Toward ethical regulation of mitochondrial donation

To the Editor: In March 2021, the federal Parliament introduced a bill to legalise the use of the reproductive technology known as mitochondrial donation in Australia.1 Mitochondrial donation would be offered initially at a single trial clinic and, eventually, it would be made more widely available. The aim is to provide at‐risk women with the opportunity to have a genetically related child who is unlikely to develop maternally inherited mitochondrial disease. Legalising mitochondrial donation would have meaningful benefits for such women. However, as the bill currently stands, its implementation raises unresolved ethical and legal issues.

Access will predictably be mediated by geographic, financial, medical and informational considerations. These include the location of the initial trial clinic, any out‐of‐pocket costs to prospective parents, and health professionals’ awareness of mitochondrial donation. Existing barriers to genomic testing, genetic counselling, and assisted reproductive technologies will also affect access. These barriers, including long waiting times and limited Medicare coverage for some genetic services, should be minimised.

Mitochondrial donation requires donor oocytes. This raises questions about how oocytes will be procured and how many should be apportioned to mitochondrial donation relative to other procedures that may require fewer eggs to achieve a live birth. One crucial issue is whether oocyte donation for mitochondrial donation should require specific consent from donors.

One option is to use oocytes donated for assisted reproduction generally, without requiring consent for their use in mitochondrial donation specifically. The first study of mitochondrial donation to yield a live birth took this approach.2 However, we believe this strategy fails to acknowledge the legitimate reservations some donors may have about the use of their oocytes in this novel reproductive procedure. Securing specific informed consent would protect donors’ wellbeing and autonomy as well as protect public trust in medicine. At a minimum, specific consent should be required in the trial stage. This could also generate important data on the views of a critical group of stakeholders (the oocyte donors) and on what impact, if any, requiring specific consent would have on oocyte supply.

Mitochondrial donation also prompts a reconsideration of the ethics of sex selection. The Australian Government has signalled that it may provide parents with the option of implanting only male embryos.3 Since mitochondrial DNA is inherited through the maternal line, this would minimise any effects on the descendants of children born via this technique. However, this use of sex selection sits uneasily with Australia’s legal prohibition on, and moral reservations regarding, non‐medical sex selection. Both male and female embryos would receive identical mitochondrial DNA and face the same risks from the procedure; sex selection reduces risks only to that child’s descendants. There is also a concern that offering sex selection would lead parents to believe it is medically indicated, creating a sense of pressure to select male embryos. As sex selection raises serious concerns without promising clear benefits, we think there are problems with offering it in this context.

Legalising mitochondrial donation raises numerous ethical issues, including access, oocyte donor consent, and sex selection. While mitochondrial donation carries important potential benefits, these issues need careful attention to ensure that its implementation in Australia is ethically robust.