Thursday, 25 November 2021
Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021; Second Reading
I'm very pleased to rise to speak on this bill, the Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021. I stress that I don't do that on behalf of the opposition or my party; I do this as an individual MP, because our party has decided, as I understand the government party room has as well, that this will be a matter debated and voted on as a conscience vote or a free vote. That is not done lightly by our side of politics. That is a decision made sparingly in Labor Party party rooms, and I will talk a little bit about that. But the remarks I make are delivered as an individual MP rather than as the shadow minister for health and ageing.
This bill is appropriately named Maeve's Law, after Maeve Hood, who the minister, in a very fine speech to the parliament eight months ago, informed us was a young girl, then five years of age—she might be six now—living in his electorate down in Victoria with mitochondrial disease. It's a reminder that, for all of the technical and ethical issues that this bill raises for members, ultimately these pieces of legislation are about people. They're about patients. In this case, they're about very young children and their parents, grandparents and wider families.
But, having said that, I note that as members of parliament we must also grapple with the fact that this bill raises a number of issues that, in many ways, are age-old in health care: the collision between discovery or technology in health care on the one hand and ethical and faith based beliefs that members of the broader community, as well as members of this parliament, hold on the other. As I say, this is not a new tension. It sometimes manifests, it would appear, as more than a tension; it manifests as a bona fide collision. This is not new. This is age-old. But we have to recognise, as the member for North Sydney and the member for Macarthur reminded us in their remarks in relation to a very important Reps inquiry report delivered today, we lived through a period of turbocharged discovery as we harnessed the benefits of big data: information technology systems that are being harnessed by the healthcare system and by researchers across Australia and the world; and new discoveries, particularly in the fields of genomics and others.
As we come to this debate, all of us recognise that this raises very sensitive issues. We are dealing with a disease that too often is fatal for very young members of our community, causing enormous grief and real suffering to their families, as we'd all understand. But it also does raise some very, very deeply held, serious ethical and faith based beliefs by many members of our community and many members of this place. In particular, the legislation impacted by this bill, the Research Involving Human Embryos Act and the Prohibition of Human Cloning Act, are both pieces of legislation passed in 2002, as Deputy Speaker Andrews would recall, being a member of the Howard government at the time. This bill involves three issues that raise particular ethical considerations for the parliament: the potential creation of embryos for purposes other than procreation or pregnancy, although I will come to the debate around that question; the destruction of an embryo, and questions around human cloning—I use that term in a technical sense as it is defined in the Prohibition of Human Cloning Act.
As I said, all of those questions have been debated in this parliament before. Deputy Speaker, you're probably the only one in the chamber right now who was involved in those debates in 2002 and 2006. They have been very broadly canvassed in the community as quite pronounced examples of that collision I talked about between this extraordinary period of discovery that we live in on the one hand, and long-held and deeply-held ethical and faith based beliefs on the other hand.
Mitochondrial disease is an incredibly serious genetic disorder which is often fatal for very, very young children. Somewhere between 2,000 and 5,000 Australians will develop severe mitochondrial disease during their life time. We're told that, on average, one baby is born every week with severe mitochondrial disease, and most of those babies will die within the first five years of their life. Mitochondrial disease is caused by a defect in the mitochondrial DNA of the baby, which is a type of DNA passed on only through the mother—that is, passed on through the egg cells rather than the sperm cells.
Importantly, mitochondrial DNA is very distinct from nuclear DNA, which makes up the overwhelming bulk, as much is 99.9 per cent, of a person's DNA. It is the nuclear DNA which determines what we would understand to be the person's unique characteristics: their look, their personality and so on and so forth. On the other hand, mitochondrial DNA, which constitutes around 0.1 per cent, one-thousandth, of a person's DNA, is essentially responsible for converting food and oxygen into energy, which is why it's described in the literature and common parlance as the 'battery pack' of the human. That's a very important distinction between mitochondrial DNA on the one hand, which is incredibly important but a very small part of the person's DNA, and, on the other hand, nuclear DNA, which goes to make up what we understand to be the unique characteristics of a human.
The proposal which is canvassed within the essentially regulatory framework that's proposed by this bill is a process that is used as part of assisted reproductive technology, or IVF or ART as we've come to know it in this country.
There are two techniques that are under consideration across the world and, relevantly, in Australia to be canvassed by this bill. There are two techniques under consideration to use a donor's mitochondrial DNA to replace the mother's mitochondrial DNA, because, as I said, ultimately it is the passing on of the mother's mitochondrial DNA, if that is defective, that causes mitochondrial disease in the baby. Both of these techniques use the donor's egg, which is not particularly novel—a well-known technology—and the donor's mitochondrial DNA. The donor's nuclear DNA—that is, all of the DNA that goes to make up what we'd understand to be the unique characteristics of the donor as a person; their appearance, their personality, their intellect and so on—is removed from the egg and it is replaced by the nuclear DNA of the mother. So all of those characteristics that we would understand to be inherited from our mothers all come from, all flow from, the nuclear DNA. And that nuclear DNA from the mother is inserted into the donor's egg along with the battery pack, along with the mitochondrial DNA. That is a very important distinction—between the nuclear DNA and the mitochondrial DNA.
There are two techniques to undertake this combination of a donor's mito DNA and the mother's nuclear DNA. Importantly, for our country—because our country has been looking to the example of the United Kingdom—both of those techniques are licensed in the United Kingdom and have been since 2015, and are both canvassed by this bill.
The first is known as maternal spindle transfer. The important distinction involved in this technique compared to the one I'll come to in a second is that the transfer of the nuclear DNA from the mother into the donor egg happens before the fertilisation of the egg. It happens before the donor's egg is fertilised by the father's sperm. This technique, it must be said, although it's proposed to be canvassed or licensed ultimately by this bill if the bill passes, is much less developed than the second technique I'll come to. It does involve transfer before fertilisation of the egg, which has an important distinction for many who will bring their ethical framework to the consideration of this bill. But it must be said it is a far more technically difficult technique and therefore far less developed, and, we should be honest and say, far less likely to be utilised in this country. It's certainly proving to be far less likely to be utilised in the United Kingdom, which is some years ahead of us in this area.
The second technique is known as pronuclear transfer, and that is the more advanced technique and the technique which, we must be honest, is more likely to be used here if this bill passes and if what is proposed in the bill becomes reality. It involves both eggs—both the donor's egg and the mother's egg—being fertilised, and it is after fertilisation that the process I outlined earlier takes place. So the mother's nuclear DNA is removed from her fertilised egg and inserted into the donor's fertilised egg, which has had its pronuclear DNA removed. So the important distinction again, as people think about their views on this bill, is that the pronuclear transfer happens after the fertilisation of the egg. The mother's fertilised egg is then destroyed.
Now, for some, it must be said, that involves the creation and the destruction of an embryo. There are different views in the community about the point at which a fertilised egg becomes an embryo, as many members here will understand. Some church and other faith based organisations and their members and adherents hold the view that an embryo is formed at the point of fertilisation. They are genuinely held beliefs.
The 2002 forms of the legislation that is proposed to be amended by this bill—the 2002 definition of an embryo—were that an embryo comes into being at the appearance of the two pronuclei, so effectively very soon after the fertilisation. In 2005 the Howard government commissioned a review of this legislation, which resulted in the Lockhart report, which was then implemented through 2006 amendments to this legislation. One of the recommendations of the Lockhart review was to amend the definition of 'embryo' and essentially push that definition further down the development pathway, if you like. The submissions from the research community in particular were that the definition of 'embryo' in the original legislation in 2002 was too restrictive. They made submissions, which were ultimately accepted by Lockhart and implemented by this parliament, to change the definition of 'embryo' to the following: 'an embryo is created at the first mitotic division, when fertilisation is complete', which is essentially the process of cleavage, some two or three days after the combination of the sperm and the egg.
So I do make the point—I think it's important I make it, given the position I hold in the Labor Party, at least—that, on my reading of the 2006 amendments to the legislation, both the pronuclear transfer and certainly the maternal spindle transfer probably do not involve activity undertaken at the point of an embryo. But I recognise that different members of this parliament, certainly different members of the community, hold other views about when an embryo ultimately is created.
This bill being debated right now, and we hope over coming days and next week in the other place, perhaps, is a long time coming. I don't make that point critically; I make it to reinforce that this has been the product of quite substantial consideration by constituent parts of this parliament but also out there in the community. In 2018 an important Senate committee report was delivered, and I'm only familiar with the Labor senators involved, but I acknowledge the involvement of Senator Keneally, Senator Pratt and Senator Watt in particular as members of that inquiry; others played a role as well. That was a very important process to hear from stakeholders, families, researchers and the like.
In 2019 and 2020, at the direction of the government, the NHMRC undertook a very exhaustive consultation process around that, essentially leveraging off the report undertaken by the Senate. In 2019 and 2020 there was substantial engagement by the minister, and I thank him for it, with my predecessor, the member for McMahon. Ultimately, in the early part of this year, on 2 February, the minister released a consultation paper, which was open for about six weeks, indicating the government's broad intent in this area, seeking submissions around that broad intent. On 24 March the minister, as I said, in a very fine speech, introduced this bill to the parliament. This is more than eight months ago. This is the first opportunity we have had to debate the bill since then. In the intervening period, the Senate Community Affairs Legislation Committee held an inquiry, which reported in August. Given that both major parties have decided this would be decided by a conscience vote, no recommendations around the substance of the bill were contained in that report, but I think the report is a valuable consolidation of the different views and the different submissions that were made to that Senate inquiry.
Finally, in the intervening period—and I will come to this in some more detail, because it relates to some amendments that the government has only released in the last hour or so—the Senate Scrutiny of Bills Committee made a report, which, as I said, I will deal with in a little more detail later. As I said, the government proposal largely replicates the United Kingdom framework 2015, which is broadly recognised around the world as the leading framework in this area. It proposes what I describe, and I think the minister agrees, as a slow, staged approach to this question. And it allows, as I said, both of those techniques—the maternal spindle transfer technique and the pronuclear transfer technique—to be researched and ultimately perhaps developed in this country. It will involve a regime of licensing by the existing NHMRC Embryo Research Licensing Committee, which was established by the 2002 legislation and which has been operating ever since, for almost two decades. The first stage, which the minister describes as stage 1A, would involve one clinic in the country being identified and licensed to undertake research and training in this area. That research and training would be directed at refining techniques and protocols that might be implemented more broadly in the community. The second stage, stage 1B, would involve a clinical licence being delivered to that clinic to allow mitochondrial donation to be undertaken with approved families. Again, that will be overseen by the NHMRC Embryo Research Licensing Committee.
I emphasise that these two stages involve quite an extensive period of time. The limited research and clinical practice in those two stages might take as much as 10 to 12 years to be developed to the point where I think this parliament would be comfortable with an expansion to broader clinical practice beyond that single clinic. Obviously, the states will also be required to opt into this scheme. Initially, that probably only involves one state, given the nature of the clinic being licensed. But that's important, given that ART, or assisted reproductive technology, is also substantially governed by state laws.
As I said, there are a number of legal and ethical issues beyond the broadly medical or technological issues that are canvassed by this bill. It is unclear, at a legal level at least, whether this does involve the creation of an embryo as defined by the legislation after the Lockhart review research, and, ultimately, the destruction of that embryo. But it is quite clear that for many in the community—and, I'm sure, for some in this parliament—an embryo is created and ultimately destroyed, within their personal understanding of an embryo. What is clear, though, to me—and, I imagine, to everyone in this parliament—is that the provisions of the prohibition against human cloning in research act are activated.
As Deputy Speaker Andrews will be very familiar with, that act contains a prohibition against the creation of an embryo that contains genetic material from more than two people—more than just what we would typically understand to be the mother and the father. There are also a number of legal changes, which I will come to. On this last point, the fact is that if you have mitochondrial DNA and the egg from a donor, the nuclear DNA from the actual mother and , obviously, the father's sperm, it involves three parents. The media often uses this term of a 'third parent' or a 'three-parent family'. I have to say I reject that label as fundamentally inconsistent with a whole range of other technologies that are undertaken in medicine. For example, organ donation introduces much more third-party genetic material than this proposed technique does. But, ultimately, I reject it because I think it's stigmatising and not helpful to a proper legal and ethical understanding and debate about this. There are also legal issues around the donor, particularly around the donor's relationship with the child. These are not new issues, and as the bill canvasses and the minister has said, they would likely be dealt with in the same way in which we deal with sperm and egg donors in the context of the Family Law Act and so on and so forth.
As I said, this will be dealt with on the Labor Party side, and, I understand, on the government side as well, as a conscience vote. That is consistent with the way in which the Labor Party has treated issues around embryo research since the national executive back in 2002, of which I was a member at the time, considered how to deal with the original legislation on research involving human embryos and human cloning. A decision was taken by the executive that this would be dealt with as a conscience vote by the Labor Party, and that is how we will deal with it on this occasion as well.
My view about this legislation is that it is well designed and it balances the extraordinary potential these emerging technologies have to improve medical practice and the quality of life for a number of Australian families, while recognising the ethical issues that are posed for many Australians and the need to tread carefully through this in a slow and staged way. The Lockhart review was an important review of this legislation after several years of operation. It involved some legislative change. In 2010, when I was the minister with responsibility for the NHMRC, I commissioned a further review of this legislation, which reported in 2011 and recommended no substantial change to the regime, particularly the role of the NHMRC Embryo Research Licensing Committee. This is an appropriately cautious and staged approach, overseen by a licensing committee that has demonstrated its value and its capability over almost two decades now. It flows from deep consideration over several years and draws, as I said, on the experience of our friends in the United Kingdom, who have been dealing with this for several more years than we have here in Australia. There is a big way to go yet in developing the protocols, the techniques and the understanding of this research, but it does provide real hope to many families across Australia. I indicate I will be voting in favour of this bill. I recognise these issues are not easy for many members of the community, including many members of this parliament, but I'm convinced this legislation is worthy of our support.
In my closing remarks, I want to pay tribute to a few people. The first is the minister, who made a very fine speech introducing this bill and who has brought his experience, his substantial intellect and his humanity to this process. He is to be credited for that. The previous shadow minister for health, the member for Ballarat, and the current shadow minister for health, the member for McMahon, worked with the minister very closely and constructively; I want to pay credit to them as well. MPs in this House have also been engaged and, even though they may come to this legislation with different ethical beliefs about the operation of it, have participated in the debate in good faith and very constructively in a way that reflects the way in which this legislation was debated all the way back to the time of the Howard government.
There were many researchers, many commissions, many community members and many faith leaders who also participated in this process either in the policy debate or in clinical practice and research. They have put their views forthrightly, respectfully and constructively. I want to thank them. Most importantly, I want to thank the mito community—the parents, grandparents and young children who are living with these devastating diseases. I recognise they are difficult conditions to respond to as a parliament and a medical community. They have been ably led by the Mito Foundation, and I want to thank them for their bravery, their fortitude and their compassion. I commend the bill.
Before I conclude my remarks, can I say a few words about amendments that have been released—I think we received them about an hour and a half ago from the government. I haven't had a chance to consult on them. As I said, I'm not speaking as the shadow minister for health; I'm speaking as an individual MP. All members will need to look at these amendments. They flow from a Scrutiny of Bills Committee report that was delivered in April. At that time, the minister wrote in reply to the report, indicating that he did not think there was a need for any amendments to the bill. That view has changed in the last 24 hours, it would appear. I think it's a pity that these amendments are being brought to the parliament so late in the day, given the very deliberative and constructive way in which this bill has been developed. I can say at first blush that these amendments look and sound like the sorts of amendments that I individually would be willing to support. But I need to indicate that we've only received them in the last hour and a half and that the debate is underway.
This is a very unique type of debate in the sense that the usual party processes don't operate. Every individual MP in this place is making a decision on this legislation according to their own views on the bill and their own conscience. So I make the point that I think it is a pity that this has happened so late in the day. It is going to be difficult to make sure that these amendments are circulated to all members who ultimately are going to have to vote as individuals in this debate perhaps early next week. But I have indicated to my colleagues that, having had a chance to look through these amendments, for what it's worth—and it may not be worth much—I would be willing to support those amendments. But I reinforce that that is only a comment that I make as an individual MP rather than on behalf of my party.