legal challenges the HFEA has faced in recent years is evidence of the controversy that continues to accompany work in this area. But the HFEA now acts as a buffer between the clinics and the opponents of their work. In most cases, it is the HFEA that appears in court rather than individual doctors and clinics. The Hashmi case is a good example of this, where it was the HFEA that was challenged through the courts [R (on the application of Quintavalle) v Human Fertilisation and Embryology Authority, 2003] rather than the clinic concerned. With no HFEA to interpret the legislation and to authorize the use of new techniques, it would be for clinics to seek their own legal advice and, in some cases, take the risk of pursuing a treatment option in the face of legal uncertainty. In praising the HFEA, Robert Edwards made this point in his evidence to the Science and Technology Committee saying: Before the HFEA ‘if you argued you went to law, there was nothing else. If you made a decision and someone did not like it, they were able to sue you. The HFEA ended all that and I would say since then, that we in Britain have been very lucky indeed’ (House of Commons Science and Technology Committee, 2005b: Ev 148).
Practitioners working in clinics are those most affected by the regulatory regime—in terms of both its burdens and its benefits. Working behind the protective screen offered by the HFEA allows them, to a large extent, to avoid public, media and legal criticism. Clinics themselves need to consider what that protection is worth. Do the burdens of regulation for clinics and individual practitioners outweigh the benefits of having that level of protection?
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Be careful what you wish for... |
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The HFEA is not perfect. There have been problems in the past with the way it has conducted its business (Toft, 2004
). It can be frustrating to practitioners who have to accept limits on their clinical discretion and who find some of the licensing procedures bureaucratic and time consuming. It can seem unfair to people who are prevented from receiving the treatment they want, such as Diane Blood (R v Human Fertilisation and Embryology Authority, ex parte Blood, 1997) who wanted to use her dead husband’s sperm for treatment, the Mastertons (Scott, 2000) who wanted to select female embryos and the Whitakers (Wright, 2003) who had to go to the United States to have PGD with tissue typing to save their son. It can seem expensive to IVF patients who must pay the HFEA licence fee on top of the cost of their treatment and intrusive to have details of their treatment held on a central register. But, there are real advantages to having a body like the HFEA. It
- protects patients
- allays public concerns
- provides an environment within which scientific progress can flourish and
- protects IVF practitioners against claims of unethical behaviour.
Although the issues have changed, these underlying reasons for having a body like the HFEA remain as real and valid today as they were in the late 1980s. As with any form of regulation, questions arise about the legitimacy of state intervention and the justification for interfering with individuals’ freedoms. But whose autonomy are we seeking to protect by reducing the role of the HFEA and at what cost? It is all too easy to focus on the negative aspects of regulation and to follow the current trend towards unbridled reproductive autonomy. But, before moving too quickly to pare regulation in this area down to the minimum, patients, clinics, researchers and society need to give careful thought to what they would lose. In an attempt to avoid the irritations of regulation, we risk throwing out the baby with the bath water—a decision we may all live to regret.
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Acknowledgements |
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I thank Ann Sommerville, Peter Braude and the two anonymous reviewers for their helpful and constructive comments on earlier versions of this article.
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Footnotes |
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*The views expressed are those of the author and not necessarily those of the BMA.
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References |
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