Cesar Palacios-Gonzales, "Regulation and Ethics of MRTs"
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A 2015 Congressional amendment precludes Mitochondrial Replacement Therapy (MRT), a life-saving IVF-based procedure that could prevent a plethora of mitochondrial DNA diseases in the U.S. Individuals do not, at present, have access to this technology to prevent the devastating consequences of mitochondrial DNA disease. At the same time, MRT continues to move forward in other countries, such as the UK. Has the time come to revisit the federal prohibition of this preventive therapy and research? Expert panelists discussed the future of MRT policy in the U.S., reviewing the latest technological developments, the regulatory barriers, and the ethical challenges affecting the clinical application of MRT. This event was free and open to the public.
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Cesar Palacios-Gonzales, "Regulation and Ethics of MRTs"
- 1. Regulation and Ethics of MRTs César Palacios-González 17-04-2019
- 2. MRTs Map
- 4. Three regulatory scenarios 1) Countries with specific regulations allowing MRTs. 2) Countries where MRTs are prohibited since: they are not included in the list of approved fertility techniques, or they are explicitly forbidden. 3) Countries with no specific legislation regarding MRTs: some of them, or some version of them, are prohibited.
- 5. UK • In order to lawfully perform an MRT in the UK: 1) A clinic requires that its licence be amended. 2) The individual in question requires approval by the HFEA’s statutory approvals committee.
- 6. UK (a) MRTs will only be allowed when: (i) there is a particular risk that any egg extracted from the ovaries of a woman named in the determination may have mitochondrial abnormalities caused by mitochondrial DNA; and (ii) there is a significant risk that a person with those abnormalities will have or develop serious mitochondrial disease.
- 7. Law 14/2006, 26 May, regarding human assisted reproductive techniques. Approved assisted reproductive techniques: 1. Artificial insemination 2. IVF and ICSI with own or donated gametes 3. Gamete Intrafallopian Transfer Spain
- 8. • Consolidated Appropriation Act of 2016 SEC. 736. None of the funds made available by this Act may be used to notify a sponsor or otherwise acknowledge receipt of a submission for an exemption for investigational use of a drug or biological product (…) in research in which a human embryo is intentionally created or modified to include a heritable genetic modification (…) US
- 9. • Regulations of the General Health Law on Health Research Art 56. Research on assisted fertilization will only be admissible when it is applied to solve sterility problems that cannot be solved otherwise (…) Mexico
- 10. Mexico States where PNT is prohibited because human life is protected from the moment of fertilization. State where PNT is prohibited if the would-be-enucleated embryo is first created for a non-reproductive purpose.
- 11. The Ethics of MRTs 1. Reproductive Freedom
- 12. The Ethics of MRTs 1. Terminology objections 2. Slippery slope objections 3. Harm objections • To egg providers • To future generations • To future children 4. Consent of the future child
- 13. Ethics 5. Destruction of human embryos objection 6. Alternatives objection 7. Resource allocation objection
Editor's Notes
- First of all, I want to thank Glenn and Eli for the invitation to speak here today, and I also want to thank them and Alex for organizing this wonderful event. Today I will talk about the regulation and ethics of MRTs.
- Before I start talking about the legal standing of MRTs in different countries I’m going to show you two maps. In blue you can see the only country, the UK, which has specific regulations allowing MRTs [these are The Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015]. And here MRTs should be understood as pronuclear transfer and maternal spindle transfer. The US, here in green, was the first country where an MRT, in this case MST, was first successfully carried out to prevent a mitochondrial DNA disease. The birth of this baby was announced in 2016 and this was news all around the world. In Ukraine, here in orange, PNT was first successfully carried out for treating infertility, and a live birth was announced in 2017 also making international headlines. It is relevant to mention that an unsuccessful PNT attempt for treating infertility was carried out in China and this was reported in 2003. In Greece, here in purple, MST was carried out for treating infertility, ending in a live birth that was made public just last Thursday. And finally in red, Australia and Singapore, countries actively discussing whether to enact laws allowing MRTs.
- We can add more detail to the previous map if we pay attention to three international collaborations surrounding MRTs. The first one is a US – Mexico collaboration, which seems to be no longer active. The result of this collaboration was the first live birth after an MST. Here the MRT procedure, and IVF, took place in the US, and the embryo transfer took place in Mexico. [This collaboration was lead by Dr. John Zhang and Dr. Alejandro Chavez-Badiola] The second collaboration is a US – Ukraine collaboration. This collaboration is active and according to figures published by them there have been six live births following MRTs. In this case Dr. Zukin, who lead the first successful PNT procedure for treating infertility joined forces with Dr. Zhang who lead the first successful MSt procedure for avoiding a mtDNA disease. The third collaboration is a Spain –Greece one. Here Spanish based scientists, lead by Dr. Nuno Costa-Borges and Dr. Gloria Calderón, worked with Greek colleagues, lead by Panagiotis Psathas, to carry out MST for treating infertility. [This specific collaboration is different from the previous ones in that here a clinical trial is being run]
- Now, in general we can say that there are three regulatory scenarios. There are countries with specific regulations allowing MRTs, the UK. There are countries where MRTs are prohibited since they are explicitly forbidden, or they are not included in the list of approved fertility techniques, for example Spain. There are countries with no specific regulations regarding MRTs: here some of them, or some versions of them, are prohibited due to other regulations that accidentally apply to them, for example Mexico.
- After a long process, MRTs were approved in the UK. This process included four scientific reports, multiple public consultations, contributions from patient groups, parliamentary debates both in the House of Commons and the House of Lords, and a report by the Nuffield Council on Bioethics which even when it is not a governmental organization it is very influential in the UK. In order to lawfully perform an MRT in the UK: a clinic requires that its licence be amended in order for MRTs to be carried out there the individual in question requires approval by the HFEA’s statutory approvals committee. As you can see this is a two step process.
- In the UK MRTs can only be carried out for preventing the transmission of a mtDNA disease and not for treating infertility. In the Regulations it is asserted that MRTs will only be allowed when a woman’s eggs may have mitochondrial abnormalities caused by mitochondrial DNA , and there is significant risk that a person with those abnormalities will have or develop serious mitochondrial disease.
- Spain is a case where MRTs are prohibited since they are not included in the list of approved assisted reproductive techniques. In Spain only Artificial insemination, IVF and ICSI with own or donated gametes, and Gamete Intrafallopian Transfer are permitted.
- The US falls within the third regulatory category. It does not have specific regulations regarding MRTs, but some MRTs are forbidden due to a federal statute that precludes the FDA from considering research applications for carrying them out. In theory, due to the wording of the Act, the FDA should consider research applications of MRTs when carried out in conjunction with sperm sorting for only creating males. This should be the so since in those cases the third party mitochondria would not be passed down to further generations. That is in theory, but in practice the FDA has taken the Act to mean that they cannot consider MRT research applications.
- Finally, Mexico also falls within the third regulatory category. It does not have specific regulations regarding MRTs. But at the federal level, due to the Regulations of the General Health Law on Health Research , MRTs can only be employed to solve sterility problems that cannot be solved otherwise.
- And at the state level, PNT is prohibited in nine states since human life is legally protected from the moment of fertilization. And in Mexico City, PNT is prohibited if the would-be-enucleated embryo is first created for a non-reproductive purpose. Let me finish by saying that a recent report by the Australian Senate has recommended that public consultation be undertaken regarding the introduction of MRTs to Australian clinical practice.
- The strongest argument in favour of MRTs is the reproductive freedom argument. Those who have advocated for the legalisation of MRTs in UK have frequently appealed to the importance of allowing couples at risk of transmitting an mtDNA disease, the freedom to choose to procreate according to their preferred life plan. Different authors have provided (slightly) different accounts of why reproductive freedom ought to be treated as a fundamental moral good, but at the core of all these accounts are two moral bases for its defence: the centrality of reproduction for the development of personal life plans (the autonomy argument for reproductive freedom) and the centrality of reproduction for the well-being of individuals (the welfarist argument for reproductive freedom).
- Let us move now to objections to MRTs. When we discuss objections against MRTs we need to be very careful about what is actually been discussed. We could be discussing the ethics of research on MRTs, the ethics of MRTs proper, the ethics of offering MRTs to couples or individuals. Paying attention to these distinctions is relevant in order to assess the purchase and strength of the objections being made against such techniques. Next I will mention very briefly some of the objections that have been raised against MRTs in the academic literature, and it is really important to notice that all of them fail. First, the terminology objection argues that by using the term Mitochondrial donation or Mitochondrial replacement techniques or Mitochondrial replacement therapy we are trying to sway the public into accepting the techniques while obscuring the fact that what is actually being transferred is the nuclear DNA. Second, The slippery slope objection argues that accepting MRTs will lead us to accept nuclear gene editing technologies, and thus that we should reject MRTs. In third place, there are three different harm objections, one regarding egg donors, another regarding future generations, and a last regarding the child created. There is a fourth objection that maintains that since we can not obtain consent from the child that would be created then we should not move ahead with the procedure
- The destruction of human embryos objection, in one version holds that the moral status of the human embryo is equal to that of a species-typical human adult and thus we should both oppose MST and PNT research, and the clinical practice of PNT. The alternatives objection holds that since couples or women can resort to adoption or egg donation then they should not opt for MRTs And finally the resource allocation objection maintains that we should not dedicate scarce resources to the development of technologies that would just help couples, or women, have children that are genetically related to them.