This article briefly reviews the various papers contained in this volume. They were originally presented at a research workshop held at Keele University in the UK in February 2003. It is suggested that the different papers raise a series of related legal, social and ethical issues and can be collectively seen to demonstrate the fact that policy formation in relation to reproductive matters is highly contested. It is concluded that ethical policy formation in this area needs to be based on (...) actual evidence of harm rather than assumed harm and that this therefore entails more empirical research into reproductive matters. (shrink)

The Human Fertilisation and Embryology Act 2008: a missed opportunity?Amel AlghraniCorrespondence to Dr Amel Alghrani, Institute for Science, Ethics and Innovation, Centre for Social Ethics and Policy, School of Law, University of Manchester, Oxford Road, Manchester, M13 9PL; [email protected] 16 September 2009 Accepted 24 September 2009 Regulating reproduction is no easy feat. In the past three decades we have witnessed a reproductive revolution and great strides have been made to alleviate the effects of infertility. Reproductive advances such (...) as in-vitro fertilisation , sex selection, reproductive cloning and embryo selection for the purpose of creating “saviour siblings” have all emerged as part of a rapid and ever-changing branch of medicine, each promising to upset the status quo and transform human reproduction.Following much activity in this area, the lengthy process of updating the legislation is now complete. The Human Fertilisation and Embryology Act 2008 received Royal Assent on 13 November 2008. The majority of the HFE Act 2008’s amendments will come into force in October of this year, with the exception of the provisions pertaining to parenthood, which commenced in April 2009. Welcoming Royal Assent, Professor Lisa Jardine, Chair of the Human Fertilisation and Embryology Authority, stated:“This is a momentous day for the HFEA and for those with fertility problems. The regulatory system that has served us so well has been renewed. Parliament has provided a clear framework for the future and a solid base on which to regulate 21st century practice within 21st century law.”1However, as scientific endeavours into developments such as artificial gametes, womb transplantation and ectogenesis continue apace, it could be argued that Jardine was perhaps overly optimistic about the achievements of the new legislation. The HFE Act 2008 is an amending statute, and as Jackson 2 notes “much of the regulatory architecture” in the 1990 legislation “remains intact”. In retaining the architecture of the 1990 legislation, and merely amending or adding certain provisions, has the government missed an ideal opportunity to consider how to equip the regulatory framework for the next phase/era of assisted reproduction?The next …. (shrink)

Of all the changes to the Human Fertilisation and Embryology Act 1990 that were introduced in 2008 by legislation of the same name, foremost to excite media attention and popular controversy was the amendment of the so-called welfare clause. This clause forms part of the licensing conditions which must be met by any clinic before offering those treatment services covered by the legislation. The 2008 Act deleted the statutory requirement that clinicians consider the need for a father (...) of any potential child before offering a woman treatment, substituting for it a requirement that clinicians must henceforth consider the child’s need for “supportive parenting”. In this paper, we first briefly recall the history of the introduction of s 13(5) in the 1990 Act, before going on to track discussion of its amendment through the lengthy reform process that preceded the introduction of the 2008 Act. We then discuss the meaning of the phrase “supportive parenting” with reference to guidance regarding its interpretation offered by the Human Fertilisation and Embryology Authority. While the changes to s 13(5) have been represented as suggesting a major change in the law, we suggest that the reworded section does not represent a significant break from the previous law as it had been interpreted in practice. This raises the question of why it was that an amendment that is likely to make very little difference to clinical practice tended to excite such attention (and with such polarising force). To this end, we locate debates regarding s 13(5) within a broader context of popular anxieties regarding the use of reproductive technologies and, specifically, what they mean for the position of men within the family. (shrink)

The Department of Health's Review of the Human Fertilisation and Embryology Act 1990 is a comprehensive public consultation on the regulation of the storage and use of gametes and embryos for fertility treatment and research in the UK. The consultation considers a range of issues, including the model and scope of regulation and proposals for a single body, the Regulatory Authority for Tissue and Embryos, to replace both the Human Fertilisation and Embryology (...) class='Hi'>Authority and the Human Tissue Authority by April 2008. The Department of Health published its report on the consultation in March 2006, and this is discussed here in relation to both the support and criticisms of the model and scope of the current and proposed regulatory frameworks, particularly with regard to policy decision-making by bodies such as HFEA and RATE. (shrink)

When fertility centers dispose of embryos, how should this be done? Current regulatory guidelines by the Human Fertilisation and Embryology Authority state that, when terminating the development of human embryos, a clinic should act with sensitivity, taking account of the embryo’s “special status” and respecting the interests of the gamete providers and recipients. As yet, it is unclear as to how and to what extent this achieved within fertility clinics in the UK. Resultantly, this paper (...) examines the largely undocumented domain of embryo disposal practice. By undertaking an empirical study into policy and procedure and noting divergence in clinic practice, it then comments on the ethical implications of these protocols for patients and practitioners. Specifically, this paper argues for a more holistic approach to embryo disposal. An approach that effectively meets the requirements of the lab, is respectful of the “special status” of the human embryo, and, perhaps most importantly, reflects the multifaceted needs of the patient. (shrink)

The Human Fertilisation & Embryology Authority (HFEA) is the UK's statutory regulator of licensed assisted conception treatments. The past 10 years have, inevitably, drawn it further and deeper into this area of legal, moral and political controversy. It is opportune to consider how it has fared in the new climate of public accountability and critical scrutiny, and whether reform or revision of its role, mandate or operation may be called for. Through a close analysis of its (...) published Annual Reports, it is possible to form a picture of a development of the HFEA which has not been consistent, coherent or comfortable. (shrink)

Three-way baby making is not new: genetic surrogacy existed in Biblical times and donor insemination was recorded in Britain over 200 years ago. However, the gift of gametes between women breaks all social conventions. This paper examines the phenomenon of gamete-donation questioning whether a ‘gift’ of such magnitude can ever be ‘free’ (as the Human Fertilisation & Embryology Authority advocates), or a ‘true’ gift (in Derridian terms). Exploration of this unprecedented ‘gift’ from a psychoanalytic approach is (...) supplemented by an interdisciplinary one, drawing on the gift literature in philosophy, anthropology, ethnography and socioeconomics, as well as neonatal research and reproductive medicine. Critics note the dearth of analyses that take seriously the psychological ramifications of contemporary treatments, protocols and expectations in reproductive medicine. Based on psychoanalytic therapy within a clinical practice devoted to reproductive issues, the author argues that institutionalised asexual reproduction alters unconscious conceptualisations of the act of procreation – converting the passionate intimacy of primal scene into a clinical coupling of gametes in a mechanised arena. The author argues that, too charged to contemplate, the gamete's transcendent quality and blurring of elementary personae/res distinctions leads protagonists, including professionals, to defensive commodification. Multiple emotional meanings are ascribed to gifted gametes by each in the triangle of donor, recipient and offspring, illustrated here with verbatim material. This article addresses some of the far-reaching socio-political consequences for class, race, age, gender and sexuality of asexual reproduction, related to selection procedures and uneven global and local distribution of fertility treatment and its cost in financial, physical, practical and emotional terms. Similarly, feminist unease over (patriarchal) reproductive control and gatekeeping policies are considered, as well as ethical concerns over genetic manipulation, pre-implantation screening, sex selection, selective foetocide and potential exploitation of transnational donors and surrogates. (shrink)

The recent desperation to clone human embryos may be seriously undermining accepted ethical principles of medical research, with potentially profound wider consequencesIn her editorial in the February 2005 issue of this journal, Nikola Biller-Andorno questioned whether the effort and resources that have been invested in debates about cloning at the United Nations might have been somewhat disproportionate, if a binding universal agreement on reproductive cloning cannot be reached.1 Although most of the overt disagreement has centred around “therapeutic” cloning, rather (...) than the potential use of nuclear transfer for reproduction, it is none the less clear that the delay and ultimate failure to date in achieving consensus on the former has also increased the likelihood of the latter becoming a foreseeable reality in the absence of a legally binding global convention. Whilst the much heralded promise of therapies has now been severely undermined by scandals of fraud,2 the available evidence from various primate studies3–5 and the history of similar work with other mammalian species6,7 have provided little reason to doubt that human reproductive cloning might be possible in principle . I completely agree with Dr Biller-Andorno’s appeal that we need to “foster a genuine, worldwide discourse on bioethical issues” and not let our debate get completely derailed by vested interests, whether politically or economically motivated. If we don’t, we can probably expect dire consequences for the future of biomedical research and its impact on society at large.Prior to the United Nations’ discussions regarding a ban on human cloning in October 2004, the Human Fertilisation and Embryology Authority in Great Britain announced that they had granted their first licence to clone human embryos by nuclear transfer,8 though no other applications had apparently been made following the legalisation …. (shrink)

In January 2008, the Human Fertilisation and Embryology Authority issued two 1-year licenses for cytoplasmic hybrid embryo research. This article situates the HFEA's decision in its wider scientific and political context in which, until quite recently, the debate about human embryonic stem cell research has focused narrowly on the moral status of the developing human embryo. Next, ethical arguments against crossing species boundaries with humans are canvassed. Finally, a new argument about the risks of (...) harm to women egg providers resulting from research involving the creation of humanesque cytoplasmic hybrid embryos is elaborated. Taken together these ethical concerns about the moral status of the human embryo, about the ethics of crossing species boundaries with humans, and about the potential harms to women, provide good reason to eschew humanesque cytoplasmic hybrid embryo research in favor of less ethically controversial means to the laudable end of successful regenerative medicine. (shrink)

The Human Fertilisation and Embryology Authority’s recent restrictive recommendations on sex selection have highlighted the need for consideration of the plausibility of ethical arguments against sex selection. In this paper, the author suggests a parental virtues approach to some questions of reproductive ethics as a superior alternative to an exclusively harm focused approach such as the procreative liberty framework. The author formulates a virtue ethics argument against sex selection based on the idea that acceptance is a (...) character trait of the good parent. It is concluded that, because the argument presented posits a wrong in the sex selecting agent’s action that is not a harm, the argument could not function as a justification of the HFEA’s restrictive position in light of their explicit commitment to procreative liberty; it does, however, suggest that ethical approaches focused exclusively on harm fail to capture all the relevant moral considerations and thus that we should look beyond such approaches. (shrink)

The Human Fertilisation and Embryology Authority have recently granted a licence to perform preimplanation genetic diagnosis (PGD) for the homozygous form of familial hypercholesterolaemia (FH), explicitly excluding its use for the heterozygous form. The grounds for such decisions centre on how serious a condition is thought to be as well as on the availability of effective treatment, and decisions are made on a case-by-case basis. The case for licensing homozygous FH is discussed and compared with other (...) cases, and the case for making a distinction between PGD for homozygous and heterozygous FH is also examined. Testing for homozygous FH raises difficult issues of non-disclosure of results for heterozygous FH. Fears that this decision may represent a ‘slippery slope’ to more widespread testing are argued to be overstated. (shrink)

In September 2007, the Human Fertilisation and Embryology Authority (HFEA) in the United Kingdom concluded that "there is no fundamental reason to prevent cytoplasmic hybrid research . . . this area of research can, with caution and careful scrutiny, be permitted." Later, in January 2008, HFEA issued two research licenses to create humanesque cytoplasmic hybrid embryos from which stem cells could be derived. This article critically examines the public consultation process that preceded these decisions, concluding that (...) the process was flawed and demonstrating how the HFEA documents summarizing the findings of the public consultation process misrepresent the public's contributions to this policymaking initiative. (shrink)

The UK Human Fertilisation and Embryology Authority was right to permit tissue typing preimplantation genetic diagnosisOn July 21 2004, the Human Fertilisation and Embryology Authority , Britain’s regulatory agency for reproductive technologies, revised its policy on preimplantation genetic diagnosis for tissue typing.1,2 The authority of the HFEA to enact such a policy was affirmed by the UK’s highest court, the House of Lords, on April 28 2005.3 Preimplantation genetic diagnosis combines in (...) vitro fertilisation with genetic testing. In PGD, embryos generally undergo biopsy prior to the eight cell stage, followed by genetic testing for a particular trait. Tissue typing PGD is done to identify an embryo that is tissue matched for a child suffering from a severe disease requiring bone marrow or cord blood stem cell transplantation and for whom no living donor exists. This procedure was first performed in 2000.4 Precise matching of tissue types is critical to successful tissue transplant, and the donors of such tissues are often referred to as “saviour siblings”.Where a tissue matched individual already exists, extracting bone marrow from that individual or collecting cord blood already in storage, rather than creating a match, presents the most immediate treatment alternative. Bone marrow donation from adults or other medically competent individuals is not generally ethically contested, and bone marrow donation from medically incompetent individuals is also permissible under certain conditions.5 Where no living tissue donor exists, however, intentionally creating a donor through tissue typing PGD is among a short list of possible treatment options.The July HFEA policy change makes PGD licensable in cases where tissue typing is the only purpose of testing. Previously, PGD was licensable in the UK only for disease testing, and tissue typing PGD was permissible only when …. (shrink)

The UK-based deliberations that led up to the legalisation of two new ‘mitochondrial donation’ techniques in 2015, and which continued after that time as regulatory details were determined, featured a division of advisory labour that is common when decisions are made about new technologies. An expert panel was convened by the Human Fertilisation and Embryology Authority, charged with assessing the scientific and technical aspects of these techniques. Meanwhile, the Nuffield Council on Bioethics addressed the ethical issues. (...) While this division of labour was undertaken in the name of thoroughness, I argue here that it can have the unintended consequence that hybrid questions that simultaneously involve ethical and technical aspects—especially questions about where to set evidential thresholds for the acceptance of new technology—do not receive enough attention. (shrink)

The UK-based deliberations that led up to the legalisation of two new ‘mitochondrial donation’ techniques in 2015, and which continued after that time as regulatory details were determined, featured a division of advisory labour that is common when decisions are made about new technologies. An expert panel was convened by the Human Fertilisation and Embryology Authority (HFEA), charged with assessing the scientific and technical aspects of these techniques. Meanwhile, the Nuffield Council on Bioethics addressed the ethical (...) issues. While this division of labour was undertaken in the name of thoroughness, I argue here that it can have the unintended consequence that hybrid questions that simultaneously involve ethical and technical aspects—especially questions about where to set evidential thresholds for the acceptance of new technology—do not receive enough attention. (shrink)

Mitochondrial replacement techniques, known in the popular media as 'three-parent' or 'three-person' IVFs, have the potential to enable women with mitochondrial diseases to have children who are genetically related to them but without such diseases. In the debate regarding whether MRTs should be made available, an issue that has garnered considerable attention is whether MRTs affect the characteristics of an existing individual or whether they result in the creation of a new individual, given that MRTs involve the genetic manipulation of (...) the germline. In other words, do MRTs affect the qualitative identity or the numerical identity of the resulting child? For instance, a group of panelists on behalf of the UK Human Fertilisation and Embryology Authority has claimed that MRTs affect only the qualitative identity of the resulting child, while the Working Group of the Nuffield Council on Bioethics has argued that MRTs would create a numerically distinct individual. In this article, I shall argue that MRTs do create a new and numerically distinct individual. Since my explanation is different from the NCOB's explanation, I shall also offer reasons why my explanation is preferable to the NCOB's explanation. (shrink)

This paper analyses the British Human Fertilisation and Embryology Authority's 2002 public consultation on sex selection, a consultation that was mainly concerned with sex selection for non-medical reasons. Based on a close reading of the consultation document and questionnaire it is argued that the consultation is biased towards certain outcomes and can most plausibly be construed as an attempt not to investigate but to influence public opinion.

There is a popular and widely accepted version of the precautionary principle which may be expressed thus: “If you are in a hole—stop digging!”. Tom Baldwin, as Deputy Chair of the Human Fertilisation and Embryology Authority , may be excused for rushing to the defence of the indefensible,1 the HFEA’s sex selection report,2 but not surely for recklessly abandoning so prudent a principle. Baldwin has many complaints about my misrepresenting the HFEA and about my supposed elitist (...) contempt for public opinion; readers of this exchange will decide for themselves.REDRAFTING THE REPORTBaldwin begins with a piece of wishful thinking:"Harris objects that in this recommendation “an absurdly high standard of caution is employed”, since a theoretical risk is associated with almost all medical procedures. This objection is misplaced: as paragraph 142 of the report indicates, the phrase “theoretical risk” is to be understood here in the light of the earlier discussion of the risks arising from the fact that flow cytometry exposes sperm to laser energy, a procedure which is known to be liable to damage DNA."Paragraph 142 does not make that clear. It does indeed refer back to a set of earlier paragraphs but these give, if anything, an upbeat assessment of the safety of flow cytometry. Paragraph 121 states: “However whilst potentially less intrusive, and with potentially lower risk to the health of patients, flow cytometry …” .2 But even if the overall burden of the report does indicate unresolved fears, the standard is still absurdly high. However, so far from endorsing the report’s judgement that flow cytometry has “potentially lower risk to the health of patients”, Baldwin now regards the risk of flow cytometry as “serious”1:"Since the application of flow cytometry to humans is a new procedure, the risk of … ". (shrink)

In April 2007, as part of its public consultation initiative, the Human Fertilisation and Embryology Authority in the United Kingdom published Hybrids and chimeras: A consultation on the ethical and social implications of creating human/animal embryos in research. This HFEA document identifies a number of possible arguments against the creation of human/animal embryos. One of these arguments concerns the worry that human/animal embryos “might be transferred to a woman to create babies with some (...) animal DNA in them.” Although the HFEA dismisses this slippery slope argument, I argue that this possible future is not as farfetched as one might think. For example, human admixed embryos might be transferred to women in an effort to prevent the transmission of mitochondrial diseases. The ethical acceptability of this possible future practice is examined from different feminist perspectives with a focus on issues of reproductive freedom and social justice. (shrink)

In “Sex selection and regulated hatred”1 John Harris launches a vehement critique of the Human Fertilisation and Embryology Authority’s recent report Sex Selection: options for regulation, raising several issues that merit discussion.He begins by complaining about the recommendation that because of the theoretical risk associated with the use of flow cytometry as a method of sperm sorting, its use should be restricted for the moment to cases in which a clear medical benefit is to be gained (...) from its use. Harris objects that in this recommendation “an absurdly high standard of caution is employed”, since a theoretical risk is associated with almost all medical procedures. This objection is misplaced: as paragraph 142 of the report indicates, the phrase “theoretical risk” is to be understood here in the light of the earlier discussion of the risks arising from the fact that flow cytometry exposes sperm to laser energy, a procedure which is known to be liable to damage DNA. Since the application of flow cytometry to humans is a new procedure, the risk of human genetic defects caused this way is still only “theoretical”; nonetheless it is serious enough to warrant caution—hence the recommendation that at present flow cytometry should be available only when its use brings clear medical benefits. The HFEA has recently been criticised by some for not being cautious enough when permitting the use of intracytoplasmic sperm injection even though in that case there are clear medical benefits from its use. It is extraordinary that Harris should now criticise the HFEA for not throwing caution to the winds concerning flow cytometry.Harris’ next point concerns the justification for this suggestion that preimplantation sex selection should be available only where it is undertaken for medical reasons. The obvious way to justify this would appear …. (shrink)

Sperm sharing arrangements involve a man (‘the sharer’) allowing his sperm to be used by people seeking donor sperm (‘the recipients’) in exchange for reduced price in vitro fertilisation. Clinics in the UK have offered egg sharing since the 1990s and the arrangement has been subjected to regulatory oversight and significant ethical analysis. By contrast, until now no published ethical or empirical research has analysed sperm sharing. Moreover the Human Fertilisation and Embryology Authority (HFEA) does (...) not record the number of sperm sharing arrangements taking place.This paper describes the sperm sharing process providing an analysis of all the UK clinics advertising sperm sharing services. The ethical rationale for egg sharing is described: reducing the number of women exposed to the risks of stimulation and retrieval. This advantage is absent in sperm sharing where donation has no physical drawbacks. The key adverse social and emotional outcome of gamete sharing arises when the sharer’s own treatment is unsuccessful and the recipient’s is successful. This outcome is more likely in sperm sharing than in egg sharing given sperm from sharers can be used by up to 10 families whereas shared eggs only go to one other family.Given its morally relevant differences from egg sharing, sperm sharing requires its own ethical analysis. The HFEA should begin recording sperm sharing arrangements in order to enable meaningful ethical and policy scrutiny. (shrink)

The destruction of an embryo must be justified in law. This is to prevent frivolous wastage and to show the respect afforded by the Warnock Report. For example, embryonic destruction during pregnancy is underpinned by the Abortion Act 1967, and embryonic destruction during fertility treatment is regulated by the Human Fertilisation and Embryology Act 1990. However, following the appeal decision in R v Human Fertilisation and Embryology Authority [2005] 2 A.C. 561, embryos can (...) now be created for a bone marrow tissue match to a sick sibling under the Human Fertility and Embryology Act 1990 according to the subjective desires of the mother. This opens the door to the first example of embryonic destruction on unique social-eugenic grounds with no clear lawful justification. It is argued that these embryos should be afforded a unique destruction provision under an amended version of section 1 of the Abortion Act 1967 in light of their ‘social-eugenic’ nature. This would protect the Human Fertilisation and Embryology Authority from accusations of undercover eugenic practices and reinstate the respect shown towards embryos in law. (shrink)

Mitochondrial donation poses the latest regulatory challenge for policy-makers in the context of assisted conception. Since 2010 the Human Genetics Commission, the Human Fertilisation and Embryology Authority and the Nuffield Council on Bioethics have all considered the policy implications of permitting use of these techniques in treatment. The Nuffield Council on Bioethics reported its recommendations in June 2012 following a consultation on the ethical issues raised by these techniques; and a separate consultation by the (...) class='Hi'>Human Fertilisation and Embryology Authority in conjunction with Sciencewise-ERC followed in September 2012. Matters for consideration included the potential relationships created by the use of three parties’ genetic material and the associated ramifications, eg whether or not there is a need to establish records of such donations and, if so, to whom should information later be provided? Thus, mitochondrial donation poses both novel and familiar questions about the ‘genetic family’, ‘parentage’ and ‘identity’. This article explores some of the ways in which mitochondrial DNA is constructed as relatively significant in recent Parliamentary debates, policy and consultation documents. It reflects on the ways in which the role of some genetic connections, or lack thereof, are mediated in law and policy. (shrink)

When is commodification acceptable?Preimplantation genetic diagnosis is usually restricted to couples who are eligible for in vitro fertilisation —infertile couples or those with a history of genetic disease. The Human Fertilisation and Embryology Authority in England and the Infertility Treatment Authority in Australia have both given permission for PGD with tissue typing to detect human leucocyte antigen compatibility in order to save an existing sibling with a life threatening condition. The procedure has also (...) been carried out in the United States.1Heavy criticism followed the February 2002 ruling of England’s HFEA to allow a family to try for a child who is free of thalassaemia and a “perfect match” for a sick sibling.2 Then in August …. (shrink)

This article critically appraises the current legal scope of the principal applications of preimplantation genetic diagnosis (PGD). This relatively new technique, which is available to some parents undergoing in vitro fertilization (IVF) treatment, aims to ensure that a child is not born with a seemingly undesirable genetic condition. The question addressed here is whether there should be serious reasons to test for genetic conditions in embryos in order to be able to select between them. The Human Fertilisation and (...) Embryology Authority and the Human Genetics Commission have decided that there should be such reasons by broadly aligning the criteria for PGD with those for selective abortion. This stance is critically explored, as are its implications for the possible use of PGD to select either against or for marginal features or for significant traits. The government is currently reviewing the legal scope and regulation of PGD. (shrink)

This article examines law’s representation of embodied female identity in the context of two medical law cases, R. v. Human Fertilisation and Embryology Authority, ex parte Blood andB v. Croydon Health Authority. Through an examination of contemporary critiques of female embodiment, in particular the work of Judith Butler, two discursive strategies are suggested for their potential to reconfigure the sexed subject within legal discourse. Firstly, the act of transgression – the flight from purportedly fixed subject (...) positions – can be read in the case of Bloodand calls into question law’s ability to contain and sustain sexed identity as prediscursive and immutable. Secondly, the exposure of the historical formation of the female subjects of legal discourse, demonstrated through a genealogical reading of B v. Croydon Health Authority, contributes to the feminist theoretical project to destabilise traditional gender categories and enables us to think beyond the category of ‘Woman’. (shrink)

Ever so often in the UK, there is a flurry of activity around the information requirements of donor-conceived individuals. In April 2013, it was the launch of a report from the Nuffield Council on Bioethics that brought the issue back to public consciousness.1Since 1991, information about treatment with donor gametes or embryos has been collected by the Human Fertilisation and Embryology Authority . Since then, over 35 000 donor-conceived individuals have been born through treatment in licensed (...) clinics. Medical information and information about donors’ appearance are collected by clinics, and donors are encouraged to put together a ‘pen portrait’ giving information about themselves for any resulting children. One focus of the new report is on improving the quality and quantity of information available about donors.Traditionally, gamete and embryo donations were practised on an anonymous basis, so that those born as a result of such donation may receive only non-identifying information about the donor when they reach the age of 18 . This changed in 2005 when donor anonymity was removed so that anyone donating after that time could be identified to individuals born as a result of the treatment. Those who have donated in the past are also able to reregister as identifiable donors. Much concern was expressed at the time that this would exacerbate the shortage of donors although the Nuffield Council on Bioethics reports that, 8 years on, those clinics that actively recruit donors appear to be successful in finding sufficient donors. The report recommends that the option of anonymous donation should not be reintroduced.A big issue of debate in the UK has been, and continues to be, whether parents should tell their …. (shrink)

Preimplantation genetic diagnosis (PGD) is available where there is a 'significant risk of a serious genetic condition being present in the embryo', the criteria established by the Human Fertilisation and Embryology Authority (HFEA) and Human Genetics Commission (HGC). There are a number of controversies about this practice, notably to what extent people can agree on the term 'serious' and whether 'serious' should only mean 'serious for the possible child' or whether it might also, or sometimes (...) instead, mean 'serious for the prospective parents'. This paper moves into different controversial territory by considering the scope of reproductive autonomy beyond selection against serious genetic conditions. Here I consider the argument that parents might actually be morally required to select children with what are sometimes called 'enhanced' features or traits to select 'the best' as this has been described. Reflection on the realities and costs of an attempt to use in vitro fertilization (IVF) and PGD to select 'the best' possible child rebuts the argument in favour of any such 'maximizing' duty on behalf of prospective parents. (shrink)

On occasion, British in vitro fertilization practitioners look over the ocean to the practice of IVF and embryo research in the United States, wonder why these areas are subject to less regulation than in the United Kingdom, and ask how much less risky and more progressive IVF and embryo research might be if subject to additional federal, or at least state, regulation. To an American audience, imbued with the centuries‐old spirit of independence, regulation and autonomy can seem in tension. From (...) a British perspective, there is no necessary conflict. There is no dissent in the United Kingdom from the proposition that individual activities, services, and industries can be regulated and, at the same time, retain and exercise such autonomy as is their right within a safe sphere. From 1994 to 2002, I was the chair of the United Kingdom's Human Fertilisation and Embryology Authority, which regulates the practice of IVF and embryo research. The existence of the HFEA assures patients that safety and aspects of the practice of assisted reproduction are monitored, leaving them free to choose without worrying about danger, in the same way that the public may take only those drugs that have passed health and safety tests. I would propose that anxious and vulnerable patients do not have more autonomy in a less regulated, market‐driven field. (shrink)

From 2002 to 2003, the United Kingdom's Human Fertilisation and Embryology Authority carried out a review of the available methods of sex selection, the central aims of which were, in the words of the subsequent report.

This article provides an analysis of the relationships between IVF and therapeutic cloning, as they played out in the UK Human Fertilisation and Embryology Authority consultation of 2006: Donating Eggs for Research: Safeguarding Donors. We develop an account of current developments in IVF and cloning which foregrounds the role of mediation in structuring the discursive context in which they are constituted. We foreground the imperative of choice and the promise of cures as key features of this (...) context. We also argue that the intercorporeal exchanges of IVF are materially restructured in relation to cloning research, despite their represented similitude in the consultation document. The discourse of choice in relation to reproductive technologies has become entrenched over the last twenty years. In relation to therapeutic cloning, it has been coupled with, and strengthened by, the discourse of cures. In examining relations between IVF and cloning with specific attention to both mediating imaginaries, and intercorporeal exchanges, we develop an analysis that displaces the rhetoric of choice and cures. This makes visible the limited subject positions available, and the limited possibilities for responding critically to the consultation. Identifying women as the gendered subjects of this consultation and placing intercorporeality at the centre of our analysis illuminates the interdependency of women undergoing IVF, cloning science and the governance of embryo research in the UK. (shrink)

The recent case of the UK woman who lost her legal struggle to be impregnated with her own frozen embryos, raises critical issues about the meaning of reproductive autonomy and the scope of regulatory practices. I revisit this case within the context of contemporary debate about the moral and legal dimensions of assisted reproduction. I argue that the gender neutral context that frames discussion of regulatory practices is unjust unless it gives appropriate consideration to the different positions women and men (...) occupy in relation to reproductive processes and their options for autonomous choice. First, I consider relevant legal rulings, media debate, and scholarly commentary. Then I discuss the concept of reproductive autonomy imbedded in this debate. I argue that this concept conflates informed consent and reproductive autonomy, thereby providing an excessively narrow reading of autonomy that fails to give due regard to relations among individuals or the social, political and economic environment that shapes their options. I contrast this notion of autonomy with feminist formulations that seek to preserve respect for the agency of individuals without severing them from the conditions of their embodiment, their surrounding social relationships, or the political contexts that shape their options. Taking these considerations into account I weigh the advantages of regulation over the commercial market arrangement that prevails in some countries and suggest general guidelines for a regulatory policy that would more equitably resolve conflicting claims to reproductive autonomy. (shrink)

Ever so often in the UK, there is a flurry of activity around the information requirements of donor-conceived individuals. In April 2013, it was the launch of a report from the Nuffield Council on Bioethics that brought the issue back to public consciousness.1Since 1991, information about treatment with donor gametes or embryos has been collected by the Human Fertilisation and Embryology Authority. Since then, over 35 000 donor-conceived individuals have been born through treatment in licensed clinics. (...) Medical information and information about donors’ appearance are collected by clinics, and donors are encouraged to put together a ‘pen portrait’ giving information about themselves for any resulting children. One focus of the new report is on improving the quality and quantity of information available about donors.Traditionally, gamete and embryo donations were practised on an anonymous basis, so that those born as a result of such donation may receive only non-identifying information about the donor when they reach the age of 18. This changed in 2005 when donor anonymity was removed so that anyone donating after that time could be identified to individuals born as a result of the treatment. Those who have donated in the past are also able to reregister as identifiable donors. Much concern was expressed at the time that this would exacerbate the shortage of donors although the Nuffield Council on Bioethics reports that, 8 years on, those clinics that actively recruit donors appear to be successful in finding sufficient donors. The report recommends that the option of anonymous donation should not be reintroduced.A big issue of debate in the UK has been, and continues to be, whether parents should tell their …. (shrink)

Proposals to modernise fertility law in the UK In November 2023, the Human Fertilisation and Embryology Authority (HFEA) published recommendations 1 for changes to the Human Fertilisation and Embryology Act. 2 The HFEA regulates fertility treatments and embryo research in the UK. The recommendations were informed by a public consultation process during which the HFEA heard from patients, professionals and others with an interest in the regulations. The consultation ran from February - April (...) 2023 and received just over 6800 responses. The recommendations focus on four main areas that the HFEA consider to be in need of modernisation within the Act – patient protection and safety; consent; access to donor information; and future scientific developments and innovation. The Authority proposes that it should be given greater freedom and flexibility to promote patient safety and good practice. For example, through a wider range of regulatory enforcement powers,... (shrink)

It is a common feature of debates on the regulation of reproductive medicine to find law portrayed as a crude form of intervention consisting in the imposition of inflexible rules on doctors and medical researchers. This paper argues that this view must be replaced by a more accurate assessment of the law's potential role in the regulation of reproductive medicine. From an analysis of the White Paper on human fertilisation and embryology, and in particular the proposed Statutory (...) Licensing Authority, the author contends that far from being an inflexible method of regulation law can foster discussion and compromise. (shrink)

In 2003, the United Kingdom's Human Fertilisation and Embryology Authority published a report entitled Sex Selection: Options for Regulation. The report outlined the findings of a 2-year review of available sex selection techniques and recommended that the United Kingdom ought not to permit any regulated technique to be used other than for medical reasons. In so doing, it reflected the widespread opinion—repeatedly expressed in the public consultations that formed the cornerstone of the HFEA's review—that there is (...) something ethically unacceptable, or at least ethically suspect, about sex selection for nonmedical, or “social,” reasons. (shrink)

Ever so often in the UK, there is a flurry of activity around the information requirements of donor-conceived individuals. In April 2013, it was the launch of a report from the Nuffield Council on Bioethics that brought the issue back to public consciousness.1Since 1991, information about treatment with donor gametes or embryos has been collected by the Human Fertilisation and Embryology Authority . Since then, over 35 000 donor-conceived individuals have been born through treatment in licensed (...) clinics. Medical information and information about donors’ appearance are collected by clinics, and donors are encouraged to put together a ‘pen portrait’ giving information about themselves for any resulting children. One focus of the new report is on improving the quality and quantity of information available about donors.Traditionally, gamete and embryo donations were practised on an anonymous basis, so that those born as a result of such donation may receive only non-identifying information about the donor when they reach the age of 18 . This changed in 2005 when donor anonymity was removed so that anyone donating after that time could be identified to individuals born as a result of the treatment. Those who have donated in the past are also able to reregister as identifiable donors. Much concern was expressed at the time that this would exacerbate the shortage of donors although the Nuffield Council on Bioethics reports that, 8 years on, those clinics that actively recruit donors appear to be successful in finding sufficient donors. The report recommends that the option of anonymous donation should not be reintroduced.A big issue of debate in the UK has been, and continues to be, whether parents should tell their …. (shrink)

This paper will examine the recent Human Fertilisation and Embryology Authority public consultation on sex selection. It will review the current regulation on sex selection in the United Kingdom and critically examine the outcomes of the HFEA consultation. The paper will argue that the current ban on embryo sex selection for social reasons and a proposed ban on sperm selection are not justified. There is no evidence for sex selection causing an increase in sex discrimination; creating (...) a slippery slope towards selection for other non-disease characteristics; or promoting a consumerist attitude towards children. The HFEA recommendations to prohibit social sex selection techniques rely upon an unwarranted concern about the risk of the procedures used. Reproductive technologies should be made available to people unless a substantial risk of harm—to the child, the parents or to society—can be identified. There is no such evidence of harm in this case. (shrink)

Ever so often in the UK, there is a flurry of activity around the information requirements of donor-conceived individuals. In April 2013, it was the launch of a report from the Nuffield Council on Bioethics that brought the issue back to public consciousness.1Since 1991, information about treatment with donor gametes or embryos has been collected by the Human Fertilisation and Embryology Authority . Since then, over 35 000 donor-conceived individuals have been born through treatment in licensed (...) clinics. Medical information and information about donors’ appearance are collected by clinics, and donors are encouraged to put together a ‘pen portrait’ giving information about themselves for any resulting children. One focus of the new report is on improving the quality and quantity of information available about donors.Traditionally, gamete and embryo donations were practised on an anonymous basis, so that those born as a result of such donation may receive only non-identifying information about the donor when they reach the age of 18 . This changed in 2005 when donor anonymity was removed so that anyone donating after that time could be identified to individuals born as a result of the treatment. Those who have donated in the past are also able to reregister as identifiable donors. Much concern was expressed at the time that this would exacerbate the shortage of donors although the Nuffield Council on Bioethics reports that, 8 years on, those clinics that actively recruit donors appear to be successful in finding sufficient donors. The report recommends that the option of anonymous donation should not be reintroduced.A big issue of debate in the UK has been, and continues to be, whether parents should tell their …. (shrink)

The author draws on his own experience of helping to make and deliver public policy to indicate the wider context in which ethical decisions have to be made: the law, contested interpretations of the law which have to be settled in the courts, and wider political and economic factors. He argues that the concept of respect for the early embryo does have substance because of the strict regulatory regime of the Human Fertilisation and Embryology Authority (HFEA). (...) He considers the arguments that the early embryo ‘[e]njoys the full rights of the human being and should be accorded respect owed to a human being’. He concludes that these arguments are not finally convincing. He also looks at the moral status of the early embryo in Christian tradition and argues that perhaps from the fourth and certainly from the seventh century in the West until 1869, offences against the early embryo were regarded as less serious than offences against the embryo when developed further. For these reasons he concludes that there should be no absolute prohibition against research on an early embryo up to fourteen days. He also looks at recent cases involving pre-implantation diagnosis (PGD) and tissue typing with a view to obtaining matching tissue from an early embryo for a sibling suffering from a life-threatening disease. Although a distinction has been made between what might be licit in the case of a genetic disorder in the sibling but illicit if the disorder is not genetic, he argues that it could be in the best interests of the early embryo, the child that is to be, if in either case if it was selected with a view to matching the tissue of a sibling. (shrink)

Ever so often in the UK, there is a flurry of activity around the information requirements of donor-conceived individuals. In April 2013, it was the launch of a report from the Nuffield Council on Bioethics that brought the issue back to public consciousness.1Since 1991, information about treatment with donor gametes or embryos has been collected by the Human Fertilisation and Embryology Authority. Since then, over 35 000 donor-conceived individuals have been born through treatment in licensed clinics. (...) Medical information and information about donors’ appearance are collected by clinics, and donors are encouraged to put together a ‘pen portrait’ giving information about themselves for any resulting children. One focus of the new report is on improving the quality and quantity of information available about donors.Traditionally, gamete and embryo donations were practised on an anonymous basis, so that those born as a result of such donation may receive only non-identifying information about the donor when they reach the age of 18. This changed in 2005 when donor anonymity was removed so that anyone donating after that time could be identified to individuals born as a result of the treatment. Those who have donated in the past are also able to reregister as identifiable donors. Much concern was expressed at the time that this would exacerbate the shortage of donors although the Nuffield Council on Bioethics reports that, 8 years on, those clinics that actively recruit donors appear to be successful in finding sufficient donors. The report recommends that the option of anonymous donation should not be reintroduced.A big issue of debate in the UK has been, and continues to be, whether parents should tell their …. (shrink)

This response to Edgar Dahl’s paper in this issue of Health Care Analysis clarifies my argument concerning sex selection and shows that our disagreement is less than he believes it is.

In this paper we address the ethical challenges of research on cytoplasmic hybrid embryos, or “cybrids”. The controversial pronouncement of the UK’s Human Embryology and Fertilisation Authority of September 2007 on the permissibility of this area of research is the starting point of our discussion, and we argue in its favour. By a rigorous definition of the entities at issue, we show how the terms “chimera” and “hybrid” are improper in the case of cybrids, and how (...) their use can bias the debate creating moral prejudices. After analysing the scientific aspects of cybrids research and sketching out current alternatives, we enter the ethical debate, starting from the premise that research on early human embryos is ethically permissible under some circumstances. We emphasise how research on cybrids has positive consequences in terms of scientific and therapeutic applications, since it allows the derivation of human embryonic stem cells genetically tailored to the somatic cell donor. Such cell lines offer a unique in vitro model both for studies of human pathogenesis and for drug screening and discovery. Research on cybrids also circumvents the problem of the scarcity of human oocytes and their ethically dubious donation. Finally, we object to the most common arguments against cybrids research, that is, moral repugnance, the slippery slope argument, the appeal to “nature”, and the unfair distribution of economical resources. (shrink)

In the United Kingdom there have been few committees or commissions dealing specifically with biomedical ethics, and where such bodies have been set up they have merely reported on a specific topic and then disbanded. However, there may well be standing committees in the future, of which the Voluntary Licensing Authority for Human In Vitro Fertilisation and Embryology is a precursor. This paper surveys the work of three special committees or working groups which have reported in (...) the period 1970 to the present. Of these the Warnock Committee is by far the most important, and the issues which it raises are discussed with specific reference to the place of philosophers and theologians on such bodies. It is concluded that, although there has been some movement in the UK toward the utilization of those with special skills and knowledge in the field of bioethics, much more could be done in this regard. Keywords: biomedical ethics, commissions and committees, philosophy, theology, reason, moral sentiment, public morality CiteULike Connotea Del.icio.us What's this? (shrink)