Mitochondrial replacement therapy (MRT) utilises nuclear transfer technology to replace defective mitochondria with healthy ones and thereby minimise the risk of a mitochondrial disease passing from a mother to her child. It promises much but comes with ethical controversy, significant risk of harm and many unknowns. Forming a position on MRT requires accurate information about the current state of knowledge, and an appreciation of the ethical issues at stake. Ethical deliberations will vary depending on the framework used. There are in (...) principle objections to MRT on the grounds of direct harm to human embryos and germline genetic modification. But even without these objections MRT can be weighed in terms of the balance between risks and benefits, alternatives and uncertainties. This paper explores the evidence and lays out the relevant issues to assist such a deliberation. (shrink)

People who are involuntarily childless need to use assisted reproductive technologies if they want to have a genetically related child. Yet, from an ethical point of view it is unclear to what extent assistance to satisfy this specific desire should be warranted. We first show that the subjectively felt harm due to the inability to satisfy this reproductive desire does not in itself entail the normative conclusion that it has to be met. In response, we evaluate the alternative view according (...) to which the satisfaction of this desire is regarded as a way to meet one’s presumed intermediate need for parenthood. This view presupposes that parenthood is one of those general categories of experiences and activities that contribute an irreplaceable value to people’s lives, but the central difficulty is to find those characteristics that mark out parenthood as an irreplaceable constituent of a valuable life. We go on to argue, however, that even if one assumes that parenthood is such an irreplaceable constituent that makes life more valuable, this does not necessarily entail a moral duty to satisfy the desire for genetic parenthood. We conclude that there is a pro tanto obligation to help people conceive a genetically related child (if this is what they prefer), but that this can be outweighed by other moral considerations, such as safety and justice concerns. (shrink)

Abstract Background The first live birth following the use of a new reproductive technique, maternal spindle transfer (MST), which is a mitochondrial replacement technique (MRT), was accomplished by dividing the execution of the MST procedure between two countries, the USA and Mexico. This was done in order to avoid US legal restrictions on this technique. -/- Sources of data Academic articles, news articles, documents obtained through freedom of information requests, laws, regulations and national reports. -/- Areas of agreement MRTs are (...) new reproductive techniques that present novel ethical and legal challenges, since genetic material from three people is employed to create a child. -/- Areas of controversy Could the first MST procedure that culminated in a live birth negatively impact reproductive medicine in Mexico? -/- Growing points The USA and Mexico need specific and clear legislation on MRTs, in order for such techniques not to be governed by prior existing legislation on assisted reproduction that is inadequate for dealing with the new challenges that these techniques present. -/- Areas timely for developing research There is a pressing need for work to be done on the international governance of new reproductive techniques. (shrink)

Mitochondrial replacement therapy requires oocytes of women whose mitochondrial DNA will be transmitted to resultant children. These techniques are scientifically, ethically and socially controversial; it is likely that some women who donate their oocytes for general in vitro fertilisation usage would nevertheless oppose their genetic material being used in MRT. The possibility of oocytes being used in MRT is therefore relevant to oocyte donation and should be included in the consent process when applicable. In present circumstances, specific consent should be (...) obtained. However, once MRT becomes more routine, such consent could be incorporated into the general consent process for oocyte donation. The reported lack of proper consent for MRT from the oocyte donor in the first baby born via the technique is an ethical failing and should be corrected in any future practice of MRT. (shrink)

Mitochondrial replacement techniques are designed to allow couples to have children without passing on mitochondrial diseases. Recently, Giulia Cavaliere and César Palacios-González argued that prospective parents have the right to use MRTs to pursue genetic relatedness, such that some same-sex couples and/or polygamous triads could use the process to impart genetic relatedness between a child and more of its caregivers. Although MRTs carry medical risks, Cavaliere and Palacios-González contend that because MRTs are identity-affecting, they do not cause harm to an (...) existing human being, and our intuitions otherwise arise from the non-identity problem. Here, I review several attempts to address the non-identity problem, and propose a solution to the problem. Furthermore, I argue that regardless of one’s stance on whether MRTs are identity-affecting, the use of MRTs to pursue genetic relatedness alone falls outside the scope of the medical profession, as they involve substantive medical risk for no medical benefit. (shrink)

In a recent paper –Lesbian motherhood and mitochondrial replacement techniques: reproductive freedom and genetic kinship– we argued that lesbian couples who wish to have children who are genetically related to both of them should be allowed access to mitochondrial replacement techniques (MRTs). Françoise Baylis wrote a reply to our paper –‘No’ to lesbian motherhood using human nuclear genome transfer– where she challenges our arguments on the use of MRTs by lesbian couples, and on MRTs more generally. In this reply we (...) respond to her claims and further clarify our position. (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)

In this paper, we argue that lesbian couples who wish to have children who are genetically related to both of them should be allowed access to mitochondrial replacement techniques (MRTs). First, we provide a brief explanation of mitochondrial diseases and MRTs. We then present the reasons why MRTs are not, by nature, therapeutic. The upshot of the view that MRTs are non-therapeutic techniques is that their therapeutic potential cannot be invoked for restricting their use only to those cases where a (...) mitochondrial DNA disease could be ‘cured’. We then argue that a positive case for MRTs is justified by an appeal to reproductive freedom, and that the criteria to access these techniques should hence be extended to include lesbian couples who wish to share genetic parenthood. Finally, we consider a potential objection to our argument: that the desire to have genetically related kin is not a morally sufficient reason to allow lesbian couples to access MRTs. (shrink)

Technological advances in genetic testing have enabled prospective parents to learn about their risk of passing a genetic condition to their future children. One option for those who want to ensure that their biological children do not inherit a genetic condition is to create embryos through in vitro fertilisation and use a technique called preimplantation genetic testing to screen embryos for genetic abnormalities before implantation. Unfortunately, due to its high cost, IVF-with-PGT is out of reach for the vast majority of (...) Americans. This article addresses an issue that has been underexplored in the medical ethics literature: the lack of insurance coverage for IVF-with-PGT.Within the US system, a key concept in insurance is that of medically necessary care, which broadly consists of diagnostic services and treatment services. In this article, I argue that IVF-with-PGT could be classified as either a diagnostic service or as a treatment service. To make this case, I show that IVF-with-PGT is similar to other types of services that are often covered by US insurance providers. In light of these similarities, I argue that the current system is inconsistent with respect to what is—and is not—covered by insurance. To promote consistency and fairness in coverage, like cases should be treated alike—starting with greater coverage for IVF-with-PGT. (shrink)

Mitochondrial replacement techniques (MRTs) usually aim to prevent the genetic transmission of maternally inherited mitochondrial diseases. Until now, only the UK and Australia have implemented specific legal regulations of MRTs. In both countries, clinical trials on these techniques are only permissible for cases with a high risk of severe mitochondrial disease in the offspring. However, these techniques can also be applied to treat infertility, especially for older women with impaired oocyte quality. In some countries without legal regulation of these techniques, (...) MRTs are already offered for this purpose. Yet, this application of MRTs has received insufficient attention in the bioethical literature so far.In this paper, I examine whether there are ethical reasons to prohibit trials on MRTs in the context of infertility when they are permitted for preventing mitochondrial disease. Allowing MRTs in one context but not the other might be justified either because their application in the context of mitochondrial disease (1) is supported by a more convincing evidence base, (2) has a higher potential benefit or (3) has a lower risk. I compare both applications of MRTs with respect to these three factors. I conclude that there is no convincing reason to prohibit clinical trials on MRTs for infertility when they are permitted in the context of mitochondrial disease. (shrink)

The distinction between germline and somatic gene editing is fundamental to the ethics of human gene editing. Multiple conferences of scientists, ethicists, and policymakers, and multiple professional bodies, have called for moratoria on germline gene editing, and editing of human germline cells is considered to be an ethical “red line” that either never should be crossed, or should only be crossed with great caution and care. However, as research on germline gene editing has progressed, it has become clear that not (...) all germline interventions are alike, and that these differences make a significant moral difference, when it comes to ethical questions about research, regulation, clinical application, and medical justification. In this paper, I argue that, rather than lumping all germline interventions together, we should distinguish between revising, correcting, and transferring genes, and I assess the consequences of this move for the ethics of gene editing. (shrink)

Since mitochondrial replacement techniques were developed and clinically introduced in the United Kingdom, there has been much discussion of whether these lead to children borne of three parents. In the UK, the regulation of MRT has dealt with this by stipulating that egg donors for the purposes of MRT are not genetic parents even though they contribute mitochondrial DNA to offspring. In this paper, I examine the way that the Human Fertilisation and Embryology Act in the UK manages the question (...) of parentage. I argue that the Act breaks the link typically made between genetic causation and genetic parenthood by redefining genetic causation solely in terms of nuclear genetics. Along with this, mtDNA is construed as a kind of supplement to the nuclear family. Drawing on the account of the supplement developed by Jacques Derrida, I argue that mtDNA and the women who donate it are seen as both essential to establishing the nuclear family but also exterior to and insignificant for it. (shrink)

Giulia Cavaliere and César Palacios-González argue that lesbian couples should have access to human nuclear genome transfer so that both members of the couple can have a genetic link to the child they intend to parent. Their argument is grounded in an appeal to reproductive freedom. In this Response, I address a number of concerns with their argument. These concerns relate to nomenclature, treating like cases alike, genetic-relatedness and the limits of reproductive rights. On this last point, I insist that (...) we should not mistake ‘wants’ for ‘needs’ or ‘rights’. I maintain that there is no right to biological parenthood, there is no compelling need for human nuclear genome transfer to satisfy a so-called need for genetically-related children, and we ought not to pander to an acquired desire for genetic filiation. (shrink)

Until recently, scientific consensus held firm that genetically manipulated embryos created through methods including Mitochondrial Replacement Therapy or human germline genome editing should not be used to initiate a pregnancy. In countries that have relevant laws pertaining to heritable human germline modifications, the vast majority prohibit or restrict this practice. In the last several years, scholars have observed a transformation of scientific and policy restrictions with insistent calls for creating a regulatory pathway. Multiple stakeholders highlight the role of social consensus (...) and public engagement for governance of heritable human germline modifications. However, in the drive to gain public acceptance and lift restrictions, some proponents provide distorted or misleading narratives designed to influence public perception and incrementally shift the consensus. This article describes eight discrete strategies that proponents employ to influence framing, sway public opinion, and revise policymaking of human germline modifications in a manner that undermines honest engagement. (shrink)

Tri-parent baby technology is an assisted reproductive treatment which aims to minimize or eliminate maternal inheritance of mutated mitochondrial DNA. The technology became popular following the move by the United Kingdom in granting license to a group of researchers from the Newcastle Fertility Centre, Newcastle University to conduct research on the symptoms of defective mtDNA. This technology differs from other assisted reproductive technology because it involves the use of gamete components retrieved from three different individuals. Indirectly, it affects the preservation (...) of lineage which is important from an Islamic point of view. This paper aims to analyze and discuss the implications of the tri-parent technology on preservation of lineage from the perspective of Maqasid al-Shari’ah based the Islamic bioethics. The analysis shows that there are a few violations of the preservation of lineage, hence the tri-parent baby technology should not be permitted. (shrink)

Der weltweit erste Mitochondrien-Transfer, auch als Erzeugung eines „Drei-Eltern-Kindes“ bezeichnet, hat 2016 eine intensive Debatte ausgelöst. Hinsichtlich des Verfahrens, das bisher nur in Großbritannien zugelassen ist, werden auch verschiedene ethische Aspekte angesprochen. Dazu gehören die Risikoabwägung, die reproduktive Selbstbestimmung und die psychosoziale Entwicklung eines Kindes, das von drei Individuen abstammt. Dabei fällt auf, dass zentrale konzeptuelle Fragen hinsichtlich des Mitochondrien-Transfers nicht geklärt sind. Ist der Mitochondrien-Transfer eine genetische Intervention in die Keimbahn? Handelt es sich bei dem Verfahren um eine medizinisch (...) indizierte Therapie oder um eine elektive Behandlung assistierter Reproduktion? Welche Konzepte von Identität und Elternschaft liegen der Auffassung eines „Drei-Eltern-Kindes“ zugrunde? Im Kontext dieser konzeptuellen Fragen muss eine ethische Analyse des Mitochondrien-Transfers durchgeführt werden. In den meisten Fällen zeigt sich allerdings, dass die ethische Analyse zu stark auf Einzelaspekte fokussiert ist, wodurch diese konzeptuellen Fragen aus dem Blick geraten. Daher verbinden wir in unserem Beitrag die ethische Analyse mit konzeptuellen Überlegungen. Dabei ist es von zentraler Bedeutung, auch die biomedizinischen Grundlagen des Verfahrens eingehend zu erörtern, um die konzeptuellen Aspekte angemessen einordnen zu können. In einem ersten Schritt erläutern wir die unterschiedlichen Verfahren des Mitochondrien-Transfers. In einem zweiten Schritt schlagen wir eine konzeptuelle Klärung der drei genannten Fragen vor. Diese konzeptuelle Klärung dient als Grundlage, um die ethischen Aspekte der reproduktiven Selbstbestimmung, Risikoabwägung sowie Elternschaft und Identitätskonzeption zu analysieren. In einem dritten Schritt fassen wir die Ergebnisse zusammen. (shrink)