Senate Committee recommends laws change so Australian babies don’t suffer with mitochondrial disease
Australian women at risk of having babies suffering with severe mitochondrial disease may soon be able to have healthy children, following the Senate Community Affairs References Committee recommendation on 27 June to move towards legalising mitochondrial donation, a ground-breaking IVF technique that replaces energy-generating DNA in the mother’s egg with donor material.
The Committee’s report has been welcomed by the Mito Foundation, the peak body supporting Australians with mitochondrial disease, a serious and potentially fatal genetic disorder that starves the body’s major organs of energy.
The Mito Foundation Chairman Dr Doug Lingard thanked the Senators for their hard work inquiring into mitochondrial donation, and called on the Australian Government to act on the Committee’s recommendations as soon as possible.
“At least 60 Australian babies each year could be prevented from suffering severely disabling and potentially fatal forms of mitochondrial disease, if mitochondrial donation was available here. It offers the first practical hope for future generations to live free of maternally inherited mitochondrial disease,” Dr Lingard said.
“In the Mito Foundation’s experience engaging with the Australian public, politicians and other stakeholders, including a Citizens’ Jury in 2017, mitochondrial donation receives overwhelming support when people understand the procedure and its ramifications.”
“By acting promptly to change our laws, Australia could become the second country in the world to establish a regulated system to provide mitochondrial donation to families affected by this devastating disease,” Dr Lingard said.
“After ten years of scientific research, ethical review and consultation, in 2015, the UK made pioneering legislative changes to allow mitochondrial donation; these were endorsed in 2016 by the Human Fertilisation and Embryology Authority, and the first clinic and patient licences were issued in 2017.
“The Committee clearly recognises that the UK’s strict regulatory system for mitochondrial donation provides a sound basis for Australia, with only minor changes likely to be required to reflect our local context.
“The Mito Foundation supports the pathway towards legislation recommended by the Committee.
“We stand ready to help in the public consultation process and urge the Australian Government to seek the advice of the National Health and Medical Research Council as soon as possible,” Dr Lingard said.
Mitochondrial donation involves replacing the faulty mitochondrial DNA in the mother’s egg (0.1% of its genetic material) with healthy donor mitochondrial DNA so the resulting baby will not suffer with mitochondrial disease.
The mother’s and father’s nuclear DNA contributes more than 20,000 genes or 99.9 per cent of the baby’s genetic make-up and determines its appearance, intelligence, behaviour and other personal characteristics. The 0.1 per cent contribution (37 genes) from the donor egg means the resulting baby’s cells can effectively convert food and oxygen into the energy needed to power its organs.
Depending on which parts of their bodies are most affected and to what extent, people with mitochondrial disease can lose their sight or hearing, be unable to walk, eat or talk normally, have strokes or seizures, develop liver disease or diabetes, suffer cardiac, respiratory or digestive problems, or experience developmental delays or intellectual disability.
How you can help
The Mito Foundation is engaging with MPs, senators and government officials with the hope of changing government legislation to allow families affected by specific types of mito, the chance to have disease-free children. The process involves the CEO, board members, scientists, patients and their families meeting with politicians and generating media coverage to support the campaign.
Australian legislation governing mitochondrial donation
Research and clinical applications of mitochondrial donation are overseen by laws made by federal and state governments. State laws are, for the most part, consistent with federal law. In all states, legislation prohibits the use of mitochondrial replacement techniques in the clinic, and research is significantly restricted.
In all states except Western Australia, research on a limited range of mitochondrial donation is permissible up to day 14 of embryo development, subject to a license being granted. In 2010, the Hon. Mark Butler MP, then Federal Minister for Mental Health and Ageing, appointed an independent committee to review the two relevant acts: the Prohibition of Human Cloning for Reproduction Act 2002 and the Research Involving Human Embryos Act 2002. The committee’s report, released on 7 July 2011, recommended the existing legislation remain unchanged. To view the report, click here.
How many Australians could benefit from mitochondrial donation?
A recent publication in the New England Journal of Medicine – Mitochondrial Donation: How Many Women Could Benefit – estimates that “the average number of births per year among women at risk for transmitting mtDNA disease is 152 in the United Kingdom and 778 in the United States”.
A simple extrapolation from UK would be approximately 56 births per year in Australia given the respective population sizes and assuming roughly equal age distribution and fertility.
What happened in the UK?
After an extensive process involving many years of consultation and three separate expert reviews, regulations to allow mitochondrial donation have been approved by the UK Parliament:
- On Tuesday 3 February 2015 MPs in the House of Commons voted by 382 to 128 to allow mitochondrial donation.
- On Tuesday 24 February 2015 peers in the House of Lords voted by 280 to 48 to allow mitochondrial donation to be licenced for use.
- On Friday 16 December 2016 the UK Human Fertilisation and Embryology Authority (HFEA) approved the use of mitochondrial donation in specific cases.
- On Friday 17 March 2017, the HFEA granted the first clinical mitochondrial donation licence to the Newcastle Fertility Centre at the International Centre for Life in Newcastle-upon-Tyne, United Kingdom. Click here to read the Mito Foundation’s media release on the licence.
- On Tuesday 6 February 2018, two UK women carrying mtDNA mutations were granted permission to undergo mitochondrial donation, giving them the opportunity to have children free of mitochondrial disease. Read a British news article about this.
Read more about the latest developments in the UK.
US developments towards mitochondrial donation
Following a study by an expert committee, on 3 February 2016 the Institute of Medicine of the US National Academies of Sciences, Engineering and Medicine recommended that initial clinical investigations of mitochondrial replacement techniques (MRT) should be considered by the US Food and Drug Administration under certain conditions.
These conditions include limiting access to women who are at risk of transmitting a severe mitochondrial genetic disease that could lead to a child’s early death or substantial impairment; and, for the time being, only allowing male embryos created through mitochondrial replacement to be implanted for pregnancy, to preclude any unforeseen consequences being passed to future generations.
The Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations Report in Brief is available here.
The National Academies of Sciences, Engineering, and Medicine media release is available here.
- The Science Behind Mitochondrial Donation
- Australian Media Coverage
- UK Licences
- How You Can Help
- AMDF’s Position Statement