Wendy Askew (Tasmania, Liberal Party) Share this | Hansard source

[by video link] I'm pleased to add my contribution to this debate and acknowledge that there are many varied thoughts and opinions on this topic across the chamber. The Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021 proposes amendments to the Prohibition of Human Cloning for Reproduction Act 2002, the Research Involving Human Embryos Act 2002, the Research Involving Human Embryos Regulations 2017, the Freedom of Information Act 1982 and the Therapeutic Goods (Excluded Goods) Determination 2018.

As we have heard from previous contributions, the successful passage of this bill would make mitochondrial donation legal in Australia and allow permitted mitochondrial donation techniques under a specified mitochondrial donation licence for research and training purposes in clinical settings. This bill was introduced to the House of representatives on 24 March last year and was referred to the Senate Community Affairs Legislation Committee on the same day. As chair of this committee, I would like to begin by thanking all submitters and witnesses to the inquiry for their input, and I acknowledge that the bipartisan committee report made no recommendations, simply noting that we were aware that all parties would allow a conscience vote in the parliament.

Maeve's law has the ultimate goal of assisting women with mitochondrial disease to have a biological child who will not inherit their predisposition to this severe and life-threatening disease. It allows for further research and training into mitochondrial donation to build up Australia's evidence base, expertise and data on the safety and efficacy of donation techniques before allowing them to be introduced more broadly. The bill also proposes creating a mitochondrial donor register to store details about people born using mitochondrial donation, with those people able to find out the identity of their mitochondrial donor once they turn 18.

Mitochondria are small structures in human cells that produce 90 per cent of the energy the body needs to function. These structures contain DNA which can be passed on from a mother to her child through the mitochondria present in the mother's egg cells. Mitochondrial disease is a complex group of inherited conditions that can impact on health and life expectancy. In some cases, this disease can be fatal. The disease itself is caused by mutations in a person's mitochondrial DNA or nuclear DNA, impacting on the ability of their mitochondria to function properly. Common symptoms include developmental delays, seizures, weakness, fatigue, muscle pain, vision and hearing loss, organ failure, heart problems and, in severe cases, premature death. Around one in 200 Australians are estimated to be predisposed to mitochondrial disease, with around 56 children born each year with a severe form of the disease. There is no known cure for mitochondrial disease, and treatment options are limited for managing symptoms, although there is significant research and clinical practice being undertaken in trying to identify a cure or find potential treatments to alleviate the condition.

The bill aims to prevent some instances of the disease by legalising mitochondrial donation. The hope is that, when in used in conjunction with IVF, the process may allow women whose mitochondria would predispose their children to the disease to have a biological child that doesn't inherit the condition. Mitochondrial donation involves the transfer of nuclear genetic material extracted from a mother's egg to a donor egg that has had its own nuclear genetic material removed but retains its own mitochondria. This procedure was introduced in the United Kingdom in 2015 following extensive public consultation and several comprehensive scientific reviews of safety and efficacy. However, only one clinic in the UK is licensed to provide this treatment to eligible women and, at this stage, no formal data has been released on the outcomes of the treatment. It is our understanding that possibly up to 21 couples have attained a licence to receive the treatment and up to eight treatments have been approved, although the success or otherwise of these treatments has not yet been released publicly due to privacy reasons.

The 2018 Senate Community Affairs References Committee inquiry into mitochondrial donation and the resulting National Health and Medical Research Council community consultation during 2019 and 2020 identified some community support for legalising mitochondrial donation in Australia but also highlighted significant ethical issues. These issues included concerns that such donations would result in three-parent children or genetic modification. In February last year the Department of Health released a public discussion paper around introducing mitochondrial donation in Australia in two stages, with this bill designed to support this implementation. The first stage would allow lab based research and training, followed by a trial with some families at one Commonwealth funded clinic. This trial is intended to determine the safety, efficacy and feasibility of mitochondrial donation technology. If the trial is successful, the second stage of implementation will allow the treatment to be made available more broadly. At that point—which, according to the Department of Health, is not expected to occur for possibly 10 years—it is proposed that this progression be subject to a further decision by the Australian government through the issuing of a new regulation by the minister. Despite being disallowable by the parliament, this approach does concern me. Should legislation be passed to implement stage 1, I believe it is vital that the parliament undertake a full and comprehensive review of the trials before finalising the final stage of progressing to clinical practice through legislation at that time.

When I was first made aware of this legislation, my daughter was expecting my first grandchild. My initial thoughts were that, like IVF, this is yet another form of scientific development that will assist young people to have a healthy family. I wondered how I would feel if my daughter had been in the situation of those mothers who have the mitochondrial mutation and go into each pregnancy wondering if they'll pass it on to their newborn child. I could relate to their predicament, and, on first reflection, I thought it likely that I would support the bill. However, through the committee inquiry process, I have come to have a better understanding of what is before us. The proposed donation techniques, the limited amount of international research to date, the fact that no known successful births have eventuated after five years of research being under taken in the UK and the fact that, in some cases, embryos are created, harvested and disposed of as part of the research made me realise I could not support the bill as proposed. I was pleased to note that several government amendments were agreed in the House of Representatives that have increased the level of reporting and removed the ability of selection by parents as part of the research. I also understand that further amendments will be moved in the Senate in relation to the variation mitochondrial donation techniques included in the bill and the progression to clinical practice licences.

Various submitters and witnesses to the inquiry, as well as further consultation that I've undertaken since, have stressed that, in the case of a pronuclear transfer, the mitochondria transfer takes place at the zygote stage of a fertilised egg, shortly before it becomes an embryo. It results in two eggs being fertilised by the father's sperm and then the mitochondria from the donor's fertilised egg is transferred into the mother's fertilised egg, and the donor's egg or zygote is then discarded. I appreciate that there are various views on this. However, I believe that a zygote is the beginning of a new life. It already contains all 46 chromosomes that will exist throughout its development to an embryo and on to the birth of a baby and on to adulthood—if given the chance to do so. I do not support the post-fertilisation techniques included in the bill. The maternal spindle transfer method of mitochondrial donation is, to me, the only ethical technique proposed—involving the transfer of the donor's egg's mitochondria into the mother's egg prior to fertilisation and the development of the zygote.

Another area of concern relates to the impact of genetic manipulation on future generations. As stated by the member for Tangney in his second reading speech:

This bill reverses the longstanding prohibition on heritable human genetic manipulation. Mitochondrial donation allows changes to the heritable genetic information of a child and will affect that child, their children, their grandchildren, their great-grandchildren and the many generations to come. That's why it's important to make sure that the provisions of this bill are considered with the utmost care and diligence.

The member for Menzies also touched on this in his second reading speech:

Some proponents suggest that the procedures are simply extensions of existing practices, such as organ transplantation and assisted reproductive technologies. I contend that this is not so. In organ transplantation, DNA is not passed onto future generations. In current reproductive technologies, neither human eggs nor human embryos are modified in the radical ways proposed in this bill.

In that contribution, Mr Andrews went on to highlight that:

The US Food and Drug Administration has taken the view that all forms of mitochondrial donation, whether using male or female embryos, constitute germline editing and has maintained its prohibition on clinical trials for this reason.

We need to take note of that decision and perhaps question why there is only one country globally that has granted licences for these mitochondrial donation techniques. Why is it that, to date, after five years of trials, there remains no evidence of a successful birth through mitochondrial donation?

Twenty years ago the Office of the Gene Technology Regulator was established to provide oversight of any proposed gene modification techniques, yet this bill specifically excludes that office from having oversight of the proposed techniques. To me this makes no sense, and I believe we should ensure that the Office of the Gene Technology Regulator, together with its Gene Technology Technical Advisory Committee, does have the opportunity to review all aspects of the proposed mitochondrial donation techniques, in the same manner that it does for all other medical genetics proposals.

This is a complex and sensitive issue, and I appreciate that there are real lives impacted by the decisions made in this place. My heart goes out to each person impacted by this disease, and I fully understand the desire and intent behind this legislation. Our responsibility is not just to the current generation but also to future generations, and we need to be assured that the final legislation, which I suspect is likely to pass despite the concerns that I've raised, offers the best protection for those to come. I therefore urge all senators to consider each amendment closely, to ensure that every possible safeguard is in place going forward.