Andrew McLachlan (SA, Liberal Party) Share this | Link to this | Hansard source

The question is that the bill stand as printed.

Deborah O'Neill (NSW, Australian Labor Party) Share this | Link to this | Hansard source

I move opposition amendment (1) on sheet 1542:

(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.

We also oppose schedule 1 in the following terms:

(2) Schedule 1, item 103, page 56 (lines 16 to 23), section 47 to be opposed.

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.

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, Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021 [Provisions] 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.

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.

Murray Watt (Queensland, Australian Labor Party, Shadow Minister for Northern Australia) Share this | Link to this | Hansard source

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.

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.

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.

Jordon Steele-John (WA, Australian Greens) Share this | Link to this | Hansard source

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.

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.

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.

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.

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.

Louise Pratt (WA, Australian Labor Party, Shadow Assistant Minister for Manufacturing) Share this | Link to this | Hansard source

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.

Matthew Canavan (Queensland, Liberal National Party) Share this | Link to this | Hansard source

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:

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.

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.

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.

Kristina Keneally (NSW, Australian Labor Party, Deputy Leader of the Opposition in the Senate) Share this | Link to this | Hansard source

I'd like to associate myself with the remarks made by Senator O'Neill and Senator Canavan and indicate to the chamber that I will be supporting this amendment.

I am prompted to my feet in part by the comments, which I do respect, from Senator Steele-John because I do fear that those who are watching this debate may form a view that those of us who do not support the bill are somehow against medical progress or medical technology. We are not. In fact, I do agree with Senator Steele-John: research, technology, progress and things that save lives should occur. And Senator Steele-John makes a very valid observation about how his own personhood demonstrates the capacity of medical research and advanced understandings that people with a disability not only survive births that they wouldn't have decades ago or centuries ago but indeed are able to live lives fully participating in the community. I say to Senator Steele-John that two of my three children would not have survived their births had it not been for caesareans and other medical interventions. I think we all have stories like that in this chamber. We all do.

One of my children didn't survive her birth. She died of a genetic condition for which there is no known cause or cure. Yet I can't support this bill because, in my mind, and on the basis of both ethical convictions and the paucity of the scientific evidence, I have serious concerns. Just because we can do something, it doesn't mean we should do it.

The way I think about the need for regulation and oversight here is not dissimilar to how I think about regulation and oversight when it comes to extraordinary powers, for example, in the national security space. The view I bring to those legislative considerations is the more intrusive a power the more necessary that there be appropriate oversight. This is an incredibly intrusive power. Let's be clear about it: if it passes this parliament, it is an incredibly intrusive intervention in human existence.

We are not only going to intervene in one of the most personal situations of the human existence—that is, how children are conceived—but we are going to do it in a way that is novel, that is untested and that will alter mitochondrial DNA. We don't yet know what the outcome of that is on human beings; we simply don't. We have theories, but we don't know. Indeed, the Senate report—this very chamber's own report—said that that was a foundational question that needed to be answered, and it hasn't been answered. What we know is that the United Kingdom does not have data to provide. I believe they have issued six licences. I could stand corrected; it might be eight, but they've got six, and no baby has been born. We just don't have that data.

So, although I will be voting against this bill even if this amendment passes, I think it is important that, if this bill does pass this parliament, there is appropriate oversight. Senator Canavan is right: we have a bill involving such significant intervention into the human condition—the very nature of who we are as human beings—and we haven't identified the appropriate oversight body. To me, that is a fundamental flaw of the legislation. It may be right that the Office of the Gene Technology Regulator is not the most appropriate body, and, if this bill were to pass and the government wants to come back and find a different oversight model, I'd be open to that. But I think there must be something. The Office of the Gene Technology Regulator is in the Department of Health, and, in the absence of having any other body, I think it's appropriate that that is the body.

Again, I come back to the comments of Senator Canavan about not having a tension or a conflict of interest between the practitioners and the oversight bodies. That's a fundamental foundational principle when it comes to how we deal with national security legislation and intrusive powers.

I think it's incredibly important that this bill use appropriate oversight should it pass. This may not be the perfect solution, but it is better than what is currently in the legislation.

Louise Pratt (WA, Australian Labor Party, Shadow Assistant Minister for Manufacturing) Share this | Link to this | Hansard source

It's important to clarify in the context of this debate that the review that was done recently into the Office of the Gene Technology Regulator specifically found that they are not an appropriate body to oversee gene technology in people. That review recommended that the act be clarified so that people are not regulated under that act, which is what this legislation before us today does.

When we look at the ongoing ramifications of the Research Involving Human Embryos Act and reproductive technology, it's not correct to say that there is no further regulation than via the NHMRC. The states have handed back much of their powers that relate to gene technology to the federal gene technology regulator, but in the case of reproductive technology, the states retain that power when reproductive technology is rolled out and when it's implemented.

The NHMRC is, in and of itself, already limited in how far it can go before it reaches the next stage of clinical trials or rollout because it can't get to a clinic in the state of Western Australia, for example, until the state government there also makes laws through its parliament. Then it has a whole new set of ethical considerations with hospitals and providers that, again, it will do through its own state regimes. I think it's really important to put that on the record.

Jordon Steele-John (WA, Australian Greens) Share this | Link to this | Hansard source

I want to acknowledge Senator Keneally's contribution in the debate this evening. Thank you for sharing your lived experience and bringing that lived experience to the debate today. As somebody who does that a lot from a different perspective, I know it can be a really tough thing to do, and I'm sure the entire Senate will join me in extending to you our deepest empathy on that terrible loss.

I would like to read something into the record for the benefit of the chamber, because I think there's a very legitimate red flag that goes up in your mind when you hear about a new technology, a new procedure, taking place in a jurisdiction overseas that has not yet produced—as has been articulated by others in the debate—peer-reviewed research that we can reference here in the debate today. That's a legitimate red flag that would come up in people's minds. It's something that hit me when I first looked at this legislation. In fact—I'll be quite open with the chamber tonight—when, as a newly minted health spokesperson, I had this legislation land on my desk, I had a bit of sickness come into my stomach. My initial view on looking at the legislation—just skimming it—was that there would be some inherent risks in the legislation before us, that we could be heading down a path without enough research and information.

Why did I have that concern? Again, I come back to both my personal experience as a disabled person and the community's broader experience. Our experience as disabled people, historically, is that if there is a socially acceptable or medically applicable way to delete us from the social fabric, to eradicate us, that is the path that is taken. I would hope that many in this place would know that notably—although not for the first or last time during the Second World War—one of the first acts of the Nazi regime was to implement something called the T4 program. The goal and principal purpose of the T4 program was the elimination of what the regime named 'useless mouths'. Vans would trawl through communities, collect disabled people and take them to a central institution where they would be euthanised and burned. They collected disabled people, people with social disabilities—so many that the town in which the primary furnace was based was blanketed in what the residents initially believed to be snow but which turned out to be human ash.

While this program is well known, though not as well known as it should be, what's less well known is that its inspiration was not drawn from some satanic death cult or the depths of deepest depravity but modelled on a framework which was used in the United States state of California, and which more or less stayed in place until the late sixties, whereby government sanctioned sterilisation of disabled women was state policy for the purpose of eliminating disabled people.

So if there were any community with a right to look at a piece of legislation like this suspiciously, it would be the disabled community, and I brought that critical lens to this debate. In doing that, I consulted with the Mito Foundation and many organisations advocating for the bill and with opponents of the bill. What I discovered, rather than a rushed and headlong attempt to introduce a vehicle by which disabled people might be deleted or somehow expunged from society, was in fact a pretty conservative bill. It's a bill consisting of three stages, the first stage of which, as the Senate knows, is a 10-year trial. This means that over that 10 years—if we take it as being correct that about 56 kids are born per year with severe mitochondrial disease and that the average life expectancy can be as low as a couple of years and up to 12—if we pass this law today, hundreds of children will be born and will die of mitochondrial diseases before this treatment even becomes available in Australia. It's a very conservative framework. During that time there will be oversight by groups of people who I put to the Senate are some of the best experts in the country in relation to facilitated reproductive procedures.

This question of the validity or existence of the scientific output of the United Kingdom's trials has been part of the Australian discourse. One of the key medical professionals involved in the framework in the United Kingdom has written to me, and I will read their letter verbatim into the record for the benefit of the chamber:

Dear Senator

I congratulate the Australian Government in their efforts to bring forward legislation to allow mitochondrial donation to reduce the risk of disease in children born to women who carry pathogenic mtDNA variants.

I am the Clinical Lead for the licenced mitochondrial donation programme in the UK.

I understand that concerns have been raised in Australia regarding the lack of information available from the UK regarding babies born of mitochondrial donation since our legislation was passed in 2015. UK legislation and regulation has allowed for such treatment to take place in a programme that was to be cautiously introduced. As with all licenced fertility treatment in the UK, regulated by the Human Fertilisation and Embryology Authority confidentiality for patients and offspring is paramount. Our programme has progressed but with small numbers of suitable patients involved it is imperative that their privacy is guarded. We will publish programme data in due course.

This lack of clinical information should not be interpreted to imply concern about the technique but is to safeguard the privacy of infants and their families.

Yours faithfully

Dr Jane A Stewart MD FRCOG

Consultant in Reproductive Medicine

I also have here a letter from Mary Herbert PhD, from the same Newcastle facility centre, who goes into great detail about some of the challenges that have faced the UK program, not least the reality of COVID-19.

So when you question the scientists who have dedicated their lives to this, let us remember that we are in the middle of a global pandemic, where our lives more than ever before are in the hands of scientists, where the constant catchcry of most—though not all—of the members of this place is to follow the health advice. We have here clear statements from leaders in their field speaking to the reasons for the absence of data which we can analyse to this point.

I put to the Senate today that not only will we have time, as the United Kingdom recovers from COVID, to gather the UK data but we will also have 10 years of our own data, if the trial is able to be conducted methodically and appropriately, which will be ensured as it will be overseen by the experts in this field at the NHMRC.

Matthew Canavan (Queensland, Liberal National Party) Share this | Link to this | Hansard source

I want to very briefly respond to some of the further points that have been made. I think we should be very clear that, if this amendment is not passed, we will have less regulation on human gene therapy than we have on animal gene therapy and plant gene therapy. That is the reality. Animal gene therapy and plant gene therapy are regulated by the Office of the Gene Technology Regulator. It's a specific, arms-length regulator. It is a regulator, not an advisory body and not a research body. It is a regulator through and through—a statutorily independent one at that. It's appropriate for something as significant as gene therapy that we do have an independent regulator.

The review of the Gene Technology Regulator which has been referenced by a number of people says:

… stakeholders identified a potential gap in regulation pertaining to the modification of humans.

It is true that they conclude that the OGTR might not be the best body to regulate human gene therapy, but they're saying there's a gap today in human gene therapy. Of course, almost all human gene therapy research and clinical practices are prohibited in Australia—there are a few very limited research trials occurring—but they're saying there's a gap. This bill does nothing to fill that gap. This bill would instead make this gap a wide chasm, because we would remove the oversight of the OGTR—as undesigned for it as the OGTR perhaps is—and replace it with a subcommittee of the NHMRC, which is not a regulator body.

Indeed, if you go to the most recent statement of expectations the government has given the NHMRC, there is not a mention of the words 'regulation' or 'regulatory' or of anything to do with regulation. That statement says:

NHMRC is the Australian Government's key entity for managing investment in, and the integrity of, health and medical research.

It is not a regulator. If we do not pass this amendment, we will effectively have self-regulation of human gene therapy. It is not appropriate that we have lower regulatory oversight for human gene therapy than we would for animal and plant gene therapy.

Simon Birmingham (SA, Liberal Party, Minister for Finance) Share this | Link to this | Hansard source

At the outset, I want to acknowledge that, in debates like these on these free and conscience votes that occur, we sometimes see the best of contributions across our chamber—contributions that draw on the personal. I acknowledge Senator Steele-John's contribution and Senator Keneally's contribution. In the other place, I know, the member for Mayo spoke with great passion and emotion about the circumstances of her grandson with mitochondrial disease and the challenges that her family was facing in relation to his diagnosis.

I think it's important that we also acknowledge the different perspectives that senators come from. Whilst the standing orders always provide that we shouldn't reflect upon the motivations of any other senator, especially in a debate like this, I think it's crucial that we respect those different perspectives, informed by those different life experiences, by those different values and by the many different factors that each senator will bring to this debate—regardless of the political position or, ultimately, the votes that will be cast on a debate—as each grapples with what is a very sensitive technology with ethical considerations that need to be approached carefully.

With all that said, I support the words of Senator Watt in relation to the explanation he provided. I do not support the amendment before the chamber and would discourage senators from supporting the amendment. The Embryo Research Licensing Committee of the National Health and Medical Research Council would be responsible, under this bill, for regulating mitochondrial donation in humans. An expert regulatory approach will be applied. It is a body well equipped to undertake that role, in terms of its expertise. It has been in place under the Prohibition of Human Cloning for Reproduction Act since 2002.

If this amendment were to succeed, we would see a duplicative arrangement and an overlap of regulatory functions, as well as of acts, potentially. That is the clear view that I present, and I urge senators to consider that the consultation has led to an approach that provides for clear oversight and that will entail strong safeguards. We do not need to be imposing other layers that, as other contributors to this debate have acknowledged, may not even be through an appropriate entity in these circumstances.

Matt O'Sullivan (WA, Liberal Party) Share this | Link to this | Hansard source

I put the question that amendment (1) be agreed to.

A division having been called and the bells having been rung—

The Chair:

I just explain to the Senate that is my intention, because this is a conscience vote, to use the people who are sitting in the whips' chairs. If there's no-one sitting in the whips' chairs, I will seek guidance from the mover of the motion. We are dealing with amendments on sheet 1542, moved by Senator O'Neill. The first question is that amendment (1) be agreed to.

The Chair:

The next question is that section 47, in item 103 of schedule 1, stand as printed.

A division having been called and the bells being rung—

Zed Seselja (ACT, Liberal Party, Minister for International Development and the Pacific) Share this | Link to this | Hansard source

Madam Chair, I don't think one-minute bells are appropriate. I am told there were some senators who were hoping to get down here for this vote who weren't at the last one. I request that there be four-minute bells.

The Chair:

I advise the Senate that I did seek the guidance of the whips, and they informed me it would be one-minute bells. If it's the wish of the Senate, we will ring them for four minutes. Is that the wish of the Senate? It is. The question is that section 47 in item 103 of schedule 1 stand as printed.

The Chair:

I'm assuming, Senator Canavan, that you don't wish to proceed with sheet 1543? Thank you.

Matthew Canavan (Queensland, Liberal National Party) Share this | Link to this | Hansard source

The Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021, as senators would realise, establishes five different types of licences. It effectively establishes two stages to introduce mitochondrial donation into our laws. As has been described, this will be a new and revolutionary form of human gene therapy that is prohibited under our laws today. Because of that, the bill seeks to establish some trial and research licences in the first stage. There are three of those that are particularly specified in this bill. Then, following the research and trials, the bill outlines two additional licences—a clinical research licence and a clinical practice licence—that would then be allowed for to provide for widespread adoption of mitochondrial services to the broader population, outside of research and trials.

I am a little concerned here that the approach adopted in this bill continues some of the deficiencies we have seen emerge in the Senate on the use and overuse of delegated legislation. This bill establishes a regulatory framework for mitochondrial donation. However, at the conclusion of the research and trial phase—the so-called stage 1 in this approach—there are no specific conditions to be placed on the licences that will apply to clinical practice trials.

Jordon Steele-John (WA, Australian Greens) Share this | Link to this | Hansard source

Point of order, Mr Temporary Chair.

Matt O'Sullivan (WA, Liberal Party) Share this | Link to this | Hansard source

Yes, Senator Steele-John?

Jordon Steele-John (WA, Australian Greens) Share this | Link to this | Hansard source

Mr Temporary Chair, I draw your attention to Senator Antic, who is moving about the chamber without a mask. I would ask that you request that he wear one in line with the rules.

The TEMPORARY CHAIR: Senators are aware of the rules, and I would remind them of that.

Matthew Canavan (Queensland, Liberal National Party) Share this | Link to this | Hansard source

As I was saying, in this so-called stage 2 of the bill, moving to clinical practice trials, the conditions that would apply to those licences are not set or outlined in this bill because, of course, we haven't done the research and the trials, so, understandably, the government cannot at this stage outline in detail those particular regulations. For example, the explanatory memorandum to this bill says:

… organisations will not be able to apply to the ERLC—

the Embryo Research Licensing Committee—

for either of the two clinical practice related licences until a particular technique is specified in the Regulations for this purpose.

The explanatory memorandum goes on to say:

… Stage 2 would commence only after mitochondrial donation techniques suitable for use in clinical practice have been prescribed in the Research Involving Human Embryo Regulations 2017.

Keep in mind what we are doing if we do not amend this approach. We will continue the trends we have seen whereby the parliament delegates enormous power to the executive, and to ministers within that executive, to effectively make laws in the future that are not subject to the full oversight and scrutiny of this parliament.

I want to recognise the fantastic work that Senator Fierravanti-Wells, Senator Carr and others on the Senate Standing Committee for the Scrutiny of Delegated Legislation have done in this space. They have produced two groundbreaking reports—reports that I'm sure will stay on the shelves of many in this place for decades—about the overuse and risks of delegated legislation. Indeed, Senator Concetta Fierravanti-Wells, in tabling the final report in this place last year, commented that:

In theory, delegated legislation should only deal with purely technical or administrative matters, but this is no longer the case. In practice delegated legislation now often deals with matters of policy significance. An already unsatisfactory situation is becoming intolerable.

I couldn't agree with those words more—that, as senators in this place, we should be the house of review, we should be holding up standards that hold the executive to account on matters of policy significance. And this is clearly a matter of significance in terms of setting the conditions that would apply to a unique, novel and revolutionary form of human gene therapy. And, in that comment, Senator Fierravanti-Wells succinctly summed up that delegated legislation should be there for technical administrative matters—stuff that is urgent and cannot necessarily go through a full parliamentary process. The bill and explanatory memorandum said that the stage 1 process will take 10-plus years. So the delegated legislation that we would be approving without the bill being amended would not necessarily be exercised for another three federal elections. A completely different Senate would be here, and they would have no direct parliamentary oversight, apart from the disallowance process, to deal with the new regulations that may be set at that point.

Another good point that was made by Senator Fierravanti-Wells's committee is that we should have sunset clauses on delegated legislation. If we approve this bill, there will be more sunlight to the executive than would exist in Nordic countries in summer. It will be 10 years before they even consider it! We don't know what developments there will be in human gene therapy. We don't know what will happen in the UK and other countries. We will give a blank cheque to an executive in 10-plus years to write their own regulations then. I admit that we can disallow them, but we all know that's inadequate. It doesn't go through the committee process properly, it doesn't have to go through both houses, there are very rarely any public hearings associated with a disallowance, and it's an up-and-down vote. We can't have this process. There is no Committee of the Whole in a disallowance process. We can't amend the regulation. We have our hands tied somewhat when it comes to dealing with delegated legislation, even in a disallowable sense.

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.

In my view, these amendments become even more important given the fact that we did not agree to the regulatory oversight of the Office of the Gene Technology Regulator. I accept the decision of the Senate that has occurred here—that we will have scrutiny through the National Health and Medical Research Council. That body, as I've outlined, is not a regulatory body. There are at least some question marks here about gaps in the regulatory process. Surely, before we proceed with clinical practice trials, we should ensure that a full parliamentary process occurs. If these gaps remain—the gaps that I perceive, and plenty of other senators perceive; it was a very tight vote—then we could seek to look at how we fix those and fill those gaps at that point.

These are commonsense amendments that I would encourage all senators to adopt. They do not stop, slow down or in any way prevent the progression of mitochondrial donation technologies. They simply make sure that the scrutiny of this parliament and its integrity is maintained and we do not continue the trend of the executive of this country taking more and more power and authority from the parliament, where it should reside.

I seek leave to move amendments (1) to (11) and (13) to (55) on sheet 1519 together.

Leave granted.

I move amendments (1) to (11) and (13) to (55) on sheet 1519:

(1) Schedule 1, item 1, page 3 (line 13), omit ";", substitute ".".

(2) Schedule 1, item 1, page 3 (lines 14 and 15), omit paragraphs (d) and (e) of the definition of mitochondrial donation licence in subsection 8(1).

(3) Schedule 1, item 10, page 5 (lines 10 to 13), omit the definitions of clinical practice licence and clinical practice research and training licence in section 8.

(4) Schedule 1, item 10, page 5 (line 23), omit "; or", substitute ".".

(5) Schedule 1, item 10, page 5 (lines 24 and 25), omit paragraphs (d) and (e) of the definition of mitochondrial donation licence in section 8.

(6) Schedule 1, item 10, page 6 (lines 14 to 22), omit the definition of patient (including the note) in section 8.

(7) Schedule 1, item 14, page 7 (lines 31 to 33), omit ", a clinical trial research and training licence or a clinical practice research and training licence", substitute "or a clinical trial research and training licence".

(8) Schedule 1, item 17, page 8 (line 24), omit "5 kinds", substitute "3 kinds".

(9) Schedule 1, item 17, page 8 (line 30), omit ";", substitute ".".

(10) Schedule 1, item 17, page 9 (lines 1 to 3), omit paragraphs 28A(d) and (e).

(11) Schedule 1, item 17, page 9 (lines 12 to 16), omit subsection 28B(3).

(13) Schedule 1, item 17, page 16 (line 25), omit "; or", substitute ".".

(14) Schedule 1, item 17, page 16 (lines 26 to 31), omit paragraphs 28H(1)(d) and (e).

(15) Schedule 1, item 17, page 17 (lines 6 to 9), omit subsection 28H(4).

(16) Schedule 1, item 17, page 19 (line 13), omit ", or a clinical practice licence,".

(17) Schedule 1, item 17, page 19 (lines 16 and 17), omit "or in clinical practice (as the case requires)".

(18) Schedule 1, item 17, page 19 (lines 31 and 32), omit "or clinical practice (as the case requires)".

(19) Schedule 1, item 17, page 20 (line 7), omit "or patients (as the case requires)".

(20) Schedule 1, item 17, page 21 (line 10), omit ", 28E(2), 28F(2) or 28G(2)", substitute "or 28E(2)".

(21) Schedule 1, item 17, page 25 (lines 3 and 4), omit "and clinical practice licences".

(22) Schedule 1, item 17, page 25 (line 6), omit "or clinical practice licence".

(23) Schedule 1, item 17, page 25 (lines 9 and 10), omit "or patient (as the case requires)".

(24) Schedule 1, item 17, page 25 (lines 18 and 19), omit "or a clinical practice licence".

(25) Schedule 1, item 17, page 25 (line 24), omit "or patient (as the case requires)".

(26) Schedule 1, item 17, page 26 (line 34), omit "or patient".

(27) Schedule 1, item 17, page 26 (line 36), omit "or patient".

(28) Schedule 1, item 17, page 27 (lines 16 and 17), omit "and clinical practice licences".

(29) Schedule 1, item 17, page 27 (line 18), omit "or a clinical practice licence".

(30) Schedule 1, item 17, page 28 (line 3), omit "and clinical practice licences".

(31) Schedule 1, item 17, page 28 (line 5), omit "or a clinical practice licence".

(32) Schedule 1, item 17, page 28 (lines 26 and 27), omit "or a clinical practice licence".

(33) Schedule 1, item 17, page 29 (lines 1 and 2), omit "or a clinical practice licence".

(34) Schedule 1, item 17, page 29 (lines 5 and 6), omit "or a clinical practice licence".

(35) Schedule 1, item 17, page 29 (lines 21 and 22), omit "or a clinical practice licence".

(36) Schedule 1, item 17, page 29 (line 25), omit "or patient".

(37) Schedule 1, item 17, page 29 (line 26), omit "or patient".

(38) Schedule 1, item 17, page 29 (lines 27 and 28), omit "or a clinical practice licence".

(39) Schedule 1, item 17, page 29 (lines 35 and 36), omit "or a clinical practice licence".

(40) Schedule 1, item 17, page 30 (line 20), omit "and clinical practice licences".

(41) Schedule 1, item 17, page 31 (lines 3 to 11), omit subsection 28S(2).

(42) Schedule 1, item 17, page 31 (lines 12 and 13), omit "or a clinical practice licence".

(43) Schedule 1, item 17, page 31 (lines 14 and 15), omit ", a child referred to in paragraph (1)(b) or a patient referred to in paragraph (2)(a)", substitute "or a child referred to in paragraph (1)(b)".

(44) Schedule 1, item 17, page 31 (lines 26 and 27), omit "or a clinical practice licence".

(45) Schedule 1, item 17, page 31 (line 30), omit "or patient".

(46) Schedule 1, item 17, page 31 (line 31), omit "or patient".

(47) Schedule 1, item 17, page 32 (line 7), omit "or patient,".

(48) Schedule 1, item 17, page 32 (lines 17 to 19), omit "for a mitochondrial donation licence other than a clinical practice research and training licence or a clinical practice licence—".

(49) Schedule 1, item 20, page 40 (line 1), omit "or a patient".

(50) Schedule 1, item 20, page 40 (line 3), omit "or patient".

(51) Schedule 1, item 51, page 46 (lines 23 to 25), omit ", a clinical trial research and training licence or a clinical practice research and training licence", substitute "or a clinical trial research and training licence".

(52) Schedule 1, item 55A, page 47 (line 20), omit "or a clinical practice licence".

(53) Schedule 1, item 94, page 53 (line 5), omit "or a patient".

(54) Schedule 1, item 94, page 53 (line 7), omit "or patient".

(55) Schedule 1, item 100, page 53 (line 22), omit "or patient".

I also oppose schedule 1 in the following terms:

(12) Schedule 1, item 17, page 13 (line 22) to page 16 (line 12), sections 28F and 28G to be opposed.

Murray Watt (Queensland, Australian Labor Party, Shadow Minister for Northern Australia) Share this | Link to this | Hansard source

I am opposing these amendments. In my view, the problem with these amendments is that they will delay the clinical application of mitochondrial donation. I have spoken, and many others have spoken, in favour of the clinical application of it in the highly regulated framework that has been put forward. If this amendment were to succeed, it would result in mitochondrial donation remaining in the clinical trial phase. A clear path has been set out from stage 1, the research stage, to stage 2, the clinical practice stage, in the legislation. I would encourage those who voted for the legislation to vote against these amendments so that we can see the clinical application of mitochondrial donation in addition to research.

Kristina Keneally (NSW, Australian Labor Party, Deputy Leader of the Opposition in the Senate) Share this | Link to this | Hansard source

I rise in support of Senator Canavan's amendments. I do so for many of the reasons that he outlined, but my plea here tonight is for those senators who are voting for the bill to consider voting for these amendments. These amendments are commonsense ones that ensure the primacy of the parliament. There is actually—and I think some of the people who are voting for this bill have acknowledged this—a slight leap of faith we are taking here, given the paucity of evidence out of the United Kingdom. Senator Steele-John, you said there is an understandable red flag for some members and senators. While I respect the position you've put, that is a red flag. For those members who are supporting this legislation, it is worth considering these amendments. Ask yourself this question: given how little we know, based on the scientific evidence and research that is available to us now, about this novel and untested technique, why are we willing to sign away the parliament's ability to revisit and to examine the results of something we won't have for 10 years time?

I actually struggle to think of another example where a parliament would agree to simply give away its decision-making authority and its primacy to an executive on such a vexed and significant question. For example, with national security laws we regularly ask for them to be sunsetted and we regularly ask for them to be revisited by the parliament. We regularly ask that they be reviewed in order to ensure that those extraordinary or interventionist powers are being used appropriately. Here, it's not about whether the powers are being used; it's about whether the evidence should prompt us to think anew about the technology we're authorising.

So even if you do agree with Senator Watt—and I respect his point of view—that you would like to see the clinical application of mitochondrial donation, it is still worth considering whether, on principle, as a parliament, we should be giving away that decision for something that the bill says could happen in 10 years time, without having the parliament examine the evidence and the data that will come from those trials.

I have been clear with the chamber about the fact that I don't support the legislation, but I do repeat my view, as I did with the last amendment, that this amendment improves the bill. And, if it is the will of the chamber that the bill is passed, I would like to see the bill improved.

I think Senator Canavan has highlighted one of the areas of the bill where, no matter what your opinion is on the final outcome, you can see the benefit to the parliament and members—some of whom might still be here in 10 years time and some not. That is, we should allow the parliament to make that decision, and not have it delegated by authority to the executive.

Louise Pratt (WA, Australian Labor Party, Shadow Assistant Minister for Manufacturing) Share this | Link to this | Hansard source

There are checks and balances in this bill, including parliamentary scrutiny. It is a disallowable instrument in terms of the regulations that are issued by the NHMRC, which would take us from stage 1 to stage 2.

What I think is also incredibly important to recognise is that, in order to put this out into clinical practice in the states and the clinics, state parliaments would also be required to amend their laws. We don't need this extra layer of regulation. We have plenty of opportunity as a parliament to monitor what the NHMRC does in its regulation and to disallow that instrument or inquire into that instrument, if we like, through a parliamentary committee process in order to engage on those issues. It is simply unnecessary to require this parliament to come back and re-legislate all of these provisions.

This amendment removes the clinical practice stage in all of these schedules; it is unnecessary. We will have an opportunity to disallow future regulations if it is considered ethical to do so. But I think the chamber needs to understand that state parliaments will also be legislating on this matter before it goes to the clinical practice stage.

Deborah O'Neill (NSW, Australian Labor Party) Share this | Link to this | Hansard source

or O'NEILL () (): I don't know about other people in this chamber but I find that so much goes on you've got to try and remember what you did even a couple of days ago. What we're talking about here is a period of 10 years ago. I could ask people in this space to think back 10 years. Where were you? What was the technology like around you? What was going on?

The legislation being made in this instance is about a type of technology that is very novel. It's a type of technology, I do want to repeat, that the committee that inquired into this bill sought to find information about. It couldn't get that information because, even though a trial has been in operation in the UK for five years, data and information to inform our practice is impossible. So after half of that period of 10 years that this bill seeks to push out to, a period of five years, the UK has still been unable to give us anything to work with or to fashion our ideas around.

Senator Keneally has made the point that there are people who are going to vote for this bill. It's pretty clear from what I have said, and my stance on other issues, that I am going to be voting against the passage of this bill. But I endorse the comments of my colleagues Senator Canavan and Senator Keneally. The role of the Senate is to provide a degree of oversight and care in considering the legislation that is advanced to us from the House. In this instance, with technology that is so potentially significant—and possibly positive—but unknowable at the moment because of a lack of transparency, we should be more mindful about what we do than those in the UK were. I think the time line that is set here is just too far. So I urge senators to give it serious consideration and support the amendment that is before Senator Canavan. It doesn't prevent the legislation going through; it is not at odds with the legislation—even for those who are voting for it—but it is an issue of care and concern for good parliamentary practice. If senators of this country aren't up for the task of looking to good parliamentary practice then I don't know who's going to do the work for us. We're here, we're on the front line and we should support this amendment in the interests of Australians.

Matthew Canavan (Queensland, Liberal National Party) Share this | Link to this | Hansard source

ANAVAN (—) (): I want to quickly make a point in response to a point that was made. A point was made that somehow, in the future, we could relegislate or relitigate if there are issues and errors. That is theoretically true, of course. That can be done. But in practice it's not going to deal with the problem that this amendment highlights. We in this place all know that to get a bill through both houses of parliament the bill, effectively, has to be a government bill. It's almost an impossibility for a private senator or even a group of senators or a group in the other place to start a private bill and have it proceed through both houses, be signed by the Governor-General and become law. That doesn't happen. It doesn't happen because the government control the numbers in the House, almost invariably, and, of course, they largely control the time and procedure here in this place.

The problem that this amendment seeks to deal is the fact that, by passing an unamended bill, in 10-plus years time we will be giving the government an almost untrammelled ability, with very little scrutiny, to make the regulations as they see fit. The alternative is to say, 'Oh well, there could be some legislation that deals with that.' That legislation would have to come from the government to pass through. So in both cases, through either regulation or legislation, it is controlled by the government. That's the way this parliament works, in practice.

So I repeat my points here. We have had extensive discussions about the unfortunate trend of more and more delegated legislation being housed in the executive and less and less scrutiny occurring from this place. We have an opportunity here tonight to stand against that trend—to push back against that trend—and I think it's one we should take.

Jordon Steele-John (WA, Australian Greens) Share this | Link to this | Hansard source

Just briefly, I'll be stating my opposition to the amendment offered by Senator Canavan. The effect of this amendment, in my view, would practically result in mitochondrial donation remaining in its clinical phase either in perpetuity or for longer than is needed.

I think what is potentially in danger of being lost in this debate is the reality, as I said at the beginning of our debate on this issue tonight, that every single year 56 kids are born with severe mitochondrial disease. Nothing in this bill—not a single part of it—is a cure for those 56 kids that are born every year. Those families—those parents—will still have to live with the unutterable pain of watching someone they love more than anything in the world slip away, knowing there is nothing that they can do.

The Mito Foundation's support of this proposal, and the advocacy that the community has displayed, isn't in the hope of legislating a cure for those who they love and know they will lose. It is an attempt to prevent such pain and suffering from visiting itself upon anyone else.

The legislation before us today—and I'll say it again—is a very conservative piece of legislation. Ten years is a long time. For 10 years, kids will be born and they will pass away and families will be torn asunder. What we have before us tonight is a question of whether at the end of that 10-year period there is a potential for a treatment widely available to the public that would prevent such tragedy from visiting itself upon any other families in this nation. This is a well-thought-out three-step process—a clinical and scientific process. I remind the chamber that we sit here in a global pandemic, and we owe our lives and our health to science and to the idea that we will put our faith in public health professionals and we will put our faith in scientists.

If at any time it comes to the attention of the Senate that information has been put into the public arena that would see us want to halt one of these stages, then disallowable instruments are open to us. I find it ironic that some contributing to this debate who have utilised the disallowable instrument effectively are speaking now to its ineffectiveness. If they would like it to be a more effective instrument, may I suggest that they liven up the idea of voting for the disallowance of regulated instruments among their party room colleagues. If more people voted to disallow instruments more often, it'd happen more often. That's the solution if you think that's a problem. Members of the government and members of the Senate could sit down with Senator Fierravanti-Wells and the Scrutiny of Delegated Legislation Committee. I've got many good ideas about how to improve the oversight powers of this Senate. How I would love to see this place play its role as the house of review rather than the subservient rubber stamp of the executive! I would absolutely love it. You bring a bill tomorrow that solves some of those problems and come back to the next sitting with that attitude, and I'll meet you there. But let's not confuse that with what is before us today. What is before us today is an opportunity to say that, for the next generation of parents, there may be a solution on the table that will prevent their suffering.

There have been a lot of conversations in here about unknowns—scientific and ethical unknowns. It's very interesting that we're talking about science and ethics and that it is playing such a part of this debate. It's good to see. I hope it heralds the return of a conversation about ethics and conscience and science in this place. We shall see when the debate concludes. But let us at this moment take this step forward. And, if we are concerned with questions of uncertainty, let us comfort ourselves with the knowledge that one thing at the moment is certain: 56 kids will lose their lives to mitochondrial disease every single year. Let us hold that as the statistical evidence it is, and let it compel us to act and to take the opportunity that is presented to us by this legislation to ensure that this suffering is not visited upon others. Let us not pretend that amendments put before this place, presented to us as improving the ability of the legislature to oversight this program, will have any effect other than the prolonging of the outcome of that much-needed research and the potential of that so hoped-for preventative measure.

So I will not be supporting this amendment offered by Senator Canavan, and I urge all of my Senate colleagues, as they take this vote tonight, not to allow themselves to become unmoored in a consideration of what might be. Keep yourselves focused, fellow senators, on the reality of what is.

Deborah O'Neill (NSW, Australian Labor Party) Share this | Link to this | Hansard source

I have to confess that often in this chamber the tone of the debate is so much less than I might have hoped it would have been when I first came here, and I have to indicate that with the freedom-of-conscience vote I think something quite significant is happening in the chamber this evening. People are thinking. People are putting their view, and they are doing it with eloquence. As a former English teacher, I absolutely rise to the turn of phrase that I've—

Slade Brockman (President) Share this | Link to this | Hansard source

We are getting an echo there. I think you are right to continue, Senator.

Deborah O'Neill (NSW, Australian Labor Party) Share this | Link to this | Hansard source

I was attempting to make positive commentary about the contribution of Senator Steele-John when I was rudely interrupted by somebody from the House who obviously isn't up to the standard of debate in the red chamber! However, as a former English teacher with an Irish Catholic family background, the lift of the language of the lyrical appeals to me and I heard that in Senator Steele-John's contribution. But the fact is—and we should remember this when we are dealing with this piece of legislation and all the amendments that we are seeking to advance—that, if we actually rely on the scientific evidence that is available to us today, it is a blank sheet.

For five years this has been going on in the UK and, for whatever reason has been advanced—and I know that families in the UK would have had the same level of hope that Senator Steele-John has just put on the record today—hope is not a strategy and desire is not science. Our job is to be not just purveyors of hope but deliverers of solid legislation that provides sufficient protection to the Australian people. If senators take the time to read the report that was put together under the chairmanship of Senator Askew, who I have to say approached this whole issue with a very open mind, the recommendations that are being advanced here tonight as amendments will do good work, in my view, to improve the quality of what is undertaken in this country and to provide protection to Australian residents who, as Senator Steele John said, will be suffering already despair, sorrow and the loss of a sense of what their lives might have been like not too long after the birth of a child who was much longed for.

So I caution against being captured by a discourse of hope and call on you to be hard-headed enough to deal with the facts and the scientific reality that, after five years, there are no reported live births in the UK. How many families have been taken on a journey of hope that has delivered nothing? We don't know. I hope there is hidden evidence. I hope there is hidden data. I hope that there are families to report on. But I can't make legislation on things I cannot see and a hope that is, I think, sadly displaced and misplaced.

Simon Birmingham (SA, Liberal Party, Minister for Finance) Share this | Link to this | Hansard source

Very briefly, I want to reiterate some of the points Senators Watt and Steele-John have made, which is that this bill provides for a carefully staged approach. Within that staged approach, there are regulatory regimes put in place in terms of the type of licensing regime that would have to be applied by the NHMRC's Embryo Research Licensing Committee, and there are strong criminal penalties that apply to those sorts of licensing regimes to provide for an effective regulatory approach.

Stage 1 around this is focused on clinical trials. Should the evidence be there in terms of supporting the evaluation of those stage 1 clinical trials, it then moves to a stage of treatment. There would need to be regulations made, as you've heard, but, as is the case in so many fields, those regulations are disallowable; the parliament would not lose the opportunity to have a say. The parliament would absolutely have a say, as disallowance motions are moved on a regular basis—maybe not as regularly as Senator Steele-John would like, and, as a government minister, I wouldn't encourage too many more of them, but it is absolutely the right of every member of either chamber to move such disallowance. Then, of course, the power of such disallowance is it must be voted on. It must be debated, or else the disallowance is considered to have been carried. So that is a significant power that senators carry when that is the case.

As others have noted as well, there are further provisions which would enable states or territories to enact laws for authorising, providing yet further restrictions that could be applied. So I contend that these amendments of Senator Canavan's are unnecessary. I urge the Senate to oppose those amendments and respect the proposal that has been developed as part of the consultations undertaken.

Louise Pratt (WA, Australian Labor Party, Shadow Assistant Minister for Manufacturing) Share this | Link to this | Hansard source

I think it's very important to note that current research licences under the NHMRC are reported on very regularly to this place and that is a very, very robust process. It is of great concern to me that we would be inserting new processes for oversight when it comes to embryo research that deviates from the robust processes we already have, because that is when mistakes and errors happen. There is no reason for this legislation to be amended so that embryos in this research area are treated any differently from the myriad IVF research that already takes place and is regulated under the NHMRC.

The Chair:

The question is that amendments (1) to (11) and (13) to (55) on sheet 1519 be agreed to.