Mitochondrial donation has been legalised in Australia with the passing of the Mitochondrial Donation Law Reform (Maeve's Law) Act 2022 (see BioNews 1139). In this commentary, we consider the road to legalisation in Australia, the key aspects of this legislation, and some remaining unanswered questions.
Australian advocates of mitochondrial donation have long campaigned for its legalisation. The Australian Government first began to look at this technology in 2018, with a Senate Committee inquiry. A series of expert working groups and public engagement activities followed (summarised here). While some have expressed frustration that legalisation has been too slow, others are concerned it is premature.
Legalisation took place within a complex pre-existing regulatory framework. Maeve's Law amends two Acts: the Prohibition of Human Cloning for Reproduction Act 2002 and the Research Involving Human Embryos Act 2002. These were originally introduced to regulate embryo research and human cloning. Until the passing of Maeve's Law, the creation of an embryo with genetic material from more than two individuals or with heritable genome alteration was prohibited, except under particular laboratory conditions. Further complexity exists because – due to questions over constitutional limitations for federal lawmaking – each Australian state has enacted mirroring legislation. However, where a state and federal Act are inconsistent, federal law prevails.
Maeve's Law is structured to allow mitochondrial donation through exemptions to the above prohibitions. It also facilitates a staged rollout of this technology, with controls in place regarding who will be able to offer and use it. The first phase will allow further evidence to be obtained regarding safety, feasibility and efficacy, including conducting a clinical trial.
Perhaps the most striking difference between the UK and Australian approaches to mitochondrial donation is that in Australia, mitochondrial donation will only initially be able to be offered under a single research protocol. A call for applications for up to AUD$15m in funding to run this trial has recently been released.
As in the UK, mitochondrial donation will be available only under appropriate licences, however, the licensing regime is also different. There will be three licences available initially: pre-clinical research and training, clinical trial research and training, and a clinical trial licence. Clinical trial licences can be used for the two main techniques of mitochondrial donation: pronuclear transfer and maternal spindle transfer. Use of certain other techniques in a pre-clinical research context would also be possible under a pre-clinical research licence, with additional emerging techniques able to be added.
Mitochondrial donation can only be used to minimise the risk that a woman's offspring will inherit mitochondria that would predispose them to mitochondrial disease. No licence is to be granted unless there is a 'particular risk' to the offspring, that there is a 'significant risk' that resulting mitochondrial disease would lead to serious illness or another serious medical condition, and that no other techniques (such as prenatal diagnosis) are able to be used. Counselling is also mandated.
The act also mandates having a protocol in place for ongoing monitoring. It's less clear how this will work in practice – 'seeking the ongoing engagement' of trial participants is required, both during pregnancy and after a child is born. But parameters for what to report, to whom and how, have yet to be determined and may be left up to the researchers themselves.
Transition from the initial trial/research stage to wider clinical practice will require only ministerial approval, based on expert advice. This will then be enacted through regulation (as in the UK) rather than amending legislation.
Oocyte donors will be able to check whether a child has been born from their donation. A specific national register will be kept. Because Australian states have been among the first globally to facilitate access to identifying information about donors, children born of mitochondrial donation in Australia will have similar rights to children born from other forms of reproductive donation.
While mitochondrial donation has been deemed to be acceptable in Australia, other aspects regarding its ethical implementation require further work. First, questions remain over equity of access, especially during the initial trial phase which will be undertaken by a single group. Given Australia's large geographic footprint, careful consideration will be needed to ensure that Australians seeking to access mitochondrial donation are not disadvantaged on the basis of location or resources. Additionally, access to genomic testing and clinical care, as well as fertility treatment remains uneven. Health professional knowledge of mitochondrial disease also remains low, which may prove a barrier to referral.
Second, the recruitment and management of oocyte donors is under-developed. While 'proper consent' is described in the Act, the legislation does not address other aspects, such as the number of oocytes needed being likely greater, and whether donor recruitment should be separate from 'standard' assisted reproduction.
An interesting aspect of the Australian Parliamentary debate was the place of sex selection in the offer of mitochondrial donation. In the initial Bill, prospective parents were to be offered the option of selecting male embryos to prevent inheritance of donated mitochondria by future offspring. This possibility was removed on amendment in the House of Representatives, to address concerns from an MP opposed to all forms of sex selection.
We agree with this removal of sex selection, albeit on different grounds. Leaving this complex and nuanced decision about a matter of significant ongoing uncertainty to parents seeking to use this technology risks burdening them with another responsibility. An offer of sex selection may carry with it an implication that the offer will be taken up.
The act is to be reviewed every seven years, with no endpoint stipulated – perhaps to address previous issues with the cloning acts, where only two reviews were specified. This will allow lawmakers to continue to monitor this and other emerging reproductive technologies and their regulation in Australia.