The National Health and Medical Research Council (NHMRC) will shortly release more information on the public consultation into legalising mitochondrial donation which is due to commence this month.
The consultation will consist of an online portal to make your own submission as well as a series of in-person forums across Australia.
To stay updated please send an email to mito.consultation@nhmrc.gov.au and ask to join the Mito Consultation mailing list.
June 2019 Update:
The re-election of the Morrison Government and particularly the re-appointment of Greg Hunt as Health Minister are welcome as they provide both continuity and momentum to the work already undertaken.
With the Government’s re-election, its response to the Senate Inquiry into the science of mitochondrial donation tabled in February this year remains relevant. The foundation is aware of substantial work undertaken on progressing this during the caretaker period of the election.
Chris Bowen has been appointed Shadow Health Minister with Catherine King moving to the infrastructure, transport and regional development portfolio. The foundation is grateful for the work done by Catherine King’s office and looks forward to working with the new Shadow Minister.
The composition of the Senate Community Affairs Committee, the House of Representatives Health Committee and the relevant parties’ backbench policy committees will not be known until Parliament resumes, which is expected in July. These committees and their members will continue to be important stakeholders in our campaign.
We expect to reach out to members of the mito community shortly to encourage them to connect with their local MPs and ensure that all new MPs and Senators are seen in a timely manner.
We have already engaged with the Health Minister and the National Health and Medical Research Council (NHMRC) to confirm the work undertaken so far and their commitment to continuing this. The Government’s response to the Senate Inquiry has mapped out a clear process for legislative change.
The foundation is currently updating its strategy with new stakeholders and planning how best to support the public consultation process towards legislative change.
Our PR campaign has been developed to support this and will be finalised once the timings and process for public consultation are confirmed by the NHMRC and the minister’s office.
While the political environment settles post-election we are ensuring that mitochondrial donation remains on the agenda and pushing for prompt action. We will keep you updated on progress.
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. 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 that its implementation can then be expedited.
The foundation is confident, having undertaken significant stakeholder engagement with politicians and members of the community that Australians will support giving parents the choice to have children free from mitochondrial disease. Other research, including a Citizens’ Jury completed by the University of Sydney, reflects the attitudes shown in other jurisdictions.
The submissions to last year’s Senate Inquiry demonstrated that 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 Council Of Australian Governments (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 government’s approach 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 for those who are running out of time to have their own healthy, genetically-related children.
The foundation thanks the Inquiry for recognising the impact that mitochondrial disease has on peoples’ lives and looks forward to 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 US?
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.