Almost a year ago, in March 2021, the Mitochondrial Donation Law Reform (Maeve’s Law) Bill was introduced into Federal Parliament by health minister Greg Hunt. The bill seeks to amend existing legislation to make mitochondrial donation legal for research, training and human reproductive purposes. The legislation is named after five-year-old Maeve Hood, who has a severe type of mitochondrial disease which was diagnosed when she was 18-months-old.
The bill has raised serious moral and ethical issues, with passionate arguments from politicians on both sides of the divide. Should the bill become law, it would allow researchers to change the human genome, with these changes heritable over generations. It would also allow human embryos to be created and destroyed purely for research purposes — something that Australian law currently forbids. Current law also prohibits the creation of human embryos by fertilisation with genetic material from more than two people, which mitochondrial donation would change with three-parent embryos created.
In December 2021, the bill passed the federal House of Representatives, without amendment, 92 votes to 29. The bill now sits with the Senate where, if passed, is likely to become law this year.
Proponents of the bill argue that this is an important step toward the eradication of the mitochondrial gene between generations and therefore enables a better quality of life. Many, however, have expressed great discomfort not only because of the serious ethical issues the bill raises but for the lack of available research data and the bill's current provision of sex selection by parents. The Australian Catholic Bishops Conference has also expressed its grave concern about the bill in a submission to the Senate Community Affairs Committee. In it, the Bishops urge federal politicians to scrap plans to allow mitochondrial donation, citing safety and ethical concerns and a lack of evidence proving that the technique is effective.
Mitochondrial disease refers to a group of inherited conditions caused by 'faulty' mitochondria — the cells that help the body to produce energy. When these cells don't function properly, people can experience organ failure, serious illness and premature death.
Only the egg cells (i.e. not sperm cells) can pass on mitochondria to the next generation, so while mitochondrial disease can affect both males and females, it is only the female who can pass on mitochondrial mutations to their children. There are currently no available cures to mitochondrial disease.
The bill put forth proposes amendments to the existing Prohibition of Human Cloning for Reproduction Act 2002, Research Involving Human Embryos Act 2002 and Research Involving Human Embryos Regulations Act 2017. If passed, it would allow for the donation of third-party DNA to existing embryos, and for the creation of an embryo for the purposes of research — an embryo that would then be destroyed. The only place in the world where this is currently legal is in the UK where a similar bill was passed five years ago. However, there are yet to be any reported live births resulting from the mitochondrial donation technique.
Prior to the bill’s passage in the lower house, the federal Member for Menzies, Kevin Andrews spoke passionately about why he opposed the bill in its current format.
‘The bill prescribes five techniques ... Two techniques involve the transfer of material between eggs — that is, the maternal spindle transfer and the germinal vesicle transfer. Three other techniques involve the transfer of material between zygotes or embryos — namely, pronuclear transfer, first polar body transfer and second polar body transfer. These three techniques necessarily involve the destruction of the zygote or the embryo,’ Mr Andrews explained.
Given the experimental nature of what is being proposed, the absence of any data from the UK and the lack of any evidence that these techniques will achieve what is being proposed, it is entirely reasonable, I submit, to ban the deliberate destruction of the zygote or the embryo at this time. Moreover, we are told that the early stages of research could take a decade. If so, there is a case for the less destructive techniques to be explored first.’
Mr Andrews also expressed concern around the provision for the availability of sex selection under the proposed bill, something which is not included in the UK legislation.
‘After attending pretreatment counselling, a patient and her spouse, if any, can request to have only male embryos selected for implantation where it is deemed safe and practical to do so. This is notionally because it is said that there is less chance of transferring defective mitochondria to a male baby — an admission, I note in passing, that in itself is about the experimental, uncertain nature of these techniques.’
In July 2021, the Australian Catholic Bishops Conference made a submission to the Senate Community Affairs Committee Inquiry into the Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021, opposing the bill. The Bishops detail a range of concerns about the legislation, noting that while the legislation seems unlikely to help many families, it would, in fact, open the door to three ethically contentious practices:
‘We disagree with the use of IVF with egg donation, but this is an option which is already legal and would allow parents to have a child without the risk of having mitochondrial disease,’ said Bishop Richard Umbers, Bishop Delegate for Life.
Mitochondrial donation, which genetically modifies a human embryo or egg, adds issues of safety and ethics with no benefit to health,’ Bishop Umbers said.
‘The Government admits that “the risks for children born using these techniques are not yet fully understood and the available scientific evidence to support this procedure is limited”, which underlines how premature this legislation is,’ Bishop Umbers continued. ‘Mitochondrial donation will not cure children who are sick.’
Furthermore, as well as other ethical considerations, the methods used in mitochondrial donation lead to human embryos being created and destroyed, both for research and for clinical work:
The legislation would for the first time allow human embryos to be created and destroyed purely for research and training. The Conference objects to the disposing of any human embryos ... Human beings have inherent dignity and their rights as people must be respected, including their right to life from the moment that the first cell of the human zygote is formed by whatever means it comes to be.
Similar reservations were recently put forward by Victorian Senator Raff Ciccone, who said that even among scientists and clinicians there were still too many questions around mitochondrial donation that remained unanswered. He reflected that the divisive nature of the subject was ‘proof enough that we may be pushing the boundaries of nature beyond a morally acceptable level’.
Referring to the different techniques that could be employed to facilitate mitochondrial DNA donation, the senator said that the ‘instrumentalisation of the human embryo’ and its use ‘merely as part of a production process’ was an ethical challenge that society must decide if it is comfortable with.
He also argued that the research presented failed to illustrate 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.’
The senator echoed Mr Andrews’ concerns around the destruction of embryos for the sake of science.
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.’
The senator argued that existing IVF procedures in Australia already allow prospective parents the opportunity to have a child without the risk of the child having mitochondrial disease. ‘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,’ he said.
Senator Ciccone also suggested that consideration must be given to the interests and wellbeing of those who will be born from mitochondrial donation. ‘The experimental nature of mitochondrial donation is likely to necessitate continual follow-up over the child’s life span,’ he said.
‘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? Those born as a result of the donation have no say in the procedure or the consequences that follow it.’
The bill is expected to be put to a conscience vote in the Senate.
Safeguarding Unit31 January 2023
Australian Catholic Bishops Conference (ACBC)16 January 2023