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senate vote 2022-02-10#9
Edited by
mackay staff
on
2022-02-11 16:19:23
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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 - Annual report
Description
<p class="speaker">Matthew Canavan</p><p>The amendments that I and other colleagues have moved through the committee stage have pretty much solely been focused on trying to improve the accountability, monitoring and oversight of what are revolutionary and novel technologies. Many of the amendments have been aimed at providing more oversight from this place, in this institution. I'm obviously disappointed that we have chosen not to strengthen our arm in providing more oversight but instead leave it effectively to the scientific community to make these decisions.</p><p>I am intending here to move another set of amendments which, while would not really provide much oversight or monitoring, would at least provide to us some more information on what is occurring in these trials than what is currently prescribed in this bill. The bill, as amended in the House—and I do give credit again, as I did in the second reading speech, to Mr Kevin Andrews. He and others pushed for some more reporting, and I thank the government for agreeing to those amendments and providing some additional reporting than what was there originally. However, the reporting that is there now on a six monthly basis does not have to prescribe any particular information, so there are no guarantees that this will include details of how many trials have occurred, how many participants have gone through those trials, how many have been approved, whether or not there have been adverse events associated with the donation techniques or even what types of donation techniques have been used, and we'll come to those later in other amendments. I don't think it's appropriate that, for something as novel and revolutionary as this, it should ultimately be up to the people that are regulating this area what information they provide us—and I use that with a lower case 'r' as they're not a regulator exactly; they're overseeing this area.</p> <p class="speaker">The Chair</p><p>Senator Canavan, it may assist the Senate if you move the amendments. I'm guessing it's the ones on sheet 1520.</p> <p class="speaker">Matthew Canavan</p><p>I'm happy to move those at the end of my contribution. I do intend to do that, but of course I would like to explain the reasons for them, and I'm sure we'll have a discussion.</p><p>We need to make sure here that the regulators do provide the information so we can assess what's going on. This is really important, because we've seen from the UK experience there hasn't been a lot of information provided about what's going on. In the UK, they legalised mitochondrial donation techniques in 2015. We have extremely limited information from the UK about the outcomes of the donations that have occurred to date or at least that people have been going through them. We don't even know if mitochondrial donation has occurred in any real sense. We know that I think 20—maybe 21—participants have been approved to proceed through the process and there have been eight, apparently, who have actually received some services. But, as I say, we're not sure of the content of those or what has occurred or the outcomes. To my mind, it is completely inadequate that after almost seven or eight years now we have not received information on the barest of details about what is occurring in the UK. It's an issue here for us. It was an issue in the Senate inquiry that I participated in that there wasn't a lot of detail about exactly how these revolutionary techniques have been used in the one jurisdiction in the world where they are legalised.</p><p>As I and some other colleagues thought through this, we thought that we should actually try to specify, as a parliament, at least some minimum information that should be in reports. We have decided annual reports are fine. As I mentioned, the government had decided on six monthly reports, but, given the slow pace of these technologies overseas, we didn't think six monthly reports were absolutely necessary. So an annual report would be fine, but we do think it should require some minimum information that can provide people with an oversight of what is occurring and how these are being developed.</p><p>By leave—I move:</p><p class="italic">(1) Schedule 1, item 17, page 34 (after line 11), at the end of Division 4A, add:</p><p class="italic">Subdivision G — Other requirements relating to mitochondria l donation licences</p><p class="italic">28Y Annual reports</p><p class="italic">(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).</p><p class="italic">(2) The report must include the following de-identified information in relation to the reporting period:</p><p class="italic">(a) the number of each kind of mitochondrial donation licence issued under section 28J; and</p><p class="italic">(b) the outcomes of the activities carried out under each licence issued under section 28J, including:</p><p class="italic">(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</p><p class="italic">(ii) the number of adverse events notified to the NHMRC Licensing Committee under paragraph 28S(3)(a); and</p><p class="italic">(c) all clinical data obtained as a result of the activities carried out under each licence issued under section 28J, including:</p><p class="italic">(i) experimental data obtained from the use of the permitted technique specified in the licence; and</p><p class="italic">(ii) clinical data about each child born as a result of a pregnancy achieved using the permitted technique specified in the licence.</p><p class="italic">(3) The Minister must table a copy of the report in each House of the Parliament within 10 sitting days of that House after receiving the report.</p><p class="italic">(4) For the purposes of this section:</p><p class="italic">(a) each of the following periods is a <i>reporting period</i>:</p><p class="italic">(i) the period of 12 months beginning on the day this section commences; and</p><p class="italic">(ii) each subsequent period of 12 months; and</p><p class="italic">(b) information is <i>de-identified</i> if the information is no longer about an identifiable individual or an individual who is reasonably identifiable.</p><p class="italic">(2) Schedule 1, item 55A, page 47 (lines 10 to 22), to be opposed.</p><p>The details of this amendment are not restrictive—more information can be provided than what is outlined here. But, as I say, we are just seeking a bare minimum of information that should be provided. In that information, we would like to see the number and kinds of mitochondrial donation licences that have been issued under section 28 J of the act. We would like to see the reporting include the outcome of the activities of each licence issued under that same section, including in this information the number of births of children as a result of pregnancies achieved by mitochondrial donation techniques. Additionally we would like to see the number of any adverse events notified to the licensing committee under a specific paragraph in the bill.</p><p>I don't see these amendments as being at all controversial. They should not be controversial. It should be a basic requirement for the reports to include this kind of information. As I say, there seems to be a risk that we may not get this type of information given the experience of the United Kingdom over the past seven or eight years. I'm sure we will hear other speakers say, 'We don't need this because it will be provided anyway,' but I'm a little bit concerned that may not occur given what has happened in the UK.</p><p>I want to make a broader point here, too, that goes harking back to the arguments we have been making. We have effectively established a system, through rejecting other amendments, of self-regulation for gene therapy research here in Australia or at least a precedent of that, in this case, on the mitochondrial donation techniques. The only regulation oversight of the mitochondrial donation techniques will be done by the organisation that is commissioning and funding the research in this field. That is self-regulation. The people at the NHMRC are great people, intelligent people, but they are directly involved in the research itself and they are being asked under this bill to regulate themselves, to be the only people actually overseeing what is occurring.</p><p>I wanted to make the point sometime in the debate, because I've noticed that the debate in this place has evolved over the past day, that a number of speakers have seemingly suggested that scientists are somewhat of an infallible species among us, that we don't need to question or oversee the work of scientists because they are very intelligent, know what they are doing and can be trusted. Some of those things are true. No doubt scientists are extremely intelligent. No doubt the successes of science are things we can learn great lessons from. No doubt the successes of science are things we have all benefited from in some way. But to suggest there are no risks involved with scientific research blinds you to the history of scientific development among the world and, indeed, the history that we are living through today.</p><p>To date, we still don't exactly know where the coronavirus came from, but we are absolutely sure that the relationship standards and oversight of research at the Wuhan Institute of Virology were definitely deficient. There were issues. Perhaps the coronavirus itself and this whole pandemic came from that lab and deficiencies associated with that the lab. We had a situation where we only learnt after the event that our own researchers at the CSIRO were cooperating with and training researchers at the Wuhan Institute of Virology on coronaviruses in bats. They were doing that. It's all come out since. They were regulating themselves and deciding this themselves. There wasn't any oversight of this. It is a bit complex, of course, and we didn't know about it. Ministers I have spoken to didn't know about it. We know now, from evidence in this place and other work by journalists like Sharri Markson, that our own CSIRO, a great organisation, with really great people, trained Shi Zhengli, the so-called bat lady, at the Wuhan Institute of Virology. They collected samples of coronaviruses in bats here in Australia and helped Wuhan Institute of Virology scientists work out how to identify which coronaviruses would be more effective in infecting human cells. They provided human stem cells to the Wuhan Institute of Virology to do further work on coronaviruses in bats. That all happened here.</p><p>That's before you get to what happened over in the United States with their scientific organisations, which seemingly had an even stronger and closer relationship with the Wuhan Institute of Virology, including funding people that did work there. We have all seen the potential cover-up that has occurred since. The complete lack of oversight over those processes may have caused the deaths of millions of people around the world and untold economic damage to almost every country.</p><p>We do need some oversight of what is occurring here. This is a bare minimum. It's just asking for some specific data. It is commonsense, and it will not in any way stop or prevent mitochondrial donation techniques occurring. I ask the Senate to approve this amendment.</p> <p class="speaker">Simon Birmingham</p><p>I discourage senators from supporting this amendment because the bill before us already provides some very clear reporting requirements; section 19 of the Research Involving Human Embryos Act requires the Embryo Research Licensing Committee of the National Health and Medical Research Council to report to the parliament about the operation of the act and the operation of licences issued under it every six months and also when required by either house of parliament. So it's been very clearly established that there is to be frequency and even on-demand, where required, reporting arrangements put in place. Others have noted the role that the NHMRC has in relation to accountability to the parliament through estimates and other vehicles as well.</p><p>The second reason as to why I discourage support for this is that, as well as it potentially being duplicative and confusing, it runs the risk of undermining some of the privacy considerations that are clear. This amendment would remove the provisions that ensure that reports that are provided do not identify any person or are not capable reasonably of being used to identify any person. Clearly those privacy considerations are important, and so I would urge the Senate to support the existing quite comprehensive reporting arrangements.</p> <p class="speaker">Murray Watt</p><p>For similar reasons to Senator Birmingham, I would also encourage senators to vote against this amendment. This amendment I accept on the surface seeks to increase transparency, but the risk is that it does the very opposite. Under Australia's Privacy Act any information provided about a cohort of less than 10 people, even if de-identified, does not achieve anonymity and therefore is not permitted. As a result, in the event that there are fewer than 10 live births in any given year, instead of receiving more information, as is suggested by the amendment, no report would be able to be tabled at all. So, again, I encourage senators to vote against this amendment.</p> <p class="speaker">The Chair</p><p>The question is that amendment (1) on sheet 1520 be agreed to.</p><p></p><p></p> -
- 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 Parliament within 10 sitting days of that House after receiving the report.*
- >
- > *(4) For the purposes of this section:*
- >
- >> *(a) each of the following periods is a reporting period:*
- >>
- >>> *(i) the period of 12 months beginning on the day this section commences; and*
- >>>
- >>> *(ii) each subsequent period of 12 months; and*
- >>
- >> *(b) information is de-identified if the information is no longer about an identifiable individual or an individual who is reasonably identifiable.*
- ### 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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