Purpose of the Bill
1.1
The Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 (bill) seeks to allow for the staged introduction of mitochondrial donation techniques in Australia under a national regulatory framework.
1.2
The bill amends the following legislation:
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).
1.3
The bill presents a two staged approach to allow for research and training, as well as further evidence to be collected, in relation to the safety and efficacy of mitochondrial donation techniques before it is considered for introduction in a broader clinical setting.
Background
1.4
The PHCR Act and the RIHE Act are the principal frameworks that regulate practices in the use of assisted reproductive technology (ART), and for research involving human embryos.
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Mitochondrial donation is currently prohibited in Australia as the PHCR Act prohibits the creation of human embryos by fertilisation with genetic material from more than two people.
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Mitochondrial DNA are inherited only from the biological mother to child. Mitochondrial donation is an ART that seeks to reduce the risk of transmitting mutations in mitochondrial DNA (mtDNA) from a mother to child.
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Several mitochondrial donation techniques involve the creation of an embryo containing nuclear DNA from a woman (the mother), a man (the father), and mitochondrial DNA from a donor egg (the donor).
Mitochondrial disease
1.8
Mitochondrial disease refers to a group of inherited conditions that significantly lowers an individual’s health and life expectancy. Abnormalities may be inherited either through the mitochondrial DNA (inherited from the mother) or through the nuclear DNA (inherited from both parents). Mutations or inherited abnormalities in an individual’s mitochondrial DNA impacts the ability of the mitochondria to function normally.
1.9
Mitochondrial donation can only assist women with mtDNA mutations, and the technology aims to reduce the risk of children inheriting some forms of mitochondrial disease. This form of mitochondrial disease is the cause of approximately half of mitochondrial disease and assists in reducing the risk of mothers passing it on to their children.
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Mitochondrial disease varies in presentation but can cause multiple organ dysfunction or failure, and in severe cases, premature death. Other common symptoms include seizures, fatigue, muscle pain, vision and hearing loss, and heart problems.
1.11
The explanatory memorandum to the bill notes, the risk of developing serious illness due to mitochondrial disease is considered to be between one in 5,000 and one in 10,000. Approximately 56 children are born each year with a severe form of the disease and the prognosis for these children is that most will die within their first five years.
1.12
There is no one age group affected by mitochondrial disease and people can develop it in infancy, early childhood, teenage years or as adults. While some symptoms can be managed, there are no effective treatments available for serious mitochondrial disease and there is no cure.
United Kingdom's experience
1.13
The United Kingdom (UK) is the first country to regulate mitochondrial donation. The UK legalised mitochondrial donation techniques for clinical implementation in 2015.
1.14
The UK's Human Fertilisation and Embryology Authority (HFEA) conducted public consultation and ongoing scientific reviews on the safety and efficacy of mitochondrial donation prior to legalisation. Currently, only the Newcastle Fertility Centre at Life has a licence to conduct research and treat patients using mitochondrial donation techniques.
1.15
At the time of writing this report, the HFEA has not published a report on the safety and efficacy of mitochondrial donation since its 2016 scientific review. The explanatory memorandum also notes, 'in order to protect the privacy of patients, no data has been released to date regarding the outcomes of treatment'.
Previous Senate inquiry into mitochondrial donation
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In 2018, the Senate Community Affairs References Committee conducted an inquiry into the science of mitochondrial donation and related matters. The final report made four recommendations for further community consultation and scientific review to be undertaken and for those findings to inform options for legislative change.
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In response to the recommendations, the National Health and Medical Research Council (NHMRC) convened a Mitochondrial Donation Expert Committee to answer the three scientific questions raised in the final report.
1.18
In 2019, the NHMRC conducted a series of community consultation activities to explore the ethical, legal and social issues associated with introducing mitochondrial donation in Australia. The NHMRC's consultation report identified several themes from this process, including the rights and wellbeing of the child and the donor, genetics of embryos and implementation considerations for granting access to the technology.
Department of Health consultation
1.19
In February and March 2021, the Department of Health conducted community consultation on the government’s proposed approach to introducing mitochondrial techniques in Australia. The Department of Health acknowledged the proposed regulatory and licensing approach is broadly aligned with the UK model.
1.20
The summary of this consultation process noted the ethical issues associated with mitochondrial donation being, the creation and destruction of embryos and the belief that it creates children with three parents or is a form of genetic modification. Individuals and groups supporting the introduction of mitochondrial donation supported the proposal of a two staged regulatory approach.
Proposed implementation
1.21
Under stage 1, mitochondrial donation would be legalised for certain research and training purposes, and to support the selection and licensing of a clinical trial to deliver mitochondrial donation to impacted families.
1.22
A single clinical trial will be allowed and is expected to run for approximately 10 years. The Commonwealth Department of Health will run a competitive grant process to identify a suitable organisation to run this trial.
1.23
The NHMRC's Embryo Research Licensing Committee (ERLC) would be given an expanded licensing and regulatory role to oversee mitochondrial donation licences, including administering applications and monitoring compliance with the licence conditions.
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Transition to stage 2 will be based on an evaluation of stage 1 and the outcomes of the clinical trial. Under stage 2 there would be a national regulatory framework which will allow for mitochondrial donation to be available in a broader clinical practice setting in participating states and territories.
Key provisions
1.25
The bill includes one Schedule with three parts.
1.26
Part 1, Items 4 and 5 deal with the main amendments to the PHCR Act to allow, under a mitochondrial donation licence, the creation of an embryo with the genetic material of more than two people, and changes to its genome that would be heritable by the child’s descendants.
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Part 1, Item 17 contains the bulk of amendments to the RIHE Act to establish mitochondrial donation licences.
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Parts 2 and 3 contain other consequential amendments and transitional provisions.
Licences
1.29
Part 1, Item 17 defines the five types of mitochondrial donation licences and authorised activities. The five licenses are:
a pre-clinical research and training licence;
a clinical trial research and training licence;
a clinical trial licence;
a clinical practice research and training licence (only available under stage 2); and
a clinical practice licence (only available under stage 2).
1.30
Part 1, Item 17, establishes the following provisions to regulate mitochondrial donation licences:
Subdivision A, specifies the kinds of mitochondrial donation licences and what they authorise;
Subdivision B, specifies rules and requirements to applying for a mitochondrial donation licence;
Subdivision C, determines applications for mitochondrial donation licences; and
Subdivision D, outlines the conditions of mitochondrial donation licences.
1.31
Part 1, Item 17, Paragraph 28P(4)(a) refers to women's eligibility to access mitochondrial donation techniques. For a woman to be eligible the woman must provide clinical diagnostic evidence that her mitochondria carries specific mutations that would give rise to the woman's offspring inheriting mitochondrial disease.
Mitochondrial donation techniques
1.32
Part 1, Items 19 and 20, inserts the below definitions of mitochondrial donation techniques.
Maternal spindle transfer (MST):
removing the maternal spindle from a human egg (egg A) of a woman;
removing the maternal spindle from a human egg (egg B) of a different woman;
implanting into egg B the maternal spindle removed from egg A, while seeking to minimise carryover of mitochondria from egg A to egg B;
fertilising egg B with a human sperm to create a zygote.
Pronuclear transfer (PNT):
fertilising, with a human sperm, a human egg of a woman to create a zygote (zygote A);
removing the pronuclei from zygote A;
fertilising, with a human sperm, a human egg of a different woman to create another zygote (zygote B);
removing the pronuclei from zygote B;
implanting the pronuclei from zygote A into zygote B, while seeking to minimise carryover of mitochondria from zygote A to zygote B.
Germinal vesical transfer (GVT):
removing the germinal vesicle from a maturing human egg (egg A) of a woman;
removing the germinal vesicle from a maturing human egg (egg B) of a different woman;
implanting the germinal vesicle removed from egg A into egg B, while seeking to minimise carryover of mitochondria from egg A to egg B;
maturing egg B in vitro to the stage ready for fertilisation;
fertilising egg B with a human sperm to create a zygote.
First polar body transfer (first PBT):
removing the first polar body from a human egg (egg A) of a woman;
removing the maternal spindle from a human egg (egg B) of a different woman;
fusing the first polar body to, or implanting the first polar body into, egg B;
fertilising egg B with a human sperm to create a zygote.
Second polar body transfer (second PBT):
fertilising, with a human sperm, a human egg of a woman to create a zygote (zygote A);
fertilising, with a human sperm, a human egg of a different woman to produce another zygote (zygote B);
removing the second polar body from zygote A;
removing the female pronucleus from zygote B;
transferring the second polar body from zygote A to zygote B.
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Under a mitochondrial donation clinical trial research and training licence or a clinical trial licence only the techniques known as maternal spindle transfer (MST) and pronuclear transfer (PNT) would be permitted.
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Under a pre-clinical research and training licence, emerging techniques known as germinal vesicle transfer (GVT), first polar body transfer (first PBT) and second polar body transfer (second PBT) would be permitted.
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Permitted techniques will only be prescribed for clinical practice research and training licence or a clinical practice licence once they have been shown to be safe and effective for use in clinical practice.
Egg donor
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Part 1, Item 17, section 28R, requires a holder of a clinical trial licence or a clinical practice licence to collect information about donors, and children born as a result of mitochondrial donation techniques. It also requires them to share this information with the Secretary of the Department of Health.
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Part 1, Item 18, requires the establishment and retention of a Mitochondrial Donation Donor Register (Donor Register) by the Secretary of the Department of Health. Any child born using a mitochondrial donation technique can apply for identifying information about their donor when they turn 18.
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The Donor Register will not be made public and would not be available under the FOI Act.
1.39
In line with current ART sperm and egg donors' rights and responsibilities established under the Family Law Act 1975, mitochondrial egg donors would not be considered legal parents.
Counselling
1.40
Under item 17, section 28P, a condition of a clinical trial licence and clinical practice licence requires an individual and their spouse to attend pre-treatment counselling. This would include being provided information in relation to the risks associated with using mitochondrial donation and alternatives to these techniques.
Embryo sex selection
1.41
Under item 17, section 28Q, if after attending the pre-treatment counselling mentioned above, a patient and her spouse can request to have only male embryos selected for implantation, where it is deemed safe and practical to do so.
Financial implications
1.42
The explanatory memorandum states that activities proposed in the bill will be undertaken as an extension of existing Government processes, and ongoing costs are anticipated to be minimal and will be offset within the Department of Health portfolio.
Legislative scrutiny
Senate Standing Committee for the Scrutiny of Bills
1.43
The Senate Standing Committee for the Scrutiny of Bills (scrutiny of bills committee) reported its concerns regarding the significant matters proposed to be dealt with in delegated legislation.
1.44
The scrutiny of bills committee questioned why matters, such as provisions defining key terms and requirements relating to the withdrawal of consent, are not included in the primary legislation.
1.45
The scrutiny of bills committee also highlighted the bill's proposed 'application for a mitochondrial donation licence must be accompanied by the fee, if any, prescribed by the regulations'. It noted the bill contains no cap on the maximum fee amount or any guidance on how the fee will be calculated.
1.46
The Hon Greg Hunt MP, Minister for Health and Aged Care provided a response to the concerns raised in the scrutiny of bills committee report. Minister Hunt proposed not amending the bill but updating the explanatory memorandum to reflect his response and noted the following:
These regulation-making powers are primarily included to ensure that appropriate guidelines are referenced, and to ensure that the legislative scheme can respond appropriately to unforeseen technological advances, and to new mitochondrial donation techniques that might be developed and prescribed in regulations made under the RIHE Act in the future. It is necessary for there to be a reasonable degree of flexibility in order to ensure that this can properly be done.
Parliamentary Joint Committee on Human Rights
1.47
The Joint Committee on Human Rights made no comment on the bill's engagement with human rights, 'based on an assessment of the bill and relevant information provided in the statement of compatibility accompanying the bill'.
1.48
The bill's statement of compatibility with human rights noted that the bill engages with a number of human rights and freedoms.
1.49
However, the statement of compatibility with human rights notes that the bill is compatible with human rights as it:
… promotes the right to health and the best interests of the child, does not affect the right to life, and to the extent that it may limit the right to privacy and the right to freedom of opinion and expression, those limitations are for a legitimate purpose and are reasonable, necessary and proportionate.
Conduct of inquiry
1.50
The bill was introduced into the House of Representatives on 24 March 2021. Pursuant to the adoption of the Senate Standing Committee for the Selection of Bills report, the provisions of the bill were referred to the Community Affairs Legislation Committee (committee) for inquiry and report by 18 August 2021.
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The committee wrote to relevant organisations inviting them to make a submission to the inquiry by 16 July 2021.
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The committee received 56 public submissions, which were published on the committee's website. A list of submissions received is included at Appendix 1.
1.53
A public hearing for the inquiry was held on 6 August 2021. The committee heard evidence from a range of organisations, peak bodies and academics. A list of witnesses is included at Appendix 2.
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The committee would like to thank those individuals and organisations that made submissions and gave evidence at the public hearing.
1.55
The committee notes this bill will be subject to a conscience vote for Members and Senators.
Note on references
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References to the Committee Hansard are to the proof Hansard. Page numbers may vary between the proof and official Hansard transcripts