The Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 (the Bill) was passed by the Senate on 30 March 2022 and amends:
- the Prohibition of Human Cloning for Reproduction Act 2002 (Cth);
- the Research Involving Human Embryos Act 2002 (Cth);
- the Research Involving Human Embryos Regulations 2017;
- the Therapeutic Goods (Excluded Goods) Determination 2018; and
- the Freedom of Information Act 1982 (Cth).
Objectives of the Bill
The Bill legalises mitochondrial donation for research, training and human reproductive purposes through a staged approach and subject to strict regulatory conditions. These reforms are aimed at preventing the transmission of severe mitochondrial disease, which is a group of conditions that can cause serious health issues and, in severe cases, death in childhood, and for which there is no known cure.
Mitochondrial donation is an assisted reproductive technology (ART) that involves replacing the mother’s mitochondrial DNA with healthy mitochondrial DNA from a donor’s egg. This treatment enables women to avoid passing mitochondrial DNA disease to their biological child.
Key features of the Bill
As mitochondrial donation was illegal under the previous legislative framework, the Bill introduces reforms to legalise, subject to a strict licencing scheme, the creation of a human embryo that:
- contains the genetic material of more than two people; and
- contains heritable changes to the genome;
for the purposes of reproduction.
Accordingly, the Bill introduces five types of mitochondrial donation licences:
- a pre-clinical research and training licence;
- a clinical trial research and training licence;
- a clinical trial licence;
- a clinical practice research and training licence; and
- a clinical practice licence.
The licences will be administered and regulated by the Embryo Research Licensing Committee of the National Health and Medical Research Council (NHMRC), with dedicated provisions for the close screening and oversight of applicants and licence holders by the NHMRC.
The Bill further sets out provisions detailing the scope of authorisation for each of licence, with strict conditions relating to licence applications, conditions and administrative requirements. In addition, licence holders would be subject to additional and ongoing requirements.
Staged approach
Given mitochondrial donation is a new medical technology, the Bill adopts a two-stage implementation approach:
- Under Stage 1, only the first three of the five licences will be available. These licences would authorise pre-clinical and clinical trial research and training as well as clinical trial activities.
- Following a review of Stage 1, and further legislative amendments in relation to the two clinical practice licences, mitochondrial donation could be made available in the clinical practice setting under Stage 2.
This staged approach is intended to allow for the expansion of scientific evidence to ensure the safety and effectiveness of techniques and their ethical application before licences permitting mitochondrial donation in clinical practice are made available.
The Bill will commence on 2 October 2022, unless proclaimed at an earlier date.
To read the Bill, click here.
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