House of Representatives/Senate

Explanatory Memorandum

(Circulated by authority of the Minister for Health and Aged Care, the Hon Greg Hunt MP)

OUTLINE

Purpose of the Bill

The Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021 (the Bill) amends the following legislation to allow for mitochondrial donation to be introduced into Australia for research and human reproductive purposes:

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

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the Research Involving Human Embryos Act 2002 (RIHE Act)

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the Research Involving Human Embryos Regulations 2017 (RIHE Regulations)

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the Therapeutic Goods (Excluded Goods) Determination 2018 (Excluded Goods Determination), and

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the Freedom of Information Act 1982 (FOI Act).

Objective of the Bill

The Bill provides for the legalisation and introduction of mitochondrial donation techniques for use in Australia under a national regulatory framework. This will allow women whose mitochondria would otherwise predispose their potential children to severe and life-threatening mitochondrial disease, to have a biological child who would not inherit that predisposition. The Bill also allows for further research and training to be undertaken to build the Australian evidence base and expertise for mitochondrial donation and enables further evidence and data to be gathered in relation to the safety and efficacy of mitochondrial donation techniques before allowing them to be introduced more broadly.

In addition, the Bill provides for a range of additional implementation considerations associated with introducing this technology, which have been identified through national and overseas consultation processes. This ensures that legalisation and introduction of this technology is undertaken in an ethically appropriate, safe and carefully controlled manner that adequately protects the health and wellbeing of any children born as a result of the use of these techniques.

Background - mitochondria, mitochondrial disease and mitochondrial donation

Mitochondria are small DNA-containing structures in human cells. They produce ninety per cent of the energy that the body needs to function. Ordinarily, mitochondria are inherited almost exclusively through the maternal line (passed from a mother to her children), through the mitochondria present in the mother's egg cells.

Mitochondrial disease refers to a complex group of inherited conditions that can significantly lower an individual's health and life expectancy, and may be fatal. It is caused by mutations in the mitochondrial DNA or nuclear DNA of an individual, which can impact the ability of that individual's mitochondria to function properly. The disease varies in presentation and severity, but common symptoms include developmental delays, seizures, weakness and fatigue, muscle pain, vision and hearing loss, multiple organ failure and heart problems; leading to morbidity and in severe cases, premature death.

The severity of symptoms and prognosis for mitochondrial disease depends on a range of factors such as the overall impact on mitochondrial functioning, the number of mitochondria affected and the distribution of the affected mitochondria in an individual's tissues and organs.

The risk of developing serious illness due to mitochondrial disease is considered to be between one in 5,000 and one in 10,000. However, around one in 200 Australians are estimated to be predisposed to mitochondrial disease and approximately 56 children are born each year with a severe form of the disease. The prognosis for these children is that most will die within their first five years. Currently there is no known cure for mitochondrial disease and treatment options are mostly limited to management of symptoms. However, some of these instances could be prevented if mitochondrial donation was legalised in Australia for the purpose of minimising this risk.

Mitochondrial donation is an assisted reproductive technology that, when combined with in-vitro fertilisation (IVF), has the potential to allow women whose mitochondria would predispose their potential children to mitochondrial disease, to have a biological child who does not inherit that predisposition.

There are a number of different mitochondrial donation techniques. However, each requires the transfer of nuclear genetic material extracted from the prospective mother's egg (either before or after it has been fertilised by a sperm cell) and the placing of that material into a donor (recipient) egg, which has had its own nuclear genetic material removed, but which retains its own intact mitochondria. In this way, the technology can be used to minimise the risk of transmission of the prospective mother's mitochondria to her offspring, as the resulting embryo predominantly contains only the donor's mitochondria.

In 2015, mitochondrial donation was legalised in the United Kingdom (UK) for human reproductive purposes to prevent the transmission of serious mitochondrial disease. The decision to legalise mitochondrial donation was made following extensive public consultation as well as several comprehensive scientific reviews of the safety and efficacy of the techniques, which were undertaken by the UK Human Fertilisation and Embryology Authority (HFEA). However, although the regulations legalising mitochondrial donation were made in 2015, the technology has been implemented cautiously under a stringent regulatory framework, with only one clinic currently licensed to provide the treatment to eligible women. In addition, in order to protect the privacy of patients, no data has been released to date regarding the outcomes of the treatment.

In Australia, the use of mitochondrial donation techniques is prohibited under the PHCR Act and the RIHE Act. Legalising mitochondrial donation for use in Australia therefore requires amendments to be made to both of these Acts before affected women can access this technology in Australia to minimise the risk of their own biological children inheriting and suffering from mitochondrial disease.

In 2018, the Senate Community Affairs References Committee undertook an inquiry into the Science of Mitochondrial Donation and Related Matters (the Senate Inquiry). The Senate Inquiry looked at the impacts of mitochondrial disease, the science of mitochondrial donation, legal and ethical considerations and regulation. The final report arising from the Senate Inquiry recommended that some further consultation should be undertaken with the community, relevant experts and the States and Territories before mitochondrial donation was introduced into Australian clinical practice.

In 2019-20, the National Health and Medical Research Council (NHMRC) undertook a series of community consultation activities in response to the Senate Inquiry recommendations to explore community attitudes to the ethical, legal and social issues associated with introducing mitochondrial donation in Australia. The NHMRC also convened a Mitochondrial Donation Expert Committee to review key scientific questions raised by the Senate Inquiry.

Both the NHMRC and the Senate Inquiry identified significant community support for legalising mitochondrial donation for use in Australia. However, these consultations also identified that among those who supported its introduction, the majority also recommended that a cautious and nationally regulated approach, with appropriate safeguards and ongoing monitoring, would be essential. A number of ethical issues associated with mitochondrial donation were also identified, with some members of the community concerned that the technology would result in 'three parent' children, or was a form of genetic modification. Concerns regarding the rights of the child, privacy of parents and children, and ensuring informed consent and donor rights and responsibilities were also identified.

There was also broad agreement by both proponents and opponents of mitochondrial donation, that there were many unknowns given the relative newness of the science, including in relation to safety and efficacy of the techniques as well as the potential for unintended consequences in the longer term that would benefit from further research. However, for those who supported the introduction of mitochondrial donation, the benefits of greatly reducing the impact of mitochondrial disease on children, families and future generations were considered to far outweigh the risks of introducing mitochondrial donation overall.

In February 2021, the Department of Health released a public discussion paper, seeking community feedback on a proposed two-stage implementation approach for introducing mitochondrial donation in Australia. The paper proposed that:

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Mitochondrial donation would initially be legalised for certain research and training purposes, and to support selection and licensing of a pilot program to deliver mitochondrial donation to impacted families (stage 1).

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Mitochondrial donation would be permitted in clinical practice more broadly under stage 2 (depending on the outcomes and an evaluation of the initial pilot program).

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The use of specified mitochondrial donation techniques would be subject to strict licensing and regulatory conditions, which would be overseen by the Embryo Research Licensing Committee (ERLC) of the NHMRC.

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Individuals seeking to access the program would also require approval from the ERLC based on clinical recommendations.

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Separate research and training licences would also be available to Australian researchers seeking to undertake broader research on mitochondrial donation techniques that aim to avoid the transmission of serious mitochondrial disease.

The following approaches to addressing key ethical concerns were also proposed:

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Prospective parents would be required to attend pre-treatment counselling, where the potential risks associated with mitochondrial donation and alternative options would be fully explained. This approach would allow for parents to make their own informed decisions, and provides for reproductive choice.

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Maintaining the privacy of families and children would be a priority. Ongoing monitoring would be undertaken through the mainstream health care system where possible, and there would be no additional invasive testing for routine monitoring purposes.

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Mandatory reporting of any adverse events.

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Mitochondrial donation egg donors would not be considered legal parents.

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Children conceived by mitochondrial donation would have the right to apply for identifying information about their donor at an appropriate age.

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Legislative amendments would expressly exclude intentional modification of the nuclear DNA or the mitochondrial DNA.

The public consultation, which concluded in March 2021, identified support for the proposed implementation approach. The amendments in the Bill have been designed to give effect to the publicly supported approach to implementing mitochondrial donation in Australia.

Overview of the Bill

The amendments made by the Bill are contained in Schedule 1 to the Bill. This Schedule is divided into three parts:

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Part 1 deals with the main amendments that provide for legalising mitochondrial donation techniques for use as part of assisted reproduction technology in Australia. The Bill has been drafted so that a reader will be able to arrive at a reasonably clear understanding of how the principal set of amendments operate from a reading of the amendments contained in this Part.

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Part 2 deals with other amendments that support the main amendments. These include consequential amendments, technical revisions, and consequential amendments to other legislation and legislative instruments that are needed to support the main amendments.

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Part 3 deals with application and transitional provisions.

The Bill amends several legislative instruments, in addition to amending Acts of Parliament. As with many modern legislative schemes, it is necessary under this scheme for some important matters to be dealt with by delegated legislation. The Bill amends relevant delegated legislation directly, so that the Parliament is able to view these delegated legislation amendments at the same time as it considers amendments to primary legislation, and thereby has a complete understanding of how the legislative package as a whole is proposed to operate.

Part 1 of Schedule 1 to the Bill (Main amendments) amends the PHCR Act, the RIHE Act and the RIHE Regulations to allow for the use of permitted mitochondrial donation techniques under a specified mitochondrial donation licence for the purposes of certain research and training, and in clinical settings. The effect of the principal amendments in the Bill are outlined in more detail below.

The amendments to the PHCR Act allow for certain currently-prohibited practices to be permitted if authorised under one of five different types of mitochondrial donation licence:

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a pre-clinical research and training licence

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a clinical trial research and training licence

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a clinical trial licence

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a clinical practice research and training licence, and

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a clinical practice licence.

The Bill amends the offence provisions of the RIHE Act and the PHCR Act that prohibit mitochondrial donation techniques, with the effect that the techniques could be used under a licence issued by the ERLC.

The Bill inserts a new Division 4A of Part 2 into the RIHE Act, after the existing Division 4 of Part 2, which will give effect to the expanded regulatory role and remit of the ERLC in relation to mitochondrial donation. It includes provisions dealing with what is authorised under each of the five types of mitochondrial donation licences, licence applications, conditions and administrative requirements (including for example notifications and matters to be specified in a licence). Additional provisions are also included which provide for particular conditions required for all mitochondrial donation licences, including in relation to authorised personnel, reporting and monitoring. For the clinical trial and clinical practice licences, specific conditions are included relating to the approval processes for individuals seeking access to mitochondrial donation.

The new Division 4A of Part 2 of the RIHE Act also provides for the ongoing requirements of licence holders in relation to mitochondrial donation licences, which mirrors to a large extent the existing process for human embryo research licence holders under the current RIHE Act but also includes requirements for record keeping, collection of information, ongoing monitoring of trial participants and patients and (in the case of clinical trial licences) children born using a mitochondrial donation technique and mandatory notification of adverse events.

The amendments to the RIHE Act also provide for the establishment and retention of a Mitochondrial Donation Donor Register under a new section 29A. The purpose of this register is to ensure that any children born using a mitochondrial donation technique are able to apply for identifying information about their donor when they turn 18. A consequential amendment to the FOI Act is also included under Part 2 of Schedule 1 to the Bill (Other amendments) that, coupled with provisions inserted into the RIHE Act, provide appropriate protections against the disclosure of personal information about any children born using mitochondrial donation techniques and their mitochondrial donor.

The principal amendments to the RIHE Regulations that are provided for in the Bill are the insertion of a new Division 2 - Provisions relating to mitochondrial donation licences, under which the permitted mitochondrial donation techniques are prescribed in detail, together with prescription of the types of mitochondrial donation licence under which their use will be permitted. The Bill only permits the techniques known as maternal spindle transfer (MST) and pronuclear transfer (PNT) for use under a mitochondrial donation clinical trial research and training licence or a clinical trial licence. This is in line with the UK, where only these two techniques have been prescribed in regulations as being suitable for use for human reproductive purposes, based on extensive research and scientific review.

In addition to MST and PNT, three other permitted mitochondrial donation techniques are prescribed by the RIHE Regulations for use under a pre-clinical research and training licence. These techniques are newer emerging techniques known as germinal vesicle transfer (GVT), first polar body transfer (1st PBT) and second polar body transfer (2nd PBT).

There are no permitted mitochondrial donation techniques that can be used under a clinical practice research and training licence or a clinical practice licence. Permitted techniques will only be prescribed for these licences once they have been shown to be safe and effective enough for use in clinical practice. This would require a future amendment to the RIHE Regulations, which would be based on expert advice provided to the Minister. In this way, whilst the Bill provides a pathway for mitochondrial donation to be used in clinical practice in the future, it is not intended that mitochondrial donation techniques would be prescribed for use in clinical practice until their use has been monitored and evaluated through a clinical trial over a number of years. The decision would be based on expert advice and the outcomes of the clinical trial.

Under Part 2 of Schedule 1 to the Bill (Other amendments), a number of minor amendments are provided for which relate to the operation of the PHCR Act, the RIHE Act and the RIHE Regulations. A consequential amendment to the Excluded Goods Determination is also included in the Bill to ensure that responsibility for the regulation of mitochondrial donation in Australia is clearly delineated.

Financial impact statement

There will be no net financial impact arising from the implementation of the Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021.

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:

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

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

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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.

Regulation impact statement

The regulation impact statement is available at the end of this explanatory memorandum.

Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

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

This Bill is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

Overview of the Bill

The purpose of the Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021 (the Bill) is to legalise mitochondrial donation for particular research, training and reproductive purposes. The legalisation of mitochondrial donation for these purposes marks a significant reform to the provision of services such as assisted reproductive technologies to people who have mitochondrial disease, or whose offspring would be at risk of inheriting a predisposition to mitochondrial disease. The Bill amends the Prohibition of Human Cloning for Reproduction Act 2002 and the Research Involving Human Embryos Act 2002, and some associated legislation, to facilitate this purpose. The Bill introduces safeguards to ensure that the techniques are safe, effective, and properly regulated, and to protect the privacy of persons who make use of mitochondrial donation techniques.

The Senate Community Affairs References Committee in its 2018 report The science of mitochondrial donation and related matters, noted the strong potential of mitochondrial donation to address the debilitating effects of inherited mitochondrial disease. In response the Minister for Health asked the National Health and Medical Research Council (NHMRC) to further consider additional matters on the science of mitochondrial donation, and to examine the social and ethical issues around mitochondrial donation. Reports on those matters were released on 5 June 2020.

Under the Bill, mitochondrial donation will be introduced in a staged and closely monitored way.

Under the first stage, mitochondrial donation will be legalised for certain research and training purposes, including for the purpose of undertaking a clinical trial of the use of mitochondrial donation techniques as part of human assisted reproductive technology. The aim of this approach is to build an Australian evidence base in relation to the safety and efficacy of mitochondrial donation techniques, and associated issues such as feasibility, service delivery, cost and impacts, prior to a decision being made on introducing the use of the techniques more broadly into clinical practice. This will also provide for building Australian expertise in the use of mitochondrial donation techniques. At the same time, the clinical trial will have the secondary benefit of allowing some affected families to access the technology as quickly and safely as possible, in a carefully selected and regulated clinical setting.

The use of specified mitochondrial donation techniques under this first stage will be subject to strict licensing conditions, which will be overseen by the existing Embryo Research Licensing Committee (ERLC) of the NHMRC. Once the clinical trial has demonstrated success over a number of years, and the results have been evaluated by experts, there will be an option to move to the second stage of this staged implementation, which would allow for accredited assisted reproduction technology centres across Australia to offer mitochondrial donation in clinical practice, as part of assisted reproductive therapy.

This second stage will commence when regulations are made prescribing mitochondrial donation techniques for use in clinical practice. However, the use of mitochondrial donation techniques as part of clinical practice in assisted reproductive technology in a particular State or Territory would not become legal immediately upon the making of such regulations. Before such techniques could be used in a particular State or Territory, the State or Territory would need to enact its own laws authorising the use of the technique. The State or Territory would, in doing so, be able to further regulate the use of the technique as part of its regulation of assisted reproductive technologies in its jurisdiction.

Throughout both stages, a certain amount of research and training in the use of mitochondrial donation techniques will also be allowed, to increase Australian-based knowledge and expertise in the techniques, outside of the context of a clinical trial of particular mitochondrial donation techniques.

In all cases, the use of mitochondrial donation techniques will need to be authorised by a licence issued by the ERLC.

These arrangements have been based on the approach to legalising the use of mitochondrial donation techniques in the United Kingdom, as part of assisted reproductive technology.

In addition to the above objective, the Bill will create a Mitochondrial Donation Donor Register, which will be a safe and secure register for storing details about persons born as a result of a mitochondrial donation procedure and their mitochondrial donors. The Bill will allow for persons born of a mitochondrial donation technique to, from when they turn 18, find out the identity of their mitochondrial donor.

Human rights implications

This Bill engages the following rights:

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The Right to Health - Article 12 of the International Covenant on Economic, Social and Cultural Rights (the ICESCR)

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The Right to Life - Article 6 of the Convention of the Rights of the Child (the CROC)

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Obligation to consider the best interests of the child - Article 3 of the CROC and Article 24(1) of the ICCPR.

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The Right to Privacy - Article 16 of the CROC, and Article 17 of the ICESCR.

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The Right to Freedom of Opinion and Expression - Article 19 of the ICESCR.

Right to Health

The Bill engages the right to health as contained in article 12 of the ICESCR. Article 12(1) recognises the 'right of everyone to the enjoyment of the highest attainable standard of physical and mental health'. Pursuant to article 2(1), Australia relevantly undertakes to 'take steps ... to the maximum of its available resources, with a view to achieving progressively the full realisation' of this right 'by all appropriate means'.

Article 12(2) further provides a non-exhaustive list of 'steps' to be taken by the Parties to achieve the full realisation of the right to health. These steps include, relevantly:

(a) The provision for the reduction of the stillbirth-rate and of infant mortality and for the healthy development of the child;

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(c) The prevention, treatment and control of epidemic, endemic, occupational and other diseases;

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The legalisation of mitochondrial donation in the manner proposed is consistent with the right to health recognised in article 12(1) of the ICESCR, on the basis that it has the potential to reduce infant mortality (Art 12(2)(a)), and prevent and control the transmission of mitochondrial disease (Art 12(2)(c)). The mitochondrial donation techniques that may be permitted to be used for reproductive purposes have been assessed as being sufficiently safe to use. However, because there is more to learn about their efficacy and safety, initially, these mitochondrial donation techniques will be legalised for use for reproductive purposes only for limited clinical trials, before they could be used more broadly as part of clinical practice in assisted reproductive technology. The reasons for this cautious approach are outlined above.

Article 24 of the CROC recognises 'the right of the child to the enjoyment of the highest attainable standard of health'. The Bill is consistent with article 24 of the CROC for the same reasons as it is consistent with article 12(1) of the ICESCR.

In summary, the legalisation of mitochondrial donation by the Bill is consistent with the right to health as expressed in the ICESCR and the CROC on the basis that it promotes the prevention of mitochondrial disease, and thereby has the potential to reduce infant mortality, and will generally increase the attainable standard of health of children who are born as a result of the procedure.

Right to life

The Bill may be seen to engage the right to life as contained in article 6 of the CROC, on the basis that it makes amendments that will permit, in particular, the creation of human embryos for a purpose other than achieving pregnancy in a particular woman. For example, under the Research Involving Human Embryos Act 2002 as amended by the Bill, the creation of embryos and their development (for up to 14 days) could be permitted for the non-reproductive purposes of developing a mitochondrial donation technique, determining its safety and efficacy, and building expertise in the technique and how to use it. This could further be permitted for the purpose of research and training in the use of mitochondrial donation techniques.

In particular, article 6(1) of the CROC states that parties '...recognize that every child has the inherent right to life'. Pursuant to article 2(1), Australia relevantly undertakes to '... respect and ensure the rights set forth in the present Convention to each child within their jurisdiction ...'. However, rights under the CROC do not apply to children before they are born. The right to life is therefore not engaged by the Bill.

Obligation to consider the best interests of the child

The Bill engages rights of parents and children. Article 3 of the CROC recognises that:

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in all actions concerning children, the best interests of the child shall be a primary consideration

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children should be ensured such protection and care as is necessary for their wellbeing.

Considering the best interests of the child requires active measures to protect their rights and promote their survival, growth, and wellbeing, as well as measures to support and assist parents and others who have day-to-day responsibility for ensuring recognition of children's rights.

The Bill promotes the rights of children by providing a pathway to rolling out the use of mitochondrial donation techniques in Australia as a part of assisted reproductive technology, to minimise risks related to children inheriting a predisposition to mitochondrial disease. The Bill also ensures that parents have the necessary assistance to be able to make informed decisions about whether to use mitochondrial donation as part of assisted reproductive technology. This is ensured through the counselling that is required to be provided, and the ongoing monitoring that is required to be offered following the use of the technique, throughout pregnancy and (during the clinical trial) during the child's development.

Some have criticised the use of mitochondrial donation in human reproduction on the basis that it is not possible for a child born of the procedure to consent to the procedure. The procedure is applied sometimes before the child is even conceived. This issue was considered by the Senate Community Affairs References Committee in its 2018 report The science of mitochondrial donation and related matters. The Senate Committee considered the notion of 'anticipated consent', and took the view that the child's consent to the use of a medical procedure that had the potential to prevent the child from having a debilitating illness could be anticipated. The Senate Committee also noted that persons who had given evidence to its inquiry and who were living with mitochondrial disease had submitted that they and their children would like to have the choice to determine whether or not a mitochondrial donation technique would be right for them and their child.

Right to privacy

The Bill engages the right to privacy as contained in article 16 of the CROC, and article 17 of the ICESCR. Article 16(1) of the CROC recognises that 'no child shall be subjected to arbitrary or unlawful interference with his or her privacy, family, home or correspondence, nor to unlawful attacks on his or her honour and reputation'. Article 17(1) of the ICESCR similarly states that 'no one shall be subjected to arbitrary or unlawful interference with his privacy, family, home or correspondence, nor to unlawful attacks on his honour and reputation'.

The Bill engages with the right as it provides for the collection, storage, security, use, disclosure and publication of personal information. In particular, new section 28R of the Research Involving Human Embryos Act 2002 requires the holder of a clinical trial licence or a clinical practice licence to obtain, or use best endeavours to obtain, certain personal information about donors for, and children born as a result of, the use of a mitochondrial donation technique. The licence holder is required under that provision to keep records of this information and provide it to the Secretary of the Department of Health. The Secretary must include that information in the Mitochondrial Donation Donor Register (the Register), required to be kept by new section 29A of the Research Involving Human Embryos Act 2002.

The interference with privacy by the abovementioned provisions is in the pursuance of a legitimate purpose. Specifically, the primary purpose of the Register is to allow any children born as a result of the use of mitochondrial donation techniques to seek identifiable information about their mitochondrial donor, after turning 18.

The Bill provides for a number of safeguards, to protect the information that is required to be collected and stored. In particular, the Register must not be made publicly available (new subsection 29A(3)). The only persons who can apply to the Secretary to obtain information from the Register are a person who was born as a result of the use of a mitochondrial donation technique under a mitochondrial donation licence, once they have turned 18 (for information in the Register about their donor), and the donor in relation to the use of a mitochondrial donation technique (for information in the Register about themselves only) (new subsections 29A(4) and (5)). If such an application is made, the Secretary is required to disclose the relevant information. Other than such disclosures, and disclosure by order of a court, any disclosure of information on the Register is a criminal offence (new subsection 29A(7)). Nor would the information be available under the Freedom of Information Act 1982 (subsections 38(2) and (3A) of, and Schedule 3 to, that Act, as amended or inserted by the Bill).

Further, new paragraph 28J(5)(f) prevents the ERLC from issuing a clinical trial licence or a clinical practice licence for a mitochondrial donation technique unless satisfied that the applicant has protocols in place to ensure that each donor in relation to a use of the technique is aware that any children born as a result of a pregnancy achieved by using the technique will be able to obtain information about the donor.

Licence holders are required to collect a range of information about donors and children born of a mitochondrial donation procedure. Ordinary privacy legislation would apply in relation to such information. Under clinical trial licences and clinical practice licences, trial participants and patients would need to deal with clinical specialists. Usual patient confidentiality would apply in relation to such dealings.

The Bill also requires persons who hold, or have held, a clinical trial licence or a clinical practice licence to have in place, and comply with, protocols for certain monitoring of trial participants and patients and, for clinical trial licences only, children born as a result of the use of a mitochondrial donation technique. The main purpose of monitoring is to understand any risks that may be presented by the use of mitochondrial donation techniques.

However, the Bill does not require trial participants, patients or children to be monitored. Rather, the holders of mitochondrial donation licences are required to have in place, and comply with, protocols for seeking the ongoing engagement of these persons, for example by explaining to these persons the benefits to themselves and others of their participation in monitoring. That is, trial participants, patients and children will only participate in ongoing monitoring on a voluntary basis.

In summary, the Bill does not unduly limit the right to privacy, because the proposed interferences with that right are for legitimate, rational objectives, and are reasonable, necessary and proportionate.

Right to freedom of opinion and expression

The Bill attaches criminal liability to the publication of information, and thereby engages the right to freedom of opinion and expression as contained in article 19 of the ICESCR, specifically article 19(2), which recognises that 'everyone shall have the right to freedom of expression; this right shall include freedom to seek, receive and impart information and ideas of all kinds...'.

Specifically, under new subsection 29A(7) of the Research Involving Human Reproduction Act 2002, a person is prohibited from disclosing information on the Register (where they have that information by virtue of performing functions associated with the Register under that Act), unless the disclosure is by order of a court, or in accordance with new subsection 29A(6) (which allows for specific and very limited disclosures). A person who contravenes new subsection 29A(7) commits an offence with a maximum penalty of imprisonment for 2 years.

Under article 19(3)(b) of the ICCPR, the right to freedom of expression may be subject to restrictions provided by law that are necessary 'for respect of the rights ... of others'. The legitimate and rational purpose of the interference with freedom of opinion and expression under new section 29A is to ensure that the right to privacy is upheld with respect to highly sensitive personal information about donors for, and children born as a result of, the use of a mitochondrial donation technique. The offence created is considered to be reasonable, necessary and proportionate in achieving this objective as it is sufficiently precise in balancing the right to freedom of opinion and expression and the right to privacy.

In summary, the Bill does not unduly limit the right to freedom of opinion and expression, because the proposed interferences with that right are for legitimate, rational objectives, and are reasonable, necessary and proportionate.

Conclusion

The Bill is compatible with human rights because 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.

Abbreviations used in this explanatory memorandum

This explanatory memorandum uses the following abbreviated references:

Notes on Clauses

Clause 1 - Short title

1. Clause 1 provides that the Bill, when enacted, may be cited as the Mitochondrial Donation Law Reform (Maeve's Law) Act 2021.

Clause 2 - Commencement

2. This clause provides for the commencement of the Bill. Each provision of the Bill specified in column 1 of the table in subclause 2(1) commences, or is taken to have commenced, in accordance with column 2 in the table.

3. Sections 1 to 3 will commence the day the Bill receives Royal Assent. Schedule 1 to the Bill will commence on a day fixed by Proclamation or, if the provisions do not commence within the period of 6 months beginning on the day the Bill receives the Royal Assent, they will commence on the day after the end of that period.

4. Before the substantive amendments made by the Bill come into operation, it will be necessary for the ERLC to undertake a range of preparatory work, including preparing a number of systems and processes to be able to deal with applications for mitochondrial donation licences.

5. Section 4 of the Acts Interpretation Act deals with the exercise of powers between enactment and commencement of an Act, and it is intended that this provision would provide suitable authority for the ERLC to undertake this preparatory work.

6. A note explains that this table relates only to the provisions of this Bill as originally enacted. It will not be amended to deal with any later amendments.

Clause 3 - Schedules

7. This clause provides that each Act that is specified in a Schedule to the Bill is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item has effect according to its terms. This is a technical provision that gives operational effect to the amendments contained in the Schedules. Schedule 1 amends the PHCR Act, the RIHE Act, the RIHE Regulations, the FOI Act and the Excluded Goods Determination.

8. In relation to the amendments the Bill makes to the RIHE Regulations and the Excluded Goods Determination, a note to clause 3 directs the reader's attention to the operation of subsection 13(5) of the Legislation Act. As a result of this provision, the amendments made by the Bill will not prevent the Governor-General from subsequently amending or repealing the RIHE Regulations, nor would it prevent the Minister from subsequently amending or repealing the Excluded Goods Determination.

SCHEDULE 1 - MITOCHONDRIAL DONATION

Part 1 - Main amendments

Prohibition of Human Cloning for Reproduction Act 2002

Item Subsection 8(1)

9. This item inserts into subsection 8(1) definitions of the following terms used in the provisions of the PHCR Act, as introduced and amended by the Bill:

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general licence - this term is defined to have the same meaning as in Part 2 of the RIHE Act, that is, a licence issued under section 21 of that Act. (See item 10, which inserts that definition into section 8 of that Act.) The term 'general licence' replaces the existing term 'licence', the definition of which is repealed by item 25. ('Licence' is currently defined to mean a licence issued under section 21 of the RIHE Act.) The purpose of these amendments is to allow licences that are issued under section 21 of the RIHE Act to be distinguished from mitochondrial donation licences

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mitochondrial donation licence - this term describes the various types of licences to be introduced by the Bill, which relate to the carrying out of mitochondrial donation techniques

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mitochondrial donation technique - this term will have the same meaning as in Part 2 of the RIHE Act (see item 10, which introduces a definition of that term into section 8 of that Act).

Item Section 12 (at the end of the heading)

10. This item amends the heading of section 12 of the PHCR Act to reflect that, as amended, section 12 will not prohibit the intentional creation of a human embryo if this is authorised by a mitochondrial donation licence (provided that other relevant requirements set out in new section 28B of the RIHE Act apply).

Item Subsection 12(1)

11. This item amends subsection 12(1) of the PHCR Act. That provision currently makes it an offence for a person to intentionally create a human embryo by a process of the fertilisation of a human egg by a human sperm outside the body of a woman, unless the person's intention in creating the embryo is to attempt to achieve pregnancy in a particular woman.

12. The effect of item 3 is that it will not be an offence to intentionally create a human embryo for a purpose other than achieving pregnancy in a particular woman, where that creation is permitted under new section 28B of the RIHE Act. New section 28B of the RIHE Act permits a person to carry out an activity as authorised by a mitochondrial donation licence, provided the licence is in force and certain other requirements are met.

13. The purpose of item 3 is to amend subsection 12(1) so that it does not prohibit a person using a mitochondrial donation technique from creating a human embryo for a purpose other than achieving pregnancy in a particular woman, provided the person is authorised to do so by a mitochondrial donation licence under the RIHE Act (and other requirements set out in new section 28B of that Act are satisfied). Pre-clinical research and training licences, clinical trial research and training licences and clinical practice research and training licences are all types of mitochondrial donation licences that will be able to authorise the creation of a human embryo using a mitochondrial donation technique for a purpose other than achieving pregnancy in a particular woman. (See, in particular, new sections 28C, 28D and 28F, introduced by item 17, which specify what each of these types of licences may permit.)

14. The RIHE Act and the PHCR Act are enforced by criminal sanctions. The Bill retains this enforcement approach, and does not trigger the provisions of the Regulatory Powers Act.

15. This is because the RIHE Act and the PHCR Act are part of a cooperative intergovernmental scheme that is underpinned by the Research Involving Human Embryos and Prohibition of Human Cloning Inter-Governmental Agreement, an inter-governmental agreement between the Commonwealth, the States and the Territories, under which each jurisdiction has passed essentially consistent legislation that deals with prohibition of human cloning for reproduction and related matters, and regulates research involving human embryos. Under the scheme, obligations are enforceable by criminal penalties, and are also largely nationally consistent. It would create difficulties under this scheme, particularly in relation to its national consistency, if the Bill were to amend the RIHE Act and the PHCR Act so as to trigger the Regulatory Powers Act in relation only to the Commonwealth legislation.

Item After paragraph 13(b)

16. This item amends section 13 of the PHCR Act. That provision currently makes it an offence for a person to intentionally create or develop a human embryo by a process of the fertilisation of a human egg by a human sperm outside the body of a woman, where the embryo contains genetic material provided by more than 2 persons.

17. This item adds a new paragraph to section 13 with the effect that it is not an offence to intentionally create or develop such an embryo where this is permitted under new section 28B of the RIHE Act. New section 28B of the RIHE Act permits a person to carry out an activity as authorised by a mitochondrial donation licence, provided the licence is in force and certain other requirements are met.

18. The purpose of this item is to amend section 13 so that it does not prohibit a person using a mitochondrial donation technique from creating a human embryo that contains genetic material provided by more than 2 persons, provided the person is authorised to do so by a mitochondrial donation licence under the RIHE Act (and other requirements set out in new section 28B of that Act are satisfied). Pre-clinical research and training licences, clinical trial research and training licences, clinical trial licences, clinical practice research and training licences and clinical practice licences are all types of mitochondrial donation licences that can authorise the creation of a human embryo that contains genetic material provided by more than 2 persons, using a mitochondrial donation technique. (See, in particular, new sections 28C, 28D, 28E, 28F and 28G, introduced by item 17, which specify what each of these types of licences may permit.)

Item After paragraph 15(1)(b)

19. This item amends section 15 of the PHCR Act. That provision currently makes it an offence to alter the genome of a human cell in such a way that the alteration is heritable by descendants of the human whose cell was altered, where the person intended the alteration to be heritable.

20. This item adds a new paragraph (1)(c) to section 15, with the effect that it is not an offence to intentionally alter the genome of a human cell in this way where this is permitted under new section 28B of the RIHE Act. New section 28B of the RIHE Act permits a person to carry out an activity as authorised by a mitochondrial donation licence, provided the licence is in force and certain other requirements are met.

21. The purpose of this item is to amend section 15 so that it does not prohibit a person using a mitochondrial donation technique from altering the genome of a human cell in such a way that the alteration is intentionally heritable by descendants of the human whose cell was altered, provided the person is authorised to do so by a mitochondrial donation licence under the RIHE Act (and other requirements set out in new section 28B of that Act are satisfied). Clinical trial licences and clinical practice licences are both types of mitochondrial donation licences that can authorise the alteration of the genome of a human cell in such a way that the alteration is heritable by descendants of the human whose cell was altered. (See, in particular, new sections 28E, and 28G, introduced by item 17, which specify what each of these types of licences may permit.)

22. For the other types of mitochondrial donation licences, as they do not authorise the creation of a human embryo for reproductive purposes, they do not authorise the alteration of the genome of a human cell with this intention of heritability.

Item At the end of subsection 20(3) (before the penalty)

23. This item amends subsection 20(3) of the PHCR Act. That provision currently 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 term 'prohibited embryo' is defined in subsection 20(4) and includes, relevantly:

•

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 2 persons (paragraph (c)), and

•

a human embryo that contains a human cell (within the meaning of section 15 of the PHCR Act) 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)).

24. This item amends subsection 20(3) of the PHCR Act so that it does not prohibit a person intentionally placing in the body of a woman a prohibited embryo listed in paragraphs (a), (c) and (f) of the definition of 'prohibited embryo', where the person is permitted to do so under new section 28B of the RIHE Act. New section 28B of the RIHE Act would permit a person to carry out an activity as authorised by a mitochondrial donation licence, provided the licence is in force and certain other requirements are met.

25. The purpose of this item is to amend subsection 20(3) so that it does not prohibit a person placing an embryo in the body of a woman knowing that, or reckless as to whether, the embryo is a prohibited embryo listed in paragraphs (a), (c) or (f), provided the person is authorised to do so by a mitochondrial donation licence under the RIHE Act (and other requirements set out in new section 28B of that Act are satisfied). Clinical trial licences and clinical practice licences are both types of mitochondrial donation licences that can authorise the placement of a prohibited embryo listed in paragraphs (a), (c) or (f) in the body of a woman. (See, in particular, new sections 28E, and 28G, introduced by item 17, which specify what each of these types of licences may permit.)

Item At the end of section 20

26. This item inserts a new subsection (5) at the end of section 20 of the PHCR Act. It provides 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 (3) of that section.

27. 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 by the law creating an offence bears an evidential burden in relation to that matter.

28. The purpose of new subsection 20(5) of the PHCR Act is to displace the operation of subsection 13.3(3) of the Criminal Code in relation to the matters set out in subsection 20(3), and thereby ensure that a defendant who wishes to rely on the exception introduced by item 6 does not bear an evidential burden in relation to that matter. That is, this item is intended to ensure that a defendant does not bear an evidential burden in relation to the matters of whether an embryo is a prohibited embryo under paragraph (a), (c) or (f) of the definition of that expression in subsection 20(4) of the PHCR Act, and whether the placement of the embryo by the person is permitted under new section 28B of the RIHE Act. Under other offence provisions of the RIHE Act and the PHCR Act, a defendant does not bear an evidential burden of proof. This item ensures that the same applies in relation to the amendment introduced by item 6.

Item Paragraphs 22(b) and 23(c)

29. This item amends sections 22 and 23 of the PHCR Act. Section 22 is an offence provision that prohibits the creation of a human embryo by a process other than the fertilisation of a human egg by a human sperm, and the development of a human embryo so created. Section 23 is an offence provision that prohibits the creation or development of a human embryo by a process other than the fertilisation of a human egg by a human sperm, where that embryo contains genetic material provided by more than 2 persons.

30. Due to the operation of paragraphs 22(b) and 23(c), both offence provisions currently operate only where the creation or development of the embryo by the person 'is not authorised by a licence'. This item amends paragraphs 22(b) and 23(c) so that sections 22 and 23 will only operate where the creation or development of the embryo by the person is not authorised by a general licence or permitted under new section 28B of the RIHE Act.

31. The amendment made by this item reflects the change in nomenclature from 'licence' to 'general licence' that will be introduced by the Bill (see items 1 and 25). The term 'general licence' will be introduced by the Bill to allow a licence issued under section 21 of the RIHE Act (currently referred to as 'a licence') to be distinguished from a 'mitochondrial donation licence'.

32. This item ensures that a person does not commit an offence under section 22 or section 23 of the PHCR Act if their actions are authorised by a general licence, or permitted under new section 28B of the RIHE Act. New section 28B of the RIHE Act permits a person to carry out an activity as authorised by a mitochondrial donation licence, provided the licence is in force and certain other requirements are met.

Research Involving Human Embryos Act 2002

Item Subsection 7(1)

33. This item inserts into subsection 7(1) or the RIHE Act definitions of terms used in the provisions of that Act, as introduced and amended by the Bill. Subsection 7(1) sets out definitions applicable to that Act generally.

34. In particular, the insertion of the definition of 'constitutional corporation' reflects a drafting decision to move the definition of that term from subsection 4(2) (see item 34) to subsection 7(1). This definition will be moved because the amendments introduced by the Bill will result in the term constitutional corporation being used throughout the RIHE Act and not only in section 4.

Item Section 8

35. This item inserts into section 8 of the RIHE Act definitions of terms used in the provisions of Part 2 of that Act, as introduced and amended by the Bill. Section 8 sets out definitions applicable only to Part 2 of that Act.

36. In particular, the new definition of 'mitochondrial donation technique' is key to the amendments introduced by the Bill. Regulations can be made that prescribe particular mitochondrial donation techniques, which could be the subject of a mitochondrial donation licence. This definition delimits the scope of the regulation-making power in this regard, as all prescribed techniques will need to be ones that satisfy all of the specified criteria included under this definition. This will provide some scope for 'future-proofing' of the legislation to allow for new, currently unknown techniques to be prescribed in the future, when they become sufficiently safe and efficacious for use in humans, without the need to amend the RIHE Act. However, any new techniques to be prescribed will be limited by the bounds of this definition; for example, it would not be possible to prescribe techniques that use DNA from more than three people, that intentionally modify the nuclear or mitochondrial DNA (such as through gene editing), or that use synthetic materials to create a human zygote (a fertilised egg cell that results from the fusion of a human egg cell with a human sperm cell).

37. In addition, only techniques for which the purpose is to minimise the risk of transmission of mitochondrial disease from a particular woman to her offspring could be prescribed in the regulations. This ensures that mitochondrial donation techniques can only be prescribed that are for the purpose of disease prevention; mitochondrial donation techniques that can only be used for purposes such as for a general fertility treatment could not be prescribed. The reasons for this are two-fold. Firstly, it addresses concerns relating to the newness of the science and the need to restrict its use whilst further research into any longer term implications is undertaken. Secondly, this addresses community concerns raised regarding the use of the technology and the findings of the Senate Inquiry and the NHMRC consultation activities, both of which identified that there was strong support for restricting the use of this technology to minimising the risk of severe mitochondrial disease and that it should not be used for broader purposes. This approach is also aligned to the UK model which restricts the use of clinical mitochondrial donation treatment to people who are at very high risk of passing a serious mitochondrial disease onto their children.

38. In relation to the new definition of 'mitochondrial donation technique', subparagraph (c)(i) provides that a mitochondrial donation technique does not include a technique that involves intentionally modifying nuclear DNA or mitochondrial DNA. Mitochondrial donation techniques involve steps such as removing material containing the nuclear DNA from a human egg cell or human zygote, and replacing it with the material containing nuclear DNA from another human egg cell or human zygote. This is central to many mitochondrial donation techniques, and is not intended to be considered as a 'modification' of nuclear DNA or mitochondrial DNA for the purposes of this subparagraph of this definition. Further, under such techniques, some mitochondria containing mitochondrial DNA from the prospective mother might inadvertently be carried over when the material that contains the nuclear DNA is transferred. Nor is this intended to be considered as a 'modification' of nuclear or mitochondrial DNA for the purposes of this definition.

39. This section also includes a 'signpost' definition to the term 'donor', in relation to a particular use of a mitochondrial donation technique. This definition is contained in subsection 28R(2). The 'donor' would be the woman who is referred to in subparagraph (b)(ii) of the definition of 'mitochondrial donation technique'. The intention underlying the Bill is that a donor would not legally become a parent solely because a child born of the use of their donated materials using a mitochondrial donation technique. This is not dealt with expressly under the Bill, but is dealt with in general laws dealing with parentage.

40. The terms 'patient' and 'trial participant' are central to the regulatory scheme, particularly in the case of clinical trial licences and clinical practice licences. Both of these types of licences involve placing an embryo created using a mitochondrial donation technique in the body of a woman, in order to seek to achieve pregnancy in that woman. The term 'trial participant' is used in the context of a clinical trial licence, and the term 'patient' is used in the context of a clinical practice licence. Notes under each definition indicate that, for a human embryo to be created for, or placed in the body of, a woman under a clinical trial licence or a clinical practice licence, the ERLC 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.

41. These definitions, and the RIHE Act and PHCR Act throughout, use the term 'woman', which is defined as meaning a 'female human'. It is intended that the term 'female' take on its ordinary meaning throughout the RIHE Act and the PHCR Act as amended by the Bill. The Macquarie Dictionary, online edition, indicates that the meaning of 'female' is 'belonging to the sex which brings forth young, or any division or group corresponding to it ... of or relating to the types of humans or animals which, in the normal case, produce ova which can be fertilised by male spermatozoa'. That is, for the purposes of this legislative scheme, any human that is 'female' in either of these senses is intended to be considered as a 'female human'.

Item Paragraph 10(1)(a)

42. Subsection 10(1) of the RIHE Act is an offence provision that prohibits a person intentionally using an 'excess ART embryo', unless permitted under a licence (to be termed a 'general licence') or certain exceptions apply. It is currently drafted on the basis that the creation of an excess ART embryo using a mitochondrial donation technique is prohibited by the PHCR Act. Now that creation of such embryos would be permitted subject to licence, the Bill amends section 10 of the RIHE Act consequentially.

43. This item amends subsection 10(1) to:

•

reflect the change in nomenclature from 'licence' to 'general licence' that is introduced by the Bill (see items 10 and 39)

•

acknowledge that, following other amendments made by the Bill, it is possible (in limited circumstances) for an excess ART embryo to be created using a mitochondrial donation technique, and

•

include an additional exception that is applicable to the use of such embryos.

44. Under new paragraph 10(1)(aa), a person is not prohibited from intentionally using an excess ART embryo where the excess ART embryo is created using a mitochondrial donation technique and the use of the embryo by the person is permitted under new section 28B (carrying out activities authorised by a mitochondrial donation licence). New section 28B permits a person to carry out an activity as authorised by a mitochondrial donation licence, provided the licence is in force and certain other requirements are met.

45. Importantly, under the amendments made by the Bill, the intention is that:

•

if an excess ART embryo is created under a mitochondrial donation licence, it will not be possible to obtain a general licence that authorises its use, and

•

if an excess ART embryo is not created under a mitochondrial donation licence, it will not be possible to obtain a mitochondrial donation licence that authorises its use.

Item Paragraph 10(2)(e)

46. Subsection 10(2) of the RIHE Act provides for when a use of an excess ART embryo by a person is an exempt use for the purposes of paragraph 10(1)(b). Paragraph 10(2)(e) currently provides that the use of an excess ART embryo is an exempt use where the use is carried out by an accredited ART centre and is for the purpose of achieving pregnancy in a woman other than the woman for whom the excess ART embryo was created.

47. This item amends paragraph 10(2)(e) of the RIHE Act to address the fact that other amendments made by the Bill will permit excess ART embryos to be created using a mitochondrial donation technique (in limited circumstances). The intention of this item is to make it clear that it is not an 'exempt use' of an excess ART embryo that was created using a mitochondrial donation technique for that embryo to be used for the purposes of achieving pregnancy in a woman other than the woman for whom the excess ART embryo was created.

48. Further, the intention is that the amendments made by the Bill would not permit an excess ART embryo to be used in this manner under either a general licence or a mitochondrial donation licence.

Item Paragraph 10A(c)

49. Section 10A of the RIHE Act makes it an offence if a person intentionally uses various types of embryos, and the use by the person is not authorised by a licence.

50. This item makes an amendment to reflect the change in nomenclature from 'licence' to 'general licence' that will be introduced by the Bill (see items 10 and 39), and the introduction by the Bill of provisions providing for the issuing of mitochondrial donation licences. The term 'general licence' will be introduced by the Bill to allow a licence issued under section 21 of the RIHE Act (currently referred to as 'a licence') to be distinguished from a mitochondrial donation licence.

51. This item also amends section 10A to permit the use of an embryo that is:

•

a human embryo created by a process other than the fertilisation of a human egg by a human sperm, or

•

a human embryo created by a process other than the fertilisation of a human egg by a human sperm that contains genetic material provided by more than 2 persons

so long as the use is permitted under section 28B (carrying out activities authorised by mitochondrial donation licences).

52. Mitochondrial donation licences will be able to authorise creation of both of these types of embryos, as well as certain uses of such embryos. Accordingly, section 10A of the RIHE Act needs to be amended consequentially to ensure that a person does not commit an offence under this section when doing things that they are permitted to do under section 28B.

Item Paragraph 10B(b)

53. Section 10B of the RIHE Act makes it an offence if a person undertakes 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 for the purposes of research or training in assisted reproductive technology, unless authorised by a licence. As indicated by paragraph (a) of the definition of 'human embryo' in subsection 7(1) of the RIHE Act, the first mitotic division marks the stage when an embryo is formed.

54. This item makes a similar amendment to reflect the change in nomenclature from 'licence' to 'general licence'.

55. Further, certain mitochondrial donation licences authorise a range of research and training that could, if this provision were not amended, contravene this provision. The relevant licences are pre-clinical research and training licences, clinical trial research and training licences, and clinical practice research and training licences. Accordingly, section 10B of the RIHE Act needs to be amended consequentially to ensure that a person does not commit an offence under this section when doing things that they are permitted to do under these types of mitochondrial donation licences.

Item After paragraph 11(b)

56. This item amends section 11 of the RIHE Act. Section 11 is an offence provision that prohibits a person intentionally using, outside the body of a woman, a human embryo:

•

that was created by fertilisation of a human egg by a human sperm, and

•

that is not an excess ART embryo

where the use is not for a purpose relating to the assisted reproductive technology treatment of a woman carried out by an accredited ART centre, and the person knows or is reckless as to that fact.

57. This item inserts a new paragraph 11(c). The effect of this new paragraph is that the use of a human embryo will not constitute an offence under section 11 if that use is permitted under new section 28B. New section 28B permits a person to carry out an activity as authorised by a mitochondrial donation licence, provided the licence is in force and certain other requirements are met.

58. Mitochondrial donation licences will be able to authorise uses of embryos of a kind referred to in this section. Accordingly, section 11 of the RIHE Act needs to be amended consequentially to ensure that a person does not commit an offence under this section when doing things that they are permitted to do under section 28B.

Item After section 11

59. This item inserts a new section 11A into the RIHE Act, which makes it an offence for a person to intentionally use any material (other than an excess ART embryo) created, developed or produced under a mitochondrial donation licence, where the use of the material by the person is not permitted under new section 28B because of the licence.

60. By-products of mitochondrial donation processes can include biological material such as a human egg with the maternal spindle removed, or a zygote with the pronuclei removed. An important part of the regulatory scheme established by the Bill is to ensure that by-products such as this cannot be used by others for general research, outside the context of a mitochondrial donation licence. The intention underlying this item is to ensure that this is the case.

61. The term 'material' in this provision is intended to be interpreted broadly, so as to extend to any by-product of a mitochondrial donation technique.

62. Paragraph 11A(a) excludes from the operation of the section an excess ART embryo. This is because use of excess ART embryos is already regulated by section 10 of the RIHE Act.

Item After Division 4 of Part 2

63. This item inserts a new Division 4A-Mitochondrial donation licences into the RIHE Act. This Division contains most of the provisions that regulate mitochondrial donation licences. These provisions are closely based on existing Division 4 of Part 2 of the RIHE Act, and where the provisions are similar, it is intended that they be interpreted and applied in a similar manner.

Subdivision A-Kinds of mitochondrial donation licences and what they authorise

28A Kinds of mitochondrial donation licences

64. New section 28A of the RIHE Act states that there are 5 kinds of mitochondrial donation licences, and specifies what they are, namely:

•

pre-clinical research and training licences referred to in new section 28C

•

clinical trial research and training licences referred to in new section 28D

•

clinical trial licences referred to in new section 28E

•

clinical practice research and training licences referred to in new section 28F

•

clinical practice licences referred to in new section 28G.

28B Carrying out activities authorised by mitochondrial donation licences

65. New subsection 28B(1) of the RIHE Act is a central provision to the regulation of the use of mitochondrial donation techniques. It expressly permits a person to carry out an activity as authorised by a pre-clinical research and training licence, a clinical trial research and training licence or a clinical trial licence, as mentioned in new sections 28C, 28D and 28E, if:

•

the licence is in force, and

•

the licence holder is a constitutional corporation.

66. The purpose of limiting the application of this provision to licence holders that are constitutional corporations is to ensure that the corporations power (section 51(xx) of the Constitution) provides constitutional support for provisions in the Bill relating to these types of licences. In this regard, see also paragraph 4(1)(a) of the RIHE Act, which indicates that the RIHE Act applies, inter alia, to things done or omitted to be done by constitutional corporations. For the definition of 'constitutional corporation', see subsection 7(1), as amended by item 10, above.

67. New subsection 28B(2) of the RIHE Act clarifies that subsection 28B(1) applies to permit relevant activities, even if the carrying out of these activities would otherwise be prohibited under State law. Under the RIHE Act, the term 'State' includes the Australian Capital Territory and the Northern Territory.

68. However, section 42 of the RIHE Act and section 24 of the PHCR Act will continue to operate alongside this provision. These provisions deal with the concurrent operation of State and Territory law, and provide that those Acts are not intended to exclude the operation of any law of a State or Territory, to the extent that the law of the State or Territory is capable of operating concurrently with these Acts. In the case of jurisdictional laws that regulate assisted reproductive technologies, the intention is that these continue to operate in relation to the use of mitochondrial donation techniques to the extent that those laws are capable of operating concurrently with the RIHE Act and the PHCR Act as amended (and in particular, subsections 28B(1) and (2) of the RIHE Act).

69. New subsection 28B(3) expressly permits a person to carry out an activity as authorised by a clinical practice research and training licence or a clinical practice licence as mentioned in new section 28F or new section 28G in a particular State or Territory if:

•

the licence is in force; and

•

carrying out that activity authorised by a law of that State or Territory.

70. It is intended that a State or Territory legislature would need to have enacted a law that positively authorises carrying out that activity in order for this to be authorised. Such activities will involve the use of the licenced mitochondrial donation technique.

71. The purpose of limiting the application of this provision in a State or Territory to circumstances where carrying out the activity is authorised by a law of that State or Territory is to ensure that mitochondrial donation techniques will not be introduced into clinical practice in a State or Territory until the legislature of that State or Territory decides that this is appropriate, and has enacted any other regulatory requirements that it thinks appropriate. This means that mitochondrial donation in a clinical practice setting may become available at different times in different States and Territories, depending on the wishes of particular States and Territories. This is because, in clinical practice, mitochondrial donation techniques are expected to be used as an element of assisted reproductive technology. Each State and Territory is responsible for regulation of assisted reproductive technology in its jurisdiction, and other than paving the way for the introduction of mitochondrial donation techniques in clinical practice, and licensing the use of those techniques, the Bill does not seek to alter this existing arrangement.

28C What a pre clinical research and training licence authorises

28D What a clinical trial research and training licence authorises

28E What a clinical trial licence authorises

28F What a clinical practice research and training licence authorises

28G What a clinical practice licence authorises

72. New sections 28C, 28D, 28E, 28F and 28G set out what is authorised by each of the different types of mitochondrial donation licences. The specific paragraphs of these sections specify particular activities that could be carried out under a mitochondrial donation licence in terms of the language of the specific provisions that are amended by earlier amending items of the Bill, discussed above.

73. Subsection (2) of each of these provisions specifies the particular activities that are authorised by each type of licence. The table at page 65 sets out, in summary form, the different activities that will be authorised by each of these provisions, to permit these to be more easily compared and contrasted. The statements of these activities in the table are in broad, summary language only, in order to allow for a comparison easily to be made. Reference should be made to the specific statements contained in the Bill itself for an accurate indication of what activities would be authorised.

74. A pre-clinical research and training licence will authorise a range of research and training activities using a particular mitochondrial donation technique (s 28C). These activities would not be directly related to a particular clinical trial or clinical practice. However, they would need to focus on developing particular mitochondrial donation techniques for use in a clinical setting. The focus could not be on pure research or abstract enquiry. Such a licence would not authorise using mitochondrial donation techniques for human reproduction. Authorised activities could be carried out in an accredited ART centre, but this would not be mandatory.

75. 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. The former would authorise the use of a mitochondrial donation technique for research and training in preparation for the clinical trial (s 28D). The latter would authorise the use of that technique for human reproductive purposes, in the clinical trial (s 28E). Authorised activities would need to be carried out in an accredited ART centre.

76. In order to use a mitochondrial donation technique in clinical practice, both a clinical practice research and training licence and a clinical practice licence will be needed. The former would authorise the use of a mitochondrial donation technique for research and training in preparation for clinical practice (s 28F). The latter would authorise the use of that technique for human reproductive purposes, in clinical practice (s 28G). Authorised activities would need to be carried out in an accredited ART centre.

77. No licence would authorise any use of a human embryo that would result in the development of a human embryo for a period of more than 14 days, excluding any period when development is suspended. The 14 day limit for human embryo research is aligned to existing international regulations for reproductive science. It is considered to be a natural biological turning point in the embryo's development as the 15th day marks the beginning of gastrulation when the three layers of germ cells differentiate and the primitive streak forms. In 1982, the Committee of Inquiry Into Human Fertilisation and Embryology adopted the 14 day limit on embryo research, which has since been adopted by regulators and policy makers around the world.

78. Even when activities are authorised by a mitochondrial donation licence, a person would still need to be permitted by section 28B of the RIHE Act to carry out the activity in order to not contravene relevant offence provisions of the RIHE Act or the PHCR Act.

Subdivision B-Applying for a mitochondrial donation licence

28H Applying for a mitochondrial donation licence

79. New section 28H sets out rules and requirements relevant to applying for a mitochondrial donation licence. New subsection 28H(1) permits a person, subject to new section 28H, to apply to the ERLC for a mitochondrial donation licence of a particular type, relating to a permitted technique for that type of licence, that authorises one or more of the activities that can be authorised under that type of licence. The ERLC is stablished by section 13 of the RIHE Act.

80. New subsections 28H(2) to (8) set out certain limitations and requirements that are relevant to applications for some or all types of mitochondrial donation licences.

81. New subsection 28H(2) prevents a person from applying for a pre-clinical research and training licence, a clinical trial research and training licence or a clinical trial licence unless they are a constitutional corporation. This reflects that subsection 28B(1) permits only constitutional corporations to carry out activities as authorised by these types of licence.

82. New subsection 28H(3) prevents a person from applying for a clinical trial licence relating to a particular mitochondrial donation technique unless the person has held a clinical trial research and training licence relating to that technique. The purpose of this provision is to ensure that a person applying for a clinical trial licence has had the opportunity to ensure that the relevant technique, as carried out by its embryologists and in its facilities, is sufficiently safe and efficacious to be used in a clinical trial setting, and to allow this safety and efficacy to be assessed by the ERLC in the context of the person's application for a clinical trial licence - see, for example, the matters that the ERLC would need to be satisfied of before granting a clinical trial licence under new subsection 28J(5).

83. Similarly, new subsection 28H(4) prevents a person from applying for a clinical practice licence relating to a particular mitochondrial donation technique unless the person has held a clinical practice research and training licence relating to that technique. It has an equivalent purpose in relation to clinical practice licences and clinical practice research and training licences.

84. New subsection 28H(5) requires an application for a mitochondrial donation licence relating to a particular mitochondrial donation technique to nominate one or more embryologists who would be authorised to use the technique under the licence. The purpose of this requirement is to enable the ERLC to assess each embryologist who may be authorised to use the technique under the licence. For example, for a clinical trial licence, the ERLC would be prohibited from issuing a clinical trial licence for a particular mitochondrial donation technique unless satisfied that each embryologist nominated under new subsection 28H(5) has consented in writing to being so nominated, has demonstrated relevant technical competence in the use of the technique, and understands the embryologist's obligations under the RIHE Act. If the licence holder were to seek to change the embryologist, it would need to seek a variation to its licence under new section 28U of the RIHE Act.

85. New subsections 28H(6) to (8) impose further requirements in relation to applications for mitochondrial donation licences, including in relation to the form that must be used and the fees that must accompany such applications.

86. Importantly, as a result of subsection 28H(6), if a licence holder were to seek to use more than one mitochondrial donation technique, it would need to apply for separate licences authorising the use of each technique.

Subdivision C- Determining applications for mitochondrial donation licences

28J Determination of application by Committee

87. New subsection 28J(1) of the RIHE Act requires the ERLC to decide whether or not to issue a licence, if a person applies for that licence under new subsection 28H(1). A decision under this section would be reviewable by the Administrative Appeals Tribunal (see items 89 and 95).

88. New subsections 28J(2) to (6) impose certain requirements in relation to the ERLC's decision-making process.

89. In particular, the following are noted.

90. New subsection 28J(2) prohibits the ERLC from issuing a licence unless it is satisfied that appropriate protocols are in place to enable proper consent to be obtained before a human egg or human sperm is used in carrying out the technique and to enable compliance with any restrictions on such a consent, and that the relevant activity or project has been assessed and approved by a Human Research Ethics Committee that meets relevant requirements. The purpose of subsection 28J(2) is to ensure that mitochondrial donation techniques are carried out ethically and in line with community expectations identified through the Senate Inquiry and the NHMRC community consultation processes. New subsection (3) is intended to ensure, among other things, that in issuing a mitochondrial donation licence, the licence appropriately restricts the use of excess ART embryos, other embryos, or human eggs or zygotes, to that which is reasonably required to achieve the goals of the activity or project only.

91. New subsection 28J(4) provides express authority for the ERLC to request and have regard to advice from any person with appropriate expertise when making a decision under section 28J. Section 16 of the RIHE Act deals with the membership of the ERLC. It is possible that the ERLC might not have a member with expertise in some matters that it needs to consider when deciding on a particular mitochondrial donation licence application. It is intended that the ERLC would be able to rely on this provision if it needed to fill any gaps in its knowledge or expertise in this context.

92. New subsection 28J(5) prevents the ERLC from issuing a clinical trial licence, or a clinical practice licence, for a particular mitochondrial donation technique, unless it is satisfied about particular matters. These requirements are intended to ensure that clinical trials and clinical practice are carried out safely, effectively and ethically, including that appropriate consent is obtained, and that participants and patients are fully informed. Of particular note:

•

Paragraphs 28J(5)(b) and (d) specify criteria for embryologists who would be authorised to use the mitochondrial donation technique, and for the staff other than embryologists who would carry out activities directly connected with the clinical trial or clinical practice. This is intended to include, for example, staff who would assist the embryologist in using the technique, staff who would assist in developing the resulting embryo, and staff involved in matters such as storing embryos and removing them from storage. It is not intended to cover staff with only a peripheral role, such as administrative support staff.

•

Paragraph 28J(5)(g) requires the licence applicant to have protocols in place to ensure that trial participants and patients have been fully informed about both the risks involved in, and alternatives to, using mitochondrial donation techniques. This approach is intended to allow individuals who are seeking treatment to make their own fully informed decisions and provides for reproductive choice. It is intended that individuals seeking treatment would be required to attend pre-treatment counselling and that this would include providing information in relation to the inherent risks associated with the use of assisted reproductive technology as well as specific risks of using mitochondrial donation techniques. These might include, for example, the potential for mitochondrial disease to re-emerge in future generations and the option to reduce this risk (where practicable and safe) by choosing only to implant male mitochondrial donation embryos, and considerations relating to the use (or not) of mitochondrial DNA haplogroup matched donor eggs. It is intended that alternatives canvassed would include, for example, the use of donor eggs without using a mitochondrial donation technique, adoption or fostering, or not having children. These requirements are aligned to the findings of the Senate Inquiry and the NHMRC community consultation activities, which identified the need for pre-treatment counselling to ensure that potential users of this technology understand its risks and ethical considerations, and are therefore able to provide fully informed consent. These requirements are also aligned with the UK model, which does not mandate the use of haplogroup matching or male-only embryos for mitochondrial donation treatment in clinical practice, and which specifies a requirement for pre-treatment counselling of all individuals seeking mitochondrial donation treatment under the UK HFEA Code of Practice.

93. New subsection 28J(6) permits the regulations to specify certain matters relating to the ERLC's processes for making decisions about mitochondrial donation licences. See the notes on item 105 below for a discussion about this regulation-making power.

28K Notification of decision

94. New section 28K requires the ERLC to notify its decision on an application for a licence under new section 28H and, if it decides to issue the licence, to provide the licence or a copy of it to:

•

the applicant

•

the Human Research Ethics Committee that assessed and approved the activity or project proposed in the application as mentioned in new paragraph 28J(2)(b)

•

the 'relevant State body' in relation to the State or Territory in which the use is to occur. The term 'relevant State body' is defined in section 8 of the RIHE Act to mean a person or body notified by a State to the Chairperson of the ERLC for the purposes of Part 2 of that Act.

95. These requirements mirror existing requirements of the RIHE Act.

28L Matters to be specified in a mitochondrial donation licence

96. New section 28L lists the matters that must be specified in a mitochondrial donation licence issued by the ERLC. These matters are:

•

the mitochondrial donation technique to which the licence relates;

•

the activity or activities referred to in new subsection 28C(2), 28D(2), 28E(2), 28F(2) or 28G(2) (as the case requires) that are authorised by the licence, and

•

the name of each embryologist nominated under new subsection 28H(5).

97. The listing of these matters enables each licence holder, and others to whom a copy of the licence is provided, to understand clearly the limitations of what is authorised by each licence.

28M Period of a mitochondrial donation licence

98. New section 28M deals with when a mitochondrial donation licence is in force. Under new subsection 28M(1), a mitochondrial donation licence:

•

comes into force on the day specified in the licence or, if no day is specified, on the day on which it is issued, and

•

remains in force until the day specified in the licence, unless it is suspended, revoked or surrendered before that day.

99. New subsection 28M(2) clarifies that a mitochondrial donation licence is not in force throughout any period of suspension. This is particularly relevant to the operation of new section 28B which permits a person to carry out an activity as authorised by a mitochondrial donation licence but only if the licence is in force (and other requirements are satisfied).

Subdivision D-Conditions of mitochondrial donation licences

28N Conditions of mitochondrial donation licences generally

100. New section 28N of the RIHE Act sets out the conditions to which all mitochondrial donation licences are subject.

101. Contravention of a condition of a mitochondrial donation licence could be an offence (section 12 of the RIHE Act as amended by the Bill - see amending item 47). Under new section 28V, the ERLC is able to suspend or revoke a mitochondrial donation licence if it believes on reasonable grounds that a condition of the licence has been breached.

102. New subsection 28N(1) makes it a condition of a mitochondrial donation licence that certain requirements are satisfied before a human egg or a human sperm is used under a mitochondrial donation licence. These requirements are that each 'responsible person' in relation to the human egg or human sperm has given proper consent to that use, and that the licence holder has reported in writing to the ERLC that such consent has been obtained, and any restrictions to which the consent is subject. The term 'responsible person' in relation to a human egg or a human sperm is defined in subsection 28N(7), discussed below.

103. New subsection 28N(2) provides that a mitochondrial donation licence is subject to the condition that a report to the ERLC under subsection (1) must not include identifiable information about a responsible person. In the case of a clinical trial licence and a clinical practice licence, one of the responsible persons would be the treatment recipient or the patient. An important privacy consideration under the amendments made by the Bill is that the ERLC does not need identifying information about these persons in order to carry out its functions, and so the scheme is designed to ensure that unnecessary personal information is never provided.

104. New subsection 28N(3) makes each mitochondrial donation licence subject to the condition that, if there are restrictions on a responsible person's consent, the use of a human egg or human sperm under a mitochondrial donation licence is in accordance with those restrictions.

105. New subsection 28N(4) provides that each mitochondrial donation licence is subject to such other conditions as are specified in the licence, and new subsection 28N(5) sets out some examples of the types of conditions that can be included. However, new subsection 28N(5) is not limiting, that is, it would be possible for other types of conditions to be included pursuant to new subsection 28N(4). Subsections 28N(4) and (5) are based on existing subsections 24(4) and (5), and it is intended that they operate in a similar manner. In particular, it is intended that it would continue to be possible for the ERLC to specify conditions in the form of requirements.

106. The type of condition referred to in new paragraph 28N(5)(f) refers to disposing of material produced by using the relevant mitochondrial donation technique as authorised by the licence, and does not have a parallel in existing subsection 24(5). This paragraph is intended to expressly permit conditions relating to disposal of any by-products of the use of a mitochondrial donation technique. See also new section 11A of the RIHE Act, amending item 16 above.

107. Under new subsection 28N(6), the conditions imposed by new subsections 28N(1), (2) and (3) apply to each embryologist specified in the licence who is authorised to use the mitochondrial donation technique to which the licence relates, and each other person who carries out other activities that are authorised by the licence.

108. New subsection 28N(7) clarifies that licence conditions specified in a licence pursuant to new subsection 28N(4) apply to the licence holder, each embryologist specified in the licence who is authorised to use the mitochondrial donation technique to which the licence relates and each other person who carries out other activities that are authorised by the licence.

109. Under the offence provision of section 12 of the RIHE Act, a person can commit an offence only if they contravene a condition of a licence that applies to the person. Subsections 28N(6) and (7) deal with when conditions apply to various persons, and are relevant to this offence provision.

110. New subsection 28N(8) defines two terms for the purposes of this section, 'proper consent' and 'responsible person'. In other contexts, the term 'valid consent' is often used in place of 'proper consent', and it is intended that these expressions would have similar meanings. The RIHE Act already defines the terms 'proper consent' and 'responsible person', however, the existing definitions (which now relate only to 'general licences') are repealed and re-enacted in Division 4 of Part 2 (items 41, 71 and 112).

111. Proper consent, in relation to the use of human eggs or human sperm for a mitochondrial donation technique to which a mitochondrial donation licence relates, is defined to mean consent:

•

that is obtained in accordance with guidelines issued by the CEO of the NHMRC under the NHMRC Act and prescribed by the regulations (see paragraph (a) of the definition of 'proper consent'), and

•

in relation to which such other requirements (if any) as are prescribed by the regulations are satisfied (see paragraph (b) of the definition of 'proper consent').

112. The Bill amends the RIHE Regulations to prescribe the 'ART Guidelines' for the purposes of this definition. See item 20, which, among other things, inserts new section 7J into the RIHE Regulations.

113. Subsection 33(3A) of the Acts Interpretation Act provides that, where an Act confers a power to make, grant or issue any instrument of a legislative or administrative character (including rules, regulations or by-laws) with respect to particular matters (however the matters are described), the power shall be construed as including a power to make, grant or issue such an instrument with respect to some only of those matters or with respect to a particular class or particular classes of those matters and to make different provision with respect to different matters or different classes of matters.

114. It is intended that subsection 33(3A) will operate with respect to paragraph (b) of the definition of proper consent to enable the regulations to prescribe different requirements for different kinds of licences.

28P Additional condition of clinical trial licences and clinical practice licences-Committee approval before creation or placement of embryo

115. New section 28P of the RIHE Act sets out an additional condition to which only clinical trial licences and clinical practice licences are subject. New subsection 28P(1) requires that the ERLC grant an approval in relation to a woman who is a trial participant or patient before the following can be carried out:

•

creating a human embryo for the woman using the mitochondrial donation technique to which the licence relates, or

•

placing a human embryo so created in the body of the woman for the purposes of achieving her pregnancy.

116. Due to the operation of new subsection 28P(9), this condition will apply to the licence holder and each embryologist specified in the licence who is authorised to use the mitochondrial donation technique to which the licence relates. It is expected that the ERLC will specify a condition in these types of licences requiring licence holders to give embryologists information about such approvals (noting new subparagraph 28N(5)(e)(i) of the RIHE Act).

117. New subsection 28P(2) permits the licence holder to apply to the ERLC for such an approval, and new subsection 28P(3) requires the ERLC to decide whether or not to grant an approval where an application is made.

118. New subsection 28P(4) sets out the matters in relation to which the ERLC must be satisfied before granting an approval, and new subsection 28P(5) sets out matters to which the ERLC must have regard in deciding whether to grant the approval (the ERLC will not need to be satisfied of the subsection 28P(5) matters, but will need to consider them and give them appropriate weight).

119. The particular matters provided for in subsection 28P(4) are aligned to the requirements in the UK where this technology has already been legalised for human reproductive purposes under strictly regulated conditions. In addition, only people who are at very high risk of passing a serious mitochondrial disease onto their children are eligible for this treatment in the UK. These individuals must also seek a licence from the UK HFEA and provide clinical evidence relating to the risk to the applicant's offspring of inheriting a serious mitochondrial disease as well as the anticipated impact and severity of the particular mitochondrial disease that the offspring would inherit.

120. Paragraph 28P(4)(a) refers to a particular risk of the woman's offspring inheriting mitochondria from the woman that would predispose her offspring to mitochondrial disease. In this context, the particular risk means that there is clinical diagnostic evidence that the woman's mitochondria carry specific mutations that would give rise to mitochondrial disease. In addition, paragraph (4)(b) stipulates that there is a significant risk that the mitochondrial disease that would develop would result in serious illness or other serious medical conditions. The paragraph aligns to the UK model in which only people who are at very high risk of passing a serious mitochondrial disease onto their children are eligible for treatment. It also ensures that mitochondrial donation treatment is not used for purposes other than those intended, such as to address general fertility issues, which are not supported by the Australian community, as evidenced by the findings of the Senate Inquiry and the NHMRC consultation activities. To address this criterion, the intention is that the ERLC would need to be satisfied that there was an appropriate level of clinical evidence to be able to make this determination. It is therefore intended that each individual application for approval by the ERLC would need to be accompanied by an acceptable level of clinical and diagnostic information, in a form approved by the ERLC, to enable the ERLC to make this decision.

121. In addition, paragraph (4)(c) requires evidence that other available techniques that could minimise the risk to the applicant's biological offspring of inheriting a severe form of mitochondrial disease would be inappropriate or unlikely to succeed. For example, in the UK this has been expressly linked to the option for using preimplantation genetic diagnosis (PGD) to determine the likelihood of an embryo inheriting a severe form of the disease, but which for some women is an option that would not be likely to succeed given the type and distribution of the particular mitochondria carried in their egg cells.

122. Requirements for the applicant to have attended pre-treatment counselling and provided consent to the application, included under paragraphs (4)(d) and (4)(e), are also aligned to the specific criteria required under the UK model and aim to ensure that all applicants are able to make fully informed decisions in relation to this treatment. This counselling could be provided by an appropriately qualified genetic counsellor, or by any professional who is sufficiently qualified and appropriately trained in the specific issues to provide the counselling (such as a clinician with expertise in mitochondrial disease).

123. New subsection 28P(7) ensures that the ERLC is not provided with identifying information about trial participants or patients. See paragraph 103 above.

124. New subsection 28P(8) provides that an approval comes into force when it is granted, and ceases to be in force at the earlier of:

•

when a child is born alive as a result of a pregnancy achieved in the woman by using the relevant mitochondrial donation technique, or

•

5 years after the approval is given.

125. A trial participant or patient would be able to apply for a further approval after this cessation.

126. Under new section 28V, the ERLC may suspend or revoke a mitochondrial donation licence if the Committee believes on reasonable grounds that a condition of the licence has been breached.

28Q Other conditions of clinical trial licences and clinical practice licences

127. New subsection 28Q(1) sets out further conditions to which clinical trial licences and clinical practice licences are subject, and which are (due to the operation of new subsection 28Q(2)) applicable to the licence holder and (for a condition set out in paragraph (1)(b) or (d)) each embryologist specified in the licence who is authorised to use the mitochondrial donation technique to which the licence relates.

128. The purpose underlying each condition is to ensure the safety and efficacy of the technique, and to address ethical concerns that have been raised with mitochondrial donation.

129. The condition of paragraph 28Q(1)(d) is that only male embryos are selected for implantation, if:

•

after attending pre-treatment counselling as referred to in paragraph 122 above, the trial participant or patient (as the case may be) and her spouse (if any) so request, and

•

if it is safe and practicable to do so.

130. The reason for this condition is as follows. Although both male and female embryos arising from mitochondrial donation techniques are considered to have an equal risk of developing mitochondrial disease, some experts consider that there is potentially an additional risk of mitochondrial disease re-emerging in the children of daughters born using mitochondrial donation techniques. This potential risk to future generations is only considered as being relevant to the offspring of females born through mitochondrial donation techniques as the mitochondria are inherited through the female germline. Whilst some animal studies have indicated that there may be some mitochondria carried to the embryo via sperm cells, the amount is considered to be minimal and unlikely to reach the clinical threshold required to elicit mitochondrial disease. The proposed approach aligns with the approach undertaken in the UK and the findings of the Senate Inquiry which determined that mandatory sex selection of male only embryos was not considered necessary in order to manage this risk. In addition, in Australia, sex selection of ART embryos is generally not permitted for non-medical purposes on moral and ethical grounds, but can be undertaken to reduce the risk of transmission of a serious genetic condition.

131. Under new section 28V, the ERLC may suspend or revoke a mitochondrial donation licence if the Committee believes on reasonable grounds that a condition of the licence has been breached.

Subdivision E- Ongoing requirements for holders of mitochondrial donation licences

28R Clinical trial licences and clinical practice licences-information about donors and children

132. New section 28R requires the holder of a clinical trial licence or a clinical practice licence to collect, or use their best endeavours to collect, certain information about donors for, and children born as a result use of, mitochondrial donation techniques under the licence. It also requires them to keep records of this information, and to give this information to the Secretary in the event of a live birth. Where a zygote is created using a mitochondrial donation technique, the donor would be the woman who donated an egg and whose mitochondria (but not nuclear DNA) is contained in the zygote - see new subsection 28R(2).

133. Identifiable information will need to be given to the Secretary for inclusion in the Mitochondrial Donation Donor Register - see new section 29A. In addition, non-identifiable information about the occurrence of live births will need to be given to the ERLC and the Secretary. This information would be of a statistical nature, would contextualise information that is provided about adverse events, would feed into policy decisions about the operation of the scheme, and would feed into decisions about the periodic reviews of the legislative scheme.

134. New subsection 28R(7) provides that a holder of a clinical trial licence is only subject to a requirement under this section if it is a constitutional corporation. This reflects that only constitutional corporations are able to hold clinical trial licences (new subsections 28H(3) and 28V(3) of the RIHE Act).

135. Under new subsection 28R(8), a person could commit an offence if they contravene these requirements.

136. These provisions permit regulations to be made:

•

specifying other details about donors and about children born of mitochondrial donation techniques that is to be collected, and

•

specifying the period for which collected information must be held.

137. In relation to the first bullet point, this regulation-making power mirrors similar provision that is made in State assisted reproductive technology laws that provide for donor registers. Were this power not to be included, Commonwealth laws would be out of step with similar State laws in this respect. This regulation-making power ensures that there is flexibility as to the sort of information collected for storage on the Mitochondrial Donation Donor Register for eventual provision to children born of the procedures.

138. In relation to the second bullet point, this period will be related in part to how long donated material and embryos created from donated materials can realistically be stored. Section 7K of the RIHE Regulations prescribes this period. See the discussion of amending item 20 below. It is possible that this period might need to change as new mitochondrial donation techniques are developed and finessed, or as more experience is gained into how parties make use of mitochondrial donation techniques, and it is important to have the flexibility to change this prescribed period as new information arises and circumstances change.

139. The scope of the regulation-making power is further described in the notes on item 105, below.

140. The primary purpose of section 28R is to enable the Secretary to include in the Mitochondrial Donation Donor Register relevant information about donors and children born as a result of the use of mitochondrial donation techniques. The Secretary is required to keep this register under new section 29A (see amending item 18). The primary purpose of the Register is to allow any children born using mitochondrial donation techniques to seek identifiable information about their mitochondrial donor, after turning 18.

28S Clinical trial licences and clinical practice licences-requirement for ongoing monitoring protocols and to notify adverse events

141. New section 28S requires a person who is or was the holder of a clinical trial licence or a clinical practice licence to have in place, and comply with, protocols for monitoring the pregnancies of trial participants/patients and for the notification of adverse events. Additionally, it requires a person who is or was the holder of a clinical trial licence to have in place, and comply with, protocols for monitoring the ongoing health and development of children born as a result of the use of a mitochondrial donation technique, and for seeking the ongoing engagement of such children and trial participants in relation to monitoring.

142. Further, the holder of a clinical trial licence or a clinical practice licence will be required to notify the ERLC, the Secretary and other persons prescribed by regulation if they become aware of certain types of adverse events having occurred. The term 'adverse event' is defined in new subsection 28S(8) by reference to the regulations. New section 7M of the RIHE Regulations defines adverse event to include events including a premature birth of a child and the birth of a child with a birth defect, a genetic abnormality or a diagnosis at birth of mitochondrial disease (see item 20).

143. Subsection 28S(4) of the RIHE Act permits the regulations to require a notification to be in the form approved by the CEO of the NHMRC and to contain any information required by the form. New regulation 7L of the RIHE Regulations requires the notification to be in an approved form, and to contain any information required by the form. It is anticipated that the approved form will require, in the case of a premature birth, an indication of how many weeks premature the birth was. This information will be required to identify if there are any additional risks associated with the use of mitochondrial donation techniques over and above the current known higher incidence for all IVF conceived babies of spontaneous premature birth before 37 and 34 weeks gestation. This requirement would be specified by an approved form rather than by the legislation as it is a technical matter that might be subject to change as experience is gained in relation to the use of mitochondrial donation techniques.

144. The use of mitochondrial donation techniques in assisted reproductive technology is still relatively new. It is important for there to be flexibility as to the kinds of events that must be notified as 'adverse events'. This is because the kinds of events that warrant notification is likely to change with experience in the use of the techniques and their outcomes, and as the technology is developed and is used more widely. The definition included for the purposes of new subsection 28S(8) of the RIHE Regulations is informed by similar definitions used in general assisted reproductive technology, and in mitochondrial donation in the UK. However, it is important that there be scope for this definition to change rapidly in response to learned experience from the use of the techniques in practice in Australia.

145. It is similarly important to have the flexibility to permit the regulations to require that other persons be notified of adverse events, as it might become apparent as the technology is used that, for example, other regulatory agencies have a need to be informed about this, particular in the case of clinical practice licences.

146. The scope of the regulation-making power is further described at item 105, below.

147. New subsection 28S(7) makes it an offence to breach the requirements imposed by this section.

148. The purpose of these requirements is to ensure that the ERLC, the Secretary and other relevant persons are properly informed of problems with the usage of the technology. This would inform the ERLC's decision-making, and policy development within the Department of Health, including in relation to the periodic reviews of the legislative amendments to be made by the Bill.

149. However, to protect the privacy of trial participants, patients, and children born to a trial participant or patient as a result of the use of a mitochondrial donation technique, new subsection 28S(5) ensures that adverse event notifications do not include any information that could be used to discover the identity of such persons.

150. New subsection 28S(6) operates so that a clinical trial licence holder is only subject to an obligation under this section if it is a constitutional corporation. This reflects that only constitutional corporations would be able to hold clinical trial licences (new subsections 28H(3) and 28V(3) of the RIHE Act).

28T Record keeping obligations for all holders of mitochondrial donation licences

151. New section 28T permits the regulations to prescribe record-keeping obligations that apply in relation to the use of mitochondrial donation techniques under mitochondrial donation licences, where the obligations are imposed on a person who is or was the holder of a mitochondrial donation licence. For a mitochondrial donation licence other than a clinical practice research and training licence or a clinical practice licence, the person on whom such an obligation is imposed is limited to constitutional corporations. This reflects that only constitutional corporations are able to hold these types of licences (new subsections 28H(3) and 28V(3) of the RIHE Act).

152. The regulations made under this provision are permitted to prescribe penalties, not exceeding 50 penalty units, for offences against those regulations.

153. As the use of mitochondrial donation techniques as part of assisted reproductive technology is still relatively new, it is important to have flexibility as to the types of records that need to be kept. This allows the requirements to adapt as the technology develops and becomes better understood. Some State assisted reproductive technology laws provide for some record-keeping requirements to be prescribed by regulation, and this regulation-making power follows that practice.

154. The maximum penalty that can be prescribed reflects the seriousness of what might be penalised under these provisions, and also the fact that penalties would be prescribed by delegated legislation and not by primary legislation.

Subdivision F-Variation, suspension, revocation and surrender

28U Variation of a mitochondrial donation licence

155. New section 28U of the RIHE Act provides for the variation of mitochondrial donation licences. The ERLC can vary mitochondrial donation licences (including by specifying additional conditions or varying existing conditions) by notice in writing given to the licence holder, if:

•

the Committee believes on reasonable grounds that it is necessary or desirable to do so, and

•

had a person applied under new section 28H for the licence as varied, the Committee would have been permitted by new Division 4A of Part 2 of the RIHE Act to issue the licence.

28V Suspension or revocation of a mitochondrial donation licence

156. New section 28V provides for the suspension and revocation of mitochondrial donation licences.

157. Under new subsection 28V(1), the ERLC may suspend or revoke a mitochondrial donation licence if it believes on reasonable grounds that a condition of the licence has been breached. The mechanism for doing this is by notice in writing given to the licence holder.

158. Under new subsection 28V(2), the ERLC must revoke each mitochondrial donation licence held by a person if that person is convicted of an offence under the RIHE Act, regulations made under that Act, or the PHCR Act. The mechanism for doing this is by notice in writing given to the licence holder.

159. Under new subsection 28V(3), if the holder of a pre-clinical research and training licence, a clinical trial research and training licence or a clinical trial licence stops being a constitutional corporation at a particular time, the ERLC is taken to have revoked the licence at that time. This reflects that subsection 28B(1) permits only constitutional corporations to carry out activities as authorised by these types of licence.

28W Surrender of a mitochondrial donation licence

160. New section 28W permits the holder of a mitochondrial donation licence to surrender the licence by written notice given to the ERLC. The holder of a mitochondrial donation licence may wish to surrender that licence, for example, if they no longer wish to carry out mitochondrial donation techniques.

28X Notification of variation, suspension or revocation of a mitochondrial donation licence

161. New section 28X requires the ERLC to notify certain persons and entities if it varies, suspends or revokes a mitochondrial donation licence. These persons and entities are the licence holder, each embryologist specified in the licence and the Human Research Ethics Committee and the relevant State body to which the ERLC notified its decision on the application for the licence under new section 28K.

162. If the holder of a mitochondrial donation licence surrenders that licence under new section 28W, the ERLC must notify each embryologist specified in the licence and the Human Research Ethics Committee and the relevant State body to which the ERLC notified its decision on the application for the licence under new section 28P.

Item After section 29

29A Mitochondrial Donation Donor Register

163. This item inserts a new section 29A into the RIHE Act. It requires the Secretary to keep a register, to be known as the Mitochondrial Donation Donor Register, in which the Secretary will include information given to the Secretary in accordance with new paragraph 28R(5)(b).

164. The primary purpose of the Register is to allow any children born as a result of the use of mitochondrial donation techniques to seek identifiable information about their mitochondrial donor, after turning 18. This reflects the views of the Senate Inquiry that mitochondrial donors should not be anonymous (at paragraph 4.45).

165. The Bill provides for a number of safeguards, to protect the information that is required to be collected and stored. In particular, the Register must not be made publicly available (new subsection 29A(3)).

166. New subsections 29A(4) and (5) permit certain persons to apply to the Secretary to obtain information from the Register. These persons are a person who was born as a result of the use of a mitochondrial donation technique under a mitochondrial donation licence and is 18 or over (for information in the Register about their donor), and the donor in relation to the use of a mitochondrial donation technique (for information in the Register about themselves only). If such an application were to be made, the Secretary would be required, under new subsection 29A(6), to disclose the relevant information. Other than such disclosures, and disclosure by order of a court, any disclosure of information on the Register is a criminal offence (new subsection 29A(7)).

167. A mitochondrial donor will therefore be able to find out whether a child has been born of their donated egg. However, donors will not be directly notified of this, and will not be able to find out any identifiable information about the child (unless the child contacts their donor directly).

168. Under new subsection 29A(8), the Secretary is permitted to delegate functions and powers in relation to the Register to an SES employee or acting SES employee in the Department. The expressions 'SES employee' and 'acting SES employee' are defined in section 2B of the Acts Interpretation Act, by reference to the Public Service Act. The effect of new subsection 29A(8) would be that only a very senior pool of public servants may be permitted to access and maintain the Register. In addition, any SES employee delegated the Secretary's functions and powers in relation to the Register must comply with any directions of the Secretary (new subsection 29A(9)).

169. Further protection will be provided by amendments to the FOI Act. See items 21, 22 and 23, below.

Research Involving Human Embryos Regulations 2017

Item Section 5

170. This item inserts into section 5 of the RIHE Regulations definitions of various terms used in the provisions of the RIHE Regulations, as introduced and amended by the Bill.

Item After section 7

Division 2-Provisions relating to mitochondrial donation licences

7A Definition of mitochondrial donation technique

171. New section 7A prescribes the techniques that are mitochondrial donation techniques for the purposes of the definition of 'mitochondrial donation technique' in section 8 of the RIHE Act. As required by that definition, each of the prescribed techniques are ones that:

•

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

•

involve using assisted reproductive technology to create a zygote that:

•

has nuclear DNA from the woman and a man, and

•

contains mitochondria from a different woman, and

•

do not involve:

•

intentionally modifying nuclear DNA or mitochondrial DNA

•

using any cell, or any component part of a cell, of an animal, or

•

creating a chimeric embryo (within the meaning of the PHCR Act) or a hybrid embryo.

172. The term 'mitochondrial donation' encompasses a number of different techniques each of which results in the creation of an embryo which includes the nuclear DNA from a man and a woman (the prospective mother) and the mitochondrial DNA of a different woman (the mitochondrial donor). There are several different ways in which this can be achieved as the nuclear DNA and the mitochondrial DNA are each located in different structures within cells. The nuclear DNA is contained within the nucleus and the mitochondrial DNA is contained within the mitochondria which are located in the gelatinous liquid (cytoplasm) that fills the inside of the egg cells.

173. Currently there are five known mitochondrial donation techniques which have been well researched to date and which are considered to be safe and effective mechanisms for creating a mitochondrial donation embryo. Each of these techniques focuses on a different mechanism for removing the nuclear DNA from one cell and placing it into a different cell which has had its own nuclear DNA removed. These are described in more detail below. In a clinical context, the 'prospective mother' is the woman seeking mitochondrial donation treatment (referred to in the Bill as the 'trial participant' or 'patient', depending on the context), whose mitochondria would predispose her offspring to mitochondrial disease. The mitochondrial donor is a different woman, whose mitochondrial DNA is not known to predispose her potential offspring to mitochondrial disease.

174. The five techniques prescribed are:

•

MST

•

PNT

•

GVT

•

first PBT

•

second PBT.

175. Each of the listed techniques is defined in new sections 7C to 7G of the RIHE Regulations.

7B Definition of permitted technique

176. New section 7B of the RIHE Regulations sets out certain matters for the purposes of section 8 of the RIHE Act which, as amended by the Bill, defines the term 'permitted technique'.

177. For a pre-clinical research and training licence, new item 1 of the table in new section 7B declares the following techniques to be permitted techniques:

•

MST

•

PNT

•

GVT

•

first PBT

•

second PBT.

178. This means that a person could apply for a pre-clinical research and training licence that permits them to use one of these listed techniques in accordance with the licence. All of the permitted techniques are well-known and well-researched mitochondrial donation techniques that have been shown to be safe and effective in animal trials. Two of the techniques, MST and PNT, have already been legalised for clinical use in the UK. In contrast, research into the emerging techniques, including GVT and the two types of PBT, is still at an earlier stage and requires further monitoring. Permitting these techniques under a pre-clinical research and training licence therefore allows for further Australian-based research for the purpose of building greater understanding of the techniques, and optimising these techniques for possible clinical use in humans to minimise the risk of transmission of mitochondrial disease.

179. For a clinical trial research and training licence and a clinical trial licence, table item 2 of the table in new section 7B declares the following techniques to be permitted techniques:

•

MST

•

PNT.

180. This means that a person could apply for a clinical trial research and training licence, or a clinical trial licence, that permits them to use one of these listed techniques in accordance with the licence. Currently, MST and PNT are the two most well-understood and well-researched mitochondrial donation methods. In 2014, the UK HFEA determined that both of these techniques were considered to be safe enough for clinical use in humans based on extensive research and scientific reviews undertaken in 2011, 2013 and 2014. Both techniques were subsequently legalised for clinical use in the UK in 2015 and are considered to be sufficiently safe to be permitted techniques for clinical use in Australia. A further scientific review undertaken by the HFEA in 2016 also found that the use of PNT in particular had been further optimised since 2014. These findings were further supported by the work of the NHMRC Mitochondrial Donation Expert Committee in 2019-20.

181. New section 7B does not declare any techniques to be permitted techniques for the purposes of a clinical practice research and training licence or a clinical practice licence. It is envisaged that a particular technique would not be declared as a permitted technique for either of these licences until:

•

there had been a clinical trial of the technique in humans, or substantial evidence of the use of the technique in humans from international pilots, which demonstrated that the technique was sufficiently safe and effective to be used in a clinical practice setting and had been considered extensively, and

•

there had been a consultation process, which would seek the views of scientists, ethicists and members of the public, in addition to the consultation that would be required under subsection 48(2) of the RIHE Act and section 17 of the Legislation Act.

7C Definition of maternal spindle transfer

182. New section 7C of the RIHE Regulations defines the mitochondrial donation technique that is known as MST.

183. The 'maternal spindle' is the group of maternal chromosomes (nuclear DNA) within the egg cell, which are shaped like a spindle. MST involves removing the 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 nuclear material) 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 when then goes on to develop into an embryo.

7D Definition of pronuclear transfer

184. New sections 7D of the RIHE Regulations defines the mitochondrial donation technique that is known as PNT.

185. A pronucleus is 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 nuclear genetic material of the sperm and egg fuse. When 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 nuclear DNA of the respective parent. PNT involves fertilisation of an egg cell from the prospective mother and of an egg cell from the mitochondrial donor to create two zygotes (the maternal zygote and the donor zygote). The two pronuclei are then removed from the maternal zygote and transferred to the donor zygote, which has had its own pronuclei removed but which retains its own intact mitochondria. This zygote then goes on to develop into an embryo.

7E Definition of germinal vesicle transfer

186. New section 7E of the RIHE Regulations defines the mitochondrial donation technique that is known as GVT.

187. GVT is similar to MST except that it uses an egg cell at an earlier stage of development. In GVT, the germinal vesicle (which develops into the maternal spindle) is extracted from an '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 nuclear material) 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 which goes on to develop into an embryo. This technique has been pioneered by Australian researchers but is at an earlier stage of development and requires further research and monitoring before it would be considered ready for clinical use in humans.

7F Definition of first polar body transfer

7G Definition of second polar body transfer

188. New sections 7F and 7G of the RIHE Regulations define the mitochondrial donation techniques that are known as PBT, and which are further possible mechanisms for mitochondrial donation.

189. There are two different techniques that may be used for PBT: first PBT and second PBT.

190. During the female reproductive cycle, a number of immature egg cells are selected for maturation and growth. As part of this process, each egg cell divides, resulting in the formation of a secondary egg cell that contains mostly the nuclear DNA and very little cytoplasm (the surrounding material in the cell in which the mitochondria are found). This secondary egg cell is known as the first polar body. The second polar body is formed during fertilisation when the egg divides again, to form a second polar body and a pronucleus.

191. First PBT involves the extraction of the first polar body (which sits outside the main egg cell) of the mother's unfertilised egg, and fuses it to an unfertilised donor egg that has had its maternal spindle (and therefore its own nuclear DNA) removed. This reconstituted egg is then fertilised by a sperm cell to form a zygote.

192. Second PBT involves extracting the second polar body (which again sits outside the main egg cell) from the mother's egg after fertilisation (that is, from the resulting zygote) and transferring it to the donor's newly fertilised egg (the donor zygote) which has had its own maternal pronuclei (the donor's nuclear DNA) removed. The second polar body from the prospective mother's egg is then fused into the reconstituted donor zygote.

193. There are thought to be some advantages to using PBT over MST or PNT, particularly as carryover of the mother's mitochondria into the donor's egg is significantly reduced. However, a scientific review undertaken by the UK HFEA found that PBT techniques were not sufficiently advanced enough as yet for use in clinical practice.

7H Determination by NHMRC Licensing Committee of mitochondrial donation licence applications-prescribed guidelines

194. New section 7H of the RIHE Regulations prescribes guidelines for the purposes of new paragraph 28J(3)(b) of the RIHE Act. These guidelines relate to the decision whether to issue a mitochondrial donation licence. This provision mirrors existing section 9 of the RIHE Regulations, made for the purposes of paragraph 21(4)(c) of the RIHE Act (general licences). Existing section 9 is to be repealed and re-enacted by items 111 and 114.

7J Definition of proper consent?prescribed guidelines

195. New section 7J of the RIHE Regulations prescribes guidelines for the purposes of new subsection 28R(8) of the RIHE Act. These guidelines relate to the definition of 'proper consent', as this concept applies in relation to mitochondrial donation licences. This provision mirrors existing section 7 of the RIHE Regulations, made for the purposes of the definition of 'proper consent' currently in section 8 of the RIHE Act. The definition of 'proper consent' as it relates to general licences is moved into Division 4 of Part 2 of the RIHE Act (items 41, 69 and 71).

196. In both cases, proper consent means consent that is obtained in accordance with the ART Guidelines, issued by the CEO of the NHMRC under the NHMRC Act. The 'ART Guidelines' are the Ethical guidelines on the use of assisted reproductive technology in clinical practice and research, issued by the CEO of the NHMRC under the NHMRC Act, as those guidelines exist from time to time (item 107).

7K Keeping records?prescribed period

197. New section 7K of the RIHE Regulations prescribes a period for the purposes of subsection 28R(4) of the RIHE Act. Section 28R deals with obligations to keep records about donors and persons born of a mitochondrial donation process. Subsection 28R(4) requires the records to be kept for the period prescribed by the regulations for the purposes of that subsection.

198. Section 7K of the RIHE Regulations prescribes the period of 25 years from when the record was created. This period has been selected for parity with similar record-keeping periods under related laws.

7L Notifying adverse events?form of notification

199. Section 28S of the RIHE Act as introduced by the Bill deals with monitoring requirements relating to clinical trial licences and clinical practice licences. It imposes an obligation to notify of adverse events. Subsection 28S(4) provides that the regulations may require a notification to be in the form approved by the CEO of the NHMRC and to contain any information required by the form.

200. New section 7L of the RIHE Regulations requires the notification to be in an approved form, and to contain any information required by the form. It is anticipated that the approved form requires, in the case of a premature birth, an indication of how premature the birth was. This information will be required to identify if there are any additional risks associated with the use of mitochondrial donation techniques over and above the current known higher incidence for all IVF conceived babies of spontaneous premature birth before 37 and 34 weeks gestation.

7M Definition of adverse event

201. New section 28S of the RIHE Act imposes various requirements on a person who holds, or held, a clinical trial licence or clinical practice licence, including a requirement to notify certain adverse events to the ERLC, the Secretary and any other persons prescribed by the regulations.

202. New subsection 28S(8) of the RIHE Act provides that an adverse event, for a trial participant or patient, or a child of a trial participant, has the meaning given by the regulations. New section 7M of the RIHE Regulations specifies the types of events that are adverse events for each of these categories of persons.

203. The events are:

•

for a trial participant or a patient - a failed embryo development, a miscarriage, a premature birth of a child, or the birth of a child with a birth defect, a genetic abnormality or a diagnosis at birth of mitochondrial disease, and

•

for a child of a trial participant - a diagnosis at any time of mitochondrial disease.

204. These events will provide the ERLC and the Secretary with an insight into adverse issues that are arising from the use of mitochondrial donation techniques. It is intended that the Secretary will use this information for future policy development, and as a consideration for periodic reviews of the amendments made by the Bill. It is intended that the ERLC will use these notifications to gain a better insight into the safety and effectiveness of mitochondrial donation techniques, and possibly as a trigger to use its monitoring powers.

Part 2 - Other amendments

Freedom of Information Act 1982

Item Subsection 38(2)

Item After subsection 38(3)

Item Schedule 3

205. These items support the amendment made by item 18. These items amend the FOI Act to enhance the privacy of information held on the Mitochondrial Donation Donor Register. The intention of these amendments is to ensure that information contained on the Register cannot be obtained under the FOI Act.

206. Information contained in the Register would be highly sensitive, and the reasons it is inappropriate for it to be possible to access information in the Register under the FOI Act are:

•

Information about a mitochondrial donor could reveal information about the genetic makeup or medical predispositions of a person born of the donor's donated egg. Such material is ordinarily kept strictly confidential, and should not be available under the FOI Act.

•

The Secretary would hold this information only for the purposes of providing it to donors, and to persons born of a mitochondrial donation technique at an appropriate age. The Register would not contain ordinary government information which the public generally should be able to seek access to.

•

Mitochondrial donation techniques are still relatively novel, and persons born of such techniques might be viewed as experimental or test subjects. It could be highly prejudicial to such persons were their identity ever to be released under the FOI Act in this context.

•

It is anticipated that there may be some with objections to the use of mitochondrial donation techniques in humans. There should be no avenue for persons who so object to be able to access information about donors or persons born of a mitochondrial donation technique under FOI.

•

Some believe that mitochondrial donors should be entirely anonymous, and might have concerns that the amendments are already going too far by revealing identifiable information. Ensuring that the register cannot be accessed under the FOI Act might address such concerns.

•

Some States provide for donor registers under their assisted reproductive technology laws. These registers cannot be accessed under State freedom of information laws. The Commonwealth laws would be out of step with this practice without these amendments.

207. However, unless the FOI Act is amended, there is no guarantee that information on the Register would be exempt from release under the FOI Act. The most relevant exemption would be section 47F of the FOI Act, which is a public interest conditional exemption that deals with personal privacy. A decision-maker under the FOI Act could consider that disclosure of information on the Register was not contrary to the public interest, on the ground that disclosure of the information would promote the objects of the FOI Act and inform debate on a matter of public importance (that being mitochondrial donation techniques as used for human reproductive purposes). The intention of these amendments is to ensure that a decision-maker will be precluded from reaching this view.

Prohibition of Human Cloning for Reproduction Act 2002

Item At the end of subsection 4(1)

208. This item adds a note at the end of subsection 4(1) of the PHCR Act, drawing the reader's attention to new section 28B of the RIHE Act as it relates to mitochondrial donation licences. Subsection 4(1) deals with the application of the PHCR Act, by reference to a range of legislative powers of the Commonwealth Parliament. The note draws the reader's attention to the fact that subsection 28B(1) is expressed as relying on only the Commonwealth Parliament's power to make laws with respect to foreign corporations, and trading or financial corporations formed within the limits of the Commonwealth, section 51(xx) of the Constitution.

Item Subsection 8(1) (definition of licence )

209. This item repeals the existing definition of 'licence' in subsection 8(1) of the PHCR Act. That existing definition defines licence to mean a licence issued under section 21 of the RIHE Act.

210. The Bill amends the PHCR Act to replace the term 'licence' with the term 'general licence', a definition of which is introduced into subsection 8(1) by item 1. 'General licence' has the same meaning as in Part 2 of the RIHE Act, that is, a licence issued under section 21 of that Act. (See item 10, which inserts that definition into section 8 of that Act.) The purpose of these amendments is to allow licences issued under section 21 of the RIHE Act to be distinguished from mitochondrial donation licences.

Item Division 1 of Part 2 (heading)

Item Division 2 of Part 2 (heading)

211. These items repeal the headings for existing Divisions 1 and 2 of Part 2 of the PHCR Act. These Division headings divide Part 2 of the PHCR Act into 2 divisions, one dealing with practices that are completely prohibited, the other dealing with practices that are prohibited unless authorised by a licence. The Bill amends the PHCR Act so that some practices that are currently completely prohibited will instead be prohibited unless authorised by a mitochondrial donation licence. Accordingly, the Division headings are no longer appropriate.

Item Paragraph 23A(b)

Item Subsection 23B(3)

Item Subsection 23B(3) (note)

212. These items make amendments to reflect the change in nomenclature from 'licence' to 'general licence' that is introduced by the Bill (see items 10 and 39). The term 'general licence' is introduced by the Bill to allow a licence issued under section 21 of the RIHE Act (currently referred to as 'a licence') to be distinguished from a mitochondrial donation licence. A mitochondrial donation licence is a new type of licence introduced by the Bill.

Item After section 23B

213. This item inserts a new section 23BA into the PHCR Act. It clarifies that a person is not criminally responsible for an offence against certain provisions of the PHCR Act in respect of particular conduct if that conduct was purportedly authorised by a provision of a general licence or a mitochondrial donation licence (including a purported licence), that licence or provision was invalid for some reason, and the person did not know, or could not reasonably be expected to have known, about the invalidity.

214. Existing section 12A of the RIHE Act already provides such clarification. New section 23B of the PHCR Act ensures that there is consistency between the RIHE Act and the PHCR Act with respect to this matter.

215. Section 23BA of the PHCR Act, and existing section 12A of the RIHE Act, are offence-specific defences.

216. Part 4.3.1 of the Commonwealth's Guide to Framing Commonwealth Offences, Infringement Notice and Enforcement Powers, September 2011, notes that offence-specific defences reverse the fundamental principle of criminal law that the prosecution must prove every element of the offence. It indicates that, therefore, a matter should only be included in an offence-specific defence, as opposed to being specified as an element of the offence, where:

•

it is peculiarly within the knowledge of the defendant, and

•

it would be significantly more difficult and costly for the prosecution to disprove than for the defendant to establish the matter.

217. The defence of new section 23BA of the PHCR Act and existing section 12A of the RIHE Act hinge on the licence, or the provision of the licence, the person was relying on being invalid, and the person who is seeking to rely on the defence not knowing, and not reasonably being expected to know, of the invalidity of the licence or the provision. Whether the person seeking to rely on this defence did not know of the invalidity of the licence or the provision would be a matter peculiarly within the knowledge of the person. Further, it would be significantly more difficult for the prosecution to establish whether the person knew or did not know of this.

Item Sections 25 and 25A

218. Item 32 repeals sections 25 and 25A of the PHCR Act. These provisions required the Minister to cause an independent review of the operation of that Act to be undertaken, as soon as possible after the second anniversary of the day on which that Act received the Royal Assent, and as soon as possible after the third anniversary of the day on which the Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006 received the Royal Assent. Because both of these reviews have been undertaken, sections 25 and 25A are now superfluous.

219. This item substitutes sections 25 and 25A with a new section 25. New subsection 25(1) requires the Minister to cause an independent review of the operation of the PHCR Act to be undertaken as soon as possible after the end of:

•

the period of 7 years starting on the commencement of Schedule 1 to the Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021 (noting that item 2 of the table in clause 2 of the Bill provides for the commencement of Schedule 1), and

•

each subsequent 7 year period.

220. However, the review is only required to be undertaken in relation to the operation of the PHCR Act in so far as that Act relates to the use of mitochondrial donation techniques.

221. New subsections 25(2) to (5) impose requirements in relation to who must undertake the review, and the process and timing of the review.

Research Involving Human Embryos Act 2002

Item At the end of subsection 4(1)

222. This item adds a note at the end of subsection 4(1) of the RIHE Act, drawing the reader's attention to new section 28B of the RIHE Act as it relates to mitochondrial donation licences. Subsection 4(1) deals with the application of the PHCR Act, by reference to a range of legislative powers of the Commonwealth Parliament. The note draws the reader's attention to the fact that subsection 28B(1) is expressed as relying only the Commonwealth Parliament's power to make laws with respect to foreign corporations, and trading or financial corporations formed within the limits of the Commonwealth, section 51(xx) of the Constitution.

Item Subsection 4(2) (definition of constitutional corporation )

Item At the end of subsection 4(2)

223. These items reflect a drafting decision to move the definition of 'constitutional corporation' from subsection 4(2) of the RIHE Act to subsection 7(1). This definition is moved because the amendments introduced by the Bill will result in the term 'constitutional corporation' being used throughout the RIHE Act and not only in section 4.

Item Subsection 7(1) (paragraph (a) of the definition of unsuitable for implantation )

224. This item updates the definition of 'unsuitable for implantation'.

225. This term is defined in subsection 7(1) of the RIHE Act, and is used in determining 'proper consent' under general licences (subsection 24(8) of the RIHE Act). Paragraph (a) of the current definition refers to guidelines dated 2004. This amendment instead relies on those guidelines as they exist from time to time.

226. These guidelines deal with technical matters regarding the suitability of an embryo for implantation, and it is inappropriate to require the RIHE Act to be updated to reflect updates to a technical document of this nature. See further the discussion of item 105, below.

Item Part 2 (heading)

227. This item repeals the heading of Part 2 of the RIHE Act and substitutes it with a new heading, which reflects the content of that Part as amended by the Bill.

Item Section 8

228. This item is consequential to the amendment made by item 48 - which repeals subsection 12(2) of the RIHE Act - which defines the expression 'engage in conduct'. This item inserts this definition into section 8 of the RIHE Act, as the expression 'engages in conduct' is used in other offence provisions that are inserted by the Bill into the RIHE Act (subsections 28R(8) and 28S(7)). It is intended that the expression 'engages in conduct' will have a corresponding meaning to 'engage in conduct', noting section 18A of the Acts Interpretation Act.

Item Section 8 (definition of licence )

229. This item repeals the existing definition of 'licence' in section 8 of the RIHE Act. Item 10 inserts a new definition of 'general licence', which is defined in identical terms, that is, to mean a licence issued under section 21 of the RIHE Act. The purpose of these amendments is to allow licences issued under section 21 to be distinguished from mitochondrial donation licences.

Item Section 8

230. This item inserts a definition of 'National Statement' into section 8 of the RIHE Act. The term 'National Statement' means 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, as existing from time to time. The National Statement is currently referred to in paragraph 21(3)(c) of the RIHE Act, as meaning that document as in force from time to time. The National Statement is referred to in new provisions of the RIHE Act that deal with mitochondrial donation licences, and this definition simplifies those references. The National Statement is also now referred to in the RIHE Regulations.

Section 8 (definition of proper consent )

231. This item repeals the existing definition of 'proper consent' in section 8 of the RIHE Act and inserts a new 'signpost' definition that refers the reader to new subsection 24(9), for a definition of that term as it is used in Division 4 of Part 2 (general licences), and to new subsection 28N(7), for a definition of that term as it is used in Division 4A of Part 2 (mitochondrial donation licences).

Item Section 8 (definition of responsible person )

232. This item repeals the existing definition of 'responsible person' in section 8 of the RIHE Act and inserts a new 'signpost' definition that refers the reader to new subsection 24(9), for a definition of that term as it is used in Division 4 of Part 2 (general licences), and to new subsection 28N(7), for a definition of that term as it is used in Division 4A of Part 2 (mitochondrial donation licences).

Item Section 10A (note)

233. This item amends the note to section 10A of the RIHE Act to reflect the change in nomenclature from 'licence' to 'general licence' that is introduced by the Bill (see items 16 and 30).

Item Paragraph 10B(a)

234. This item amends existing paragraph 10B(a) of the RIHE Act by substituting the term 'ART' with the term 'assisted reproductive technology'. This amendment is a minor amendment solely aimed at ensuring consistent use of terminology in the RIHE Act.

Item Section 12 (heading)

Item Subsection 12(1)

Item Subsection 12(1)

Item Subsection 12(2)

235. Section 12 of the RIHE Act provides that it can be an offence to contravene a condition of a licence. These items ensure that an offence could be committed by contravening a condition of a general licence or a mitochondrial donation licence. In relation to item 48, see the notes on item 38 above about the repeal of subsection 12(2).

Item Subsection 12A(1)

Item Paragraph 12A(1)(a)

Item Subsection 12A(2)

236. These items amend section 12A of the RIHE Act to reflect the change in nomenclature from 'licence' to 'general licence' that is introduced by the Bill (see items 16 and 30), and the introduction by the Bill of provisions providing for the issuing of mitochondrial donation licences.

237. See paragraphs 213 and following above, which discuss amending item 31 of the Bill, for the policy rationale for this offence-specific defence.

Item Paragraph 14(a)

238. This item amends paragraph 14(a) of the RIHE Act to reflect the change in nomenclature from 'licence' to 'general licence' that is introduced by the Bill (see items 16 and 30).

Item After paragraph 14(a)

239. This item amends section 14 of the RIHE Act, which sets out the functions of the ERLC. It inserts a new paragraph (aa), which provides that it is a function of the ERLC to perform functions in relation to mitochondrial donation licences under new Division 4A of Part 2.

Item Paragraph 14(b)

240. This item amends paragraph 14(b) of the RIHE Act so that it refers to the ERLC's functions under section 29 of the RIHE Act, rather than its functions under Division 5 of the RIHE Act. The intention of this amendment is to ensure that the ERLC does not inadvertently take on any functions in relation to the Mitochondrial Donation Donor Register, which is dealt with in Division 5 of Part 2 of the RIHE Act.

Item Paragraph 19(3)(e)

Item Division 4 of Part 2 (heading)

Item Section 20 (heading)

Item Subsection 20(1)

241. These items amend various provisions and headings to reflect the change in nomenclature from 'licence' to 'general licence' that is introduced by the Bill (see items 16 and 30).

Item Paragraph 20(1)(e)

242. This item amends existing paragraph 20(1)(e) of the RIHE Act by substituting the term 'ART' with the term 'assisted reproductive technology'. The purpose of this amendment is to ensure consistent use of terminology in the RIHE Act.

Item After subsection 20(1A)

243. This item inserts a new subsection into section 20 of the RIHE Act. As amended, subsection 20(1) permits a person to apply to the ERLC for a general licence, authorising certain activities. New subsection 20(1B) clarifies that subsection 20(1) does not permit the ERLC to authorise any activity that involves the use of a mitochondrial donation technique, or the use of any material created, developed or produced under a mitochondrial donation licence. The intention is that these uses will only be able to be authorised by a mitochondrial donation licence. The Bill is intended to draw a clear distinction between:

•

general licences on the one hand (which cannot authorise the use of anything created, developed or produced using a mitochondrial donation technique), and

•

mitochondrial donation licences on the other hand (which deal with authorisations to use material that is created, developed or produced using a mitochondrial donation technique).

Item Subsection 21(1)

244. This item amends subsection 21(1) of the RIHE Act to reflect the change in nomenclature from 'licence' to 'general licence' that would be introduced by the Bill (see items 16 and 30).

Item Paragraph 21(3)(c)

245. This item is consequential upon the amendment made by item 38A, above.

Item Subsection 22(1)

246. This item amends subsection 22(1) of the RIHE Act to reflect the change in nomenclature from 'licence' to 'general licence' that is introduced by the Bill (see items 16 and 30).

Item Section 23 (heading)

247. This item has the effect of amending the heading to section 23 of the RIHE Act to reflect the change in nomenclature from 'licence' to 'general licence' that is introduced by the Bill (see items 16 and 30).

Item Subsections 23(1) and (2)

248. This item amends subsections 23(1) and (2) of the RIHE Act to reflect the change in nomenclature from 'licence' to 'general licence' that is introduced by the Bill (see items 16 and 30).

Item Section 24 (heading)

249. This item has the effect of amending the heading of section 24 of the RIHE Act to reflect the change in nomenclature from 'licence' to 'general licence' that is introduced by the Bill (see items 16 and 30).

Item Subsections 24(1), (2) and (4)

250. This item amends subsections 24(1), (2) and (4) of the RIHE Act to reflect the change in nomenclature from 'licence' to 'general licence' that is introduced by the Bill (see items 16 and 30).

Item Subsection 24(6)

251. This item amends subsection 24(6) of the RIHE Act to correct an error in that provision. Subsection 24(6) currently refers to subsections (1), (2) and (3) of section 24. However, there is currently no subsection 24(3).

Item Paragraph 24(8)(a)

252. This item amends paragraph 24(8)(a) of the RIHE Act to reflect the change in nomenclature from 'licence' to 'general licence' that is introduced by the Bill (see items 16 and 30), and to reflect the inclusion of a new definition of 'proper consent', applicable to Division 4 of Part 2 (which includes paragraph 24(8)(a)), in a new subsection 24(9) (see item 71). Item 41 repeals the existing definition of 'proper consent' and inserts a new definition that will refer the reader to new subsection 24(9), for a definition of that term as it is used in Division 4 of Part 2 (general licences), and to new subsection 28N(7), for a definition of that term as it is used in Division 4A of Part 2 (mitochondrial donation licences).

Item Paragraph 24(8)(b)

253. This item amends paragraph 24(8)(b) of the RIHE Act to reflect the change in nomenclature from licence to general licence that is introduced by the Bill (see items 16 and 30).

Item At the end of section 24

254. This item inserts a new subsection 24(9) at the end of existing section 24 of the RIHE Act. It contains definitions for the terms 'proper consent' and 'responsible person', for the purpose of Division 4 of Part 2 of the RIHE Act. The definitions of 'proper consent' and 'responsible person' are identical to the existing definitions of those terms in section 8. Items 41 and 42 repeals the existing definitions of 'proper consent' and 'responsible person' and inserts new definitions that each refer the reader to new subsection 24(9), for definitions of those terms as they are used in Division 4 of Part 2 (general licences), and to new subsection 28N(7), for definitions of those terms as they are used in Division 4A of Part 2 (mitochondrial donation licences).

Item Section 25 (heading)

Item Subsections 25(1), (2) and (4)

255. These items amend section 25 of the RIHE Act and its heading to reflect the change in nomenclature from 'licence' to 'general licence' that are introduced by the Bill (see items 16 and 30).

Item Subsection 25(4)

256. This item amends subsection 25(4) of the RIHE Act so that it refers to 'this Division', rather than 'this Part'. This amendment reflects structural changes to the RIHE Act that are introduced by the Bill.

Item Section 26 (heading)

Item Subsection 26(1)

Item Subsection 26(2)

Item Section 27 (heading)

Item Section 27

Item Section 28 (heading)

Item Subsections 28(1) and (2)

257. These items amend various provisions and headings of the RIHE Act to reflect the change in nomenclature from 'licence' to 'general licence' that are introduced by the Bill (see items 16 and 30).

Item Division 5 of Part 2 (heading)

258. This item changes the heading of Division 5 of Part 2 of the RIHE Act so the heading reflects the content of that Division as amended by the Bill.

Item Subsection 29(1)

Item Paragraph 29(1)(b)

Item After paragraph 29(1)(b)

Item Paragraph 29(1)(c)

Item Paragraph 29(1)(d)

Item Paragraphs 29(1)(e) and (f)

259. Items 83 to 88 amend section 29 of the RIHE Act, which requires the ERLC to maintain a database containing particular information in relation to licences issued under section 21. The intention of these amendments is to ensure that section 29 deals with general licences and mitochondrial donation licences in a similar manner.

260. Item 83 amends subsection 29(1) to reflect the change in nomenclature from 'licence' to 'general licence' that is introduced by the Bill (see items 16 and 30), and the introduction by the Bill of provisions providing for the issuing of mitochondrial donation licences. As amended, subsection 29(1) requires the ERLC to maintain a database containing particular information in relation to both general licences and mitochondrial donation licences.

261. Item 84 amends paragraph 29(1)(b) to clarify that the information required to be included in the database under that paragraph is only required to be included in relation to a general licence (and not a mitochondrial donation licence). That information is a short statement about the nature of the uses of excess ART embryos or human eggs, and creations or uses of other embryos, that are authorised by the licence.

262. Item 85 introduces a new paragraph 29(1)(ba) which requires instead that, for a mitochondrial donation licence, the database include a short statement about the nature of the uses of excess ART embryos or human eggs, and creations or uses of other embryos or zygotes, that are authorised by the licence. Unlike paragraph (b), this paragraph refers to the creations or uses of zygotes that are authorised by the mitochondrial donation licence. This is because the definition of 'mitochondrial donation technique' in section 8 refers to the creation of a zygote with certain characteristics. A zygote is basically a fertilised egg cell which occurs following fusion of a sperm cell with an egg cell. It is an early developmental stage from which an embryo is formed. From an ethical perspective, there are many who feel that a zygote is a living organism, and entitled to the respect that all life is entitled to. For that reason, it is important that the ERLC's database also include this information about zygotes.

263. Item 86 repeals paragraph 29(1)(c), which currently requires the database to include information about the conditions to which each licence is subject. A new subparagraph (f)(i) with the same effect is introduced by item 88.

264. Item 87 amends paragraph 29(1)(d) to clarify that the information required to be included in the database under that paragraph is only required to be included in relation to a general licence (and not a mitochondrial donation licence). That information is the number of excess 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.

265. Item 88 introduces a new paragraph 29(1)(e) (in substitution for the existing paragraph (e)), requiring instead that, for a mitochondrial donation licence, the database include 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. Unlike paragraph (d), this paragraph refers to the creations or uses of zygotes that are authorised by the mitochondrial donation licence. In this regard, see paragraph 262 above.

266. Item 88 also introduces a new paragraph 29(1)(f) (in substitution for the existing paragraph (f)), which requires that the database include information, in relation to each general licence and each mitochondrial donation licence, about:

•

any conditions to which the licence is subject; and

•

the date on which the licence was issued; and

•

the period throughout which the licence is to remain in force.

267. These requirements reflect the existing requirements in paragraphs 29(1)(c), (e) and (f).

Item Section 31 (paragraph (a) of the definition of eligible person )

Item Section 31 (paragraph (b) of the definition of eligible person )

Item Section 31 (paragraph (c) of the definition of eligible person )

Item Section 31 (paragraph (d) of the definition of eligible person )

Item Section 31 (paragraph (e) of the definition of eligible person )

Item Section 31 (at the end of the definition of eligible person )

268. Items 89, 90, 91, 92, 93 and 94 amend the definition of 'eligible person' in section 31 of the RIHE Act, which defines that term for the purposes of Division 6 of Part 2. Section 32 permits an eligible person to apply to the Administrative Appeals Tribunal for review of certain specified decisions of the ERLC. Section 31 deals with what persons are eligible to seek review.

269. Items 89, 90, 91, 92 and 93 amend paragraphs 31(a), (b), (c), (d) and (e) so that they appropriately reference decisions made in relation to mitochondrial donation licences as well as decisions made in relation to existing types of licences. A similar range of decisions relating to mitochondrial donation licences are reviewable as compared to general licences.

270. Item 94 inserts a new paragraph 31(f), which sets out a new type of eligible person, namely, in relation to a decision under new subsection 28P(2) not to grant an approval under section 28P in relation to a trial participant or a patient. The eligible persons, who can seek review of the decision, are:

•

the licence holder who applied for the approval, and

•

the trial participant or patient.

Item Paragraph 32(1)(a)

Item Paragraph 32(1)(b)

Item Paragraph 32(1)(c)

Item Paragraph 32(1)(d)

Item Paragraph 32(1)(e)

Item At the end of subsection 32(1)

271. Items 95, 96, 97, 98, 99 and 100 amend section 32 of the RIHE Act. Section 32 permits an eligible person to apply to the Administrative Appeals Tribunal for review of certain specified decisions of the ERLC.

272. Items 95, 96, 97, 98 and 99 amend paragraphs 32(1)(a), (b), (c), (d) and (e) so that they appropriately reference decisions made in relation to mitochondrial donation licences as well as decisions made in relation to existing types of licences. A similar range of decisions relating to mitochondrial donation licences are reviewable as compared to general licences.

273. Item 100 inserts a new paragraph 32(1)(f), which sets out a new category of decision, namely a decision under new section 28P not to grant an approval in relation to a trial participant or a patient.

Item Paragraph 35(2)(b)

274. This item amends paragraph 35(2)(b) of the RIHE Act to include a reference to new section 28J. Currently, subsection 35(2) provides that an inspector is not authorised to enter premises under subsection 35(1) unless certain requirements are satisfied, including (under paragraph (b)) that the premises are premises at which the occupier of the premises is carrying out activities authorised by a licence issued under section 21. This requirement is adjusted to that the occupier is required to be carrying out activities authorised by a general licence issued under section 21, or a mitochondrial donation licence issued under section 28J.

Item Part 5 (heading)

275. This item changes the heading of Part 5 so the heading better reflects the content of that Part as amended by the Bill.

Item Divisions 1 and 2 of Part 5

276. This item repeals Divisions 1 and 2 of Part 5 of the RIHE Act and substitutes them with a new Division 1 entitled 'Arrangements relating to clinical trials of mitochondrial donation techniques' and a new Division 2 entitled 'Other miscellaneous matters'.

Division 1-Arrangements relating to clinical trials of mitochondrial donation techniques

277. Broadly stated, Division 1 provides legislative authority for Commonwealth expenditure on a clinical trial of a mitochondrial donation technique, together with associated research and training. The provisions are modelled on similar provisions contained in the Financial Framework (Supplementary Powers) Act 1997 and the Industry Research and Development Act 1986, and the intention is that the provisions operate in a similar manner.

46 Arrangements relating to clinical trials of mitochondrial donation techniques

278. New subsection 46(1) gives the Commonwealth legislative authority to enter into (or vary, give effect to, or otherwise administer) a contract, agreement or deed (or other arrangement) in relation to the carrying out of activities by a constitutional corporation in connection with conducting a clinical trial under a clinical trial licence, and associated activities. It also gives the Commonwealth legislative authority to spend money by paying it to such a constitutional corporation for that purpose. The limitation to constitutional corporations reflects that subsection 28B(1) of the RIHE Act permits only constitutional corporations to carry out activities as authorised by these types of licence.

279. New subsection 46(2) provides that the power conferred on the Commonwealth by new subsection 46(1) may be exercised on behalf of the Commonwealth by the Minister or the Secretary. The note draws the reader's attention to new section 46B (also inserted by item 103) which permits the Minister and Secretary to delegate this power.

280. The RIHE Act will not appropriate money for such a payment. Another Act (such as an annual appropriation Act) would need to provide the source of the appropriation.

46A Terms and conditions relating to clinical trial arrangements

281. New section 46A requires that the terms and conditions on which money may be payable by the Commonwealth under an arrangement under new section 46 must be set out in a written agreement between the Commonwealth and the corporation, and requires the corporation to comply with those terms and conditions. It provides that such an agreement may be entered into on behalf of the Commonwealth by the Minister or the Secretary. The note draws the reader's attention to new section 46B (also inserted by item 103), which permits the Minister and Secretary to delegate this power.

46B Minister or Secretary may delegate powers in relation to arrangements

282. New subsections 46B(1) and (3) permit the Minister and the Secretary to delegate any or all of their powers under new section 46 or 46A to an SES employee, or acting SES employee, in the Department who is also an official of the Department for the purposes of the PGPA Act. The expressions 'SES employee' and 'acting SES employee' are defined in section 2B of the Acts Interpretation Act, by reference to the Public Service Act. The intended effect of new section 46B is that only a very senior pool of public servants could be delegates.

283. New subsections 46(2) and (4) require that a person to whom power is delegated under new subsection 46B(1) or (3), in exercising powers under such a delegation, must comply with any directions of the Minister, if the power is delegated under subsection 46B(1), or the Secretary, if the power is delegated under subsection 46B(3).

46C Relationship of this Division with certain other Acts

284. New section 46C mirrors existing provisions of the FFSP Act and the IRD Act, and is intended to operate in the same manner.

285. New subsection 46C(1) provides that section 23 of the PGPA Act does not authorise the Secretary to exercise, on behalf of the Commonwealth, the power to be conferred on the Commonwealth by the new section 46 under this Bill.

286. New subsection 46C(2) provides that the new Division 1 of Part 5 does not by implication limit the operation of the FFSP Act. The FFSP Act provides legislative authority for a wide range of Commonwealth expenditure. By providing specific legislative authority for expenditure on a particular matter in this Division, the Bill is not intended to limit the operation of the FFSP Act in any way.

46D Executive power of the Commonwealth

287. New section 46D clarifies that Division 1 of Part 5 does not impliedly limit the executive power of the Commonwealth (section 61 of the Constitution). The Commonwealth's executive power supports a range of Commonwealth expenditure. By providing specific legislative authority for expenditure on a particular matter in this Division, the Bill is not intended to limit the Commonwealth's executive power in any way.

Division 2-Other miscellaneous matters

47 Interaction with the Gene Technology Act 2000

288. New section 47 of the RIHE Act provides that a mitochondrial donation technique is taken not to be 'gene technology' for the purposes of the Gene Technology Act when used as authorised, or purportedly authorised, by a mitochondrial donation licence. The purposes of this provision are twofold.

289. First, this would streamline the regulatory environment by ensuring that there is only a single regulator for the use of mitochondrial donation techniques in humans, and for associated research and training. Without this amendment, such use of mitochondrial donation techniques might potentially, depending on the specific details of the technique, be regulated both by the NHMRC and by the Gene Technology Regulator. However, given the comprehensive and detailed regulatory scheme introduced into the RIHE Act as amended by the Bill, additional regulation by the Gene Technology Regulator would be duplicative and would lead to an inefficient regulatory environment overall. By providing that mitochondrial donation techniques when used in this manner are not 'gene technology' for the purposes of the Gene Technology Act, the intention is that the Gene Technology Regulator would not have regulatory responsibility for dealings in organisms that have been modified by such techniques when so used, or that have inherited traits from such organisms.

290. Second, this means that a human who is born as a result of the use of a mitochondrial donation technique is not a 'genetically modified organism' for the purposes of that Act. This reflects recommendation 6 of the final report of the Third Review of the National Gene Technology Scheme, October 2018.

291. The intended effect of this amendment is that such techniques will also not be regulated under State or Territory laws that correspond to the Gene Technology Act.

47A Immunity from civil actions relating to mitochondrial donation licences

292. New subsection 47A(1) of the RIHE Act provides an immunity for the Commonwealth, and a 'protected person' covered by an item of the table in that provision, from civil actions, suits and proceedings in respect of loss, damage or injury of any kind suffered by another person as a result of the actions and omissions set out in the table.

293. This provision is proposed because it is thought to be necessary and appropriate in order to ensure efficient and effective administration of the legislative scheme as amended by the Bill. Immunity from civil liability, other than where there is bad faith, is necessary to maintain the integrity of the regulatory framework.

294. Under the RIHE Act as amended, it will be possible (under licence) to create embryos using mitochondrial donation techniques, where the embryos could be implanted into the body of a woman for the purposes of achieving pregnancy. There are known risks associated with assisted reproductive technology. Further, the use of mitochondrial donation techniques for human reproductive purposes is relatively new, and is expected to carry its own set of risks. Some of the risks, were they to crystallise, could result in the sort of events that are referred to in the definition of 'adverse event' that is included in new section 7M of the RIHE Regulations. The prescribed 'adverse events' include a failed embryo development; a miscarriage; a premature birth of a child; the birth of a child with a birth defect, a genetic abnormality, or a diagnosis of mitochondrial disease; or mitochondrial disease appearing later in life.

295. The amendments made by the Bill include a range of provisions which are intended to mitigate and manage these risks, including:

•

the need for a clinical trial research and training licence or a clinical practice research and training licence before undertaking a clinical trial or clinical practice, respectively

•

assessment of licence applications, approval of trial participants and patients, and ongoing monitoring, by the ERLC

•

the need for embryologists to have demonstrated technical competence in the use of relevant mitochondrial donation techniques in accordance with protocols for their safe and effective use

•

the need for other staff who will carry out activities directly connected with the clinical trial or clinical practice to be appropriately qualified, trained and competent

•

the requirement for there to be facilities, equipment and processes for using the relevant mitochondrial donation technique that are suitable for that purpose

•

requirements for techniques to be used in accredited ART centres

•

the need for trial participants and patients to be fully informed about the risks involved in using mitochondrial donation techniques, and the alternatives to the use of those techniques, and

•

the ability to make regulations prescribing a range of matters which refer to and rely on certain documents as in force from time to time, so as to ensure that the regulatory scheme is up-to-date and reflects current best-practice.

296. However, despite these measures, it is expected that there would remain residual risks of there being an adverse event following a pregnancy / childbirth where the embryo was created using a mitochondrial donation technique. It is expected that these residual risks would primarily be managed by clinical experts and others involved in using the procedure, and that such persons would be well-placed to do this.

297. Providing the Commonwealth and the 'protected persons' listed in new section 47A of the RIHE Act with this immunity from civil actions helps to ensure that these persons are able to undertake their roles in the administration of the scheme. Without this protection, difficulties might arise in the scheme's administration, if it were to be the case that the Commonwealth, or persons referred to in the definition of 'protected persons', were unwilling to perform their functions and exercise their powers under the legislation, fearing there to be civil liability for adverse events that might arise from the use of a mitochondrial donation technique in achieving a particular pregnancy.

298. The exception relating to acts or omissions in bad faith would balance this protection, and ensure that it applies only in appropriate circumstances.

299. Importantly, section 47A would not protect the Commonwealth, nor 'protected persons', from any criminal liability, providing further protection to others such as women seeking to achieve a pregnancy using a mitochondrial donation technique.

47B Review of operation of Act every 7 years

300. Item 103 repeals (amongst other provisions) sections 47 and 47A of the RIHE Act. These provisions required the CEO of the NHMRC to cause an independent review of the operation of that Act to be undertaken, as soon as possible after the second anniversary of the day on which that Act received the Royal Assent, and as soon as possible after the third anniversary of the day on which the Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006 received the Royal Assent. Because both of these reviews have been undertaken, sections 25 and 25A are now superfluous.

301. Item 103 inserts (amongst other provisions) a new section 47B, which requires the Minister (not the CEO of the NHMRC) to cause an independent review of the operation of the RIHE Act to be undertaken as soon as possible after the end of:

•

the period of 7 years starting on the commencement of Schedule 1 to the Mitochondrial Donation Law Reform (Maeve's Law) Act 2021 (noting that item 2 of the table in clause 2 of the Bill provides for the commencement of Schedule 1).

•

each subsequent 7 year period.

302. However, the review is only required to be undertaken in relation to the operation RIHE Act in so far as that Act relates to the use of mitochondrial donation techniques.

303. Subsection 47B(2) requires that such a review must be undertaken by the persons who undertake the review for the relevant 7 year period required by section 25 of the PHCR Act, and undertaken concurrently with that review (see item 32).

304. New subsections 47B(3) to (6) impose requirements in relation to the process and timing of the review.

Item Division 3 of Part 5 (heading)

305. This item is consequential upon the previous item, and repeals the heading of Division 3 of Part 5 of the RIHE Act.

Item At the end of section 48

306. Section 48 of the RIHE Act contains a general regulation-making power, and imposes mandatory preconditions on the making of the regulations.

307. New subsection 48(3) expressly permits regulations made for the purposes of certain provisions of the RIHE Act to make provision in relation to a matter by applying, adopting or incorporating, with or without modification, any matter contained in guidelines issued by the CEO of the NHMRC under the NHMRC Act as in force or existing from time to time. This displaces the operation of subsection 14(2) of the Legislation Act, in relation to such guidelines. Section 14(2) would otherwise prohibit such application, adoption or incorporation of most instruments or other writing as in force or existing from time to time.

308. The relevant provisions of the RIHE Act are:

•

Division 4 (general licences) of Part 2

•

Division 4A (mitochondrial donation licences) of Part 2, and

•

a definition in section 7 or section 8 of an expression that is used in either or both of those Divisions.

309. Division 4A of Part 2 of the RIHE Act deals with the processes relating to mitochondrial donation licences. Mitochondrial donation techniques are still relatively new, and their use in assisted reproductive technology in humans is even newer. While such techniques are considered sufficiently safe and efficacious to be used at least in a clinical trial setting in humans, it is not yet possible to specify with precision what risks might emerge in their use, and how their use should best be regulated. For this reason, Division 4A includes powers to make regulations that deal with certain aspects of the regulatory process. Such regulation-making powers ensure that, if any new issues or risks were to emerge with the technology, it would be possible to legislate to swiftly deal with these issues or risks without the need to go through the more time-consuming Parliamentary legislation-making processes.

310. In relation to the use of mitochondrial donation techniques in clinical practice in particular, it will not be possible to provide fully for all details of the regulatory scheme until the results of the clinical trial are known. The clinical trial is expected to provide insight into precisely how mitochondrial donation should best be regulated in clinical practice.

311. Further, it is anticipated that some of these regulations might, like existing regulations made under the RIHE Act, rely for some of their content on documents such as guidelines issued by the CEO of the NHMRC, which could be updated from time to time. To ensure that the regulations remain current and up-to-date, it is important that the Governor-General is able to make regulations that make provision in relation to matters dealt with by Division 4A of Part 2 of the RIHE Act by applying, adopting or incorporating, with or without modification, any matter contained in such guidelines as in force or existing from time to time.

312. Subsection 14(2) of the Legislation Act will continue to apply in relation to any other kind of document that might be referred to in the regulations.

313. The CEO of the NHMRC is a statutory office established by the NHMRC Act, and the CEO is appointed by the Minister. The issuing of guidelines is one of the statutory functions of the CEO of the NHMRC, and the NHMRC Act deals in detail with how the CEO issues guidelines, including in relation to matters such as consultation about guidelines. Given the expertise of the CEO of the NHMRC, and this regulatory scheme, it is considered appropriate for the RIHE Regulations to be able to refer to guidelines issued by the CEO as existing or in force from time to time.

314. The Bill treats for Division 4 of Part 2 in the same way. Many of the documents that are prescribed for the purposes of Division 4A as existing or in force from time to time are also prescribed for the purposes of Division 4. It is important that the regulations are able to refer to the same versions of such documents, to avoid unwarranted complexity and inconsistencies in the regulatory scheme.

Research Involving Human Embryos Regulations 2017

Item Section 5 (after the heading)

Item Section 5 (definition of ART Guidelines )

Item Section 5 (definition of National Statement )

Item Section 5 (definition of Objective Criteria for Unsuitable Embryos )

Item Part 2 (heading)

Item After section 6

Item Section 7

Item Before section 8

Item Section 9

Item Part 4

315. These items make a range of consequential amendments to the RIHE Regulations. Items 106, 107, 108, 109, 110, 111, 112, 113, 114 and 115 are minor amendments to the structure of the RIHE Regulations, consequent on other changes made by the Bill.

316. Items 107, 108 and 109 effectively amend the defined terms indicated so that references are to those documents as existing from time to time. See further at item 105, discussed above. In relation to item 108, the definition of 'National Statement' is being repealed on the basis that term is instead defined in the RIHE Act - see item 40. The term 'National Statement' is intended to have the same meaning in the RIHE Regulations, noting paragraph 13(1)(b) of the Legislation Act.

317. Item 115 repeals Part 4 of the RIHE Regulations. This Part sets out transitional, savings and application provisions that dealt with applications for licences that were made, but not finally determined, before the repeal of the Research Involving Human Embryos Regulations 2003, which were repealed by the current RIHE Regulations. There are now no applications for licences to which this Part applies, and so the Part is being repealed on the basis that it has no further work to do.

Therapeutic Goods (Excluded Goods) Determination 2018

Item Schedule 2 (after table item 4D)

318. The Therapeutic Goods Act imposes legal requirements in relation to the import, export, manufacture and supply of therapeutic goods in Australia. Under subsection 7AA(2) of the Therapeutic Goods Act, the Minister may, by legislative instrument, determine that specified goods (other than goods declared to be therapeutic goods under an order in force under section 7), when used, advertised, or presented for supply in a way specified in the determination, are excluded goods for the purposes of the Therapeutic Goods Act. Such goods are not therapeutic goods (pursuant to paragraph (h) of the definition of 'therapeutic goods' in subsection 3(1) of that Act). Such goods are also not 'biologicals' for the purposes of the Therapeutic Goods Act. The Minister has made the Excluded Goods Determination under section 7AA of the Therapeutic Goods Act.

319. Item 116 inserts a new item into the table in Schedule 2 to the Excluded Goods Determination, which specifies goods for the purposes of subsection 7AA(2) of the Therapeutic Goods Act. New item 4E prescribes goods that are human eggs or human sperm, when used in carrying out an activity as authorised or purportedly authorised by a mitochondrial donation licence under the RIHE Act. When used, advertised, or presented for supply in this way, goods that are human eggs or human sperm will not be therapeutic goods (or biologicals) for the purposes of the Therapeutic Goods Act, and will therefore not be regulated by that Act.

320. The reference to 'purportedly authorised' in new item 4E reflects the possibility that a licence issued under the RIHE Act might not be valid. The intention is that, if a licence holder had been working under a mitochondrial donation licence that turned out to be invalid, then so long as the licence appeared on its face to authorise what the licence holder had done, the licence holder would be able to rely on new item 4E.

321. Item 4E is intended to incorporate the RIHE Act as in force from time to time, noting sections 13 and 14 of the Legislation Act, and section 10 of the Acts Interpretation Act.

Part 3-Application and transitional provisions

Item Reports to Parliament

322. Subsection 19(3) of the RIHE Act requires the ERLC to cause reports to be tabled in Parliament at certain points in time, which include information about the operation of that Act, and the licences issued under it.

323. Subitem (1) of this item changes the operation of subsection 19(3) for a transitional period after the commencement of Schedule 1 to the Bill. It operates so that, during the period of 6 months starting on the commencement of the Schedule, the following are to be disregarded:

•

the amendments of the RIHE Act made by the Schedule,

•

any mitochondrial donation licences issued under the RIHE Act as amended by that Schedule.

324. That is, during this period, 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 ERLC's reports under subsection 19(3). However, subitem (2) of this item operates so that any information that will have been required to be included in a report under that subsection apart from subitem (1) will need to be included in the first report required to be tabled under subsection 19(3) of the RIHE Act after the end of that 6 month period.

325. This item has been included because, given that Schedule 1 to the Bill will commence upon Proclamation, it is not known on what date the amendments made by that Schedule will commence. In contrast, reports under section 19 of the RIHE Act are due on fixed dates. If the amendments made by the Bill were to commence too close to the date the next report under section 19 is due, there might not be sufficient time to prepare the report as required by section 19. Accordingly, this item is intended to ensure that there will be sufficient time to prepare reports for the purposes of section 19.

Item Determination of pre-commencement general licence applications

326. This item is a transitional provision that applies in relation to applications for licences made under subsection 20(1) of the RIHE Act (to be termed 'general licences') which are not finally determined before the commencement of Schedule 1 to the Bill.

327. The focus of the provision is essentially on documents that are taken into account when the licence application is assessed. As a result of other amendments made by the Bill, references would be to such documents as in force from time to time, instead of to such documents as in force at particular times. This transitional provision has the effect that, for the purposes of such licence applications, the relevant version of those documents is not the version as in force from time to time. Rather, the version of the document that would have been applicable but for the Bill would continue to be relevant.

Table of activities authorised by different types of mitochondrial donation licences

As referred to in paragraph 73 (page 26), which discusses amending item 17 of the Bill, the types of activities authorised by different types of mitochondrial donation licence are as follows.

REGULATION IMPACT STATEMENT

Background to mitochondrial disease and mitochondrial donation

Mitochondria are small DNA-containing structures in human cells. They produce 90 per cent of the energy that the body needs to function. Ordinarily, mitochondria are inherited almost exclusively through the maternal line (passed from a mother to her children), through the mitochondria present in the mother's egg cells.

A small proportion of an individual's genes (approximately 0.1 per cent) come from the mitochondria, and they are critical to the normal functioning of human cells. The remaining 99.9 per cent of an individual's genes come from the nuclear DNA, which informs appearance and personal characteristics.

Mitochondrial disease refers to a complex group of inherited conditions that can significantly lower an individual's health and life expectancy, and may be fatal. It is caused by changes to the mitochondrial DNA or nuclear DNA of an individual, which impact the ability of that individual's mitochondria to function properly. These diseases vary in presentation and severity, but common symptoms include developmental delays, seizures, weakness and fatigue, muscle pain, vision and hearing loss, multiple organ failure and heart problems; leading to morbidity and in severe cases, premature death.

The severity of symptoms and prognosis for the disease depends on a range of factors such as the overall impact on mitochondrial functioning, the number of mitochondria impacted and the way in which the affected mitochondria are distributed among an individual's tissues and organs.

The risk of developing serious illness due to mitochondrial disease is considered to be between one in 5,000 and one in 10,000. However, around one in 200 Australians are estimated to be predisposed to mitochondrial disease. In Australia, approximately 56 children are born each year with a severe form of the disease. The prognosis for these children is that most will die within their first five years.

Currently there is no known cure for mitochondrial diseases and treatment options are mostly limited to management of symptoms.

Mitochondrial donation

Mitochondrial donation is an assisted reproductive technology that, when combined with in-vitro fertilisation (IVF), has the potential to allow women whose mitochondria would predispose their potential children to mitochondrial disease, to have a biological child who does not inherit that predisposition. It involves a complex process to create an embryo which includes nuclear DNA from a man and the woman seeking to have a child (the prospective mother) and mitochondrial DNA from a different woman (the mitochondrial donor).

Mitochondrial donation can therefore minimise the risk of transmission of the prospective mother's mitochondria and in doing so aims to prevent future generations from inheriting these severe and debilitating diseases. Mitochondrial donation cannot however, be used to cure people with existing mitochondrial disease nor can it prevent mitochondrial disease caused by changes occurring in an individual's nuclear DNA.

The science of mitochondrial donation is complex. The term 'mitochondrial donation' collectively refers to a number of specific techniques aimed at ensuring only healthy mitochondria are passed on to an embryo.

Only two mitochondrial donation techniques, Pronuclear Transfer (PNT) and Maternal Spindle Transfer (MST), are currently considered safe enough for use in clinical practice in the United Kingdom (UK), where mitochondrial donation has been legalised.

The following figure illustrates how the DNA from 3 individuals are combined using various mitochondrial donation processes.

Figure 1: The mitochondrial donation process

Interaction with the nationally consistent scheme

Currently mitochondrial donation techniques are prohibited in Australia under the Prohibition of Human Cloning for Reproduction Act 2002 (PHCR Act) and the Research Involving Human Embryos Act 2002 (RIHE Act).

In addition, in 2004 the Commonwealth and the states and territories agreed to the Research Involving Human Embryos and Prohibition of Human Cloning for Reproductive Purposes Intergovernmental Agreement (the IGA).^[1]

The IGA creates a nationally-consistent scheme for the regulation of research involving human embryos and the prohibition of human cloning and some other practices. Under this scheme, all states and territories (other than the Northern Territory) have enacted corresponding laws that have the effect of achieving national consistency with the Commonwealth's PHCR and RIHE Acts. The IGA considers amendments to Commonwealth legislation that will not form part of the nationally consistent scheme (clauses 13 and 14).

Legalisation of mitochondrial donation under Commonwealth law would therefore require amendments to be made to both the PHCR Act and the RIHE Act. Furthermore, if mitochondrial donation was legalised for the limited purposes contemplated by the Bill, it would not be necessary for those amended provisions to form part of the nationally consistent scheme under the IGA. This would allow mitochondrial donation to be legalised in those limited circumstances through amendments made to the PHCR Act and the RIHE Act without corresponding amendments needing to be made to state or territory law.

Consistent with the existing regulatory scheme, when legalised, mitochondrial donation would be regulated by the National Health and Medical Research Council (NHMRC) Embryo Research Licensing Committee (ERLC). The ERLC has a range of prescribed functions to ensure tight control of research involving human embryos.^[2] This approach would be in line with the regulatory framework that has been implemented in the United Kingdom for mitochondrial donation.

Previous examinations of mitochondrial donation

In 2018, the Senate Community Affairs References Committee undertook an inquiry into the Science of Mitochondrial Donation and Related Matters (the Senate Inquiry).^[3] The Senate Inquiry looked at the impacts of mitochondrial disease, the science of mitochondrial donation, legal and ethical considerations and regulation. The final report arising from the Senate Inquiry recommended that some further consultation should be undertaken with the community, relevant experts and the states and territories before mitochondrial donation was introduced into Australian clinical practice.^[4] In 2019-20, the NHMRC undertook a series of community and expert consultation activities in response to the Senate Inquiry recommendations.^[5]

The consultations undertaken in Australia followed on from similar, extensive, consultations undertaken by the UK Human Fertilisation and Embryology Authority (HFEA) prior to the legalisation of mitochondrial donation in the UK. HFEA conducted four separate scientific reviews of the safety and efficacy of mitochondrial donation techniques (in 2011, 2013, 2014 and 2016), which led to an expert panel recommending PNT and MST as the two techniques for cautious adoption into clinical practice.^[6] In addition, the HFEA undertook two public consultation processes: one on the ethical issues raised by mitochondrial donation in 2011-12;^[7] and the other on the proposed draft regulations for mitochondrial donation in 2014^[8].

RIS question 1: What is the policy problem you are trying to solve?

This proposal examines options to minimise the risk of children inheriting mitochondria from their mothers that would predispose those children to severe mitochondrial disease.

In Australia, approximately 56 children are born each year with a severe form of mitochondrial disease and most will die within their first five years.^[9] Some of these instances could be prevented if mitochondrial donation was legalised in Australia for the purpose of minimising this risk.

As noted above, mitochondrial donation is currently prohibited for use in Australia under the PHCR Act and the RIHE Act, and corresponding state and territory laws. Unless the existing legislation is amended to legalise mitochondrial donation in Australia, affected women will not be able to access this technology in Australia and will be prevented from having their own biological children who are not predisposed to severe and debilitating mitochondrial disease.

The risks for children born using these techniques are not yet fully understood and the available scientific evidence to support this procedure is limited. This is due to the small number of births globally and restrictions around patient privacy which limits the sharing and publication of data. The implications for subsequent generations also remain unknown.

Public consultation on mitochondrial donation undertaken in Australia, has highlighted that some people in the community are concerned about the potential legalisation of mitochondrial donation in Australia. The NHMRC and Senate Inquiry processes identified a number of sensitivities, including a number of ethical issues and safety concerns.

For some in the community these ethical issues are highly personal and significant, preventing support of mitochondrial donation, despite its potential significant benefits.

The Australian Government is aware of these sensitivities and is seeking to introduce mitochondrial donation which finds a balance between helping couples to have biological children who are not at risk of mitochondrial disease while managing other risks and minimising potential harms.

Any proposed approach for Australia will also require prospective parents seeking access to this technology to attend pre-treatment counselling, where alternative options and the potential risks of mitochondrial donation will be fully explained. This approach will allow for parents to make their own informed decisions, and provides for reproductive choice.

International status of mitochondrial donation

In 2015, regulations were passed in the UK approving mitochondrial donation to be used for human reproductive purposes to prevent the transmission of serious mitochondrial DNA disease.^[10]

Access to mitochondrial donation is tightly regulated in the UK. Facilities wishing to provide the service and prospective parents wishing to access it must both meet strict licensing conditions. Permitted techniques include MST and PNT, which are considered to be safe enough to be used for human reproductive purposes. For prospective parents, conditions for approval are based on clinical considerations such as the specific mitochondrial DNA changes carried by the mother (linked to likelihood of passing on severe mitochondrial disease), the percentage of impacted mitochondria and evidence that this is the only option for having a biological child without passing on severe disease.

Currently, only one facility has been licenced, and the licence only allows for the use of PNT^[11]. As of November 2020, it is understood that up to 21 couples had attained a licence to receive treatment and up to 8 treatments had been approved. However, the outcomes of these treatments have not been made publicly available for reasons of privacy.

Other countries such as the United States of America (USA) and Canada do not currently allow the technique.^[12] The Japanese government recently announced that it will lift its ban on the nuclear transfer of a fertilised egg for the purposes of research (but not for reproductive purposes) into mitochondrial disease.^[13]

A small number of children are reported to have been born following the application of mitochondrial donation techniques in countries where these techniques are not currently prohibited including, for example, Mexico, Greece and the Ukraine.^[14]

RIS question 2: Why is Government action needed?

There is currently no known cure for mitochondrial disease and treatment options are mostly limited to the management of symptoms. Mitochondrial donation offers the only means of minimising the risk of a woman whose mitochondria would predispose the woman's offspring to mitochondrial disease, having a biological child who did not inherit this predisposition.

As noted above, previous reviews into mitochondrial donation have identified the need for the Australian Government to examine options to mitigate the impact of mitochondrial disease on families, including through the consideration of pathways to legalise mitochondrial donation techniques.

Given that mitochondrial donation techniques are currently prohibited in Australia under Commonwealth laws, action by the Australian Government, rather than by state or territory Governments, would be needed to make this technology legally available. It should also be noted that any Australians seeking to travel to the United Kingdom to access this treatment are significantly inhibited from doing so at present, given the risks associated with the COVID-19 pandemic. It is also understood that this is not currently being offered as an option by the only licensed clinic in the UK and that this position is unlikely to change in the near future.

RIS Question 3: What policy options you are considering?

This RIS presents 3 options.

Option 1 - Maintain the status quo

Under this option there would be no future pathway to make mitochondrial donation available in Australia.

Affected women would not be able to access mitochondrial donation techniques in Australia but may still choose to have a biological child who may be impacted by mitochondrial disease. Alternatively, they may try to access the mitochondrial donation procedure overseas, or they may pursue alternative options to have a non-biological child such as adoption.

Option 2 - Legalise mitochondrial donation as a pathway to clinical use

Two alternatives to amend the existing legislation and regulations to legalise mitochondrial donation in Australia are presented below. While both result in the possibility of mitochondrial donation being made available in select clinical settings, they are differentiated by the speed and process they follow to reach this outcome.

Option 2A

This option would introduce mitochondrial donation through a staged process, which would provide for a cautious introduction of the technology. This approach would initially legalise mitochondrial donation for use in research settings and through a clinical trial for human reproductive purposes to determine the safety, efficacy and feasibility of mitochondrial donation for reducing the risk of transmission of serious mitochondrial disease in humans (Stage 1), before permitting its application in clinical practice more broadly under Stage 2.

Transition to Stage 2 would be a decision of the Commonwealth Government, following consideration of the progress and outcomes of the trial, and other expert advice.

Under this option, the PHCR Act and the RIHE Act would be amended to legalise mitochondrial donation under Commonwealth law for the purposes of pre-clinical research and training, and for a clinical trial of a specified mitochondrial donation technique, including associated research and training. Regulation and monitoring of mitochondrial donation licences would be undertaken by the ERLC in line with current processes for monitoring research involving human embryos but expanded to include specific mitochondrial donation licences.

To enable transition to Stage 2, the PHCR Act and the RIHE Act would also be amended to legalise mitochondrial donation for clinical practice and associated research and training using permitted mitochondrial donation techniques. However, organisations will not be able to apply to the ERLC for either of the two clinical practice related licences until a particular technique is specified in the Regulations for this purpose. Permitted techniques for clinical practice will not be specified until Stage 1 has been completed and the safety and efficacy of the mitochondrial donation technique has been demonstrated.

It is also not necessary that the amended provisions form part of the nationally consistent scheme under the IGA. This is because regulation of the use of mitochondrial donation techniques in clinical practice in a particular state or territory would be an aspect of the general regulation of assisted reproductive technologies in that state or territory. States and territories generally are responsible for regulating assisted reproductive technology in their jurisdiction, and the regulation is generally not consistent across Australia. As a result, clinical practice in the use of mitochondrial donation techniques will not need to be nationally consistent, and will not need to form a part of the nationally consistent scheme under the IGA.

However, it will be open to states and territories, together with the Commonwealth, to agree to regulate clinical practice in mitochondrial donation in a nationally consistent way in the future, should they choose to do so prior to the transition to Stage 2.

Further detail on the proposed stages is provided below:

Stage 1 (research and clinical trial)

•

The ERLC of the NHMRC will regulate mitochondrial donation in Australia. To facilitate this, the role and remit of the ERLC, will be expanded to include licensing and oversight of research and training licences, and clinical trial licences required to use mitochondrial donation techniques on human embryos.

•

The ERLC will initially develop the administrative requirements and assessment procedures for those individuals and organisations applying for one of 3 licence types allowing for mitochondrial donation in Australia:

1.

Pre-clinical research and training: lab-based research only, not including research and training in preparation for a clinical trial

2.

Clinical trial research and training: research and training in preparation for a clinical trial

3.

Clinical trial: licence allowing for mitochondrial donation for reproductive purposes, in a clinical trial setting.

•

The ERLC and NHMRC will also develop processes for monitoring licence holders, which will include desktop and on-site inspections by NHMRC inspectors.

•

The Commonwealth Department of Health will run a competitive grant process to identify a suitable organisation to run a clinical trial under stage 1.

•

It is expected this trial will run for around 10 years. While there is a relatively small number of women that may be assisted through the trial, it will not be a fast process due to the potential for participants to require multiple IVF procedures before a successful pregnancy is achieved.

Transition from Stage 1 to Stage 2

As noted above, transition to clinical practice using a specified mitochondrial donation technique under Stage 2 would commence only after mitochondrial donation techniques suitable for use in clinical practice have been prescribed in the Research Involving Human Embryo Regulations 2017.

This decision will be made taking into consideration the outcomes of the clinical trial, and other expert advice.

Stage 2 (clinical practice)

At this stage, jurisdictions may choose to opt-in to the national regulatory framework, which will allow for licenced clinical practice, in participating states or territories.

As part of the regulatory scheme, two additional licences overseen by the ERLC, will be introduced in addition to the licences available in Stage 1, including:

1.

Clinical practice research and training: allows an accredited clinic to prepare for using the permitted technique in a clinical practice setting

2.

Clinical practice: would allow the use of specified mitochondrial donation techniques in a clinical practice setting.

Option 2B

This option would permit mitochondrial donation to be introduced into clinical practice for reproductive purposes, with the aim of reducing the risk of transmission of serious mitochondrial disease in humans.

In effect, this option would skip Stage 1 (above), which is focused on further research and a clinical trial, and go straight to a national model that allows for mitochondrial donation to be offered in clinical practice.

Once introduced into clinical practice, organisations (such as IVF clinics) would be able to apply for a licence to offer this procedure, which is currently prohibited, as part of their business model.

The use of specified mitochondrial donation techniques for research and training and clinical practice would be subject to the same strict licensing conditions overseen by the ERLC as outlined in Stage 2 above.

Option 3 - Support access to overseas treatment options

This option was raised in the Senate Inquiry, and would see the Australian Government providing assistance for impacted couples to access mitochondrial donation in countries such as the UK where the procedure has been legalised and is well regulated. Couples could also choose to seek their own treatment outside of Australia, however this would likely be a health and financial risk if it was not in a country where the procedure was carefully regulated.

Government support for couples to access mitochondrial donation overseas is not currently available. However, a Medical Treatment Overseas Program is administered by Government, which provides financial assistance for Australians with life-threatening medical conditions to receive proven life-saving medical treatment overseas where effective treatment is not available in Australia. Mitochondrial donation would not meet the existing mandatory medical criteria, and should this option be pursued, consideration would need to be given to the merit in expanding the criteria beyond life-threatening conditions.

RIS Question 4: What is the likely net benefit of each option?

Option 1 - Maintain the status quo

This option means that impacted couples would not be able to access mitochondrial donation techniques in Australia. They but may still choose to have a biological child who is impacted by mitochondrial disease, seek to access the procedure offshore or pursue alternative options to have a non-biological child such as adoption.

Under this option a number of children are likely to continue to be born in Australia each year with severe mitochondrial disease, and with a life expectancy of less than five years.

There is no regulatory impact, or cost, associated with maintaining the status quo. There is also no net benefit associated with this option.

Option 2 - Legalise mitochondrial donation as a pathway to clinical use

Legalising mitochondrial donation in Australia would require the establishment of an appropriate regulatory and licensing framework to ensure access to the procedure is carefully controlled, and conducted safely and ethically by licenced facilities with suitably qualified expertise. The proposed framework outlined below (and detailed at Attachment A) has been largely modelled on the approach undertaken in the UK and adapted to existing mechanisms that are aligned to the Australian system.

The proposed Australian regulatory framework and licensing requirements will have a regulatory impact on the organisations wishing to offer mitochondrial donation, the families wishing to access the technology and the ERLC, the body responsible for administering the licensing system.

Option 2A

For Option 2A, during Stage 1, organisations wishing to undertake a clinical trial using mitochondrial donation techniques for human reproductive purposes will be required to apply to the ERLC for two separate, consecutive licences: an initial clinical trial research and training licence followed by a clinical trial licence.

To receive Government funding for the trial, the organisation will also need to apply for and be successfully awarded a Commonwealth clinical trial grant. It is expected that only a small number of organisations (1 - 3) will be interested in undertaking the clinical trial. It is also intended that Commonwealth funding will be approved for one clinical trial under Stage 1. Therefore, only one organisation will be likely to apply for a clinical trial research and training licence and a clinical trial licence.

The third category of licence, a pre-clinical research and training licence, under Stage 1 is separate and will only permit research and training to be undertaken for non-reproductive purposes, without a view to conducting a particular clinical trial. It is expected that only a very small number of organisations (up to 5) may wish to apply for this type of licence.

Under Stage 2, any clinics located in states and territories that opt-in to the national regulatory framework governing the broader clinical provision of mitochondrial donation, who wish to offer mitochondrial donation, will be required to apply to the ERLC for a clinical practice research and training licence followed by a clinical practice licence.

Individuals wanting to access the procedure through the clinical trial or through Stage 2 will also need to apply and seek approval from the ERLC that they are appropriate candidates for mitochondrial donation.

Option 2A, also allows for a rigorous clinical trial of this technology in Australia under Stage 1, so that detailed knowledge about the technique is known to Australian policy developers and regulators prior to its broader introduction into clinical practice. This approach allows for the development of knowledge to ensure that the safest and most effective use of the technology can be ascertained before it is made more generally available under clinical practice. This will also ensure that the medium and some of the longer-term risks will be known and can be assessed and managed appropriately.

As detailed at Attachment B, the total regulatory costs associated with Option 2A

(Stage 1 and 2) is $188,857 annually or $1,888,568 over ten years. This cost will be incurred by businesses.

Option 2B

For Option 2B, which proceeds straight to clinical provision of mitochondrial donation, the regulatory costs associated with Stage 1 of Option 2A would not be incurred.

As with Option 2A Stage 2, organisations wishing to provide mitochondrial donation under Option 2B would need to apply for a clinical practice research and training licence and a clinical practice licence.

Given there is only a single licenced clinic in the UK, with a population of over 60 million people, it is possible that only a single clinic will be granted a licence for clinical practice in Australia. However, given the geographical size of Australia, in estimating the potential regulatory costs associated with Option 2B it has been estimated that up to three may apply.

Essentially, Option 2B bypasses Stage 1 of Option 2A and proceeds directly to Stage 2. This approach would result in the immediate implementation of a novel genetic technology into clinical practice, before its safety and effectiveness is fully understood, and the medium and long term effects are not yet known. This would be also be undertaken in circumstances where there are few overseas precedents that could inform the implementation in Australia. This may create risks as to the health of children born of the procedure which could not be mitigated due to the lack of knowledge.

As detailed at Attachment B, the total regulatory costs associated with Option 2B is $141,643 annually or $1,416,426 over ten years. As with Option 2A, this cost will be incurred by businesses.

Overall, given the extremely specialised and technical nature of the procedure and the very small number of couples per annum who would be expected to seek these services, the overarching regulatory impact associated with both Option 2A and 2B is considered minimal compared to the net benefit.

Option 3: Financial assistance for affected parents to seek assistance from UK

Under Option 3, it would be up to prospective parents to determine whether to pursue access to existing services available in the UK, and whether they wished to seek Australian Government assistance to help meet the costs associated with their decision. As such there are regulatory costs for individuals associated with applying for government support and acquitting expenses for any support received.

Option 3, extending the Medical Treatment Overseas Program to people seeking mitochondrial donation would involve direct fiscal costs for the Government. Eligible applicants would be entitled to reimbursement for the costs of overseas hospital accommodation the cost return business class international air fares; other costs including travelling expenses incurred within Australia associated with travel between the applicant's home and the airport, passport fees, travel insurance and departure tax; and non-hospital accommodation expenses.

As detailed at Attachment B, the total regulatory costs associated with Option 3 is $17,920 annually or $179,200 over ten years. This cost will be incurred by individuals.

Assessing the net social benefit

During consultation, some religious groups opposed the introduction of mitochondrial donation on the grounds that it would have a negative impact from a social and ethical perspective. These stakeholders may see a positive net social benefit from Option 1, maintaining the status quo, which could be argued would avoid unintended consequences that might arise from adopting the techniques without further analysis and consideration.

For Option 2, broader impacts to the health sector will be assessed separately prior to mitochondrial donation techniques being approved for clinical practice. Impacts will be assessed using similar criteria to that employed to inform the UK Government's decision. Particularly, a cost benefit analysis was undertaken to estimate the impacts associated with enabling mitochondrial donation treatment to take place, which included financial benefits over time. Specifically, the financial impacts that were quantified were:

•

benefits to patients who receive the treatment and their families

•

benefits to business providing this service

•

reduction of costs to the NHS (the UK Health Service) in provisioning support for the management of mitochondrial disease

•

general benefits to the UK economy due to the greater contribution to be expected from healthy people born

•

the cost of provisioning mitochondrial donation techniques, and

•

the cost of administering regulations supporting mitochondrial donations.

In the Australian context, the impacts that will need to be assessed at the clinical practice phase of this proposal (that is, in approximately 10+ years) will include:

•

cost to clinics that will provide the treatment

•

costs to individuals seeking approval to have the treatment

•

costs to ERLC and other bodies who will regulate clinics/providers of treatment^[15]

If clinical application of the research results in fewer children being born with severe mitochondrial disease there will be likely regulatory impact. Reducing the health burden on individuals could also reduce the regulatory burden on medical enterprises as potentially affected children need to interact with the health system less. This impact cannot be measured at this stage, and further analysis will be triggered by a subsequent regulatory decision point post the clinical trial.

Economic and social benefits will also result from people who would otherwise have been suffering illness contributing more actively to the economic and social activity.

As noted above, the economic analysis of the health system and administrative costs of introducing mitochondrial donation vs the predicted health savings which was undertaken in 2014, estimated a net benefit of £32 million (approximately AUD $60 million) per annum if mitochondrial donation enabled the births of just 20 children that year. This estimate did not include savings from reduced social service costs and the possibility for greater workforce participation by parents due to a reduction on caring duties.

The net social benefits associated with Option 3 reflect the same considerations. Supporting affected families to gain access to life-saving technology in the UK will result in financial and infrastructure benefits as fewer people would need to access the Australian health system for treatment of mitochondrial disease.

Potential risks or unintended consequences

Under Option 1 there would be no change to the current system. Prospective parents would have no mechanism for having a biological child with a minimised risk of inheriting mitochondrial disease.

Options 2 and 3 would both include the possibility of unintended consequences, given the newness of the science, and relatively little known including about the long-term effects.

Option 2 would build in follow-up protocols and notification of adverse events to manage risks to trial participants and/or patients and any children born, to identify and further manage the risks of any unintended consequences. Option 2A has more enhanced follow-up than option 2B, as these matters would be considered in depth as part of the Stage 1 clinical trial.

Option 3 would not clearly provide an ongoing mechanism for follow-up, as there is no clinical oversight or follow up expressly included in this option or adverse events notification to Australian regulators or policy makers. This would reduce the ability for Australian regulators and policy makers to have much insight into the safety and effectiveness of the treatments overall, as little detailed information is released about overseas treatment.

In contrast, Option 2 provides the best way of managing unintended consequences, as Australian policy makers and regulators will have insight into the technique and its safety and effectiveness. If unintended consequences were to emerge, it would then be possible to manage these. Option 2A is also better than Option 2B in this regard, as the clinical trial will give Australian policy makers and regulators a good insight into the safety and efficacy of the treatments, before they can be applied in general clinical practice.

Legislative considerations

Under Option 2, amendments would be made to the PHCR Act and the RIHE Act to allow for the following to be undertaken:

•

specific research and training using permitted mitochondrial donation techniques

•

clinical trials using permitted mitochondrial techniques, and

•

eventually clinical practice, once permitted mitochondrial donation techniques have been specified.

The legislation does not however deal with where in Australia the research and training, or the clinical trial, could be carried out. Nor does it deal with the number of persons who can obtain licences for such research and training, or to conduct a clinical trial. However, even once permitted techniques have been prescribed for use in clinical practice, clinical practice will only be possible in a particular state or territory if the state or territory has enacted laws to authorise the practice.

RIS Question 5: Who did you consult and how did you incorporate their feedback?

In 2018, the Senate Community Affairs References Committee undertook an inquiry into the Science of mitochondrial donation and related matters (the Senate Inquiry).^[16] The Senate Inquiry looked at the impacts of mitochondrial disease, the science of mitochondrial donation, legal and ethical considerations and regulation. The final report arising from the Senate Inquiry recommended that some further consultation should be undertaken with the community, relevant experts and the states and territories before mitochondrial donation was introduced into Australian clinical practice.^[17]

In 2019-20, the NHMRC undertook a series of community and expert consultation activities in response to the Senate Inquiry recommendations^[18]. Experts agreed mitochondrial donation may reduce the risk of transmission of mitochondria from the prospective mother and in doing so can prevent future generations from inheriting mitochondria that predispose them to mitochondrial disease. However, these techniques also raise a number of ethical issues that have been identified through public consultation processes undertaken both in Australia and overseas. These include the creation of so-called 'three-parent babies', and concerns regarding heritable genetic modifications, outlined as follows.

Some people are concerned that embryos subject to mitochondrial donation would result in children born through the use of this technology having 'three parents'. However, most experts agree that this is not an accurate description. Children born using this technology still only have two biological parents - a mother and a father and will inherit the majority of their characteristics and personality traits from their biological parents through their nuclear DNA. A female donor involved in a mitochondrial donation process, only provides healthy mitochondria.

This aligns with the findings of the 2018 Senate Inquiry, which concluded that mitochondrial donation techniques do not lead to children having three genetic parents. More importantly, the introduction of this technology will expand the reproductive options for some women and couples affected by severe forms of this disease. It will allow them to have their own biological children, while ensuring that those children will not suffer the devastating consequences of severe mitochondrial disease.

Some people are concerned that mitochondrial donation is a form of genetic engineering, allowing for the creation of 'designer' babies and that, in the future, the technology could be used to modify embryos to produce children with perceived improvements.

Others disagree with the idea that embryos resulting from mitochondrial donation are 'designer' babies, as the mitochondrial DNA donated through this process does not have a meaningful impact on the identity or personal characteristics of the resulting child.

There is also concern that manipulating or altering of genetic material in embryos may result in other unintended (and as yet unknown) consequences. However, legislative amendments will not permit any intentional modification of the mitochondrial DNA or the nuclear DNA.

Mitochondrial donation can involve both the creation and destruction of embryos, depending on the specific technique used. For some people, the creation and destruction of embryos inherent in mitochondrial donation makes the procedure unethical. Concerns centre on denying embryos the chance to live as well as destroying one embryo to allow for the creation of another embryo.

Questions about the moral status of the embryo are not new. Several submitters to the 2018 Senate Inquiry noted that they could see little ethical difference between mitochondrial donation techniques and other procedures that have already been legalised such as pre-implantation genetic diagnosis.

Some experts suggest mitochondrial donation should be limited, at least initially, to the implantation of only male embryos (as the mitochondria are inherited maternally). They argue that this would prevent transmission of the altered genome to future generations, especially in the short term whilst any longer term risks of the procedure are monitored.

This view was not supported in the UK, where sex selection is not considered to be necessary in the context of mitochondrial donation. In Australia, sex selection of embryos is banned unless it is to reduce the risk of transmission of a serious genetic condition. For mitochondrial donation, there may be a case in favour of sex selection. However, there are risks, including that it would reduce the efficiency of the treatment as only half the viable embryos would be usable and would also cross into the existing global controversy about sex selection by couples who prefer male children.

The proposed approach for Australia is to require prospective parents to attend pre-treatment counselling, where the potential risks of the technique would be fully explained. This approach would allow for parents to make their own informed decision, including in relation to sex selection, and provides for reproductive choice.

The wellbeing and rights of the child have also been raised as an area of concern for some members of the community. Mitochondrial donation promotes the health and wellbeing of any resulting children through the prevention of severe mitochondrial disease. However some argue that it will be impossible to protect the interests of children born through this process.

To address this, any legislation will ensure that the privacy of families and children is maintained and that ongoing monitoring will be undertaken through the mainstream health care system with no invasive testing being undertaken for routine monitoring purposes. Mandatory reporting of any adverse events will be required, however individual privacy will be paramount.

Donor rights and responsibilities have also featured in consultation processes undertaken both in Australia and overseas. One issue raised relates to the donor's parental rights to, and responsibilities for, any resulting child and whether the donor may wish to have access to (or make a claim on) any child resulting from her donation. People have also highlighted the need to ensure donors are not exploited nor the provision of eggs incentivised.

To address these issues, it is proposed that donor rights and responsibilities for Australian mitochondrial donation egg donors would be largely aligned to current ART regulations. This would include that:

•

Mitochondrial donation egg donors would not be considered legal parents in line with current ART sperm and egg donors under the Family Law Act 1975; and

•

Children conceived by mitochondrial donation would have the right to apply for identifying information about their donor when they turn 18 years old.

Submissions to the NHMRC public consultation process found that individuals and organisations representing clinicians and scientists were mostly supportive, although this was generally for a cautious introduction within an appropriate regulatory environment.^[19] Patients and advocacy groups were also generally supportive.

Organisations and individuals presenting religious views were generally not supportive. Amongst those opposed, many felt the techniques themselves crossed unacceptable ethical lines. Some felt these techniques created children with three parents or were a form of genetic modification. A number of respondents had concerns regarding the safety of the techniques and the potential for unintended consequences.

For those who supported the introduction of the technology, the benefits of reducing the impacts of mitochondrial disease were seen to outweigh the risks of introducing the technology.

Both the Senate Inquiry and the NHMRC consultation activities identified that that whilst there is support for legalising mitochondrial donation for use in Australia, there is currently not a consensus view. These processes also identified a range of technical scientific, legal and ethical considerations that need to be taken into account in the context of any proposed legislative change.

The range of community and expert views raised during the Senate Inquiry and NHMRC consultations strongly influenced the development of Option 2A, which offers a cautious and staged approach with emphasis on research and a clinical trial, ahead of broader introduction into clinical practice.

In developing Option 2A, the Department of Health consulted within Government, with relevant portfolio agencies (namely, the NHMRC, the Office of the Gene Technology Regulator and the Therapeutic Goods Administration), the Australian Government Solicitor and with the Attorney-General's Department.

The Department also convened an expert panel, with specialist members and consulted with the panel when developing details of the preferred option. The expert panel provided medical, scientific and legal advice on which techniques can and should be approved in Australia, and assisted with developing an implementation pathway and regulatory framework to safely and effectively enact these changes.

Consultation on a staged approach to legalising mitochondrial donation

The views of key stakeholders on whether to legalise mitochondrial donation are well known as a result of previous reviews and consultations. What was less clear was their views in regard to a staged approach to legalising mitochondrial donation, in particular the required amendments to legislation, the potential regulatory framework and the practical aspects associated with implementation.

To help further inform the Government's consideration of the available options, a public consultation paper outlining a staged approach to legalising mitochondrial donation as a pathway to clinical use was released on 5 February 2021 and closed on 15 March 2021.

This consultation provided the opportunity for members of the public, peak bodies, professional stakeholders, and state and territory governments, to consider the merits of a staged approach and inform the development of any legislative amendments and the potential practical implementation of such an approach.

The public consultation process included

•

A media release from Minister Hunt on the opening of the consultation period.

•

Use of the Department of Health's Consultation Hub for managing the public consultation process.

•

A dedicated web page on the Government's proposed approach on the Department of Health website which included: details of the public consultation; a Q&A section and links to the information on the NHMRC website about mitochondrial donation and the outcomes of their public consultation process and reports.

•

A dedicated email address for inquiries.

In addition to the release of a discussion paper, the Department of Health also undertook targeted consultations on an exposure draft of the legislation with:

•

relevant groups such as the Mito Foundation and religious representatives;

•

Commonwealth government agencies;

•

Mitochondrial disease experts, researchers and industry groups; and

•

state and territory governments, given the PHCR Act and the RIHE Act are part of a uniform legislative scheme, with states and the Australian Capital Territory having passed mirroring legislation.

Those stakeholders contacted directly were provided with the opportunity to meet with senior staff to discuss the proposed approach. Meetings were subsequently held with the Mito Foundation, states and territories and various religious organisations. A panel of scientific and legal experts were extensively consulted in the development of the relevant legislation.

All feedback and submissions from the consultation process were carefully considered in the development of the legislation for allowing mitochondrial donation in Australia. A Consultation Outcomes Report was published on the Department's website shortly after the consultations closed.

A significant proportion of the responses to the Department's online survey were from individuals who had a lived experience or family members with, or who have passed away from, mitochondrial disease. These respondents expressed their full support for the Government in legalising mitochondrial donation. The majority of submissions from respondents who did not have a direct experience of mitochondrial disease still held strong views in support of introducing mitochondrial donation. Some concerns were raised during the consultation process, primarily relating to the destruction of embryos, genetic germline modification, and privacy for patients. Where possible, these issues have been addressed in the legislation.

RIS Question 6: What is the best option from those you have considered?

The overarching net benefit position arising from Options 2 and 3 is that the Government has an obligation to secure and support the health of Australian citizens and ensure, to the extent possible, that babies are not born with severe medical conditions. Therefore, there is an inferred imperative for the Australian Government, if it has access to potentially lifesaving technology, to introduce and develop such clinical practices as a fundamental public good. This would not occur under Option 1, maintaining the status quo.

If Option 3, support to access the UK health system, is pursued it is possible that benefits for the Australian health system and economy could be realised more quickly than under option 2A. That said, the COVID-19 pandemic has disrupted global travel between Australia and the UK significantly, and normal flight services may not be restored for some years. Australian Government support for families to access treatment oversees would be extremely unusual, and is not likely to be supported. The only licensed clinic in the UK that can undertake this technique is also not currently accepting referrals from non-British patients and it is unclear when, if ever, this would become an option for Australian's seeking access to this technology in the UK.

There are also practical advantages for couples in having mitochondrial donation available in Australia, as opposed to having to travel and undergo treatment overseas. These include but are not limited to: financial considerations; the capacity for the parent not undergoing the procedure to continue employment; the possibility that families may have other children or relatives requiring their care in Australia; access to emotional support that would be absent overseas.

Accordingly, Option 2A, a staged approach to legalising mitochondrial donation as a pathway to clinical use, is the preferred option. It is preferred over Option 2B as it responds to community and expert opinion to proceed cautiously, with a focus on further research, safety and efficacy, while still providing for the small number of families seeking to utilise mitochondrial donation now, through the clinical trial. It will also allow for greater knowledge and understanding of the technology, including immediate, medium and longer term risks and how these may be mitigated before this technology is offered more broadly. In addition, given the small number of women expected to seek access to this technology in the first few years, restricting it to an initial clinical trial will not limit access but will assist with building an understanding of the feasibility of introducing this technology more broadly. This approach will also enable eligible women in Australia to access this treatment more quickly.

The establishment of an appropriate regulatory framework will ensure only licenced facilities are able to use these techniques. The creation of separate licences for specific activities will enable close monitoring and ensure that safety and efficacy remain primary considerations as organisations move towards clinical application of approved techniques.

Under Option 2A there is no guarantee that mitochondrial donation will be made available through clinical practice more broadly (Stage 2). Rather this will be a separate decision for Government, based on the outcomes from Stage 1, community and expert views and a detailed consideration of the associated benefits.

Should the Government decide to proceed to clinical application of mitochondrial donation, important knowledge, experience and an evidence base would be lost to Australia if Stage 1 was bypassed. The loss of approximately 10 years' worth of enabling knowledge might manifest as increased risks in the event mitochondrial donation was permitted for clinical use in the short term (that is, without a clinical trial).

Medical tourism is another associated advantage with Option 2 (whether 2A or 2B), however this is not the reason for pursuing introduction of mitochondrial donation in Australia. Investing in a period of research and training may see Australia become an expert hub in the region and a centre for medical tourism if neighbouring countries don't adopt similar techniques.

Based on available data, the medical tourism market in Australia is small and scattered. A 2011 study by Deloitte Access Economics found that in 2010, visitors for medical reasons (around 12,800 people) comprised only 0.23 per cent of total visitors in Australia - around 5.5 million people.^[20] At this stage it is impossible to predict how these numbers would increase should Australia become a hub of expertise in mitochondrial donation techniques, but it would be reasonable to expect these figures to increase, particularly if Australia becomes a desired medical destination for people from the United States and New Zealand, two potential source markets identified in the Deloitte study.

Benefits arising from medical tourism with regard to expenditure and enhanced practical knowledge and training would clearly not be realised under Options 1 and 3. Whereas there would be benefits under Option 2B, the more cautious monitoring process and skills development under Option 2A creates safeguards that would likely enhance Australia's attraction as a medical destination for overseas patients.

RIS Question 7: How will you implement and evaluate your chosen option?

The preferred option would be implemented in the following staged manner:

1. Implementation - Stage 1 (10+ years)

Under Stage 1 the Australian Government will amend the PHCR Act and the RIHE Act to legalise mitochondrial donation for certain research and training purposes, and to support selection and licensing of the first clinic for delivery of mitochondrial donation to impacted families.

The use of specified mitochondrial donation techniques under Stage 1 will be subject to strict licensing conditions, which would be overseen by the existing ERLC of the NHMRC.

Initially Stage 1 will include implementing any administrative changes to expand the current role and remit of the ERLC in line with the amendments to the RIHE Act, under which this committee is established. This will include establishing required administrative arrangements for licensing and oversight of mitochondrial donation licences, including for research and training licences, and clinical trial licences required to create human embryos using the mitochondrial donation techniques permitted for each licence as well as approval processes for individuals seeking treatment. The Commonwealth Department of Health portfolio will also undertake a competitive grants process to identify a suitable organisation to undertake the closely monitored clinical trial.

It is expected that Stage 1 will take around 10 years, based on the potential for participants to require multiple IVF procedures before a successful pregnancy is achieved.

Throughout Stage 1, ongoing monitoring and evaluation will occur.

2. Implementation - Stage 2

Clinical practice using approved mitochondrial donation techniques under Stage 2 would commence only after the RIHE Regulations have been amended to specify mitochondrial donation techniques that are suited to be used in clinical practice. This decision will be based on the clinical trial progress and outcomes and other expert advice.

State and territory governments will be able to opt-in to the national regulatory framework if they wish. Clinics within those jurisdictions will then be able to apply for a licence via the ERLC to offer mitochondrial donation as part of clinical practice.

The amendments to the PHCR Act and the RIHE Act to implement Option 2 in this manner would be reviewed periodically, every 7 years.

Models of care

There are several models of care that could be used by the organisation selected for the clinical trial to deliver mitochondrial donation to families. Equity of access, and the impact on families as they participate in the clinical trial have been considered, as has the requirements of each party (mother, father and donor) from a medical perspective.

Practically, the trial is likely to require a partnership approach which would be led by a research organisation with significant mitochondrial disease and research expertise that would be responsible for:

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administering the trial, supporting an appropriate governance structure, data collection and management, undertaking research and regular progress reporting, including reporting of adverse events;

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licence applications and ongoing compliance with licensing requirements;

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trial participant application processes including providing he clinical and research expertise and support to assist the ERLC to assess individual participant approvals (through the establishment of an independent Clinical Advisory Committee);

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managing and coordinating with the relevant partner organisations to manage ethics approvals and ensuring all research is conducted in accordance with all Australian regulatory, legal and ethical frameworks; and

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developing overarching processes and protocols for working with families, including consent protocols and pre-treatment counselling, and ensuring a consistent approach and experience for families across the clinical trial partner organisations.

Access to a specialist diagnostic lab for genetic and pathology diagnosis would also be required to support application processes for participation in the trial as well as specialist mitochondrial disease clinics responsible for referral, pre-treatment counselling, and ongoing clinical support of the families participating in the trial.

Service delivery for the IVF and mitochondrial donation techniques would need be provided through a specialist IVF provider. Ideally families will be able to access some or all of the required services in the capital city closest to them.

The Department of Health will be responsible for ongoing project management and regular review of the legislation.

Mitochondrial Donation Donor Register

The Department of Health would also establish and manage a confidential Mitochondrial Donation Donor Register (the Register). The purpose of this register is to provide children born as a result of mitochondrial donation the option to apply for identifying information about their mitochondrial donor, after they reach the age of 18 years. Mitochondrial donors would also be able to request to review their own information on the Register for the purposes of updating that information should they wish to do so. Donors would not however be able to access information about any children born or any other details on the Register.

It will be an offence to disclose information on this Register, unless it is for the purpose of disclosing to the child born as a result of a mitochondrial donation technique after they turn 18, a mitochondrial donor for the purposes of updating their own information, or by order of a court.

ATTACHMENT A

Proposed regulatory framework to support legalising mitochondrial donation as a pathway to clinical use

In the case of Option 2A, in Stage 1, organisations wishing to undertake a clinical trial using mitochondrial donation techniques for human reproductive purposes, will be required to apply to the ERLC for two separate, consecutive licences including an initial clinical trial research and training licence followed by a clinical trial licence. To receive Government funding for this trial, the organisation will also need to apply for and be successfully awarded a Commonwealth clinical trial grant.

Note the pre-clinical research and training licence is separate, and is for a limited range of lab-based research only which is not conducted for the purposes of a particular clinical trial and which can only be undertaken using mitochondrial donation techniques permitted for this purpose under the regulations.

The clinical trial research and training licence will permit research and training to be undertaken using techniques that have been approved for use in a clinical trial, currently MST and PNT, with a view to these techniques being applied in a clinical trial setting.

It will not be possible to obtain this licence for the use of other techniques that have not been specified under the regulations as approved for use in a clinical trial.

The licence will be for research and training (as specified in the legislation) with a view to:

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determining the safety and efficacy of using the licenced clinical mitochondrial donation technique in preventing the transmission of serious mitochondrial disease

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developing and refining protocols for the safe and effective use of mitochondrial donation techniques in a clinical trial setting

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training staff to perform the technique in a clinical setting, and

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establishing suitable facilities within which the technique can be safely and feasibly performed.

It is expected that only a small number of organisations (1 - 3) will be interested in undertaking the clinical trial. It is also intended that Commonwealth funding will be approved for one clinical trial under Stage 1. Therefore, only one organisation will be likely to apply for a clinical trial research and training licence.

The approved clinical trial organisation will then need to apply for a clinical trial licence before proceeding with the Commonwealth funded clinical trial. This licence will permit the conduct of a clinical trial (for human reproductive purposes) using MST and/or PNT. A clinical trial licence can only be obtained if the licence applicant has met all the conditions required as specified in the legislation.

In addition, each individual woman seeking treatment under the clinical trial, will be required to seek approval to participate, through the ERLC. The organisation undertaking the clinical trial will be responsible for obtaining the information required by the ERLC to be able to assess the eligibility of each individual to participate in the trial. This will include, but will not be limited to, a range of clinical advice, including the particular risk of the women's offspring inheriting mitochondrial disease, the severity of the disease or illness that would be inherited, whether other available techniques could be used to reduce the risk and whether the woman and her spouse (if any) had attended pre-treatment counselling.

A third category of licence will also be available under Stage 1, a pre-clinical research and training licence. This licence will permit research and training to be undertaken for the purposes of building evidence and expertise in recognised mitochondrial donation techniques to ensure the most effective technique is able to be used in the future, using permitted techniques specified under regulations. This licence will permit research and training to be undertaken for non-reproductive purposes. It is expected that only a very small number of organisations (up to 5) may wish to apply for this type of licence. Organisations wishing to apply for a 'pre-clinical research and training' licence will be required to apply to the ERLC for a licence.

Under Stage 2, any clinics in states and territories that opt-in to the national regulatory framework, who wish to offer mitochondrial donation will be required to apply to the ERLC for a 'clinical practice research and training' licence and 'clinical practice' licence. In addition, the individuals wanting to access the procedure, will need to seek ERLC approval.

ATTACHMENT B

Calculation of the costs associated with each option

Option 1: Maintain the status quo

There are no regulatory costs associated with this option.

Table 1: Regulatory Burden Estimate for Option 1

Option 2A : Research and clinical trial

Under Stage 1, the primary regulatory costs for entities wanting to build expertise in mitochondrial donation will be associated with the need to obtain (and maintain, where relevant) the required licences.

While some of the details and principles of the Australian regulatory framework and licensing requirements for mitochondrial donation will be provided for under the legislation, further detailed licensing requirements will be developed by the ERLC as their role is expanded following enactment of the proposed legislation. However, it is anticipated that it will closely follow the existing ERLC licensing requirements for the use of excess ART embryos and the UK HFEA licensing requirements. Based on the advice of the NHMRC this is estimated to take an organisation around 40 hours to complete.

Given the complexity of the application and compliance processes, it is assumed that both administrative personnel and clinical experts will need to be involved. Following advice from the Office of Best Practice Regulation (OBPR) the default labour cost of $73.05 per hour (including on-costs) has been used to calculate the 'administrative officer' component.^[21] The equivalent cost for a clinical expert, based on recent Department of Health experience, is $1000 per hour (including on-costs). The following costings have been prepared on the assumption that they will both complete 50 per cent of each licence application process.

It is assumed that entities applying for any of the licences will have suitable facilities and expertise, and that they will not need to incur additional capital or staffing costs as a direct consequence of the regulatory framework. Organisations holding any of the licence types will also incur some regulatory costs associated with maintaining the conditions of the licence which have been estimated to be equivalent to that of the initial application.

Licences will be required for any type of mitochondrial donation research and training, clinical trial or clinical practice, as detailed above. Under Stage 1 these licences would include, a:

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pre-clinical research and training licence;

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clinical trial research and training licence; and

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clinical trial licence.

Under Stage 2 (clinical practice) these licences would include, a

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clinical practice research and training licence; and

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clinical practice licence.

Regulatory costs for applying for a pre-clinical research and training licence would involve no additional regulatory cost as requirements associated with applying for this licence would be the same as for any current application to the ERLC for other embryonic research.

The regulatory cost of applying for the clinical trial research and training licence

Initially, an organisation proposing to undertake a specific clinical trial would need to apply for a clinical research and training licence to enable that organisation to develop clinical and patient protocols and to build technical expertise and proficiency in using the techniques to create viable human embryos. On the assumptions outlined above, an individual facility is likely to expend around $21,460 applying for such this licence. The expectation is that only one organisation will apply for this licence.

While the organisation would be required to expend this cost upfront in completing the licence application, it is anticipated that this expense would be reimbursed by the Commonwealth through the provision of funding under a clinical trial grant.

The organisation would also incur annual compliance costs associated with maintaining the conditions of the licence, for instance meeting the reporting requirements to ERLC. The yearly compliance cost is estimated to be equivalent to the initial licence application cost.

Annualised over ten years the total cost of the licence would be $23,607, as calculated in Table 2 below.

Table 2: Calculating the regulatory cost of the clinical trial research and training licence

The regulatory cost of applying for the clinical trial licence

A clinical trial licence would be needed by the facility approved to undertake the clinical trial. As with the clinical trial research and training licence, the expectation is that a clinical trial licence application will take around 40 hours to complete, with input shared between administrative and clinical experts.

It is expected that only one facility will receive Commonwealth funding to undertake the clinical trial and therefore only one organisation will be eligible to apply for a clinical trial licence, making the annualised regulatory cost of this licence over ten years $23,607, as calculated in Table 3 below.

Table 3: Cost of the clinical trial licence

The estimated total regulatory cost associated with Stage 1, which is the summation of the regulatory costs for applying for and complying with the two clinical trial related Stage 1 licences, is $472,142 over 10 years, or $47,214 annually.

With Stage 1 likely to last around 10-12 years, and the decision on whether to proceed to Stage 2 dependent on the outcomes of Stage 1 the estimated regulatory impacts for Stage 2 provided below will need to be reviewed prior to transition to this Stage.

The regulatory cost of applying for the clinical practice research and training licence

A clinical practice research and training licence is the initial licence required by organisations wishing to provide mitochondrial donation in a clinical setting. This licence will allow organisations to develop clinical and patient protocols and to build technical expertise and proficiency in using the techniques to create viable human embryos. It is assumed that up to three organisations may wish to apply for this licence. The application process is expected to have the same variables as above, ie take around 40 hours to complete, by administrative and clinical personnel.

The estimated regulatory cost of the clinical practice research and training licence is $70,821 annually or $708,210 over 10 years. Table 4 outlines how this cost has been calculated.

Table 4: Calculating the regulatory cost of the clinical practice research and training licence

Once proficiency in using the technology has been established and appropriate clinical and patient protocols for providing mitochondrial donation in a clinical practice setting have been developed, each organisation would then need to apply for a clinical practice licence before the technique could be offered to prospective mothers.

The regulatory cost of applying for the clinical practice licence

A clinical practice licence will be required by any organisation wishing to provide mitochondrial donation in a clinical setting. It is assumed that all three organisations holding a clinical practice research and training licence would subsequently apply for a clinical practice licence. The application process is expected to have the same variables as above, ie take around 40 hours to complete, by administrative and clinical personnel.

The estimated regulatory cost of the clinical practice licence is $70,821 annually or $708,213 over 10 years. Table 5 outlines how this cost has been calculated.

Table 5: Calculating the regulatory cost of the clinical practice licence

The estimated total regulatory cost associated with Stage 2, which is the summation of the regulatory costs for applying for and complying with the two Stage 2 licences is $1,416,426 over 10 years, or $141,643 annually.

The estimated total regulatory cost associated with Option 2A (Stage 1 + Stage 2) is $1,888,568 over ten years, or $188,857 annually.

As identified in Table 6 below it will be businesses who incur the regulatory costs associated with Option 2A.

Table 6: Regulatory Burden Estimate Table for Option 2A

Option 2B : Straight to clinical practice

In the UK, with a population of over 60 million people, there is only a single clinic licenced to undertake mitochondrial donation. It is possible that only a single clinic will be granted a licence in provide the service in Australia, however it is estimated that up to three may apply.

As outlined above for Stage 2, each organisation would need to apply for an initial clinical practice research and training licence, followed by a clinical practice licence. Both application processes are expected to have the same variables as above, ie take around 40 hours to complete, by administrative and clinical personnel.

The regulatory costs of these two licences are the same as presented in Stage 2 under Option 2A. For transparency, the calculations are presented again below in Tables 7 and 8.

Table 7: Calculating the regulatory cost of the clinical practice research and training licence

Table 8: Calculating the regulatory cost of the clinical practice licence

The estimated total regulatory cost associated with Option 2B is equivalent to Stage 2 under option 2A (that is the cost associated with the two clinical practice licences). That is $1,416,426 over ten years, or $141,643 annually.

As identified in Table 9 below it will be businesses who incur the regulatory costs associated with Option 2B.

Table 9: Regulatory Burden Estimate Table for Option 2B

Option 3 : Financial assistance for affected parents to seek assistance from UK

It would be up to prospective parents to determine whether they would want to pursue access to existing services available in the UK, and whether they wished to seek Australian Government assistance to help meet the costs associated with their decision. As such there are regulatory costs for individuals associated applying for government support.

A maximum of 56 families (the number of Australian children born annually with severe mitochondrial disease) could apply for support each per year. The actual number of applicants would almost certainly be fewer, as the technology available would only assist families where the disease is caused by the inherited mitochondria themselves. For many children born with mitochondrial disease, this stems from the nuclear DNA and mitochondrial donation techniques would not have prevented the disease.

The application and acquittal process is expected to take around 10 hours to complete, by each family.

Each application would require a specialist referral. But as each applicant family would almost certainly be receiving specialist advice already, this cost should be regarded as 'business as usual' and not considered additional to accessing the support scheme.

Figure 10: Regulatory cost of accessing Australian Government assistance for access to existing UK services

The estimated total regulatory costs associated with Option 3 is $179,200 over ten years, or $17,920 annually.

While not visible in Table 11 below due to the low level of the cost incurred under this option, it will be families that meet the associated costs of Option 3.

Table 11: Regulatory Burden Estimate Table for Option 3