Chapter 1 - Introduction

[1]        Deoxyribonucleic acid (DNA) is a chain of nucleotides carrying the genetic instructions for the growth, development, functioning and reproduction of living organisms.

[2]        House of Commons Library (UK), Mitochondrial Donation, Standard Note: SN/SC/6833, 29 January 2015, p. 5.

[3]        Committee on the Ethical and Social Policy Considerations of Novel Techniques for Prevention of Maternal Transmission of Mitochondrial DNA Diseases, US Institute of Medicine, Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations, February 2016, p. 1.  

[4]        This subset of mitochondrial disease is often referred to as mtDNA disease.

[5]        Australian Mitochondrial Disease Foundation (AMDF), Mitochondrial Disease: the need for mitochondrial donation, p. 1.  

[6]        House of Commons Library (UK), Mitochondrial Donation, Standard Note: SN/SC/6833, 29 January 2015, pp. 6–7.

[7]        Committee on the Ethical and Social Policy Considerations of Novel Techniques for Prevention of Maternal Transmission of Mitochondrial DNA Diseases, US Institute of Medicine, Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations, February 2016, p. 1.  

[8]        Ainsley Newson, Stephen Wilkinson and Anthony Wrigley, 'Ethical and legal issues in mitochondrial transfer', EMBO Molecular Medicine, June 2016, p. 2.   

[9]        National Health and Medical Research Council (NHMRC), Submission 4, p. 7.

[10]      NHMRC, Submission 4, p. 1.

[11]      NHMRC, Submission 4, p. 1.

[12]      NHMRC, Ethical Guidelines on the use of assisted reproductive technology in clinical practice and research (ART Guidelines), 2007, https://www.nhmrc.gov.au/guidelines-publications/e79  (accessed 22 May 2018).

[13]      NHMRC, National Statement on Ethical Conduct in Human Research, 2007, https://www.nhmrc.gov.au/guidelines-publications/e72 (accessed 22 May 2018).

[14]      NHMRC, Submission 4, p. 1.

[15]      Fertility Society of Australia (Fertility Society), Submission 27, p. 1.

[16]      Dr Petra Wale, Board Member, Fertility Society, Committee Hansard, 17 May 2018, p. 41.

[17]      NHMRC, Submission 4, p. 1.

[18]      Dr Nadine Richings, Vice Chair, Scientists in Reproductive Technology (SIRT), Committee Hansard, 17 May 2018, p. 42.

[19]      Dr Richings, Committee Hansard, 17 May 2018, p. 42.

[20]      Minutes for three decisions have been published: two applications were approved and for the other application, more information was requested regarding alternative options available to the patient. See Reports archive available at https://www.hfea.gov.uk/choose-a-clinic/clinic-search/results/17/.

[21]      R J Castro, 'Mitochondrial replacement therapy: the UK and US regulatory landscapes', Journal of Law and the Biosciences, vol. 3, no.3, 1 December 2016, pp. 726–735.

[22]      National Academies of Sciences, Engineering and Medicine (USA), Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations, 3 February 2016, available at http://www.nationalacademies.org/hmd/Reports/2016/Mitochondrial-Replacement-Techniques.aspx.

[23]      Consolidated Appropriations Act 2018, Pub L No 115-141, §734.

[24]      Straits Times, 'Bioethics committee seeks views of emerging genetic modification technology to prevent disorders', 19 April 2018, https://www.straitstimes.com/singapore/health/bioethics-committee-seeks-views-on-emerging-genetic-modification-technology-to (accessed 8 May 2018).

[25]      Journals of the Senate, No. 90, 21 March 2018, p. 2864.

[26]      See: www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/ MitochondrialDonation.

Chapter 2 - Living with mitochondrial disease

[1]        Mr Sean Murray, Chief Executive Officer, Australian Mitochondrial Disease Foundation (AMDF), Committee Hansard, 17 May 2018, p. 1.

[2]        Deoxyribonucleic acid (DNA) is a chain of nucleotides carrying the genetic instructions for the growth, development, functioning and reproduction of living organisms.

[3]        AMDF, Mitochondrial Disease: the need for mitochondrial donation, p. 1.

[4]        House of Commons Library (UK), Mitochondrial Donation, Standard Note: SN/SC/6833,
29 January 2015, p. 5.

[5]        Mr Murray, Committee Hansard, 17 May 2018, p. 4.

[6]        AMDF, Submission 26, p. 2.

[7]        Committee on the Ethical and Social Policy Considerations of Novel Techniques for Prevention of Maternal Transmission of Mitochondrial DNA Diseases: US Institute of Medicine, Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations, February 2016, p. 1.

[8]        Professor John Christodoulou, Chair, Genomic Medicine, Department of Paediatrics, University of Melbourne, Committee Hansard, 17 May 2018, p. 13.

[9]        Rhonda, Committee Hansard, 17 May 2018, p. 33.

[10]      Mr Murray, Committee Hansard, 17 May 2018, p. 2.

[11]      Name Withheld, Submission 32, p. 2.

[12]      Name Withheld, Submission 39, p. 1.

[13]      Shelley, Committee Hansard, 17 May 2018, p. 38.

[14]      Rhonda, Committee Hansard, 17 May 2018, pp. 38–39.

[15]      Shelley, Committee Hansard, 17 May 2018, p. 38.

[16]      Professor Carolyn Sue, Director, Kolling Institute of Medical Research, Mitochondrial Disease Research Centre, Committee Hansard, 17 May 2018, p. 26.

[17]      Mr Murray, Committee Hansard, 17 May 2018, p. 3.

[18]      Mr Murray, Committee Hansard, 17 May 2018, p. 2. It was later clarified that not all the 1 in 200 individuals will develop sever mitochondrial disease. See AMDF, Submission 26.1, p. 3.

[19]      Professors David Thorburn, John Christodoulou, Carolyn Sue, John Carroll, Mike Ryan and Aleksandra Filipovska, Submission 59, p. 3.

[20]      Professors Thorburn, Christodoulou, Sue, Carroll, Ryan and Filipovska, Submission 59,    pp. 3–4.

[21]      Professor Thorburn, Head of Mitochondrial Research and Diagnostic Laboratories, Murdoch Children's Research Institute and Victorian Clinical Genetics Services, Committee Hansard, 17 May 2018, p. 11.

[22]      Professor Sue, Committee Hansard, 17 May 2018, p. 26.

[23]      Professor Sue, Committee Hansard, 17 May 2018, p. 26.

[24]      United Mitochondrial Disease Foundation, Mitochondrial Disease in Adults, http://www.umdf.org/mitochondrial-disease-in-adults/ (accessed 30 May 2018).

[25]      AMDF, Mitochondrial Disease Information: Where does mitochondrial disease hide if it is NOT diagnosed, https://www.amdf.org.au/mito-info/ (accessed 31 May 2018).

[26]      AMDF, Submission 26, p. 2.

[27]      Professor Christodoulou, Committee Hansard, 17 May 2018, p. 12.

[28]      Name Withheld, Submission 18, p. 1.

[29]      Name Withheld, Submission 18, p. 1.

[30]      Name Withheld, Submission 9, p. 1.

[31]      Name Withheld, Submission 36, p. 1.

[32]      Name Withheld, Submission 36, pp. 1–2.

[33]      Name Withheld, Submission 14, p. 1.

[34]      Name Withheld, Submission 11, p. 1.

[35]      Shelley, Committee Hansard, 17 May 2018, pp. 33–34.

[36]      Justin, Committee Hansard, 17 May 2018, p. 35.

[37]      Ms Monica Mary Ferrie, Chief Executive Officer, Genetic Support Network of Victoria, Committee Hansard, 17 May 2018, p. 2.

[38]      Name Withheld, Submission 18, p. 2.

[39]      Name Withheld, Submission 33, p. 2.

[40]      Mary, Committee Hansard, 17 May 2018, p. 34.

[41]      Mary, Committee Hansard, 17 May 2018, pp. 34–35.

[42]      AMDF, Submission 26, p. 12.

[43]      Name Withheld, Submission 39, p. 2.

[44]      Name Withheld, Submission 8, p. 2.

[45]      Name Withheld, Submission 8, p. 2.

[46]      AMDF, Submission 26, p. 12.

[47]      Name Withheld, Submission 32, p. 2.

[48]      Justin, Committee Hansard, 17 May 2018, p. 36.

[49]      Justin, Committee Hansard, 17 May 2018, p. 36.

[50]      Professors Thorburn, Christodoulou, Sue, Carroll, Ryan and Filipovska, Submission 59, p. 4.

[51]      Associate Professors Catherine Mills and Karinne Ludlow, Professor Robert Sparrow, Dr Narelle Warren, Submission 20, p. [11].

[52]      Murdoch Children's Research Institute and Victorian Clinical Genetics Services, Submission 23, p. 16.

[53]      Name Withheld, Submission 14, p. 2.

[54]      Name Withheld, Submission 32, p. 2.

[55]      Name Withheld, Submission 38, p. 2.

[56]      Justin, Committee Hansard, 17 May 2018, p. 36.

[57]      Professor Filipovska, Submission 17, p. 1.

[58]      Name Withheld, Submission 8, p. 1.

[59]      Name Withheld, Submission 9, p. 1.

[60]      Name Withheld, Submission 39, p. 2.

[61]      Name Withheld, Submission 38, p. 2.

[62]      Shelley, Committee Hansard, 17 May 2018, p. 34.

[63]      House of Commons Library (UK), Mitochondrial Donation, Standard Note: SN/SC/6833, 29 January 2015, pp. 6–7.

[64]      Professors Thorburn, Christodoulou, Sue, Carroll, Ryan and Filipovska, Submission 59, p. 1.

[65]      Professors Thorburn, Christodoulou, Sue, Carroll, Ryan and Filipovska, Submission 59,    pp. 1–2.

[66]      Mitochondrial Disease News, Prenatal Diagnostic Testing for Mitochondrial Diseases May Help Future Parents, UK Study Shows, 10 March 2015, https://mitochondrialdiseasenews.com/2015/03/10/prenatal-diagnostic-testing-for-mitochondrial-diseases-may-help-future-parents-a-study-in-uk-shows/ (accessed 15 June 2018).

[67]      Professor Christodoulou, Committee Hansard, 17 May 2018, p. 16.

[68]      Professor Thorburn, Committee Hansard, 17 May 2018, pp. 15–16.

[69]      Name Withheld, Submission 8, pp. 1–2.

[70]      Name Withheld, Submission 39, p. 2.

[71]      Mary, Committee Hansard, 17 May 2018, p. 35.

[72]      Professor Sheryl de Lacey, Submission 55, p. 3.

[73]      Australian Catholic Bishops Conference, Submission 28, p. 2. See also Australian Christian Lobby, Submission 51, p. 8; Social Issues Committee of the Anglican Church Diocese of Sydney, Submission 56, p. 3.

[74]      AMDF, Submission 26.1, [p. 13].

[75]      AMDF, Submission 26.1, [p. 13].

[76]      Anglicare, Looking to Adopt, https://www.anglicare.org.au/what-we-offer/foster-care-adoption/adoption/looking-to-adopt/ (accessed 30 May 2018).

[77]      Professor de Lacey, Submission 55, p. 3.

[78]      Name Withheld, Submission 8, p. 2.

[79]      Archbishop Anthony Fisher, Vice President, Australian Catholic Bishops Conference, Committee Hansard, 17 May 2018, p. 68.

[80]      Social Issues Committee of the Anglican Church Diocese of Sydney, Submission 56, p. 1.

[81]      Name Withheld, Submission 14, [p. 2].

[82]      Name Withheld, Submission 14, [p. 2].

[83]      Name Withheld, Submission 15, p. 2.

[84]      Professor Sue, Committee Hansard, 17 May 2018, p. 24.

[85]      Name Withheld, Submission 6, p. 1.

Chapter 3 - Science of mitochondrial donation

[1]        Deoxyribonucleic acid.

[2]        Wellcome Trust, Submission 1—Attachment 3, [p. 3]; National Health and Medical Research Council (NHMRC), Submission 4, p. 3; Dr Peter McCullagh, Submission 46, [p. 6].

[3]        Wellcome Trust, Submission 1—Attachment 3, [p. 3].

[4]        Mr Sean Murray, Chief Executive Officer, Australian Mitochondrial Disease Foundation (AMDF), Committee Hansard, 17 May 2018, pp. 3–4.

[5]        The Human Fertilisation and Embryology (Mitochondrial Donation) Regulation 2015 (UK), reg. 4 (UK Regulations).

[6]        Professors David Thorburn, John Christodoulou, Carolyn Sue, John Carroll, Mike Ryan, Aleksandra Filipovska, Submission 59, p. 5. See also J Zhang, H Liu, S Luo, Z Lu, A Chavez-Badiola, Z Liu, M Yang, Z Merhi, SJ Silber, S Munne, M Konstantinidis, D Wells, JJ Tang, T Huang, 'Live birth derived from oocyte spindle transfer to prevent mitochondrial disease', Reproductive Biomedicine Online, vol. 34, no. 4, pp. 361–368.

[7]        Professors David Thorburn, John Christodoulou, Carolyn Sue, John Carroll, Mike Ryan, Aleksandra Filipovska, Submission 59, p. 5.

[8]        A zygote is a fertilised egg which may then develop into an embryo.

[9]        Professors Thorburn, Christodoulou, Sue, Carroll, Ryan, Filipovska, Submission 59, p. 4.

[10]      Professor Justin St John, Professor and Head, Mitochondrial Genetics Group, Hudson Institute of Medical Research, Committee Hansard, 17 May 2018, p. 44.

[11]      UK Regulations, reg. 7.

[12]      Mr Murray, Committee Hansard, 17 May 2018, p. 4; Professor John Carroll, Director, Monash Biomedicine Discovery Institute, Monash University, Committee Hansard, 17 May 2018, p. 25.

[13]      Prohibition of Human Cloning for Reproduction Act 2002 (Cloning Act), s. 14; NHMRC, Submission 4, p. 7.

[14]      NHMRC, Submission 4, p. 7.

[15]      Cloning Act, s. 20; NHMRC, Submission 4, p. 7.

[16]      Human Fertilisation and Embryology Authority (HFEA), Review of the safety and efficacy of polar body transfer to avoid mitochondrial disease, October 2014, additional information received 30 May 2018, p. 4.

[17]      HFEA, Review of the safety and efficacy of polar body transfer to avoid mitochondrial disease, October 2014, additional information received 30 May 2018, p. 6.

[18]      HFEA, Review of the safety and efficacy of polar body transfer to avoid mitochondrial disease, October 2014, additional information received 30 May 2018, pp. 5–6.

[19]      Professors Thorburn, Christodoulou, Sue, Carroll, Ryan, Filipovska, Submission 59, p. 7.

[20]      Professor Justin St John, Submission 31, [p. 2].

[21]      Professor St John, Committee Hansard, 17 May 2018, p. 43.

[22]      Professor St John, Committee Hansard, 17 May 2018, p. 43.

[23]      Professors Thorburn, Christodoulou, Sue, Carroll, Ryan, Filipovska, Submission 59, p. 5.

[24]      Professor David Thorburn, Head of Mitochondrial Research and Diagnostic Laboratories, Murdoch Children's Research Institute and Victorian Clincial Genetics Services, Committee Hansard, 17 May 2018, p. 12; Associate Professors Catherine Mills and Karinne Ludlow, Professor Robert Sparrow, Dr Narelle Warren, Submission 20, p. 3; Murdoch Children's Research Institute and Victorian Clinical Genetics Services (Murdoch Children's Research Institute), Submission 23, p. 4; AMDF, Submission 26, [p. 10]; Biomedical Ethics Group, Murdoch Children's Research Institute, Submission 34, [p. 2].

[25]      Wellcome Trust, Submission 1—Attachment 1, p. 2; The Human Genetics Society of Australia, Submission 2, [p. 1]; Monash Biomedicine Discovery Institute, Submission 19, [p. 2]; Murdoch Children's Research Institute, Submission 23, p. 2; AMDF, Submission 26, [p. 10]; Fertility Society of Australia, Submission 27, p. 2 (Fertility Society); Dr Nigel Turner, Submission 37, [p. 1]; Nuffield Council on Bioethics, Submission 43, [p. 1]; Wellcome Centre for Mitochondrial Research, Submission 45, [p. 3]; Dr Shanti Balasubramaniam, Submission 52, [p. 3].

[26]      Wellcome Trust, Submission 1—Attachment 1, p. 2.

[27]      HFEA, Review of the safety and efficacy of methods to avoid mitochondrial disease, June 2014, additional information received 30 May 2018, p. 5.

[28]      HFEA, Review of the safety and efficacy of methods to avoid mitochondrial disease, November 2016, additional information received 30 May 2018, p. 5.

[29]      Professor Carroll, Committee Hansard, 17 May 2018, p. 22.

[30]      Professor Christodoulou, Submission 12, p. 2.

[31]      NHMRC, Submission 4, p. 4.

[32]      Professor St John, Submission 31, [p. 4].

[33]      Associate Professor Damian Dowling, School of Biological Sciences, Monash University, Committee Hansard, 17 May 2018, p. 52; Associate Professor Dowling, Submission 25, p. 2.

[34]      Professor John Christodoulou, Chair, Genomic Medicine, Department of Paediatrics, University of Melbourne, Committee Hansard, 17 May 2018, p. 17.

[35]      Professor Christodoulou, Submission 12, p. 3.

[36]      Professor Christodoulou, Submission 12, p. 3.

[37]      Associate Professor Dowling, Submission 25, p. 2.

[38]      Associate Professor Dowling, Submission 25, p. 2.

[39]      Professor St John, Committee Hansard, 17 May 2018, p. 41; Professor St John, Submission 31, [p. 2]; Dr Ian Trounce, Submission 47, [p. 1].

[40]      Murdoch Children's Research Institute, Submission 23, p. 5; Professor Mary Herbert, Submission 49, p. 3.

[41]      Professors Thorburn, Christodoulou, Sue, Carroll, Ryan, Filipovska, Submission 59, p. 6.

[42]      Professors Thorburn, Christodoulou, Sue, Carroll, Ryan, Filipovska, Submission 59, p. 6.

[43]      Wellcome Centre for Mitochondrial Research, Submission 45, [p. 2].

[44]      Murdoch Children's Research Institute, Submission 23, p. 4. See also Louise A Hyslop, Paul Blakeley, Lyndsey Craven, Jessica Richardson, Norah M E Fogarty, Elpida Fragouli, Mahdi Lamb, Sissy E Wamaitha, Nilendran Prathalingam, Qi Zhang, Hannah O'Keefe, Yuko Takeda, Lucia Arizzi, Samer Alfarawati, Helen A Tuppen, Laura Irving, Dimitrios Kalleas, Meenakshi Choudhary, Dagan Wells, Alison P Murdoch, Douglass M Turnbull, Kathy K Niakan, Mary Herbert, Nature, vol. 534, pp. 383–386.

[45]      Professor Carroll, Committee Hansard, 17 May 2018, p. 25.

[46]      Fertility Society, Submission 27, p. 2.

[47]      Associate Professor Dowling, Committee Hansard, 17 May 2018, p. 52; Dr McCullagh, Submission 46, [p. 6].

[48]      Dr McCullagh, Submission 46, [p. 6].

[49]      National Academies of Sciences, Engineering and Medicine (USA), Mitochondrial Replacement Techniques: Ethical, Social and Policy Consideration, February 2016, quoted in NHMRC, Submission 4, p. 5.

[50]      NHMRC, Submission 4, p. 5.

[51]      Mr Murray, Committee Hansard, 17 May 2018, p. 6.

[52]      Professor Thorburn, Committee Hansard, 17 May 2018, p. 15; Dr Balasubramaniam, Submission 52, [p. 4].

[53]      Professor Thorburn, Committee Hansard, 17 May 2018, p. 15.

[54]      Professors Thorburn, Christodoulou, Sue, Carroll, Ryan, Filipovska, Submission 59, pp. 6–7.

[55]      Professor Carolyn Sue, Director, Kolling Institute of Medical Research, Mitochondrial Disease Research Centre, Committee Hansard, 17 May 2018, p. 26; Professors Thorburn, Christodoulou, Sue, Carroll, Ryan, Filipovska, Submission 59, p. 7.

[56]      Professor St John, Submission 31, [p. 3]; Associate Professor Dowling, Submission 25, p. 3.

[57]      Murdoch Children's Research Institute, Submission 23, p. 6. See also Associate Professor Dowling, Submission 25, p. 4.

[58]      Professor St John, Committee Hansard, 17 May 2018, p. 41.

[59]      Professor St John, Committee Hansard, 17 May 2018, pp. 41–42; Professor St John, Submission 31, [p. 3]; Associate Professor Dowling, Submission 25, p. 3; Dr Trounce, Submission 47, [p. 1].

[60]      Professor St John, Committee Hansard, 17 May 2018, pp. 41–42; Professor St John, Submission 31, [p. 3].

[61]      Associate Professor Dowling, Submission 25, p. 3.

[62]      Associate Professor Dowling, Submission 25, p. 3.

[63]      Professor Thorburn, Committee Hansard, 17 May 2018, p. 15.

[64]      Professor Thorburn, Committee Hansard, 17 May 2018, p. 18.

[65]      Professors Thorburn, Christodoulou, Sue, Carroll, Ryan, Filipovska, Submission 59, p. 5.

[66]      Associate Professor Dowling, Submission 25, p. 4.

[67]      Associate Professor Dowling, Committee Hansard, 17 May 2018, p. 53.

[68]      Associate Professor Dowling, Submission 25, p. 4; Ralph Dobler, Damian K Dowling, Edward Morrow, Klaus Reinhardt, 'A systematic review and meta-analysis reveals pervasive effects of germline mitochondrial replacement on components of health', Human Reproduction Update, 2018, pp. 1–16.

[69]      Ralph Dobler, Damian K Dowling, Edward Morrow, Klaus Reinhardt, 'A systematic review and meta-analysis reveals pervasive effects of germline mitochondrial replacement on components of health', Human Reproduction Update, 2018, p. 2.

[70]      Professors Thorburn, Christodoulou, Sue, Carroll, Ryan, Filipovska, Submission 59, p. 5.

[71]      Progress Educational Trust, Submission 48—Attachment 1, p. 3 (footnotes removed).

[72]      Progress Educational Trust, Submission 48—Attachment 1, p. 3.

[73]      Professor Sue, Committee Hansard, 17 May 2018, p. 23.

[74]      Wellcome Centre for Mitochondrial Research, Submission 45, [p. 3].

[75]      Professors Thorburn, Christodoulou, Sue, Carroll, Ryan, Filipovska, Submission 59, p. 6.

[76]      Professor Thorburn, Committee Hansard, 17 May 2018, p. 14. See also HFEA, Scientific review of the safety and efficacy of methods to avoid mitochondrial disease through assisted conception: 2016 update, November 2016, additional information received 30 May 2018, p. 8.

[77]      Murdoch Children's Research Institute, Submission 23, p. 14; Australian Academy of Sciences, Submission 35, p. 5; Professors Thorburn, Christodoulou, Sue, Carroll, Ryan, Filipovska, Submission 59, p. 7.

[78]      HFEA, Scientific review of the safety and efficacy of methods to avoid mitochondrial disease through assisted conception: 2016 update, November 2016, additional information received 30 May 2018. The reviews were carried out in 2011, 2012–13, 2014 and 2016.

[79]      HFEA, Scientific review of the safety and efficacy of methods to avoid mitochondrial disease through assisted conception: 2016 update, November 2016, additional information received 30 May 2018, p. 55.

[80]      Mr Murray, Committee Hansard, 17 May 2018, p. 8.

[81]      Murdoch Children's Research Institute, Submission 23, p. 2.

[82]      Monash Biomedicine Discovery Institute, Submission 19, [p. 3]; Monash Children's Research Institute, Submission 23, p. 14; Fertility Society, Submission 27, p. 1. See also Professor Sue, Committee Hansard, 17 May 2018, p. 24; Professor Carroll, Committee Hansard, 17 May 2018, p. 24.

[83]      Fertility Society, Submission 27, p. 1.

[84]      Professor Christodoulou, Submission 12, pp. 2–3.

[85]      Fertility Society, Submission 27, p. 2.

[86]      Dr Petra Wale, Board Member, Fertility Society, Committee Hansard, 17 May 2018, p. 46.

Chapter 4 - Ethics of mitochondrial donation

[1]        Australian Catholic Bishops Conference, Submission 28, p. 2.

[2]        Dr Petra Wale, Board Member, Fertility Society of Australia, Committee Hansard, 17 May 2018, p. 44; Professor Justin St John, Professor and Head, Mitochondrial Genetics Group, Hudson Institute of Medical Research, Committee Hansard, 17 May 2018, p. 44.

[3]        Social Issues Committee, Anglican Church Diocese of Sydney, Submission 56, p. 2; Plunkett Centre for Ethics, Submission 30, p. 2; Australian Catholic Bishops Conference, Submission 28, p. 3; Catholic Health Australia, Submission 60, pp. 1–2.

[4]        Australian Catholic Bishops Conference, Submission 28, p. 3.

[5]        Plunkett Centre for Ethics, Submission 30, p. 2 (emphasis in original).

[6]        Plunkett Centre for Ethics, Submission 30, p. 1.

[7]        Dr Bernadette Tobin, Director, Plunkett Centre for Ethics, Committee Hansard, 17 May 2018, p. 65. The Plunkett Centre for Ethics is a collaboration between the Australian National University, St Vincent's Health Network Sydney and Calvary Health Care.

[8]        Mr Ash Howlett and Dr Steve Mercer, Submission 40, [p. 4]; Associate Professor Ainsley Newson, Submission 29, p. 5.

[9]        Mr Howlett and Dr Mercer, Submission 40, [p. 4].

[10]      Associate Professor Ainsley Newson, Committee Hansard, 17 May 2018, p. 58.

[11]      Associate Professor Newson, Submission 29, p. 5.

[12]      Dr John A Duley, Submission 7, [p. 2]; Associate Professor Catherine Mills, Associate Professor Karinne Ludlow, Professor Robert Sparrow and Dr Narelle Warren, Submission 20, [p. 9]. See for example: Tracy Bowden, 'Three-parent babies: calls to allow controversial mitochondrial donation procedure in Australia', ABC News, 19 November 2017, http://www.abc.net.au/news/2017-11-20/three-parent-babies-and-mitochondrial-donation/9100228 (accessed 29 May 2018).

[13]      Dr Tobin, Committee Hansard, 17 May 2018, p. 65.

[14]      Dr Tobin, Committee Hansard, 17 May 2018, p. 65; Australian Christian Lobby, Submission 51, p. 5.

[15]      Associate Professor Ainsley Newson, Submission 29, p. 4.

[16]      Wellcome Trust, Submission 1—Attachment 3, [p. 4].

[17]      Professor John Christodoulou, Chair of Genomic Medicine, Department of Paediatrics, University of Melbourne, Committee Hansard, 17 May 2018, p. 16.

[18]      Associate Professor Damian Dowling, School of Biological Sciences, Monash University, Committee Hansard, 17 May 2018, p. 53.

[19]      Wellcome Trust, Submission 1—Attachment 3, [p. 4].

[20]      Professor Carolyn Sue, Director, Kolling Institute of Medical Research, Mitochondrial Research Centre, Committee Hansard, 17 May 2018, p. 23; Professor Christodoulou, Committee Hansard, 17 May 2018, p. 16.

[21]      Professor Christodoulou, Committee Hansard, 17 May 2018, p. 16.

[22]      Professor Sue, Committee Hansard, 17 May 2018, p. 21.

[23]      Raymond Hoffenberg, 'Christian Barnard: his first transplants and their impact on concepts of death', British Medical Journal, vol. 324, 2001, pp. 1478–1480 quoted in Dr Duley, Submission 7, [p. 2].

[24]      Ms Monica Ferrie, Chief Executive Officer, Genetic Support Network of Victoria, Committee Hansard, 17 May 2018, p. 2.

[25]      Professors David Thorburn, John Christodoulou, Carolyn Sue, John Carroll, Mike Ryan and Aleksandra Filipovska, Submission 59—Attachment 1, [33.28].

[26]      Professors Thorburn, Christodoulou, Sue, Carroll, Ryan, Filipovska, Submission 59—Attachment 1, p. 191.

[27]      Associate Professor Newson, Submission 29, p. 4.

[28]      Professor Christodoulou, Committee Hansard, 17 May 2018, p. 13.

[29]      Professor Sue, Submission 24, p. 4.

[30]      Dr Wale, Committee Hansard, 17 May 2018, p. 46.

[31]      Australian Catholic Bishops Conference, Submission 28, p. 3; Australian Christian Lobby, Submission 51, p. 5.

[32]      Archbishop Anthony Fisher, Vice President, Catholic Bishops Conference and Chairman, Bishops Commission for Family, Youth and Life, Committee Hansard, 17 May 2018, p. 64.

[33]      Dr Tobin, Committee Hansard, 17 May 2018, p. 68.

[34]      Associate Professor Newson, Submission 29, p. 8. Additional information about the citizen's jury process can be found in Associate Professor Newson's submission.

[35]      Associate Professor Newson, Committee Hansard, 17 May 2018, p. 50.

[36]      Professor Christodoulou, Committee Hansard, 17 May 2018, p. 14.

[37]      Social Issues Committee of the Anglican Church Diocese of Sydney, Submission 56, p. 2.

[38]      Social Issues Committee of the Anglican Church Diocese of Sydney, Submission 56, p. 2.

[39]      Archbishop Fisher, Committee Hansard, 17 May 2018, p. 64.

[40]      Professor David Thorburn, Head of Mitochondrial Research and Diagnostic Laboratories, Murdoch Children's Research Institute and Victorian Clinical Genetic Services, Committee Hansard, 17 May 2018, p. 19.

[41]      Professor Sue, Committee Hansard, 17 May 2018, p. 31.

[42]      National Health and Medical Research Council (NHMRC), Ethical guidelines on the use of assisted reproductive technology in clinical practice and research, 2017 (ART Guidelines), p. 43, https://www.nhmrc.gov.au/_files_nhmrc/file/guidelines/ethics/16506_nhmrc_-_ethical_guidelines_on_the_use_of_assisted_reproductive_technology-web.pdf (accessed 7 June 2018).

[43]      NHMRC, ART Guidelines, pp. 43–44.

[44]      NHMRC, ART Guidelines, p. 43.

[45]      Australian Christian Lobby, Submission 51, p. 5.

[46]      Dr Tobin, Committee Hansard, 17 May 2018, p. 67.

[47]      Mary, Committee Hansard, 17 May 2018, p. 38.

[48]      Justin, Committee Hansard, 17 May 2018, p. 37.

[49]      Professor John Carroll, Director, Monash Biomedicine Discovery Centre, Committee Hansard, 17 May 2018, p. 30; Dr Nadine Richings, Vice-Chair, Scientists in Reproductive Technology (SIRT), Committee Hansard, 17 May 2018, p. 42; Professor Aleksandra Filipovska, Submission 17, p. 2; Biomedical Ethics Research Group, Murdoch Children's Research Institute, Submission 34, [p. 2]; Australian Academy of Sciences, Submission 35, p. 5; Nuffield Council on Bioethics, Submission 43, [p. 2].

[50]      NHMRC, Submission 4, p. 4.

[51]      Wellcome Centre for Mitochondrial Research, Submission 45, [p. 5].

[52]      NHMRC, Submission 4, p. 4.

[53]      Associate Professor Newson, Submission 29, p. 5.

[54]      Professor Sheryl de Lacey, Submission 55, p. 2.

[55]      Professor Sheryl de Lacey, Submission 55, p. 2.

[56]      NHMRC, ART Guidelines, pp. 83–85.

[57]      NHMRC, ART Guidelines, p. 85.

[58]      Murdoch Children's Research Institute and Victorian Clinical Genetic Services, Submission 23, p. 4.

[59]      Biomedical Ethics Research Group, Murdoch Children's Research Institute, Submission 34, [p. 2].

[60]      Biomedical Ethics Research Group, Murdoch Children's Research Institute, Submission 34, [p. 2].

[61]      Distinguished Professor Jenni Millbank, Distinguished Professor Isabel Karpin and Professor Anita Stuhmcke, Submission 57, [p. 5].

[62]      Associate Professor Catherine Mills, Committee Hansard, 17 May 2018, p. 50.

[63]      Associate Professor Newson, Committee Hansard, 17 May 2018, p. 55; Murdoch Children's Research Institute and Victorian Clinical Genetic Services, Submission 23, p. 8; Dr Newson, Submission 29, p. 3.

[64]      Associate Professors Mills and Ludlow, Professor Sparrow and Dr Warren, Submission 20, p. 3.

[65]      NHMRC, Submission 4, p. 5.

[66]      Associate Professors Mills and Ludlow, Professor Sparrow and Dr Warren, Submission 20, [pp. 16–17]. See Karinne Ludlow, 'The policy and regulatory context of U.S., U.K., and Australian responses to mitochondrial donation governance', Jurimetrics, vol. 58, p. 256.

[67]      Associate Professor Newson, Submission 29, p. 3. See Ainsley Newson and Anthony Wrigley, 'Is mitochondrial donation germ line gene therapy? Classifications and ethical implications', Bioethics, vol. 31, pp. 55–67.

[68]      Professors Thorburn, Christodoulou, Sue, Carroll, Ryan and Filipovska, Submission 59,
pp. 8–9.

[69]      Australian Christian Lobby, Submission 51, p. 7.

[70]      Australian Christian Lobby, Submission 51, p. 8; Catholic Health Australia, Submission 60, [p. 2].

[71]      Dr Tobin, Committee Hansard, 17 May 2018, p. 66.

[72]      Associate Professor Newson, Committee Hansard, 17 May 2018, p. 55.

[73]      Wellcome Trust, Submission 1—Attachment 3, [p. 2]; Professor Filipovska, Submission 17, p. 1; Associate Professors Mills ans Ludlow, Professor Sparrow and Dr Warren, Submission 20, p. 249; Professor Sue, Submission 24, p. 2; Associate Professor Dowling, Submission 25 —Attachment 1, [p. 1]; Australian Mitochondrial Disease Foundation (AMDF), Submission 26, [p. 2]; Australian Academy of Sciences, Submission 35, p. 2; Lily Foundation, Submission 44, [p. 2]; Wellcome Centre for Mitochondrial Research, Submission 45, [p. 5]; Dr Shanti Balasubramaniam, Submission 52, [p. 6]; Professor Sheryl de Lacey, Submission 55, p. 1; Dr Robin Lovell-Badge, Submission 58—Attachment 1, p. 1060.

[74]      NHMRC, Submission 4, p. 9; Plunkett Centre for Ethics, Submission 30, p. 1; Australian Christian Lobby, Submission 51, p. 3; Dr Cathy Herbrand, Submission 54, p. 3; Professors Thorburn, Christodoulou, Sue, Carroll, Ryan and Filipovska, Submission 59, p. 1; Catholic Health Australia, Submission 60, [p. 1].

[75]      Australian Christian Lobby, Submission 51, p. 4.

[76]      Dr Tobin, Committee Hansard, 17 May 2018, p. 65.

[77]      AMDF, Submission 26.1, [p. 4].

[78]      Professors Thorburn, Christodoulou, Sue, Carroll, Ryan and Filipovska, Submission 59, p. 1.

Chapter 5 - Regulation

[1]        Deoxyribonucleic acid.

[2]        Human Fertilisation and Embryology Authority (HFEA), Submission 53, p. 1.

[3]        National Health and Medical Council (NHMRC), Submission 4, p. 5.

[4]        The HFEA Statutory Approvals Committee is supported by an international panel of experts in mitochondrial disease, including Professor David Thorburn. This panel conducts peer review of applications.

[5]        HFEA, Reports archive, https://www.hfea.gov.uk/choose-a-clinic/clinic-search/results/17/ (accessed 12 May 2018).        

[6]        NHMRC, Submission 4, p. 4.

[12]      Associate Professor Catherine Mills, Committee Hansard, 17 May 2018, p. 50.

[21]      A clinical trial usually involves a double-blind study of the efficacy of a treatment or medication, which would not be appropriate in the context of mitochondrial donation. Notwithstanding this, the term clinical trial is useful for a layperson to conceptualise the limitations that would be placed on accessing mitochondrial donation if introduced in a controlled manner to Australian clinical practice. An appropriate description would be an observational clinical trial.

[22]      Department of Industry, Innovation and Science and NHMRC, What is a clinical trial? https://www.australianclinicaltrials.gov.au/what-clinical-trial (accessed 13 May 2018).

[23]      Department of Health, Life Saving Drugs Program, http://www.health.gov.au/LSDP (accessed 13 May 2018).

[27]      See for example AMDF, Submission 26, [p. 9]; Australian Academy of Science, Submission 35, p. 7; Biomedical Ethics Research Group, Murdoch Children's Research Institute, Submission 34, [p. 4]; Fertility Society, Submission 27, p. 2; Human Genetics Society of Australasia, Submission 2, p. 4; Monash Biomedicine Discovery Institute, Submission 19, [p. 2]; Murdoch Children's Research Institute, Submission 23, p. 2; Progress Educational Trust, Submission 48, p. 2; Wellcome Centre for Mitochondrial Research, Submission 45, [p. 6].

[42]      Associate Professor Mills, Committee Hansard, 17 May 2018, p. 54.

[45]      Professor John Carroll, Director, Monash Biomedicine Discovery Institute, Monash University, Committee Hansard, 17 May 2018, p. 25.

[46]      Professor Carolyn Sue, Director, Kolling Institute of Medical Research, Mitochondrial Disease Research Centre, Committee Hansard, 17 May 2018, p. 27.

[47]      Professor Justin St John, Professor and Head, Mitochondrial Genetics Group, Hudson Institute of Medical Research, Committee Hansard, 17 May 2018, p. 45.

[51]      Professor Sue, Committee Hansard, 17 May 2018, p. 24.

[52]      Dr Petra Wale, Board Member, Fertility Society, Committee Hansard, 17 May 2018, p. 27.

[53]      Professor Sue, Committee Hansard, 17 May 2018, p. 27.

[56]      Scientists in Reproductive Technology (SIRT) is a sub-committee of the Fertility Society, consisting of embryologists and other scientists involved in ART.

[57]      Dr Nadine Richings, Vice Chair, SIRT, Committee Hansard, 17 May 2018, p. 42.

[61]      NHMRC, Ethical Guidelines on the use of assisted reproductive technology in clinical practice and research, para 8.1.

[62]      Professor Sue, Committee Hansard, 17 May 2018, pp. 25–26.

[65]      Professor Thorburn, Committee Hansard, 17 May 2018, p. 15.

[69]      Distinguished Professors Jenni Millbank and Isabel Karpin and Professor Anita Stuhmcke, Submission 57, p. 5.

[75]      Professor Christodoulou, Committee Hansard, 17 May 2018, p. 14.

[79]      Associate Professor Mills, Committee Hansard, 17 May 2018, p. 51.

[80]      Associate Professor Newson, Submission 29, p. 7.

[81]      Associate Professor Newson, Submission 29, p. 8. Citizen's jury outcomes quoted from 'Using deliberative engagement to assess public attitudes towards novel reproductive technologies: a citizens' jury on mitochondrial donation': Confidential attachment to Submission 29; cited with permission.

[82]      Associate Professor Mills, Committee Hansard, 17 May 2018, p. 52.