10th Feb 2022, 12:47 PM – Senate Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 - in Committee - Sections 28F and 28G

The majority voted in favour of a motion that sections 28F and 28G in item 17 of schedule 1 remain unchanged. In parliamentary jargon, they voted that those sections stand as printed.

This was a free vote (also known as a conscience vote), which means our senators voted according to their own beliefs rather than strictly along party lines.

Text of sections 28F and 28G

28F What a clinical practice research and training licence authorises

(1) A clinical practice research and training licence authorises carrying out any of the activities mentioned in subsection (2) that are specified in the licence, at an accredited ART centre, in undertaking research and training for the purpose of doing all of the following in preparation for using the permitted technique specified in the licence in a clinical practice setting:

(a) developing protocols for using the technique safely and effectively, in a clinical practice setting, for the purpose of minimising the risk of women’s offspring inheriting mitochondria that would predispose them to mitochondrial disease;

(b) ensuring that each embryologist nominated under subsection 28H(5) has technical competence in the use of the technique in accordance with those protocols;

(c) ensuring that the holder’s facilities, equipment, processes and protocols for using the technique are suitable for using the technique in a clinical practice setting.

(2) The activities are as follows:

(a) 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;

(b) creation of human embryos that contain genetic material provided by more than 2 persons, using the permitted technique specified in the licence:

(i) by fertilisation of a human egg by a human sperm outside the body of a woman; or

(ii) other than by the fertilisation of a human egg by a human sperm;

and use of such embryos;

(c) 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;

(d) 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;

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

(3) A clinical practice research and training licence does not authorise any use of a human embryo that would:

(a) result in the development of a human embryo for a period of more than 14 days, excluding any period when development is suspended; or

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

28G What a clinical practice licence authorises

(1) A clinical practice licence authorises carrying out any of the activities mentioned in subsection (2) that are specified in the licence, at an accredited ART centre, for the purpose of doing both of the following in a clinical practice setting:

(a) creating a human embryo for a patient, using the permitted technique specified in the licence, with the intention of minimising the risk of the embryo inheriting mitochondria that would predispose any resulting child to mitochondrial disease;

(b) placing the embryo in the body of the patient for the purposes of achieving her pregnancy.

(2) The activities are as follows:

(a) 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;

(b) creation of human embryos that contain genetic material provided by more than 2 persons, using the permitted technique specified in the licence:

(i) by fertilisation of a human egg by a human sperm outside the body of a woman; or

(ii) other than by the fertilisation of a human egg by a human sperm;

and use of such embryos;

(c) alteration of the genome of a human cell (within the meaning of section 15 of the Prohibition of Human Cloning for Reproduction Act 2002 ) using the permitted technique specified in the licence, in such a way that the alteration is heritable by descendants of the human whose cell was altered;

(d) placement in the body of a woman of any of the following kinds of human embryo created using the permitted technique specified in the licence:

(i) a human embryo created by a process other than the fertilisation of a human egg by human sperm;

(ii) a human embryo that contains genetic material provided by more than 2 persons;

(iii) a human embryo that contains a human cell (within the meaning of section 15 of the Prohibition of Human Cloning for Reproduction Act 2002 ) whose genome has been altered in such a way that the alteration is heritable by descendants of the human whose cell was altered;

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

(2) A clinical practice licence does not authorise any use of a human embryo that would result in the development of the embryo outside the body of a woman for a period of more than 14 days, excluding any period when development is suspended.

What does this bill do?

According to the bills digest:

Mitochondrial disease is a group of conditions that can cause serious health issues and, in severe cases, can cause death in childhood. There is no known cure for mitochondrial disease.

Mitochondrial donation is an assisted reproductive technology (ART) that can assist women to avoid passing mitochondrial DNA disease to their biological child. This technology is not a cure for mitochondrial disease but is rather a way to prevent children from inheriting mitochondria that can cause mitochondrial disease.

Under the current legislative framework, mitochondrial donation is illegal under the Prohibition of Human Cloning for Reproduction Act 2002 (Cth) and the Research Involving Human Embryos Act 2002 (Cth). The Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 (the Bill) amends relevant Acts and associated Regulations to make mitochondrial donation legal for research, training and human reproductive purposes. The overall aim is for women at risk of passing on mitochondrial disease to have reproductive options for biological children without the increased risk of their child having mitochondrial disease.

Primarily the Bill makes changes to ensure that it is no longer an offence to create, for the purposes of reproduction, and under the relevant mitochondrial donation licences, a human embryo that:

• contains the genetic material of more than two people and
• contains heritable changes to the genome.

Read more in the bills digest.