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

Schedule 1   Mitochondrial donation

Part 1   Main amendments

Research Involving Human Embryos Regulations 2017

20   After section 7

Insert:

Division 2 - Provisions relating to mitochondrial donation licences

7A Definition of mitochondrial donation technique

For the purposes of the definition of mitochondrial donation technique in section 8 of the Act, the following are mitochondrial donation techniques:

(a) maternal spindle transfer;

(b) pronuclear transfer;

(c) germinal vesicle transfer;

(d) first polar body transfer;

(e) second polar body transfer.

7B Definition of permitted technique

For the purposes of the definition of permitted technique in section 8 of the Act, a mitochondrial donation technique mentioned in an item in the following table is declared to be a permitted technique for a mitochondrial donation licence mentioned in that item.

Definition of permitted technique

7C Definition of maternal spindle transfer

Maternal spindle transfer is a technique that involves taking the following steps, without intentionally modifying any nuclear DNA or mitochondrial DNA:

(a) removing the maternal spindle from a human egg ( egg A ) of a woman;

(b) removing the maternal spindle from a human egg ( egg B ) of a different woman;

(c) implanting into egg B the maternal spindle removed from egg A, while seeking to minimise carryover of mitochondria from egg A to egg B;

(d) fertilising egg B with a human sperm to create a zygote.

7D Definition of pronuclear transfer

Pronuclear transfer is a technique that involves taking the following steps, without intentionally modifying any nuclear DNA or mitochondrial DNA:

(a) fertilising, with a human sperm, a human egg of a woman to create a zygote ( zygote A );

(b) removing the pronuclei from zygote A;

(c) fertilising, with a human sperm, a human egg of a different woman to create another zygote ( zygote B );

(d) removing the pronuclei from zygote B;

(e) implanting the pronuclei from zygote A into zygote B, while seeking to minimise carryover of mitochondria from zygote A to zygote B.

7E Definition of germinal vesicle transfer

Germinal vesicle transfer is a technique that involves taking the following steps, without intentionally modifying any nuclear DNA or mitochondrial DNA:

(a) removing the germinal vesicle from a maturing human egg ( egg A ) of a woman;

(b) removing the germinal vesicle from a maturing human egg ( egg B ) of a different woman;

(c) implanting the germinal vesicle removed from egg A into egg B, while seeking to minimise carryover of mitochondria from egg A to egg B;

(d) maturing egg B in vitro to the stage ready for fertilisation;

(e) fertilising egg B with a human sperm to create a zygote.

7F Definition of first polar body transfer

First polar body transfer is a technique that involves taking the following steps, without intentionally modifying any nuclear DNA or mitochondrial DNA:

(a) removing the first polar body from a human egg ( egg A ) of a woman;

(b) removing the maternal spindle from a human egg ( egg B ) of a different woman;

(c) fusing the first polar body to, or implanting the first polar body into, egg B;

(d) fertilising egg B with a human sperm to create a zygote.

7G Definition of second polar body transfer

Second polar body transfer is a technique that involves taking the following steps, without intentionally modifying any nuclear DNA or mitochondrial DNA:

(a) fertilising, with a human sperm, a human egg of a woman to create a zygote ( zygote A );

(b) fertilising, with a human sperm, a human egg of a different woman to produce another zygote ( zygote B );

(c) removing the second polar body from zygote A;

(d) removing the female pronucleus from zygote B;

(e) transferring the second polar body from zygote A to zygote B.

7H Determination by NHMRC Licensing Committee of mitochondrial donation licence applications - prescribed guidelines

For the purposes of paragraph 28J(3)(b) of the Act, the following guidelines are prescribed:

(a) the ART Guidelines;

(b) the National Statement.

7J Definition of proper consent - prescribed guidelines

For the purposes of the definition of proper consent in subsection 28N(8) of the Act, the ART Guidelines are prescribed.

7K Keeping records - prescribed period

For the purposes of subsection 28R(4) of the Act, the period for which a record must be kept is 25 years after the creation of the record.

7L Notifying adverse events - form of notification

For the purposes of subsection 28S(4) of the Act, a notification for the purposes of subsection 28S(3) of the Act must:

(a) be in the form approved by the CEO of the NHMRC; and

(b) contain any information required by the form.

7M Definition of adverse event

For the purposes of the definition of adverse event in subsection 28S(8) of the Act, an adverse event is:

(a) for a trial participant or a patient - any of the following in connection with a pregnancy achieved in the trial participant or patient as a result of using a mitochondrial donation technique:

(i) a failed embryo development;

(ii) a miscarriage;

(iii) a premature birth of a child;

(iv) the birth of a child with a birth defect, a genetic abnormality or a diagnosis at birth of mitochondrial disease; and

(b) for a child of a trial participant - a diagnosis at any time of mitochondrial disease.