On 24 March 2021, the Government introduced the Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 (the Bill).
Mitochondrial donation is an assisted reproductive technology that, when combined with in-vitro fertilisation, has the potential to allow women whose mitochondria would predispose their potential children to mitochondrial disease, to have a biological child who does not inherit that predisposition.
The Bill provides for the legalisation and introduction of mitochondrial donation techniques for use in Australia under a national regulatory framework. Under the Bill, mitochondrial donation will be introduced in a staged and closely monitored way. In the first stage, mitochondrial donation will be legalised for certain research and training purposes, including for the purpose of undertaking a clinical trial of the use of mitochondrial donation techniques as part of human assisted reproductive technology. Once the clinical trial has demonstrated success over a number of years and the results have been evaluated by experts, there will be an option to move to the second stage, which would allow for accredited assisted reproduction technology centres across Australia to offer mitochondrial donation in clinical practice, as part of assisted reproductive therapy.
The Department of Health (the Department) prepared and certified a Regulation Impact Statement (RIS), which the Office of Best Practice Regulation (OBPR) assessed as adequate and therefore sufficient to inform a decision. However, the OBPR’s assessment was that, to be consistent with good practice, the RIS would have required further analysis to articulate both the costs and benefits of each option, including the status quo, for businesses, individuals and the community.
The Department estimated the average annual regulatory cost to be $188,857.