Mitochondrial donation is an IVF technique (also known as mitochondrial replacement IVF technique, mitochondrial transplant or mitochondrial replacement) that could prevent transmission of mitochondrial disease (mito) from mother to child.
Currently this technique is not available in Australia. AMDF is beginning to engage with MPs, Senators and government officials to change government legislation to allow families affected by specific types of mito the chance to have disease-free children. The process will involve the CEO, board members, scientists, patients and their families meeting with politicians to support the change. To be successful, we need the help of the mito community.
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 AMDF’s media release on the licence.
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.