Maeve’s Law Bill

House of Representatives 30/11/2021

Mr KHALIL (Wills) (18:48): It’s not often in this place we are given an opportunity to vote according to our conscience. When these times do come around, it is a moment of great import for this parliament because, while we disagree much of the time in this place, what makes this type of vote different is that our debate will be not just along party policy lines but also based on each member’s philosophy, values and conscience.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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