Murray Watt (Queensland, Australian Labor Party, Shadow Minister for Northern Australia) Share this | Link to this | Hansard source

I am just resuming where I left off earlier today. I outlined at the outset that the Labor caucus has decided to approach the Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021 as a matter of conscience for our members. I outlined that I would be supporting the bill, and I'll explain why a little bit further into my contribution here.

What I was doing earlier today was simply explaining some of the factual basis for what the bill is proposing to do. I think I left off where I was distinguishing between two of the different techniques for mitochondrial donation which are under consideration within this bill. The two techniques are known as maternal spindle transfer and pronuclear transfer. Maternal spindle transfer means the transfer of the nuclear DNA from the mother into the donor's egg, which happens before the donor's egg is fertilised by the father's sperm. The second technique, known as pronuclear transfer, involves both eggs—the donor's egg and the mother's egg—being fertilised. The mother's nuclear DNA is removed from her fertilised egg and inserted into the donor's fertilised egg, which has its pronuclear DNA removed. The reason I go over that again is that it is an important distinction, especially as we are all considering our views on this bill, because the pronuclear transfer happens after the fertilisation of the egg, and the mother's fertilised egg is then destroyed.

As I've said, the vote on this bill, due to its sensitive nature, will be a matter of conscience for members of the Labor Party caucus. This is an extremely delicate issue that raises some very deeply held and serious ethical and faith based beliefs among many in our community. Sadly, mitochondrial disease often has a human consequence, and that is one of the reasons for my decision to support this bill. It can be fatal for very young children, causing enormous grief and real suffering to their families, and there are hundreds of heartbreaking examples. I will go through just a couple.

Baby Chloe Mets was conceived by IVF and was born happy and healthy to first-time parents Joanne and Allan. When Chloe was just six weeks old, a specialist broke the news that their beautiful baby girl might have mitochondrial disease but there was no treatment or cure for the disease. Their bundle of joy was in good health until her immunisations triggered an episode of acute distress and led to an imbalance of chemicals in her little body. The mito episodes were unpredictable and traumatic. Chloe was in and out of hospital for about six weeks. A series of medications kept her relatively stable right up until her final day. Her parents say that she kept people guessing from the moment she was born until the very moment they lost her.

Chloe was diagnosed with mitochondrial respiratory chain disorder. Her parents were told there is only one other case with the same genetic mutation. Joanne then discovered she carries the same mutation, but she's never shown any symptoms. Now she and her husband are in a process of understanding what the mutation means for their family. They believe that legalised mitochondrial donation would give them an opportunity to have a child who doesn't have to experience the same devastating impacts of mitochondrial disease that Chloe did. They are holding on to hope that mitochondrial donation will be an available option. And they're not alone.

Bethany Hodge grew up watching her sister suffer the symptoms of mitochondrial disease, including tremors in her hands, balance issues, hearing loss, speech impairment and intellectual delay. Her family knew there was something wrong, but doctors could not determine the cause of her symptoms or what could be done to help Bethany's sister. After suffering with no solution for years, Bethany's sister was eventually diagnosed with a type of mitochondrial disease called MERRF, myoclonic epilepsy with ragged red fibres. It was soon discovered that Bethany, her mother and her brother were also carriers of this disease.

Bethany grew up watching her sister suffer through the pain of this disease, which makes it difficult to eat, dress, read and write. Now Bethany is ready to start a family of her own and is terrified to pass on that pain to her children. Bethany says:

Mitochondrial donation would allow my partner and I to start a family with the peace of mind … It will stop this vicious cycle of it being passed on from generation to generation.

As I've said, I recognise that there are a range of views on this bill, both within the Labor caucus and across this chamber. It is important that these matters get proper consideration and that all of the ethical, medical and other factors concerning the bill are fully examined. I want to acknowledge the work that a range of groups have done to examine this bill and the potential role of and ethics surrounding mitochondrial donation. A Senate inquiry looking at this matter was held a couple of years ago, and I was a member of the committee that undertook that inquiry. Of course, there's been a more recent inquiry in relation to the bill itself. Since that initial Senate inquiry there's also been an NHMRC review, and the Department of Health issued a discussion paper which gave members of the public an opportunity to have their say on something that is really important and a challenging topic.

As for me, I consider that this bill is an important step in ensuring that families like Joanne's and Bethany's can live without the devastating pain that this disease causes. I recognise, once again, that mitochondrial donation is a scientific development that members of our community may struggle with. That's why I think it is important that what this bill proposes is a pretty cautious approach to allowing mitochondrial donation to occur. What is proposed initially is its application in research, before empowering the creation of regulations which would allow for wider implementation of mitochondrial donation.

One of the reasons I am comfortable supporting this bill is that I think it is putting forward a highly regulated framework that takes into account ethical considerations and that also requires more research to be undertaken. I feel that there are some good parameters being put around the adoption of what is a challenging and new technology. I believe that this bill has struck the balance in addressing the ethical concerns of members of the public by providing a regulated, careful rollout while also providing a path forward to improve the quality of life for thousands of Australian families. Mitochondrial donation, if this bill is passed, will be introduced in a staged way. I think that is the right approach for a challenging topic like this.

In summary, because of the real benefits that I think this will provide to thousands of Australians, because of the way that ethical considerations have been dealt with in this bill and because of the regulated framework that is being put forward, I am personally offering my support for the bill and I will be voting for it.

Jordon Steele-John (WA, Australian Greens) Share this | Link to this | Hansard source

Mitochondrial diseases are significant, life-limiting, serious diseases. In Australia each year around 56 children are born with mitochondrial diseases. These diseases develop as a result of genetic faults within the DNA of our cells' mitochondria—parts of our cells that provide the very power for the body's cells. When a fault in the mitochondria is transferred from the parent's egg to a child, there is a likelihood that the child will be born with mitochondrial disease.

The Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021 moves us closer to granting people the ability to make a choice when they are considering conceiving a child. This choice enables a medical procedure that would allow people to decide not to pass this genetic abnormality on to their child. Passing Maeve's Law through the Senate will allow parents with a high likelihood of having a child who will develop mitochondrial disease to be a step closer to choosing to undergo a procedure to replace the mitochondria that have a genetic abnormality with mitochondria from a donor egg.

After careful consideration, I have decided that I will be supporting this legislation. I have heard firsthand the experiences of families that have journeyed with the impact of mitochondrial disease, and I've had firsthand experience of children born with this disease too. I emphasise to the Senate that it is a significant, multisystemic and progressive disease. It can impact your heart, your muscles, your brain and much, much more. It leads to multiple-organ failure and can be deeply unpredictable in its nature. Indeed, the average life expectancy is between three and 12. It is clear from the evidence that has been presented to the multiple inquiries that have played an integral part in pulling together this piece of legislation that this is, without a doubt, a devastating, life-threatening disease.

I acknowledge that this bill as written commences with a stage 1, defined as a research and clinical trial phase. It is anticipated that this stage will take around 10 years. In speaking to parents, I have found it clear that, while there is hope in the passage of this bill, it is in its nature bittersweet for those who are wanting to reduce the likelihood of transfer now. This is especially true because mitochondrial donation has been legalised in the United Kingdom since 2015, with the first donation procedures occurring in 2018. For this UK example, assessments were completed on parents carrying mutations on a gene that would cause a rare mitochondrial disease called MERRF syndrome. This syndrome can be devastating and neurodegenerative in its nature. It is a disorder that worsens over time, often resulting in early death after the person loses muscle control and experiences dementia. Examples like this are exactly why we must commence making this procedure available to those who need it as soon as it is safe to do so.

We also need to ensure that funding for rare diseases continues to be made available. The Greens support ensuring that people with rare conditions, including mitochondrial diseases, are provided with wraparound healthcare services—for the person with the disease, their family and their support network. I call on the government to prioritise funding for research, including resourcing organisations that are doing much of the heavy lifting in this area, particularly the Mito Foundation. I am proud, in making this speech tonight, to be wearing a pin in solidarity with the foundation.

I will close by thanking the many people who have campaigned for and enabled this change. Getting to this point has been many years in the making. Those passionate about this matter participated in the 2018 inquiry into the science of mitochondrial donation, the National Health and Medical Research Council community consultation in 2019-20, and the Department of Health process early in 2021. When supporting someone through a significant illness or experiencing one ourselves, it can feel as though change is slow and hard to come by. Today is one of those historic moments when the community and its collective voice have been heard by people in this place and we get the opportunity to take a major step forward together.

Raff Ciccone (Victoria, Australian Labor Party) Share this | Link to this | Hansard source

I rise tonight to speak on the Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021, which is before the chamber. In July of last year the World Health Organization released a report detailing some of the ethical concerns raised by genetic interventions such as mitochondrial DNA donation. The report presented a number of important questions with regard to this new technology, questions such as: Who should have access to it? Who should make and enforce regulations for human gene editing? Indeed, should we be editing the genetic make-up of humans at all? These are some of the questions which were presented, and they're also questions with which we are presented here in the Senate today as we discuss and debate this bill in greater detail—the same questions that we are each seeking to find answers to.

There is no denying that these questions are, for most, deeply personal. The views of both advocates and opponents are often informed by their own lived experiences, some of them traumatic, and by their values and their faith. Let me, at the outset, state that I respect all these views. Whilst my own personal decision as to how I vote on this issue may be different to what others might wish for, I hope that together we can all recognise the validity of other people's decisions and that which informs them.

There are, for the most part, two different techniques that can be employed to facilitate mitochondrial DNA donation: pronuclear transfer and maternal spindle transfer. The pronuclear transfer involves the creation of two embryos from which parts of each will be removed to then create a third, with the first two being disposed of. The maternal spindle transfer, on the other hand, uses a separate process which avoids the destruction of two embryos but also involves three genetic parents and the associated difficulties of a threefold shared linage. The instrumentalisation of the human embryo in this way, the use of a human embryo merely as part of a production process, is a proposition that we as a society must consider if we are comfortable with. It is the ethical challenge which is before us.

At this stage, we still don't know everything about mitochondrial donation. The science behind it is complex and makes it difficult to determine whether this technology is currently completely safe and effective. As with many other new medical technologies, the risks associated with mitochondrial donation are still unknown. Many scientists and clinicians suggest there are too many questions around mitochondrial donation that still need answering. Indeed, one might suggest that the divisive nature of this subject is proof enough that we may be pushing the boundaries of nature beyond a morally acceptable level, especially when the consequences are potentially so severe.

I share concerns about this technology and I hold concerns about what it does, what it might do and what it means for us as human beings to employ this technology in the way that this bill as currently drafted would propose we should do. While it's true that mitochondrial donation has the capacity to create inheritable changes in DNA that could have significant benefits in the prevention of a disability or a disease, we're also confronted with the many questions which I alluded to earlier. At what cost do we decide to forego legitimate ethical concerns? Surely it is incumbent upon us to acknowledge the unknown impact of some of these changes? There's the inability of future generations to provide consent to these changes and the implications of altering a person's genetic composition.

We do not know how much mitochondrial DNA is transferred from the mother's affected eggs during the process of mitochondrial donation. Studies have shown incidence of carryover of mitochondria from the woman with mitochondrial DNA disease into the reconstructed embryo, presenting a potentially new risk factor for mitochondrial DNA disease in the child. In fact, mitochondrial DNA carried over from the woman with the DNA disease may have a greater chance to replicate than donor mitochondrial DNA.

It is also unclear whether mitochondrial donation could result in significant changes to the development of the embryo in comparison to normal embryo development. Whether the nucleus transferred from the mother's egg must adapt to the donor's egg is still being investigated—specifically, whether this adaptation could compromise the reconstructed egg's development.

There is also debate as to whether compatibility between the nuclear and the mitochondrial DNA is important. Some studies have shown a mismatch could compromise metabolism and overall health, but, again, there is still very limited data available. With so many questions yet to be answered, how could we, in good conscience, approve of such an intervention?

In considering this bill, the Senate must also have regard to the interests and wellbeing of the people who will be born from mitochondrial donation. What consideration is given to the rights of the child? Those born as a result of the donation have no say in the procedure or the consequences that follow it. The experimental nature of mitochondrial donation is likely to necessitate continual follow-up over the child's life span. Whilst this is true of many medical interventions, is it fair to expect this of someone who's had no say in how they were brought into this world?

Information relating to the health and wellbeing of a person born from mitochondrial donation and of future generations is still required to better understand the science. However, this information cannot be gathered unless families also provide consent to follow up. Prospective parents have a choice. They have a choice in their pursuit of conceiving a child. They do so on behalf of someone who is yet to be born. One might argue that the child will simply be grateful to be born, but there is no way to know whether the child may feel conflicted as their personal beliefs and values develop over time. Will they feel comfortable knowing that their parents made a decision that has or could have severely compromised their existence? How will this impact the child's relationship with their parents?

The social implications of mitochondrial donation are also significant. Beyond their immediate family, would the child want to know or foster a relationship with the mitochondrial DNA donor? It is true that the contribution of DNA from the donor is very small. However, this does not detract from the fact that it took three parents to bring the said child into the world. The genetic relationship between an egg donor and a child born from mitochondrial donation is extremely complex. I don't think anyone in this place would argue against that. An egg donor's nuclear DNA would not be present in the child, as only mitochondrial DNA would remain in the implanted embryo. However, if one or both parties were to value the donated mitochondrial DNA differently, it could be cause for major distress.

Consideration must also be given to the status of the embryo. Some, such as I, firmly believe that life begins at conception, and the process of mitochondrial donation involves the use and destruction of human embryos, a morally significant component in the creation of new life. As the earliest stage of development in a human being's life, an embryo should be considered precious.

In Australia, we already have assisted reproductive technology in the form of IVF. The use of IVF with egg donation is an option which is already legal and allows parents to be able to have the opportunity to have a child without the risk of the child having mitochondrial disease. Mitochondrial donation is distinct from the traditional IVF, as it involves a third party in the production of an embryo. Using IVF to produce embryos that result in the birth of a child is one thing, but, if mitochondrial donation were to be approved in Australia, it would involve the creation of embryos with no intention of fostering life first. Instead, embryos would be used for a scientific purpose that involves experimentation on and destruction of a morally significant component of human life. This is already evidenced in the United Kingdom, where, despite the procedure having been legal for five years and the regulating authority having already approved pregnancy, there are yet to be any reported live births resulting from the mitochondrial donation technique.

Further, the Prohibition of Human Cloning for Reproduction Act 2002 and the Research Involving Human Embryos Act 2002 make it an offence to create for the purposes of reproduction a human embryo that contains the genetic material of more than two people. They also specify that it is an offence to create for the purposes of reproduction a human embryo that contains heritable changes to the genome. Mitochondrial donation involves both interventions. Legislators passed these laws to prohibit such interventions because the consensus back then was that they were inherently wrong. Legislation was passed under the premise that interventions of this nature cannot and should not be justified irrespective of the good intentions that may motivate such interventions. Performing one of these procedures would be a serious breach of these established ethical boundaries. We must question why these boundaries should no longer be respected.

I sympathise with prospective parents wanting to use mitochondrial donation to have a healthy child. Who doesn't want to have a healthy child? However, just because we can do something does not mean that we should, nor does it mean it is ethical. The reality of this decision is that there are no no-harm options. We must inevitably make a decision on where the harm will fall. Allowing mitochondrial donation through pronuclear transfer would involve creating human embryos with an intent to destroy them, turning them into a therapeutic product that degrades and strips them of inherent human dignity. We must question what precedent this process would establish.

We are at a crossroads with this decision here in the Senate. As the genetic manipulation of our own evolution has never precisely been possible, the power genetic molecular biology research and technology has bestowed upon us should not be taken lightly, as we have the capacity to shape the future of humanity from its earliest stages of development. Stepping down this path would permit us to take over our own genetic evolution. This is a reality that I struggle to feel comfortable with.

Matt O'Sullivan (WA, Liberal Party) Share this | Link to this | Hansard source

I rise today to speak on the Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021, known as Maeve's law. Before I outline to the Senate my thoughts on this bill, and I indicate here that I will be opposing this bill on moral grounds, I think it's worth reflecting on the mature and sober manner in which this debate has been conducted not just here—and that was a terrific contribution by my colleague Senator Raff Ciccone—but also over in the House of Representatives. A conscience vote has been exercised by both parties for the consideration and amendment of this bill, and so it should have been. It is good that this is happening. While the debates and shenanigans in parliament can border on or even enter into the pantomime, Australians should rest assured that when it comes down to it, although democracy can be messy, it is of course the best form of government and it gets things done. Reading and listening to speeches on both sides of this debate has been very insightful. We've seen the unique position where there are some on the other side agreeing with others on this side and vice versa. It's great to see this happen. You can't always say that about political speeches. They don't always bring the very best out in this sort of occupation, but this bill is different.

As I stated before, I will be opposing this bill. While I appreciate its intention and honour those that have lobbied for it, this bill presents some serious moral issues to me, and I do not believe that the appropriate safeguards are there and have been enacted to prevent the worst excesses of this science. I do, however, note and endorse the amendment that was passed in the House of Representatives preventing sex elective procedures. This is a good and vital amendment.

At this time I'll pause to acknowledge the many people that have reached out to me, particularly those from the Mito Foundation, family members and friends and communities that have been touched by this disease. I can't imagine what it's like to get the news that your child has inherited this gene and is suffering from this disease. As a parent, obviously you want the best for your children. To get that sort of news must be absolutely heartbreaking, and I know you'd do everything you can for your children. For potential parents finding out they're carriers of the gene, there may be trauma and difficulty in hearing a speech like this, when all you want to do is to be able to have a child of your own. I acknowledge that and accept that. My position on this bill might not be the kind of support that you would love to have had. I do respect that and appreciate that.

I would like to pay tribute to the member for Menzies, the Hon. Kevin Andrews. Sadly, he's going to be leaving parliament at the end of this term, but he's left a wonderful legacy. One of the things that he did recently in the other place was contribute a number of amendments that I think, had they passed, would have made a significant contribution to this bill and made it a much more balanced, acceptable bill. If we had amendments such as those—and I believe that similar amendments might have been foreshadowed to come into this place—I would certainly be considering them and more than likely passing them, if they were in the same form as many of those amendments in the House of Representatives.

That being said, the fundamental biological truth of two parents coming together to create a child is not one that I could vote to alter. Comparisons to organ donation are disingenuous, as it does not result in DNA being passed on. Speaking in the other place, the member for New England, the Deputy Prime Minister, put it well. I'm sure he won't mind me quoting him verbatim here:

… 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.

This very much echoes my position. The idea that a life, or what could amount to a life, is created simply to be harvested and destroyed seems dystopian and wrong to me. Despite what good may come from it, there are always ways that technology could be deployed to really interfere with that. Despite the best intentions of this bill, it will eventually create embryos with the genetic material of three adults while destroying another embryo or zygote. It is for this reason in particular that I cannot support this bill. The idea of using three embryos simply as a source of genetic materials is anathema to me, as someone who believes that life does begin at conception. Were the amendments preventing this type of procedure passed, then perhaps this bill could have been considered differently. Two of the five methods outlined in the bill do not require the destruction of embryos and zygotes, and I hope that research will focus on this area. But I do, of course, still have that issue around three genetic parents impacting.

I also note that, although this technology has been legalised in the United Kingdom for roughly five years, there have not been any viable births as a result. It's not as if this technology's widely embraced around the world and is providing results. It's banned in many jurisdictions. The United Kingdom has also not released any data on the efficacy of the project, and this causes me concern. I was involved in a briefing by experts in this area, and it was a question that was raised. They couldn't provide the data, citing privacy reasons. It might be that there are a few people who have actually engaged in this and, while their identity might not be revealed to me directly if they released the data, of course sometimes by just releasing data you can potentially breach the privacy of those individuals who have participated in such a program. It really concerns me; we're trying to make a decision on whether the efficacy of this program justifies a change in law, and not having that data means I can't have any confidence that we're doing the right thing.

While there have been reports of this procedure producing viable births in Mexico and in the Ukraine, neither of these two countries has explicitly legalised the technique and no medical journal has ever verified it. The World Health Organization has also cautioned against editing the human genome in a way that can be passed on to future generations, while the United States has outlawed mitochondrial donation trials.

I do not understand the need for Australia to rush into this area of medical research. Concerningly, contained within the legislation are immunities from civil liberty for ministers and civil servants. This kind of implies some uncertainty around the long-term effects of the procedure. While I genuinely support the attitude of 'at your own risk', this raises some serious questions over informed consent in this case.

I would like to thank those on both sides who have put their thoughts forward in a respectful and well-intentioned way, and certainly those who are advocating strongly for this for the way they have approached us. We don't always get approached on issues—I'm sure my colleagues can attest to this!—in such a respectful, collegiate and responsible way. But those involved in this topic have certainly conducted themselves well, and I very much appreciate the time and effort that's been put in by them. I have given careful thought to this and I expect that the bill will pass, probably on a similar ratio to what we saw in the House of Representatives. The bill will pass with or without my support. But, that being said, for the reasons I've outlined here today I cannot support it.

Stirling Griff (SA, Centre Alliance) Share this | Link to this | Hansard source

I don't intend to speak on the provisions of this bill; other speakers have already explained in detail how they work. I also don't intend to speak about the arguments in favour of the bill; these have been very well canvassed and will no doubt be explored much further. Instead, I want to talk about love. It's not something we often discuss in this chamber but it lies at the heart of so much of what we do. As senators, there are issues and policies we advocate for because they are sensible or rational solutions to problems that exist. But there are other things we advocate for—things we champion out of love, things that are very much close to our hearts, things we desperately want to see done, things that give us a reason to be here.

The bill we are debating today, the Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021, is not a matter of love for everyone. Some will vote with their heads. Some will vote based on their religious beliefs. And some will vote with their hearts. But this bill is certainly a labour of love for some—some senators, some members of the other place and, most importantly, some Australians whose lives have been touched by mitochondrial disease. They want to see a relatively small change in law but one with massive ramifications for those trying to understand, treat and prevent mitochondrial disease. Their motivation is not personal gain—far from it. Their motivation is not fame or fortune. Their motivation is simply to reduce the amount of incredible and needless suffering in this world.

That change would allow for changes to be made to the human genome. I appreciate there are those, particularly in some religious circles, who do not think this is appropriate. Their view is that this is not a utilitarian matter—not a question of cost and benefits but a matter of principle and duty. I can see how that fits with their beliefs, their values and their ethics, but there are some moral issues where the pros so outweigh the cons. This is very much one of them. Mitochondrial donation is a very important issue that this chamber needs to deal with and deal with in this sitting period.

Back in 2018, I participated in the inquiry by the Senate Standing Committee on Community Affairs into the science of mitochondrial donation. It was one of the most powerful and gut-wrenching hearings I've been involved with. What I heard and what I learned has stayed with me for many years. Mitochondrial disease is not just a medical condition. It's not like flu or a scraped knee. It's not a mild irritant that will soon pass. It is a death sentence. Think about that for a moment. It is a death sentence—no doubt about that at all—which is delivered before a child takes even his or her first breath. It's a death sentence which will only come after months, years or even decades of distress, pain and suffering. It's a death sentence which condemns families to anguished lives from seeing their child live the worst possible life. It's a death sentence which leaves bereaved mothers unable to conceive out of fear that the same tragic fate awaits their next child. I simply cannot imagine anything worse.

I cannot imagine the amount of suffering, anguish and pain this awful disease imposes on people. It affects many people; potentially one in 5,000 Australians is born with mitochondrial disease and serious health implications. That is a staggering number of people who face staggering pain. If we can do something to reduce the scale of this suffering or even to prevent it entirely, we have an absolute moral obligation to do so. I heard the arguments and read the objections in the 2018 inquiry, but, to be completely honest, I cannot accept them. I cannot accept there is a system of ethics or morality, rational or spiritual, which accepts this amount of suffering as acceptable. Certainly, it cannot be a system based on love because love is the antithesis of suffering.

I most certainly will be supporting this bill. I ask every other senator listening to this to think seriously about what they love and who they love and to ask themselves, if it were their child, or their grandchild who was suffering from mitochondrial disease, whether they would not give everything they have to make this change to ease that suffering.

Catryna Bilyk (Tasmania, Australian Labor Party) Share this | Link to this | Hansard source

I'd like to start my contribution on the Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021 by thanking Shelley Beverley, a young woman living with mitochondrial disease who met with me and shared her story. Shelley's story is a perfect example of the devastation that mitochondrial disease causes. As a genetic disease, those who live with it are likely to see its impact not only on themselves but on multiple family members.

Shelley lost her mother in 2016 after she experienced heart failure, muscle weakness and fluid on her lungs. Her brother died the following year, a few weeks short of his 35th birthday, after experiencing seizures and stroke-like symptoms. He had also suffered from migraines, vomiting and hallucinations. Shelley herself has experienced many horrific symptoms, including hearing loss, muscle weakness and diabetes. She also has a high risk of heart failure. She regularly visits a range of specialists, and the disease has put incredible pressure on her career, finances and family. Adding to this pressure is the constant fear that, like her mother and brother, her life may be cut short by this awful disease. Shelley and her partner have a strong desire to have a happy, healthy child. If you want to read Shelley's story in more detail, it's available on the Mito Foundation website. For me, meeting with Shelley has given me a very personal and a very human perspective on what is an otherwise technical, clinical and ethical debate. And there are thousands more Australians with similar tragic stories to tell.

For those listening who are not familiar with mitochondrial disease, I'll just take a few minutes to explain what it is. The disease gets its name from the complex tiny organelles that cause it, mitochondria. Mitochondria reside in our body's cells. They provide our cells with the energy they need to power their biochemistry. You could say mitochondria are the batteries of our cells. Mitochondria have their own DNA, which is passed down through generations as the organelle replicates inside our cells. Children inherit mitochondria from their mother, as they reside in the mother's egg during conception. As such, the genetic risk for mitochondrial disease is always passed down from mother to child.

Mitochondrial disease occurs when the body's cells contain mitochondria with faulty DNA. This leads to the cells not receiving the energy they need to function, and as a result they start to break down. Just going back to the battery analogy, if a battery is faulty, the machine it is running loses power and dies. It is this process of the cells dying from lack of energy that leads to the devastating symptoms of mitochondrial disease. Around one in 200 people carry the genetic risk for mitochondrial disease, but one in 5,000 will be born with mitochondrial disease or disorders that lead to severe illness. There is no cure; prevention is the only option. While some people with mitochondrial disease go on to lead full and relatively normal lives, a particularly tragic outcome is that many sufferers do not survive childhood or even infancy. Around 50 babies a year are born with severe mitochondrial disease. Many of those children will die before their fifth birthday, and my conscience says to me: if I can stop one of those children dying, I will do my utmost.

By identifying carriers, it is possible to stop it from being transmitted. Sadly, this presents another cruel outcome of the disease: that a carrier cannot have children without the risk of passing it on. But this problem can be overcome with the mitochondrial donation IVF technique. This procedure provides an opportunity for women with mitochondrial disease to have children who are genetically similar to them but without passing on their mitochondria and, therefore, without passing on the disease. This bill will legalise this procedure and provide the appropriate regulatory framework for it. As such, the bill offers the possibility of allowing carriers to have children while, once and for all, eliminating this disease so that future generations do not have to suffer.

Mitochondrial donation is an assisted reproductive technology procedure in which nuclear DNA from the egg of a birth mother who carries the genetic risk for mitochondrial disease is inserted into a donor egg which is then combined with the father's sperm. The resulting child will inherit the nuclear DNA of their mother and father and the mitochondrial DNA of the egg donor.

A 2018 Senate inquiry explored a wide range of issues related to mitochondrial donation, and this was followed by an extensive community consultation in 2019 and 2020 conducted by the National Health and Medical Research Council, or the NHMRC. Both inquiries did an excellent job of exploring the scientific, social, moral and ethical considerations that go into whether to allow mitochondrial donation and the associated regulatory considerations. As a result, senators have an abundance of well-considered information that has been brought together through broad consultation to inform our positions on the bill.

I understand that there are senators in this place who hold moral, ethical or religious objections to this procedure, and I respect their opinion. As long as the senators have thought through these issues thoroughly and deeply, I appreciate the effort they have put in regardless of the conclusions they come to. For me personally, through my careful consideration of these issues, the case for legislative change is abundantly clear. I don't intend in my contribution to thoroughly explore the full range of issues outlined in the NHMRC's report or the Senate inquiry. I will, however, outline a couple of the key objections to this technique and respond to them.

One argument against legalising the procedure is that it's unnecessary. As the argument goes, parents have other options available to them, such as adoption or fostering, and a strong parenting bond can form with their child even though the child is not closely genetically related to them. The same argument, of course, could be applied to all parents accessing assisted reproductive technology, including ART procedures that are already lawful and regulated. And, just as an aside, in Tasmania there was one child adopted last year. So, if people need to adopt a child, it's not as easy as just getting your name on a list.

I and, I believe, society reject the view that parents who find it difficult, for whatever reason, to conceive by natural means should be denied the opportunity that is available to other parents. People living with mitochondrial disease should not face this discrimination on top of all the struggles and challenges this disease already presents. Even if we put aside the question of whether parents should be able to have genetically similar children, adoption and fostering, as I've said, may not be viable options. As was noted in the Senate inquiry, adoption and fostering programs have strict eligibility criteria, including health screening, and this counts them out as an option for parents with mitochondrial disease. Should mitochondrial donation be permitted in Australia, it may be the only viable pathway for women with mitochondrial disease.

Another common objection is the argument that this technique is a dangerous new experiment creating three-parent babies. Related to the three-parent argument is the argument put by some that children born by this technique will be confused about their parentage. The term 'three-parent baby' is an emotive term, but it's not accurate. The reality is that a child born under this technique inherits their nuclear DNA and, therefore, their genetic characteristics from two parents. The mitochondrial DNA contributed by the egg donor makes up about 0.1 per cent of the total DNA inherited. Even so, it would not have any effect on the child's appearance, personality or a range of other features. In fact, the only noticeable difference it will make to the child is that they will be free of mitochondrial disease. In practical terms, the child will have two biological parents and will grow up knowing and loving those parents. There is no reason to regard the egg donor as a parent at all. They are no more a parent than any other donor of bodily products, such as a blood donor or an organ donor. I've chosen to address two of the key arguments against this bill. There are, obviously, more arguments, but they're the two that I really wanted to respond to.

I just want to say, as I come to my conclusion, that I really appreciate the phenomenal amount of work that has gone into this bill, particularly from the health minister, Mr Greg Hunt, and the shadow minister, Mr Mark Butler. I also want to acknowledge Mr Butler's predecessor, Mr Chris Bowen, who has also studied and consulted extensively on this issue and with whom I had very informative discussions about mitochondrial donation when it was first raised with me. The other person I would really like to thank is Mike Freelander, the member for Macarthur, a paediatrician of about 40 years experience who I also sought information from. I found him so helpful in those discussions. Again, I want to thank Shelley Beverley for her strong advocacy and for sharing her story with me and explaining what this legislative change means for her and her family. Finally, I would really like to thank the Mito Foundation, whose representatives have also spoken to me and strongly advocated for this bill on behalf of the thousands of Australians living with mitochondrial disease.

It's been several years since the parliament and the government started exploring the option of legislating to allow mitochondrial donation. Australians living with this disease have waited far too long for a regulatory framework to catch up with the advances in medical technology. But we have the opportunity to allow women carrying the genetic risk for mitochondrial disease to have biological children without the fear of passing on the disease. Parties across both chambers have granted their members and senators a conscience vote on this issue, and I have no hesitation in supporting it. I commend the bill to the Senate.

Malcolm Roberts (Queensland, Pauline Hanson's One Nation Party) Share this | Link to this | Hansard source

As a representative of Queensland and Australia, I announce that One Nation's position is to oppose this bill, the Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021. This bill would legalise research that remains experimental, with no accurate predictions of outcome.

Mitochondria are tiny parts of a cell that generate most of the chemical energy needed to power the cell's biochemical reactions and are part of our DNA. I empathise with those parents who are identified as potentially at high risk of transferring this genetic disorder to their future children. There are high risks to those children born out of the proposed experiments and a high risk of end-of-life scenarios if the experiments fail in utero or before that point. This is risky. The bill contemplates the use of multiple techniques, which may be addressed under licence, to achieve pregnancy after genetic intervention. The intention is to intervene genetically, with the outcomes permanent across future generations, by removing identified offending genetic content. One problem is that future generations may be affected by other, as yet unidentified, changes—unknown at this stage—that are permanent. Irrespective of what some say, this bill is promoting gene editing, a practice that should be discouraged, as it goes beyond therapy. It will not help any people with mitochondrial disease—not one. There are many alternatives for achieving parenthood for the couples identified as at high risk of passing on mitochondrial disease.

There are a number of specific problems with the bill, some of which I'll now highlight. There's been a clear failure to involve independent, unbiased persons in the decision-making process. The regulator, the Office of the Gene Technology Regulator, is excluded under the bill—excluded—without adequate explanation from any consultation role in issuing a licence for experimentation. That's a big concern.

The bill puts limits on the extent to which information shall be reported. Why, especially when it's experimental? There remains no feedback on the effectiveness of experimental procedures carried out in the United Kingdom, where experiments similar to those proposed here were legalised in 2015. To say that the failure to report back on the outcomes of experiments conducted in the United Kingdom over a six-year period is only because of privacy issues is somewhat fallacious. I ask: is the real reason for the failure to report back that there have been no successes?

There are serious deficits in the bill related to a lack of accountability for adverse outcomes of the experiments. What's to happen to human tissue when there is failed embryo development? There are indemnities from liability for virtually all involved in the activities if something goes wrong. Where's the accountability, the scrutiny, for an experiment? There are no ways for a child born out of the experimental procedures to be compensated for injuries, negative conditions or loss stemming from the experimental activities. There is no accountability for those who would intervene and experiment with living human beings. That's wrong, and I cannot support this bill.

I wish to commend Senators Deb O'Neill and Matt Canavan for their considered amendments, which would ensure both scrutiny and accountability. We will support their amendments. I remain very concerned about this bill and the potential lack of respect it shows for the nature of being human, the lack of respect for human dignity and the lack of respect for the way we value people.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Carol Brown (Tasmania, Australian Labor Party, Shadow Assistant Minister for Infrastructure and Regional Tourism) Share this | Link to this | Hansard source

I'm very pleased to be able to make a contribution today on the Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021, the purpose of which is to legalise mitochondrial donation for particular research, training and reproductive purposes. The bill also amends the Prohibition of Human Cloning for Reproduction Act 2002 and the Research Involving Human Embryos Act 2002. The bill also seeks to introduce many safeguards.

I would first like to thank Dr Mike Freelander, the member for Macarthur, for providing me and other colleagues with his insights into the bill and for distributing the research paper on mitochondrial transfer produced by Oliver Hervir, an intern from ANU working in Mike's office. I also acknowledge the advocacy and determination of the Mito Foundation.

From time to time, those of us entrusted to serve in this place have the privilege and the responsibility to be able to support meaningful change that has the potential to dramatically improve people's lives. The bill before us today is one such opportunity. Under the bill, mitochondrial donation will be introduced in a staged and closely monitored way. The first stage allows for certain research and training purposes, including the undertaking of a clinical trial.

The bill before us has been a long time in the making. It's been nearly five years since the production of the 2018 Senate Community Affairs References Committee report recommending that some further consultation should be undertaken with the community and relevant experts. In response to the Senate report, the National Health and Medical Research Council, the NHMRC, undertook a series of community consultations to seek community attitudes to the ethical, legal and social issues associated with introducing mitochondrial donation in Australia. The NHMRC also convened an expert committee to review key scientific questions raised by the Senate inquiry. The NHMRC and the Senate inquiry identified significant community support for legalising mitochondrial donation for use in Australia. The consultation also identified concerns about the technology. In February 2021, the health department released a public discussion paper seeking feedback on a proposed two-stage implementation approach. Public consultation, which concluded in March 2021, identified support for the proposed approach.

The change that this bill seeks to make is significant, but, in my view, it's a change that we, as the parliament, should endorse. The change will make a big difference to families. It's been a long time coming, as I've said, and I'm sure many passionate advocates are listening in today, filled with much emotion. Today, I hope, is your day. I hope that, at the conclusion of this debate, you'll be able to celebrate a well-deserved achievement. I'm sure you were as heartened as I was when the bill passed the House of Representatives with a significant margin—92 votes to 29.

As we know, this bill has been appropriately dubbed 'Maeve's law'. I want to acknowledge and pay tribute to a brave and special young girl, Maeve Hood, and her family. As we know, Maeve was diagnosed with a severe type of mitochondrial disease, Leigh syndrome, at 18 months of age. Maeve's mum and dad, Sarah and Joel, have been tireless advocates for the law reform needed to allow for the use of IVF technology that can prevent mitochondrial disease. This advocacy will have undoubtedly taken its toll. It's never easy talking so frequently about something so personal, more so about someone you love, especially your own child. I would like to pay tribute to them and acknowledge their pivotal role in making this much-needed change happen.

But they're not the only ones. There are so many people—parents and their children—in the Australian community who have experienced the ravages of a rare genetic disease and who have shared their stories to bring this issue to the attention of policymakers. Your passion, commitment and advocacy has meant something. It has led to this day. It has worked. The passage of this bill through this place will allow women to give birth without passing on a genetic disease. This will be enabled through making a mitochondrial donation process lawful. When necessary, a pregnant woman will be able to replace their own mitochondrial DNA with healthy mitochondrial DNA from a donor egg from another woman.

It has been estimated that as many as 56 babies born each year in Australia could potentially be saved from inheriting mitochondrial disease with the passage of this legislation. Indeed, one Australian baby who will develop a severely disabling form of mitochondrial disease is born every week. That's according to the Mito Foundation, which works to enrich the lives of people with mitochondrial disease and has led much of the research, policy work and calls for law reform and funding to enable IVF mitochondrial donation. Sadly, most children diagnosed with mito die in the first five years of life. There is no cure and there is no real treatment. The Mito Foundation estimates that one in 200 people, or 120,000 Australians, carry the genetic change that puts them at risk of developing mito or passing it on to their children. This bill would dramatically change the lives of these Australians, should they have children.

A series of amendments were made to this bill in the other place and were well received by advocates, the medical profession and the medical research profession. The amendments addressed concerns raised by the Senate Standing Committee for the Scrutiny of Bills around what the committee saw as a lack of clarity in some provisions of the bill. The committee did not seek to change the function or intent of the bill. It is pleasing to see the government act constructively in pursuing these amendments to this bill, and I must acknowledge here the work of the Minister for Health and Aged Care, Mr Hunt.

The amendments agreed to in the House provide greater clarity and privacy protections without changing or impacting the intent or substance of the bill. In particular, the amendments clarify that donated mitochondria must be sourced from human eggs; expand and clarify the circumstances in which proper consent is needed before mitochondrial donation techniques are used; clarify the circumstances in which the Embryo Research Licensing Committee is able to seek expert advice when performing its statutory functions; enhance mitochondrial donor privacy through provisions relating to the register; and further enhance privacy by ensuring that the ERLC's statutory reports to parliament cannot disclose identifiable personal information. I welcome these changes, and I welcome this bill.

The passage of this bill provides Australian parents affected by mitochondrial disease with a choice to minimise the risk of their children inheriting this life-threatening disease. I will be voting for the passage of this bill to allow parents to have that choice, and I sincerely hope this bill is successful and becomes law. I commend the bill to the Senate.

Janet Rice (Victoria, Australian Greens) Share this | Link to this | Hansard source

As the speakers before me have noted, this is an incredibly complex issue. I felt I had to rise and speak to this proposed legislation today, the Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021, despite the fact that the issue of mitochondrial disease is not one that I have followed closely as many of my colleagues have. I have not met with families who have suffered from mitochondrial disease. I have not personally heard their anguish. But it's clearly a very important piece of legislation addressing some really complex issues. There have been so many concerns about mitochondrial donation that have been raised through various inquiries and stakeholder consultation activities.

On the one hand, we have families that are suffering the anguish, the trauma, the huge grief of having children born with mitochondrial disease who die, usually before they are five years old. We have the anguish of potential parents who don't know whether they want to go ahead with pregnancies because of potentially bearing a child that is going to suffer with mitochondrial disease. To be able to do something for these families is something that, yes, you would think this parliament should do. On the other hand, there are issues that have been raised about the risks, the rights of the child, future adults and future generations, issues with the creation and destruction of embryos, the creation of embryos from more than two people, the limited supply of donated eggs, donor rights and responsibilities, the fact that trial participants potentially were able to undertake sex selection following pre-treatment counselling, and the unintended or unknown consequences of manipulating or altering genetic material, which may lead to genetic engineering.

As I said, there have now been numerous inquiries looking at all of these issues in all of their complexity. In particular, the most recent one, the Community Affairs Legislation Committee inquiry into this bill, noted that this is a matter of conscience. As that report said, it:

… engages difficult ethical, social and scientific issues. The committee notes that the changes proposed are significant and that the bill would amend existing laws that strictly control embryo research and prohibit cloning.

I want to really thank everyone who has engaged in the consideration of these issues. I want to thank the advocates for this bill who have been engaged in this space for a long time and who understand that nuance and complexity and have advocated for an approach that respects human life and fully recognises the powerful complexity of the processes that are involved. I particularly want to thank and recognise the families who live with mitochondrial disease and the Mito Foundation, who have been working on their behalf.

I also want to thank those who are taking a position not in support of this bill, because I think it's very important that they have been able to bring their concerns forward for us to consider. In particular, I want to thank Bob Phelps from Gene Ethics, who has been lobbying very hard against this bill and who has made me think long and hard and read a lot more about this issue and about this bill than I thought I was going to when we first started considering the issue. I think it's important that all of these issues are thoroughly canvassed and considered by all of us so we all grapple with these issues and all come to a decision, on balance, as to where we stand. Particularly, I thank Bob. I've worked with Bob for a long time on the issue of genetically modified organisms and I have a lot of respect for his passion for public policy that properly considers the risks of genetic modification, particularly, in this instance, of human genetic modification. I've been grappling, as all of us have, with working out where I stand on this. Where I have come to is that, on balance, the benefits of this bill outweigh the risks. Having heard and deliberated over evidence from multiple advocates on multiple occasions, I believe this legislation will provide meaningful and welcome change for people who suffer from mitochondrial disease. I believe the checks and balances in this legislation will significantly ameliorate the risks associated with these new techniques.

I recognise that this is not a straightforward, simple step to take. It involves changing legislation, and it's important to have really strong protections in place. I remain concerned about the lack of data from the UK trials. I think it would be a much easier position for us to take if we had data from those UK trials and if there were published literature saying, 'This is what the results of the trials have been.' I'm going to support this legislation. On balance, I think it is good legislation. It is going to have a lot of benefits for people who are suffering from mitochondrial disease. But I foreshadow that I have quite a bit of sympathy for the further amendments being proposed in this place that add some extra checks and balances to make sure we have a really good understanding of the science and, as the clinical trial goes on through the years, of how to make sure that we know that these are appropriate techniques and processes to carry on into the future.

In conclusion, I thank those from across this parliament who have approached this complex debate constructively, and I look forward to hearing the debate during the committee stage about further amendments that could improve this legislation. On balance, however, I feel it is important legislation that should be passed.

Matthew Canavan (Queensland, Liberal National Party) Share this | Link to this | Hansard source

At the start of my contribution to this debate on the Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021 I recognise that the desire to create a human life is perhaps the most fundamental human desire. There is something inbuilt, seemingly, in human beings that makes them want to have a child of their own to pass their legacy beyond their time in this world. I can deeply understand the desire of those in our community who are afflicted by mitochondrial disease to successfully have a child and raise it as their own. I am in the fortunate situation of having five children of my own with my wife. They are the greatest joy in my life, even though I sometimes joke that the only reason I had children was so I could have grandchildren. Again, the desire to pass on that genetic material is something I seemingly have.

Those who are afflicted by mitochondrial disease in a severe fashion have a difficult choice to make about whether to have children because it is a disease that can be passed on genetically. I can't understand the angst that those people must go through because I do not have children or loved ones who are afflicted by this disease. I pay respects to those committed individuals who have for a long time advocated for these changes. I have seen some of the experiences that those families have been through and I acknowledge their great desire to see a solution to this terrible disease that they have been burdened with.

While I respect those efforts, I cannot support this bill for two main ethical considerations I have with its approach. The first of those is the inclusion in this bill of techniques that would seek to remove defective mitochondria in a way that, in my view, necessarily destroys life. I don't think we should ever seek to use a human life as an instrument or a tool to help someone else's life. I believe in the dignity and sanctity of each individual human life and that we should, to the extent that it is possible, strive and aim to protect each individual, sacred human life.

However, this bill would approve two techniques that would result in the creation of zygotes, or embryos, with the purpose of using one of those zygotes—or, in my view, one of those lives—to help the other that has defective mitochondria, which would result in the necessary destruction of the mitochondrial donor life. The two techniques in this bill are the pronuclear transfer technique and the second polar body transfer technique. They are apparently, according to Dr Megan Best, similar to methods that are used in cloning. Because they result in the destruction of a life, I simply cannot support an approach that goes down this path.

I recognise there is a dispute about when a life begins. It seems to me that once conception occurs there is a continuum from that conception that involves the evolution of a human being. There is really no other distinct point that ethicists have identified which switches a zygote through to an embryo or to a later stage. There's no discontinuity there. There have been some artificial boundaries defined by human beings but there's nothing we can actually identify. I don't see 'at that point it's a zygote, at that point it's an embryo' myself.

The second ethical issue and concern I have with this bill—and it has been raised with others—is around removing the prohibition on transferring genetic material between two human beings. This would result in permanent changes to the human germline. There are a lot of things we do not know about these techniques and the ramifications of them. There can be, as we know from animal trials, mistakes and so-called off-target errors made in genetic modification. I do not think we are at a stage where we should overturn this prohibition, with so much still unknown about these techniques.

I am also concerned about the broader ethical considerations of using the same techniques approved in this bill to tackle other diseases or afflictions, or even, ultimately, to look at more heritable traits around attributes of height, strength and other things. I know this bill does not do that, but it is hard to separate here the development of these techniques from the ethical considerations of those broader applications that might occur once the techniques have been established.

Because of those ethical considerations, I can't support the bill as a whole. However, I would like to flag that I and others in this chamber will be moving amendments to tackle some of the ethical considerations I have. In particular, there is a specific amendment I propose to move that would remove the pronuclear transfer and second polar body transfer techniques—the ones that involve the destruction of a fertilised egg—from the bill and, therefore, deal with that ethical consideration I have. That amendment would still leave the maternal spindle transfer technique and the first polar body transfer technique as ways with which to make the mitochondrial donation that do not result in the creation of two fertilised eggs. In that case the donation would occur at the egg stage, before conception. That would therefore absolve that first ethical consideration I have.

I had another ethical consideration with the bill as it was originally drafted and proposed in the House. At that stage the bill provided for the approval to destroy any female embryos that were created from the mitochondrial donation methods. The rationale for that was that almost all mitochondria are acquired from the mother, so an added protection was originally there to allow parents going through this process to destroy the female embryos and therefore reduce any residual risk of mitochondria being transferred to their children. I thank the government for considering amendments that were previously drafted, and I also acknowledge the efforts of Mr Kevin Andrews in pushing those in the House. The bill has already been amended in the House to remove that, and I think it's sensible that we should not allow a form of sex selection to be approved or legalised in this country.

The other amendments I will seek to move don't completely ameliorate the ethical concerns I have but would, I think, go some way to providing greater oversight by parliament and other bodies on the development of these techniques if that is approved by this parliament. Originally, the bill only required a review after seven years. I again acknowledge the efforts of Mr Kevin Andrews, whose amendments have now inserted annual reporting into the bill. However, I flag that I would like to move further amendments that would require more detail in that annual reporting, including detail on the number of participants and any births that have occurred, in a de-identified and private way.

The amendments I will move also seek to remove the so-called stage 2 of this bill. This bill establishes a number of licences that are, if you like, ready to go—licences that involve further research and trials of mitochondrial donation. My amendments would not affect the three licences. However, two further licences are in the so-called stage 2 process, which would result in the clinical practical application and provision of mitochondrial donation services to the broader community. At this stage, as the bill outlines, there's no regulatory framework to govern the stage 2 licences, the clinical practice licences, because there's just too much we do not know at this stage about how that framework could work once the trials and research are concluded. I do not see a strong rationale for us to give preapproval, if you like, to these licences. This bill would allow the Minister for Health and Aged Care in the future to provide a regulatory framework for these licences through mere regulation rather than parliamentary legislation.

There has been a broader debate over the past couple of years in this house about the appropriateness of delegating legislation to ministers. I recognise the work of Senators Carr and Fierravanti-Wells, through the Senate Standing Committee for the Scrutiny of Delegated Legislation, in highlighting the concern that there's too much legislation that is providing authority to ministers to effectively make laws through regulation, with more limited parliamentary oversight. Of course, some of these regulations can be disallowed in the future, but we all know that process is a much more limited one than the passage of legislation through committees and through the scrutiny of the two chambers.

By removing stage 2 of the bill, what I propose is that, following the conclusion of research and trials, the government of the day, or any senator or member, would need to bring through additional legislation to provide a regulatory framework for the clinical practice elements of this bill. To me, it seems that that enhances our role and our job as senators, and the role of members in the other place, to provide proper parliamentary oversight over these novel and revolutionary techniques. Almost all contributors to this debate, both for and against, have recognised the uncertainties and unknowns associated with some of these technologies. To me, it seems absolutely appropriate that we walk down this path one step at a time and that we do not seek to jump over a level of parliamentary scrutiny and oversight here. So I'll be moving that amendment as well.

I'll just quickly flag a few other amendments that I know some colleagues of mine will be moving; I will perhaps leave it to them to explain in more detail. I think this bill errs in exempting the Office of the Gene Technology Regulator from having oversight of these processes. Again, in a similar vein, these are novel and revolutionary approaches. We have a regulator established to deal with a lot of these issues, especially in regard to animal and plant life. It seems strange that the OGTR would be removed from the process here and that instead this bill would establish that the NHMRC Embryo Research Licensing Committee is the responsible body. I think we should be using the existing expertise in this area through the OGTR.

I will also flag that, should my stage 2 amendments fail and should stage 2 remain in the bill, I'll move amendments that seek to prescribe at least a minimum number of trial participants to go through the first stage before a stage 2 could be regulated by the minister. Finally, I don't see a strong rationale to exempt those providing these procedures from civil liability through these processes. That has not been explained to me in sufficient fashion.

Overall I think this bill is an understandable reaction to a disease that is debilitating for many people. But we as senators, I hope, cannot allow that emotion to absolve us of the need to provide proper scrutiny of these techniques, which can have much, much broader ramifications for human development, the ethical treatment of life and the protection of what is the most sacred, fundamental human desire: to create another life and to protect, support and nurture that life.

Deborah O'Neill (NSW, Australian Labor Party) Share this | Link to this | Hansard source

I rise to make a contribution to what I'd have to say is a profoundly respectful debate about a complex matter. I want to commend all of those participants whose words I've heard already this evening.

The Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021 is 'Maeve's law'. It arises out of the experience of the frailty of the human condition in a particular person, young Maeve, around whom this bill really is centred. If it's passed, this would be a landmark piece of legislation with very long-lasting consequences for health care in Australia. But I don't believe that it would enhance those health outcomes. In fact, as it's constructed, and at this point of time, it raises serious and profound questions about ethical issues of great importance, such as cloning, the sex selection of infants, children having three parents and germline tampering.

I am a Labor senator brought up in the Catholic faith, and, with all the sinners alongside me in that church, I still take my moral guidance very significantly from a belief in the fundamental dignity of human life. My party, the Labor Party, seek to effectively govern and effectively participate in the parliament by binding on how we vote. There are very few occasions on which a conscience vote is enabled, but this is one of those pieces of legislation to which a conscience vote has been allocated. I acknowledge that it's not just through the language of faith that people come to a moral and ethical disposition, but the language of my faith and the teachings of my faith have significantly informed my views about the sanctity of life.

I want to acknowledge one of my colleagues in the other place, Dr Mike Freelander, who has served the people of the Macarthur region for decades as a paediatric specialist before he came here. I know that he continues to serve in that public hospital at no charge, providing his service to the community. He's a man of great integrity—I'm very proud to serve alongside him—and he is supporting this piece of legislation. He has also been in a position where he has looked after children with mitochondrial disease, and I acknowledge his expertise. We hold very different views about what the action of this parliament should be with regard to this bill, but the conversations have always been very informative and very respectful. Again, that has characterised the debate to date.

Before I put out in a more linear form the rationale for my view, I want to acknowledge the advocacy of young Maeve Hood and her family. It's never easy to step into the hurricane that is national politics and attempt the long and slow process of political reform, but the Hood family have actually undertaken that with considerable grace and candour. Many families turn their grief and loss into profound activism. Maeve and her beautiful family, and other families like theirs, are in my prayers. I pray for their health and wellbeing.

I do know the suffering and grief of losing someone so young. It was not one of my own children. I am happily a mother to three now grown adults. But I can still remember just before my niece, Lucy O'Neill, was to turn four, having her on my hip at her pre-fourth birthday while she blew out her candles. She didn't quite make four. She died of liver cancer. I know families, so many of them, that have had young children die of brain cancer. That suffering is best translated into a positive effort, and that is what Maeve's parents have attempted to do here.

But we are legislators and we need to think about what this bill will do and establish and the broadest good and the least harm that we can manage. This bill as it's currently constructed would legalise processes in Australia that currently carry large custodial sentences or fines. We are seeking to overturn law that if you acted against right now you would go to jail. The law is preventing the creation, for the purposes of reproduction, a human embryo that contains genetic material of more than two people or contains heritable changes to the genome. My fellow senators, we shouldn't have to change legislation to do ethical science. The process that we're considering here in this legislation is only legal in one other country in the entire world, and that is the United Kingdom. We are not even sure that the five years of research that have been undertaken with the carve-out that they created in their law has actually come up with anything at all that's approaching a success.

I have here beside me the report of the Senate Community Affairs Legislation Committee that I served on that investigated this piece of legislation. We sought to inform ourselves about what's really going on. The committee made one recommendation, which was to make no recommendation as this is a conscience matter. The report simply summarised the submissions and views available at the time of reporting. We couldn't report any factual data or evidence despite five years in the UK of the program that is before us for consideration tonight, here in Australia. It's been going in the UK for five years and there is no data. There is no evidence. We can't see if there's been any progress at all because the way in which that legislation passed did not allow sufficient scrutiny.

If time allows this evening, I will move the amendments that I have already advanced and that I think are available to senators. They were alluded to in comments by Senator Canavan. I've been speaking with colleagues throughout the day about my concerns and why we need to make amendments to what is before us. Even if the bill should pass, it should pass in a different form.

I do not believe that Australia should become a society where people can have designer babies. That will not be the intention of those who seek to advance this legislation, but it could well and truly be the intention of somebody entrepreneurial—and I say that in the worst possible way—who sees the opportunity to make money for themselves at a cost to others that is beyond possible consideration. We shouldn't be thinking about enabling the construction of designer babies made to specifications where people tinker with an embryo to pursue a perfect child. I'm deeply troubled by the production of genetic material, the building blocks of life, to be casually discarded as by-products of a process.

Another relatively unknown implication of this legislation is that children born of this process will have three—not two but three—genetic parents: a father, a mother and the donor of the mitochondria. It's a very significant change and it's a new frontier for society. We need to acknowledge the novelty of this social change and the effects on any child growing up with this knowledge. We need to acknowledge the profound issues that this bill raises in terms of the moral, social, scientific, ethical and practical realities that it will enable.

The techniques that are under consideration will have long-term, irreversible and unknown consequences for the germ line of those born following the treatment. That means that that child and all its descendants will carry unknown consequences to their children and their children's children. This will not end with one generation. It goes on and on, and we have not seen that before on this planet. Children of MRT are the first in human history to be genetically modified from the moment of their origin. Surely one day they will ask, 'Who am I?' in the most fundamental way that we ask ourselves as human beings: 'Who do I belong to? Who am I really like? Where does this bit of me come from? Who are my parents?' Perhaps a register of the donor will hold that information without error, in perpetuity, or perhaps it will be like everything else in our society—a little bit broken, at least. And where's the security? That's just for the holding of information, let alone the understanding of the deepness of our need to explore our identity.

Some senators will argue that this proposed path we're debating is the only way to address the very real impact that mitochondrial disease and the deaths of much-loved young Australians have on the people who know and love those young Australians. But what's being proposed in this bill is not really a solution to eliminating mitochondrial disease; it is an attempt to create a new way of interacting with the disease.

I want to point out that, as Senator Canavan eloquently described at the beginning, the gift of actually being able to have children is something we all deeply understand, and people make choices for and against that. But it does concern me that there are options that are available to these mothers who want to have children without the mitochondrial consideration. There's the capacity to undertake IVF with a donor egg—even perhaps from a sibling, to get that genetic connection. There is the capacity to adopt. Both of those models are legal, exist within the law and don't ask us to change what we have currently outlawed.

If this bill is enacted, it is going to receive the benefit of 10 million of Australia's hard-earned taxpayer dollars, and the time and energy that it will draw will take people away from what I consider to be other, very pressing medical research that will have a much broader impact across the community. And that is our task as parliamentarians: to weigh up the relative merit, benefit and risk. There is merit and there is benefit, but there is extraordinary risk embedded in what we are considering here today. How many will this bill affect, compared to the advances that could be made in treating current diseases such as brain cancer in children or liver cancer in children under five?

What's proposed here isn't a cure; it's a radical technology trial to enable a choice for those who would prefer their children to be genetically related to them but not carry the genetic disorder. I believe that the legislation on the experimental mitochondrial donation treatment is simply not worth the scale of the risk that is embedded in what is being put before us. Perhaps if we had more data from the UK that could underpin a solid assumption about the capacity of this initiative to work, I might be more inclined to give it some support, but that is not the case. We're literally flying blind here. This proposed treatment shatters decades of long consensus around experiments regarding human cloning and germline editing. We will, if this bill passes, create a new frontier in the use of cloning and gene editing.

I indicate that I will have further comments to make when we get a little further along in this process, and there are three amendments that I've put before the Senate for consideration. The first goes to the need for the creation of evidence and data that can be observed, and that there is an experimental threshold where we should have at least 20 occasions on which this technology has been successful. The second goes to, before we advance, civil liability protections, and the third goes to the Gene Technology Act. I look forward to continuing the debate in the coming day.

Amanda Stoker (Queensland, Liberal Party, Assistant Minister to the Attorney-General) Share this | Link to this | Hansard source

Mitochondrial disease can be serious and debilitating. It causes a range of symptoms, including muscle and neurological problems with symptoms that can range from the mild to the severe, and sometimes it can prove fatal. Between one in 5,000 and one in 10,000 Australians will develop severe mitochondrial disease. For those individuals affected—Australians like Julian, Shelley, Rosie, Alana, Pippa, Kara, Dot, Marcus and so many more—the seriousness of the condition is only compounded by there being no cure at this stage. This bill offers hope to each of those people and their families, and that hope is so important. These people's lives matter. Every life matters. Yet those two short sentences carry with them the very difficulty of this bill.

The Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021 sets out a legal framework for mitochondrial donation. In doing so it provides hope for a world without mitochondrial disease, but it does this by allowing in this country—we'll be only the second country in the world to permit it—five different experimental procedures, some of which require human life to be created and then destroyed during the donation process. That's why, after careful consideration of this bill and the procedures it allows, and with something of a heavy heart for those families who I know are looking for answers, I can't support it in its current form.

Mitochondrial donation is not a cure for mitochondrial disease; it instead aims to prevent children inheriting the mitochondria that causes the disease. This is a really worthwhile goal. While mitochondrial donation is yet to lead to a successful birth—as I mentioned, the UK is the only country to have legalised the procedure to date—this on its own shouldn't be a deal-breaker. We all want Australia to be a leader in medical research because we all want Australians to get the best possible medical care. That inevitably that has to involve experimentation. But our desire for medical progress must be balanced against the nature of the research involved and the ethical ramifications of it for the rest of society. In the case of this bill I believe it ignores ethical implications in the hope that it will lead in time to viable medical treatments.

Mitochondrial donation involves a permanent modification of the human germline. That's not germs as in bacteria, but, rather, a reference to genetics. The procedure involves combining the genetic material from two females in order for eggs and zygotes to be created without the genetic disease. A human embryo created through this process will contain, necessarily, the genetic material of more than two people. That is an ethical boundary that causes me concern.

The reasons for wanting a treatment of this kind are completely understandable, particularly from those who carry the disease. It must be heartbreakingly difficult for those who desperately want to become parents but know they carry the gene. I can only say how much empathy I have for those in that position. But we're only in the very early stages of understanding the human genome. We have a limited understanding of genetics, and there's a real risk that our experiments will cause off-target effects—in other words, unintended consequences that occur due to editing the genome in the wrong place. The consequences of our actions won't only affect the child born through a successful procedure; it will affect all of their future descendants.

It's important to stop and think about the ethical threshold we may be about to cross. By allowing genetic manipulation to reduce disease, we are permitting genetic manipulation that could equally be used for a host of non-therapeutic purposes. It's not beyond contemplation that the science used in mitochondrial donation could be used for other, more troubling, purposes. These include editing the physical attributes of a child or creating human enhancements. I regard both of these as unethical, especially if human lives are created and then destroyed during the donation process in order to make it possible.

There are, as I understand it, potential methods by which mitochondrial donation may be able to be pursued without creating human lives solely to end them for the purposes of donation. I'm open to the pursuit of treatments that don't require such ethically troubling steps. I'm open to amendments that will enable treatments to be pursued for mitochondrial donation that don't involve the creation of embryos for their destruction. I remain troubled by the risks of the editing process and the use of the genes of more than two people to make a child. Ultimately, it's not right, in my view, for the life of one human to be prioritised over another, or used as parts for another. There is goodness in every human. There is dignity in every human, and there is the spark of the divine: unique talents, gifts and contributions to be made in every single human. That's why I can't, in good conscience, support this bill without amendments that adequately safeguard against these risks.

Louise Pratt (WA, Australian Labor Party, Shadow Assistant Minister for Manufacturing) Share this | Link to this | Hansard source

Today I speak in favour of the Mitochondrial Donation Law Reform (Maeve's Law) Bill. I know people consider this bill to be a test, in some cases, of their dearest convictions and closely held beliefs, and it certainly speaks to mine. The debates before us tonight have evolved over time, alongside human scientific discovery and our need to legislate ethical frameworks for science and, indeed, demand for and developments in reproductive technology.

I voted in the state parliament of Western Australia in the early 2000s to ban human cloning. It was important at the time, and there were debates about making genetic copies. It was, nevertheless, put forward at the time that it would be the role of the legislature to amend or change those preclusions based on changing the ethical framework in the context of new discoveries and ensuring continued scientific development in a proper scientific and ethical framework.

In this case, the bill before us is not really about gene editing. That's not what we're doing here. It's about mitochondrial DNA and its donation. It's about DNA that comes from outside the nucleus, from which all our personal attributes come. In the case of this bill, I don't put an overemphasis on excess embryos or believe that it's like cloning or that it creates three-parent children. I don't believe it does, and, indeed, expert evidence demonstrates the same. This bill is about preventing painful and unnecessary death. It is not about legislation to prevent physical diversity or about designer babies.

Many of us will remember from school science class—for some of us, it's the only thing we've remembered!—that mitochondria are the powerhouse of the cell. I don't know if you remember that from science class, but I certainly do. Mitochondria produce 90 per cent of the energy that the body needs to function. For people without proper mitochondrial material in their cells—can you imagine anything more difficult and horrifying?—it feels like you've got the flu all the time, with the utter pain that comes with that, only getting more and more extreme. It's not just a physical variation; it is a painful and catastrophic condition for many people, especially for young children who have a severe form of the disease. As part of an inherited condition, it lowers people's health and life expectancy. It's caused by a mutation in mitochondrial DNA or nuclear DNA in a individual. Although the number of people born with the disease is low, one in 200 people are estimated to be predisposed to mitochondrial disease and also to be carriers. Here today we have an opportunity to support reproductive science that prevents this cruel disease.

If mitochondrial donation is successful, it's not going to prevent all cases of the disease but, hopefully, over time, it might reduce its incidence in the Australian population. To use this technology you will of course have to know that you're a likely carrier and that you and your partner's genes will combine to create a child that has a high likelihood of the disease, so it won't be a panacea or prevent all disease. Of course, people are still going to have sex, and they're still going to have babies without the benefit of this technology. It highlights the importance of people understanding their own genetics and their genetic history.

I believe, as I said before, that mitochondrial donation is not human cloning, gene editing or the creation of a three-parent child. It is an assisted reproductive technology that could be used in addition to IVF treatments, enabling a woman whose mitochondria would predispose her to children with mitochondrial disease to have a biological child who does not inherit that trait by using donated mitochondrial material from a donated egg or embryo. It involves the extraction of nuclear genetic material from the prospective mother's egg and the placement of that material into a donor egg which has its own genetic material removed, keeping its own mitochondria.

We know that this technology isn't going to help people who are suffering through this terrible disease right now, or those who will unknowingly pass this trait on, but the evidence from overseas does show that mitochondrial donation could stop the inheritance of mitochondrial disease and give people a long and healthy life. So what good reason can there be for not preventing such a painful death in a young child? That is the reality for children born with mitochondrial disease: most will die in their first five years.

I was on the inquiry which investigated the science of mitochondrial donation back in 2018, and I thank the Mito Foundation group for pushing for the law reform that is before us today. The parliament and the government have been cautious. At the time, we found that further research and community consultation needed to be done and, over the past couple of years, it has been done. The National Health and Medical Research Council along with the Department of Health have done just that. They've undertaken a series of community consultations looking into community attitudes to ethical, legal and social issues associated with introducing mitochondrial donation.

When we look to the motivation of many people in the chamber here, yes, they have their own concerns about the creation of excess embryos and the destruction of those embryos, and that is a valid ethical concern for them and many other Australians. However, IVF and reproductive technology is widely used in Australia, and that technology comes with all of those ethical questions around excess embryos, the scientific research and all of those different ethical questions. We all know children who have been created through reproductive technology. I'm a very privileged mother to have had the opportunity to have a child through IVF, so it's no surprise to me that there's significant community support for this legislation and the technology but also, as outlined, concern over the rollout.

People have recommended a regulated approach with ongoing safeguards and ongoing monitoring, which is the case in the legislation before us. There are several protections in the legislation, including counselling for parents about the potential risks and alternative options such as gamete donation. Those protections are all there in the kind of counselling that's available to people using this technology. It's also consistent with gamete donation and other counselling provisions which are well known. Privacy for parents and children is a top priority, as is mandatory reporting for any adverse events. Mitochondrial egg donors are not, of course, considered legal parents. These are all well-known frameworks within our existing reproductive technology landscape, and I think it is really important for this chamber to understand that in the context of it being put forward that this is somehow extremely novel and unknown. It is not. It has been part of the landscape of reproductive technology for decades now.

The bill has included in it a staged and closely monitored path forward, with the first stage legalising mitochondrial donation for certain research and training purposes, including undertaking a clinical trial. Should this legislation pass, I certainly wish all of the families and donors involved in that all the best. The bill implements a cautious approach consistent with other reproductive technology. In relation to mitochondrial research, as we know, it's based on the approach used in the UK, which has been in place since 2015. As a mother who has used IVF to have my beautiful son, I understand the stress of infertility and the willingness to endure countless IVF cycles to make a family. The debates about donor conception and the need for children to understand their genetic origins are also important. But, frankly, in that regard, this bill has less complexity in it than legislation dealing with other donor conceptions, I think. There are other options that remain in play for people who carry these genetic variations—you can use a donor—but they are at least as complex as those dealt with in the bill before us. Donated genetic material is hard to come by. I think it will be easier for donors who know they are donating their mitochondrial DNA rather than all their DNA, which is the case for someone who requires an egg donor to bypass carrying this trait forward.

I also note that from November 2021 many patients can claim a Medicare rebate for preimplantation genetic testing. I was offered this after a number of failed IVF cycles, but it seemed to me: what was the point? It was many thousands of dollars per test. It is little wonder that I decided simply to do more cycles of IVF and forgo the test on the embryo. The kinds of tests that are available currently offer no solution when all of your embryos carry this kind of trait. Again, for those worried about excess embryos, the alternative is years of failed IVF cycles—yes, more embryos and more expense under the current fertility options for these families.

IVF raises myriad ethical questions. One not particularly related to this bill—but many of our debates overlook some of the most fundamental issues in reproductive technology—is the social and economic conditions that mean people delay having a child to start with and then have to resort to using reproductive technology. I would hope that those of you in the chamber who are opposed to IVF might work with others who support it to address some of these underlying issues on which we agree. I certainly hope that mitochondrial donation research will mean fewer IVF cycles and, in the future, healthy babies for many more Australian couples.

This bill has been extensively consulted on and thought through. It has a system in place that will ensure its ethical application. I consider myself extremely lucky to have a healthy child, and in supporting this bill I do so because I want to support other parents to have the same opportunity—an opportunity to have a healthy child of their own. I'm proud to support the legislation before us today.

Susan McDonald (Queensland, National Party) Share this | Link to this | Hansard source

I want to start by acknowledging the extensive discussion of the science and the technology that has already been had. I want to acknowledge the incredible contributions of so many of my colleagues in the chamber. It has been an education. I've enjoyed listening to people and will continue to follow the debate for the rest of tonight and tomorrow, because this is a very, very complex piece of legislation and a human issue. Any parent's first response on hearing that they are having a baby or on hearing of a pregnancy is, 'I hope the child will be healthy.' Sadly, not all children are born healthy, but modern medicine has assisted to change the fate of many children. With medical advancement comes not only a desire to do good but a responsibility to do what is right. So our ethics are: to do no harm, don't intervene—health at what cost?

Strangely, we often see more outrage expressed about animal testing of products than about the value of human life and the welfare of human beings. Each day, human children, Australian children, are abused in squalor. There is elder abuse and domestic violence, but mention animal testing and people lose their minds. So what value do we put on human life? When is an embryo a life? For women who've experienced joy at seeing a tiny heart beating on a pregnancy scan, life begins at conception. On the other hand, extreme right-to-choose activists openly celebrate abortion at any stage of pregnancy. For me, this is a dilemma. I support technology that allows parents to have healthy children, but this legislation deals with genetic modifications and donations of mitochondrial DNA. I'm a mother who wants everyone to experience having their own children but also feels that people at risk of passing on disabling conditions via their genes should have access to technology.

We've just had a great contribution from Senator Pratt about access to other methods of having children—whether that be IVF, adoption or surrogacy—instead of going down a technological road. But, of course, the problem is that the child does not feel biologically the parents' own. My own experience is that I understand only too well the all-consuming desire to have your own child. For me, it was a very, very long six years before I was able to have a baby. But this desire to hold your own child is more complex in this situation, because the mother knows the risk of having her own child. She knows the pain and the suffering that she may have endured and certainly understands what is possible for that child.

Critics fear that legislating the use of mitochondrial technology will open the door to laws allowing the choosing of babies' gender, hair colour or height. But Maeve's law, this legislation, is intentionally narrow to avoid that. Mitochondrial donation techniques don't alter personal characteristics and traits, because personal characteristics and traits such as eye colour are derived from the nuclear material. Others are worried that living embryos will be discarded once genetic material is obtained, but our legislation dictates that the procedure happens before an embryo is created.

I have followed the discussion of the amendments that are being proposed by Senator Canavan and Senator O'Neill, and possibly others, and I look forward to seeing those come forward, because I hope that they may assist me with some of the concerns that I have come upon in researching this legislation.

I want to acknowledge the friends and the families of Maeve, their advocacy and how personal this issue is to them—how close this is to their hearts, in a way that many of us will never understand. But we live in a world where science and technology mean that we have to make decisions that previous parliaments could not have imagined. The ethical considerations around artificial intelligence, as simple as driverless cars, and the science of human DNA selection and amendment are incredibly, incredibly serious and important to the future of our race, our species and our society going forward. This is technology that is being considered in animals, but I keep reflecting: just because we can, does it mean we should?

So I will spend the rest of this debate period re-reading the correspondence that I've received from a wide range of stakeholders and following the discussions and contributions of my colleagues. The ability to use technology, hopefully, to remove suffering from this particular disease and perhaps others in the future is incredibly tempting, but I don't feel confident that we truly understand the door that we'd be opening by passing this legislation. For that reason, I look forward to any amendments that are being proposed to this legislation, because it truly is, I believe, a fork in the road of our society, the use of technology and how we think about human life.

Katy Gallagher (ACT, Australian Labor Party, Shadow Minister for Finance) Share this | Link to this | Hansard source

I rise to speak in support of the passage of the Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021. This bill marks one of those moments where this place can have a clear and significant impact on the personal lives of some Australian families. It's a reform that has been years in the making and it's a reform that can bring hope and relief to many. Maeve's Law is named in honour of little Maeve Hood, who at 18 months was diagnosed with Leigh syndrome, a severe mitochondrial disorder. The bill was named after Maeve because of the tireless work of her parents, Sarah and Joel, along with the Mito Foundation, who worked to raise awareness and build support for those in our community with mitochondrial disease. It is a testament to their efforts and tireless campaigning that this bill has made it to the Senate floor, and I really hope we will pass this bill as the other place did in the last sitting of 2021. I thank the Hood family, Sean Murray of the Mito Foundation, who has worked so hard explaining to MPs and senators why this bill is so important, and the many other families who have championed this issue.

Mitochondrial disease affects all communities in Australia. Just last November over 1,000 Canberrans participated in the 35-kilometre 'Bloody Long Walk' for the Mito Foundation. They walked for the many families who have felt the pain of losing loved ones to this dreadful disease. In preparing for this bill I spent time reading the stories of those Australians who have shared their lives and their stories in advocating for these laws. They are the stories of sons and daughters, mums and dads. And there's little Maeve, who is only five and who has done so much along with her parents to raise awareness of mitochondrial disorders. But there are so many more, and more than 30 stories appear on the mitochondrial website.

I read every single one of those stories in educating myself to get a full appreciation of why it is so important to pass this bill. Behind those names are the stories of babies, toddlers, young children, teenagers, young adults, middle-aged Australians and older Australians, all affected by mitochondrial disease. The stories are often difficult to read, and the generosity in sharing them, in the single hope that we will change the laws and help families, is the most unselfish of acts. The stories from mums and dads about losing their babies to this disease, written with such love and loss, were painful to read and almost impossible for me to comprehend. The photos that accompanied each story were of cheerful cherubic faces, children with wide smiles surrounded by families, and adults and parents—everyday Australians struck down out of the blue, at random and often with debilitating and life-limiting symptoms. The stories told were of not knowing what was happening to young babies as they started to show symptoms, of the misdiagnoses, of the testing, of the guilt and pain from learning that the condition is passed on from parent to child, and that you as the carrier of the faulty gene had caused this disease to occur in your babies, and of the uncertainty and fear that comes with caring for someone with mitochondrial disease.

Alastair was a Canberran who was diagnosed with mitochondrial myopathy in his late 60s. He suffered from poor hearing, loss of balance and extreme fatigue. Unfortunately, Alastair deteriorated quickly. He needed his wife, and eventually his son, to care for him before he passed away aged 74. Alastair told his son, 'Be careful having kids'—what a burden that must be to carry. These people and many others who have been touched by mitochondrial disease are the most powerful of advocates for the change that this law proposes.

This bill is an opportunity to take advantage of the advances in reproductive technology to avoid the heartache, pain and anguish of having a child with severe mitochondrial disease. It would amend existing legislation to make mitochondrial donation legal for research, training and human reproductive purposes, allowing families to have a biological child in a way that minimises the risk of transmitting mitochondrial disease. Other senators have gone through the detail of this bill in their contributions, so I won't repeat that other than to say that we know around 56 children are born with the disease each year—approximately one child a week. This bill can reduce that number, and on those grounds alone I support this bill.

I acknowledge that the bill does raise concerns for some senators. On votes of conscience, when the colours of party are stripped away, we stand here as individuals. We all bring our own perspective and our own life experience to this chamber. I come to this vote as someone who spent years working in the disability sector. I come to this vote as someone who spent eight years as a minister for health. I come to this vote as someone who has experienced the death of loved ones and the deep grief that follows. But, mostly, I come to this vote as a mum of three amazing children.

Debate interrupted.

Senate adjourned at 22 : 00