House debates

Tuesday, 30 November 2021


Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021; Second Reading

6:03 pm

Photo of Josh BurnsJosh Burns (Macnamara, Australian Labor Party) Share this | | Hansard source

I begin this contribution on the Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021 by saying that I know that many people on all sides of the House will have deep convictions and strongly held views about the specifics of this bill. This is my personal view that I express, and I obviously respect others who have a different view. In this bill I will be voting to support this legislation and this important reform.

Mitochondrial disease is a disease that is devastating for young children, devastating for parents and devastating for everyone who it touches. One in 200 people, or 120,000 Australians, carry the genetic change or specific genetic nature that potentially puts them at risk of developing mitochondrial disease or passing it on to their children. What this bill does is enable a regulatory arrangement so that IVF or an IVF-style treatment can be used to take the nuclear DNA from a patient's egg which contains the mitochondrial genetic aspect and then place it into a healthy donor egg. Every aspect of the DNA that makes us who we are, passed on by our mother, remains. This is a very, very specific change and very, very advanced technology that gives parents with this small genetic nuance a chance to have a healthy child. That's it. That's all it does. It gives them a chance to have a healthy child.

I had the privilege of working as an adviser in the Victorian government during the voluntary assisted dying debate in Victoria, when the Victorian government and the Victorian parliament legislated voluntary assisted dying. What that bill did was set up a very specific arduous process for someone to go through that awful choice. It was complex legislation. It was very narrow, and it set up a precedent for a difficult yet important framework to facilitate a momentous societal change, and I think that this bill is no different. This bill is specific. It is complex. It is also done in a way that doesn't limit this parliament but reaches for a high standard of legislation to make specific changes to improve the lives of Australians. In this place, if we are not reaching for difficult legislation and if we are not reaching to solve complex issues for Australians, then we are lowering ourselves. This is not an easy issue, but it is my view that bills like this are actually what make this place incredibly important. When we reach to solve problems such as mitochondrial disease, it shines and serves us all well as parliamentarians.

The other thing I'll say is that we, in this place, are truly blessed. We are blessed as people, as parents, as parliamentarians. Our lot in life, each of the 151 members of this place, is pretty darn good. We all have the full function available to us. We all can come into this place and stand up not only for ourselves but for the more than 100,000 people who elected us here. We've all been given a lot in life. That is something that I am extremely appreciative of and extremely grateful for. But the person whom this bill was named after, Maeve, wasn't. The families and the parents of people who carry the mitochondrial genetic nuance are given a much more difficult set of cards. To stand in this place and to give to those parents and to give to those families and, most importantly, to give to those future children that small improvement is a wonderfully generous gift that we could all give. I couldn't be prouder to stand in this place and say that I think we should all give it. I support this legislation.

Maeve is five. She has a difficult journey ahead of her. She struggles to walk. She struggles to talk. This disease is taking away the very things that we all take for granted. She has older sisters, and her parents have shown immense courage in using her story in order to ensure that others don't have to go through the incredibly difficult and challenging journey that Maeve has to.

So I say that I am proud to support this bill, that I am appreciative of all the things that I have been given, that I have a beautiful, healthy daughter who is able to live her life, and I hope she lives a long and prosperous and healthy and happy life. I hope that other Australian kids have the same opportunities that we all have and that we give this very, very small change to give them that chance.

6:10 pm

Photo of Barnaby JoyceBarnaby Joyce (New England, National Party, Leader of the Nationals) Share this | | Hansard source

Thank you very much, Mr Deputy Speaker, for this opportunity to speak on something which I know is heartfelt and I know comes with many contentions. And I know that, most likely, I am on the losing side of the debate, but nonetheless the purpose of this chamber is for an examination and to announce a position and to give some cogent reason as to why you hold it.

Mitochondrial disease and the effects of it—no-one is suggesting for one second what dire circumstances they are, and no-one is suggesting for one second that, obviously, a life better lived, with a better quality of life, is something we search for. But things must be seen through the prism of consequences and balance, and, for my part, I won't be supporting the Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021. I say that at the start, and I do it for a number of reasons. One is that mitochondrial donation has been legal in the United Kingdom for nearly five years, but there have been no reported live births in the UK, so it's not clear if this procedure is safe and practical. Also, with the changing of the human genome, it has consequences that we really don't understand, and we don't understand it to the extent that the legislation emphasises this danger by giving immunity from civil liability for the adverse effects, and this removal of liability from both the minister and senior public servants states, in its very nature, that there is an uncertainty about exactly where this leads. If, as I and others have said, it is too dangerous for the decision-makers then it's probably something that requires absolute caution as to whether you proceed down that path. I suppose one of the core issues, of course, is that mitochondrial donation involves the creation and then the destruction of human embryos. And that's a philosophical divide—I respect other people's opinions, but it's something that is quite strongly held.

So, to give reason to that, my explanation is: where, in a person's life, does another person have a greater right over it than themselves? And I cannot resolve myself to what that point is. If people pose the question, 'Is it the day before you were born?' then I think the vast majority of people say: 'No, that is not right. You can't terminate a life the day before it is born.' So we go on a journey and say, 'Maybe it's two days before,' and people say likewise. You say, 'Well, a week before.' Or is it at a point where it would be viable? Children, of course, can be born as early as 22 weeks and survive. How do you define the legal rights of one against the legal rights of the other? How do you get to a point where you say that, by reason of where the person is in their life, they have no rights, and then, at a certain point, a certain juncture, they do? I find trying to rationalise that point so often philosophically implausible, for my own part. I know other people have different views. Then there is the point of: Where do you go back to? How do you find that spot? What is the issue? Of course, people have varying views as to where the rights of the individual start and where they don't. If it's your capacity to look after yourself, then no child after they're born can look after themselves. No-one argues that they don't have rights. In fact, they probably aren't able to look after themselves until possibly as an early teenager, but there's not a parabola of rights where at certain ages through your life you have absolute rights and then they dwindle towards the end and they dwindle towards the start.

I have a view that it is a lineal position of rights and it's constant all the way through, and your capacity to comprehend your rights is merely that. If a person is asleep, they have no comprehension of their rights, but their rights nonetheless exist. If a person is knocked unconscious in an accident, they don't by doing so lose their rights. Have their rights in any way diminished? In fact, exceptional actions are taken to conserve the life and conserve their rights. So our actions in other parts of our life show, or other actions of any government show, that there is an absolute desire for the maintenance of life and the maintenance of the rights that exist for that life.

In the idea of liberty, of things that are attached to it, of liberalism, is a sense of attachment of a person's rights and protection of a person's rights and that a person has got to be allowed the capacity at some point to be master of their own ship, if so doing, and that what we should be doing is making sure that there are no impediments placed in the way of that person living the life that they wish to live. But, if a person's life is taken away from them, then of course they don't have any life at all.

How do we find the point where we believe that someone's rights come into existence? I can't find that. So you go back and back and back. I arrive at the point that when there is conception, when there is the capacity for the human egg—go right back: add ovum to the egg—that after that point, once there is fertilisation, there is a process in train where what you are talking about is the development of the human person, but I believe that at that point is the establishment of rights and they must be respected.

My main issue with this is the creation of that life for the known outcome, the deliberate outcome of knowing that there will be the destruction of that life. It wasn't an accident. It wasn't something that was not incurred; you actually create a life to destroy it, and I have a philosophical problem with that that goes beyond just a philosophical position, that actually divines how I am with this free vote—so we're talking about our positions—how I can't discern a latter stage where a person establishes a greater right, and neither has anybody ever been able to say to me they could clearly display or explain a latter stage where a person becomes a part of those rights.

In the complexion of this, of course, as always, is the issue of trying to deal with mitochondrial disease, with the mitochondrial defects, and, if that is not the solution, what is? We have an incredible capacity to develop the techniques into the future that are able to deal with this. We've had issues in the past, such as stem cell technology where it was implied that the only way was with embryonic stem cells, and it became apparent later that a vastly more apt process is stem cells that can be found in a person's own body, and this vastly reduces the capacity of rejection.

With our intrusion into the process of the human genome, we must acknowledge that down the track there will be genetic inheritance of the changes that we have made. They may be of no consequence. They may be completely free of any detriment to generations that come after us. But we just don't know. We haven't been able to work that issue out. We haven't gone far enough into this. We are talking not only about the rights of the embryo that was destroyed but also about the rights of people down the track, in future generations, as to what will affect them.

I think there's also another issue that is incredibly pertinent now, and we see that. A person has a right to understand what their genetics are and who their biological parents are. You can see it creates incredible hurt and frustration when people can't understand who they are. Everybody has an absolute desire to say, 'I know who supports me, who I was brought up with and who I call my mother and father,' whether they're biologically their mother or father or not, and they absolutely respect that. But the torment for many people is that they say, 'I don't know who my father is,' or, 'I don't know who my biological mother is; I don't know who that person is.' They live a life of searching for exactly what is the substance that makes them up and the essence of who they are.

We can see that portrayed in so many things, where so many people go to certain sites to find out what their heritage is, to search through it, to see what makes them up and to see what their genetics actually go back to, what is the source and what is the point. With this, we are creating a genomic line that will make that impossible. There will be a point where even genetic testing will be inconclusive, because you've got a combination of genetic material that comes from three people, not from two. So, for subsequent generations of these people, what makes them will be of a vastly different complexion and a vastly greater complexity than for people who are making the decision today.

So more needs to be done. I've tried to make sure that I didn't hide my philosophical view. It's clearly stated. I think that, on a lot of the issues which people worry about in this place, they say, 'I know you've got a view; you just don't say it.' Well, for the purpose of this, I have clearly stated my view. I note that there's been an agreement by the minister that sex selection is something that will not be supported, and I think that is a good thing, because inherently, once we do that, we start saying that one human being is of more value than another human being by reason of their gender. That, I think, is abhorrent to both sides of the chamber and is not accepted. That, in essence, also creates questions. People are thinking about this. It is not as simple and straightforward as it might first appear.

I thank the House for the opportunity to lay down a brief iteration of some of the concerns that I have and some form of reasoning as to why I hold them. For those reasons, I shan't be supporting this.

6:24 pm

Photo of Matt KeoghMatt Keogh (Burt, Australian Labor Party, Shadow Minister for Defence Industry) Share this | | Hansard source

'Mitochondrial disease' refers to a complex group of inherited conditions that can significantly lower an individual's health and life expectancy and that may be fatal. Mitochondrial disease is caused by mutations in the mitochondrial DNA or nuclear DNA of an individual, which can impact the ability of that individual's mitochondria to function properly. The disease varies in presentation and severity, but common symptoms include developmental delays, seizures, weakness and fatigue, muscle pain, vision and hearing loss, multiple organ failure and heart problems, leading to morbidity and, in severe cases, premature death.

The Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021 aims to enable procedures intended to prevent the inheritance of mutated mitochondrial DNA, which is inherited exclusively through the mother. Mitochondrial disease is an umbrella term including a wide range of illnesses, with the severity of the disease dependent on how much of the DNA contains the mutation. The risk of developing serious illness due to mitochondrial disease is considered to be between one in 5,000 and one in 10,000. However, it is estimated that around one in 200 Australians is predisposed to mitochondrial disease, and approximately 56 children are born each year with a severe form of the disease. There are no typical symptoms, and, historically, diagnosing mitochondrial diseases has been challenging. Critically, a mother can carry mitochondrial disease unknowingly. There is no cure for mitochondrial disease, just the treatment of symptoms. In its most severe form, the disease can be debilitating, and children can die early in life.

This bill contains provisions that only women with a high level of mutations would be eligible to use mitochondrial donation, which this bill proposes to enable, in an effort to stop the mother from passing on the mutated genes to her offspring. This technique will not remove mitochondrial disease from the community. Children with mitochondrial disease would still be born. Mitochondrial donation will not impact asymptomatic female carriers, because they wouldn't realise they're at risk. Nuclear DNA mutations, which make up approximately 50 per cent of mitochondrial disease, are caused by this. This is not impacted by this legislation, nor would it impact on new mutations in the child born.

Research for treatments needs to remain the focus. In the view of many, the bill before us today is ill advised and certainly premature. It would allow deliberate heritable human germline gene manipulation and transfer. The risks for children born using these techniques are not yet fully understood, and the available scientific evidence to support this procedure is limited. The United Nations Convention on the Rights of the Child exhorts signatories, including Australia, to act on the principle that a child, by reason of its physical and mental immaturity, needs special safeguards and care, including appropriate legal protection before as well as after birth. While, of course, no child ever consents to being born, and all the joy and agony that that can come with, the implementation of this bill would burden future generations with unpredictable impacts on human gene pool integrity and pass without Australians being informed or giving consent to these changes.

It ignores experts who say clinical use of mitochondrial DNA transfer is too risky to yet be allowed in humans. While it would enable mitochondrial DNA disease afflicted parents to have children genetically related to them, the children would also be related to a third party. There would be three genetic parents for such a child. This procedure is a high-risk experiment instead of safer methods for such parents to have mitochondrial DNA disease-free children, though admittedly not ones related to both parents. Moving down this path would also create a climate of acceptance for other uses of the techniques—potentially, gender selection, genetic enhancement or to renovate older human eggs that are unfit for purpose. Such procedures should also remain not permitted. I encourage all members of parliament and those interested in these areas to watch the 1997 movie Gattaca. It is an accessible and thought-provoking way to understand and consider some of these issues. It will certainly make one pause. This bill will also enable a process that requires the creation of an embryo solely for the intended purpose of destroying it.

In 2019-20, the National Health and Medical Research Council undertook a series of community consultative activities on this matter. There was also a Senate inquiry. Through those consultative processes, there was significant community support for legalising mitochondrial donation for use in Australia. However, these consultations also identified that the majority also recommended that a cautious and nationally regulated approach with appropriate safeguards and ongoing monitoring would be essential. A number of ethical issues associated with mitochondrial donation have also been identified, with some members of the community concerned that the technology would result in three-parent children or a form of genetic modification. Concerns regarding the rights of the child, privacy of parents and children and ensuring informed consent and donor rights and responsibilities were also identified. Ultimately, there were many unknowns, given the relative newness of the science, including in relation to the safety and efficacy of the techniques as well as the potential for unintended consequences in the longer term that would benefit from further research.

Protecting the human rights of any child who may be born using the new experimental mitochondrial DNA techniques should be prioritised, especially to meet our responsibilities under the Convention on the Rights of the Child. As it stands, it appears a child born in the clinical experiments and any descendants would have no rights to redress or compensation for adverse health or other impacts resulting from the use of the high-risk, novel techniques and procedures that this bill proposes to license.

The bill greatly reduces the genetically engineered mitochondrial DNA child's rights when it grants immunity from civil liability or accountability to Commonwealth government officials, government appointees or other categories of protected person for a broad range of protected actions. So, should a child's right have priority over the aspirations of its parents with mitochondrial DNA disease to try for their own genetically related child through this clinical process? The child, created using its mother's nuclear DNA, would still have a high risk of suffering the same debilitating mitochondrial disease as she does. Such prospective parents already have several well-established, much safer, lower-risk options available to create a mitochondrial-DNA-disease-free family without it needlessly and unacceptably infringing the rights of the child or their descendants.

The law already permits IVF, screening of donated sperm and egg, adoption and fostering, which more assuredly protect the rights of a child to good health and freedom from its parents' disease. In the United States, mitochondrial donation is banned due to the impact it may have on germline, and it needs more research. The view there is that it is currently too unsafe for use in humans. While in the UK such procedures have been permitted since 2017, there is no confirmed live birth using this method and it is not permitted in any other country. This is all with good reason.

I understand that, as a father of two so far seemingly healthy children, this is all relatively easy for me to say. My heart swells for the parents who, knowing their biological children would also have this debilitating disease, are confronted with such very difficult choices. In no way do I dismiss their passionate, good-faith advocacy and I have nothing but compassion for their situation. It may still be that further research allows us to revisit this issue in the future with more very necessary information. There must be more conclusive research data on the safety, efficacy, equity and ethics of this gene manipulation before I am able to vote for this in good conscience. It's simply too risky. One should not be playing God. I cannot support the bill.

6:33 pm

Photo of Michael McCormackMichael McCormack (Riverina, National Party) Share this | | Hansard source

I appreciate the sensitive and respectful way that members are approaching this issue and talking about this issue. I get that it is a conscience vote and these sorts of ethical debates are always very hard, because you have to grapple with your own conscience. You have to, of course, take the views of your electorate. Many people are influenced largely by their upbringing, their church, what their parents told them and what they have experienced in their own lives. I am no different to anybody in this place in that regard.

This is a very difficult topic. I've had correspondence from many people within my electorate. I've listened to their views. I've respected their opinions. I've talked with many constituents. I've had letters from religious leaders within the Riverina. I appreciate that my bishop, Mark Edwards—I'm a Catholic—who is new to the diocese and for whom I've got the highest regard, has quite correctly pointed out to me that he heads a very conservative diocese. He says his heart and, he assured me, the hearts of everyone go out to families who have children with mitochondrial disease and to those with the understandable desire that their future children not suffer these burdens. He pointed out to me—and no-one would have any countenance to this—that we all want to spare children illness and suffering. I understand that, and I respect that.

When I entered parliament in 2010, the erstwhile senator John Williams said to me once, as we were having a quiet discussion about life, that no-one should ever complain about getting old because, as he quite correctly pointed out, some don't get the chance. Some don't get the opportunity to grow old; they die young. Whilst it's far removed from this debate, a 20-month-old child was, sadly, taken today when they were crushed by a truck in Temora Shire. When I read the report, my stomach churned—and I can hear the member for Dawson grieving behind me, just from hearing me say that. It is heart-wrenching. The member for Dawson and I have had a few disagreements lately, but I respect his advocacy. I know he is the father of a very young daughter. My children aren't that young these days, I'm happy to say.

The previous speaker said that he hopes his children grow up healthy and happy, and I think that's all parents can ever hope for. Nobody starts out as a parent wanting anything other than that. Sure, as life goes on they all want them to be astronauts or prime ministers or the best they can be. But at the outset they just want their kids to be happy and healthy, and, quite frankly, if they're happy and healthy then being astronauts or prime ministers or anything else doesn't really matter—as long as they be their best selves.

To former Senator Williams's point that not everybody gets the chance to live to an old age: I have grappled with my conscience and I have tried to read as much as I can about this debate before us. These views have been expressed to me by people within my electorate. My office staff are very, very good when I'm out and about in my very large electorate. When I was the Deputy Prime Minister they took a number of constituents' interviews, and I thank them for that. They listened empathetically and with a heartfelt manner, as they always do. My staff are so exceptional.

Two people came to my Wagga Wagga office and to my Parkes office with their own stories about why they felt this legislation was so important. This afternoon I rang one of those constituents. She was on her way to delivering some goodies as a part of a fundraiser for a local high school. That's the sort of person she is. This is the sort of person that I know we've all got in our electorates. Her name is Nicole Baldry. She's a young mother. She's a farmer with her husband, Carl, near Bethungra. Nicole and Carl have four beautiful children, but one of them is not with them anymore. They have Angus, who is 12; George, who is eight; and Rupert, who is almost two. But they don't have Henry. Henry died on 7 April 2016. He was a beautiful child in every way. I shared with Nicole my own mother's grief that she had for a baby lost, stillborn. I am looking forward to meeting Senator Kristina Keneally on Thursday about her particular advocacy in that regard. My mother grieved for her whole life at losing a baby who she carried to full term and lost on the day he was born. Whilst we never got to know that little boy, my mother never stopped mourning him.

I know that Nicole and Carl will never stop mourning baby Henry, who died at nine days old—nine days young. She said he was perfect for the first 10 hours, but he never fed and never opened his eyes. She wrapped him up and laid him in a little crib, and he made a noise that she felt was odd. She had had two children, and mothers know instinctively when something is not right, much more so than, perhaps, fathers. I am a father, and I admit that mothers know; they just do. She said she called the nurse, and the nurse came straight away for a welfare check on her as a young mum having just had a newborn. The nurse ran down the corridor and got some other help to see what was wrong with little Henry, and Henry was not right. This was at Wagga Wagga Base Hospital. Henry was transferred to Sydney, and later on he died in Westmead Children's Hospital.

It took, almost unbelievably, a full year—just think about that; 12 long months—for the biopsies to determine that little Henry died from mitochondrial disease. The grieving of Nicole and Carl didn't stop then; at least they knew what Henry had passed away from. Nicole is a very big advocate for this legislation to be passed because she doesn't want to see other families suffer the way she has, the way her family has. She says that whilst she doesn't actually have it, there is a fifty-fifty chance she would carry it on to any future babies; both she and her husband carry the genes to pass it on.

When couples fall in love—most of us can probably remember when we fell in love with Ms Right or Mr Right—they might get engaged and get married, and they might just decide to have children together. We live in a modern world, and no-one holds anything against people. What people want is to provide a loving, caring, nurturing home. When they have kids, they just want them to be happy and healthy, but when you fall in love, you don't know the person with whom you fall in love, be it a male-female, female-female or male-male relationship. You don't know whether the genes that you both possess are going to cause hardship and heartache and debilitating illnesses and diseases for the children, the offspring, that you may produce in the future. This legislation can provide you with at least the ability to predetermine that your children will be happy and healthy. Going back to what former senator Williams said, that is all that you want for your kids—for them to grow up to an older age.

I know it's difficult legislation. I appreciate that it's a conscience vote and there will be members who will vote no all in good conscience. There will be members who vote yes all in good conscience. No-one should think any less of anybody for whichever way they do decide to vote. Indeed, people out in our electorates should not think anything less of how anyone decides to vote, just like with the Voluntary Assisted Dying Bill in the New South Wales parliament, which has been taking up so many headlines in so many newspapers in recent times. These are difficult debates, but having a vote on these is what I think makes our society better and makes our society stronger.

Far be it from me to come into this place, having served 11 years here, and not vote the way that I think some families would like me to vote, because I don't want to have to look them in the eye down the track years from now and for them to have a child who is profoundly ill because of a mitochondrial condition that could have been avoided had perhaps I voted a different way. I don't want to, in one sense, play God in that respect. I appreciate religious leaders will say, 'You are playing God anyway.' I'd like to think I am faith driven. I do pray—I pray for a better society every day in many ways.

But, having spoken to Nicole Baldry today, she said that she could see why people would say that mitochondrial intervention would provide blue-eyed, blond-haired, genetically perfect children. That's not what this is about. It's about making sure that, if people are predisposed to or carrying mitochondrial genes, they can avoid passing it on to children who would then potentially suffer a life of heartache, pain, disfigurement, and going to school and suffering all the torment and bullying that, sadly, children who are born different—if I can put it that way—endure, even today. Nicole said, and it was quite profound, 'I would do anything to stop my child living through that.' I know that what Nicole Baldry said would be the view of so many parents.

Nicole told me she met a 74-year-old man who suffered from conditions of mitochondrial symptoms. He expressed to her how difficult his life had been, how hard his entire existence had been, because of what he had endured. I have to say that her conversation, her arguments and her advocacy were very compelling. For that reason—not just Nicole's viewpoint but the viewpoints of many others, whilst fully respecting the viewpoints of those opposed—I will be supporting this legislation. In good conscience and for the fact that I want kids to have their best start, their best lives, I will be supporting this legislation, as difficult as it is.

6:48 pm

Photo of Peter KhalilPeter Khalil (Wills, Australian Labor Party) Share this | | Hansard source

It's not often in this place we are given an opportunity to vote according to our conscience. When these times do come around, it is a moment of great import for this parliament because, while we disagree much of the time in this place, what makes this type of vote different is that our debate will be not just along party policy lines but also based on each member's philosophy, values and conscience.

The Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021 amends existing acts to make mitochondrial donation legal in Australia. We've heard that mitochondrial donation is a procedure that allows women to have a biological child in a way that minimises the risk of transmission of mitochondrial disease. We've heard that this is a disease for which there is no cure, that can leave young children with multiple organ failure or heart problems, can cause seizures and can be fatal. Mito disease is a genetic, often inherited, disorder that can be passed on from the mother and, in some cases, develop at conception. Each year, here in Australia, around 56 children are born with a severe form of the disease. That's one child a week. The tragic projection for these children is that many will die within the first five years of their lives.

One of these children, and the namesake of this bill, Maeve Hood, has a severe type of mitochondrial disease that was diagnosed at 18 months. Thankfully Maeve is one of the more fortunate children and is still here with us. She's five years old and has just finished her first year of kindergarten. But her family, of course, lives with the uncertainty that each day brings. As a father of two young children, and I know many of the members here would have the same feeling, I can only imagine the heartache and anguish of parents of children who suffer from such a devastating disease. There are significant mental health costs associated with watching a family member's child or friend die from mito.

Also, the financial costs associated with mitochondrial disease are high. The Mito Foundation estimates lifetime healthcare costs for a child born with a rare disease, such as mito, is around $2.5 million in the UK and about $5 million in the US. Aside from these sorts of costs which are incurred, there are social services, income disability support and reduction in economic participation from affected individuals, parents and other carers. In his submission to the Senate inquiry, Professor Thorburn, a co-Group Leader of Brain & Mitochondrial Research at the Murdoch Children's Research Institute, estimated that mitochondrial donation could provide between $33 and $66 million a year in healthcare savings based on a conservative estimate of five to 10 children per year born without mito.

The purpose of Maeve's Law is to legalise mitochondrial donation for particular research, training and reproductive purposes. Mitochondrial donation is an IVF based technique known as assisted reproductive technology, or ART. There are several mitochondrial donation techniques, including maternal spindle transfer, MST, and pronuclear transfer, PNT. Both of these techniques are currently legal in the United Kingdom. Basically, depending on these techniques, nuclear DNA is removed from the affected mother's egg at different stages. With MST it's prefertilisation and with PNT it's after fertilisation of the egg. The nuclear DNA is removed from the affected mother's egg, which contains the mutated mitochondria, and the nuclear DNA is inserted into a healthy donor egg which has had its nuclear DNA removed but retains its mitochondrial DNA, which is the donation part. For the record, this is only 0.1 per cent of the entire human DNA. This is not a treatment for people who already suffer from mito, of course, but the procedure aims to allow a mother who carries mitochondrial DNA mutations to have a genetically related child who has a reduced risk of mitochondrial disease occurring. The Mito Foundation estimates that in Australia between 50 and 60 children each year could be born free from mito if mitochondrial donation was legalised.

We know that there are a number of medical and ethical concerns that have been raised with respect to the legalisation of this procedure in Australia. I recognise these concerns and have engaged and consulted with stakeholders over the past 12 months. In 2018 the Senate Community Affairs References Committee undertook an inquiry, which I've referred to, into the science of mitochondrial donation and examined the impacts of the disease and the legal and ethical considerations associated with a mitochondrial donation. One of the issues raised is the status of the embryo, and many stakeholders raised ethical concerns that the creation of an embryo for the purpose of destroying it violates the dignity that is owed to the embryo. I would note that this objection also applies broadly to the ethical use of embryos. It is not limited to mitochondrial donation but in fact applies to all forms of ART, including IVF, which, as we know, has helped families have children for some 37 years.

It's important to note that there are different religious views and interpretations about the moral status of the embryo. Not all faiths are the same. Even within the Christian faith, there are big differences between the Catholic faith and the Orthodox faith, for example, about at which point in time the embryo is considered to have that moral status. This is why some of these faiths have different views around contraception and IVF and other types of technologies.

The other big issue is the so-called third-parent issue, which we've heard some people raise. As part of the inquiry, a question was raised as to whether mitochondrial donation is different or distinct from germline genetic modification. 'Germ line' refers to the cells through which DNA is inherited by offspring. In humans this includes reproductive cells. In most jurisdictions, germ-line modification is illegal as it allows for the alteration of certain characteristics of a child. The inquiry by the Senate Community Affairs Legislation Committee received a number of submissions on this issue. The committee's report concluded that mitochondrial donation should not be considered a form of germ-line genetic modification, even though it results in changes to mitochondrial DNA that can affect future generations—again, noting that this relates to only 0.1 per cent of the entire human DNA—because mitochondrial DNA has no effect on the traits or characteristics of a person such as personality, appearance, intelligence and so on. The committee accepts that there is a substantive difference between mitochondrial DNA and nuclear DNA. It's the latter that changes the characteristics of a person. The genetic contribution of the so-called third parent in this process is the donation through the process of MST or PNT, where the mitochondrial DNA is donated, and it is vastly smaller than the contribution of the intending parents.

In the UK, where mitochondrial donation has already been legalised, the donor is considered to be the equivalent of an organ donor. This is an important point because the UK took the view that MST and PNT resulted in some germ-line modification, because the effects are passed on. However, it was decided that mitochondrial donation techniques do not constitute genetic modification, since this was defined as requiring germ-line modification of the nuclear DNA—the majority part of what makes a person a human being. That is what can be passed on to future generations. There were similar fears raised about heart and bone marrow transplants when those technologies were first proposed and utilised.

There are of course issues in relation to carryover mutated mito-DNA and haplogroup matching—very scientific and very technical—which I have spent a fair bit of time going through, as I think all members have, to try and better understand the science. We know that mitochondrial DNA is transferred maternally through the biological mother and that, therefore, the mitochondrial DNA changes can transfer through the female child. Hence there has been a call in some submissions and in other jurisdictions for only male embryos to be used so as to limit that transfer. There are also issues around haplogroup matching and whether that should be a voluntary matching by the parents with the donor and the mother's eggs. These are issues that I have raised, discussed and consulted on with stakeholders who are medical professionals, scientists, religious leaders and other stakeholders to satisfy myself as a lawmaker that these issues are substantively and ethically dealt with in this legislation, particularly through the very careful and staged approach to the implementation of this technology in our jurisdiction.

Another issue that has been raised is whether donors should be anonymous or whether the child has a right to know the identity of the donor. This question needs to be considered from the perspective of the donor and the perspective of a child who may be born of this technique. In the United Kingdom they allow a child to discover only non-identifying information about the donor from the age of 16, making the donation effectively anonymous. On the other side of the debate, under UK law a donor is entitled to know how many children have been born from their donated material, the sex of those children and the years in which they were born. The rationale in the UK for making the donation anonymous is that mitochondrial donation is more akin to organ or tissue donation than to reproductive donation, and the preference for anonymity reflects that fact.

On the other side of the debate too, women who choose to donate their eggs for mito-donation may be making a small contribution to this process, but it is fundamental to the child born as a result. To understate this contribution overlooks the significance of the physical donation and the difference it will make to the child's life. There are many other significant factors to consider, including the child's right to know their biological heritage and the shift in Australian attitudes towards making known information about a person's biological heritage in both the adoption space and other forms of IVF. These factors led the committee to find that children who are born from mitochondrial techniques should be entitled to know the donor if they want to but that it should be conceptualised as being similar to an organ donation, because they are donating non-nuclear genetic material. As such, the bill sets out the Mitochondrial Donation Donor Register, which will be a safe and secure record for storing details about those born as a result of mito donation. It will also allow the child, once 18, to find out the identity of their donor. Other groups have identified concern for anticipated consent, which is the issue about whether the child would consent to the procedure, something that we can never know for sure, obviously, but it's important to note in this debate.

I do want to note for the record that I support the amendments to this bill, which address some of those ethical and medical concerns raised through the committee inquiry process, particularly clarifying that donated mitochondria must be sourced from human eggs; expanding and clarifying the circumstances in which 'proper consent' is needed before mitochondrial donation techniques are used; clarifying the circumstances in which the Embryo Research Licensing Committee is able to seek expert advice when performing its statutory functions; enhancing mitochondrial donor privacy through provisions relating to the register; and further enhancing privacy by ensuring that the ERLC statutory reports to parliament cannot disclose identifiable personal information. These amendments reflect the recommendations of the Senate Standing Committee for the Scrutiny of Bills. No doubt, the science around this is immensely complex. The United Kingdom conducted four scientific reviews that concluded the benefits outweighed the potential risk, and these reviews are utilised as the basis for many conclusions that we have drawn here in Australia.

It is also important to note that mito donation will be introduced in a very staged and closely monitored way as part of this legislation, the first stage being donation legalised for certain research and training purposes, including for the purpose of undertaking a clinical trial of the use of mitochondrial donation techniques, whether it be MST or PNT or some of the other, more experimental techniques as part of the human ART. The second stage will commence when regulations are made prescribing mito donation techniques for use in clinical practice. These arrangements have been based on the approach the UK has taken in legalising mito donation.

I strongly support this staged introduction of mitochondrial donation and the very close monitoring that is part of it. This law is not about allowing Gattaca style designer babies, free of all genetic alteration; it's not about that, as the previous speaker noted. It provides strict legislative oversight, allowing one or two medical facilities to start trials to find out which methods work best. The reality is it will likely be a decade or more before any treatment will become available outside a clinical trial setting. But it provides families with hope that this terrible disease will not be passed on through future generations.

I would like to recognise the work of Maeve's parents, Joel and Sarah Hood, the many tireless advocates, and the member for Macarthur and the member for Higgins for their advocacy on this law. The bill is in Maeve's honour, but, if passed, will ensure that other children and parents don't have to suffer the consequences of this horrible disease, like Maeve and so many other children and parents have had to deal with—children that otherwise would have lived a rich, full life past the age of five. I support this bill and the amendments.

7:03 pm

Photo of Anne WebsterAnne Webster (Mallee, National Party) Share this | | Hansard source

WEBSTER () (): I am glad to rise today to speak in favour of this important bill. The Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021 offers a chance to prevent an insidious genetic disease inflicting further pain and misery on future generations. I understand this bill is controversial, and I would like to outline why I am in favour of it.

Mitochondria are tiny structures within our cells which produce 90 per cent of our body's energy needs. They are passed from mother to child through the mother's egg cells. These tiny but vital structures within our cells can be afflicted by disease. These diseases are genetic, caused by mutations in the mitochondrial DNA. The disease varies in presentation and severity, but common symptoms include developmental delays, seizures, weakness and fatigue, muscle pain, vision and hearing loss, multiple organ failure and heart problems, leading to morbidity and, in severe cases, premature death. Around one in 200 Australians are estimated to be predisposed to mitochondrial disease, and approximately 56 children are born each year with a severe form of the disease. The prognosis for these children is that most will die within their first five years. Currently, there is no known cure for mitochondrial disease, and treatment options are mostly limited to management of symptoms.

This terrible disease can be prevented. 'Mitochondrial donation' refers to an IVF process that allows a woman whose own mitochondria may predispose her children to genetic disease to have a biological child that does not inherit that predisposition. Mitochondrial donation allows the mother's mitochondria, which may pass on the genetic disease, to be replaced with a donor's in the IVF process. The egg with the donor's mitochondria and the mother's nucleus DNA can then be fertilised by the father's sperm.

It is important to address some of the criticism of this bill. This process does not create designer babies. It is a targeted process, only substituting a donor's healthy mitochondria for the mother's mitochondria. Mitochondrial DNA has no bearing on eye colour, appearance or any other factor to do with a person's personality. That is all in the nucleus DNA, which is unchanged in the process. For this reason, it does not create three-parent babies. The child will have only two biological parents—its father and mother—and will get its nuclear DNA and all its inherent characteristics from its biological parents. The mitochondrial DNA will have no bearing on this. Mitochondrial donation is not cloning. Children born through this process will inherit their nucleus DNA and their genetic diversity from their biological parents in the same way as any child naturally born.

My decision to be in favour of this bill was assisted by the experience in the United Kingdom. In 2015, the United Kingdom legalised mitochondrial donation after extensive public consultation and scientific reviews. They now have a licensed clinic which operates in a very stringent regulatory framework. The bill before us today is, in many ways, inspired by what is best practice determined through the UK experience.

This bill seeks to amend a number of Commonwealth laws to permit mitochondrial donation for research and human reproductive purposes. The bill does this in a highly regulated and controlled manner, which is appropriate for a new area of research in a delicate area. The bill will be implemented in stages. The first stage will see the legalisation of mitochondrial donation for certain research and training purposes. This will allow an assessment of feasibility and safety to be made before any broader rollout. This will also help build expertise within Australia and will allow clinical trials, which will have the added benefit of allowing some affected families to have access to the technology sooner in a regulated clinical setting.

The bill will allow for five different mitochondrial donation licences to be granted for areas including clinical trials, research and practice. The Embryo Research Licensing Committee, the ERLC, of the NHMRC will see its regulatory remit expanded to oversee these licences and their requirements, such as reporting and monitoring. Certain licences will have specific conditions relating to the approval processes for individuals seeking access to mitochondrial donation. These licences will also specify only certain mitochondrial donation techniques. Initially, the bill permits only the techniques known as maternal spindle transfer, or MST, and pronuclear transfer, or PNT, for use under a mitochondrial donation clinical trial research and training licence or clinical trial licence. This is also the case in the United Kingdom, and these two techniques have had extensive scientific research and review. It is important to highlight that some of these mitochondria donation processes involve fertilised eggs that are not used. However, these are dealt with very early in the process, before the number of cell divisions required to form an embryo.

The second stage will only occur after years of demonstrated success in clinical trials. Depending on the results of the trials, further regulations and discussions of legalisation with states and territories could see accredited assisted reproductive technology centres across Australia offer mitochondrial donation.

The bill largely aligns with current regulations on assisted reproductive treatment, or ART. Mitochondrial egg donors are not considered legal parents, and eggs can only be donated voluntarily by family, friends or others who agree to donate or have eggs in excess of their own needs.

I note the extensive public consultation that has occurred with this bill. In 2018, the Senate Community Affairs References Committee conducted an inquiry into the science of mitochondrial donation and related matters. The final report made four recommendations for further community consultation and scientific review to be undertaken, and for those findings to inform options for legislative change. The Senate Community Affairs Legislation Committee considered the bill, with public submissions and hearings, in its August 2021 report summarising its submissions. The NHMRC also dealt with this topic at length in 2019, with public consultations, webinars and a citizens panel. This year in February 2021 the Department of Health released a public discussion paper.

The ethical questions people may have regarding the bill are well documented in these public consultations, and I thank everyone who raised their concerns to the various committees and panels. I think what we have now is a measured and targeted bill that addresses many of the concerns of adopting this new technology while providing an option for parents who, through no fault of their own, may have predisposition to this awful genetic disease: an option to have their own genetic children who have healthy mitochondria. It is easy to get caught up in the detailed regulations and medical and legal terminology with this bill, but the fact remains that this bill is about doing the greatest good for the greatest number of people. I have had many in my electorate talk to me about this issue. They do not want to see their children or any child suffer from a preventable disease, and neither do I.

Debate adjourned.