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