Thursday, 10 February 2022
Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021; In Committee
The committee is considering the Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021 and amendment (12) on sheet 1519 moved by Senator Canavan. The question is that sections 28F and 28G in item 17 of schedule 1 stand as printed.
The question is that sections 28F and 28G in item 17 of schedule 1 stand as printed.
At the request of Senator O'Neill, I move amendment (1) on sheet 1540:
(1) Schedule 1, page 6 (after line 37), after item 10, insert:
10A At the end of Division 1 of Part 2
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.
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.
I urge senators to vote against this amendment. This bill already effectively requires successful clinical outcomes from the clinical trial phase before moving to stage 2, the use of mitochondrial donation techniques in clinical practice. As outlined in the revised explanatory memorandum, stage 2 will only commence after the clinical trial has demonstrated success over a number of years and the results have been evaluated by experts. Over that period of time it is expected that significantly more data than the minimum data proposed in this amendment will be acquired.
Proponents of this amendment may say, 'Then why not put a minimum requirement in?' However, that may create the false impression that it would be appropriate to move to clinical practice once this minimum threshold has been reached and raise misplaced expectations in stakeholders. It is an important area in which we should rely upon expert assessment of the appropriateness of movement from the clinical phase of trials into clinical practice, and that we have that expert assessment of all available data, whatever is deemed to be required, to make sure there is confidence in that regard.
In addition this amendment could also create further legal uncertainty, as it might be that this would be the only consideration that could legally be taken into account when deciding whether to move to stage 2, with an implication that the broader range of factors intended to be taken into account couldn't be considered. I urge senators to oppose this amendment. The bill as drafted sets out very clearly the high standards required to move from trial to practice and that it is, rightly, for scientific experts to make sure those standards have been met.
We discussed at length last night the fact that, as drafted, this bill has only minimal regulatory oversight of these processes. Indeed, there isn't really a regulator as such—certainly not a solely devoted regulator—in charge of issuing the licences associated with mitochondrial donation. It is governed completely by the NHMRC and the minister, neither of whom are themselves a dedicated regulator. That would have been ideal from the perspective of myself and others in this chamber; ideally we would have preferred to have independent arm's-length regulation through the OGTR, as we discussed last night. Those amendments have failed. It would seem, in that environment, to be prudent to put some quantitative hurdles before proceeding to a widespread clinical practice.
Just like our amendments last night, none of the amendments here stop, prevent or slow down the provision of mitochondrial donation services. Of course we'll need to have participants go through these trials, which will include, potentially, live births. There are clinical trial licences that can be issued before reaching this 20-participant threshold, so we can have real outcomes for parents going through the trials in terms of not passing on mitochondrial defects to children, if these processes work. That can happen all through the trial period; there's no limitation, through this amendment, on that occurring. We can still do all of that.
If this amendment is accepted, we just have to do 20 trials before we would proceed to widespread clinical application outside of a more monitored trial framework. We think that is a more than reasonable number. I dismiss the arguments put by the government, through Senator Birmingham, that somehow this would be an artificial hurdle. It seems a pretty weak argument that somehow, just because we reach 20, everybody thinks we have to go to stage 2. There's nothing in this amendment which would suggest that at all. Indeed, this amendment does not get rid of the provision that Senator Birmingham highlighted which requires successful trial applications to occur before moving to stage 2. So, just because we have 20 trial participants, if none of those are successful, there are other provisions in this bill which would prevent stage 2 from occurring.
I am concerned, though, that the term 'successful' that Senator Birmingham is relying on is not defined in the bill. Potentially it could mean just one success would be sufficient to meet that hurdle before proceeding to stage 2. It doesn't need to be plural. We know from the evidence received through the Senate committee that there is a risk through these processes of so-called off-target genetic modifications, which may not become apparent through simply one, two or a small number of mitochondrial donation processes. So it would make sense to do some larger number. The number 30 is normal in statistics. Thirty participants tends to get you a low-confidence interval when you're dealing with risk and uncertainty. We haven't gone quite as high as 30, but 20 seems like a reasonable number of participants to go through this trial, so that we have clear, risk-adjusted data on whether or not these donation processes can succeed in the broad, before proceeding to the stage 2 process.
There are a couple of points that I would like to make in speaking to this amendment this afternoon. First of all, as we discussed a little bit last night, I think it's important to acknowledge the structural conservatism of the legislation before the chamber currently. That is to say that, if this bill passes today, it will trigger one of three stages of this overall legislative process.
Stage 1 is a trial of 10 years in duration. As I observed last night, on average, 56 kids are born with severe mitochondrial disease every single year. That means before we get to the point 10 years down the road of broadly offering the public and parents the opportunity to make a choice to undergo a procedure that may save the life of a child, about 560 kids may well have lost their lives. A decision has been made in the course of the crafting of this legislation—informed as it has been by multiple Senate inquiries and community consultation—that the duration of that waiting period and, therefore, the potential for that loss of life which may have been prevented by the earlier provision of these services to the public, is the correct balance to be struck. That's the proposition that has been put before the chamber by this legislation. The proposition of such a long trial period is why the proponents of this bill and the community organisations that have been campaigning for this bill see this moment as bittersweet. That's because, even if the legislation passes, they know that their suffering and sadness will be perpetuated, year on year, through many families before such a medical opportunity for the prevention of that suffering is offered to the community.
Within that context, we consider Senator O'Neill's amendment. I will note two aspects of this amendment. Firstly, that it asks us to, in addition to that 10-year trial period, and the conclusion of that 10-year time period, add another barrier to the provision of this technique to the community. It asks that we add the barrier that the procedure, the technique, has been used on at least 20 trial participants, meaning that, at the conclusion of the 10-year period, there would be another benchmark to be met. I ask the chamber, and I have asked myself, whether such a number is inherently arbitrary in its nature.
We saw in the House of Representatives Mr Andrews offer an amendment which was different in its nature. It asked for five positive outcomes. That's rather than 20 trial participants. But it was no less arbitrary in the selection of its number. It was five positive outcomes. It could have been 10, four, 15, 20 or 34. It was up to him. It was about what made him feel personally comfortable. So it is, too, with this amendment. Twenty trial participants are offered to us today. It could have been 15, it could have been five or it could have been 40. The proposition in this amendment is that, regardless of what has been gained through the clinical studies carried out by the NHRMC by, as we heard last night, some of the eminent minds in the nation in relation to IVF treatments, who have been doing this work so well since the early 2000s, we should add an additional barrier of an arbitrary nature.
Given that constant ticking clock of life and the suffering that will be the reality of kids that will already, as I said, be born in their hundreds between the passage of this legislation and the provision of this service to the community, I personally believe that that is an unacceptable and unnecessary additional barrier. I do not think it adds value to this legislation to insert an arbitrary number simply because it meets a level of personal comfort. This is not a scientifically informed number. This is an arbitrary number for personal comfort. We here this afternoon are considering a piece of legislation which turns upon the axis of science. So let us have faith in the experts, as we have had faith in the experts during the pandemic. Let's not put arbitrary barriers in the way of the provision of this legislation.
The second point I will make is in relation to subsection (b) of the amendment, which seeks to have the outcomes of the use of the technique on the trial participants published. We circle back again to this question of public scientific data. Last night I read into the Hansard a letter sent by one of the eminent scientific experts leading the work in the United Kingdom setting out explicitly that the absence of scientific publication of the outcome of this legislation is to in no way be interpreted as anything other than the impact of COVID-19 combining with the complexity of the United Kingdom's privacy requirements in relation to assisted reproductive techniques and that those privacy requirements are being worked through. In due course, those findings will be published. We in this Senate have no reason to believe that statement to be anything other than a true and accurate reflection of what has taken place in the United Kingdom.
We also know that this legislation gives us 10 years in which to see the findings of the UK processes that are playing out and to play our role as scrutinising legislators when making inquiries of the NHMRC. So many avenues are available to us to scrutinise this process, and we should apply ourselves to that scrutiny, not place arbitrary barriers in the way of a much-needed advancement in medical science. For those reasons I will be opposing the amendment, and I urge the entirety of my Senate colleagues, including those across the chamber, to join me in that opposition.
Just briefly, I want to respond to some of the, I think, errors or misinterpretations of this amendment in Senator Steele-John's statement and to some of the accusations made. Senator Steele-John said that this legislation gives us 10 or more years to evaluate the trial and research phase. The legislation does not do that. The government estimates in the explanatory memorandum that the research and trial phase may take 10 years, but there is nothing in the legislation which prescribes that the research and trial phase will last 10 or more years. It could be done in two or three. There is no limit at all placed on the number of years.
I also want to respond to Senator Steele-John's statement that this was not based on science at all. I only briefly mentioned this in my original contribution, but I will just lay out here that in fact there is a statistical, scientific basis for the number of 20 trial participants that we have settled on in this amendment. As I mentioned before, the outcomes that are going to come from mitochondrial donation techniques are going to be different for different people, absolutely for sure. Almost all medical treatments have different effects on different people. It would normally be possible to express the effects in some kind of normal statistical distribution, in terms of their success or failure or other attributes. When something is uncertain or provides outcomes that do not deliver a definitive result, in scientific statistics the common rule, as I mentioned in my original contribution, is that, if your sample size is at least 30, you generally will have a sample size that accords with the overall population. It's known as the central limit theorem, and the rule of thumb is that, once you get to about 30, your so called t-stat, which is what you get from a sample population, will start to converge on the limit of the z-stat which is what you get from the—almost always hypothetical—population distribution. So 30 is usually the figure used.
We didn't choose 30, because we can see that in the UK, after almost eight years of work, they have only had eight participants go through, so, if 30 were chosen as a threshold, it might be a generation's time before we go into that clinical phase. So, even though 30 would be the statistical, scientific number, we thought it would be more reasonable to choose a lower number: 20. Keep in mind that you've already had eight go through in the UK, without a single successful live birth, so an additional 12 on top of that number of participants seems a fairly reasonable request of the science in this regard. Yes, that will take a number of years, but in no way, as I said before, will that hold up the provision of these services, because the provision of the services can occur right now. Once the bill passes—if the bill passes—the provision of mitochondrial donation services can occur straightaway, not through the clinical practice process but through a trial process. So no-one will be denied or unnecessarily delayed in their provision of the services. Of course, while the trial is occurring, they'll be subject to significant monitoring and oversight, which are the conditions that are placed in this bill. I do think it's reasonable that 20—or at least something like 20—participants go through such a trial phase so we understand all of the different potential effects that might occur in different people with different genetic structures as best as we can before going through to the clinical practice stage, where there is less oversight and less intense activity than would be associated with a trial phase.
I would like to make a number of comments on this in support of Senator O'Neill's amendment. First of all, I would like to commend Senator O'Neill and Senator Canavan. I support his earlier comments of 20 minutes ago and will not be repeating them. I support them very strongly.
I want to draw attention to Senator Birmingham's comments and in particular to Senator Birmingham's assumption that parliament will make the right decision ten years from now, well into the future. That has been misplaced, unfounded. In fact, we see that quite often in this parliament it has a history—and I don't just mean this parliament; I mean parliaments for many decades now—of senators and members in the lower house making decisions that not only weren't based in data but contradict the data. Now, here we are, forecasting what will be the case in ten years time. That's why Senator Canavan's and Senator O'Neill's amendments and their speeches are so important. We have a history of ignoring and even contradicting the hard data, and now we're forecasting ten years into the future, so we're assuming success. And, as Senator Canavan said, without the definition of success that's not scientific, that's absurd. Uncertainty and risk abound everywhere. We haven't seen what's come out of the United Kingdom yet. The level of confidence in this is very, very low. I'm reminded of President Eisenhower warning us of the military-industrial complex. In that same speech, which most people know about—they don't know about this statement—he also warned us about the science and technology agenda and to not assume that experts know what they're talking about.
We're sitting here in masks, and there's no evidence anywhere that they have any effect. There's plenty of evidence showing they don't. Many of the senators right now have been double injected, whatever that means—fully injected, whatever that means—because that'll change; we haven't had any evidence on that and we've seen evidence of severe adverse effects.
We see protesters out the front, some of whom who have been injected, saying that they are opposed to the coercion. Will we see this coercion continue for the next ten years and fulfil Senator Canavan's concerns? I'll read a text here from someone coming down from Queensland: 'We're on our way to Canberra today, taking a car full of people. Thanks, once again, for everything we're doing for truth in this most critical time.' Truth in a parliament! Fancy being thanked for telling the truth. 'Whoever would have thought in our lifetimes we would see the removal of our freedoms and the destruction of our democracy.' This lady is a mature, very strong, very intelligent lady who has concerns about what is happening to our country and the loss of freedoms.
I'll go to another: 'Compliance and blind faith have been the problem. People have been taught to trust people in positions of power.' Here we are, going into the future unknown and making forecasts as to what'll happen and what will be successful and won't be successful. I have no faith in experts—it is just a label. I have faith in data. I have no faith in parliamentarians. That's why I will be supporting Senator Canavan and Senator O'Neill.
I rise in support of Senator O'Neill's motion. I acknowledge and give support to the comments of Senator Canavan. I think it's important for senators to remember the lack of data around the very scheme that we are being asked to legalise. There is a significant lack of data. It is the case that this technique would create a human being the type of which is expressly prohibited from being created today—that is, a human being with three people contributing to its genetic make-up. In this debate I've heard some senators make claims that none of the mitochondrial DNA actually affects the unique characteristics of who we are. That's not entirely true. In fact, I would encourage senators to read the report that came out of the 2018 Senate inquiry. We simply do not know the scientific effects on future generations of altering mitochondrial DNA. We simply do not know.
The Senate report went into this in some detail. The Senate report said this was 'a foundational question to be answered prior to any legalisation of mitochondrial donation.' Let me repeat that. This is a Senate report. These are not dissenting comments; this was a cross-partisan report from an inquiry chaired by our former colleague Greens senator Rachel Siewert, who did remarkable work. I was a member of that inquiry. It said that this is 'a foundational question to be answered prior to any legalisation of mitochondrial donation'. I would argue, based on the lack of evidence available to us—in fact, I did argue this in my speech on the second reading—that we have not answered that foundational question. In being asked to vote on this bill, we have a foundational question that has not been resolved.
I will come to how this amendment improves slightly on the bill by helping us try to put in a stage where that foundational question is resolved. Allow me to remind senators: in the United States, this technique is expressly prohibited. It is not permitted in the United States. The only jurisdiction that has legalised mitochondrial donation is the United Kingdom. We know that from the debate. In 2015, they legalised it. The department of health in the United Kingdom states on its website, 'We have limited evidence on risks and success rates,' of mitochondrial donation. That is undeniably true. In over six years, no baby has been born in the United Kingdom using mitochondrial donation. There have been reports—unverified reports—of babies born in Mexico and Ukraine. They have not been subject to any independent scientific verification or determination of whether or not the children are healthy or, indeed, whether they were born alive and healthy. We are literally legislating in the absence of evidence.
I've heard some senators make the observation that we should rely on science. I would be quite happy to rely on science. The reality is there isn't much science available to us in legalising this. I understand—and the arguments that Senator Steele-John puts—that this is a multistage process and we're going to have these clinical trials and we're going to get the science. If we're going to get it, what is so wrong with this parliament ensuring that there is a robust evidentiary base and that it is publicly verifiable? That is what this amendment does. It is this parliament's way of saying that if we are going to move to the next stage then we should be sure that there is a robust evidence base and that it is publicly verifiable.
It's not just about trusting the science; we also need to share it with the public. We need to take the public with us if we're going to make changes like this. Imagine where we would have been in COVID if we hadn't had information available to us to make decisions about booster shots, about vaccination, about mask wearing and about social distancing. We took the public with us, because we were able to share the science with them. That is what this amendment does.
In the United Kingdom, there have been 21 licences granted for mitochondrial donations since 2015, and as many as eight have been subsequently approved for treatment. However, there is no public reporting available for these outcomes. Senator Steele-John posits the argument—I'm not quarrelling with him—that this might be because of COVID and it might be because of privacy concerns. If we take the latter—privacy concerns that haven't been resolved—that's a failure of the UK parliament that we should not repeat.
Senator Canavan moved an amendment about the clinical trial stage not automatically moving on after ten years. That was voted down by the Senate. We also sought last night to put in a stronger regulatory regime through amendments. That was also rejected by the Senate. I acknowledge that. But what I would say in response to arguments put by Senator Birmingham is that there's nothing automatic in here. This does not automatically move us, after 20 trials, to the next stage. And this is the kind of thing we do in legislation all the time—we put in things in the legislation so that, if something is going to move on to another stage, appropriate benchmarks have been met before that happens.
So my frustration here is that this is not a barrier to moving on to the next stage of a mitochondrial donation; it is actually a safeguard. I do think, when we are legalising a technique where there is almost no verifiable scientific evidence to answer what our own Senate committee found to be a foundational question, that is it is entirely legitimate—indeed, it's entirely unremarkable—for the Senate to ask that there be some robust evidentiary base and that it be shared with the public. That's all this amendment does. It doesn't seek to create a legal barrier. It doesn't seek to exclude any other consideration. I've heard some senators raise a concern that perhaps you need more than 20 trials. Perhaps you do, but how will we know that unless we're able to be confident that 20 have happened and we're able to see the evidence for ourselves and take the public with us.
So I would encourage senators to just consider that we are legislating for something that is going to go for more than ten years. We are legislating for something where decisions are going to be taken by executive governments. People who might sit in those positions may not have even been elected to parliament yet. We have given away our capacity to have that decision come back to the chamber. We did that last night in rejecting one of Senator Canavan's amendments. We missed an opportunity to get a stronger regulatory regime in place for what is a novel and untested technique.
This amendment is simply making the rather unremarkable request that we have a solid evidence base and that it is publicly verifiable and able to be examined by the parliament and by the Australian people.
I wanted to quickly respond to a couple of things in relation to the contributions from Senators Canavan and Keneally. First of all, in relation to the view that Senator Keneally has put to the chamber that we as a body should take note of the absence of the legalisation of these techniques in the United States, I put to the chamber that that is not a factor that should factor into our consideration. There are many legislated differences between Australia and the United States, which I'm sure we all welcome. At the top of my mind is gun control. We have very good gun control in Australia; there is a catastrophic absence of that in the United States. The United States's legislative framework shouldn't feed into our considerations.
Secondly, I turn to the comment that Senator Keneally made in relation to the privacy settings that exist in the United Kingdom and whether they should be fixed before the legislation passes. Privacy in relation to facilitated reproductive techniques is paramount. It's paramount in IVF techniques across the board. Why is it paramount? Senator Rice will be very familiar with this phenomenon as well. People born of medically facilitated techniques are often considered, in religious contexts, to be abominations and are subject to profound discrimination. So it is very important that we guarantee the privacy of those individuals. On Senator Keneally's point, I would also say that this is a trial. What's so wrong with inserting a number?—simply because it is arbitrary. It is an arbitrary number, as Senator Canavan said—something like 20. Well, why not 10? Why not five? Why not nine? It is arbitrary and there is no place in a scientific trial for us to insert ourselves in that process.
Finally, I make mention of the contributions made last night and today that touch on the rights of a child born of more than two parents. I simply put to you that we have two choices before ourselves today: to pass this piece of legislation or to not pass this piece of legislation—to pass it in a form that works or to put it in a form that hampers this work. If we take the path of passing these amendments, or voting down this bill, we will never have the opportunity to ask the individuals potentially born of these techniques what they would wish in relation to these rights. However, if people in this chamber are really very interested in having conversations with individuals born of complicated facilitated medical techniques then let us pass this bill and, in a decade, have the opportunity to ask them.
I will be very brief. I was originally quite sympathetic to this amendment, and in fact had informed Senator O'Neill that I'd probably support it. I now think it is not an appropriate amendment to support. I can see where it's coming from—the need to ensure there's appropriate scrutiny, accountability and transparency—good data and really good scrutiny of the trial. But the arbitrary nature of 20 participants doesn't provide that appropriateness. There's a much more complex lot of factors that you need to take into account, rather than having an arbitrary 20 participants go through a trial.
The other part of the amendment that I was sympathetic to was the need for published data. It is an issue that, for whatever reason, we have not got any published data out of the UK trial. That said, essentially we're beginning a trial. Yes, we absolutely need the scientific evidence—that is the whole purpose of this first stage of the trial. I also note that we do, in fact, have NHMRC at every estimates—if we want to have them—where they can be questioned, and if the Senate feels that they are not doing an appropriate job of oversighting this trial then it is open to us to put more measures in place. So I put on the record that, having considered this very thoroughly, I've decided not to support this amendment.
For clarity on the remarks that Senator Rice made—and I'm not privy to the discussions she may or may not have had with Senator O'Neill—is reducing the number from 20 to another number something that the good senator would be considering?
The TEMPORARY CHAIR: Senator Rice, would you like to respond?