The Senate Community Affairs References Committee Science of mitochondrial donation and related matters June 2018 Commonwealth of Australia 2018 ISBN 978-1-76010-783-3 Secretariat Ms Kate Gauthier (Inquiry Secretary) Mr Michael Kirby (Senior Research Officer) Ms Carol Stewart (Administrative Officer) PO Box 6100 Parliament House Canberra ACT 2600 Phone: 02 6277 3515 Fax: 02 6277 5829 E-mail: [email protected] Internet: www.aph.gov.au/senate_ca This document was produced by the Senate Community Affairs Committee Secretariat and printed by the Senate Printing Unit, Parliament House, Canberra. This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Australia License. The details of this licence are available on the Creative Commons website: http://creativecommons.org/licenses/by-nc-nd/3.0/au/ ii MEMBERSHIP OF THE COMMITTEE 45th Parliament Members Senator Rachel Siewert, Chair Western Australia, AG Senator Slade Brockman, Deputy Chair Western Australia, LP Senator Jonathon Duniam Tasmania, LP Senator the Hon Kristina Keneally New South Wales, ALP Senator Louise Pratt Western Australia, ALP Senator Murray Watt Queensland, ALP Participating members for this inquiry Senator Stirling Griff South Australia, CA iii iv TABLE OF CONTENTS Membership of the Committee ........................................................................ iii Abbreviations ....................................................................................................vii List of Recommendations .................................................................................. ix Chapter 1 Introduction .............................................................................................................. 1 What is mitochondrial disease? .............................................................................. 1 Mitochondrial donation .......................................................................................... 3 Regulation of mitochondrial donation and related research ................................... 3 Overseas status of mitochondrial donation ............................................................ 5 Report structure ...................................................................................................... 8 Conduct of the inquiry ............................................................................................ 8 Chapter 2 Living with mitochondrial disease ........................................................................ 11 What is mitochondrial disease? ............................................................................ 11 Living with mitochondrial disease ....................................................................... 16 Costs of mitochondrial disease ............................................................................. 20 Options for having children .................................................................................. 23 Committee view .................................................................................................... 29 Chapter 3 Science of mitochondrial donation ........................................................................ 31 Mitochondrial donation techniques ...................................................................... 31 Potential risks ....................................................................................................... 39 Is an additional scientific review required? .......................................................... 51 Australian clinical capacity .................................................................................. 51 Committee view .................................................................................................... 52 Chapter 4 Ethics of mitochondrial donation .......................................................................... 55 Moral issues .......................................................................................................... 55 Medical and health ethics ..................................................................................... 61 Scientific ethical considerations ........................................................................... 69 Concluding committee view ................................................................................. 75 Chapter 5 Regulation................................................................................................................ 77 Introduction .......................................................................................................... 77 UK path to regulation ........................................................................................... 77 Australian legislative prohibitions on germline modification .............................. 79 Australian approach to introduction ..................................................................... 82 Australian regulatory regime ................................................................................ 83 Accessing overseas clinics ................................................................................... 91 State law ............................................................................................................... 92 Public consultation ............................................................................................... 93 Recommendations ................................................................................................ 96 Appendix 1 Submissions and additional information received by the Committee ............... 99 Appendix 2 Public hearings ...................................................................................................... 103 vi ABBREVIATIONS AMDF Australian Mitochondrial Disease Foundation ART assisted reproductive technology ART Guidelines Ethical Guidelines on the use of assisted reproductive technology in clinical practice and research Cloning Act Prohibition of Human Cloning for Reproduction Act 2002 committee Senate Community Affairs References Committee DNA deoxyribonucleic acid Embryo Research Research Involving Human Embryos Act 2002 Act Fertility Society Fertility Society of Australia Health Ethics Australian Health Ethics Committee Committee HFEA Human Fertilisation and Embryology Authority, United Kingdom Human Research National Statement on Ethical Conduct in Human Research Guidelines IVF in vitro fertilisation LHON Leber's Hereditary Optic Neuropathy mtDNA mitochondrial DNA Murdoch Children's Murdoch Children's Research Institute and Victorian Genetic Research Institute Clinical Services NDIS National Disability Insurance Scheme NHMRC National Health and Medical Research Council PGD pre-implantation genetic diagnosis PNT pronuclear transfer technique RTAC Reproductive Technology Accreditation Committee of the Fertility Society of Australia SCNT Somatic cell nuclear transfer SIRT Scientists in Reproductive Technology of the Fertility Society of Australia UK United Kingdom UK Regulations The Human Fertilisation and Embryology (Mitochondrial Donation) Regulation 2015 USA United States of America viii LIST OF RECOMMENDATIONS Recommendation 1 5.99 The committee notes the strong potential of mitochondrial donation to address the debilitating effects of inheriting mitochondrial disease. The committee recommends that public consultation be undertaken regarding the introduction of mitochondrial donation to Australian clinical practice. To facilitate this consultation, the committee further recommends the Australian Government prepare a consultation paper, including options for legislative change that would be required. The Minister for Health should seek advice from the National Health and Medical Research Council on the most appropriate timing and format for this consultation. Recommendation 2 5.100 The committee recommends that the Australian Government task the National Health and Medical Research Council with advising on the following questions: • Whether mitochondrial donation is distinct from germline genetic modification. • 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? • Whether other approaches to inheriting mitochondrial disease should also be the focus of Australian research. 5.101 The committee recommends the findings be used to inform future legislative process. Recommendation 3 5.103 The committee recommends the Minster for Health take the findings of this report to the Council of Australian Governments (COAG) Health Council to progress the implementation of this report's recommendations with the states and territories. Recommendation 4 5.104 The committee recommends, noting the need for community consultation and scientific review, the urgency of treatment for current patients and the small number of patients seeking this treatment, that the Australian Government initiate dialogue with the relevant authorities in the United Kingdom to facilitate access for Australian patients to the United Kingdom treatment facility as an interim measure. x Chapter 1 Introduction 1.1 Mitochondrial donation is a reproductive technology procedure to reduce the chances of a woman passing on mitochondrial disease—a potentially life-threatening condition—to her children. 1.2 Mitochondrial donation was legalised for use on humans in the United Kingdom (UK) in 2015. The UK is the only