ANZSREI supports the introduction of legislative change and implementation of mitochondrial donation for the reduction of transmission of mitochondrial disease.
ANZSREI acknowledges that the long term safety of mitochondrial donation is uncertain and families wishing to access this treatment need to demonstrate understanding of this uncertainty.
Animal studies of mitochondrial donation are limited but encouraging.
Mitochondrial donation is the preferred term rather than ‘three person IVF’.
Currently women with mitochondrial disease have limited reproductive options but these include the use of donated oocytes or travel to overseas centers which offer mitochondrial donation, which is often expensive and performed in an unregulated setting. Alternatively, it is possible to undertake preimplantation genetic testing of embryos and prenatal testing of the early fetus created from affected oocytes. However, these techniques have variable success in reducing mitochondrial disease transmission risk and many families do not wish to consider termination of an affected pregnancy.
Mitochondrial donation is a new technology with potential transgenerational effects that was approved for clinical use in 2015 in the United Kingdom. ANZSREI considers that the regulatory framework existing within Australia supports introduction of this new technology in an ethical, adaptive and socially responsible way.
Two technologies have been proposed. Use of pronuclear transfer will require special consideration as an embryo will be created which is intended for destruction. Whilst this requires legislative change it may also create ethical and personal issues for society and staff working within ART units. Spindle cell transfer, requiring a high level of expertise, does not have this ethical concern. In any event, respect for conscientious objection of all team members should be upheld.
Sensitive and confidential follow up of the families undertaking mitochondrial donation technology will be required and should be part of the consenting process. Parents of children conceived following mitochondrial donation will need to commit to regular reporting until the children are eighteen, after which the child may consent, or decline, to continue follow-up. Respect for the children conceived by this technology should be maintained and in particular, the identity of the children should be protected if requested by the family.
Whilst known donation of oocytes is increasingly preferred by clinics and should still be encouraged by clinics offering mitochondrial donation, respectful acknowledgement of the wishes of the oocyte donor/s and recipient families should be covered carefully by counsellors as part of the preparation for use of mitochondrial donation. Adequate cooling off time should be a part of this process. Traceability of the oocyte donors should be maintained and if requested, the identity of the oocyte donor should be able to be made available to the children at or after the age of eighteen years. These are standard practices currently operating for third party reproduction in Australian clinics.
ANZSREI supports mandatory open, de-identified disclosure of the activity and results of the approved clinic/s on at least an annual basis.
Introduction of this technique should be limited by expertise within experienced units. Multi-center and collaborative use of this technology as determined by expertise within the unit is desirable because of proximity in care and to maintain family privacy as required. This expertise should include a multi-disciplinary team with expertise in genetics and mitochondrial disease to establish which families are at high risk of phenotypic abnormalities and therefore candidates for this new technology which has uncertain long-term outcomes.
Funding of patients accessing mitochondrial donation should be at the same or greater level, as currently available for other couples in Australia with infertility.
As the technology of mitochondrial donation advances, the application of different techniques and expanded indications for use of mitochondrial donation may become evident. Therefore, some flexibility regarding the methods and indications for mitochondrial transfer within the existing framework should be enabled and is supported by ANZSREI.
Prepared by ANZSREI Executive and approved by ANZSREI
10 March 2021