Tuesday, 30 November 2021
Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021; Second Reading
The Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021 amends the Prohibition of Human Cloning for Reproduction Act 2002 and the Research Involving Human Embryos Act 2002 in order to make mitochondrial donation legal in Australia. The purpose of the bill is to allow women to have a biological child in a way that minimises the risk of transmission of the effects of mitochondrial disease. As many members have pointed out, it's a disease for which there is no cure, regrettably, and it leaves children suffering from seizures, from fatigue, from multiple organ failure, from heart problems and, in severe cases, from death. Here in Australia it's estimated that around 56 children are born with a severe form of this disease each year.
Many members have spoken of their hope that these novel techniques will alleviate this disease. Our emotional reactions are valid. To wish to relieve suffering is a very human reaction and a very human desire. However, for me there are other considerations that need to be weighed in this discussion, and in coming to a decision in what is a conscience vote, or free vote, in this place. This debate has been conducted with civility and decorum. In coming to my decision I recognise and respect that there are a range of views, each informed by a desire to respond in the best possible way to the circumstances. It's in that spirit that I offer my contribution this evening.
I believe we need to understand what this bill will do. First, the bill legalises, under specific conditions, practices which less than 20 years ago were prohibited by this same parliament as unacceptable and attracted custodial penalties. These include creating, for the purpose of reproduction, a human embryo that (a) contains genetic material of more than two people and (b) contains heritable changes to the genome. That in itself is not an argument for change; I'm simply pointing out that something that this parliament regarded as unacceptable not that long ago is now being proposed to be changed.
Secondly, there is no evidence to date that these practices will either cure or effectively treat mitochondrial disease. There is currently much research and clinical practice devoted to looking for a cure or for a treatment for ways of alleviating the condition. Genetic technologies—in particular, gene editing—hold out hope in the future for a genuine cure.
Thirdly, the practices foreshadowed in this bill are unlike any existing form of health care or artificial reproduction. 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.
Fourthly, mitochondrial donation is yet to be proven safe and efficacious in human research. 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. The contribution of DNA, whether mitochondrial or nuclear, to the genetic make-up of a child is yet to be understood. Mitochondrial DNA, even in small amounts, may contribute to personal characteristics in a child in ways that are not yet recognised. It is not yet known whether DNA from the nucleus or the mitochondria will in fact be compatible. Nor is it known whether, given that up to three per cent of the mother's mitochondria is likely to be passed on, the disease will not rebound in future generations.
Much reference has been made to the UK, where this research has been underway for some five to six years. There's one clinic there which is authorised. We are told that 21 couples have received treatment, but there is no data about the effectiveness of that treatment, even in a de-identified way, that's available to us. The member for Makin, in his contribution tonight, referred to a paper written by a number of the scientists involved in those trials in the UK, and even those scientists who are proponents of this technique still say that this is simply something that still has potential and that safety and efficacy is yet to be proven. There have been reports of possible use in Mexico and Ukraine, but there are no verifiable, respected reports in the medical or scientific literature. And, as I said, the techniques remain banned in other areas.
So I have a number of concerns or reservations. The first relates to the mitochondrial donation techniques. The bill prescribes five techniques, and these are set out in a diagrammatic form on page 67 of the explanatory memorandum. Two techniques involve the transfer of material between eggs—that is, the maternal spindle transfer and the germinal vesicle transfer. Three other techniques involve the transfer of material between zygotes or embryos—namely, pronuclear transfer, first polar body transfer and second polar body transfer. These three techniques necessarily involve the destruction of the zygote or the embryo. I note in passing that, under the bill, only two techniques—namely, maternal spindle transfer and pronuclear transfer—are permitted for the clinical trial licence phase. Of these two techniques which are permitted if the bill passes in the forthcoming future, pronuclear transfer involves the destruction of the zygote or the embryo.
Accordingly, my concern is about the destruction of the zygote or the embryo, one of the lines of techniques which would be permitted by this bill. Accordingly, I foreshadow that I will move amendments at the detailed stage to remove from the bill the techniques that involve the destruction of a zygote or an embryo. This would allow the research to continue using gametes. Given the experimental nature of what is being proposed, the absence of any data from the UK and the lack of any evidence that these techniques will achieve what is being proposed, it is entirely reasonable, I submit, to ban the deliberate destruction of the zygote or the embryo at this time. Moreover, we are told that the early stages of research could take a decade. If so, there is a case for the less destructive techniques to be explored first.
My second reservation relates to the provision for the availability of sex selection under this bill. Under proposed section 28Q, after attending pretreatment counselling, a patient and her spouse, if any, can request to have only male embryos selected for implantation where it is deemed safe and practical to do so. This is notionally because it is said that there is less chance of transferring defective mitochondria to a male baby—an admission, I note in passing, that in itself is about the experimental, uncertain nature of these techniques. I note that the UK legislation does not appear to allow sex selection. Accordingly, I propose in the amendments being circulated to remove that provision from the bill.
My third area of concern relates to reporting requirements. I believe that in something as significant as this—undertaking research which has not been undertaken in this country before and has possibly only been undertaken in the UK—there should be some annual reporting to the parliament about the research which is undertaken. I don't believe that a review after seven years is sufficient to inform either the parliament or the people of Australia as to what's occurring in relation to this research, if it occurs.
My fourth area of concern relates to a technique being proven before it's used in general clinical practice. These matters are contained in the amendments which have been or will be circulated.
However, I understand from discussions that I've had today that two of these areas of concern will be addressed in government amendments—namely, the concerns about sex selection and the concerns about the reporting. If that is the case, when we reach the consideration in detail stage of the debate on this bill, obviously I won't proceed with my amendments in relation to these issues. However, I foreshadow that I will move to put the amendments in relation to the other matters. If these matters are not addressed tomorrow by the amendments which the government is proposing, obviously I will put to the House all four sets of amendments in relation to this matter.
Like other speakers, I have given much consideration to these matters. Indeed, it's not the first time that I have considered some of these matters. I was here, as some members were, almost 20 years ago, when this whole area of cloning and stem cell research was considered by the parliament. Indeed, I chaired the committee that looked into it prior to the legislation being passed. My position is consistent with that which I held at that stage. It's one that, if these amendments were passed, would actually allow the research to continue, but without the destruction to embryos or zygotes and in a way which would not permit, for the first time in this country, sex selection to occur. I commend the amendments to the House.
House adjourned at 21:08