The Government released its response to the Senate Community Affairs Committee’s Report into The Science of Mitochondrial Donation and Related Matters on 20 February 2019.
Mito Foundation welcomes government response to recommendations from Senate Inquiry on mitochondrial donation in Australia, whilst recognising the need for swift action for those impacted by mitochondrial disease (mito).
Changing the law to enable Australian parents access to mitochondrial donation is critical given that one child every week is born who will develop an avoidable form of mitochondrial disease and many of these children will die.
The Foundation welcomes the commitment to develop a process for public consultation by the end of April 2019 and trusts that its implementation can then be expedited.
The Foundation is confident, having undertaken significant stakeholder engagement over the last few years, including with politicians and members of the community that Australians will support giving parents the choice to have children free from mitochondrial disease. In addition, other research including a Citizens’ Jury completed by the University of Sydney, reflect the attitudes shown in other jurisdictions, including the UK.
This is demonstrated by the submissions to last year’s Senate Inquiry in which the overwhelming majority supported legislative change to enable mitochondrial donation.
Underpinning the public consultation is the Government’s commitment to consult with scientists and other experts about mitochondrial donation before April. The Foundation looks forward to contributing to this work and notes that the timeframe reflects both the urgency of the task and the work done in other jurisdictions, notably the UK where mitochondrial donation is already legal. Beginning this work immediately is of critical importance.
The Foundation appreciates the Government’s decision to progress engagement with the COAG Health Council on mitochondrial donation and trusts that this can be expedited to enable Australian families access to mitochondrial donation as soon as possible.
The Foundation acknowledges the approach taken by the Government to the recommendation regarding access to international services for those Australians desiring to access mitochondrial donation in the short term. This approach recognises the challenges facing those members of our community who are running out of time in their quest to have healthy, genetically-related children of their own whilst balancing this against the desire for local consultation and review.
The Mito Foundation implores the Government to commence the required groundwork on accessing international services in parallel to ensure that, after consultation, when the decision to progress is taken there are no untoward delays for parents.
We appreciate the fact that access to international services has been identified only as a ‘short term solution’ whilst consultations progress regarding our own legislative change. Sending Australian patients overseas for treatment, whilst timely and welcome in this instance, is not a feasible long-term solution for Australian families.
The Foundation thanks the Government and the Senators who undertook the Inquiry for recognising the impact that mitochondrial disease has on the lives of people in the mito community and looks forward to continuing working towards access to mitochondrial donation for our community.
Read the Government’s response to the Senate Report
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.
What happened in the UK?
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.