Public attitudes towards novel reproductive technologies: a citizens' jury on mitochondrial donation.

STUDY QUESTION: Does an informed group of citizens endorse the clinical use of mitochondrial donation in a country where this is not currently permitted? SUMMARY ANSWER: After hearing balanced expert evidence and having opportunity for deliberation, a majority (11/14) of participants in a citizens' jury believed that children should be able to be born using mitochondrial donation. WHAT IS KNOWN ALREADY: Research suggests that patients, oocyte donors and health professionals support mitochondrial donation to prevent transmission of mitochondrial disease. Less is known about public acceptability of this novel reproductive technology, especially from evidence using deliberative methods. STUDY DESIGN, SIZE, DURATION: This study comprised a citizens' jury, an established method for determining the views of a well-informed group of community members. The jury had 14 participants, and ran over one and a half days in 2017. PARTICIPANTS/MATERIALS, SETTING, METHODS: Jurors were members of the public with no experience of mitochondrial disease. They heard and engaged with relevant evidence and were asked to answer the question: 'Should Australia allow children to be born following mitochondrial donation?' MAIN RESULTS AND THE ROLE OF CHANCE: Eleven jurors decided that Australia should allow children to be born following mitochondrial donation; 7 of whom added conditions such as the need to limit who can access the intervention. Three jurors decided that children should not (or not yet) be born using this intervention. All jurors were particularly interested in the reliability of evidence, licensing/regulatory mechanisms and the rights of children to access information about their oocyte donors. LIMITATIONS, REASONS FOR CAUTION: Jurors' views were well informed and reflected critical deliberation and discussion, but are not intended to be representative of the whole population. WIDER IMPLICATIONS OF THE FINDINGS: When presented with high quality evidence, combined with opportunities to undertake structured deliberation of novel reproductive technologies, members of the public are able to engage in detailed discussions. This is the first study to use an established deliberative method to gauge public views towards mitochondrial donation. STUDY FUNDING/COMPETING INTEREST(S): This study was funded by a University of Sydney Industry and Community Collaboration Seed Award (2017), which was awarded contingent on additional funding from the Mito Foundation. Additional funding was provided by the Mito Foundation. The Foundation was not involved in jury facilitation or deliberation, nor analysis of research data. TRIAL REGISTRATION NUMBER: Not applicable.

Legal principles and seminal legal cases in oocyte donation.

Oocyte donation has played an increasingly important role in assisted reproductive technologies since the early 1980s. Over the past 30 years, unique legal standards have evolved to address issues in the oocyte donation procedure itself as well as the disputes over issues, such as parentage, that inevitably arise with new technologies, particularly for individuals seeking to build nontraditional families. This essay will explore oocyte donation's legal aspects as well as seminal law concerning the procedure, including statutory law (uniform and model provisions and enacted state laws) and selected judicial opinions concerning surrogacy and parentage, testing of oocyte donors, mix-ups of donated oocytes, and donor compensation.

Payment to egg donors is the best way to ensure supply meets demand.

Compensated egg donation has been available in the USA since 1984 and is subject to a variety of regulations. The impact of variation from state to state on the regulation of egg donor compensation can be discerned from an analysis of data reporting to both the Centers for Disease Control and Prevention (CDC) and the Society for Assisted Reproductive Technology (SART). Although the CDC data sets are considered as the most complete, they did not, and do not, separately account for cycles conducted with frozen donor eggs, though SART data beginning in 2013 do account for these cycles. A synthesis of SART and CDC data sets allows for the most precise estimates of egg donor supply and also allows for an analysis of the impact of compensation on the incidence of egg donation. In Louisiana, where compensation is expressly forbidden, there appear to be no anonymous, altruistic donations. However, the supply of anonymous donor eggs is reliable in states that allow compensation. This difference implies that the only way to ensure an adequate supply of donated eggs is to compensate the donors accordingly.

The limits of evidence: evidence based policy and the removal of gamete donor anonymity in the UK.

This paper will critically examine the use of evidence in creating policy in the area of reproductive technologies. The use of evidence in health care and policy is not a new phenomenon. However, codified strategies for evidence appraisal in health care technology assessments and attempts to create evidence based policy initiatives suggest that the way evidence is used in practice and policy has changed. This paper will examine this trend by considering what is counted as 'good' evidence, difficulties in translating evidence into policy and practice and how evidence interacts with principles. To illustrate these points the removal of gamete donor anonymity in the UK in 2005 and the debates that preceded this change in the law will be examined. It will be argued that evidence will only ever take us so far and attention should also be paid to the underlying principles that guide policy. The paper will conclude with suggestions for how underlying principles can be more rigorously used in policy formation.

Kamakahi vs ASRM and the future of compensation for human eggs.

A recent lawsuit that alleges that the American Society for Reproductive Medicine (ASRM) engages in price-fixing by capping the amount of compensation paid for human oocytes has several critical ethical and policy implications that have received relatively little attention. ASRM has argued that ceilings on donor compensation prevent enticement, exploitation, and oocyte commodification. Critics counter that low donor compensation decreases supply, because fewer women are then interested in donating, which then increases prices for the service that physicians, not donors, accrue, and that ethical goals can be better achieved through enhanced informed consent, hiring egg donor advocates, and better counseling and screening. Yet, if compensation caps are removed, questions emerge concerning what the oocyte market would then look like. Informed consent is an imperfect process. Beyond the legal and economic questions of whether ASRM violates the Sherman Anti-trust Act also lie crucial questions of whether human eggs should be viewed as other products. We argue that human eggs differ from other factory-produced goods and should command moral respect. Although eggs (or embryos) are not equivalent to human beings, they deserve special consideration, because of their potential for human life, and thus have a different moral status. ASRM's current guidelines appear to address, even if imperfectly, ethical challenges that are related to egg procurement for infertility treatment. Given public concerns about oocyte commodification and ASRM's wariness of government regulations, existing guidelines may represent a compromise by aiding patients who seek eggs, while simultaneously trying to avoid undue influence, exploitation, and eugenics. Although the ultimate outcome of this lawsuit remains unclear, policy makers, providers, lawyers, judges, and others should attend seriously to these issues. Alternatives to current ASRM guidelines may be possible (eg, raising the current caps to, say, $12,000 or $15,000, potentially increasing donation, while still avoiding certain ethical difficulties) and warrant close consideration. These complex conflicting ethical issues deserve more attention than they have received because they affect key aspects of clinical practice and the lives of countless patients.

A doação compartilhada de óvulos no Brasil sob enfoque do Direito e da Bioética / Egg sharing in Brazil from the legal and bioethical point of view

Este artigo analisa os aspectos jurídicos e bioéticos da prática médica da doação compartilhada de óvulos no contexto da Reprodução Assistida no Brasil. Trata-se de uma prática criada pela classe médica para auxiliar na obtenção de gametas femininos e beneficiar as pacientes que buscam alcançar a gravidez com assistência profissional (AU)

This paper examines the legal and bioethical aspects of medical practice of shared egg donation in the context of Assisted Reproduction in Brazil. This is a practice created by physicians to aid in obtaining female gametes and benefit patients seeking to achieve pregnancy with professional assistance (AU)

Federalism and bioethics.

The absence of comprehensive federal oversight of human biotechnologies in the United States continues to stimulate academic discourse on the relative merits of European-style regulatory agencies as compared to the current, decentralized approach. Many American bioethicists support the latter, maintaining that the key features of federalism--policy experimentation and moral pluralism--allows for the efficient regulation of these complex and contentious issues. This paper examines state-level regulation of oocyte donation to assess claims regarding the superiority of this decentralized regulatory approach. Further, this paper introduces an additional element to this examination of state law, which concerns the degree to which the health and safety of key participants is addressed at the state level. This inquiry assesses one facet of fertility medicine and biomedical research law, oocyte donation, an analysis that can be used to inform the broader discourse regarding the regulation of human biotechnologies and bioethical issues by the states.

In search of donor relations and identity: the missing voices of Israel's children.

The voices of donor offspring and their families are missing from the debate regarding gamete donor anonymity v. openness in Israel, their unique predicament unheeded. Despite a context of worldwide change, various fears and myths impede the outlawing of donor anonymity, with Israel's medical establishment and legal representatives invested in maintaining a status quo characterized by regulations that discriminate between families whose members know their biological parents/siblings and those who do not. The most prominent of these is that abolishing anonymity leads to long-term shortage of donors, despite well-documented evidence to the contrary. A review of key research findings regarding the particular needs and experiences of offspring, recipients and donors clearly supports the need for a well thought-out re-evaluation of persistent fears and myths via the prism of grassroots reality. This evidence-based approach can lead to the formulation of recommendations that should facilitate, reflect and constitute such policy change.

Is the HFEA's policy on compensating egg donors and egg sharers defensible?

This paper asks whether the Human Fertilisation and Embryology Authority's (HFEA's) recently revised policies on compensating egg donors and egg sharers are defensible, paying particular heed to the ethical arguments, concepts, and principles deployed in support of them. The paper proceeds by briefly outlining both the 'old' and 'new' HFEA policies before describing and explaining the main arguments that are supposed to underpin these. The arguments are then subjected to scrutiny and generally found wanting. The paper's primary conclusion is that treating egg sharers more generously than egg donors (which is what both the 'old' and 'new' policies do) is inconsistent and unjustified. In order to render the HFEA's policies consistent, it would need either to limit more strictly the benefits-in-kind available to egg sharers or to take a more permissive approach to monetary compensation for egg donors. The paper's secondary conclusion is that the latter is preferable. Egg donors could, provided that suitable regulatory controls were in place, be compensated more generously without this being ethically problematic. Furthermore, since egg sharing is in some respects more problematic than other forms of egg donation, there is something to be said for encouraging a move away from sharing to donation.

[Can one authorize oocyte donation in the Grand Duchy of Luxembourg?]. / Peut -on autoriser le don d'ovocytes au GDL?

In the case of early ovary extinction, the only way to have a child is either adoption or egg/embryo reception by donation. To day, egg donation is prohibited in Luxembourg by ministerial decision in 2003. Germ cell donation is part of artificial reproductive therapy. Oocyte donation, in particular, needs to be done by IVF treatment, which makes it more complicated then sperm donation What makes it more difficult is the fact that there are no oocyte bank yet. Today, prohibition encourages procreative tourism what only wealthy people can afford. Although donation programs are well established many questions arise about egg donation such as refunds, divulging information, women's age limit, health insurance participation.

New York State's landmark policies on oversight and compensation for egg donation to stem cell research.

In 2009, New York became the first US state to implement a policy permitting researchers to use public funds to reimburse women who donate oocytes directly and solely to stem cell research, not only for the woman's out-of-pocket expenses, but also for the time, burden and discomfort associated with the donation process. The debate about the propriety of such compensation was recently renewed with the publication of a stem cell study in which women were provided with compensation for donating their eggs. This article explores the scientific and ethical rationales that led to New York's decision to allow donor compensation. The multifaceted deliberation process and comprehensive policies may serve as a model for other states and countries considering the issue of oocyte donor compensation.

Time for a national approach to donor conception in Australia.

There is a growing recognition of the interests and rights of individuals conceived using donated gametes in assisted reproductive technology to information about their biological parentage. In Australia these rights vary between jurisdictions according to differing statutory provisions. In February 2011 the Senate's Legal and Constitutional Affairs References Committee published its report on Donor Conception Practices in Australia. The report recommended the development of a nationally consistent approach to donor conception and recommended the enactment of legislation in those Australian jurisdictions without legislation regulating donor conception. This editorial reviews the Senate Committee report and its recommendations and supports calls for a nationally harmonised approach to donor conception in Australia.

Ovum donation: examining the new Israeli law.

Ovum donation affords countless couples that under natural circumstances would not be able to produce offspring the ability to carry out natural pregnancies. With advancements in biotechnology including egg collection and in vitro fertilization (IVF), physicians can now successfully implant fertilized embryos. Due to Israel's tremendous involvement in IVF for its own citizens, the national laws that govern egg donation are of great importance. On September 5th 2010, the Israeli Parliament (Knesset) passed a law that allows young women between the ages of 21 and 35 to donate their eggs for paid financial compensation. The new law allows infertile women between the ages of 18 and 54 to request egg donation and IVF, which will partially be covered under state insurance plans. This article provides a description of the new Israeli law regulating ovum donation and the practical, moral and ethical debate surrounding the new system.

The oversight and practice of oocyte donation in the United States, United Kingdom and Canada.

In vitro fertilization using donated oocytes is an important medical technique that provides the only option for some infertile patients to have children. The technique remains ethically contentious, however, and, as a result of this controversy, different oversight approaches have been developed in countries around the world. This paper examines the oversight and practice of oocyte donation in Canada, the United Kingdom and the United States to examine how policy choices have influenced the development and use of this medical technology. Examining per capita utilization of oocyte donation in these three countries provides evidence that supply-side policies-specifically policies affecting the compensation of potential oocyte donors-have substantially influenced the use of this technology. These results should provide useful insight for policymakers developing or revising oocyte donation policies.