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senate vote 2022-02-09#5
Edited by
mackay staff
on
2022-02-11 15:08:53
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Title
Bills — Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021; in Committee- Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 - in Committee - Definition of gene technology
Description
<p class="speaker">Andrew McLachlan</p><p>The question is that the bill stand as printed.</p> <p class="speaker">Deborah O'Neill</p><p>I move opposition amendment (1) on sheet 1542:</p><p class="italic">(1) Schedule 1, page 3 (before line 3), before the heading specifying <i>Prohibition of Human Cloning for Reproduction Act 2002</i>, insert:</p><p class="italic"> <i>Gene Technology Act 2000</i></p><p class="italic">1A Subsection 10(1) (definition of <i>gene technology</i> )</p><p class="italic">Repeal the definition, substitute:</p><p class="italic"><i>gene technology</i> means:</p><p class="italic">(a) any technique for the modification of genes or other genetic material; and</p><p class="italic">(b) a mitochondrial donation technique (within the meaning of Part 2 of the <i>Research Involving Human Embryos Act 2002</i>);</p><p class="italic">but does not include:</p><p class="italic">(c) sexual reproduction; or</p><p class="italic">(d) homologous recombination; or</p><p class="italic">(e) any other technique specified in the regulations for the purposes of this paragraph.</p><p>We also oppose schedule 1 in the following terms:</p><p class="italic">(2) Schedule 1, item 103, page 56 (lines 16 to 23), section 47 to be opposed.</p><p>It seeks to amend schedule 1. In effect, it's about introducing a degree of accountability and transparency to the MRT process that is the subject of the bill in the debate.</p><p>I'm particularly keen to advance this amendment in light of the evidence that we were unable to actually ascertain as we undertook the inquiry through the Community Affairs Legislation Committee, which tabled this report, <i>Mitochondrial Donation Law Reform (M</i><i>aeve's Law) Bill 2021</i><i> [P</i><i>rovisions</i><i>]</i> in August 2021. We participated in what felt like a very rushed hearing, and perhaps that's why today it's really important that we do take the time. We've had the time to have a look. My amendment really responds to the fact that when we look at the UK—the only other jurisdiction in the world where this scheme, this technique, is being operated—we were unable to get any data to explain to us about what was going on, to get an indication of what had happened in the five years that this scheme has been in place in the UK. I don't think we need to make the same mistake in Australia. Australians expect us to be transparent about what's going on, and Australians are investing $10 million, if the bill should pass, in a new technology that requires radical change to the laws of this country to allow techniques that have been illegal for the last 20 years. We deserve to know what's going on.</p><p>I believe that the long-term effects of germline editing should absolutely require a higher level of oversight from expert government agencies than is currently provided for in this bill, and I do believe that there is a role for the existing government bodies to oversee this process as they would do in normal circumstances. So, we need to let the efficacy and safety of these techniques first be proven through the rigours of the scientific process before we legalise them, and they should be given the scrutiny that is outlined in my amendment. I urge senators to vote for this commonsense measure of a higher degree of accountability that currently exists within the bill.</p> <p class="speaker">Murray Watt</p><p>I would like to speak against this amendment. With the greatest of respect to my colleague Senator O'Neill, we have different views on this subject. 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. In my view, this is an unnecessary additional step. It would duplicate and confuse matters, given the expertise and responsibilities that already sit with the NHMRC Embryo Research Licensing Committee.</p><p>For those who are unaware, the NHMRC Embryo Research Licensing Committee was established in 2002 and is responsible for overseeing the Research Involving Human Embryos Act 2002 and the Prohibition of Human Cloning for Reproduction Act 2002. These are the two laws which Maeve's Law seeks to amend. As such, the committee: considers application for licences to conduct research involving human embryos; issues those licences or chooses not to issue those licences; monitors activities covered by those licences; and carries out other related activities, such as reporting to parliament and maintaining information. Membership of this committee comprises individuals with expertise in research ethics, assisted reproductive technology, law, embryology and the regulation of assisted reproductive technology. Given both the responsibility of this principal committee for the relevant legislation and its expertise in the relevant law and scientific fields, in my view, it is the most appropriate and qualified group within Australia to oversee the licensing regime outlined within Maeve's Law.</p><p>As I say, I understand where Senator O'Neill is coming from on this, but, in my view, the existing committee that operates under the NHMRC umbrella is the appropriate body to do this work. It already does this type of work. There's no need to add a further regulatory body to this system.</p> <p class="speaker">Jordon Steele-John</p><p>In talking to this amendment moved by Senator O'Neill before the chamber, I want to make something clear. I am the spokesperson for the Greens in the health space and I will making contributions on this legislation, but, as a party, we too have decided on a conscience vote. So the contributions that I make in relation to this amendment are reflective of my personal position and won't necessarily reflect the views of my colleagues, and my vote won't necessarily be in the same direction, as it is a conscience vote.</p><p>I will come to the amendment directly in a moment, but I just want to offer a couple of really quite authentic observations in relation to the conscience debate that we have been having on this legislation to this point. First of all, last night we had a couple of contributions, some which were directly referencing so-called traditional ways of coming into the world, traditional forms of reproduction. Other contributions alluded to there being a traditional way in which a human being comes into the world. As a disabled person, I feel an obligation to draw the chamber's attention to the fact that my sitting here today, alive and an MP for WA, is a testament to the reality that the definition of what it is to be a traditional human being and to live evolves over time. Had I been born a couple of hundred years ago, I would have been left to the wolves. Had I been born 50 years ago, and less in some places, it would have been the traditional course of life for me to be institutionalised and never see the light of day. What are the traditional ways of going about life and the traditional supports that we provide to people? These are definitions that evolve over time, not only in that social space and that historical context but medically.</p><p>I, like so many other people in the world, am the product of a caesarean birth procedure. There was a time when such a procedure did not exist, and the traditional way of medicine—the traditional way forward—would have been for me and my mum to have died. Luckily, over the course of time and with the advancement of science, we have improved medical practices, and those improved medical practices enable us to offer better life chances to babies, kids and parents to live good, happy, healthy lives. There is no such thing as a fixed point in time whereby the traditional state of things can be defined.</p><p>On the amendment specifically, it is my view that this would have the effect of blurring the lines in relation to the regulation and oversight of this procedure and slowing down the trial and implementation stage. One of the challenges we have here is that this could well create confusion as to the responsible regulatory body. In my view, requiring the Gene Technology Regulator to become involved in the regulation of mitochondrial donation could well have a duplicative effect. That's before you even lift the lid, go beneath and ask yourself where the expertise lies. Currently, within the NHMRC, we have the Embryo Research Licensing Committee, which, it is proposed, will have regulatory oversight of this process. With the change proposed by the amendment, the Gene Technology Regulator would also have oversight and regulatory responsibility—hence, potentially, the confusion that I talked about before.</p><p>But I also think we have another question to consider with the amendment, and that is simply that the regulator is currently responsible for—and I'll quote directly—'agriculture and genetically modified material'. I would never want to see a baby born due to these procedures being, at any point in their existence, identified or designated, by a government regulator or any other body, as 'genetically modified material'. That's not appropriate, and it is totally unnecessary given the fact that within the NHMRC's IVF division there is a team of folks who have been doing work on facilitated reproductive procedures since the early 2000s. This is a team of the nation's experts, who are more than capable, in my view, of carrying out this oversight role as proposed in the legislation before the chamber today. For those reasons, I personally will not be supporting the amendment.</p> <p class="speaker">Louise Pratt</p><p>I want to endorse the comments of Senator Jordon Steele-John. These regulations need to be separate. We have regulation for reproductive technology, and we have regulation for genetically modified material, which people are not.</p> <p class="speaker">Matthew Canavan</p><p>I do think there is a need for an arms-length regulator for techniques that are very novel and revolutionary. I would posit that even those who are passionately in favour of this bill understand how revolutionary the techniques we are talking about are. The techniques involve transferring, for the first time, genetic material between two human cells for the purposes of reproduction. This is at the cutting edge, in the world, of these techniques. We have heard through this debate that the United Kingdom is the only country that has legalised this approach to date, and to date there has not been a successful live birth emerging from mitochondrial donation in that country. So it is something that we should ensure has a significant level of oversight and regulation. I know that some have raised the point that the Office of the Gene Technology Regulator may not be the appropriate body to regulate human gene therapy. Indeed, there was a review of the National Gene Technology Scheme in 2018, which did conclude that the definition of GMO in that act be amended to exclude a human being from the definition. That's consistent with those who have argued against this amendment. However, that amendment has not been made. That recommendation has not been acted on. What no-one else has put forward in this debate at this stage is that that review also said:</p><p class="italic">The Review notes that this amendment may result in the need for another existing, or new, regulatory body to expand its scope of regulatory activity, to ensure that appropriate regulatory oversight is provided in this area.</p><p>The National Health and Medical Research Council is a great body and a fantastic institution in this country. It is not a regulator. It is a provider of health advice and research to governments and other organisations. It is not an arms-length regulator of an activity. I say that without casting any aspersions on the people who work in the NHMRC or the persons that would be part of the Embryo Research Licensing Committee that this bill would form. I'm sure they are all very good people, but they are people that are directly involved in the provision of these techniques and therefore cannot themselves sit at arm's length. That has been admitted to me in discussions where there has been the admission that many people on the ERLC will have conflicts of interest. They will be disclosed, I'm sure, in the appropriate manner, but just the mere fact of having those conflicts of interest means they will not be an arms-length regulator.</p><p>In my view, not proceeding with this amendment would be inconsistent with the recommendations of the recent review of the National Gene Technology Scheme. We do not yet have a separate regulator established. That has not been considered. The Gene Technology Act has not been amended in the way recommended by that review in 2018. So we are putting cart before the horse here in excluding regulation from the OGTR before a proper consideration of the recommendations of that review—unless we move this amendment.</p> <p class='motion-notice motion-notice-truncated'>Long debate text truncated.</p>-
- 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."
- 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 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).
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