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Joint Standing Committee on Foreign Affairs, Defence and Trade
08/06/2018
Human organ trafficking and organ transplant tourism

BARRY, Ms Lucinda, Chief Executive Officer, Australian Organ and Tissue Donation and Transplantation Authority

CLARKE, Ms Louise, Assistant Secretary, Office of Health Technology Policy Branch, Department of Health

McDONALD, Professor Stephen, Executive Officer, Australia and New Zealand Dialysis and Transplant Registry

SHAKESPEARE, Ms Penny, Acting Deputy Secretary, Health Financing Group, Department of Health

CHAIR: We will resume the hearing. Welcome. I invite you to make some opening comments, if you wish to.

Ms Shakespeare : No, thank you.

CHAIR: Anyone else? No. I will start with some questions. By way of background, how is ANZDATA administered?

Prof. McDonald : There's a contract between AOTA and now SAHMRI, the South Australian Health and Medical Research Institute, for funding but, effectively, it is administered by my team and me. The data collection is done in conjunction with the renal community in Australia, so the data is collected by nephrologists and clinicians in the renal units throughout Australia and New Zealand and forwarded to us. We then use that data to produce a variety of outputs to use for health service planning, safety and quality, clinical service development and research, and so on.

CHAIR: Last year, the Department of Health provided the committee with ANZDATA in a question on notice, which was for kidney transplants between 2001 and 2014. Is there any more recent data?

Prof. McDonald : Yes, there is. The most recent available data that we have published is up to the end of 2016. Within our data collection, at the end of each calendar year, we do a cross-sectional survey of all the renal units throughout Australia and New Zealand to determine where the events have occurred. That takes a number of months, so the end-of-2017 data is not yet available, but the end-of-2016 data is the most recent available and published data.

CHAIR: In relation to overseas travel by Australians for non-renal transplants, what's the most up-to-date data on that?

Prof. McDonald : I'm here as a representative of the Dialysis and Transplant Registry, and we only collect data about kidney transplants. There are other registries which I'm not involved in that may well be able to supply that data for liver, heart and lung transplants.

CHAIR: We had evidence this morning from Professor Coates, the president-elect of the Transplantation Society of Australia and New Zealand, of a survey which they're currently conducting in relation to overseas transplants. They have surveyed more than 600 practitioners to date. They've received, I think, 175 responses, and his evidence was that those responses to date indicate that the number of people travelling overseas from Australia for transplants is about three to four times what the official data records. Do you wish to comment?

Prof. McDonald : Yes, I'll certainly respond to that. My apologies: I was waiting to see if there was a specific question. Yes, I'm not surprised at that. In my substantive role as a nephrologist caring for patients, I've been involved in that survey. This highlights an important limitation of the data that we collect around transplants performed overseas. The organisation that I represent is funded for and has as its mission the collection and use of data around activity and outcomes of kidney transplants in Australia and New Zealand, and also dialysis patients. As part of that, it is important and helpful to collect data—and we do collect data in many cases—about when transplants are performed overseas. For example, when people have so-called end-stage kidney disease, typically they would progress through a series of different treatments, different forms of dialysis, transplantation and perhaps back to dialysis. You can imagine that, if we're following up somebody who was on dialysis and suddenly is no longer there, it's helpful to know why.

So we do have some data about transplants performed overseas, and similarly when people come into the system from overseas, but we don't have as a focus specific data collection about overseas transplants. The other key issue is that the consent provisions for us, like many registries, are opt-out, so participation is not compulsory. There are also a small percentage of people that are lost to follow-up at any given time, and that's typically 1½ to two per cent. But there are around 25,000 people who have a dialysis or transplant in Australia, so, putting all of those factors together, we've got a situation in which we collect some data.

We don't know why people travel overseas. We can make some inferences, and there are a number of different ways to cut the data, and I'm happy to explain about those. They'd include, if you like, nefarious purposes and absolutely legitimate purposes. We don't have an ability to distinguish between those. I suspect there is underreporting from both Professor Coates's survey and my own anecdotal area. In truth, that underreporting doesn't substantially affect our ability to deliver against our funded purpose, but it is an incredibly important caveat when looking at the data we produce.

Having said that, we do collect some data, and it is helpful, I think, to put that out, but it's critical to understand the caveats and also the different ways, in fact, of counting the transplants. This does need some explanation. We have a large number of people in our database. Depending on the question that you ask, we can do various analyses. If you ask how many people are treated in Australia at the end of 2016 who have had a kidney transplant performed overseas, that'll give you one answer. If you ask a different question, 'How many people who had their initial dialysis treatment in Australia subsequently had a kidney transplant done overseas and returned to Australia?' that gets another answer, and that is a different question, because you can make some different inferences about the answer. But we still don't know why they travelled overseas.

We do actually ask people which country the transplant was performed in, but we have a substantial missing or 'don't know' response rate to that, in the order of 20 per cent to 25 per cent. There is a similar lack of data around whether it's a living or deceased donor. You can adopt an even more restrictive definition and say, okay, we can look at the data and say, rather than just people that started dialysis in Australia that were being dialysed immediately prior to their transplant—that's, if you like, the most restrictive definition, but it perhaps gets closest to people who travelled overseas specifically to receive a transplant, and that's the set of numbers that we currently publish. But, depending on which question is asked, you will get different numbers and you'll be able to draw different inferences from the data.

CHAIR: A number of the witnesses before the committee, including the medical groups, have generally supported the idea of mandatory reporting of transplants where patients are known to medical professionals in Australia—or become known to medical professionals in Australia. Does anybody have any views about that?

Ms Shakespeare : Generally, in our health programs and approaches, health data is considered something that is owned by the individual patient. In most of our programs, mandatory reporting would not be considered an appropriate approach—if patients did not want to reveal their particular health data—it is something that can be considered on a case by case basis. For instance, My Health Record, which is a major Health portfolio program now that's collecting health information about health services provided to Australians in Australia, is very much focused on patients controlling their data and who sees it.

CHAIR: What about a register of transplants which included those that occurred overseas?

Ms Shakespeare : We'd need to look at different options. If there were to be additional registers or broader registers established, and whether or not identified data was mandatorily reported—de-identified data, we would have to look at different policy approaches.

CHAIR: Because if a person goes overseas and gets a transplant and comes back to Australia, that's a considerable cost on the Australian health system when they return. Is it worth knowing that information?

Ms Shakespeare : We would look at the value of knowing that information, whether or not that was something that needed to require mandatory reporting versus the general principles where we allow patients to control their health data.

CHAIR: And, in looking at it, do you have any inclinations?

Ms Shakespeare : I can't say that I have. That would have to be a matter considered by government.

CHAIR: Right. We have registers, as you alluded to, for other operations—a joint register, as I understand it—so there is precedent for doing this in other areas of health?

Ms Shakespeare : The National Joint Replacement Register collects information about joint surgeries. But, to the best of my recollection, patients are not identified through that process.

CHAIR: Right.

Senator MOORE: Is that compulsory?

Ms Shakespeare : I'd need to check on that for you.

Prof. McDonald : I can shed some light on that. They occupy the other half of the floor that we occupy. Participation in the Joint Replacement Register is not compulsory but it is very highly supported by the orthopaedic surgical community. Both the Joint Replacement Register and ANZDATA are essentially clinical quality registers. That's what they exist for, that's what they're set up to do and that's what they are funded to do. So the data we collect and indeed the consent arrangements around patients are orientated around that.

I think, as you discuss and consider this issue, it seems to me the intent of the suggestion of a register around transplants performed overseas is different. It is a legal intent and potentially there are a series of issues that arise from asking or enforcing reporting of potential crimes, and that's a world that I don't have any personal experience of but I think it would need to be carefully considered. It's one thing to ask both patients and practitioners to report data on patients going through the usual consent processes for an organisation that directly links back to improving the health system and the care of individual patients. The suggestion that we've got in front of us is for a collection of data that may be incriminatory of a patient's conduct and I don't know what effect that would have. It would vary by jurisdiction but it would certainly colour the conversations that I have as a practitioner with my patients. It's hard to see as direct a link between the collection of that data and the direct improvement of that individual patient's care.

In terms of the funding, it is worthwhile expanding on that to say that most of the costs arise from the immunosuppressive drugs that are required for transplantation. Until relatively recently—that is, the last two or three years—they were only available through section 100 of the PBS, which effectively meant that if you had an organ transplant you needed to be managed by a renal unit or a liver transplant unit. That changed, and in many ways that's given patients greater convenience. They are now able to be prescribed by general practitioners. But it does open up another area, which is, if somebody hypothetically had a transplant done overseas, they could come here and they don't necessarily need to engage with a renal unit. It would certainly be clinically highly desirable to do so, but they don't actually medically need to do so to access their drugs. In terms of where you would need to go to ensure that you had the mandatory reporting, it's a much broader remit than any of the existing registries operate in. The Joint Replacement Registry draw their data from orthopaedic surgeons, from the renal community and so on.

CHAIR: As I understand it, the bill before the New South Wales parliament would require mandatory reporting in that state. Do you have any views about the desirability of that being done over state basis if it was to pass the New South Wales parliament?

Ms Shakespeare : It is a state and territory responsibility to regulate organ donation and transplantation, so I think that's really a matter that sits with that level of government.

CHAIR: Would it not be desirable to do this nationally if it was to be done?

Ms Shakespeare : Again, it's a state and territory responsibility. There are ways that national consistency in state and territory laws can be achieved. We've had different models, we have national corporations law, we have national registration of health practitioners through mirror legislation that was passed in states and territories, but this is a state and territory legislative responsibility.

CHAIR: On another matter, it's been suggested by many of the witnesses before this inquiry that Australia should ratify the European convention in relation to transplantation. Any views about the desirability of doing that?

Ms Shakespeare : I think we'll need to leave that to our colleagues in the Department of Foreign Affairs.

CHAIR: There's no health aspect to this that you want to comment on?

Ms Shakespeare : I think the ratification of international treaties is primarily a matter for the Department of Foreign Affairs.

CHAIR: I understand that. But, in some past lives that I had, it was usually common to consult with other affected departments as to their views about the matter.

Ms Shakespeare : I think, again, that would be an internal government process and we're not at that point. As far as I know, we haven't been consulted.

CHAIR: We are free to report that the department doesn't have any views about this?

Ms Shakespeare : I don't think it's necessarily appropriate for us to have views without that being considered through government first.

CHAIR: I just wanted to give you the opportunity, Ms Shakespeare.

Senator MOORE: I want to go back to data. We've had conflicting evidence before us today from different groups. The first lot of witnesses have no respect for the way that we collect data on overseas transplants at the moment. They came up with various ideas, and we will follow those up later, about how you could do it better. Subsequent witnesses said that it was the best data in the world that we have in Australia. When they were making that statement, I didn't realise that they were only referring to kidneys. They were talking particularly about ANZDATA and that is only on kidneys—and even on that there are some questions. Ms Barry, is the Australian Donation and Transplantation Activity Report something your organisation does?

Ms Barry : Yes, it is.

Senator MOORE: Where do you get your data? That report covers all the different types of transplants. It's very beautiful, by the way.

Ms Barry : Thank you very much.

Senator MOORE: The graphics are very cute, and I think it gives a snapshot, which I know is the idea. Where do you get your data from? I'll come back to you, Professor—but that is particularly kidneys. I'm looking at transplants across the board. The inquiry is about transplants across the board—every form of organ transplant. Does your data come from states and territories or hospitals?

Ms Barry : The activity report focuses on donation data and we also put transplant data in. The donation data is coordinated through our focus on donation through states and territories and we collect data on donation, not specifically around transplant. It comes from the transplant registries, and ANZDATA feed that data into us.

Senator MOORE: How many registries are there?

Ms Barry : There are four registries.

Senator MOORE: Are they all Commonwealth funded?

Ms Barry : We give a contribution of funding to those registries.

Senator MOORE: What are they?

Ms Barry : Cardiothoracic, liver, kidney and pancreas.

Senator MOORE: And the kidney one is ANZDATA?

Ms Barry : Yes.

Senator MOORE: And there are three others that operate on a voluntary basis?

Ms Barry : Correct.

Senator MOORE: Where are they located?

Ms Barry : They are located across a couple of states and territories. We basically supply them with a contribution of funding to operate, but they operate in a number of jurisdictions who have put their hands up to do that.

Senator MOORE: I certainly think—and we had this discussion with previous witnesses—that, domestically, the data could be really sound. When the person was saying that it was the best data in the world, I have no doubt about the domestic quality of the data. What I don't see is any real focus on the international stuff, which is what the focus of this committee is. Professor McDonald, you talked about the different questions you ask and the answers you get, which automatically creates a lack of trust for me, in that, if you're looking at a database to be robust, it shouldn't be a number of questions. If there is an intent in that data collection to look at the international experience—if that's one of the goals of getting that data—it should be one question. In the kidney one, is one of the reasons to have that data to check out overseas donations?

Prof. McDonald : The specific answer to that question is no.

Senator MOORE: So that's not part of your remit?

Prof. McDonald : It's not one of the funded aims in our contract. We do, though, incidentally collect that data. If you look around at other data sources, this is an area that is very difficult to find any sort of data about.

Senator MOORE: You're not wrong.

Prof. McDonald : We hope that, by putting it out warts and all, we can at least contribute to a discussion and a debate. It is very fit for a purpose, but this is a different purpose—and I cannot emphasise that enough. Having said that, it is what it is. It is available. One of the questions is: what can you infer from what the data is? The numbers that we do collect do suggest that the number of transplants per year by the various definitions is gradually falling. You can draw a number of conclusions from that. It may be that the number of Australians travelling overseas for transplantation is falling. It may be there is a greater rate of under-reporting over time. I can't directly answer those questions. I'm glad to see the points about the lack of reliability of the data acknowledged, but I would emphasise that there is data on the table to be talked about and—

Senator MOORE: We should be happy with the other advice, saying it's the best in the world?

Prof. McDonald : I'm very happy to hear that. I can't take the credit for that. That was my colleagues and forebears, and it's also about the size of Australia, which means it's small enough to know everybody.

Senator MOORE: Ms Barry, do you know whether the particular task of looking at overseas transplants is part of the remit for the other three registries or is it similar to the one for kidneys?

Ms Barry : I would need to check, but the advice I've had so far is, no, it isn't focused at all on the overseas transplants. As Mr McDonald said, all the data that we collect here is domestically focused and it's about looking to improve our system and to capture data from a domestic level.

Senator MOORE: Has anyone given thought to the resources that would be necessary and the data collection that would be necessary to have a focus on the international situation? It is difficult to see and to count because they've gone away and they've come back and there are different entry points into the system. Are you aware of any process within the government over the years that looked at a data collection source that would cover that point?

Ms Barry : I might ask Penny. I'm relatively new in my role. But not that I'm aware of. It's had a domestic focus to make sure that our system is functioning and it is around quality in clinical practice within Australia.

Senator MOORE: We don't have a data source which is focused on this issue?

Ms Shakespeare : I'm unaware of anything. Health portfolio agencies, such as the Organ and Tissue Authority and the programs that it funds, including the registry, are very much focused on the delivery of services to Australians in Australia. We have limited capacity to obtain. We'd need to look at the reasons we were doing that. Are they part of delivering an effective health system for Australians or are they for other reasons which might sit in other parts of government?

Senator MOORE: Or a combination of reasons—a combination of funding sources if recommended. The other point—and I suppose it is on data in a way—is Medicare numbers. A number of witnesses have suggested that one way of quantifying the number of overseas transplants would be a particular Medicare number. If people needed a particular number for post-overseas transplants, that would be a very clear way of having an idea about what's going on. Has that ever been considered?

Ms Shakespeare : I think it would be very difficult to implement in practice. If we look at the sorts of health services that people might need post-transplantation—

Senator MOORE: What are 110 and 116?

Ms Shakespeare : I'd need to check on those particular items for you. I can run through some of the health services that people might need following a transplant. There are serology tests, general pathology tests—these are covered under different items—antibody testing, X-rays, echocardiograms, CT scans, ultrasounds, MRIs, cancer screening and biopsies. Then there are more technical things, like endoscopic retrograde cholangiopancreatography, percutaneous transhepatic cholangiography, angiograms and bronchoscopy. These things may not be needed by all patients. We have a lot of different items—

Senator MOORE: Or only some of the transplant types. Some would be necessary if you had cardio; some would be necessary if you had a kidney transplant; some would be necessary if you had a liver transplant. But they're not all the same.

Ms Shakespeare : Sure. There are many different types of complications that people might experience which would lead to, again, different types of health services that are covered under very different Medicare items.

Senator MOORE: With that list of services you've just given me, can you provide on notice what their Medicare numbers are?

Ms Shakespeare : Certainly we can provide Medicare items.

Senator MOORE: It would be really useful to see that list and what their current Medicare numbers are.

Ms Shakespeare : Those are some examples of services. People might need to be seeing specialists or consultant physicians under general consult items. They may need to see GPs. They may require different types of medicines. So there are different things available, and I think it's quite difficult for us to just group them all together under a single item. That's not the way that Medicare is structured. We may have different doctors involved with different specialties.

Senator MOORE: Professor, in your medical practice, are there very many Medicare numbers that you need for someone post transplant?

Prof. McDonald : The Medicare Benefits Schedule numbers, I think, are what you're referring to. The Medicare number is obviously for an individual.

Senator MOORE: Yes.

Prof. McDonald : Typically, post transplantation, the 110 you referred to is the initial consult via a consultant physician.

Senator MOORE: I knew you'd know it!

Prof. McDonald : Of course. A 116 is a subsequent consultation—absolutely. It's about $64, I think, at the moment. There are some specific things, but there are very few, I think. In the MBS, if you were going to look at markers that were very specific to transplantation, you might look towards the immunosuppressive drugs, which would be on the PBS schedule. But even there there are other indications for those drugs. An example might be tacrolimus, which is one of the mainstays of immunosuppression. It's also occasionally used for other kidney diseases and for rheumatoid arthritis. So there aren't specific item numbers that I can think of quickly that are always and only applicable to transplants. Even things like a kidney transplant biopsy gets put through under the same item number, in terms of both the medical procedure and the pathology, as a native kidney biopsy. When you initially asked your question, I thought it was somehow or other around the Medicare number related to an individual. I don't know how that would work, but, if you wanted to track service utilisation related to an individual, that would be a different way of approaching that.

Senator MOORE: Yes. It was given to us as Medicare but, when you explain it, it's actually more the MBS. You would know that, Kevin, from your past job.

CHAIR: I take it from what you were saying, Professor McDonald, that there's no real way that we can determine what the cost is of people who go overseas and have a transplant and come back to Australia.

Prof. McDonald : No, not directly. You would need to do it indirectly by having an estimate of the number of overseas transplants and multiplying that by the average cost, and you would also need to have an estimate of how many of those overseas transplants were related, if you like, to transplant tourism versus more legitimate causes. This is the caveat around the data. As an example, I will choose one of the patients I see, a lady whom I have known for a number of years and who has been back and forth between Australia and South Africa. She went back to South Africa, ended up having a kidney transplant from her brother and has subsequently relocated back to Australia. That's an example of something that is on our registry as a transplant performed overseas on someone who had previously had encounters in Australia, but it is aboveboard. That's one end of the spectrum, and at the other end of that spectrum are the morally reprehensible activities of deceased donation in China. But distinguishing the motivation is difficult or impossible.

CHAIR: Leaving aside the motivation, the evidence we have from the medical specialists is that the success rate is lower and the infection rates are much higher, as a generalisation, for those who go overseas.

Prof. McDonald : Yes.

CHAIR: Indeed, Professor Coates's survey, which is incomplete at this stage, show that, of those who have known infections at return, 53 per cent have bacterial infection, 47 per cent have viral infection and 15 per cent have fungal infection. I know that doesn't tell us what the numbers are, but one can at least surmise from that evidence that there is an additional cost to the health system in Australia.

Prof. McDonald : Indeed, and that would reflect, I guess, the common clinical understanding. Professor Coates's survey updates some previous work and is consistent with work done in other countries as well that indicates that for people who receive transplants overseas—the work I have in my mind was done in Canada, but there was some previous work done in Sydney—as well as not being acceptable in the moral and legal dimension, it's just actually just a bad idea for your health.

CHAIR: Which leads me to a broader question, and that is: has the health department education programs for people about the risks associated with going overseas? Without getting into why people go or if somebody gets a donation of a kidney from a sister or other relative—I'm not trying to get into the moral and ethical issues of why they do it—nonetheless, it would seem as a generalisation that the risks are much higher in doing that. In fact, what Dr Fraser said this morning is that, if you've got to wait on a waiting list for 15 months or 18 months on dialysis, the best advice is that it is much better to do that rather than going overseas, just from the clinical perspective. The advice that he and the profession would generally give is: wait the 15 or 18 months or whatever, rather than going off overseas. This is purely from a position of the clinical outcome that is more likely if you have a procedure done here. The question is: what are we doing? Obviously, there are probably more people than we know going overseas. Some may be more legitimate than others. Nonetheless, overall, a transplant in China, the Philippines or Egypt or wherever it occurs around the world is probably carrying higher risks than in Australia.

Senator MOORE: He did link that with the confidence of having a set waiting time, so that if you had a waiting time of 18 months to two years that would be advice you would be able to give. He linked it to that. At the moment, some of the waiting lists in parts of Australia are not 18 months to two years.

Ms Shakespeare : We would certainly expect clinicians who are treating a patient to provide advice that was best suited to their particular circumstances. It doesn't surprise me at all to hear that some of the physicians you have been talking to say that that is the advice they give to patients. As trusted advisers who are clinical experts, that advice is best coming from the patients' treating doctors, but, as a government, we are certainly doing a lot to increase our capacity for local donation and transplantation in Australia. I might ask Ms Barry to talk more about that.

Ms Barry : In the sense of our national program, it is really important that people are educated and aware of what's happening in Australia. We have in the last nine years increased donation by over 100 per cent, which has resulted in at least a 75 per cent increase in the number of transplants. In fact, under the program—and I'm not sure that you would have seen it on the activity report—over 10,000 people have been transplanted. Some of the waiting lists have actually gone down, when you look at the data—not that the organ and tissue authority holds the waitlist.

Senator Moore, it is important to note as well around the waitlists that it is quite complicated, because there are people who are highly sensitised and it may take a long time to find a match to ensure that they have a great outcome from their transplant. Professor McDonald could probably talk more to that. There is a fact sheet, which was developed particularly towards medical professionals about overseas transplants and talking to their patients. That is on both our websites. So, if somebody were looking through Donate Life, they would be able to find that fact sheet; Home Affairs also has it on theirs. That is to help medical professionals who we believe are best placed and who have a one-to-one relationship with their patients to have that conversation with them about going overseas. The real positive is that, since the national program has been put in place around organ donation—which is about increasing the number of transplants, because you don't become an organ donor unless there is a recipient for you to donate to—Australia's capacity for people to receive a transplant here has greatly improved.

Senator MOORE: We had evidence about the impact that private health insurance had on some other countries. They used the example of Israel. When Israel stopped having government insurance to fund overseas transplants, the numbers plummeted. And, almost at the same time, the increase in domestic donations and transplants rose. That was a particular example in that country. Is the health department aware of what, if any, private health insurance is available for people going overseas for transplants?

Ms Shakespeare : Under the Private Health Insurance Act 2007, complying health insurance products, which are the ones rebated by the government, cannot cover treatment overseas.

Senator MOORE: I thought that was true but it's nice to have it said. That's not an issue for us, covering the cost—if you can imagine, from a country where you're covered by private health insurance to go overseas, that's a wider option. With the Israeli example, I'm pretty sure they have an opt-out system. You're aware of the ongoing debate about the opt-in opt-out system with donation. It was raised in submissions to us today. Just so you know, some of the people who were talking, generally, about the transplant issue had a subsequent piece of evidence that said they would prefer to have an opt-out system in Australia on the basis that they think it would be more effective. The work that's been done in the program, that you've told us about, over the last nine years, what would be your assessment of the current situation on donation in Australia?

Ms Barry : What I would say is that there's absolutely significant progress in Australia's donation program. I think there is more that we can do, absolutely. But being able to do donation, as I said before, is reliant on having a transplant system that is able to work with capacity and capability. As we've increased the number of donors there has been some pressure downstream on pre and post transplant, so health ministers decided in April this year to do a pre- and post-transplant review, which is about to commence with the Department of Health, with OTA involved in that as well. It is looking at that capability and capacity to ensure that we optimise every potential donation that we can. If you like, I could make some comments around the opt-out system.

Senator MOORE: Could we put that on notice? It's an ongoing debate.

Ms Barry : Absolutely.

Senator MOORE: It would just be useful, seeing as we had evidence today that particularly recommended that option. If we could have something back from the department on notice, I know you've looked at it.

Ms Barry : There's just the one thing to say to you in the room: the system that we have with a specialised donation system, with doctors and nurses who are trained in donation throughout 90 hospitals in Australia, even if you look at the world leader in organ donation, Spain—if you talk to the godfather, Rafael Matesanz, he will tell you that putting the clinical system in place is what drove Spain's donation system, not necessarily opt-out. But we will continue to monitor what's going on, internationally, on opt-out to see if it does change donation numbers.

CHAIR: Thank you very much, and I thank you for participating in the inquiry today. If there is any further information you can provide, we would appreciate that.