Bill
Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021
passed, as at 2022-04-01. Health portfolio.
- Sponsor
- Not recorded
- Portfolio
- Health
Recorded stages
- introduced — 2021-03-24
- second reading — 2021-03-24
- second reading — 2021-11-25
- second reading — 2021-11-29
- second reading — 2021-11-30
- second reading — 2021-12-01
- second reading — 2021-12-01
- committee — 2021-12-01
- third reading — 2021-12-01
- introduced — 2021-12-02
- second reading — 2021-12-02
- second reading — 2022-02-08
- second reading — 2022-02-09
- second reading — 2022-02-09
- committee — 2022-02-09
- committee — 2022-02-10
- committee — 2022-03-30
- third reading — 2022-03-30
- passed — 2022-03-30
- royal assent — 2022-04-01
Divisions
- The majority voted in favour of *disagreeing* with [amendments](https://www.openaustralia.org.au/debate/?id=2021-12-01.136.1) introduced by Menzies MP [Kevin Andrews](https://theyvoteforyou.org.au/people/representatives/menzies/kevin_andrews) (Liberal), which means they failed This was a [free vote](https://peo.gov.au/understand-our-parliament/how-parliament-works/parliament-at-work/crossing-the-floor/) (also known as a conscience vote), which means our MPs voted according to their own beliefs rather than strictly along party lines. ### What would this amendment do? MP Andrews [explained that](https://www.openaustralia.org.au/debate/?id=2021-12-01.136.1): > *These amendments go to what I believe is a fundamental area of difference in terms of the ethical consideration of this matter, and I'll put it in this context: there are essentially five techniques which are provided for in this bill, but they can be split into two categories. There's a category of mitochondrial techniques which involve the transfer of material between eggs—namely, the maternal spindle transfer and the geminal vesicle transfer. They don't involve any destruction of an embryo in order to undertake those techniques. There are three other techniques that involve transfer of material between zygotes or embryos—namely, pronuclear transfer, first polar body transfer and second polar body transfer. These three techniques involve, necessarily as part of the undertaking of the procedure, the destruction of a zygote or an embryo.* > > *I note in passing that under the bill only two techniques—namely, maternal spindle transfer and pronuclear transfer—are permitted for the clinical trial licence phase. But one of these techniques—namely, pronuclear transfer—involves the destruction of the zygote or the embryo. Accordingly, these amendments, when taken together, would remove from the bill those techniques or procedures which result in the destruction of the embryo. It would allow mitochondrial research to b — 2021-12-01, House of Representatives: affirmative, ayes 93, noes 29
- The majority voted against an [amendment](https://www.openaustralia.org.au/senate/?gid=2022-02-09.178.1) introduced by NSW Senator [Deborah O'Neill](https://theyvoteforyou.org.au/people/senate/nsw/deborah_o'neill) (Labor), which means it failed. This amendment would have changed the definition of "gene technology." Speaking in opposition to the amendment, Queensland Senator [Murray Watt](https://theyvoteforyou.org.au/people/senate/queensland/murray_watt) (Labor) [explained that](https://www.openaustralia.org.au/senate/?gid=2022-02-09.179.1): > *This amendment would change the definition of 'gene technology' to include mitochondrial donation. This would, in practice, require the Office of the Gene Technology Regulator to become involved in the regulation of mitochondrial donation.* This was a [free vote](https://peo.gov.au/understand-our-parliament/how-parliament-works/parliament-at-work/crossing-the-floor/) (also known as a conscience vote), which means our senators voted according to their own beliefs rather than strictly along party lines. ### Amendment text > *(1) Schedule 1, page 3 (before line 3), before the heading specifying Prohibition of Human Cloning for Reproduction Act 2002, insert:* > > *Gene Technology Act 2000* > > *1A Subsection 10(1) (definition of gene technology)* > > *Repeal the definition, substitute:* > > *gene technology means:* > > *(a) any technique for the modification of genes or other genetic material; and* > > *(b) a mitochondrial donation technique (within the meaning of Part 2 of the Research Involving Human Embryos Act 2002);* > > *but does not include:* > > *(c) sexual reproduction; or* > > *(d) homologous recombination; or* > > *(e) any other technique specified in the regulations for the purposes of this paragraph.* ### What does this bill do? According to the [bills digest](https://www.aph.gov.au/Parliamentary_Business/Bills_Legislation/bd/bd2021a/21bd065): > *Mitochondrial disease is a group of conditions that can cause serious h — 2022-02-09, Senate: negative, ayes 29, noes 32
- The majority voted in favour of a motion that section 47 in item 103 of schedule 1 stand as printed. In other words, they voted to keep that section unchanged. This was a [free vote](https://peo.gov.au/understand-our-parliament/how-parliament-works/parliament-at-work/crossing-the-floor/) (also known as a conscience vote), which means our senators voted according to their own beliefs rather than strictly along party lines. ### Text of Section 47 > *47 Interaction with the Gene Technology Act 2000* > > *(1) A mitochondrial donation technique is taken not to be gene technology for the purposes of the Gene Technology Act 2000 when used as authorised or purportedly authorised by a mitochondrial donation licence.* > > *(2) In this section:* > >> **mitochondrial donation licence** *includes a purported mitochondrial donation licence.* ### What does this bill do? According to the [bills digest](https://www.aph.gov.au/Parliamentary_Business/Bills_Legislation/bd/bd2021a/21bd065): > *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 t — 2022-02-09, Senate: affirmative, ayes 34, noes 29
- The majority voted against [amendments](https://www.openaustralia.org.au/senate/?gid=2022-02-09.192.7) (1) to (11) and (13) to (55) on sheet 1519, which means they failed. They were introduced by Queensland Senator [Matthew Canavan](https://theyvoteforyou.org.au/people/senate/queensland/matthew_canavan) (LNP). Senator Canavan [explained that](https://www.openaustralia.org.au/senate/?gid=2022-02-09.192.7): > *In the amendments that I will be moving tonight, I will propose that we should seek to remove the stage 2 licences from this bill. These amendments would not stop mitochondrial donation research and trials from continuing. As I've outlined, they've got 10 years of those to go—at least. These amendments would not stop that from occurring and the progression of this technology happening. All that agreeing to this amendment would mean is that, at the conclusion of those trials and research, the government of that day, or members and senators at that time, would put forward additional legislation which would then govern the regulatory framework for clinical practice trials.* This was a [free vote](https://peo.gov.au/understand-our-parliament/how-parliament-works/parliament-at-work/crossing-the-floor/) (also known as a conscience vote), which means our senators voted according to their own beliefs rather than strictly along party lines. ### What does this bill do? According to the [bills digest](https://www.aph.gov.au/Parliamentary_Business/Bills_Legislation/bd/bd2021a/21bd065): > *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 mi — 2022-02-09, Senate: negative, ayes 30, noes 32
- The majority voted in favour of a [motion](https://www.openaustralia.org.au/senate/?gid=2022-02-10.49.2) that [sections 28F and 28G](https://parlinfo.aph.gov.au/parlInfo/search/display/display.w3p;db=LEGISLATION;id=legislation%2Fbills%2Fr6697_first-reps%2F0001;query=Id%3A%22legislation%2Fbills%2Fr6697_first-reps%2F0000%22;rec=0) in item 17 of schedule 1 remain unchanged. In parliamentary jargon, they voted that those sections *stand as printed*. This was a [free vote](https://peo.gov.au/understand-our-parliament/how-parliament-works/parliament-at-work/crossing-the-floor/) (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, a — 2022-02-10, Senate: affirmative, ayes 36, noes 25
- The majority voted against an [amendment](https://www.openaustralia.org.au/senate/?gid=2022-02-10.51.1) introduced on behalf of NSW Senator [Deborah O'Neill](https://theyvoteforyou.org.au/people/senate/nsw/deborah_o'neill) (Labor), which means they failed. Victorian Senator [Raff Ciccone](https://theyvoteforyou.org.au/people/senate/victoria/raff_ciccone) (Labor) [explained that](https://www.openaustralia.org.au/senate/?gid=2022-02-10.51.1): > *This amendment proposed by Senator O'Neill will introduce a threshold where outcomes on 20 trial participants are required and published before the mitochondrial donation clinical licences are granted. The lack of data from the United Kingdom, the only jurisdiction where these practices are legal, should impel us to raise the threshold on these experimental gene editing techniques before we proceed in granting them a licence. The impacts and efficacy of these proposed techniques are still in theory, and thus a large number of trials should be undertaken and the results should be shared before these techniques are permitted to go ahead.* This was a [free vote](https://peo.gov.au/understand-our-parliament/how-parliament-works/parliament-at-work/crossing-the-floor/) (also known as a conscience vote), which means our senators voted according to their own beliefs rather than strictly along party lines. ### Amendment text > *(1) Schedule 1, page 6 (after line 37), after item 10, insert:* > > *10A At the end of Division 1 of Part 2* > > *Add:* > > *9A Minimum data required before clinical practice stage* > > *Before the Governor-General makes regulations declaring a mitochondrial donation technique for the purposes of the definition of permitted technique in section 8, the Minister must be satisfied that:* > > *(a) there is sufficient clinical evidence that the technique has been used on at least 20 trial participants; and* > > *(b) the outcomes of the use of the technique on the trial participants have been published.* ### What does — 2022-02-10, Senate: negative, ayes 25, noes 36
- The majority voted against an [amendment](https://www.openaustralia.org.au/senate/?gid=2022-02-10.159.5) introduced by Queensland Senator [Matthew Canavan](https://theyvoteforyou.org.au/people/senate/queensland/matthew_canavan) (LNP), which means it failed. This was a [free vote](https://peo.gov.au/understand-our-parliament/how-parliament-works/parliament-at-work/crossing-the-floor/) (also known as a conscience vote), which means our senators voted according to their own beliefs rather than strictly along party lines. ### Amendment text > *(1) Schedule 1, item 17, page 34 (after line 11), at the end of Division 4A, add:* > > *Subdivision G — Other requirements relating to mitochondrial donation licences* > > *28Y Annual reports* > > *(1) The NHMRC Licensing Committee must, within 1 month after the end of each reporting period, give the Minister a report in accordance with subsection (2).* > > *(2) The report must include the following de-identified information in relation to the reporting period:* > >> *(a) the number of each kind of mitochondrial donation licence issued under section 28J; and* >> >> *(b) the outcomes of the activities carried out under each licence issued under section 28J, including:* >> >>> *(i) the number of births of children as a result of pregnancies achieved using a mitochondrial donation technique under a clinical trial licence or a clinical practice licence; and* >>> >>> *(ii) the number of adverse events notified to the NHMRC Licensing Committee under paragraph 28S(3)(a); and* >> >> *(c) all clinical data obtained as a result of the activities carried out under each licence issued under section 28J, including:* >> >>> *(i) experimental data obtained from the use of the permitted technique specified in the licence; and* >>> >>> *(ii) clinical data about each child born as a result of a pregnancy achieved using the permitted technique specified in the licence.* > > *(3) The Minister must table a copy of the report in each House of the Parli — 2022-02-10, Senate: negative, ayes 27, noes 35
- The majority voted in favour of keeping [item 55A](https://parlinfo.aph.gov.au/parlInfo/search/display/display.w3p;db=LEGISLATION;id=legislation%2Fbills%2Fr6697_third-reps%2F0001;query=Id%3A%22legislation%2Fbills%2Fr6697_third-reps%2F0000%22;rec=0) of schedule 1 unchanged. In parliamentary jargon, they voted that that item *stand as printed*. This was a [free vote](https://peo.gov.au/understand-our-parliament/how-parliament-works/parliament-at-work/crossing-the-floor/) (also known as a conscience vote), which means our senators voted according to their own beliefs rather than strictly along party lines. ### Text of item 55A > *55A At the end of section 19* > > *Add:* > >> *(4) A report under this section must not include information about any of the following matters unless the NHMRC Licensing Committee considers that the information does not identify, and is not reasonably capable of being used to identify, any person:* > >> *(a) approvals under subsection 28P(3) (including applications for such approvals and the outcomes of those applications);* >> >> *(b) births of children as a result of pregnancies achieved using a mitochondrial donation technique under a clinical trial licence or a clinical practice licence;* >> >> *(c) adverse events notified to the NHMRC Licensing Committee under paragraph 28S(3)(a).* ### What does this bill do? According to the [bills digest](https://www.aph.gov.au/Parliamentary_Business/Bills_Legislation/bd/bd2021a/21bd065): > *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.* > > * — 2022-02-10, Senate: affirmative, ayes 34, noes 27
Plain-language summary
Written by a model from the explanatory memorandum; not the record, as at 2021-03-24.
The bill would legalise mitochondrial donation techniques in Australia under a national regulatory framework.
It would amend the Prohibition of Human Cloning for Reproduction Act 2002, the Research Involving Human Embryos Act 2002, the Research Involving Human Embryos Regulations 2017, an Excluded Goods Determination, and the Freedom of Information Act 1982.
The bill would allow women carrying mitochondrial mutations to have a biological child without inheriting those mutations, and would permit further research and training before broader clinical use.
- Legalise mitochondrial donation for research and human reproductive purposes.
- Establish a national regulatory framework for the technology.
- Allow women with mitochondrial disease risk to have a biological child without inheriting that risk.
- Enable further research and training to build evidence and expertise.
- Gather data on safety and efficacy before broader introduction.
- Implement ethical safeguards identified through consultation.
Women whose mitochondria would predispose their children to severe mitochondrial disease, and their families.
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