Mitochondrial Donation Law Reform (Maeve's Law) Act 2022 (26 of 2022)

Schedule 1   Mitochondrial donation

Part 1   Main amendments

Research Involving Human Embryos Act 2002

10   Section 8

Insert:

clinical practice licence means a licence referred to in section 28G.

clinical practice research and training licence means a licence referred to in section 28F.

clinical trial licence means a licence referred to in section 28E.

clinical trial research and training licence means a licence referred to in section 28D.

donor , in relation to a particular use of a mitochondrial donation technique, has the meaning given by subsection 28R(2).

general licence means a licence issued under section 21.

mitochondrial donation licence means:

(a) a pre-clinical research and training licence; or

(b) a clinical trial research and training licence; or

(c) a clinical trial licence; or

(d) a clinical practice research and training licence; or

(e) a clinical practice licence.

mitochondrial donation technique means a technique, prescribed by the regulations for the purposes of this definition, that:

(a) 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; and

(b) involves using assisted reproductive technology to create a zygote that:

(i) has nuclear DNA from the woman and a man; and

(ii) contains mitochondria from a human egg of a different woman; and

(c) does not involve:

(i) intentionally modifying nuclear DNA or mitochondrial DNA; or

(ii) using any cell, or any component part of a cell, of an animal; or

(iii) creating a chimeric embryo (within the meaning of the Prohibition of Human Cloning for Reproduction Act 2002) or a hybrid embryo.

patient means a woman whose pregnancy is sought to be achieved using a mitochondrial donation technique under a clinical practice licence.

Note: For a human embryo to be created for, or placed in the body of, a woman under a clinical practice licence, the NHMRC Licensing Committee 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: see paragraph 28P(4)(a).

permitted technique for a mitochondrial donation licence of a particular kind means a mitochondrial donation technique that is declared by the regulations to be a permitted technique for a mitochondrial donation licence of that kind.

pre-clinical research and training licence means a licence referred to in section 28C.

trial participant means a woman whose pregnancy is sought to be achieved using a mitochondrial donation technique under a clinical trial licence.

Note: For a human embryo to be created for, or placed in the body of, a woman under a clinical trial licence, the NHMRC Licensing Committee 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: see paragraph 28P(4)(a).