Research Involving Human Embryos Act 2002

A pre‑clinical research and training licence authorises carrying out any of the activities mentioned in subsection (2) that are specified in the licence in undertaking research and training for the purpose of doing all of the following:

developing the permitted technique specified in the licence for potential future use in a clinical setting as a way to minimise the risk of women’s offspring inheriting mitochondria that would predispose them to mitochondrial disease, but without the immediate aim of:

conducting a clinical trial; or

using the technique in a clinical practice setting;

better understanding the technique, including its safety and efficacy in minimising the risk of women’s offspring inheriting mitochondria that would predispose them to mitochondrial disease;

building expertise in the technique and how to use it.

The activities are as follows:

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 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;

creation of human embryos by a process of the fertilisation of a human egg by a human sperm outside the body of a woman, using the permitted technique specified in the licence, and use of such embryos;

research and training involving the fertilisation of a human egg by a human sperm up to, including and after the first mitotic division, outside the body of a woman for the purposes of research or training in the use of the permitted technique specified in the licence;

use of any material (other than an excess ART embryo) created, developed or produced under a mitochondrial donation licence.

A pre‑clinical research and training licence does not 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; or

involve placing a human embryo into the body of a woman for the purposes of achieving pregnancy in that woman.