Mitochondrial donation is an assisted reproductive technology (ART) that might help prevent certain rare mitochondrial diseases. The Parliament recently passed a Bill to allow the introduction of this ART technique in Australia, through a staged approach and under strict regulatory conditions, to prevent transmission of severe mitochondrial disease.
The Act has received Royal Ascent from the Governor General and will come into effect on 2 October 2022, unless proclaimed at an earlier date. The Act amends the Research Involving Human Embryos Act 2002 (the RIHE Act) and the Prohibition of Human Cloning for Reproduction Act 2002 (PHCR Act). NHMRC’s Embryo Research Licensing Committee (ERLC) will be the responsible authority for the new licensing scheme.
- Implementation of the mitochondrial donation licensing scheme
- Australian Government Department of Health Consultation
- NHMRC CEO Statement on Mitochondrial Donation
- Expert Scientific Statement
- NHMRC Community Consultation
- Senate Inquiry and Government Response
The use of mitochondrial donation in Australia will be regulated by a licensing scheme. In the initial stage of implementation ERLC will be responsible for administering three new licences:
- mitochondrial donation pre-clinical research and training licences
- mitochondrial donation clinical trial research and training licences
- mitochondrial donation clinical trial licences.
All three licences are able to permit the use of pronuclear transfer (PNT) and maternal spindle transfer (MST) mitochondrial techniques while three other mitochondrial donation techniques would be permitted under a mitochondrial donation pre-clinical research and training licence.
NHMRC is supporting ERLC in its preparations for the new licensing scheme through managing the drafting of:
- licence application and reporting forms
- application forms for the creation of embryos and placement of created embryos in the bodies of women
- draft licence conditions.
Please note, once ERLC has finalised the licence application forms a link will be provided through this webpage. An announcement will also be included in Tracker, you can sign up to receive Tracker by email.
The Australian Government Department of Health undertook a consultation process between February and March 2021 to provide an opportunity for members of the public, interested stakeholders, peak bodies and experts to consider the proposed staged approach to legalising mitochondrial donation in Australia, and to participate in the consultation process. Further information about mitochondrial donation and the consultation summary report is available on the Department of Health website.
NHMRC expert advice and consultation
The NHMRC CEO statement on mitochondrial donation (5 June 2020) announced the outcomes of NHMRC’s work on mitochondrial donation, undertaking in 2019 and 2020. It includes the release of the Expert Statement and Consultation Report.
The Mitochondrial Donation Expert Working Committee was established in 2019 to advise the NHMRC CEO on the three scientific questions about mitochondrial donation arising from the Senate Inquiry. The Mitochondrial Donation Expert Working Committee Statement to the NHMRC CEO on the science of mitochondrial donation, March 2020 (Expert Statement) provides the Committee’s advice on the science of mitochondrial donation and was formulated through a series of meetings, workshops, and out-of-session advice.
The Expert Statement makes it clear that there is a diversity of views among experts working in the field about whether the current risks and scientific unknowns are such that it would be appropriate at this time to consider mitochondrial donation for introduction into Australian clinical practice.
NHMRC sought the community’s views on the ethical and social considerations of the possible introduction of mitochondrial donation into Australian clinical practice through a range of consultation activities undertaken in 2019. The Report on NHMRC’s public consultation on the social and ethical issues raised by mitochondrial donation (Consultation Report) describes the multi-modal approach to the consultation, demonstrates how the consultation successfully informed and engaged with a broad range of community members, and presents an analysis of the views of the Australian community on mitochondrial donation.
The Consultation Report describes the resources that were developed to support the consultation and the successful use of media activities to encourage engagement from the general community. NHMRC developed the Mitochondrial Donation Issues Paper and a Mitochondrial Donation Public Consultation Video to provide clear and concise information on this complex matter to support the community consultation process.
The major themes that emerged from the consultation were the rights and wellbeing of children, factors relating to egg donation and the donor and implementation considerations. The Consultation Report shows that there are social and ethical issues that must be taken into account in considering mitochondrial donation, and that there is a range of opinions in the community, with a number of respondents being opposed to its introduction while others are supportive.
Citizens’ panel – a Citizens’ panel process was also used to capture the views and attitudes of the general community about the social and ethical issues of mitochondrial donation. The panel comprised ordinary citizens who engaged with mitochondrial donation experts and stakeholders to learn more about the scientific, ethical and social issues associated with mitochondrial donation, and developed a position statement. The Mitochondrial Donation Community Consultation Citizens’ Panel Position Statement has been provided to NHMRC and included in the feedback delivered to the Australian Government in NHMRC’s Consultation Report.
NHMRC hosted two webinars during the public consultation period. You can view both webinars below.
The following NHMRC webinar was held on Tuesday 19 November:
The following NHMRC webinar on mitochondrial donation was on Wednesday 30 October 2019:
Watch NHMRC and experts give an overview of mitochondrial disease and mitochondrial donation.
The Senate Community Affairs References Committee conducted an Inquiry into the Science of Mitochondrial Donation and Related Matters. The Inquiry examined the impact of mitochondrial disease on Australian families and the healthcare sector, the safety and efficacy of existing donation techniques, and ethical considerations.
The Inquiry Report, which was handed down on 27 June 2018, made four recommendations (summarised):
- Undertake public consultation on the possible introduction of mitochondrial donation into Australian clinical practice
- Obtain expert advice through NHMRC about key scientific questions relating to mitochondrial donation
- Engage with state and territory governments on the findings of the Inquiry, and
- Seek access for Australian patients to mitochondrial donation procedures in the United Kingdom.
The Australian Government response to the Inquiry Report was tabled on 20 February 2019. The Government asked NHMRC to deliver on the first two recommendations.