Tuesday, 30 November 2021
Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021; Second Reading
I begin my remarks on the Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021 by quoting the Australian government Department of Health website on mitochondrial donation. The very first line says:
Mitochondrial donation is an IVF-based assisted reproductive technology. It has the potential—
and I stress the word 'potential'—
to prevent mitochondrial disease in babies born to mothers who may otherwise pass on the disease.
This legislation, as other speakers have already pointed out, enables a staged process for mitochondrial donation. The process does not provide a cure for those children already born with the disease, nor does it prevent future children from being born with the disease. The two-stage process, however, does follow a similar process commenced in the UK in 2015. The two-stage process will firstly allow the selection and licensing of a clinical trial that could run over a 10-year period, whereby mitochondrial donation will be provided to selected families—again, I stress the words 'selected families'. The very selection process itself is a matter that could be argued about as well. If successful, the procedure would then be made available more broadly across Australia. It would be made more broadly across Australia if it were embraced and adopted by each of the state and territory governments, and we've got no certainty about that either.
The legislation has been the subject of extensive community consultation and review by the Senate Community Affairs Legislation Committee. I note that in that review the committee did not form a recommendation; they simply presented their evidence from the inquiry. I have to say I thought it was very good evidence from all parties that made a submission in respect to this very matter.
The legislation also invokes several human rights including the right to health, the right to life, the obligation to consider the best interest of the child, the right to privacy and the right to freedom of opinion and expression. Again, we could debate each and every one of those matters with respect to this bill, but I don't wish to do that; I simply raise the point that there are several other matters that are associated with this proposal. I don't believe that anyone in this parliament wants to see children or their parents suffer in any way. I think that that's been very clear from each of the contributions that I have listened to in the course of this debate—and, I might say, I've listened to just about everyone's contribution to this bill.
Preventing suffering is the objective of this legislation. The illness that mitochondrial donation hopes to prevent is complex, and the procedure proposed is untested and controversial. I believe the UK trials are the only documented trials in the world. There may be others taking place that we don't know about, and I suspect that that may well be the case, but, in terms of what we do know about, the UK trials, which were legislated in 2015, some six years ago, are the only ones that we have to rely on. My understanding is that they commenced at Newcastle University in 2018. To date, we have had no information about the success or otherwise of those trials. So it makes you wonder: 'Why is that? Why has no information come out of that research over the last three-year period?' Indeed, I'm not even aware of whether there have been any successful births as a result of the trials that have taken place there.
A paper prepared by three academics from Newcastle University and published in Science and Society in August 2020 concludes that mitochondrial transfer is a potential cure—again, I stress the words 'potential cure'—for many diseases but proof of efficacy and safety is still lacking. I want to quote only a section of that paper because I think it's very relevant to this issue. The paper is headed Mitochondrial transplantationa possible therapeutic for mitochondrial dysfunction? It goes on to say:
The inference, stretching back to experiments in the 1980s, suggests that it may be possible—at least for careful injection of freshly isolated mitochondria … but the efficiency of this process is extremely poor, and without a strong selection for the injected mtDNA and time to facilitate the selection, the overall effect on cell function will be minimal. Irrespective, mitochondria, particularly those that have lost their membrane potential, are constantly turned over in the cell inferring that if transplanted mitochondria had any benefit, this may be just relatively short-lived.
Considering all these caveats, it is difficult to see how transplantation could lead to long-term benefits directly from the transplanted mitochondria.
The authors of that paper are not opposed to the trials. I make it clear that their comments are in no way implying that they oppose what is happening at Newcastle University. It begs the question: given that we've got the trials in the UK and given that only people who are at very high risk of passing a serious mitochondrial disease to their children are eligible for the treatment in the UK, why is it that we have no information, and why is it that there is such a restriction? Why is it that only people who have a very high risk of passing on a serious mitochondrial disease are eligible for the trial? It tells me clearly that there are very genuine concerns about even the trials in Newcastle. I have no doubt that they are trying to manage their process as well as they can.
With those comments, I am left with these questions. Firstly, why is it that no information has been released about the UK trials? I would have thought that if the trials had been operating successfully they would want that information to be released. However, there might be a good reason for that. Secondly, why is that no other country has legitimised this procedure? I have no doubt that there are researchers right around the world who would be aware of this procedure, yet no other country seems to be following that path. Why is that? I have not heard anyone making a contribution to this debate explain why that is the case. What research is currently underway, both here in Australia and elsewhere in the world, to cure children born with mitochondrial disease? I've heard very little about that. It seems to me that our focus should be as much on the children who are already born as it is on those whom we might try to help in the future. Finally, what options are available to parents who live with the risk of mitochondrial disease right now?
There were some caveats requested by GeneEthics in their submission to members of parliament, to whom I have no doubt they would have written, and to others. They said, I think quite properly, that if the legislation is to pass they would like to be assured that there would at least be things like annual reports to parliament, standalone laws so that decisions aren't made simply by regulation, proper counselling services for people who are going to be engaged in the trials and clear lines of accountability for those who are conducting the trials.
Lastly, we haven't heard from anyone about the potential risks or adverse effects of this procedure. Again, most of the speakers have come into the chamber, quite rightly wanting to support whatever it is that we can do to avoid children being born with mitochondrial disease, but I haven't heard of any medical report in respect of the risks of the proposed procedure. I have listened to the passionate speeches of other members, including that of the member for Mayo, whom you yourself, Mr Deputy Speaker Zimmerman, referred to. I received an email from a family in my own electorate, who lost their nine-month-old daughter to mitochondrial disease, asking me to support this legislation. I have no doubt that they would have gone through a terrible period. I personally know of infants who have died from an incurable illness, and I have felt the heartache that it caused their parents. I've read in full the paper from Oliver Hervir, which was circulated by the member for Macarthur and to which he referred. It's a very good paper. I think it tries to summarise the issue very, very well. But my role in this parliament is to make evidence based decisions that ensure that the unintended consequences don't outweigh the possible benefits that we are seeking. Nor do I want to give false hope to desperate parents whilst possibly diverting research dollars away from other cures.
I do welcome the two-stage approach that is proposed in this legislation, and I certainly welcome the highly regulated and reviewed clinical trials process that is being proposed. There is no question that, if this legislation goes through, it gives me a high level of confidence and comfort that there will be adequate safeguards put into the trial process. But the unanswered questions still remain, and to my mind there is still no clear way forward. Neither approval nor rejection of this legislation, to my mind, provides certainty. I will comfortably accept the will of this parliament, but I am still to be convinced that this legislation is driven more by compassion and hope than it is by proven science.
I will finish with a quotation from a submission made by the Robinson Research Institute in Adelaide, which is a branch of the University of Adelaide. I'm familiar with the Robinson Research Institute; I've been through their research facilities. The facilities are very impressive, and the people who work within the institute are very impressive. The Robinson Research Institute is a medical research institute that comprehensively addresses how to give all children the healthiest start in life. I'll quote part of their submission to the Senate committee. They said:
In summary, our primary concerns with the currently proposed Mitochondrial Donation Law Reform are that:
1) it allows genome modification in human embryos and
2) the possibility that children conceived in this manner could have developmental defects because the technology has not been tested and refined to a level appropriate for clinical use.
We believe that it is essential to answer the above questions by conducting further research before Mitochondrial Donation be permitted for use to treat carriers of mtDNA disease.
The Robinson Research Institute, as I said, is a credible body that I have a lot of faith in. That is their view, and, unless I hear differently, that will be my view.