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:

•

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

•

the Research Involving Human Embryos Act 2002 (RIHE Act)

•

the Research Involving Human Embryos Regulations 2017 (RIHE Regulations)

•

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

•

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:

•

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).

•

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).

•

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.

•

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

•

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:

•

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.

•

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.

•

Mandatory reporting of any adverse events.

•

Mitochondrial donation egg donors would not be considered legal parents.

•

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

•

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:

•

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.

•

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.

•

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:

•

a pre-clinical research and training licence

•

a clinical trial research and training licence

•

a clinical trial licence

•

a clinical practice research and training licence, and

•

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:

•

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

•

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

•

the establishment and maintenance of new data systems.

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

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

Regulation impact statement

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