Tuesday, 30 November 2021
Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021; Second Reading
As I was saying before, while I am no scientist, I do give deep consideration to some of the ethical and faith based issues with aspects of this legislation. I have really wrestled with a number of the concepts that are outlined in this bill, particularly given my own personal situation a number of years ago, which I outlined. I had to wrestle through that for a personal decision that I am very glad to have undergone.
I believe that more consideration needs to be given to some other aspects, including the potential permanent modification of what is called the human germ line. 'Germ line DNA' refers to the tissues derived from reproductive cells that eventually can become incorporated into every cell in the body of the offspring. This modification could potentially lead to potential for off-target effects such as addition in the wrong places. There are also concerns about these same techniques being used for non-therapeutic purposes—for example, height or eye colour. While only one other country, the United Kingdom, has legalised mitochondrial donations—it did so in 2015—I understand that there are some concerns about this kind of manipulation in other countries in the world and that around 40 countries have signed a memorandum on any methods that edit the human germ line. It is for this reason that I believe that we should tread with great caution to ensure that robust safety measures and safeguards are in place to protect future generations.
This bill establishes a staged approach to implementing the technology should this legislation be adopted. Under stage 1, donation would be legalised for certain research and training purposes and to support selection and licensing of a pilot program for impacted families. Under stage 2, mitochondrial donation would be permitted in clinical practice more broadly if the initial pilot program were to be successful. A regulatory framework will be established to ensure that this process is managed effectively and in line with community expectations. The role of the current Embryo Research Licensing Committee of the National Health and Medical Research Council will be expanded under this bill to include licensing and oversight of research and training in this area.
Children born using this technology still have two biological parents: a mother and a father. Children will inherit characteristics and personality traits from their biological parents, as the female donor only provides healthy mitochondria. Donor rights and responsibilities will also be based largely on current regulations. This includes that mitochondrial donors would not be considered legal parents, in line with the current arrangements for sperm and egg donors under the Family Law Act 1975, and that children conceived by mitochondrial donation will have the right to apply for identifying information about their donor when they turn 18 years old. This bill aligns with other Australian laws preventing exploitation and incentives for donors and allows donor eggs to be provided voluntarily from family members, friends or individuals who agree to donate.
Severe mitochondrial disease can have a really devastating impact and effect on families, including causing long-term ill health and poor quality of life. In Australia, around 56 children are born with a severe form of the disease each year. I want to acknowledge and welcome the advance in genetic science which gives all of us hope for a world without mitochondrial disease.
I support the intention of the bill and I believe that we must work to lower the risk of transmission of mitochondrial disease. However, as I have outlined in the House tonight, we need to: consider the implications of some of the techniques that could be potentially used to achieve successful mitochondrial donation; ensure that the frameworks needed to regulate this kind of technology are in place; and understand the impact it could create for future generations.
Given the concerns I have raised tonight about some aspects of this legislation, I intend to abstain from the second reading vote on this bill. But I will be supporting any sensible and carefully drafted amendments that seek to deal with some of the concerns I have raised, should they be moved in this place. I hope that there is a way through which considers some of the faith based issues that I and, no doubt, others will raise, and that others have raised with me in the community when I have spoken to people who are interested in this particular issue.
In closing, I thank the government for providing a conscience vote on a matter that is as deeply personal as this, and I also thank all members of the House for their thoughtful consideration of the matters we are debating tonight and for the very insightful contributions we have heard.
I thank the member for Robertson for her contribution. I think the contributions of members on both sides of this debate have been very thoughtful and very considered. It really is the parliament at its best. We are having a conscience vote on an issue that I know is deeply personal for a lot of people. I want to say tonight that I know there are genuine views on both sides, with people in favour of this legislation and people who are concerned about this legislation. While I respect all those views I will be voting in favour of this legislation, the Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021. I believe that if we have the opportunity to prevent the suffering of children, to extend their lives, we should take that opportunity.
I understand that some people in the community have a concern that this is a slippery slide into designer babies, into choosing the genetic make-up of children in the future. I understand the member for Robertson's concerns. She was speaking about the different types of mitochondrial donation techniques, the maternal spindle transfer technique as compared with the pronuclear transfer technique. I have thought deeply about these issues and I genuinely believe that, with the pain, the suffering, the shortened life span and the illness suffered by many children who have a mitochondrial disease, the sadness of children's families and the impact on those families make these scientific advances worth pursuing.
This bill amends existing legislation to make mitochondrial donation legal for research, training and human reproductive purposes. As others before me have explained, mitochondrial disease refers to a group of inherited conditions caused by mutations in a person's DNA impacting their mitochondria—the part of our cells that helps the body produce energy. When these cells don't function properly, the body can experience organ failure, serious illness and death, particularly when the mitochondrial disease affects high-energy-use organs like the heart and the brain. But, of course, there are a broad range of impacts that can be experienced by sufferers of these conditions. It's extremely serious. Children with severe cases suffer tragically shortened life spans, usually between three and 12 years. Currently there are no available cures. There is a lot of encouraging research into elements of treatment, but there is no cure. Prevention is, I believe, obviously something we should be aiming for.
About one baby a week is born with mitochondrial disease. That is one family every week who is getting the news that the life of their beautiful new baby is likely to be shorter and that there are likely to be significant health impacts during that shortened life. The aim of this bill is to give parents who are at risk of passing on this disease options to have biological children without those children carrying increased risks of these diseases. Mitochondrial donation involves creating an embryo through IVF using DNA from the prospective mother and father as well as healthy mitochondrial DNA from a donor. It is worth restating, of course, that in Australia we are bound by an existing regime that ensures that that donation is made not for financial gain but altruistically.
The bill facilitates this change by changing existing legislation to ensure that it's no longer an offence for the purposes of reproduction and under relevant mitochondrial donation licenses to create a human embryo that (a) contains the genetic material of more than two people and (b) contains heritable changes to the genome. There are tightly established processes around this. The bill takes an approach that is staged and controlled, with the hope that the techniques will be safe and that there will be no unforeseen consequences in opening up this approach.
As the member for Macarthur, Dr Mike Freelander, has said, this isn't about allowing a free-for-all for genetic alterations; it's about providing strict legislative oversight to allow one or two clinics to begin trials. I want to congratulate the member for Macarthur, the member for Higgins and the others in this parliament who have been working in a very cooperative way to advance this bill. The minister for health, the shadow minister for health and the former shadow minister for health, Chris Bowen, have all been very supportive of progressing this issue. I understand that people of good faith will disagree with these changes, but it is my belief that, as long as we can establish proper safeguards, our priority should always be the health and welfare of children. No child would ever make the choice to be born with these conditions that can be so life limiting, and I think that if we have the opportunity of giving more children the chance of a life free from mitochondrial disease it is important that we take that opportunity.
I have spoken to Sean Murray, the CEO of the Mito Foundation. Sean came to me a few years ago, beginning the process of lobbying not just on this bill but on a range of better genetic testing for parents and a range of other changes that the Mito Foundation want to see. I want to thank Sean for explaining how important this change is, and I want to congratulate the Mito Foundation on the wonderful work they do: educating people about mitochondrial disease; talking to parents who are likely to have a child with a mitochondrial disease or who have had a child born with a mitochondrial disease; supporting those families; backing the research; fundraising to do more research on treatment and prevention; and setting up the Mito Registry, which allows sufferers of mitochondrial disease to register to be part of clinical trials to access new treatments and new medicines and to be part of other studies. The Mito Foundation have obviously been championing this legislation and doing amazing work, both in their lobbying and in the fundraising they need to do to keep going. Their Bloody Long Walk was held just recently. I know that it's a very difficult environment for fundraising at the moment, but I want to congratulate the Mito Foundation on the fundraising that they have achieved and congratulate the people who have been involved in that.
Sean told me about the challenges facing people affected by this condition and how it has impacted generations of his family. So, as well as thanking him for sharing his story and thanking the Mito Foundation for the work they do, I want to thank the brilliant doctors, nurses and other health professionals that support children and some adults who are suffering mitochondrial diseases. I want to also thank the researchers who give people hope for treatment and cure. And I want to thank all of those families, in particular, who have been campaigning for this change—Sean Murray and the Hood family, Maeve's parents—whose advocacy over so many years has resulted in this bill. The reason I will support it is that, if we can prevent children being born with a condition that shortens their lives and comes with pain and suffering, I believe that we should.
I intend to speak only briefly tonight on this bill, the Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021. I do think it is important, particularly in the context of a conscience vote, that members indicate to their communities where their views lie in relation to this matter so they understand the vote they are about to take. I'm delighted that this has been the subject of a conscience vote. I can think of a few other issues where I would like to see a conscience vote as well over the weeks ahead, but it is an appropriate matter for us to be considering in this way.
I particularly want to thank the Minister for Health and Aged Care, Greg Hunt, for his work to make sure that the entire parliament has been able to consider what is obviously a very significant issue. I know his shadow minister has done the same. I particularly want to highlight the work and the contributions during this debate of the member for Higgins and the member for Macarthur. We are blessed to have two such eminent doctors and medical specialists within our ranks, and I think it improves our capacity and the quality of debate in this parliament.
I also want to give an acknowledgement to Professor Carolyn Sue, who is the executive director of the Kolling Institute of Medical Research at the Royal North Shore Hospital. Carolyn spoke to me about this legislation, or the concept of mitochondrial donation, many, many months ago. She is one of the leaders in the field of understanding mitochondrial disease, she is a strong advocate for this bill and she is a very impressive medical professional, and I am grateful for the dedication that she has brought to this issue.
For me, whilst I understand the reservations some members of this House have, the issue is very clear. This is about providing a new opportunity that didn't previously exist for so many Australians who have mitochondrial disease, and I particularly think of the children and their parents who encounter the devastating diagnosis that mitochondrial disease is present. It is a disease that affects people in different ways. It affects different organs of the body. The mitochondria are the battery packs of our cells. The manifestation of a genetic mutation does affect people differently, but the prognosis for many is so devastating.
As chair of the Standing Committee on Health, Aged Care and Sport, what I do know is that rare diseases like this can scar families forever, both because of the level of care that's required and often because the prognosis can be so grim. During my time as chair, I have met with, heard from and read the writings of so many parents and so many medical professionals who have highlighted the important potential that we have to start to address some of those rare diseases that have eluded medical science to date. Mitochondrial disease is one of those. It is extraordinary that we are debating this bill today because it reflects just how far medical science has progressed over the last decade. It reflects the work that's being done in so many areas, with genomics and precision medicine. It has opened an opportunity to improve the quality of life and prevent serious illness in newborns and to ensure that parents can go forward knowing that they're not risking having children that might suffer these ailments.
So, in a circumstance where 120,000 Australians carry a mitochondrial mutation, where 56 children each year are born with mitochondrial mutations and potential for disease, this bill makes sense. I particularly want to acknowledge the testimony that we heard in this place from the member for Mayo about her own family circumstances, about her own grandchild. That was incredibly moving. I spoke to her afterwards. When you see the photos of that baby, that infant, knowing what he will be deprived of in the years ahead, it just makes sense that we pass this legislation today. Yes, there are ethical issues, but this represents a very cautious approach. It represents a staged approach. It is world leading. The UK is the only other nation that's been down this path before us in the way that we're proposing. But I do have a high degree of trust in our medical experts and our medical scientists. Therefore, it will give me a great deal of pleasure to provide the hope to so many families that supporting this bill will entail. I commend the bill to the House.
I rise to speak on the Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021. Parenthood is a gift. It's the most precious gift, having a child with the characteristics and personality quirks of yourself and your partner, and when a couple is unable to have a healthy baby, we must, as a community, do all we can to assist. Under Medicare we provide access to IVF technologies, we have allowed surrogate arrangements, and once a child is born we do all we can to make sure that that child can have the very best medical care and start to their life.
The quality of a life lived does not determine the value that is inherent in it. All life, at all stages, has inherent dignity, value and worth, and it is critical that, as we seek to debate these difficult issues that cut to the heart of our morals and values, we keep that at the front of our minds at all times.
Mitochondrial disease is an insidious, incurable and often fatal condition that can be caused by over 250 different gene abnormalities. Women with mitochondrial disease can pass the disease to their children, and the mechanisms for doing so are multifaceted and complex. We know that the disease can be passed on through the mitochondrial DNA, but it can also be passed on through a woman's germline DNA.
We know that mitochondrial donation does not cure mitochondrial disease, and it's not effective for asymptomatic women who are mitochondrial disease carriers, or those with DNA mutations—which account for half of all mitochondrial disease cases—or for those instances where new genetic mutations occur spontaneously in the embryo. However, genetic manipulation through mitochondrial donation may allow some women with known mitochondrial disease to have a genetically related baby which may be free of mitochondrial disease.
But the gift of parenthood in such circumstances—or indeed in any circumstances—should not override the rights of the child. This is a complex genetic manipulation process, and all of the associated ethical concerns should be addressed through the use of a donor egg or existing egg and sperm screening techniques. But it's understandable that this would not address the natural desire of a couple to have a child that is genetically related to both parents. I can understand that.
I want to clarify that it's important for me, and I expect for us all, that we provide hope wherever it's possible, to relieve suffering and to improve human life. Yet, at times, we need to look at the research and the scientific and medical techniques and procedures, and decide whether it's a path that we should go down. These are not just personal medical decisions. These decisions have long-term consequences for families and for generations should there be any unintended or unforeseen consequences of the procedures. These decisions go to the heart of how we protect our common human genetic legacy. I'm not a scientist, and I've found it challenging to absorb all of the concepts and nuances of this scientific research. I'll support a number of amendments in order to ensure this bill gives the greatest protections to the most vulnerable in our society. I appreciate the member for Menzies and his conviction in bringing forward these amendments.
The banning of sex selection for embryos is the first amendment to this bill that I will vote in favour of. It is vital to the equality of our society that we do not seek to prioritise or favour children of one sex over another. I do worry that the ability of couples to select children on the basis of sex will see entrenchment of gender imbalance amongst us.
Secondly, I'll be supporting the amendments to ban post-fertilisation techniques such as PNT. I cannot support a process whereby a zygote is intentionally created but then is not given the opportunity for that life to continue and to flourish. The technique of choice in the UK takes a fertilised egg from the mother. The DNA is extracted and put into a fertilised egg from the donor and the father which has the DNA removed. This is the pronuclear transfer method. In this case, one embryo has been created which is not 'for the purpose of achieving a pregnancy in a particular woman', as is required by current legislation. To fertilise an egg and create the conditions for life only for the purpose of destruction is not something that sits comfortably with me.
Finally, I will support amendments to improve the reporting frameworks and time lines and to see an increase in clinical trials before moving ahead with these techniques. It is vital that, if this bill is to pass and the opportunities for mitochondrial donation begin to take place, the science and all the protections for those who will be taking part, including any potential children, are as robust and rigorous as possible.
I've researched the issue as extensively as I can and considered the correspondence I've received from various advocacy organisations. I've come to a conclusion based on the research and my own conscience. I thank all of those who have contacted me on this particular matter.
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.
I want to thank my colleagues in this chamber who have taken the time to wrestle with these vexed issues. Though we may have arrived at different outcomes, all should be commended for the respectful way we've been able to engage in this complex and difficult debate. This displays the best of our democratic process.
While I do have some reservations around the implications of this bill, should the amendments brought forward that I will support be voted down, I will not take any action to prevent the passage of this bill. I'm actually confident this bill will pass, and I hope that those whom this bill seeks to assist find the comfort and help that it looks to bring. I hope that it's successful. I hope that we make technological advances so more parents can receive the gift of parenthood, which I have had the privilege to receive.
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.
I intend to make a short contribution to this debate, and I have wrestled, as so many members have, with the issues that underlie it. Mitochondrial disease refers to a group of largely inherited genetic conditions that can significantly lower an individual's health and life expectancy and that may be fatal. Mitochondrial disease is difficult to diagnose. Currently, there's no cure, and treatment options are limited largely to the management of symptoms. Severe mitochondrial disease can have a devastating effect on families, including the premature death of children; painful, debilitating suffering; long-term ill health; and poor quality of life. The common factor among mitochondrial disease is that the mitochondria are unable to completely burn food and oxygen to generate energy which is essential for normal cell function. This is a disease that's often inherited. Symptoms might include poor growth, developmental delays and muscle weaknesses. The risk of developing serious illness due to mitochondrial disease is considered to be from one in 5,000 to one in 10,000. One in 200 Australians are estimated to be predisposed to mitochondrial disease.
Mitochondrial donation involves the removal of nuclear DNA from a patient's egg containing faulty mitochondria and inserting it into a healthy donor egg which has had its nuclear DNA removed. This can be done before the egg is fertilised or post fertilisation. The fertilised egg is transferred into the mother exactly as per current IVF practice. As the nuclear DNA is retained, the unique genetic information that makes us who we are and determines what we look like is passed on from mother to child but the mitochondrial defects are not. Mitochondrial donation is currently prohibited in Australia, as the current act prohibits the creation of human embryos by fertilisation with genetic material from more than two people. The only country in the world where it's currently legal is the UK. What the bill before the House, the Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021, will do is amend the existing Commonwealth legislation to allow for mitochondrial donation to be introduced into Australia for research and human reproductive purposes.
Maeve's Law is named after five-year-old Maeve, who lives with Leigh syndrome. Legalising mitochondrial donation would allow impacted Australians to have genetically related children without the risk of them inheriting mitochondrial DNA defects which would drastically limit their lives. Aside from the devastating physical and emotional impact on patients and their families, many patients have repeated and prolonged hospital visits and are unable to work, and may need full-time care. Whilst mitochondrial donation techniques result in an heritable change to the genome, they do not involve gene editing of either the nuclear DNA or the mitochondrial DNA, which has been expressly prohibited in the bill.
Under this bill, donor eggs may be provided voluntarily from family members, friends or individuals who agree to donate eggs or have eggs that are in excess of their own needs from IVF clinics. A two-stage implementation approach is proposed to introduce mitochondrial donation in Australia. Stage 1: mitochondrial donation would initially be legalised for certain research or training purposes and to support selection and licensing of a pilot program to deliver mitochondrial donation to impacted families. Stage 2: mitochondrial donations would be permitted in clinical practice more broadly, depending on the outcomes and an evaluation of the initial pilot program. The role of the current Embryo Research Licensing Committee of the National Health and Medical Research Council would be expanded under the bill to include the licensing and oversight of research and training licences, a clinical licence for the initial pilot stage and future clinical practice licences using mitochondrial donation techniques. The use of specified mitochondrial donation techniques would be subject to strict licensing and regulatory conditions which would be overseen by the Embryo Research Licensing Committee of the National Health and Medical Research Council, and individuals seeking to access the program would require approval from the ERLC based on clinical recommendations.
On the ethical and other issues that have been raised by this bill, I note that my friend the member for Menzies has circulated some amendments. Some of those amendments I intend to support and some I won't. I particularly want to support the amendments relating to prohibiting these techniques for using these technologies for sex selection. I don't believe that assisted reproductive technology should be used for sex selection. I also support proposals to improve reporting requirements from the National Health and Medical Research Council.
I've considered the ethical implications of this proposal more broadly and have great respect for my friends who have serious ethical concerns about mitochondrial donation. Many of those ethical concerns are aligned with views about IVF and egg donation more broadly. I should say, both from a theological perspective and also from a personal perspective, I don't have an issue with IVF or egg donation and it would be hypocritical for me to say that I had a view with assisted reproductive technology.
I want to acknowledge my friend the member for Boothby, who's in the chamber tonight, for the wonderful work that she has done in this place on endometriosis. Like the member for Boothby, my wife suffers from endometriosis, and we would not have our son, James, who's now 3½ nor our daughter who is due next year without the benefit of assisted reproductive technology. I, therefore, find myself in support of the use of this technology more broadly.
The other thing that I should say is in considering these matters I sought the advice of Rabbi Gab Krebs of Masada Synagogue, an Orthodox rabbi and a great scholar. In fact, he's due to become the rabbi of Moriah College next year. He consulted Jewish authorities in Israel as well on these issues, and I note the words of Lord Robert Winston, the distinguished biologist, bioethicist and Orthodox Jew. The perspective of Orthodox Judaism on mitochondrial donation, as is the perspective on IVF and egg donation more broadly, is that there is no particular prohibition in Orthodox Judaism in relation to the use of these technologies.
The interesting debates in Orthodox Judaism about the question of mitochondrial DNA relate so often, as these questions do in the Halakah, to the question of identity. If you have a non-Jewish mother who has donated the mitochondria, is the child Jewish? Or: if the non-Jewish mother is the egg donor and the Jewish mother is donating the mitochondria, because a child is a Jewish under in Orthodox Judaism if their mother is Jewish—this has raised some interesting Halakah debates which are not entirely settled, and I'm sure will continue to be debated as these matters go on.
Having considered this matter and thought about the ethical implications of my own faith tradition, I have come to the view that, subject to some of the member for Menzies' amendments which I support, the bill should be broadly supported.
I come to the dispatch box in the debate with the necessary degree of humility. I was a lawyer before coming to this place, not a scientist. Everything I know about the science of this is based on what I've read of scholars far more learned in these subject matters than I. I'm also not a person who lives with the disease. Every bit of personal knowledge that I have about mitochondrial disease has been gleaned from listening to the exceptional debates that have been given by colleagues in the chamber over the course of the last three days, the things that I've read and from consultations with local constituents who've been forthcoming with their views and personal experiences, some of which I'll reflect upon in my contribution.
The bill, if passed, will legalise the donation of healthy mitochondrial DNA into egg cells. It'll allow the use of a safe and highly effective medical procedure, which has now been proven overseas for a number of years. It was first legalised in the United Kingdom in 2017. The US also allows the procedure, although under more limited circumstances. But, most importantly, and the thing that is bearing upon my consideration of the issue, it's going to help to ease needless pain and suffering, and that has been determinative of my approach to the issue.
Mitochondria is the cell structure that makes our daily miracles possible. It has its own DNA structure separate from the nucleic DNA that determines what we look like. I didn't know about these things until I researched the background to this bill, and I'm a better person for it. Mitochondrial DNA, on the other hand, is the power grid for human existence. Laughing, running and even sleeping—none of this would be possible but for the energy that mitochondria provides at the molecular level, so a minor defect in mitochondrial DNA can cause major health issues. It is often very fatal for a newborn babies. It also causes a wide range of complications for sufferers old and young—stroke, deafness, blindness, even childhood dementia. Those with a defective gene can live for years without even knowing it until the debilitating symptoms begin to appear. There is no cure. The best hope to defeat this disease is its prevention. That is the hope contained within this bill, and it is why I will be supporting this bill.
Along with the modified IVF technology with which so many Australian families are already familiar, this bill will allow doctors to replace mutated mitochondrial DNA with healthy DNA. In doing so, it will break the chain of hereditary gene defects and begin the march towards eliminating mitochondrial disease. It is not beyond the realms of possibility that, like other diseases, it could be eradicated. In Australia, this would save 56 babies a year from either premature death or a lifetime of pain or needless limitation. It would save the families of those children the anguish that raising a child with this condition bears. It would reduce just a little bit of the pressure on carers by reducing the demand for the resources that they lovingly, without a grudge, provide to support them. This is exactly what this parliament should be doing.
I acknowledge those who argue these clear benefits must be weighed against the religious, ethical and moral convictions, and the cost and benefit. The medical procedure that this bill would allow involves the transfer of healthy mitochondrial DNA from a donor egg into the egg of a mother carrying an embryo. As such, it requires a donor egg, which, as various submitters have argued, means the creation of that egg for the specific purpose of carrying out that medical procedure—that is, not of conception but of carrying out this procedure. Submissions from many faith groups and others have raised questions about the ethics of this. We cannot and should not blithely dismiss or disregard these objections. I respect their convictions on those issues, but I personally am of the belief that the benefits to those 56 families of the 56 infants born with mitochondrial disease every year outweigh these ethical considerations and concerns. Those babies and their families deserve a chance at a life without the pain and limitations that mitochondrial disease brings.
If some choose not to take up the medical option that the passing of this bill would provide because of their personal convictions, I understand that. But I don't believe that it is the role of this parliament to prevent that option being available to those families who know with some certainty that they will be passing this disease on to their children. This point was brought home to me loud and clear earlier when I took the time to discuss the issue with a constituent of mine, Rhonda Murray. Rhonda has faced mitochondrial disease across generations of her family. I want to thank her for her advocacy. She told me of how the disease robs the body of energy and how it can strike vital organs at any time without warning. Strokes, hearing impairment and severe fatigue can suddenly develop with little or no warning.
Rhonda's mother was 40 years of age before she began showing the crippling symptoms of fatigue and multiple strokes. Once the symptoms take hold, there is no turning back; they are there for life and they are untreatable. When symptoms occur in babies, the results are serious and often fatal: difficulty breathing, difficulty eating and listlessness. Rhonda herself has inherited the genetic mutation that causes mitochondrial disease and has, in turn, passed it onto her two daughters. She's fighting hard, along with her family and others, to get this bill passed. She's not doing it for her own sake—her fate is sealed—but so that her daughters can one day go on to have healthy children of their own in the knowledge that they won't be passing that disease onto another generation of Murrays. Hearing Rhonda's advocacy on this issue on behalf of her future grandchildren was powerful, to say the least. So I'll be voting on the bill and I'll be considering the amendments that have been foreshadowed. I understand that the member for Menzies takes a different view to me on these. But I know him to be a thoughtful contributor to debates in this place so I'll be considering the amendments that he moves on their merits, together with those that have been foreshadowed by other speakers in this debate and moved by government members or others.
On a day on which this parliament has been occupied by some of the worst behaviour that we've seen this year and—can I put it without passing judgement—some of the less wonderful debates, I think it is a pleasure for all members of this place to be closing the proceedings on a debate where we've seen some of the very best contributions, even from those who I strongly disagree with. In my view, a conscience vote in this parliament always brings out the very best. Some of the debates that I've heard in this debate and in other conscience debates in this place have been of a very high calibre indeed. It just goes to show that our democracy is robust and it brings forth some of the very best and the very worst that we see in public discourse in this place and outside of this place.
I'll be voting for the bill. I thank members of this place for the opportunity, and all of those who've put their effort into ensuring the bill comes before this house before the close of this session this year.
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