NHMRC to facilitate a public consultation on mitochondrial donation.

Following the Australian Government response to the Senate Community Affairs References Committee report of its Inquiry into the Science of Mitochondrial Donation and Related Matters the NHMRC Chief Executive Officer has been asked to facilitate a public consultation on the possible introduction of mitochondrial donation into Australian clinical practice. She has also been asked to advise the Government on key scientific questions identified by the Senate Inquiry. To facilitate this, NHMRC has established the Mitochondrial Donation Expert Working Committee to provide advice to the CEO on the legal, regulatory, scientific and ethical issues relating to mitochondrial donation.  

Public Consultation: starts September 2019

NHMRC will conduct a public process to obtain views from the Australian community on the social and ethical implications of mitochondrial donation. This is a complex assisted reproductive technology, which may be considered for introduction into Australian clinical practice.  

To support this process NHMRC will use a multi-modal approach to capture a range of community and consumer perspectives. This will include a call for submissions on specific issues through the NHMRC public consultation portal.  

To support the consultation process, NHMRC will develop an issues paper and educational materials. These materials will support community participation in the consultation process by providing full, clear and concise information on this complex matter.  

Consultation outcomes will be provided to the Australian Government in conjunction with the Committee’s expert advice on the scientific questions posed in Recommendation 2 of the Inquiry Report.

Consultation Schedule 

Timing Activity
September 2019 
  • Launch public consultation
  • Release issues paper
  • Open online submissions portal
October 2019
  • Forums and events (TBA)
November 2019
  • Forums and events (TBA)
  • Close online submissions portal

This schedule will be updated with information on the consultation process as it becomes available. To receive email updates on public consultation activities as they become available please contact NHMRC at mito.consultation@nhmrc.gov.au and ask to be added to our Mito Consultation mailing list. 

Senate Inquiry and Government Response 

The Senate Community Affairs References Committee conducted an Inquiry into the Science of Mitochondrial Donation and Related Matters. The Inquiry examined the impact of mitochondrial disease on Australian families and the healthcare sector, the safety and efficacy of existing donation techniques, and ethical considerations. 

The Inquiry Report, which was handed down on 27 June 2018, made four recommendations (summarised): 

  1. Undertake public consultation on the possible introduction of mitochondrial donation into Australian clinical practice
  2. Obtain expert advice through NHMRC about key scientific questions relating to mitochondrial donation
  3. Engage with state and territory governments on the findings of the Inquiry, and
  4. Seek access for Australian patients to mitochondrial donation procedures in the United Kingdom.

The Australian Government response to the Inquiry Report was tabled on 20 February 2019. The Government has asked NHMRC to deliver on the first two recommendations.  

Mitochondrial Donation Expert Working Committee 

The NHMRC CEO has established the Committee under section 39 of the National Health and Medical Research Council Act 1992. Members have been selected to provide a range of expertise and perspectives on the issues identified in the Australian Government’s response to the Senate Community Affairs References Committee inquiry report. 

Recent Activities

The Committee held its first meeting on 26 March 2019. Discussion focussed on: 

  • The context for the Committee, including relevant background on the Senate Standing Committee on Community Affairs report of its Inquiry into the Science of Mitochondrial Donation and Related Matters and Government Response, and
  • Broad issues and potential questions to underpin a community consultation on mitochondrial donation. 

Terms of Reference

The Mitochondrial Donation Expert Working Committee (‘the Committee’) will provide advice to the NHMRC Chief Executive Officer on the legal, regulatory, scientific and ethical issues identified by the Senate Community Affairs References Committee Inquiry into: The Science of Mitochondrial Donation and Related Matters (‘the Inquiry’).  

The Committee will:

  1. advise on key questions to underpin community-wide consultation and increase community literacy on issues raised by mitochondrial donation to be delivered by April 2019
  2. consider relevant literature and advise on questions posed within Recommendation 2 of the Inquiry Report, specifically:
    1. whether mitochondrial donation is distinct from germline genetic modification
    2. is there any new information to indicate that research findings from the United Kingdom that the science of mitochondrial donation is safe for introduction into controlled clinical practice cannot be applied in an Australian context, and
    3. whether other approaches to inheriting mitochondrial disease should also be the focus of Australian research
  3. advise on any other relevant issues as requested by the NHMRC Chief Executive Officer.

Committee Membership

Chair,
Associate Professor
Bernadette
Richards

Chair with broad expertise in relevant areas. Member-in-common with the NHMRC Australian Health Ethics Committee and Embryo Research Licensing Committee.

Dr
Clare
Boothroyd

Member with expertise in the clinical application of assisted reproductive technologies or gene therapies.

Professor
John
Christodoulou
AM

Member with expertise in the genetics of mitochondrial disease and/or genetic modification.

Professor
Sheryl
de Lacey

Member with expertise in the ethical and theological considerations relating to mitochondrial donation.

Reverend
Kevin
McGovern

Member with expertise in the ethical and theological considerations relating to mitochondrial donation.

The Hon
Judi
Moylan
AO

Member with expertise in Consumer health issues relating to mitochondrial disease.

Mr
Sean
Murray

Member with expertise in the consumer health issues relating to mitochondrial disease.

Associate Professor
Ainsley
Newson

Member with expertise in the ethical and theological considerations relating to mitochondrial donation.

Professor
Dianne
Nicol

Member with expertise in legislative and regulatory framework relevant to mitochondrial donation.

Professor
John
Rasko
AO

Member with expertise in the clinical application of assisted reproductive technologies or gene therapies, and their regulation.

Professor
Justin
St. John

Member with expertise in the genetics of mitochondrial disease and/or genetic modification.

Professor
Patrick
Tam

Member with expertise in the science of embryology and developmental biology.

Professor
David
Thorburn

Member with expertise in the genetics of mitochondrial disease and/or genetic modification.