Title Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021
Database Bills Digests
Date 15-06-2021
Source Bills Digest Service
Parl No. 46
Author STOREN, Rebecca
SMITH, Elizabeth, (DPS)
Citation Id 8013254
Key item No
Major subject Clinical trials
Genetic disorders
In vitro fertilisation
Licences
Minor subject Bills
Law reform
Legislative amendments
Pages 60p.
Volume no. 065 (2020-21)
System Id legislation/billsdgs/8013254


Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021

ISSN 1328-8091

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BILLS DIGEST NO. 65, 2020–21 15 JUNE 2021

Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 Rebecca Storen Social Policy Section Elizabeth Smith Science, Technology, Environment and Resources Section

Contents

The Bills Digest at a glance .............................................. 5

List of abbreviations ........................................................ 7

Key list of terms .............................................................. 8

Purpose of the Bill ........................................................... 9

Structure of the Bill ......................................................... 9

Background ................................................................... 10

Scientific background .................................................... 10

Mitochondria and mitochondrial DNA ...................... 10 Figure 1: illustration of nDNA and mtDNA within a cell......................................................................... 11

Mitochondrial DNA disease....................................... 11

Figure 2: the mixed nature of healthy and mutated mtDNA within cells ................................... 12

Mitochondria donation ............................................. 12

Figure 3: simplified overview of mitochondrial donation techniques ............................................... 13

Policy background ......................................................... 14

Current legislation ..................................................... 14

RIHE Act and PHCR Act ............................................ 14

Intergovernmental agreement and state and territory legislation .................................................. 14

International policy ................................................... 14

Australia’s inquiry and consultations ........................ 15

Senate Community Affairs Committee inquiry ....... 15 Governments response to the Senate Committee’s report ................................................. 15

Date introduced: 24 March 2021

House: House of Representatives

Portfolio: Health

Commencement: Sections 1 to 3 commence on Royal Assent. Schedule 1 commences on the earlier of Proclamation or six months after Royal Assent.

Links: The links to the Bill, its Explanatory Memorandum and second reading speech can be found on the Bill’s home page, or through the Australian Parliament website.

When Bills have been passed and have received Royal Assent, they become Acts, which can be found at the Federal Register of Legislation website.

All hyperlinks in this Bills Digest are correct as at June 2021.

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Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 2

NHMRC Mitochondrial Donation Expert Working Committee ............................................................... 16

NHMRC community consultations .......................... 16

Figure 4: outline of the themes from the community consultation online submissions .......... 17 Department of Health consultation ........................ 17

Embryo research licensing ............................................. 18

Tabling of Reports ..................................................... 18

Maintaining a Licence Database ............................... 18

Regulation of Excess ART Embryos ........................... 18

Human Research Ethics Committees ........................ 19

Proposed two-stage process .......................................... 19

Table 1: proposed two-stage process for the introduction of mitochondrial donation ................. 20 Stage 1—research, training and clinical trials ......... 20 Transition from Stage 1 to Stage 2 .......................... 20

Stage 2—clinical practice ........................................ 21

Ethical and social considerations ................................... 21

Treatment and prevention ........................................ 22

Options for having children ....................................... 22

Figure 5: current non-medical reproductive options for women where there is a risk of transmitting mitochondrial disease to offspring .... 23 Figure 6: current reproductive options for women where there is a risk of transmitting mitochondrial disease to offspring ......................... 24

Use of new techniques .............................................. 24

Sex selection .............................................................. 24

Status of the embryo ................................................. 25

The rights and wellbeing of the child ........................ 26

The donor .................................................................. 27

Committee consideration .............................................. 27

Senate Standing Committee for Selection of Bills .... 27 Senate Standing Committee for the Scrutiny of Bills ............................................................................ 27

Mitochondrial donation licence application fee ..... 27 Definition of ‘proper consent’ and provision for withdrawal of consent ............................................ 28

Privacy ..................................................................... 29

Policy position of non-government parties/independents.................................................... 30

ALP ............................................................................. 30

The Greens ................................................................ 31

Minor parties and independents .............................. 31

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Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 3

Position of major interest groups................................... 31

There are few effective treatments and no cures .... 32 Current reproductive options ................................... 32

Scientific considerations ........................................... 32

Ethical considerations ............................................... 33

Legal considerations .................................................. 33

Financial considerations ............................................ 33

Financial implications .................................................... 34

Statement of Compatibility with Human Rights.............. 35

Parliamentary Joint Committee on Human Rights ... 35 Key issues and provisions .............................................. 35

Overview ................................................................... 35

Changing the term ‘licence’ to ‘general licence’ ..... 36 PHCR Act amendments ............................................. 36

Changes to legalise the use of mitochondrial donation .................................................................. 36

Definitions added .................................................... 38

RIHE Act amendments .............................................. 38

Definitions added .................................................... 38

Changes to the offence provisions of the RIHE Act............................................................................ 38

Mitochondrial donation licences ............................ 39

Table 2: activities authorised under mitochondrial donation licences ............................. 40

Applying for a mitochondrial donation licence ....... 41 Mitochondrial Donation Donor Register................... 48 Information kept in the register .............................. 48

Who can access register information? .................... 48 Register management ............................................. 49

Mitochondrial donation techniques ......................... 49

Permitted techniques for mitochondrial donation licences .................................................... 50

Table 3: permitted techniques for the mitochondrial donation licences. ............................ 50

Mitochondrial donation techniques definitions ..... 50 Table 4: mitochondrial donation techniques definitions ................................................................ 50

Further changes to the RIHE Act ............................... 51

Proposed Division 1—Arrangements relating to clinical trials for mitochondrial donation techniques ............................................................... 52

Proposed Division 2—Other miscellaneous matters .................................................................... 52

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Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 4

Table 5: Immunity from civil actions relating to mitochondrial donation licences ............................. 53

Changes to the Therapeutic Goods (Excluded Goods) Determination 2018.................................... 54

Seven-year review of the new arrangements ........... 54 Other provisions ........................................................ 55

Changes to the Freedom of Information Act 1982 ......................................................................... 55

Application and transitional provisions .................... 55 NHMRC Licensing Committee reports to Parliament ............................................................... 55

Pre-commencement licence applications ............... 55 Concluding comments ................................................... 55

Appendix ...................................................................... 57

Table 6: definitions added to the RIHE Act and the RIHE Regulations ............................................... 57

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Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 5

The Bills Digest at a glance Mitochondrial disease is a group of conditions that can cause serious health issues and, in severe cases, can cause death in childhood. There is no known cure for mitochondrial disease.1

Mitochondrial donation is an assisted reproductive technology (ART) that can assist women to avoid passing mitochondrial DNA disease to their biological child. This technology is not a cure for mitochondrial disease but is rather a way to prevent children from inheriting mitochondria that can cause mitochondrial disease.2

Under the current legislative framework, mitochondrial donation is illegal under the Prohibition of Human Cloning for Reproduction Act 2002 (Cth) and the Research Involving Human Embryos Act 2002 (Cth). The Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 (the Bill) amends relevant Acts and associated Regulations to make mitochondrial donation legal for research, training and human reproductive purposes. The overall aim is for women at risk of passing on mitochondrial disease to have reproductive options for biological children without the increased risk of their child having mitochondrial disease.

Primarily the Bill makes changes to ensure that it is no longer an offence to create, for the purposes of reproduction, and under the relevant mitochondrial donation licences, a human embryo that:

• contains the genetic material of more than two people and

• contains heritable changes to the genome.

Given mitochondrial donation is a new medical technology, the Bill introduces it in a staged and controlled manner with a two-stage implementation approach. This is intended to allow for the expansion of scientific evidence to ensure the techniques are safe and effective and undertaken in an ethically appropriate manner.3 The Bill introduces five types of mitochondrial donation licences:

1. a pre-clinical research and training licence 2. a clinical trial research and training licence 3. a clinical trial licence 4. a clinical practice research and training licence and 5. a clinical practice licence.

Initially, only three of the potential five licences will be available from the National Health and Medical Research Council (NHMRC). These initial licences would authorise pre-clinical and clinical trial research and training and clinical trial activities to take place. This would enable the scientific evidence to continue to expand and would also allow ‘the safety, efficacy and feasibility of mitochondrial donation for reducing the risk of transmission of serious mitochondrial disease in humans’.4

The Bill contains provisions detailing what is authorised under each of the mitochondrial donation licences, with provisions relating to licence applications, conditions and administrative requirements. The licences will be administered and regulated by the Embryo Research Licensing Committee of the NHMRC (referred to in this Digest as the NHMRC Licensing Committee), with dedicated provisions for the close vetting and oversight of applicants and licence holders by the NHMRC.

1. National Health and Medical Research Council (NHMRC), Mitochondrial donation issues paper: ethical and social issues for community consultation, NHMRC, [Canberra], [2019], p. 3. 2. Ibid.

3. Explanatory Memorandum, Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021, p. 7. 4. Ibid., p. 71.

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Stage 2, which would permit mitochondrial donation in clinical practice, is dependent on the success of the licenced techniques and the findings of the Stage 1 review. As such, the two clinical practice related licences are subject to further amendments to legislation before they can be made available.

Whilst at the time of writing there has been limited commentary since the introduction of the Bill, there have been robust discussions through different consultation processes. Respondents have primarily focussed on the ethical and social considerations and it has also been widely noted that this is a new scientific technology. Due to the complex and sensitive nature of the subject, people who have engaged with the consultation processes appear to hold views that tend to be heavily skewed either for or against.

In acknowledgement of the ethical issues and concerns raised by the new technology endorsed by this Bill (including privacy, embryo creation and destruction, consent and donor rights) the Minister for Health has stated that the Bill will be put to a conscience vote.5

5. G Hunt, ‘Second reading speech: Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021’, House of Representatives, Debates, (proof), 24 March 2021, op cit., p. 2.

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Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 7

List of abbreviations Abbreviation Definition

ART Assisted reproductive technology

CROC Convention on the Rights of the Child

DoH Department of Health

ERLC Embryo Research Licensing Committee of the NHMRC

GVT Germinal vesicle transfer

HFEA Human Fertilisation and Embryology Authority (United Kingdom)

HREC Human Research Ethics Committee

ICESCR International Covenant on Economic, Social and Cultural Rights

IVF In-vitro fertilisation

MST Maternal spindle transfer

mtDNA Mitochondrial DNA

nDNA Nuclear DNA

NHMRC National Health and Medical Research Council

PBT Polar body transfer (either first polar body transfer or second polar body transfer)

PHCR Act Prohibition of Human Cloning for Reproduction Act 2002

PNT Pronuclear transfer

RIHE Act Research Involving Human Embryos Act 2002

RIHE Regulations Research Involving Human Embryos Regulations 2017

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Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 8

Key list of terms Term Definition

Human embryo The early stage in the process of development, during the period from approximately the second to eighth week after fertilisation.

Germinal vesicle The nucleus of an immature egg cell that contains nDNA.

Heritable changes Changes that can be inherited by future generations.

In-vitro Research or process performed outside a living organism.

In-vitro fertilisation

A technology using human egg cells and sperm to create embryos in the laboratory.

Maternal spindle A spindle-shaped group of chromosomes within the egg cell that contains the mother's nDNA.

Mitochondria

Organelles (small structures within a cell) for energy generation and other cell functions. Mitochondria contain a small amount of DNA.

Mitochondria DNA

The DNA that resides in the mitochondria rather than the nucleus of a cell.

Mutation

A change in the DNA sequence that can result in biological effects or disease.

Nuclear DNA

The genetic material in the nucleus of a cell. DNA is assembled into chromosomes. A human cell usually has 46 chromosomes, 23 from each parent. Sperm cells and egg cells each have 23 chromosomes.

Polar bodies

Polar bodies are formed during the process of female egg maturation and fertilisation. When the egg cell divides it splits nDNA evenly between both daughter cells. However, the cytoplasm (the surrounding material in the cell in which the mitochondria are found) is split unevenly and results in one daughter cell receiving very little cytoplasm, these are called polar bodies.

Pronucleus

The nucleus of a sperm or an egg cell during the process of fertilisation. The sperm cell becomes a pronucleus after the sperm enters the egg, but before the nDNA of the sperm and egg fuse. Once an egg cell is fertilised by a sperm it initially becomes a zygote with two pronuclei (one from the mother and one from the father) each of which contains the nDNA of the respective parent.

Zygote

A single-celled organism resulting from a fertilised egg cell (containing the genetic material of both the mother and the father), before the first cell division. Source: PHCR Act, section 8; RIHE Act, section 7; Explanatory Memorandum, Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021, pp. 20, 42–43; National Health and Medical Research Council (NHMRC) Mitochondrial Donation Expert Working Committee, Expert Statement: Mitochondrial Donation Expert Working Committee, NHMRC, [Canberra], n.d., pp. 9–11.

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Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 9

Purpose of the Bill The purpose of the Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021 (the Bill) is to introduce mitochondrial donation techniques in a staged and cautious approach, initially through research and a clinical trial. Following a review of Stage 1, and further legislative changes, mitochondrial donation could be made available in the clinical practice setting. Once more widely available it is estimated that this technology could prevent 60 babies being born with mitochondrial disease each year in Australia.6

The Bill:

• provides for mitochondrial donation techniques to be administered under five types of mitochondrial donation licences. Only three of the five licences would be available in Stage 1, which would allow pre-clinical and clinical trial research and training and clinical trial activities to take place

• provides for the licences to be administered and regulated by the NHMRC Licensing Committee

• sets out provisions dealing with what is authorised under each of the five types of mitochondrial donation licences, with strict conditions relating to licence applications, conditions and administrative requirements. In addition, licence holders would be subject to additional, and ongoing, requirements

• Stage 1 will allow eligible women to access mitochondrial donation by participating in the clinical trial. It is anticipated that a low number of people will access the technology, and the women who do participate, may require multiple rounds of IVF. As such, the trial is expected to take place over approximately 10 to 12 years.7

The following legislation is engaged and amended to give effect to the purpose of the Bill:

• the Prohibition of Human Cloning for Reproduction Act 2002 (PHCR Act)

• the Research Involving Human Embryos Act 2002 (RIHE Act)

• the Research Involving Human Embryos Regulations 2017 (RIHE Regulations)

• the Therapeutic Goods (Excluded Goods) Determination 2018 and

• the Freedom of Information Act 1982 (FOI Act).

Structure of the Bill The Bill comprises a single schedule of three parts:

• Part 1 contains the main amendments to the PHCR Act, RIHE Act and the RIHE Regulations.

Items 4 and 5 of the Bill makes the most significant amendments to the PHCR Act by changing the legislation to ensure that it is no longer an offence to allow, under a mitochondrial donation licence, the creation of an embryo with:

– the genetic material of more than two people (item 4) – changes to its genome that would be heritable by the child’s descendants (item 5). Item 17 of the Bill makes the bulk of the amendments to the RIHE Act by adding proposed Division 4A of Part 2, comprising of:

– Subdivision A—Kinds of mitochondrial donation licences and what they authorise – Subdivision B—Applying for a mitochondrial donation licence – Subdivision C—Determining applications for mitochondrial donation licences – Subdivision D—Conditions of mitochondrial donation licences

6. NHMRC, Mitochondrial donation issues paper, op. cit., p. 3. 7. Department of Health (DoH), Legalising mitochondrial donation in Australia: public consultation paper, DoH, [Canberra], [2021], p. 6.

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Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 10

– Subdivision E—Ongoing requirements for holders of mitochondrial donation licences – Subdivision F—Variation, suspension, revocation and surrender • Part 2 of the Bill contains other amendments to the PHCR Act, RIHE Act, FOI Act, RIHE Regulations and the Therapeutic Goods (Excluded Goods) Determination. These amendments

will support the main amendments in Part 1.

• Part 3 of the Bill contains application and transitional provisions for the RIHE Act and the RIHE Regulations.

A detailed explanation of Part 1 is outlined on pages 4 and 5 of the Explanatory Memorandum to the Bill.8

Background

Scientific background

Mitochondria and mitochondrial DNA Mitochondria are small DNA-containing structures found in human cells. Mitochondria produce roughly 90 per cent of the energy our body needs to function and also support a number of other functions.9

Mitochondrial DNA (mtDNA) differs from nuclear DNA (nDNA) in a variety of ways, a few of which include:

• mtDNA contains 37 genes, nDNA contains 20,000 to 30,000 genes

• mtDNA is inherited primarily from the biological mother due to the mitochondria being present in the mother’s egg cell,10 nDNA is inherited from both biological parents

• a single cell can contain numerous mitochondria, and each of these can contain numerous copies of mtDNA, a single copy of nDNA is contained in the nucleus of most cells and there is usually just one nucleus per cell11

• mtDNA has a much higher mutation rate than nDNA, estimated to be 100 times higher.12

Figure 1 below provides an illustration of nDNA and mtDNA within a cell.

8. Explanatory Memorandum, op. cit., pp. 4–5. 9. Mito Foundation, ‘Mitochondrial disease information’, Mito Foundation website, n.d. 10. Some research has suggested that in rare cases fathers may pass on a small amount of mtDNA to offspring. 11. NHMRC, Mitochondrial donation issues paper, op. cit., p. 6. 12. H Chial and J Craig, ‘MtDNA and mitochondrial diseases’, Nature Education, 1(1), 2008, p. 217.

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Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 11

Figure 1: illustration of nDNA and mtDNA within a cell

Source: NHMRC, Mitochondrial donation issues paper: ethical and social issues for community consultation, NHMRC, [Canberra], [2019], p. 7.

Mitochondrial DNA disease Mitochondrial DNA disease refers to a mixed (heterogenous) group of inherited conditions caused by mutations in mtDNA or nDNA that impact the function of mitochondria (that is, reduce their ability to produce energy) and can cause serious illness. This results in cell injury and death and can lead to whole organ systems failing, which can be fatal.13 Currently, there is no known cure and treatment is mostly limited to the management of symptoms.14

It is estimated that approximately:

• one in 200 Australian babies are born with some level of mtDNA mutation that could lead to mitochondrial DNA disease in their lifetime, although for many, the levels of mutated mtDNA are too low to cause disease. This is estimated to be roughly 120,000 Australians15

• between one in 5,000 and one in 10,000 Australians are estimated to develop severe or life-threatening mitochondrial DNA disease during their lifetime

• the average lifespan of children born with mitochondrial DNA disease is estimated to be between three and 12 years of age. However, the (symptomatic) onset of the disease can affect people at any age and some individuals do not develop symptoms until adulthood.16 [emphasis added]

Mitochondrial DNA disease can cause a lot of different symptoms because mitochondria are located everywhere within the body. Due to their role in energy production, the disease

13. Mito Foundation, ‘Mitochondrial disease information’, op. cit. 14. NHMRC, Mitochondrial donation issues paper, op. cit., p. 8. 15. Australian Mitochondrial Disease Foundation (AMDF), Submission to Senate Community Affairs References Committee, Science of Mitochondrial Donation and Related Matters, [Submission no. 26], 9 May 2018, p. 2.

16. NHMRC, Mitochondrial donation issues paper, op. cit., p. 8.

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Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 12

particularly affects organs that have a higher energy use, such as the heart, muscles and brain. The proportion of unhealthy mtDNA (referred to as mutation load) may affect the severity of the mitochondrial DNA disease, for example, a low level of mutated mtDNA may mean that a person does not exhibit any symptoms.17 Because one cell can contain many mitochondria, this can result in heterogeneous mtDNA within the same cell. When the cell divides the mitochondria are split between the two daughter cells in a random manner (unlike nDNA).18 As a result, a cell can have a mix of healthy and unhealthy (or mutated) mtDNA (see Figure 2).19

Figure 2: the mixed nature of healthy and mutated mtDNA within cells

Source: NHMRC, Mitochondrial donation issues paper, op. cit., p. 9.

For women who are heterogeneous carriers of mitochondrial DNA disease (that is, they have both healthy and mutated mtDNA) it can be difficult to predict the impact on a future child. This can leave people facing difficult decisions on whether to have children and, if they do conceive, whether to seek prenatal testing (if that is an option).20 Prenatal testing is discussed further under the ‘Treatment and prevention’ and ‘options for having children’ sections on pages 22–24.

Mitochondria donation Mitochondrial donation is an assisted reproductive technology (ART), involving in-vitro fertilisation (IVF).21 IVF refers to procedures where human eggs, sperm or embryos are handled outside of the body (in-vitro) in order to establish a pregnancy.22 The purpose of mitochondrial donation is to reduce the risk of a child inheriting mitochondrial DNA disease from a woman carrying the condition.23

This is achieved by creating an embryo using nDNA from the prospective mother and father and healthy mtDNA from a donor. Several different mitochondrial donation techniques can achieve this outcome, including:

17. Ibid. 18. Chial and Craig, ‘MtDNA and mitochondrial diseases’, op. cit., p. 217. 19. NHMRC, Mitochondrial donation issues paper, op. cit., p. 8. 20. Ibid. 21. Ibid., p. 3. 22. J Newman, R Paul and G Chambers, Assisted reproduction technology in Australia and New Zealand 2018, National Perinatal

Epidemiology and Statistics Unit, University of NSW, Sydney, 2020, p. vi. 23. NHMRC, Mitochondrial donation issues paper, op. cit., p. 12.

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Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 13

• maternal spindle transfer (MST)

• pronuclear transfer (PNT)

• polar body transfer (PBT) and

• germinal vesicle transfer (GVT).24

Pages 42 and 43 of the Explanatory Memorandum to the Bill provides a detailed definition for each of these techniques.25 A simplified overview is given below in Figure 3.

Figure 3: simplified overview of mitochondrial donation techniques

Source: NHMRC, Mitochondrial donation issues paper, op. cit., p. 13.

24. Ibid. 25. Explanatory Memorandum, op. cit., pp. 42–43.

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Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 14

Mitochondrial donation is a relatively new technology and the long-term consequences are still unknown.26 Other options for having children are available to women that carry mtDNA mutations, these are discussed further under the ‘Options for having children’ section on pages 22 to 24 of the Bills Digest.

It is important to note that mitochondrial donation cannot cure existing mitochondrial DNA disease or prevent mitochondrial DNA disease caused by mutations in nDNA. Estimates suggest mitochondrial donation may be able to assist in the prevention of mitochondrial DNA disease in 60 births per year in Australia.27 If mitochondrial donation becomes part of clinical practice in Australia, it is expected that only a small number of women will access the technique.28

Policy background

Current legislation

RIHE Act and PHCR Act The Research Involving Human Embryos Act 2002 (RIHE Act) and the Prohibition of Human Cloning Act 2002 were passed by Parliament in December 2002 in response to community concerns, including ethical ones, about scientific developments in relation to human reproduction and the use of human embryos. Both Acts were amended in 2006 and the Prohibition of Human Cloning Act 2002 was renamed the Prohibition of Human Cloning for Reproduction Act 2002 (PHCR Act).29

The Acts establish a regulatory framework that prohibits certain practices, including human cloning, and regulates the uses of excess human embryos created through ART.30

Intergovernmental agreement and state and territory legislation In March 2004, the Council of Australian Governments (COAG) agreed to the Research Involving Human Embryos and Prohibition of Human Cloning for Reproductive Purposes Intergovernmental Agreement (the IGA). The IGA creates a nationally consistent scheme for the regulation of research involving human embryos, the prohibition of human cloning and other unacceptable practices.31

Under the IGA all of the states and territories (other than the Northern Territory) have introduced legislation that is consistent with the Commonwealth’s RIHE Act and PHCR Act.32 Due to the staged approach and the way the Bill proposes introducing mitochondrial donation, namely for very limited purposes restricted by the proposed mitochondrial donation licences, the amendments introduced by the Bill will not need to form any part of the nationally consistent scheme under the IGA. This allows mitochondrial donation to be legalised under those limited circumstances without corresponding amendments needing to be made to state or territory law for Stage 1.33

International policy In 2015, the United Kingdom (UK) passed legislation to legalise mitochondrial donation using the PNT and MST techniques. Prior to this, the UK amended legislation to allow researchers to develop mitochondrial donation techniques and conducted multiple reviews of the science as well as

26. NHMRC, Mitochondrial donation issues paper, op. cit., p. 14. 27. Ibid., p. 12. 28. Explanatory Memorandum, op. cit., p. 81. 29. NHMRC, ‘Commonwealth and state legislation’, NHMRC website, n.d. 30. Ibid. 31. Council of Australian Governments (COAG), Research Involving Human Embryos and Prohibition of Human Cloning,

Intergovernmental Agreement, COAG, 31 March 2004 . 32. NHMRC, ’Commonwealth and state legislation’, op. cit. 33. Explanatory Memorandum, op. cit., pp. 67–68.

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public consultations on the social and ethical issues. To date, the UK is the only country that has changed its laws and regulations to allow mitochondrial donation.34

Despite being legal, access to mitochondrial donation in the UK is tightly regulated, approved on a case-by-case basis and only approved for patients at high risk of transmitting mutations that will lead to serious mitochondrial DNA disease. At the time of writing, only one facility has been licenced to provide mitochondrial donation, and the licence only allows for the use of PNT. As of November 2020, it has been reported that up to 21 couples have attained a licence to receive treatment and up to eight treatments have been approved. The outcomes of these treatments have not been made publicly available for privacy reasons.35

Other countries such as the United States, Singapore and Sweden have released reports or conducted consultations regarding mitochondrial donation, but legislation has remained unchanged. In countries that have no specific government legal restrictions on mitochondrial donation techniques, such as Mexico and Ukraine, there are reports of mitochondrial donation having taken place.36

Australia’s inquiry and consultations

Senate Community Affairs Committee inquiry In 2018, the Senate Community Affairs References Committee (Senate Committee) undertook an inquiry into the Science of Mitochondrial Donation and Related Matters. Among other things, the inquiry examined the impact of mitochondrial disease on Australian families and the healthcare sector, the safety and efficacy of existing donation techniques, and the ethical considerations.37

The Senate inquiry received 60 submissions and held one public hearing. The Committee’s final report explores the experience of people with mitochondrial DNA disease and their families, the science of mitochondrial donation and the ethics and regulation of mitochondrial donation.38 The final report made four recommendations to Government:

1. undertake public consultation on the possible introduction of mitochondrial donation into Australian clinical practice

2. obtain expert advice through the National Health and Medical Research Council (NHMRC) about key scientific questions relating to mitochondrial donation

3. engage with state and territory governments on the findings of the inquiry and

4. as an interim measure, initiate dialogue with the relevant authorities in the UK to facilitate access to the UK treatment facility for Australian patients seeking mitochondrial donation.39

Governments response to the Senate Committee’s report The Government tabled a response to the Senate Committee’s report in February 2019. The Government supported the Senate Committee’s recommendations for expert advice and further consultation activities with the Australian public and state and territory governments. Regarding opening a dialogue with the UK for the potential access of Australians to their mitochondrial

34. G Cohen, EY Adashi, S Gerke, C Palacios-Gonzalez and V Ravitsky, ‘The regulation of mitochondrial replacement techniques around the world’, Annual Review of Genomics and Human Genetics, 21, August 2020, pp. 567–568. 35. Explanatory Memorandum, op. cit., p. 69. 36. Cohen, et al, ‘The regulation of mitochondrial replacement techniques’, op. cit., p. 578. 37. Senate Community Affairs References Committee, Science of mitochondrial donation and related matters, Inquiry homepage. 38. Senate Community Affairs References Committee, Science of mitochondrial donation and related matters, The Senate,

Canberra, June 2018. 39. Ibid., pp. ix–x.

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donation services, the Government stated that it will reconsider this recommendation following the consultation outcomes and expert advice.40

The Government tasked the NHMRC to establish a panel of scientists and other experts to provide advice on the legal, regulatory, scientific and ethical issues identified by the Senate inquiry. The work was intended to develop the key questions to inform a community-wide consultation.41

NHMRC Mitochondrial Donation Expert Working Committee In March 2019, the NHMRC convened a Mitochondrial Donation Expert Working Committee (NHMRC Expert Committee) to examine the questions posed by the Senate Committee. In June 2020, the NHMRC Expert Committee statement was released, reporting on three specific questions from the Senate inquiry.42 The Chair of the Expert Committee stated:

The Committee agreed that, given the complexity of the issues raised, some disagreement was both to be expected and acceptable. As such, the Expert Statement reflects the consensus view of the Committee on each question as far as was possible.43

NHMRC community consultations Between September and November 2019, the NHMRC undertook community consultation on the social and ethical considerations of the possible introduction of mitochondrial donation in Australian clinical practice.44 The consultation process included:

• the release of a Mitochondrial Donation Issues Paper to support and inform the consultation process45

• a citizens’ panel composed of ordinary citizens who engaged with mitochondrial donation experts and stakeholders to learn more about the issues and develop a position statement

• an online submission portal to allow people to submit their written views on the topic

• two NHMRC hosted webinars discussing the topic

• public forums held in Sydney and Melbourne and

• targeted roundtable discussions for key stakeholders to present their views and discuss perspectives.46

In June 2020, the NHMRC published the Community Consultation Report that discussed the outcomes of the consultation process.47 From the online submissions, the report identified five major themes, outlined below in Figure 4.

40. Australian Government, Australian Government response to the Senate Community Affairs References Committee Inquiry into: The Science of Mitochondrial Donation and Related Matters, Canberra, January 2019. 41. Ibid., p. 7. 42. NHMRC, Expert statement: Mitochondrial Donation Expert Working Committee, NHMRC, [Canberra], 2020. 43. Ibid., p. 1. 44. NHMRC, ‘Mitochondrial donation’, NHMRC website, n.d. 45. NHMRC, Mitochondrial donation issues paper, op. cit. 46. NHMRC, ‘Mitochondrial donation’, op. cit. 47. NHMRC, Mitochondrial donation community consultation report, NHMRC, [Canberra], 2020.

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Figure 4: outline of the themes from the community consultation online submissions

Source: NHMRC, Mitochondrial donation community consultation report, NHMRC, 2020, p. 21.

The Community Consultation Report concluded:

It is clear that there is a range of opinions in the community about mitochondrial donation, with a number of respondents being passionately opposed to its introduction while others are supportive. This range of views must be taken into consideration in any future work on this issue.48

Department of Health consultation The Minister for Health announced, on 5 February 2021, that the Department of Health (DoH) had commenced a consultation process on a proposal to introduce mitochondrial donation using a two-stage process (discussed further below).49 The public consultation took place from 5 February 2021 to 15 March 2021 and received 74 survey responses and 27 written submissions.

48. Ibid., p. 5. 49. G Hunt (Minister for Health and Aged Care), Harnessing new technology to save lives, media release, 5 February 2021.

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Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 18

The DoH released its Consultation Summary Report on 22 March 2021. The report found that the majority of the feedback reflected the responses provided through the Senate inquiry and NHMRC consultation process.50

Embryo research licensing The PHCR Act and the RIHE Act establish a regulatory framework around research and the creation, and use of human embryos through ART. The RIHE Act and the PHCR Act outline arrangements between the Commonwealth and the states and territories. Both Acts prohibit particular activities while identifying some activities that can only be undertaken if authorised by a licence.

The NHMRC Licensing Committee is a Principal Committee of the NHMRC and is established under Division 3 of Part 2 of the RIHE Act. It is responsible for overseeing the RIHE Act and the PHCR Act.51 To undertake research on human embryos, including use of excess ART embryos and research and training involving fertilisation, the researcher must operate under the approved activities of a licence issued by the NHMRC Licensing Committee.52

Tabling of Reports The RIHE Act requires the NHMRC Licensing Committee to table reports to either House of Parliament twice a year, upon request or at its discretion, about the operation of the Act and the licences issued.53

Maintaining a Licence Database Section 29 of the RIHE Act requires the NHMRC Licensing Committee to maintain a public database on each licence, including information on:

• the name of the licence holder

• the number of excess ART embryos or human eggs authorised for use by the licence

• a short statement of the nature of use of these excess embryos or eggs, and creation or uses of other embryos, authorised by the licence.54

Regulation of Excess ART Embryos Part 2 of the RIHE Act regulates the use of excess ART embryos, other embryos and human eggs. Section 9 provides the following definition of excess embryos for this Part:

excess ART embryo means a human embryo that:

(a) was created, by assisted reproductive technology, for use in the assisted reproductive technology treatment of a woman; and

(b) is excess to the needs of:

(i) the woman for whom it was created; and

(ii) her spouse (if any) at the time the embryo was created.

50. DoH, Consultation summary report: public consultation on the approach to introduce mitochondrial donation in Australia, DoH, [Canberra], [2021], p. 3. 51. NHMRC, ‘Embryo Research Licensing Committee’, NHMRC website, n.d. 52. NHMRC, ‘Information for applicants’, NHMRC website, n.d. The passage of this Bill will result in licences being renamed to

general licences to differentiate from mitochondrial donation licences. 53. Research Involving Human Embryos Act 2002, section 19. The reports are published on the NHMRC website. 54. Research Involving Human Embryos Act 2002, section 29. The database is available on the NHMRC website.

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(2) For the purposes of paragraph (b) of the definition of excess ART embryo, a human embryo is excess to the needs of the persons mentioned in that paragraph at a particular time if:

(a) each such person has given written authority for use of the embryo for a purpose other than a purpose relating to the assisted reproductive technology treatment of the woman concerned, and the authority is in force at that time; or

(b) each such person has determined in writing that the embryo is excess to their needs, and the determination is in force at that time.55

Human Research Ethics Committees In considering a licence application, the NHMRC Licensing Committee must be satisfied of a number of criteria, including the proposed project/activities having been assessed and approved by a Human Research Ethics Committee (HREC).56 Research institutions, such as hospitals and universities, have a HREC that reviews all research proposals that would involve human participants to ensure the proposed work is ethically acceptable. The NHMRC has published the National Statement on Ethical Conduct in Human Research (National Statement), which sets out the requirements of a HREC and the researchers.57

Proposed two-stage process The introduction of mitochondrial donation in Australia has been framed as a two-stage implementation process. The two-stage approach intends to provide a way for the mitochondrial donation technology and procedures to be introduced cautiously, with time allowed to gather evidence on the safety, efficacy and clinical utility of the techniques.58

A brief overview of the two-stage approach is provided in Table 1 below.

55. Research Involving Human Embryos Act 2002, section 9. 56. Ibid., paragraph 21(3)(c). 57. NHMRC, National statement on ethical conduct in human research, NHMRC, [Canberra], 2018. 58. Explanatory Memorandum, op. cit., pp. 70–71.

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Table 1: proposed two-stage process for the introduction of mitochondrial donation

Source: DoH, Legalising Mitochondrial Donation in Australia: Public Consultation Paper, DoH, [Canberra], [2021], p. 5.

Stage 1—research, training and clinical trials It is proposed that Stage 1 would include:

• an expansion of the role and remit of the NHMRC Licensing Committee to include licensing and oversight of specific mitochondrial donation licences

• the NHMRC Licensing Committee developing the administrative requirements and assessment procedures for individuals and organisations applying for one of the following three licence types which permit mitochondrial donation in Australia:

– pre-clinical research and training licence – clinical trial research and training licence and – clinical trial licence • the NHMRC Licensing Committee and the NHMRC developing monitoring processes for licence holders

• the DoH running a competitive grants process to identify a suitable organisation to undertake the clinical trial

– this trial is anticipated to take approximately 10 years, as the number of participants is expected to be low and each participant may require multiple IVF procedures before a successful pregnancy is achieved.59

Transition from Stage 1 to Stage 2 To facilitate the transition to Stage 2, the Bill amends the PHCR Act and the RIHE Act to establish all five licences, including the two clinical practice related licences. However, organisations will not

59. Ibid., pp. 71–72.

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be able to apply to the NHMRC Licensing Committee for either of the two clinical practice licences until a particular technique is specified in the RIHE Regulations for this purpose. The permitted mitochondrial donation techniques for clinical practice will not be authorised until Stage 1 is completed and the safety and efficacy of the techniques have been demonstrated.60

The states and territories are responsible for the regulation of ART in their jurisdiction. When undertaken in a clinical practice setting, mitochondrial donation is expected to be categorised as an assisted reproductive technology. If Stage 2 goes ahead, mitochondrial donation for the purposes of clinical practice will not be able to occur in a state or territory until the relevant state or territory legislation is amended to allow it.61

According to the Explanatory Memorandum of the Bill, the transition to Stage 2, and the specification of the permitted techniques in the Regulations, will be decided by the Government following consideration of the progress and outcomes of Stage 1, and other expert advice.62

Stage 2—clinical practice Under Stage 2, it is proposed that:

• jurisdictions may choose to be part of a national regulatory framework, which will allow for licenced clinical practice, in participating states or territories

• as part of the regulatory scheme, the following two licences, to be overseen by the NHMRC Licensing Committee, would be available:

– the clinical practice research and training licence and – the clinical practice licence.63

Ethical and social considerations This Bill will be put to a conscience vote.64 The Minister for Health outlined the reasoning behind this decision in his second reading speech:

Some members of the community … have raised concerns about issues such as privacy of parents and children, creation and destruction of embryos, ensuring informed consent, donor rights and the newness of the science. I acknowledge that not all members of the community are comfortable with the use of this technology, and that's reflected in the free vote—the ability to vote with conscience—that has been called for jointly by the major parties.65

The NHMRC Expert Committee Issues Paper states:

In addition to questions around safety and effectiveness, scientists, researchers and others have identified ethical and social issues that arise from the use of mitochondrial donation in research and in clinical treatment. These include the rights of the child, the status of the embryo, the role and rights of women donating eggs, and community considerations.66

It is these considerations that appear repeatedly in the submissions and reports from the Senate inquiry, the NHMRC community consultation activities and in the summary report on the most recent consultation undertaken by the DoH. These are complex and complicated issues and ones

60. Ibid. 61. Ibid., p. 25. 62. Ibid., p. 72. 63. Ibid. 64. See the Parliamentary Library’s Free votes in the Commonwealth Parliament 1950-2021: a quick guide for a list of free votes

granted in the Commonwealth Parliament. 65. Hunt, ‘Second reading speech: Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021’, op. cit., p. 2. 66. NHMRC, Mitochondrial donation issues paper, op. cit., p. 17.

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that people have strong and opposing views on. This section briefly summarises some of the key ethical and social considerations raised in the different consultation undertaken.

Treatment and prevention There is no cure for mitochondrial disease and no single treatment option, instead treatment is tailored to the individual.67 It is estimated that approximately one in every 200 children born in Australia has some level of mutation in their mitochondria with between one in 5,000 and one in 10,000 Australians developing severe mitochondrial disease.68 In 2006 a paper was released in The Lancet that suggested that at least 3,500 women in the UK, most of child-bearing age, were likely to be carriers of mtDNA mutations which could be passed on to their children, potentially causing mitochondrial disease.69 A review undertaken in 2012 provided some additional context on the estimated figures for the UK:

However, bearing in mind the limiting factors listed above, a widely-quoted figure (approximated from different published papers) is that around one in 6,500 children is thought to develop a more serious mitochondrial disorder, where some of these disorders can be fatal. In the context of neuromuscular disease, this figure would make mtDNA disorders one of the most common inherited neuromuscular disorders.70

In a submission to the Senate inquiry in 2018, Professor Christodoulou, a clinical geneticist, stated:

There are currently very few effective treatments for this group of disorders, and so prevention is the main approach that can be currently offered to families. For nuclear-encoded gene mutations traditional prenatal testing or pre-implantation genetic diagnosis techniques are very effective and have a long and established track record. However, apart from a few specific exceptions, for primary mitochondrial DNA disorders these approaches are generally not as definitive for a number of reasons. It is for this latter group of disorders where mitochondrial donation is particularly relevant.71

In the NHMRC community consultation, concerns were raised, including by people with mitochondrial disease, that the introduction of mitochondrial donation could have negative impacts and could exacerbate ‘negative social perceptions and treatment of people with a disability’.72

Options for having children There are three main non-medical options available for perspective parent/s who are at increased risk of passing on mtDNA mutations that could cause mitochondrial disease (see Figure 5):

• adoption

• fostering and

• natural conception.73

There are also three main medical options currently available (see Figure 6):

67. Mito Foundation, ‘Mitochondrial disease information’, op. cit. 68. NHMRC, Mitochondrial donation issues paper, op. cit., p. 8. 69. DT Brown, M Herbert, VK Lamb, PF Chinnery, RW Taylor, RN Lightowlers, L Craven, L Cree, JL Gardner, DM Turnbull, ‘Transmission of mitochondrial DNA disorders: possibilities for the future’, The Lancet, 368(9529), 1 July 2006, pp. 87–9.

70. Nuffield Council on Bioethics, Novel techniques for the prevention of mitochondrial DNA disorders: an ethical review, Nuffield Council on Bioethics, London, [2012], p. 25. 71. J Christodoulou, Submission to Senate Community Affairs References Committee, Science of Mitochondrial Donation and Related Matters, [Submission no. 12], 3 May 2018. 72. NHMRC, Mitochondrial donation community consultation report, op. cit., p. 25. 73. NHMRC Mitochondrial Donation Expert Working Committee, Expert Statement, op. cit., p. 66.

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Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 23

• prenatal testing

• pre-implementation genetic testing and

• use of a donor egg.74

As identified in Figures 5 and 6 below, there are advantages and disadvantages for all options, including some medical options not being clinically appropriate for all women. According to the Senate Committee’s final report, some submissions that did not support mitochondrial donation argued in favour of non-genetic options.75

For some people, having a child who is genetically related to them is extremely important but this desire is not always considered a compelling enough reason to introduce mitochondrial donation by people and organisations who made submissions to the NHMRC and Senate inquiry.76 In the (US) National Academies of Sciences, Engineering, and Medicine (NASEM) report on the ethical, social and policy considerations of mitochondrial donation, the authors conclude that the current options available achieve some of the desirable attributes of mitochondrial donation but not all of them.77 The Senate Committee expressed the view that it is ‘desirable for governments to support fertility treatment as a social good’ but this is not an unlimited responsibility and any treatments should be provided equitably.78

The range of options available, which may include mitochondrial donation, provide people with different choices, with some options appealing to some people and not others. Importantly, for people to make these choices, they need readily available access to appropriate information and support to assist them in making their decisions.

Figure 5: current non-medical reproductive options for women where there is a risk of transmitting mitochondrial disease to offspring

Source: NHMRC Mitochondrial Donation Expert Working Committee, Expert Statement, NHMRC, [Canberra], 2020, p. 66.

74. Ibid., p. 67. 75. Senate Community Affairs References Committee, Science of mitochondrial donation and related matters, op. cit., p. 26. 76. Ibid.; NHMRC, Mitochondrial donation community consultation report, op. cit. 77. National Academies of Sciences, Engineering, and Medicine (NASEM), Mitochondrial replacement techniques: ethical, social,

and policy considerations, The National Academies Press, Washington, 2016. 78. Senate Community Affairs References Committee, Science of mitochondrial donation and related matters, op. cit., p. 27.

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Figure 6: current reproductive options for women where there is a risk of transmitting mitochondrial disease to offspring

Source: NHMRC Mitochondrial Donation Expert Working Committee, Expert statement, NHMRC, [Canberra], 2020, p. 67.

Use of new techniques As outlined in the scientific background, research on the safety and efficacy of mitochondrial donation techniques is continuing with new evidence emerging and with knowledge gaps remaining. Through the community consultation process undertaken by the NHMRC, the unknown, unforeseen or unintended consequences were considerations identified in submissions for proponents and opponents of mitochondrial donation.79

Sex selection Sex selection through the use of ART is permitted in Australia but is an option reserved for cases that would reduce the risk of transmission of a genetic condition or disease that would severely impact the person’s quality of life.80 Sex selection for male embryos with mitochondrial donation is considered for two different reasons.

As outlined in the Senate inquiry, some experts have suggested the children from women who were themselves born using a mitochondrial donation technique may have an additional risk of developing mitochondrial disease than the children of men born using mitochondrial donation due to mtDNA carryover.81

Sex selection is also raised in consideration of inheritable genetic modifications. As outlined in the scientific background, mtDNA is inherited almost exclusively through the maternal line. Therefore, if a man was born using mitochondrial donation, any child he would have would inherit the mother’s mtDNA and not his mtDNA. As such, the changes to his mtDNA will not be passed on to the next generation.

79. NHMRC, Mitochondrial donation community consultation report, op. cit. 80. NHMRC, Ethical guidelines on the use of assisted reproductive technology in clinical practice and research, NHMRC, Canberra, 2017, p. 69. 81. Senate Community Affairs References Committee, Science of mitochondrial donation and related matters, op. cit., p. 44.

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In the NASEM report, it is recommended that mitochondrial donation be limited to male embryos in the first instance to avoid heritable genetic modifications. The authors argue this position is not about the acceptability of sex selection and is rather based on the need to proceed slowly and prevent potential adverse heritable changes being passed to future generations.82 The Nuffield Council on Bioethics, based in the UK, raise concerns about the use of sex selection with mitochondrial donation and provide the following extract from a submission it received during its consultation:

In suggesting that only males be conceived initially, there is an underlying assumption that the unknown long-term adverse consequences would relate only to the mitochondria (passed to the next generation through eggs, not sperm). As this may not be the case, there is no justification for limiting the risk to one particular sex. No technique for the eradication of disease should be permitted until there is reasonable evidence for its safety. We would not argue that experimental treatments should not be permitted in medicine, however… if such a course of action as selecting only males needs to be considered, it implies that at the time of offering the treatment too little is known about its safety. Another implication is that should sex selection be permitted the boys born from such treatment would live with uncertainty about their future health, beyond that normally experienced. The potential psychological implications of this would need to be included in pre-treatment counselling of the couples.83

The potential for sex selection was identified in the Senate inquiry, with a number of scientific witnesses being of the opinion that there was no clear justification for sex selection for male embryos if mitochondrial donation was introduced in Australia.84 This issue was also considered by the NHMRC Expert Committee who reflected that restricting mitochondrial donation to male embryos would introduce its own problematic ethical, scientific and practical considerations.85

Status of the embryo As noted in the NHMRC community consultation report, broader concerns about ART and the status of the embryo featured in many submissions it received as ‘for many people, it is not possible to separate the different technologies and issues related to embryos …’86 These concerns were also identified in submissions made to the Senate inquiry. Therefore, this issue is briefly touched on, noting it does not only relate to mitochondrial donation.

Submissions received by both the Senate inquiry and the NHMRC raise concerns about the creation of embryos for techniques that may not use the whole embryo and as such, part of the embryo will be disposed of (as with PNT), or not using the embryos for reproductive purposes. A number of submissions to the Senate inquiry reflected on the moral status of the embryos. Some submissions expressed their view on the inherent dignity of the embryo (and sometimes at earlier development stages, such as the zygote) which must be respected and that embryos should not be treated as a means to an end.87

In contrast, some submissions received by the NHMRC community consultation process acknowledged that embryos would be destroyed as part of mitochondrial donation but respondents did not necessarily consider this unethical.88

82. NASEM, Mitochondrial replacement techniques, op. cit. 83. Nuffield Council on Bioethics, Novel techniques for the prevention of mitochondrial DNA disorders, op. cit., p. 80. 84. Senate Community Affairs References Committee, Science of mitochondrial donation and related matters, op. cit., p. 45. 85. NHMRC Mitochondrial Donation Expert Working Committee, Expert Statement, op. cit., p. 5. 86. NHMRC, Mitochondrial donation community consultation report, op. cit., p. 54. 87. Senate Community Affairs References Committee, Science of mitochondrial donation and related matters, op. cit., p. 56. 88. NHMRC, Mitochondrial donation community consultation report, op. cit., p. 56.

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The rights and wellbeing of the child The health and wellbeing of people born from mitochondrial donation are important factors to be considered, especially given some of the health risks associated with the technology are still unknown.89

There is no way to obtain the views of a child that would be born using mitochondrial donation. The following is an extract from the Senate inquiry’s report on the science of mitochondrial donation and related matters relating to the issue of whether a child would have consented to mitochondrial donation:

People who live with a mitochondrial disease and their children had little difficulty imagining whether a person who was born from a mitochondrial donation technique would consent. Mary, a person living with a mitochondrial disease, asked her children whether they thought they would have consented to the procedure:

In the process of preparing my submission, I talked to my children about this and I said to them: 'What do you think?' They said, 'If we had a child with mitochondrial disease, we would love that child we would understand what the child was going through.' But their view was that everyone who has mitochondrial disease, their families that are affected by it, should have this choice.

Justin, who also lives with a mitochondrial disease, told the committee that he believes that a child who was born of the technique would understand the choice that had been made for them:

What I have learned over the last 2½ years is that having a disability or a sickness like we've got is about compromise. You are compromising the whole time about what you used to have in your life that you don't have anymore. Being part of a family where the other members of the family are disabled or are sick and is also about compromise—you can't do the things you need to do. So I'm confident that any child, if this technology was to go forward, born through mitochondrial donation would understand that life is about compromises when you are in this situation. If that means that I can't participate in recreational genetics, if that means that a second woman gave me the slightest part of my DNA, I think that would be a compromise I would be able to live with.90 [references removed]

It is also not possible to identify how a child born using mitochondrial donation would feel about the donor (or how the donor may feel about the child), with this potentially depending on the individuals involved and their unique situations.91 In response to the NHMRC consultation, many submissions raised questions about whether the child would be able to access information about the donor, with some people considering it important that the child be able to do so.92

The privacy of the child and their family is another consideration that is raised repeatedly. Respondents to the NHMRC community consultation raised the need to avoid ‘medicalising’ the child but also the need for additional information about the safety and efficacy of mitochondrial donation.93

89. NHMRC, Mitochondrial donation issues paper, op. cit., pp. 18–19. 90. Senate Community Affairs References Committee, Science of mitochondrial donation and related matters, op. cit. p. 67. 91. Nuffield Council on Bioethics, Novel techniques for the prevention of mitochondrial DNA disorders, op. cit., p. 71. 92. NHMRC, Mitochondrial donation community consultation report, op. cit., p. 42. 93. Ibid., p. 37.

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The donor Different considerations and concerns have been raised in relation to the donor, one of the most common ones being the idea of a child with three parents. In the Senate inquiry, the main question this point prompted was whether a mtDNA donor should be considered a parent.94

This question can be considered in two different ways: from a genetic perspective and from a social one. With regards to genetic contribution, several submissions and witnesses flagged the proportion of the genetic material that the mtDNA contributes (0.1 per cent) and the role of the mtDNA. From a social perspective, some think that the mtDNA donor can be considered equivalent to an organ or tissue donor.95 For some people, organ and tissue donation is accepted and acceptable medical practice but for others, this is not the case. One of the concerns raised about donation is that it can impact the identity of the recipient, including, but not limited to, the adoption of some of the traits of the donor.96 Whilst these concerns are not unique to mitochondrial donation, they may still impact some people’s views on it. The Senate Committee concluded that mitochondrial donation would not lead to a child having three parents and mtDNA donation should be conceptualised as being similar to organ donation.97

In considering the donor, as is the situation with egg donation in general, robust processes will need to be implemented to ensure informed consent and address potential issues like coercion. In addition, harm minimisation and respect will also need to be considered.98 In the NHMRC community consultation, the donor’s right to confidentiality or even anonymity was raised as an important consideration, with submissions suggesting donors should be able to be anonymous and other submissions stating that donors should be identifiable.99

Committee consideration

Senate Standing Committee for Selection of Bills At its meeting on 13 May 2021, the Senate Standing Committee for the Selection of Bills deferred consideration of the Bill to its next meeting.100

Senate Standing Committee for the Scrutiny of Bills The Senate Standing Committee for the Scrutiny of Bills (the Committee) reported on this Bill on 21 April 2021.101 The Committee’s concerns largely arose from significant matters within the Bill being assigned to delegated legislation.102

Mitochondrial donation licence application fee The Committee expressed concerns regarding proposed paragraph 28H(7)(d), which provides that an application for a mitochondrial donation licence must be accompanied by a fee, if any, prescribed by the Regulations. The Committee questioned why the fee-making power is to be determined by delegated legislation and why the Bill, and the Explanatory Memorandum for the

94. Senate Community Affairs References Committee, Science of mitochondrial donation and related matters, op. cit., pp. 58–61. 95. Ibid. 96. NASEM, Mitochondrial replacement techniques, op. cit., p. 101. 97. Senate Community Affairs References Committee, Science of mitochondrial donation and related matters, op. cit., p. 61. 98. NHMRC, Mitochondrial donation issues paper, op. cit., p. 22. 99. NHMRC, Mitochondrial donation community consultation report, op. cit., p. 47. 100. Senate Standing Committee of Selection of Bills, Report, 5, 2021, The Senate, Canberra, 13 May 2021, [p. 3]. 101. Senate Standing Committee for the Scrutiny of Bills, Scrutiny digest, 6, 2021, The Senate, Canberra, 21 April 2021, pp. 25–29. 102. Ibid.

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Bill, contained no information or guidance on how the fee will be calculated, any cap on the maximum fee amount or, how to ensure that the fee will be necessary and appropriate.103

The Committee considered that, at a minimum, the Bill should include a provision stating that the fee must not be such as to amount to taxation, noting the advice set out in paragraph 24 of the Office of Parliamentary Counsel Drafting Direction No. 3.1.104

The Committee requested further advice from the Minister, including:

• how the amount of any fee charged will be calculated and how it will be ensured that a fee charged to a person will be necessary and appropriate and

• whether the Bill can be amended to provide at least high-level guidance regarding how fees will be calculated, including, at a minimum, a provision stating that the fee must not be such as to amount to taxation.105

Definition of ‘proper consent’ and provision for withdrawal of consent The Committee expressed concerns regarding proposed subsection 28N(8) and proposed subsection 24(9), which provide for the definition of 'proper consent' concerning the use of a human egg or a human sperm for Division 4A of Part 2 and 'proper consent' concerning the use of an excess ART embryo or a human egg for Division 4 of Part 2, respectively. Both of these proposed subsections refer to the definition of ‘proper consent’ as consent that is obtained under guidelines issued by the CEO of the NHMRC under the National Health and Medical Research Council Act 1992 and prescribed by the Regulations.106

The Committee also expressed concerns regarding proposed subsection 28N(9) which provides that the Regulations may provide in relation to the withdrawal of consent, including that consent cannot be withdrawn in certain circumstances.107

The Committee questioned why significant matters, such as provisions defining key terms as well as requirements relating to the withdrawal of consent, are not included in the primary legislation. The Committee acknowledged the justification, in the Explanatory Memorandum for the Bill, for the use of delegated legislation regarding item 105 of the Bill, but questioned why the justification did not cover proposed subsections 28N(8) and (9) and proposed subsection 24(9).108

The Committee expressed general concern regarding provisions in a Bill that allow for the incorporation of legislative provisions by reference to other documents because such an approach:

• raises the prospect of changes being made to the law in the absence of parliamentary scrutiny, (for example, where an external document is incorporated as in force 'from time to time' as it is here this would mean that any future changes to that document would operate to change the law without any involvement from Parliament);

• can create uncertainty in the law; and

103. Ibid., p. 25. 104. Ibid. 105. Ibid., pp. 25–26. 106. Ibid., p. 26. 107. Ibid. 108. Ibid. pp. 26–27.

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• means that those obliged to obey the law may have inadequate access to its terms (in particular, the committee will be concerned where relevant information, including standards, accounting principles or industry databases, is not publicly available or is available only if a fee is paid).109

The Committee requested further advice from the Minister, including:

• why it is considered necessary and appropriate to leave provisions defining the scope of the term ‘proper consent’ (proposed paragraph 28N(8)(b) and proposed subsection 24(9)) and requirements relating to the withdrawal of consent (proposed subsection 28N(9) to delegated legislation

• whether the Bill can be amended to include at least high-level guidance regarding these matters on the face of the primary legislation

• why it is considered necessary and appropriate to apply the ART Guidelines as in force or existing from time to time (noting that this means that future changes to the guidelines and therefore the definition of ‘proper consent’ will be incorporated into the law without any parliamentary scrutiny) and

• whether the Bill could be amended to provide for the meaning of 'proper consent' on the face of the instrument or the Bill, rather than relying on the incorporation of the ART Guidelines.110

Privacy The Committee expressed concerns regarding proposed section 28R(1)(e) and proposed section 28R(3)(d), which provides that the Regulations may prescribe information that the holder of a clinical trial licence or a clinical practice licence must collect for a donor, or a child born as a result of mitochondrial donation. The Committee noted that the Regulations (as a legislative instrument) are not subject to the full range of parliamentary scrutiny and questioned why significant matters, such as the collection of personal information, is not included in the primary legislation. 111

The Committee acknowledged the justification made in the Explanatory Memorandum of the Bill, that delegating the collection powers to the legislative instrument maintains administrative flexibility and is consistent with state ART laws, but did not accept the justification to be sufficient.112

The Committee requested further advice from the Minister, including:

• why it is considered necessary and appropriate to leave the scope of sensitive information-collection powers to delegated legislation and

• whether the Bill can be amended to include further guidance regarding these matters on the face of the primary legislation.113

The Minister’s response was received by the Committee on 10 May 2021 but had not been published at the time of writing.114

109. Ibid., p. 27. 110. Ibid., p. 28. 111. Ibid. 112. Ibid., pp. 28–29. 113. Ibid., p. 29. 114. Senate Standing Committee for the Scrutiny of Bills, ‘Ministerial responses’, The Senate, Canberra

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Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 30

Policy position of non-government parties/independents Due to the complex nature of the Bill, the Cabinet, the Party Room and the Opposition have agreed to allow a conscience vote, meaning members of Parliament are not obliged to follow their party line, but can vote according to their own moral, political, religious, or social beliefs.115

ALP During the Bill’s second reading speech the Minister for Health, Greg Hunt, stated that that the Opposition supports the Bill:

That's why, as a minister, as a father and as an individual; with the passionate support of the Prime Minister, who is patron of the Mito Foundation, publicly and proudly; with the support of the opposition—and Chris Bowen has been a champion in supporting this and has passed that baton to his successor, Mark Butler; with the support of the community; and with the support of people such as Sarah and Joel Hood, and Catherine McGovern from the foundation, we seek to avoid the heartache, pain and anguish of having a child with severe mitochondrial disease.116

This is supported by an article reporting the then Shadow Minister for Health, Chris Bowen, advising that Labor will support changing the laws to allow for mitochondrial donation.117 In a speech in 2020, Mr Bowen stated he has had conversations with the Minister for Health on the best way to jointly manage the process of a mature, non-partisan debate in Parliament about the next steps needed to tackle mitochondrial DNA disease, including mitochondrial donation.118

Following the second reading speech of the Bill, Labor MP Catherine King commended the Minister for Health on the work he has done for the Bill and acknowledged that, whilst mitochondrial donation is a difficult issue, it is incredibly important.119

In September 2020, Labor MP Dr Andrew Leigh, conducted an online and a face-to-face forum with his constituents to discuss and listen to their views on mitochondrial donation.120 When asked if he already had a view on the legalisation of mitochondrial donation, Dr Leigh stated: ‘My vote will be guided by the process, not bound.’121 Since the public forums, he has not offered any further views on mitochondrial donation.

In 2019, during Private Members’ Business, Labor MP Dr Mike Freelander spoke on the importance of legislating for mitochondrial donation.122

While not explicitly stating her support for the legalisation of mitochondrial donation, during the tabling of the report prepared by the Senate Committee inquiry in 2018, Labor Senator Louise Pratt, a member of the Committee, reiterated her support for the report and stressed the importance of examining the laws to see if they should be amended.123

115. Hunt, ‘Second reading speech: Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021’, op. cit., p. 1. 116. Ibid. 117. T Elliott, ‘Cell block’, The Saturday Age, 21 March 2020, p. 5. 118. C Bowen (Shadow Minister for Health), Address to the Rare Voices Australia Launch of the National Strategic Action Plan for

Rare Diseases, Canberra, speech, 26 February 2020, pp. 2–3. 119. C King, ‘Second reading speech: Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021’, House of Representatives, Debates, (proof), 24 March 2021, p. 3. 120. S Whyte, ‘Public forums will shape Leigh's vote’, The Canberra Times, 21 September 2020, p. 6. 121. Ibid. 122. M Freelander, ‘Private Members Business: Health Care’, House of Representatives, Debates, 25 November 2019, p. 5687. 123. L Pratt, ‘Committees: Community Affairs References Committee Report’, Senate, Debates, 27 June 2018, p. 4210.

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The Greens At the time of writing, only one member of the Australian Greens had commented on their position regarding the legalisation of mitochondrial donation. During the tabling of the report prepared by the Senate Committee inquiry in 2018, Senator Rachel Siewert, who was Chair of the Committee, stated:

There's no doubt in my mind that this mitochondrial donation has a very strong potential for helping those families who are affected by mitochondrial DNA where the disease is inherited. There's no doubt in my mind that this has potential. But there are some things that need to occur if this type of donation technique is to occur. There is also no doubt in my mind that it would help affected people and those who have genetically linked children. It would certainly help.124

Minor parties and independents At the time of writing, none of the other minor parties or independents had formally stated a position on the Bill.

Position of major interest groups At the time of writing, the Mito Foundation had welcomed the Bill but did not comment on any specific component. No other commentary on the Bill had been identified from other interest groups.125 However, different groups have expressed broader views on legalising mitochondrial donation in Australia over the course of the consultation processes undertaken by the Senate inquiry, the NHMRC and the DoH. The following section provides an overview of key elements raised by interested group through the Senate inquiry. Respondents considered a number of questions posed by the Senate Committee and provided feedback from a range of perspectives, including responses from:

• people with mitochondrial disease and their families

• scientists

• people providing clinical services (for example, clinical genetics and assisted reproduction)

• ethicists and religious organisations.

As previously noted, these are complex and complicated issues on which it is perhaps not possible to reach an agreed position. The submissions included in the following section have been selected to illustrate the range of commentary rather than nominating ‘major interest groups’ only. Not all submissions to the Senate inquiry have been included in the following discussion, but they are available on the Senate inquiry webpage.126 It should be noted that the submissions are a few years old and some positions discussed below are also raised in the previous section on ethical and social consideration.

Senate Community Affairs References Committee Inquiry into: The Science of Mitochondrial Donation and Related Matters

124. R Siewert, ‘Committees: Community Affairs References Committee Report’, Senate, Debates, 27 June 2018, p. 4208. 125. Mito Foundation, ‘Hope for Families with Mito’, Mito Foundation website, n.d. 126. Submissions to the 2018 Senate Community Affairs Reference Committee Inquiry into: The Science of Mitochondrial Donation and Related Matters are available on the Parliament of Australia website.

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There are few effective treatments and no cures In its submission to the Senate inquiry, the Mito Foundation (the Australian Mitochondrial Disease Foundation) raised the issue that ‘there are few effective treatments and no cures for mitochondrial disease’.127

The Human Genetics Society of Australasia (HGSA) noted the importance of not over-hyping the potential of mitochondrial donation as it is not ‘life saving’ or a ‘magic bullet’ as it does not save the life of a person born with mitochondrial disease nor does it cure all mitochondrial DNA disease.128 The Mito Foundation noted this point in its supplementary submission and draws attention to the similarities with disease prevention and health promotion approaches.129

In its submission, the Australian Catholic Bishops Conference (ACBC) raised concerns about dedicating resources to mitochondrial donation as it does not help people who already have mitochondrial disease. The ACBC also stated that there is a risk that this could imply people with mitochondrial disease have lives of less worth than others.130

Current reproductive options The Mito Foundation noted in its submission that people are choosing to remain childless to avoid the risk of their child having mitochondrial disease. It goes on to state that mitochondrial donation is the only option for some people with a mtDNA disorder to have children who are genetically related to them and will not inherit mitochondrial DNA disease.131

The HGSA noted the emotional impact that mitochondrial disease can have, stating the ‘clinical experience of HGSA members suggests that mothers who have transmitted these disorders are often plagued with guilt as there is a lack of effective treatments…’.132

The ACBC is of the opinion that ART is not in the best interest of prospective parents, or their potential children, as it raises issues affecting the dignity of all the parents and children. Instead of using ART, ACBC identified several alternative reproductive options, noting none of these options ‘are easy and go against the strong human desire for genetically-related children’.133

Scientific considerations The Mito Foundation pointed out that the risks and benefits of IVF are well known, including that it is not 100 per cent effective or safe. It supported the introduction of mitochondrial donation in Australia being limited to institutions and clinics with staff with demonstrated expertise in embryology and IVF.134

In its submission, the HGSA stated it is ‘not aware of any evidence to suggest that there would be significant risks to the children who would be born following mitochondrial donation’.135 The Fertility Society of Australia (FSA) echoed this view, stating that ‘it would appear that the balance

127. AMDF, Submission to Senate Community Affairs References Committee, op. cit., p. 2. 128. Human Genetics Society of Australasia (HGSA), Submission to Senate Community Affairs References Committee, Science of mitochondrial donation and related matters, [Submission no. 2], 7 May 2018, p. 1. 129. AMDF, Supplementary Submission to Senate Community Affairs References Committee, [Submission no. 26], 9 May 2018,

p. 4.

130. Australian Catholic Bishops Conference (ACBC), Submission to Senate Community Affairs References Committee, Science of mitochondrial donation and related matters, [Submission no. 28], 11 May 2018. 131. AMDF, Submission, op. cit., p. 4. 132. HGSA, Submission, op. cit., p. 3. 133. ACBC, Submission, op. cit., pp. 4 and 12. 134. AMDF, Submission, op. cit., pp. 10–11. 135. HGSA, Submission, op. cit., p. 2.

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of risk versus benefit in this debilitating disease is now at a point where [mitochondrial donation] should occur’.136

The Biomedical Ethics Research Group from the Murdoch Children’s Research Institute (MCRI) acknowledged the safety concerns justifying a cautious implementation but noted that these concerns should not legally prohibit the introduction of mitochondrial donation.137

Ethical considerations The Mito Foundation raised concerns that failure to introduce mitochondrial donation in Australia may result in some people exploring fertility tourism options.138 In responding to certain considerations raised about egg donors, the Mito Foundation noted that egg donation is voluntary in Australia and therefore did not agree with concerns about the donor experience reducing the validity of mitochondrial donation.139 The FSA argued that there is an ethical obligation to use a technology that could avoid people having a disabling or fatal illness or condition.140 The Biomedical Ethics Research Group from the MCRI stated that there is ongoing debate in the bioethics literature on the moral significance, if there is any, of mitochondrial DNA and genetic connectedness.141

The ACBC raised several ethical concerns about mitochondrial donation, including that PNT is a form of human cloning (due to the transfer of nDNA) and the use of genetic material from more than two people would threaten the rights of a child to inherit their relationship to natural parents.142 The Plunkett Centre for Ethics raised similar ethical concerns about mitochondrial donation to the ACBC and also suggested that introduction of mitochondrial donation would open the door ‘to eugenic germ-line genetic manipulation’.143 Both the ACBC and the Plunkett Centre for Ethics raised concerns about the language ‘mitochondrial donation’ being misleading as, with some of the techniques, the nDNA is moved rather than the mtDNA.144

Legal considerations The Australian Academy of Science recommended Australia introduce mitochondrial donation techniques into clinical use and research, similar to the approach taken in the UK, with due diligence of regulation and oversight.145 This position is supported by the FSA and HGSA, with the HGSA strongly advocating for a flexible and responsive governance system to minimise unintended consequences experienced with the existing regulation.146

Financial considerations Using the Impact Statement of The Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015 (UK), the Mito Foundation suggested that the introduction of mitochondrial

136. Fertility Society of Australia (FSA), Submission to Senate Community Affairs References Committee, Science of Mitochondrial Donation and Related matters, [Submission No. 27], n.d., p. 1. 137. Biomedical Ethics Research Group from the Murdoch Children’s Research Institute (MCRI), Submission to Senate Community Affairs References Committee, Science of Mitochondrial Donation and Related Matters, [Submission No. 34], n.d., p. 2. 138. AMDF, Submission, op. cit., p. 11. 139. AMDF, Supplementary Submission, op. cit., pp. 7–8. 140. FSA, Submission, op. cit., p. 2. 141. Biomedical Ethics Research Group, MCRI, Submission, op. cit., pp. 4–5. 142. ACBC, Submission, op. cit., pp. 2–3. 143. Plunkett Centre for Ethics, Submission to Senate Community Affairs References Committee, Science of Mitochondrial

Donation and Related Matters, [Submission No. 30], 14 May 2018, p. 4. 144. Ibid., p. 1; ACBC, Submission, op. cit., p. 5. 145. Australian Academy of Science, Submission to Senate Community Affairs References Committee, Science of Mitochondrial

Donation and Related Matters, [Submission No. 35], May 2018, p. 2. 146. HGSA, Submission, op. cit., p. 3.; FSA, Submission, op. cit., p. 2.

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donation could deliver a net benefit of approximately $61 million (AUD) per year and $575 million (AUD) over ten years.147 It also provided an estimate that a National Disability Insurance Scheme plan may fund up to $120,000 per month for a child with mitochondrial disease.148

The Biomedical Ethics Research Group from the MCRI presented an ethical argument on finite resources, suggesting that treating one person with an expensive treatment can reduce the resources available for other people. Therefore, allowing mitochondrial donation to prevent mitochondrial disease would benefit others by increasing available capacity in the health system.149 The ACBC stated that given its ethical and risk related concerns, it does not support the use of the limited resources available in both health and research for the introduction of mitochondrial donation.150

Financial implications The Explanatory Memorandum to the Bill states that there will be no net financial impact arising from the implementation of the Bill, and further explains:

Following the passage of the legislation, it is anticipated that there will be some additional costs associated with establishing new administrative processes for receiving and processing applications for and issuing of the new mitochondrial donation licences. There will also be some ongoing costs to Government associated with providing:

- ongoing support for the ERLC and for ongoing compliance monitoring related to the new licences

- ongoing project management and support for any Commonwealth funded clinical trial of mitochondrial donation, and

- the establishment and maintenance of new data systems.

However, as these activities will be undertaken as an extension of already established Government processes, the ongoing costs are anticipated to be minimal and will be offset within the Department of Health portfolio. In addition, whilst it is not possible to accurately predict, it is anticipated that ten or fewer mitochondrial donation related licence applications would likely be sought per annum.

It is also anticipated that if the clinical trial of mitochondrial donation were to prove successful in minimising the risk of future generations inheriting severe mitochondrial disease, this would provide a potentially significant cost saving to the health and social welfare systems through a reduced burden of disease and increased potential for workforce participation. However, it not currently possible to provide estimates of these potential savings before any outcomes of the trial have been realised. 151

Attachment B to the Regulation Impact Statement (RIS) on pages 86 to 94 of the Explanatory Memorandum to the Bill provides calculations of the costs associated with the three policy proposals discussed by the RIS:

1. maintain the status quo (mitochondrial donation is not legalised in Australia)

2. legalise mitochondrial donation in Australia as a pathway to clinical use and

147. AMDF, Submission, op. cit., p. 12. The Impact Statement of The Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015 is available from the legislation.gov.uk website. Attachment B of the Explanatory Memorandum to the Bill provides calculations of the regulatory costs associated with each option (see pages 86 to 94).

148. Ibid. 149. Biomedical Ethics Research Group, MCRI, Submission, op. cit., p. 5. 150. ACBC, Submission, op. cit., p. 2. 151. Explanatory Memorandum, op. cit., p. 6.

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3. support access to overseas treatment options.152

Statement of Compatibility with Human Rights As required under Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011, the Government has assessed the Bill’s compatibility with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of that Act. The Government considers that the Bill is compatible.153

Parliamentary Joint Committee on Human Rights The Parliamentary Joint Committee on Human Rights had no comment in relation to the Bill.154

Key issues and provisions

Overview The use of mitochondrial donation techniques is currently prohibited under the PHCR Act and the RIHE Act.155 Accordingly, the Bill amends these two Acts, and the RIHE Regulations to permit the staged introduction of these techniques.

It is an offence under the current PHCR Act to:

• create or develop embryos through the process of fertilisation with genetic material from more than two people and

• make heritable changes to the genome of a human embryo for reproductive purposes.156

In part, this ban does not extend to pronuclear transfer (PNT), which is currently permitted under licence, as the technique uses two zygotes, created with the genetic material of two people, however this technique is prohibited from creating human embryos for reproductive purposes.157

This Bill proposes two significant changes which would allow, under licence, the creation of an embryo for reproductive purposes with:

• the genetic material of more than two people and

• changes to its genome that would be heritable by the child’s descendants.

Only two licences would allow for the use of these embryos for reproductive purposes, the clinical trial licence and the clinical practice licence. Stage 1 of mitochondrial donation will introduce the clinical trial licence. The clinical practice licence has been identified for potential introduction in Stage 2 of mitochondrial donation.158

In addition, under the RIHE Act, the woman and her ‘spouse’, if any, will be permitted to nominate only male embryos for placement.159 As outlined in the background, sex selection through the use of ART is permitted in Australia but is an option reserved for cases that would reduce the risk of transmission of a genetic condition or disease that would severely impact the person’s quality of life.160 Given the scientific and ethical considerations of sex selection for mitochondrial donation,

152. Ibid., pp. 70–73, 86–94. 153. The Statement of Compatibility with Human Rights can be found at page 7 of the Explanatory Memorandum to the Bill. 154. Parliamentary Joint Committee on Human Rights, Human rights scrutiny report, 5, 2021, 29 April 2021, p. 44. 155. Explanatory Memorandum, op. cit., p. 2. 156. Prohibition of Human Cloning for Reproduction Act 2002, section 13 and 15. 157. Senate Community Affairs References Committee, Science of mitochondrial donation and related matters, op. cit., pp. 34–35. 158. DoH, Legalising mitochondrial donation in Australia: public consultation paper, op. cit., p. 5. 159. Proposed paragraph 28Q(1)(d) at item 17 of the Bill; Spouse is defined in the RIHE Act as: in relation to a person, includes a

de facto partner of the person within the meaning of the Acts Interpretation Act 1901. 160. NHMRC, Ethical guidelines on the use of assisted reproductive technology in clinical practice and research, op. cit., p. 69.

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the Bill requires a woman/ the couple to attend counselling before deciding if they would like to only place a male embryo.

Stage 1 of mitochondrial donation would be through a clinical trials framework for both the licence holder and the ‘trial participant’ (that is, the woman who is seeking to use mitochondrial donation for reproductive purposes). Stage 2, if implemented, would consider the introduction of clinical practice licences and any woman seeking to use mitochondrial donation for reproductive purposes would be known as a ‘patient’ instead.

The criteria to become a trial participant (or patient) includes evidence that the woman’s child would be at an increased risk of developing severe mitochondrial disease. The Bill would not allow for the use of mitochondrial donation techniques for any other reproductive purpose than to minimise the risk of a child developing severe mitochondrial disease.161

Changing the term ‘licence’ to ‘general licence’ The Bill’s introduction of the new term ‘mitochondrial donation licence’ means that the current ‘licence’ used throughout both the RIHE Act and the PHCR Act is no longer sufficient. ‘Licence’ is currently defined to mean a licence issued under section 21 of the RIHE Act.162 In order to differentiate the ‘mitochondrial donation licences’ from the other ‘licences’ within the legislation, the Bill systematically amends the term ‘licence’ in both the RIHE Act and the PHCR Act to ‘general licence’.163

PHCR Act amendments

Changes to legalise the use of mitochondrial donation The Bill makes significant changes to the PHCR Act by amending sections of Part 2—Prohibited practices, allowing for the use of mitochondrial donation techniques for reproductive purposes under the relevant mitochondrial donation licences.

Creating human embryos for a purpose other than achieving pregnancy Currently, section 12 of the PHCR Act makes it an offence to create a human embryo (by fertilising the egg with sperm outside the body of a woman) for a purpose other than achieving pregnancy in a woman. Items 2 and 3 amend section 12 to allow the intentional creation of a human embryo for purposes other than to achieve pregnancy in a woman, provided the creation is authorised by the relevant mitochondrial donation licence.

This amendment has been made to allow a person to create embryos for research and training purposes under the relevant mitochondrial donation licences.

Creating human embryos with genetic material from more than two people Currently, section 13 of the PHCR Act makes it an offence to intentionally create or develop a human embryo by the process of fertilisation where the embryo contains genetic material provided by more than two persons. Item 4 amends section 13 to allow the creation or development of a human embryo that contains the genetic material of more than two persons provided the creation is authorised by the relevant mitochondrial donation licence.

161. Mitochondrial donation techniques have been identified and explored as an option for oocyte rejuvenation for women aged over 40 or who have poor ovarian response to improve the woman’s chance of having a baby. International concerns have been raised on the use of these techniques for these reasons (for example, the European Society of Human Reproduction and Embryology issued a position statement on ‘Spindle transfer in the treatment of infertility’ on 9 July 2019).

162. Prohibition of Human Cloning for Reproduction Act 2002, subsection 8(1); Research Involving Human Embryos Act 2002, section 8. 163. Explanatory Memorandum, op. cit., p. 16. See items 1, 2, 8, 10 and 13 of the Bill.

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Due to the DNA contained within mitochondria, this amendment has been made to allow the creation of embryos using DNA from three people, the nDNA from the prospective parents and the mtDNA from the donor.

Heritable changes in the genome Currently, section 15 of the PHCR Act makes it an offence to make heritable changes to the genome of a human embryo. Item 5 amends section 15 to allow heritable changes to be made to the genome of a human embryo provided those changes are authorised under the relevant mitochondrial donation licence.

The heritable change is in reference to the donor’s mtDNA. Instead of inheriting the prospective mother’s mtDNA, a child born from mitochondrial donation will inherit and, if female, has the ability to pass on to the next generation, the donor’s mtDNA.

When prohibited embryo can be used Currently, subsection 20(3), makes it an offence to intentionally place an embryo in the body of a woman knowing that, or reckless as to whether, the embryo is a prohibited embryo. The relevant prohibited embryos for these amendments are defined in subsection 20(4) and include:

• a human embryo created by a process other than the fertilisation of a human egg by human sperm (paragraph (a))

• a human embryo that contains genetic material provided by more than two persons (paragraph (c))

• a human embryo that contains a human cell whose genome has been altered in such a way that the alteration is heritable by human descendants of the human whose cell was altered (paragraph (f)).

Item 6 amends subsection 20(3) to allow for the intentional placement of a prohibited embryo in the body of a woman, if the embryo meets the definitions under paragraphs 20(4)(a), (c) and (f), and is authorised under a mitochondrial donation licence.

Subsection 13.3(3) of the Criminal Code provides that a defendant who wishes to rely on any exception, exemption, excuse, qualification or justification provided the law creating an offence bears an evidential burden in relation to that matter, which would require adducing or pointing to evidence that suggests a reasonable possibility that the matter exists. Item 7 will insert proposed subsection 20(5) into the PHCR Act, to provide that, despite subsection 13.3(3) of the Criminal Code, a defendant does not bear an evidential burden in relation to any matter in subsection 20(3). This means that a person being prosecuted for an offence under subsection 20(3) will not bear an evidential burden as to whether an embryo is a prohibited embryo under paragraphs 20(4)(a), (c) or (f), or whether the placement of the embryo is permitted under a mitochondrial donation licence. The prosecution will need to prove these elements in order to establish the offence. This reflects the approach taken in two other offences in the PHCR Act and the RIHE Act—the offences of creating a human embryo for a purpose other than achieving pregnancy in a woman and unauthorised use of an excess ART embryo.164

Other amendments Section 22 of the PHCR Act provides that it is an offence to create a human embryo other than by fertilisation, or develop such an embryo, if not authorised by licence. Section 23 provides that it is an offence to create or develop a human embryo containing genetic material provided by more than two people, unless authorised by licence. Item 8 changes the nomenclature in these provisions to reflect the change from ‘licence’ to ‘general licence’ and to ensure that a person does not commit an offence under section 22 or section 23 if their actions are authorised by a

164. See Prohibition of Human Cloning for Reproduction Act 2002, section 12; Research Involving Human Embryos Act 2002, section 10.

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Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 38

general licence, or permitted under proposed section 28B of the RIHE Act, which permits a person to carry out an activity as authorised by a mitochondrial donation licence.

Definitions added Item 1 inserts the definitions for ‘general licence’, ‘mitochondrial donation licence’ and ‘mitochondrial donation technique’ into the PHCR Act. These same definitions are proposed in item 10 for inclusion in the RIHE Act (refer to Table 6 in the Appendix).

Further changes to the PHCR Act

Item 24 of the Bill adds a note to section 4 of the PHCR Act, which sets out the constitutional powers that support the operation of the Act, to include reference to proposed section 28B of the RIHE Act for activities that would be authorised by mitochondrial donation licences, relying on the corporations power in the Constitution.

Division 2 of Part 2 of the PHCR Act (sections 22 to 23B as amended by items 8 and 28 to 30) sets out offences relating to the creation, development or use of specified embryos, unless authorised by a general licence or a mitochondrial donation licence. Sections 12, 13, 15 and 20 (as amended by items 2 to 7 of the Bill) set out offences relating to the creation, development, use or placement of specified embryos, unless authorised by a mitochondrial donation licence. These offences will be referred to as licence offences (proposed subsection 23BA(2) at item 31). Proposed subsection 23BA(1) clarifies that a person cannot be held criminally responsible for a licence offence in respect of particular conduct authorised by a provision of a general licence or a mitochondrial donation licence if that licence or provision was invalid for some reason and the person did not know, and could not reasonably be expected to have known, about the invalidity.

RIHE Act amendments

Definitions added Item 9 inserts the definitions outlined in Table 6 in the Appendix, into section 7 of the RIHE Act.

Item 10 inserts the definitions outlined in Table 6 in the Appendix, into section 8 of the RIHE Act.

Changes to the offence provisions of the RIHE Act Item 11 expands subsection 10(1) of the RIHE Act, which is an offence provision, prohibiting the use of excess ART embryos unless permitted under licence or if certain exceptions apply. Proposed paragraphs 10(1)(a) and (aa) allow use of excess ART embryos in accordance with a mitochondrial donation licence and amends the language of ‘licence’ to ‘general licence’.

Currently, paragraph 10(2)(e) provides for the use of an excess ART embryo in accredited ART centres for reproductive purposes in a woman other than the woman for whom the embryo was created. Item 12 amends this paragraph so that the use of an excess embryo in this way will only be permitted where that embryo was not created using a mitochondrial donation technique as authorised by a mitochondrial donation licence.

Section 10A provides that it is an offence to use specified types of embryos, where that use is not authorised by a licence. (The specified embryos are embryos that were created by a process other than the fertilisation of a human egg by a human sperm; that contain genetic material provided by more than two people; that were created using precursor cells taken from a human embryo or a human fetus; or which are hybrid embryos.) Item 13 amends paragraph 10A(c) to update the term ‘licence’ to ‘general licence’. It will also ensure that the offence does not apply to use of an embryo created by a process other than the fertilisation of a human egg by a human sperm, or that contains genetic material provided by more than two people, if that use is authorised by a mitochondrial donation licence.

Section 10B provides that it is an offence to undertake research or training involving the fertilisation of a human egg by a human sperm up to, but not including, the first mitotic division, outside the body of a woman, unless authorised under licence. Item 14 amends section 10B to

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Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 39

update the term ‘licence’ to ‘general licence’. It will also ensure that the offence does not apply to such research and training authorised by a mitochondrial donation licence.

Section 11 provides that it is an offence to intentionally use, outside the body of a woman, a human embryo that is not an excess ART embryo, where the use is not carried out by an accredited ART centre for a purpose relating to the ART treatment of a woman, and the person knows or is reckless as to that fact. Item 15 amends section 11, so that the offence does not apply where the use of the embryo is permitted under a mitochondrial donation licence.

Item 16 inserts proposed section 11A, making it an offence for people to use material created under a mitochondrial donation licence for any other activities than the ones authorised by the licence.

Mitochondrial donation licences The RIHE Act regulates research involving human embryos, providing a regulatory framework for a licensing system that is overseen by the NHMRC Licensing Committee.165 Item 17 creates a new Division 4A in Part 2 of the RIHE Act and contains most of the provisions that regulate mitochondrial donation licences and licensing, with many similarities to the existing licensing process. Proposed Division 4A contains proposed sections 28A to 28X.

Kinds of mitochondrial donation licences and what they authorise Proposed section 28A identifies five types of mitochondrial donation licence:

• pre-clinical research and training licence

• clinical trial research and training licence

• clinical trial licence

• clinical practice research and training licence

• clinical practice licence.

The Bill provides for the first three of these licences to be issued, as part of the Stage 1 implementation of mitochondrial donation, with the Australian Government intending to authorise one clinic to undertake a Commonwealth funded clinical trial.166 Proposed subsection 28B(1) permits preclinical research and training, clinical trial research and training and clinical trial licence holders to use mitochondrial donation techniques if their licence is in force and the licence holder is a constitutional corporation (that is, a trading, foreign or financial corporation within the meaning of paragraph 51(xx) of the Constitution—see item 9). Proposed subsection 28B(2) permits preclinical research and training, clinical trial research and training, and clinical trial licence holders to carry out activities under their licence despite state or territory law. Further amendments would be required to the RIHE Act and the RIHE Regulations to permit mitochondrial donation techniques for clinical practice as well as changes to state or territory legislation to permit the use of these techniques in a particular state or territory (proposed subsection 28B(3)).167

The purpose of a mitochondrial donation licence The purpose of a preclinical research and training licence is to:

165. The NHMRC Embryo Research Licensing Committee is established under Division 3 of Part 2 of the RIHE Act and is responsible for overseeing the RIHE Act and the PHCR Act. This Committee is referred to as the NHMRC Licensing Committee throughout the Bill and the ERLC in the Explanatory Memorandum.

166. Hunt, ‘Second reading speech: Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021’, op. cit., p. 2. 167. Explanatory Memorandum, op. cit., p. 8.

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• develop the technique specified in the licence for potential future use in a clinical setting to minimise the risk of a child inheriting mtDNA that could predispose them to mitochondrial DNA disease (proposed paragraph 28C(1)(a))

• better understand the technique (proposed paragraph 28C(1)(b))

• build staff expertise (proposed paragraph 28C(1)(c)).

The purpose of a clinical trial research and training licence is to:

• develop protocols for using the technique specified in the licence safely and effectively in a clinical trial setting, to minimise the risk of a child inheriting mtDNA that could predispose them to mitochondrial DNA disease (proposed paragraph 28D(1)(a))

• ensure the competency of the embryologist/s identified on the licence (proposed paragraph 28D(1)(b)) and

• ensure the centre is sufficiently set up for using the technique in a clinical trial (proposed paragraph 28D(1)(c)).

The purpose of a clinical trial licence is to determine whether the technique specified in the licence is safe and effective for potential use in a clinical practice setting to create a human embryo and place that embryo in a trial participant to achieve a pregnancy (proposed subsection 28E(1)).

The purpose of the clinical practice research and training licence mirrors that of a clinical trial research and practice licence, but with the intention of preparing for use in the clinical practice setting instead (proposed subsection 28F(1)).

The purpose of the clinical practice licence is to create a human embryo using the technique specified in the licence with the intention to place the embryo in the patient to achieve a pregnancy (proposed subsection 28G(1)).

Activities authorised under mitochondrial donation licences With the exception of the pre-clinical research and training licence, licence holders will need to undertake the activities approved in their licence in an accredited ART centre.168 Table 2 provides an overview of the activities permitted under the five different licences.

Table 2: activities authorised under mitochondrial donation licences

168. ART centres are accredited by the Reproductive Technology Accreditation Committee (RTAC), which was established by the Fertility Society of Australia. To receive RTAC accreditation, a centre will need to comply with relevant legislation and guidelines. RTAC accreditation is required for a centre to be eligible for Medicare funding.

Activity Pre-clinical

research and training licence

Clinical trial research and training licence

Clinical trial licence

Clinical practice research and training licence

Clinical practice licence

Proposed subsection

28C(2) 28D(2) 28E(2) 28F(2) 28G(2)

Creation of human embryos other than by fertilisation

√ √ √ √ √

Creation of human embryos √ √ √ √ √

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Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 41

Source: Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021; Explanatory Memorandum, Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021, p. 65.

Applying for a mitochondrial donation licence A person will need to apply to the NHMRC Licensing Committee for a mitochondrial donation licence, specifying the technique and activities they wish to undertake (proposed subsection 28H(1)). For some licence types, there are prerequisites the applicant will need to meet:

• only a person who has held a clinical trial research and training licence for the specific technique can apply for a clinical trial licence (proposed subsection 28H(3))

with genetic material from more than two people

Creation of human embryos through fertilisation outside of the body of a woman

√ √ √ √ √

Creation of human embryos with heritable changes to its genome

× × √ × √

Research and training involving fertilisation

√ √ × √ x

Use of material created, developed or produced under a licence (other than excess ART embryos)

√ √ √ √ √

Placement in a woman of an embryo created by a mitochondrial donation technique for reproductive purposes

× × √ × √

Development of an embryo for more than 14 days

× × × × ×

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Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 42

• only a person who has held a clinical practice research and training licence for the specific technique can apply for a clinical practice licence (proposed subsection 28H(4)).169

The information provided in the Explanatory Memorandum is slightly different, stating: ‘in order to conduct a clinical trial in a mitochondrial donation technique, both a clinical trial research and training licence and a clinical trial licence will be needed’.170 The reasoning provided for this dual requirement is that the clinical trial research and training licence would allow for the preparation of the clinical trial, whilst the clinical trial licence would allow for use of the technique for reproductive purposes.171

Only a constitutional corporation may apply for a pre-clinical research and training licence, a clinical trial research and training licence, or a clinical trial licence (proposed subsection 28H(2)).

Each application will be required to:

• nominate at least one embryologist, who would be authorised to use the technique (proposed subsection 28H(5))

• apply for only one type of licence (proposed paragraph 28H(6)(a))

• apply for only one mitochondrial donation technique (proposed paragraph 28H(6)(b)).

Proposed subsection 28H(7) outlines the information the applicant will need to provide, in an approved form, as determined by the NHMRC Licensing Committee:

• identify the type of licence applied for

• specify the technique

• meet the requirements specified in the Regulations (if any)

• meet the other requirements identified by the NHMRC Licensing Committee

• be accompanied by the fee prescribed by the Regulations (if any).172

Determination of application by the NHMRC Licensing Committee Proposed section 28J specifies the criteria the NHMRC Licensing Committee will need to consider before deciding to issue a licence.

The NHMRC Licensing Committee would need to be satisfied:

• the appropriate protocols are in place to obtain proper consent (defined below) and to ensure compliance with any restrictions to the consent (proposed paragraph 28J(2)(a))

• the activities in the application have been assessed and approved by a Human Research Ethics Committee (HREC), which is compliant with the National Statement on Ethical Conduct in Human Research (National Statement) (proposed paragraph 28J(2)(b)).173

The NHMRC Licensing Committee will need to consider the following information in its deliberations on whether to issue a licence:

169. This proposed subsection is included to ‘future-proof’ the RIHE Act and will not be applicable in Stage 1 of mitochondrial donation implementation. 170. Explanatory Memorandum, op. cit., p. 26. 171. Ibid. 172. This Bill does not propose prescribed fees in the Regulations but proposed paragraph 28H(7)(d) would allow for fees to be

introduced under the RIHE Act. 173. The National Statement on Ethical Conduct in Human Research is issued by the CEO of the NHMRC under the National Health and Medical Research Council Act 1992.

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Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 43

• restricting the number of excess ART embryos, other embryos, human eggs, or zygotes to what is likely to be required to achieve the goals of the proposed activities in the application (proposed paragraph 28J(3)(a))

• any relevant guidelines issued by the NHMRC (proposed paragraph 28J(3)(b))

– proposed section 7H of the RIHE Regulations (at item 20 of the Bill) requires the NHMRC Licensing Committee to consider the Ethical guidelines on the use of assisted reproductive technology (ART Guidelines)174 and the National Statement • the HREC assessment (proposed paragraph 28J(3)(c))

• whether the applicant has complied with conditions of other mitochondrial donation licences, as relevant (proposed paragraph 28J(3)(d)).

Proposed subsection 28(J)(4) will allow the NHMRC Licensing Committee to seek, and have regard to, the advice of appropriate experts.

Expansion of considerations in issuing a clinical trial licence Proposed subsection 28(J)(5) expands on the considerations the NHMRC Licensing Committee would need to be satisfied of before issuing a clinical trial licence or a clinical practice licence:

• the applicant has appropriate protocols in place for the technique to be safe and effective in minimising the risk of a child inheriting mitochondria that could predispose them to mitochondrial disease

• each embryologist identified in the application has:

– consented in writing to be nominated – demonstrated technical competence in the use of the nominated technique – understands their obligations under the Act • the applicant’s facilities, equipment and processes are fit for purpose

• the staff who would be directly involved in the clinical trial or clinical practice have the appropriate qualifications, training and competencies

• the applicant is likely to be able to comply with their obligations under proposed section 28R (information about donors and children, discussed below)

• the applicant has protocols in place to ensure any donors would be aware that any children resulting from a pregnancy that used their egg would be able to obtain information about them through the Mitochondrial Donation Donor Register

• the applicant has protocols to ensure trial participants or patients are fully informed about:

– the risks involving the mitochondrial donation techniques – alternatives to mitochondrial donation.175 In addition, the regulations may specify further requirements for the NHMRC Licensing Committee and/or the need for each embryologist to demonstrate their technical competence with the nominated technique.

Notification of decision and matters specified in the licence Consistent with the existing notification requirements for (general) licences in section 22 of the RIHE Act, proposed section 28K outlines requirements for the NHMRC Licensing Committee to notify, and provide a copy of the mitochondrial donation licence, to:

• the applicant

174. The Ethical guidelines on the use of assisted reproductive technology (ART Guidelines) are issued by the CEO of the NHMRC under the National Health and Medical Research Council Act 1992. 175. Alternatives to mitochondrial donation are briefly discussed in the above section on the ethical and social considerations.

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Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 44

• the HREC

• the relevant state/territory body of the jurisdiction in which the activities will occur.

Proposed section 28L outlines three matters that must be specified in the licence:

• the approved technique

• the activities that have been authorised

• the name of each embryologist.

In line with existing requirements in section 23 of the RIHE Act for (general) licences, a mitochondrial donation licence would come into force either on the date of issue or the date specified on the licence and remain in force until the date specified on the licence, unless it is suspended, revoked or surrendered before that day (proposed section 28M).

Conditions of mitochondrial donation licences Prior to a human egg or a human sperm being used, the licence holder will need to ensure:

• proper consent has been obtained (proposed paragraph 28N(1)(a))

• the NHMRC Licensing Committee has been notified in writing that this consent has been obtained, including any restrictions the consent is subject to (proposed paragraph 28N(1)(b)). This notification must not include identifiable information for the responsible person (biological donor) (proposed subsection 28N(2)).

If restrictions were placed on the responsible person’s consent, then the licence would be subject to those conditions (proposed subsection 28N(3)).

Proposed subsection 28N(5) is based on subsections 24(4) and (5), which apply to (general) licences, and outlines other conditions that may be specified in the licence, including:

• the persons authorised by the licence, including the embryologists, to carry out the authorised activities

• the number of human eggs that can be used under the licence, or the number of embryos or zygotes that can be created or used under the licence176

• reporting requirements

• monitoring

• the licence holder will need to provide information about the licence to the embryologists and other persons authorised by the licence

• disposing of material produced by the technique.

The licence conditions apply to the licence holder, each embryologist named on the licence and each person who carries out activities authorised by the licence (proposed subsections 28N(6) and (7)).

Proposed subsection 28N(8) gives two definitions for proposed Division 4A of Part 2 of the RIHE Act:

• Proper consent, in relation to the use of a human egg or sperm, means consent is obtained in line with the NHMRC guidelines that are prescribed under Regulations and any other requirements specified in the regulations. Proposed section 7J of the RIHE Regulations (at item

176. Under subsection 19(3) of the RIHE Act, the NHMRC Licensing Committee is required to table reports in Parliament by 30 June and 31 December each year (and when requested). These reports include information on current licences, including the number of embryos authorised for use under the licence. This provision is amended by Item 117.

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Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 45

20 of the Bill), prescribes the ART Guidelines.177 Other requirements prescribed in the Regulations may include (but are not limited to) how to withdraw consent and circumstances in which consent cannot be withdrawn.

• Responsible person, in relation to the use of a human egg or human sperm, refers to the biological donor of that egg or sperm.

Additional conditions for clinical trial and clinical practice licences Additional conditions apply to clinical trial licences and clinical practice licences which require approval from the NHMRC Licensing Committee before the creation or placement of an embryo (proposed section 28P). The NHMRC Licensing Committee must be satisfied of the following before granting this approval:

• there is a particular risk of the woman’s offspring inheriting mtDNA from the woman that would predispose them to mitochondrial disease

• there is a significant risk that the mitochondrial disease that would develop in those offspring would result in serious illness or other serious medical conditions

• that other available techniques could potentially be used to minimise the risks would be inappropriate or unlikely to succeed

• that the woman and her spouse (if any) have attended counselling and been fully informed of:

– the risks involved in using mitochondrial donation techniques and – alternatives to using mitochondrial donation techniques • that the woman has given written consent to the making of the application and

• other matters as specified in the regulations (proposed subsection 28P(4)).

In addition, the NHMRC Licensing Committee must consider:

• the clinical basis of the risk to the woman’s offspring of mitochondrial DNA disease

• the inheritance pattern in the woman’s family

• the likely clinical manifestation of the disease in the woman’s offspring (proposed subsection 28P(5)).

If approval is granted, it comes into force when it is granted and ceases at the earlier of the following:

• five years following approval

• when a child is born alive as a result of placement following mitochondrial donation (proposed subsection 28P(8)).

In addition, following counselling, the woman and her spouse can request only male embryos be used for placement (proposed subsection 28Q(1)).178

Ongoing requirements for mitochondrial donation licence holders Proposed section 28R outlines the requirements for clinical trial licence holders and clinical practice licence holders to record specific information about the donor and children born following mitochondrial donation.

The clinical trial or clinical practice licence holder must collect specific information about the donor:

177. The Ethical guidelines on the use of assisted reproductive technology (ART Guidelines) issued by the CEO of the NHMRC under the National Health and Medical Research Council Act 1992. 178. The justification for this approach is discussed in the above section on the ethical and social considerations.

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Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 46

• their full name

• their residential address at the time they provided proper consent

• their date and place of birth

• any additional information provided by the donor for the purposes of inclusion on the Mitochondrial Donation Donor Register

• any other information required under the Regulations.

A woman becomes known as a donor when a zygote is created using her mitochondria and the nDNA from another woman.

The person who is or was the licence holder must endeavour to collect the following information for each child born alive following mitochondrial donation:

• their full name

• their sex

• their date of birth

• any other information prescribed by the Regulations.

The records on the donor and the child need to be retained for the period prescribed in the regulations. Proposed section 7K of the RIHE Regulations (at item 30 of the Bill) provides that the records must be retained for 25 years after their creation.

If the person who is or was the licence holder becomes aware that a child has been born alive, they will need to notify the Secretary and the NHMRC Licensing Committee. In addition, they will need to notify the Secretary of the donor and child’s details.

It is an offence to intentionally engage in conduct knowing that, or reckless as to whether, the conduct breaches the above requirements. The maximum penalty for this offence is imprisonment for two years.

Adverse events - ongoing monitoring and reporting requirements for clinical trial and clinical practice licence holders Proposed section 28S outlines the monitoring and reporting requirements of the person who is or was the licence holder of a clinical trial licence or clinical practice licence, who will need to have protocols in place to:

• monitor the pregnancy and childbirth

• monitor the ongoing health and development of the child

• seek the ongoing engagement of trial participants (and patients) who achieve pregnancy and children to engage with this monitoring

• notify the below entities of any ‘adverse events’:

– the NHMRC Licensing Committee – the Secretary – any additional people as prescribed in the Regulations. The Regulations require notification of an adverse event to be made in a form approved by the CEO of the NHMRC and to contain any information required by the form (proposed section 7L of the RIHE Regulations, at item 20 of the Bill). IVF conceived babies have a recorded higher incidence of spontaneous premature birth.179 To identify if there are any additional risks

179. Explanatory Memorandum, op. cit., p. 36.

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Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 47

associated with the use of mitochondrial donation techniques, this form will likely require that in the case of premature birth, information be provided on how premature the birth was.180

An ‘adverse event’ for a trial participant or patient or a child of a trial participant is defined in proposed section 7M of the RIHE Regulations, at item 20 of the Bill, as follows:

• for a trial participant or a patient:

– a failed embryo development – a miscarriage – a premature birth of a child or – a child born with a birth defect, a genetic abnormality or a diagnosis at birth of

mitochondrial disease. • for a child of a trial participant:

– a diagnosis at any time of mitochondrial disease. In the instance of a notification of an adverse event, the person providing the advice must not include any information that could be used to discover the identity of the trial participant/patient and/or the child (proposed subsection 28S(5)).

It is an offence to intentionally engage in conduct knowing that, or reckless as to whether, the conduct breaches the above requirements. The maximum penalty for this offence is imprisonment for two years (proposed subsection 28S(7)).

The Regulations may prescribe record-keeping requirements that may include penalties, not exceeding 50 penalty units, for offences against the regulations. The value of a penalty unit is currently $222.181

Variation, suspension, revocation and surrender of a licence The NHMRC Licensing Committee can, by providing notice in writing to the licence holder, vary the licence if the Committee believes, on reasonable grounds, that it is necessary or desirable. This can be done in response to an application from the licence holder or on the Committee’s initiative (proposed section 28U).

The Committee may suspend or revoke a licence if it believes on reasonable grounds that a condition of the licence has been breached. If the holder of a licence is convicted of an offence under the RIHE Act or the Regulations, or the PHCR Act, the NHMRC Licensing Committee must revoke the licence/s held by the licence holder. If the licence holder for any of the pre-clinical or clinical trial licences ceases to be a constitutional corporation, the NHMRC Licensing Committee is taken to have revoked the licence at that time (proposed section 28V).

The licence holder can surrender the licence by giving the NHMRC Licensing Committee written notice (proposed section 28W).

If the NHMRC Licensing Committee does vary, suspend or revoke a licence it will need to notify the licence holder, the HREC and the relevant state or territory body. In addition, if a licence is surrendered, the Committee will need to inform the relevant HREC and state or territory body (proposed section 28X).

180. Ibid. 181. Crimes Act 1914, section 4AA and the Notice of Indexation of the Penalty Unit Amount. Accordingly, the maximum penalty for an offence against record-keeping obligations in the Regulations would be $11,100.

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Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 48

Mitochondrial Donation Donor Register Item 18 of the Bill introduces proposed section 29A into the RIHE Act, which details the requirement for a Mitochondrial Donation Donor Register (the Register) to be established. The purpose of the Register is to allow any person who is over the age of 18 and was born as a result of the use of mitochondrial donation to apply for, and be provided with, identifiable information regarding their mitochondrial donor.

Information kept in the register The register must be updated and kept by the Secretary of the DoH (proposed subsection 29A(1)) or a delegated SES employee or acting SES employee in the Department (proposed subsection 29A(8)). The Register must include the following information, outlined in proposed paragraph 28R(5)(b):

• the donor’s full name

• the donor’s residential address at the time that the donor gave proper consent

• the donor’s date and place of birth

• any other information the donor has provided to a licence holder at the time that the donor gave proper consent

• the name, sex and date of birth of each child born alive as a result of a pregnancy achieved using a mitochondrial donation technique

• any other information prescribed by the Regulations.

Who can access register information? Information in the Register cannot be made publicly available (proposed subsection 29A(3)). An application for access to information in the Register may be made by:

• a person born as the result of mitochondrial donation, who is over the age of 18 (proposed subsection 29A(4))

• a donor (proposed subsection 29A(5)).

People over the age of 18 who were born as the result of mitochondrial donation can apply for identifiable information about their donor. Donors are only able to apply for information from the register about themselves, in relation to the use of a mitochondrial donation technique. Paragraph 167 of the Explanatory Memorandum of the Bill states that a donor will be able to discover whether a child has been born from their donation.182 However, proposed subsection 29A(5) provides that a donor may only apply to view the information in the register about themselves, as described in proposed subsection 28R(1). This information does not include whether a child has been born from their donation. Proposed paragraph 28R(1)(e), which requires information prescribed by the Regulations to be recorded about the donor, specifies that the information must be ‘about the donor’. When applied for by the people outlined above, the information must be provided (proposed subsection 29A(6)).

It is a criminal offence for a person to disclose information on the Register (where they have that information by performing functions associated with the Register) for reasons other than those outlined in proposed subsections 29A(4) and (5), or in accordance with a court order. The maximum penalty for committing such an offence is two years imprisonment (proposed subsection 29A(7)).

182. Explanatory Memorandum, op. cit., p. 40.

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Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 49

The privacy of the donor The donor’s rights to confidentiality or anonymity have been raised during community consultation as an important consideration. The function of the register to allow people born of mitochondrial donation techniques who are aged over 18 to access personal information about their donor means they would be able to contact their donor if they so desire.

This approach differs from the UK’s model for mitochondrial donors.183 In the UK, children born of mitochondrial donation who are over the age of 16 can access the following non-identifying information about their donor:

• information on the donor’s personal and family medical history

• a personal description (if provided), and

• any additional information the donor has agreed to share with the child.184

During the community consultations conducted by the NHRMC, arguments were made both for and against the disclosure of a donor’s personal information. Proponents and opponents appear to agree that the donor’s medical and genetic information should be available for health purposes.185

Register management The RIHE Regulations may provide for the following aspects of the Register (proposed subsection 29A(10)):

• other information to be kept on the Register

• correcting and updating information

• keeping and maintenance

• verification of the information in an application for the disclosure of information on the Register.

The Bill’s amendments to the Regulations do not include any provisions for the details of the Register outlined in proposed subsection 29A(10). Given a child born of mitochondrial donation must wait 18 years before applying for information from the Register, the consistent management and upkeep of the information will be important to ensure that correct information is supplied to the applicant.

Mitochondrial donation techniques Item 19 inserts the definitions of the five mitochondrial donation techniques into section 5 of the RIHE Regulations, which sets out definitions.

Item 20 inserts proposed Division 2–Provisions relating to mitochondrial donation licence into Part 2 of the Regulations.186

Proposed section 7A prescribes five mitochondrial donation techniques for the purposes of the proposed definition in section 8 of the RIHE Act, inserted by item 10 of the Bill:

• maternal spindle transfer (MST)

• pronuclear transfer (PNT)

183. Human Fertilisation & Embryology Authority (HFEA), ‘Mitochondrial donation treatment’, HFEA website, 13 February 2021. 184. Ibid. 185. NHMRC, Mitochondrial donation community consultation report, op. cit., pp. 47–48. 186. See also item 110 of the Bill, which inserts a Division 1 into Part 2 of the Regulations.

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Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 50

• germinal vesicle transfer (GVT)

• first polar body transfer (PBT)

• second polar body transfer (PBT).

Permitted techniques for mitochondrial donation licences Proposed section 7B defines the permitted techniques for the mitochondrial donation licences that will be available under Stage 1, as outlined below in Table 3.

Table 3: permitted techniques for the mitochondrial donation licences.

Mitochondrial donation licences Permitted techniques

Pre-clinical research and training licence MST, PNT, GVT and PBT

A clinical trial research and training licence or a clinical trial licence MST and PNT

Source: Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021.

Mitochondrial donation techniques definitions Proposed sections 7C, 7D, 7E, 7F and 7G insert the definitions for MST, PNT, GVT, PBT (1st and 2nd) respectively.

Table 4 below provides a simple definition and explanation of how the five techniques work.187

Table 4: mitochondrial donation techniques definitions

Term Definition

Proposed sections

GVT

A technique that involves removing the germinal vesicle (which contains the mother’s nDNA) from the prospective mother’s immature egg cell. The germinal vesicle is then placed into a donor egg from which the donor’s germinal vesicle (and therefore the donor’s nDNA) has been removed. Once the germinal vesicle has been transferred to the donated egg, and the egg matures, it is fertilised by the father’s sperm to create a zygote.

7E

PBT

A technique that involves removing the prospective mother's polar body (which contains the mother’s nDNA) and fusing it to a donor egg that has had the donor’s nDNA removed. This reconstituted egg is either then fertilised by the prospective father’s sperm to form a zygote (1st PBT) or has already been fertilised by the prospective father’s sperm before the transfer (2nd PBT).

7F and 7G

PNT

A technique that involves fertilisation of both the prospective mother and the donor's egg cell with the prospective father’s sperm to create two zygotes (a maternal zygote and a donor zygote). The pronuclei are then removed from the maternal zygote and transferred to the donor zygote, which has had its own pronuclei (and therefore the donor’s nDNA) removed but which retains its own intact mitochondria.

7D

187. Further information regarding the techniques can be found on pages 42 to 43 of the Explanatory Memorandum of the Bill.

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Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 51

Term Definition

Proposed sections

MST

A technique that involves removing the maternal spindle from an egg cell of the prospective mother. The spindle is then placed into a donor egg from which the donor’s maternal spindle (and therefore the donor’s nDNA) has been removed. Once the maternal spindle has been transferred to the donated egg, this egg is fertilised by the father’s sperm to create a zygote.

7C

Source: Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021.

Further changes to the RIHE Act Item 33 adds a note to section 4 of the RIHE Act, which sets out the constitutional powers that support the operation of the Act, to include reference to proposed section 28B for activities that would be authorised by mitochondrial donation licences, relying on the corporations power in the Constitution.

Section 20 (as amended by items 57 to 60 of the Bill) allows a person to apply to the NHMRC Licensing Committee for a general licence authorising the creation of human embryos, the use of excess embryos, and research and training involving fertilisation of a human egg. Item 60 clarifies that the NHMRC Licensing Committee is not permitted to authorise a mitochondrial donation technique, or the use of material created, developed or produced from a mitochondrial donation technique, under a general licence.

Item 71 inserts definitions of proper consent and responsible person that apply to Division 4 of Part 2 of the RIHE Act (general licences). (See Table 6 for additional information).

Section 29 of the RIHE Act (as amended by items 83 to 88 of the Bill), requires the NHMRC Licensing Committee to make certain information on general licences and mitochondrial donation licences publicly available on a database. Such information includes the name of the person to whom a licence is issued, licence conditions and, for a general licence, the number of ART embryos or human eggs authorised to be used under the licence, and the number of other embryos authorised to be created or used under the licence. Items 85 and 88 amend section 29 to insert two additional information requirements for mitochondrial donation licences. These amendments require the database to include, for each mitochondrial donation licence:

• a short statement on the use of excess ART embryos, human eggs and other embryos authorised under the licence and

• the number of excess ART embryos or human eggs authorised to be used under the licence, and the number of other embryos or zygotes authorised to be created or used under the licence.

Section 32 of the RIHE Act provides for certain decisions of the NHMRC Licensing Committee to be reviewed by the Administrative Appeals Tribunal (AAT). Items 95 to 100 amend section 32 to provide that the following decisions of the NHMRC Licensing Committee in relation to mitochondrial donation licences are also reviewable by the AAT:

• a decision under proposed section 28J of the RIHE Act (at item 17) not to issue a mitochondrial donation licence

• a decision under proposed section 28M (at item 17) in relation to the period of a mitochondrial donation licence

• a decision under proposed subsection 28N (at item 17) to specify a condition in a mitochondrial donation licence

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Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 52

• a decision under proposed section 28U (at item 17) to vary or refuse to vary a mitochondrial donation licence

• a decision under proposed section 28V (at item 17) to suspend or revoke a mitochondrial donation licence

• a decision under proposed subsection 28P(3) (at item 17) not to grant an approval to create a human embryo for a trial participant or patient using a mitochondrial donation technique or place such an embryo in the body of the trial participant or patient.

Item 103 repeals Division 1 and 2 of Part 5 of the RIHE Act and substitutes them with proposed Division 1—Arrangements relating to clinical trials of mitochondrial donation techniques and proposed Division 2—Other miscellaneous matters.

Proposed Division 1—Arrangements relating to clinical trials for mitochondrial donation techniques Broadly speaking proposed Division 1 of Part 5 of the RIHE Act purpose is to provide Commonwealth legislative authority for expenditure on a clinical trial of a mitochondrial donation technique, as well as the associated research and training.

Proposed subsection 46(1) provides the Commonwealth legislative authority to enter into a contract (or agreement, deed or other arrangement) with a constitutional corporation regarding conducting a clinical trial under a clinical trial licence, and the associated activities. It will also allow the Commonwealth to pay a constitutional corporation for that purpose. This legislative authority can be exercised by the Minister or by the DoH Secretary (proposed subsection 46(2)). The Minister and the Secretary can delegate their powers under proposed section 46B, discussed further below.

Terms and conditions relating to clinical trial arrangements Proposed section 46A requires that the terms and conditions relating to clinical trial matters must:

• be set out in a written agreement between the Commonwealth (or by the Minister or the Secretary on behalf of the Commonwealth) and the corporation

• be complied with by the corporation and

• outline any circumstances in which the corporation must repay amounts to the Commonwealth.

Minister or Secretary may delegate powers in relation to arrangements Proposed section 46B details the powers of delegation for both the Minister and the Secretary. The Minister and the Secretary may delegate their powers under proposed section 46 or 46A to an SES or acting SES employee (proposed subsections 46B(1) and (3)). The delegate must comply with the directions of the Minister or the Secretary (proposed subsections 46B(2) and (4)).

Proposed section 46D ensures that proposed Division 1 of Part 5 does not limit the executive powers of the Commonwealth (see section 61 of the Constitution).

Proposed Division 2—Other miscellaneous matters Proposed section 47 provides clarification that for the purposes of the Gene Technology Act 2000, mitochondrial donation techniques are not considered to be gene technology when authorised under a mitochondrial donation licence. This inclusion means that any child born following the use of a mitochondrial donation technique would not be meet the definition of a ‘genetically modified organism’.

Proposed subsection 47A provides immunity for the Commonwealth and a ‘protected person’ (defined in the table below) from civil actions, suits and proceedings in respect of loss, damage or

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injury of any kind suffered by another person as a result of the actions and omissions outlined below in Table 5.

Table 5: Immunity from civil actions relating to mitochondrial donation licences

Protected persons Protected matters

Any of the following persons: • the Minister • the Secretary • a person to whom powers or

functions are delegated under proposed subsections 29A(8)188 • an inspector • an officer or employee of the Department • a member of the NHMRC Licensing Committee • the CEO or an employee of the NHMRC • a member of a HREC.

The performance or purported performance, or the exercise or purported exercise, of the person’s functions, duties or powers under the following in so far as they relate to mitochondrial donation licences: • the RIHE Act or a legislative instrument made

under it • the PHCR Act or a legislative instrument made under it.

A person who the NHMRC Licensing Committee requests, or purportedly requests, to provide advice as mentioned in proposed subsection 28J(4).189

The provision, or purported provision, by the person of advice in response to such a request.

A person who gives, or purportedly gives, information to the Secretary under proposed paragraph 28R(5)(b).190

The giving, or purported giving, of the information by the person.

Source: Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021.

There are known risks associated with mitochondrial donation, and because of the newness of the mitochondrial donation techniques for human reproductive purposes, there is potential for yet unknown consequences to emerge.191 Due to these known risks and the potential for yet unidentified risks, the protection afforded to the Commonwealth and a ‘protected person’ under proposed subsection 47A allows these persons to undertake their administrative tasks without fear of civil liability for adverse events that might arise from the use of a mitochondrial donation technique.192

188. Proposed section 29A of the RIHE Act, at item 18 of the Bill, requires the Secretary to keep a Mitochondrial Donation Donor Register. Proposed subsection 29A(8) allows the Secretary to delegate their powers or functions relating to the Register to an SES employee, or acting SES employee, in the Department.

189. Proposed section 28J of the RIHE Act, at item 17 of the Bill, specifies the criteria the NHMRC Licensing Committee will need to consider before deciding to issue a mitochondrial donation licence. Proposed subsection 28J(4) allows the Committee to request advice from any person with appropriate expertise to assist it in making a decision on a licence application.

190. Proposed section 28R outlines the requirements for clinical trial licence holders and clinical practice licence holders to record specific information about donors and children born following mitochondrial donation. Proposed paragraph 28R(5)(b) allows the Secretary to require information about a child born as a result of a pregnancy achieved using a mitochondrial donation technique to be provided in an approved form.

191. Explanatory Memorandum, op. cit., pp. 58–59. 192. Ibid.

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Proposed subsection 47A(2) makes the exception that the above protection does not apply to an act or omission in bad faith.

Proposed subsection 47A(4) ensures that the protection provided above is subject to section 40 of the RIHE Act, which provides for compensation for damage to equipment or other facilities in certain circumstances.

Changes to the Therapeutic Goods (Excluded Goods) Determination 2018 Subsection 7AA(2) of the Therapeutic Goods Act 1989 (TG Act) allows the Minister, by legislative instrument, to determine that specified goods when used, advertised, or presented for supply in a way specified in the determination, are excluded goods for the purposes of the TG Act. Excluded goods are not therapeutic goods and are therefore not subject to the requirements relating to import, export, manufacture or supply under the TG Act. Schedule 2 of the Therapeutic Goods (Excluded Goods) Determination 2018 sets out certain goods and the manner in which they must be used, advertised or presented for supply in order to be excluded goods.

Item 116 amends Schedule 2 of the Therapeutic Goods (Excluded Goods) Determination 2018 to provide that human eggs and human sperm are excluded goods when used in activities authorised by a mitochondrial donation licence. This inclusion means that when these goods are used in the authorised way, they are exempt from the operation of the TG Act.

Seven-year review of the new arrangements Current sections 25 and 25A of the PHCR Act and sections 47 and 47A of the RIHE Act provide for two reviews of those Acts, to be undertaken concurrently. As both these reviews have taken place, these sections are superfluous. Items 32 and 103 repeal those sections and replace them with proposed section 25 of the PHCR Act and proposed section 47B of the RIHE Act, respectively. The proposed provisions will require the Minister to arrange an independent review of the operation of the PHCR Act and RIHE Act, in so far as they relate to the use of mitochondrial donation techniques, to be undertaken as soon as possible after the end of:

• the period of seven years starting on the commencement of Schedule 1 to the Bill and

• each subsequent seven-year period.

The people undertaking the Review are chosen by the Minister, with agreement from each state and territory (proposed subsection 25(2) of the PHCR Act and proposed paragraph 47B(2)(a) of the RIHE Act). The reviews must be undertaken concurrently (proposed paragraph 47B(2)(b) of the RIHE Act). The reviewers will be required to provide a report of the review to the Minister for presentation to Parliament (proposed subsection 25(3) of the PHCR Act and proposed subsection 47B(3) of the RIHE Act). The report must be completed within 12 months after the end of the relevant seven-year period (proposed subsection 25(4) of the PHCR Act and proposed subsection 47B(4) of the RIHE Act). The people undertaking the review must consult and set out the views in the report for the Commonwealth and the states and territories as well as a broad range of people with relevant expertise or experience (proposed subsection 25(5) of the PHCR Act and proposed subsection 47B(5) of the RIHE Act).

One report may be provided for the reviews under both Acts (proposed subsection 47B(6) of the RIHE Act).

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Other provisions

Changes to the Freedom of Information Act 1982 Items 21, 22 and 23 make changes to the Freedom of Information Act 1982 (FOI Act) to ensure that information recorded on the register remains private and cannot be accessed under the FOI Act.

Application and transitional provisions

NHMRC Licensing Committee reports to Parliament Under current subsection 19(3) of the RIHE Act, the NHMRC Licensing Committee must table reports in Parliament. These reports include information about the operation of that RIHE Act, and the licences issued under it.

Item 117 will change the operation of subsection 19(3) for a transitional period so that information about the operation of new provisions of the RIHE Act, and information about mitochondrial donation licences, will not have to be provided in the NHMRC Licensing Committee’s reports for a period of six months after the commencement of Schedule 1. However, this information must be included in the next report.

Given that the NHMRC Licensing Committee must table reports in Parliament on fixed dates, and it cannot be known on what date the amendments made by Schedule 1 will commence, there may not be sufficient time to prepare the report as required by section 19. This transitional amendment has been made to provide ample time to prepare a report including the new amendments.

Pre-commencement licence applications Item 118 is a transitional provision that applies to applications for licences, made under subsection 20(1) of the RIHE Act, that have not been processed or finalised before the commencement of Schedule 1 to the Bill. For such licence applications, the following documents that would have been applicable but for the Bill continue to be relevant:

• current paragraph 21(3)(c) of the RIHE Act

• the following provisions of the Regulations:

– the current definitions of the ART Guidelines and the National Statement in section 5 – current section 7 ‘Definition of proper consent—prescribed guidelines’, and – current section 9 ‘Determination by NHMRC Licensing Committee of licence applications— prescribed guidelines’.

Concluding comments The Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 will allow, for the first time, embryos to be created for reproductive purposes that contain the genetic material from more than two people and have heritable changes to their genome. If the Bill is passed, women who are at high risk of having children with serious mitochondrial disease will be able to consider mitochondrial donation as an option for having children. Initially this would be by participating in a clinical trial and it may later be available in a clinical practice setting.

Mitochondrial donation will be introduced in two stages, with Stage 1 anticipated to take 10 years, with a review scheduled to take place seven years after the commencement of the Act. Stage 1 will allow the Embryo Research Licensing Committee of the NHMRC to authorise three of the five types of mitochondrial donation licences, including a clinical trial licence. If Stage 2 is implemented

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Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 56

as anticipated, the remaining two licences would be available and would allow for use of the approved technique in a clinical setting, making mitochondrial donation more widely available. Stage 2 will require further legislative changes, including to state or territory legislation where the clinical practice activities would take place.

There are complex and complicated issues surrounding the introduction of mitochondrial donation, as, not only is it scientifically a relatively new technology with new evidence emerging and known knowledge gaps, it also raises a number of ethical and social considerations. There are people who strongly support the introduction of mitochondrial donation and there are people who strongly oppose its introduction. Considerations include the use and status of human embryos, the health and wellbeing of the child, the rights and impact on the women who donate their eggs, and broader community considerations, such as equitable access. Given the complexities of the issues, the Government will call for a conscience vote on the Bill.

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Appendix

Table 6: definitions added to the RIHE Act and the RIHE Regulations

Term Definition Bill item number

Clinical practice licence A licence referred to in proposed section 28G. Item 10

Clinical practice research and training licence A licence referred to in proposed section 28F.

Item 10

Clinical trial licence A licence referred to in proposed section 28E. Item 10

Clinical trial research and training licence A licence referred to in proposed section 28D.

Item 10

Constitutional corporation Constitutional corporation means a trading, foreign or financial corporation within the meaning of paragraph 51(xx) of the Constitution. Item 9

Donor If a particular use of a mitochondrial donation technique results in the creation

of a zygote that: a) has nuclear DNA from a woman and a man and b) contains mitochondria from a different woman. The woman mentioned in paragraph (b) is the donor in relation to that use of the technique.

Items 10 and 17 (proposed subsection 28R(2))

General licence A licence issued under section 21. Item 10

Mitochondrial donation licence a) a pre-clinical research and training licence b) a clinical trial research and training licence c) a clinical trial licence d) a clinical practice research and training licence e) a clinical practice licence.

Item 10

Mitochondrial donation technique A technique, prescribed by the Regulations for the purposes of this definition, that:

a) can be used to minimise the risk of a woman's offspring inheriting mitochondrial from that woman that would predispose the offspring to mitochondrial disease and

Item 10

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Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 58

Term Definition Bill item number

b) involves the use of ART to create a zygote that has the parental nDNA and donor mitochondria and c) does not involve: i. intentionally modifying nDNA or mtDNA or

ii. using any animal cell or cell component or iii. creating a chimeric embryo or hybrid embryo.193

National Statement The National Statement on Ethical Conduct in Human Research, issued by the CEO of the NHMRC under the National Health and Medical Research Council Act 1992.

Item 40

Patient A woman whose pregnancy is sought to be achieved using a mitochondrial

donation technique under a clinical practice licence.194

Item 10

Permitted technique (for a mitochondrial donation licence)

A mitochondrial donation technique that declared by the Regulations as permitted to be used under a specific mitochondrial donation licence (outlined in the proposed changes to the Regulations).

Item 10

Pre-clinical research and training licence A licence referred to in proposed section 28C. Item 10

Proper consent for the purposes of Division 4 (general licences) of Part 2 of the RIHE Act

Consent that is obtained in accordance with the Ethical guidelines on the use of assisted reproductive technology (ART Guidelines) issued by the CEO of the NHMRC under the National Health and Medical Research Council Act 1992.

Item 41 (proposed definition of proper consent at section 8 of the RIHE Act); item 71 (proposed subsection 24(9) of the RIHE Act) and item 112 (proposed amendment of section 7 of the RIHE Regulations).

193. Chimeric embryo is defined at subsection 8(1) of the PHCR Act; hybrid embryo is defined under section 7 of the RIHE Act. 194. For a human embryo to be created for, or placed in the body of, a woman under a clinical practice licence, the NHMRC Licensing Committee must be satisfied that there is a particular risk of the woman’s offspring inheriting mitochondria from the woman that would predispose the offspring to mitochondrial disease: see proposed paragraph 28P(4)(a) at item 17 of the Bill.

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Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 59

Term Definition Bill item number

Proper consent for the purposes of proposed Division 4A (mitochondrial donation licences) of Part 2 of the RIHE Act

Consent: • that is obtained in accordance with the Ethical guidelines on the use of assisted reproductive technology (ART Guidelines) issued by the CEO of the NHMRC under the National Health and Medical Research Council Act 1992 and

• in relation to which any other requirements prescribed in the Regulations are satisfied.

Item 17 (proposed subsection 28N(8) of the RIHE Act; item 20 (proposed subsection 7J of the RIHE Regulations); and item 41 (proposed definition of proper consent at section 8 of the RIHE Act).

Responsible person for the purposes of Division 4 (general licences) of Part 2

a) in relation to an excess ART embryo: i. each person who provided the egg or sperm from which the embryo was created; and ii. the woman for whom the embryo was created, for the purpose of achieving

her pregnancy; and iii. any person who was the spouse of a person mentioned in subparagraph (i) at the time the egg or sperm mentioned in that subparagraph was provided;

and

iv. any person who was the spouse of the woman mentioned in subparagraph (ii) at the time the embryo was created; or b) in relation to an embryo other than an excess ART embryo - each person whose reproductive material, genetic material or cell was used, or is proposed

to be used, in the creation or use of the embryo; or c) in relation to a human egg—the woman who was the biological donor of the egg.

Item 42 (proposed definition of responsible person at section 8 of the RIHE Act); item 71 (proposed subsection 24(9) of the RIHE Act)

Responsible person for the purposes of Division 4A of Part 2

Responsible person in relation to a human egg or a human sperm is the person who is the biological donor of the human egg or human sperm. Item 17 (proposed subsection 28N(8));

item 42 (proposed definition of responsible person at section 8 of the RIHE Act).

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Term Definition Bill item number

Trial participant A woman whose pregnancy is sought to be achieved using a mitochondrial donation technique under a clinical trial licence. Item 10

Source: Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021.

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