Maeve’s Law for Mitochondrial Donation Passes Parliament

This article applies to organisations that undertake clinical research.

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

Please be advised that the Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 (Cth) (the Bill) passed parliament on 30 March 2022 and received Royal Assent on 1 April 2022.  Schedule 1 of the Bill, primarily amending the Prohibition of Human Cloning for Reproduction Act 2002 (Cth) (the PHCR Act), the Research Involving Human Embryos Act 2002 (Cth) (the RIHE Act) and the Research Involving Human Embryos Regulations 2017 (Cth) (the RIHE Regulations) will commence on a day to be proclaimed, or 6 months after Royal Assent if not proclaimed prior.  The remainder of the Bill will commence on 1 April 2022.

The Bill, known also as Maeve’s Law, is named for Maeve Hood, a five-year-old girl who suffered from Mitochondrial disease, a complex group of inherited conditions passed via maternal mitochondria that can have significant effects on a person’s development and life expectancy.

The Bill creates a national regulatory framework that will allow for the legalisation of mitochondrial donation techniques and its introduction for research purposes. This will allow for the refinement of mitochondrial techniques in Australia, and practical training of relevant professionals, building the expertise in this country.  Further, the Bill aims to pave the way for the clinical use of mitochondrial donation techniques by improving the evidence and data in relation to the safety and efficacy of those techniques.

Amendments to the RIHE Act and RIHE Regulations

Licences

Key to the amendments made by the Bill is the introduction of a mitochondrial donation licence to allow for the use of permitted mitochondrial donation techniques under the licence for certain research and training, and in clinical settings.  For the purposes of the RIHE Act, under regulation 7A of the RIHE Regulations, mitochondrial donation techniques include:

  • maternal spindle transfer, as defined under regulation 7C;
  • pronuclear transfer, as defined under regulation 7D;
  • germinal vesicle transfer, as defined under regulation 7E;
  • first polar body transfer, as defined under regulation 7F; and
  • second polar body transfer, as defined under regulation 7G.

Permitted techniques are contained in regulation 7B, which outlines the types of mitochondrial donation techniques permitted under each class of licence.

Subscribers should note that licences issued under section 21 of the RIHE Act are now considered general licences, with mitochondrial donation licences as a separate and distinct licence type.

As defined in the RIHE Act, several classes of mitochondrial donation licence are created, including:

  • 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.

Certain activities will be permitted only under certain licences.

Under the new section 28C, a pre-clinical research and training licence authorises the carrying out of activities listed in section 28C(2) that are specified in the licence.  Namely, in undertaking research and training for the purposes of developing the permitted technique for potential future use in a clinical setting to minimise the risk of inheritance of mitochondrial disease but without the immediate aim of conducting a clinical trial or using the technique in a clinical setting.  The licence may also be used to better understand the permitted technique, including its safety, and to build expertise in the technique and how to use it.

Activities that may be carried out under this licence include, for example:

  • creation of human embryos other than by fertilisation of a human egg by a human sperm, using the permitted technique specified in the licence, and use of such embryos;
  • creation, and use, of human embryos that contain genetic material provided by more than 2 persons, using the permitted technique specified in the licence:
    • by fertilisation of a human egg by a human sperm outside the body of a woman; or
    • other than by the fertilisation of a human egg by a human sperm

However, as with other provisions of the RIHE Act, a pre-clinical licence will not authorise the use of a human embryo that would result in the development of a human embryo for a period of more than 14 days or involve placing a human embryo into the body of a woman for the purposes of achieving pregnancy.

Licences will also be made with certain conditions.  Generally, licences will be issued with conditions outlined in section 28N, such as that proper consent must be obtained prior to activities being carried out under the licence, and such consent is to be reported to the NHMRC Licensing Committee in a way that does not include the name, or any other identifying information, of a responsible person (as defined in section 28N(8)).  Clinical trial and clinical practice licences will be subject to additional controls and conditions outlined in sections 28P, 28Q, 28R and 28S.

Notably, the classes of licence created by this Bill not only provide a framework for the research and development of mitochondrial donation techniques, but also legalise the clinical application of such techniques through the clinical practice licence. This licence will authorise the carrying out of the activities mentioned in section 28G(2) (including the creation and use of embryos other than by fertilisation of a human egg by a human sperm using the permitted technique specified in the licence) at an accredited ART centre for the purpose of creating a human embryo for a patient and placing the embryo in the body of the patient for the purpose of achieving pregnancy.

Licence application

An application is to be made to the NHMRC Licensing Committee for any of the licences established under the Bill.  The person applying for the licence must be a constitutional corporation if they intend to apply for a pre-clinical research and training licence, a clinical trial research and training licence, or a clinical trial licence.  Additionally, the licence classes and application processes are structured in such a way that the person applying for a licence must first have held a training and research licence – for example, under section 28H(3), a person cannot apply 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 application must be in the approved form and specify the kind of licence being applied for and the permitted technique to which the licence will relate.  Additionally, the application must be made in accordance with any requirements under any regulations made and subject to other requirements imposed, and specified in writing, by the NHMRC Licensing Committee.

Determinations will be made by the NHMRC Licensing Committee in accordance with the requirements of section 28H, such as the Committee being satisfied that the appropriate protocols are in place to enable proper consent is obtained before activities are carried out under the licence and that the activity or project proposed in the application has been assessed and approved by the HREC.  The Committee must also have regard to other factors, including, but not limited to, restricting the number of excess ART embryos or other embryos, human eggs, or zygotes that are likely to be required in the activity or project and any relevant guidelines issued by the CEO of the NHMRC and prescribed by the regulations, being (in accordance with the new regulation 7H) the ART Guidelines and the National Statement.

PHCR Act

Under the PHCR Act, references have been added to provisions, such as section 15 (Offence—heritable alterations to genome) to include mitochondrial donation licences and activities relating to those licences.  For example, a person commits an offence, punishable by imprisonment of up to 15 years, if the person alters the genome of a human cell in a heritable way where the alteration is not permitted under section 28B of the amended RIHE Act.

Additionally, section 23BA has been added to the PHCR Act to clarify that a person is not criminally responsible for a licence offence in respect of particular conduct if:

  • the conduct by the person is purportedly authorised by a provision of a general licence or a mitochondrial donation licence; and
  • the licence or the provision is invalid, whether because of a technical defect or irregularity or for any other reason; and 19
  • the person did not know, and could not reasonably be expected to have known, of the invalidity of the licence or the provision.

A review provision, requiring the review of the PHCR Act by the responsible Minister every 7 years, has also been inserted.  This review, under the replaced section 25, requires the Minister to consult broadly, including with the States and a range of persons with expertise in or experience in relevant disciplines.

Please click here to access the full Bill.


Contact

For further information please contact the Law Compliance team:

Phone: 1300 862 667

Email: info@lawcompliance.com.au

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