Division Description Changes — Bills — Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021; in Committee — 10th Feb 2022

Change	Division
senate vote 2022-02-10#8 Edited by mackay staff on 2022-02-11 16:11:36	Title Bills — Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021; in Committee Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 - in Committee - Introduce threshold Description ~~<p class="speaker">The</p>~~ <p>CHAIR (): The committee is considering the Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021 and the amendment on sheet 1540, moved by Senator Ciccone at the request of Senator O'Neill. The question is that the amendment be agreed to.</p> ~~<p class="speaker">Matthew Canavan</p>~~ <p>nator CANAVAN (—) (): I think it might just be worthwhile to repeat very briefly what is this amendment is about. This amendment would require a minimum of 20 participants to go through the trial phase before proceeding to the clinical stage of mitochondrial donation. I repeat that nothing in this amendment would delay or prevent Australian parents from accessing mitochondrial services. The bill, if amended, would still immediately allow the trial processes to occur, including the full suite of mitochondrial donation processes through to live birth, so parents can go through that process. The intention of this amendment is to ensure there is a sufficiently large amount of data such that we can have information about the risks of this revolutionary and novel technique before proceeding to provide it in a wider clinical fashion, where there will be much less oversight and involvement of researchers on a day-to-day basis as per the trial phase.</p> <p>It's a simple amendment. It provides some protection for us as legislators in that there'll be sufficient information before the minister, who will make regulations to go to the clinical phase. As discussed last night, some senators here would have preferred if we had required legislation to come back to this place before we could proceed to the clinical phase, that we did not delegate that power to the minister, but those amendments have not been proceeded with. This is a sensible approach that would still allow the minister the delegated power to proceed to the clinical stage, but after 20 participants go through the trial.</p> ~~<p class="speaker">The Chair</p>~~ ~~<p>The question is that amendment (1) on sheet 1540 be agreed to.</p>~~ ~~<p></p>~~ ~~<p></p>~~ 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 make*s 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 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 mak*e 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](https://www.aph.gov.au/Parliamentary_Business/Bills_Legislation/bd/bd2021a/21bd065).

~~The~~
CHAIR (): The committee is considering the Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021 and the amendment on sheet 1540, moved by Senator Ciccone at the request of Senator O'Neill. The question is that the amendment be agreed to.
~~Matthew Canavan~~
nator CANAVAN (—) (): I think it might just be worthwhile to repeat very briefly what is this amendment is about. This amendment would require a minimum of 20 participants to go through the trial phase before proceeding to the clinical stage of mitochondrial donation. I repeat that nothing in this amendment would delay or prevent Australian parents from accessing mitochondrial services. The bill, if amended, would still immediately allow the trial processes to occur, including the full suite of mitochondrial donation processes through to live birth, so parents can go through that process. The intention of this amendment is to ensure there is a sufficiently large amount of data such that we can have information about the risks of this revolutionary and novel technique before proceeding to provide it in a wider clinical fashion, where there will be much less oversight and involvement of researchers on a day-to-day basis as per the trial phase.
It's a simple amendment. It provides some protection for us as legislators in that there'll be sufficient information before the minister, who will make regulations to go to the clinical phase. As discussed last night, some senators here would have preferred if we had required legislation to come back to this place before we could proceed to the clinical phase, that we did not delegate that power to the minister, but those amendments have not been proceeded with. This is a sensible approach that would still allow the minister the delegated power to proceed to the clinical stage, but after 20 participants go through the trial.
~~The Chair~~
~~The question is that amendment (1) on sheet 1540 be agreed to.~~
~~~~
~~~~
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 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 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](https://www.aph.gov.au/Parliamentary_Business/Bills_Legislation/bd/bd2021a/21bd065).