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The Illusion of Peer Review

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My exchange with the Professional Services Review (PSR) during the December 2025 Senate Estimates only deepened my concerns regarding the integrity of their review process. It is becoming increasingly clear that their ‘peer review’ is a mere box-ticking exercise, dominated by lawyers rather than the medical peers the legislation intended.

I questioned why lawyers, rather than the doctors themselves, are drafting the reports. While the PSR claims lawyers only “put together” the doctors’ views to ensure procedural fairness, it appears to me that the heavy lifting, sometimes over 150 hours of drafting, is done by legal staff, while committee members may spend as little as seven to 10 hours reviewing the final product.

I raised the issue that there is no legal requirement for committee members to share the same subspecialty as the GP under review. A GP in a niche field like aerospace medicine could be judged by practitioners with zero experience in that specific group.

I questioned Professor Dr Dio and Ms. Weichert on the lack of basic legal protections, such as the absence of a presiding judge, the inability to cross-examine the committee on their views of “general body” standards, and the lack of a formal merits review.

Several questions were taken on notice, specifically around providing detailed log of hours spent by both staff and committee members on reports over the last three years. We need to see if the time spent by doctors actually justifies calling this a “peer-reviewed” outcome.

— Senate Estimates | February 2026

Transcript

Senator ROBERTS: At the December 2025 Senate estimates, Professor Dr Dio, you indicated that lawyers prepare their reports from the review scheme but that the committee members review the reports. In what way does the PSR monitor the performance of the committee—including if the committee has read the entire report and the material presented to it before signing it off? 

Prof. Di Dio: The committee diligently reads the draft reports and the final reports, and we have staff who liaise with the committee at various stages after draft reports and final reports have been sent to them. So should for any reason a committee member not do their duty and read in the draft report, the legal officer in charge of giving service to that committee would firstly of course remind the committee members to review the report, and if they do not, they would then come to me. But that’s a theoretical possibility, because I cannot recall that happening.  

Senator ROBERTS: The PSR committee process is supposed to be a peer review process performed by doctors. Why then don’t the doctors write their own reports? If administrative support is needed, why are lawyers drafting their reports instead of administrative or secretarial staff, which would come at a lower cost to the department?  

Prof. Di Dio: Because the reports are incredibly important. We are passionate about according natural justice and procedural fairness to all practitioners under review. It is my view that the best way to do that is to have the best qualified, quality people writing those reports. Reports of this nature would be best written by people who are very good at supporting doctors in providing their reports.  

Senator ROBERTS: ‘Best qualified’ to me would seem to be the doctors—and then trimmed up or modified by the lawyers.  

Ms Weichert: The lawyers are writing up what the doctors have formed a view about as part of that committee process, as part of the hearing process, the concerns they have put to a person under review and the things that have come back—the lawyers are just putting it together. They are the doctors’ concerns or the medical practitioners’ concerns. It is they who sign off on the report, who approve the report. They are the peer review committee members’ views.  

Senator ROBERTS: If it can be shown that a lawyer spends over 150 hours drafting a report, but a committee member only spends seven to 10 hours reviewing the material and reading the report, is this truly considered by the PSR to be a legitimate peer review?  

Ms Weichert: That’s not taking into account any of the time that was spent in the hearing, in questioning and the time that the committee members have turned the matter throughout the process.  

Prof. Di Dio: A hearing might take eight days; it might take 50 or 60 hours. The prehearing reading might take many, many hours. The contemplation of what happened during the committee hearing might take the committee members many, many hours to turn their mind to it.  

Senator ROBERTS: Over the past three years, as an average, what percentage of the total services reviewed has the committee found the services provided by doctors to be inappropriate?  

Prof. Di Dio: I will have to take that on notice.  

Senator ROBERTS: This question is about general practitioners. The Royal Australian College of General Practitioners recognises 37 specific interest groups as subspecialities. If a GP is under review by the committee, is it correct that there is no legal requirement for the committee members to share the same subspecialty? For example, if a GP practices solely in aerospace medicine, there’s no legal requirement for the committee to have any experience in aerospace medicine, because they all fall within the category of general practitioners. Why is there no subspeciality matching?  

Prof. Di Dio: The subspecialty matching is that members of the committee are general practitioners. But the PSR strives to find general practitioners who have experience in those matters. I can assure you that for some practitioners who are in craft groups that are exotic, as you say, like me—I have particular special interests—we try to match those as much as we can. But, under the law, a general practitioner can review a fellow general practitioner.  

Senator ROBERTS: Is it correct that the legislation allows just three committee members to decide what is unacceptable to the general body of general practitioners? In deciding what the general body of general practitioners find unacceptable, do the committee members have to have any regard to any external resources or consideration of other doctors? Do the lawyers draft that part of the report as well, about what the general body of doctors think?  

Prof. Di Dio: One of the things that we train committee members to do, to absolutely and scrupulously give fairness to the practitioners under review, is try as much as possible to ask one question at a time to avoid the risk of the practitioner missing the opportunity to respond to any and all of the questions put to them. I’d be very grateful if you could ask me the first couple, and I’ll go through them with you systematically. 

Senator ROBERTS: Is it correct that the legislation allows just three committee members to decide what is unacceptable to the general body of practitioners?  

Prof. Di Dio: Yes. Ms Weichert: It’s at least three. There are certain circumstances where there could be additional committee members appointed, but it is usually three.  

Senator ROBERTS: In deciding what the general body of general practitioners find unacceptable, do the committee members have to have any regard to any external resources or consideration of other doctors?  

Prof. Di Dio: The committee members have to have regard to all of the evidence before them so that they can—  

Senator ROBERTS: All of the evidence before them?  

Prof. Di Dio: Yes. The committee members welcome from the practitioner any materials that they wish to submit as further evidence either before, during or after the hearing.  

Senator ROBERTS: While PSR committees are intended to operate as expert peer-review bodies, concerns include the absence of a presiding judge, the lack of merits review, the inability to cross-examine the committee on what they believe to be the views of the general bodies, the downweighting of significant evidence, limited engagement with defence submissions and a lack of transparency. Why do PSR procedures deny these basic elements of procedural fairness and justice, and how does the PSR contend that the peer-review function is being properly exercised in their absence?  

Prof. Di Dio: Could you ask the six points one at a time, and I’ll gladly respond to them.  

Senator ROBERTS: They’re intended to operate as expert peer review bodies. Concerns include the absence of a presiding judge.  

Prof. Di Dio: The process is a peer-review process. So, if somebody is trying to find out whether I’ve engaged in inappropriate practice, then the best placed people to do that are my peers, not a judge.  

Ms Weichert: And, ultimately, we are applying the scheme as it is set out in the Health Insurance Act, so that provides for a committee—  

Senator ROBERTS: That may be the problem. The lack of merits review?  

Prof. Di Dio: Under the act, there is no formal merits review; however, we try as much as we can to build fairness into this process by having multiple opportunities to respond and make submissions—multiple opportunities.  

Senator ROBERTS: The inability to cross-examine the committee on what they believe to be the views of the general bodies?  

Prof. Di Dio: The committee is there to ask questions and find out if the practitioner under review has engaged in inappropriate practice. It’s not the committee that is under review.  

Ms Weichert: But the person under review can put forward their information when they’re answering the questions and the information that they would like the committee to consider, and that will occur as part of the process.  

Senator ROBERTS: The downweighting of significant evidence?  

Prof. Di Dio: What do you mean by that?  

Senator ROBERTS: As I said, ‘the downweighting of significant evidence’—  

Prof. Di Dio: I don’t understand what you mean.  

Senator ROBERTS: with significant evidence being put cursorily or downgraded.  

Prof. Di Dio: What significant evidence? Who has reviewed something cursorily or downgraded it? I don’t understand.  

Senator ROBERTS: If there is significant evidence put before the committee, it’s downgraded in terms of the verdict.  

Prof. Di Dio: I don’t understand what you mean by that.  

Senator ROBERTS: Okay. Limited engagement with— 

Prof. Di Dio: I would gladly take that on notice if it’s clarified for me. I just don’t quite understand. I’m not in any way being disrespectful.  

Senator ROBERTS: Okay. I can’t understand how you can’t see that, because the words seem to be selfexplanatory.  

Prof. Di Dio: Are you suggesting that, during a committee process, a practitioner under review gives significant evidence and the committee then downgrades or chooses to ignore it?  

Senator ROBERTS: Yes.  

Prof. Di Dio: I’m not aware of that occurring.  

Senator ROBERTS: Limited engagement with defence submissions and a lack of transparency?  

Prof. Di Dio: ‘Limited engagement with defence submissions’—again, practitioners under review can make submissions. Those submissions are welcome, and they are reviewed.  

Senator ROBERTS: Okay. Next question—  

CHAIR: Senator Roberts, can I interrupt you for one quick second. There are media in the room, and I need to give a short statement. The media have requested permission to film and take photos of proceedings, and the committee has agreed to this. I remind the media that this permission can be revoked at any time. The media must follow the direction of secretariat staff. If a witness objects to filming, the committee will consider this request. The media are also reminded that they are not able to take images of senators’ or witnesses’ documents or of the audience. Media activity may not occur during suspensions or after the adjournment of proceedings. Copies of resolution 3, concerning the broadcasting of committee proceedings, are available from the secretariat. My apologies, Senator Roberts.  

Senator ROBERTS: Thank you, Chair. A former PSR director has been found liable in the Queensland court for misfeasance in public office for failing to perform her statutory duties. Given these matters raised, why should the PSR’s legislation, governance and current officeholders not be subject to a comprehensive independent review?  

Prof. Di Dio: We did have a comprehensive review in 2023 called the Philip review, which made findings. We have acted on all of those findings, including the appointment of associate directors to the scheme.  

Senator ROBERTS: The former director was found liable for making a decision without adequately considering submitted materials. Isn’t that exactly what’s still happening?  

Ms Weichert: We do not consider that to be happening.  

Senator ROBERTS: Okay. What percentage of the department’s budget is spent on the committee review process, and how many cases per year go through a committee process?  

Prof. Di Dio: I can’t tell you the exact amount— An incident having occurred in the committee room—  

Senator RUSTON: You might want to turn your device off, Malcolm; you’ll have Bridget McKenzie after you! Prof. Di Dio: It might save us all a bit of time!  

Senator ROBERTS: Only if it’s in super-rational mode—other than that, it’s just filled with garbage. Can you take that percentage on notice?  

Senator CAROL BROWN: It hallucinates from time to time. You have to be careful.  

Senator ROBERTS: Yes. I might just turn it off.  

Prof. Di Dio: I woke up this morning, and ChatGPT told me I was going to have a stress-free day, so I think it was hallucinating! Without notice, I can’t tell you exactly what percentage of the budget is spent on committee hearings, but we can take that on notice and give you an accurate reading.  

Senator ROBERTS: Thank you.  

Prof. Di Dio: The second part of your question was—  

Senator ROBERTS: How many cases per year go through a committee process? Prof. Di Dio: It changes from year to year, but we get approximately 100 to 120 cases per year referred from Medicare, which in turn represents about 30 per cent of the cases that Medicare reviews. Of those cases, a ballpark figure of approximately 10 per cent get no further action under section 91, about 80 per cent get an agreement with the director or the associate director under section 92 and about 10 per cent get referred to a committee. So maybe 10 practitioners get referred to a committee in a year. 

Senator ROBERTS: Thank you. I need to put on record that we’re not debating whether or not the PSR should be there. They are process which I now understand are legislated. That’s what the problem is for us and for doctors. It is very concerning. Take this as a question on notice. Please table a log of the hours spent on each of the draft and final reports by the PSR staff combined and each of the committee members for the last three years of PSR committee matters. It’s expected that this log will table around 60 rows for each of the cases it reviewed over that period.  

Prof. Di Dio: Thank you.  

Senator ROBERTS: Thank you very much for appearing. See you next time. 

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Avoiding the Next Robodebt

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I questioned the Minister regarding Schedule 1 of the Health Legislation Amendment (Miscellaneous Measures No. 1) Bill 2025, specifically the automation of Medicare Provider Numbers (MPNs).

My primary concern, as always, is ensuring that “automation” isn’t just a fancy word for another government digital disaster. We’ve seen the Robodebt fiasco, the Bureau of Meteorology website fiasco, Australia Post software fiasco and the Border Force Cargo management automation fiasco; my job is to make sure Australians aren’t the next victims of a “government stuff-up.”

I asked the Minister why legislation is needed for a process that is already using computers. She replied that this bill provides legislative support for existing practices and introduces safeguards, adding that computers will not be used to revoke or suspend provider numbers without a human request.

I asked if this automation of MPNs was a “Trojan horse” for Artificial Intelligence (AI). Despite the Explanatory Memorandum mentioning “computer programs” for non-discretionary decisions, the Minister stated on the record that there is no intention or requirement to use AI for allocating MPNs.

Finally, I sought clarification on changes to Commonwealth supported places. Under the new rules, medical students who withdraw from their degree, even late in their studies, will no longer be forced to repay the scholarship cost (though they remain liable for HECS). The Minister said that this is about “fairness” rather than recouping funds from students facing hardship.

I remain sceptical of any move toward “automated” government software, and I will be monitoring these automated systems very closely.

Transcript

Senator ROBERTS: Minister, schedule 1 of the bill automates the issuance of Medicare providers numbers, MPNs. ‘Automation’, I assume, means computer software. Computers are used now for the process. What is different about the process being proposed that it requires legislation to enact it?  

Senator McALLISTER (Minister for the National Disability Insurance Scheme): Thank you for your patience, Senator Roberts. I was just obtaining advice so I can advise you correctly. This new part of the act will ensure that the system can approve the use of a computer program for certain decisions relating to the allocation and management of Medicare provider numbers. It will not—and this, I think, will be important to you—enable the approval of the use of a computer program to make decisions about revoking a Medicare provider number or suspending a Medicare provider number where the suspension is not at the request of a health professional.  

It will also include safeguards around the use of computer programs to make decisions relating to Medicare provider numbers. Those safeguards include a requirement to notify a person where a computer program was used to make a decision about their Medicare provider number; a requirement to make it public when the use of a computer program to make decisions about Medicare provider numbers has been approved; a power to make substitute decisions where they are satisfied that a decision made by the operation of a computer program is incorrect; and a requirement to include information in the Services Australia annual report about the number and types of substituted decisions. 

Importantly, these things introduce safeguards, and they also, as is indicated in the explanatory memorandum, provide legislative support for an existing practice where some Medicare provider numbers have been allocated by use of a computer program, rather than by a human delegate.  

Senator ROBERTS: I think you anticipated one of my future questions, but, in the meantime, who decides if a person is qualified for a Medicare provider number, including the decision to give a Medicare provider number to a new arrival in the country? I’m asking this to see how this automation will impinge on the process of determining qualifications.  

Senator McALLISTER: May I clarify. I think what you’re asking is, ‘How would a new migrant to Australia have their qualifications recognised for the purpose of practising in an Australian context?’ Is that correct?  

Senator ROBERTS: That’s part of the question. The other part concerns any Australian who’s here right now; how would they be qualified?  

Senator McALLISTER: I’m terribly sorry. I might ask you to clarify further. You said that you’re asking about how a person who is here now would obtain a Medicare provider number. Do you mean an Australian citizen or another person? What are you trying to elicit from me?  

Senator ROBERTS: Anybody who’s qualified to get a Medicare provider number—how would you make sure they are qualified, and how would you make sure that we’re not excluding people?  

Senator McALLISTER: The advice I have is that the bill that’s before us doesn’t change any of the existing arrangements. Those arrangements, of course, include a series of processes to ensure that a person seeking to practise within the Medicare system is qualified.  

Senator ROBERTS: How extensive are the checks, and is there any hint of automation being more than just computer software? Is the bill intending to allow for the use of AI for automatic MPNs?  

Senator McALLISTER: No.  

Senator ROBERTS: So there’s no requirement for artificial intelligence to be used in allocating MPNs?  

Senator McALLISTER: The advice I have is no.  

Senator ROBERTS: I’ll quote from the explanatory memorandum:  

The Bill will enable the Chief Executive Medicare to approve the use of a computer program to make appropriate, non-discretionary decisions relating to the registration and claims process.  

Can I confirm you intend to use AI for that process? If so, what checks are in place to make sure the AI is fit for purpose?  

Senator McALLISTER: The advice I have in relation to AI is that there is no intention. We do not require AI to perform the functions that are set out in the bill. In relation to your earlier question about the process by which a person becomes eligible for obtaining a Medicare number, the Parliamentary Library’s Bills Digest in relation to this says:  

To be eligible to provide a Medicare service, health professionals must meet certain criteria. Practitioners eligible to have Medicare benefits payable for their services ‘at the place of practice as well as refer patients to other health professionals for Medicare eligible services, such as pathology and diagnostic imaging from the place of practice’, may apply online or in writing to Services Australia for a MPN for the locations where these services/referrals/requests will be provided.  

MPNs are used by health practitioners both ‘as a means of identifying themselves and their place of practice for the purposes of claiming Medicare benefits for eligible services, and as an identifier to support other Medicare-related programs …  

Senator ROBERTS: To clarify for constituents and to get some reassurance: you didn’t hesitate when you used the word ‘intention’ with regard to AI and then said there was no requirement. After the robodebt fiasco, the Bureau of Meteorology website fiasco, the Australia Post software fiasco and the Border Force cargo management automation, constituents have every right to point out that these stuff-ups keep happening because of the way in which new technology is rolled out. That’s a big concern. Now you’re giving the software decision-making powers, and it sounds like there are no plans to do that with due care. What security steps are being taken to reassure our constituents that the automations proposed in this bill don’t become yet another government stuff-up? I acknowledge that not all of the stuff-ups have occurred on your watch. 

Senator McALLISTER: This bill puts in place safeguards to ensure that, to the extent that a computer is utilised, the circumstances in which a computer is being used are made very explicit. It also puts some constraints around the kinds of decisions that may be taken by a computer in the context of this process—that is, the process of obtaining a Medicare provider number. I read to you earlier some of those safeguards, which are set out in the explanatory memorandum. As I indicated to you, the advice I have is that this process, which involves the use of a computer for certain purposes that are quite tightly defined and constrained, does not require the use of AI.  

Senator ROBERTS: This final question has a lengthy preamble. Item 3124ZH1 removes the requirement for students who do not complete their degree to repay the Commonwealth supported place cost. Students can currently withdraw from the program without consequence up to the HECS census date in their second year of study. If the student withdraws after that date, they incur a debt to the Commonwealth equal to the full cost of their Commonwealth supported place up to the date of withdrawal in addition to any HECS or HELP liability. The proposed amendment, as I understand it, seeks to extend the existing grace period from the HECS census date in the second year of study to the award of the medical degree. Can you please explain that provision? It sounds like they can pull out right at the end of their degree and not have to pay back the cost. Is that right?  

Senator McALLISTER: Senator, you’re correct that at the moment a person who withdraws from their degree doesn’t need to pay the cost of the scholarship back if they withdraw prior to the census date you alluded to. I believe that they do remain liable for the HECS costs incurred by them in the pursuit of their studies up to that point. You are also correct that a purpose of this bill is to extend the period during which a person may withdraw without incurring a debt associated with their receipt of Commonwealth payments.  

Senator ROBERTS: Sorry, that was my second-last question; I’ve got another one now. What is the rationale behind extending the withdrawal date so they won’t have to pay it back?  

Senator McALLISTER: Earlier in the debate I read out an email from a person who has incurred a debt in precisely these circumstances, and they spoke about the hardship they had experienced as a consequence of that. This person made the point that the purpose of the bonded nature of this program is to ensure that people who do qualify as medical professionals fulfil their obligation to work in an area that is underserved by medical practitioners. The purpose is not in itself to recoup funds from students, and we simply seek to make the system fairer. 

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Integrity in Parental Leave

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One Nation fully supports the heart of the Fair Work Amendment (Baby Priya’s) Bill 2025. Losing a child to stillbirth is a crushing, heartbreaking tragedy and parents deserve the full support of our paid parental leave system during such a dark time. We agree that no employer should be able to unilaterally cancel leave when a family is grieving.

However, I introduced an amendment to fix a serious flaw in the current drafting. As it stands, the definition of “stillbirth” would allow a woman who undergoes a voluntary late-term abortion to claim 26 weeks of taxpayer-funded parental leave.

Our position is clear: ✔️ YES to supporting parents through the tragedy of stillbirth or infant loss. ✔️ YES to protecting mothers who need emergency medical terminations for health reasons. ❌ NO to using taxpayer dollars to provide “parental leave” for elective abortions.

Paid parental leave is a benefit designed to support families and the bond between parent and child. It should not be extended to those who voluntarily choose to terminate a pregnancy.

I called on the Senate to support our common-sense amendment to ensure this bill serves its true purpose: supporting grieving families.

Transcript

The Fair Work Amendment (Baby Priya’s) Bill 2025 amends the Fair Work Act 2009 to extend entitlements to paid parental leave in the case of stillbirth or death of a child. Stillbirths or deaths of a child are crushing—heartbreaking to parents. My wife, Christine, and I have two children and one grandchild. Nothing else comes close, as I’m sure every parent feels. Nothing else comes close to having a child, except possibly losing a child. One Nation supports the bill’s core intent for the very reason I’ve just mentioned.  

The bill only deals with paid parental leave; it does not alter the existing provisions around unpaid parental leave. The bill will prevent employers from unilaterally cancelling periods of paid parental leave in cases of stillbirth or the death of a child during the paid parental leave period. The bill will not prevent employers and employees from agreeing between themselves to cancel such periods of leave, usually so the employee can return to work early for sound reasons. And the bill does not change arrangements for payment of allowances to parents who are not employed. The bill does not impose any requirement on employers to provide employer-funded paid parental leave, because the employer does not pay parental leave; the government does, at a cost of $2.9 billion a year. Some companies pay parental leave at a higher rate. Often, they pay the employee’s regular pay and top up the government payment themselves. In this case, the bill will make those employers pay this higher rate to an employee who voluntarily terminated their pregnancy when their child was delivered stillborn. I will say that again: in this case, the bill will make those employers pay this higher rate to an employee who voluntarily terminated their pregnancy when the child was delivered stillborn. 

Why has One Nation submitted an amendment to the Baby Priya bill? Why have I submitted an amendment to the Baby Priya bill? The bill requires employers to provide paid parental leave to employees who have a stillborn baby, or where the baby dies during the parental leave period. One Nation do not oppose this measure in principle; we support it. Our amendment does not change the outcome of the bill for most women, including the situation Baby Priya’s parents, very sadly, found themselves to be in.  

The definition of a stillborn baby in the bill relies on section 77A(2) of the Fair Work Act 2009, which defines a stillborn child as one: 

(a) who weighs at least 400 grams at delivery …; and 

(b) who has not breathed since delivery; and 

(c) whose heart has not beaten since delivery. 

Yet here’s a key concern of many constituents across Australia and my state of Queensland: nothing in this definition takes account of a voluntary abortion resulting in a stillbirth, which is most late-term abortions. These involve injecting the human baby with a drug that stops their heart and then is delivered as a stillbirth. In the bill as it was introduced, a mother in that situation would qualify for 26 weeks of paid parental leave. This is the very specific issue One Nation’s amendment seeks to correct. We do not believe it is right for a woman who deliberately terminates her pregnancy to then qualify for 26 weeks paid parental leave at taxpayer expense. I must emphasise that neither this bill nor One Nation’s amendment changes anything around emergency terminations in the event of serious health issues affecting the mother. Nothing changes. That’s already protected in legislation; I want to make that very clear. For example, early delivery without killing the baby first is normal obstetric practice for emergency health conditions late in pregnancy such as high blood pressure, liver or kidney disease or cancer that requires chemotherapy. 

Here are some more important facts on abortion that have informed One Nation’s amendment. There is no upper gestational limit on abortion in any Australian state jurisdiction—none. In each jurisdiction, abortion is permitted until birth with the approval of two doctors after a certain gestation. In some jurisdictions such as Queensland, the second doctor who approves the late term abortion is not even required to examine the pregnant woman. A late term abortion is an abortion at 20 weeks or more in gestation. This is consistent with the definition provided by the Royal Australian and New Zealand College of Obstetricians and Gynaecologists in its practice guideline on late term abortion. 

How many late term abortions are performed in Australia every year? We don’t know because only Victoria, Queensland and South Australia publish the figures. The other states are obviously ashamed of how many they perform. The total number of known late term abortions in 2024 was 5,559. Of those, 75 per cent were for non-life-threatening conditions. This makes a complete mockery of the leftist talking point that women don’t abort their babies on a whim. Some do. 

There is a strong case for the productivity benefit of paid parental leave though, including in cases of natural death of the child. One Nation quite clearly supports this. It’s only the extension of this benefit to women who deliberately kill their baby, murder their baby, that One Nation objects to. I ask the Senate to support this amendment. 

In good conscience, we cannot wave through legislation that forces employers and taxpayers to fund 26 weeks of parental leave for terminated births or neonatal neglect.

While the loss of a child to natural causes is a tragedy, we are currently witnessing a horrifying reality in our hospitals: babies born alive after termination are being left to die alone in cold steel tins. This isn’t just a policy debate; it is a question of fundamental humanity.

Australia must stop and listen. We refuse to let this be treated as a tool for social media points or gender warfare. The Australian people deserve a formal inquiry to review these harrowing circumstances and have their voices heard.

Transcript

One Nation supports Senator Hanson-Young’s amendment. This bill will have far-reaching impacts on Australia. It’s not to be rushed through the parliament. One Nation is the party of the natural environment and the party of the human environment. We want to give Australians a say. Workers, employers and small businesses—the parliament needs to listen to these people and give them a say. 

I’d also like to now move my amendment to the Selection of Bills report as circulated in the chamber. 

The PRESIDENT: Senator Roberts, you can’t. We are dealing with Senator Hanson-Young’s amendment at this point. You can speak to your motion if you wish to, but you can’t move it. 

Senator ROBERTS: Thank you. I will speak to it now, and that’ll save us time later. One Nation has moved to send the Fair Work Amendment (Baby Priya’s) Bill 2025 to committee. The bill, as worded, allows employer paid parental leave for the parents of a baby who has been born still as a result of a termination or of a live birth abortion. Loss of a child due to natural circumstances is crushing, but where a child is terminated and born alive that child is cast away into a cold steel tin and left inhumanly to die from neglect in a bucket of cold steel. This is what’s going on our country. Alone, scared and suffering, the child dies a slow and terrifying death. 

This happens every few weeks in a hospital somewhere in Australia. The mother’s employer or the taxpayers should not have to foot the bill for 26 weeks paid leave for an aborted baby or neonatal murder—they should not. This is too important an issue to wave through parliament for social media likes and gender warfare points. A committee inquiry is needed to review this position and allow the public their say. The people of Australia need to have an opportunity to have their say, and we need to listen. 

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Health Reform: Australia Missing In Action

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In early December 2025, the U.S. FDA announced immediate and sweeping reforms to its vaccine approval and monitoring processes. These changes include stricter clinical trials, restrictions on high-risk groups such as pregnant women, and a comprehensive overhaul of vaccine safety monitoring.

I asked the Australian TGA whether they were following these developments and if there was a need for Australia to adopt similar measures. Their response was a “no,” wrapped in many pointless words.

Health Secretary Kennedy is making great progress in dragging the medical establishment back to the center. At present, I believe pharmaceutical companies and their profits exert too much influence on our health administration, to the detriment of common sense, honesty, and duty of care.

I will continue to hold the TGA to account.

– Senate Estimates | December 2025

Transcript

Senator ROBERTS: For now. The FDA announced immediate and sweeping reforms to their vaccine approval and monitoring processes, including stricter clinical trials; restrictions on high-risk groups, such as
pregnant women; and an overhaul of the vaccine safety monitoring system. This is going on under a new administration. The reforms closely mirror measures which operated in Australia until COVID, when our safety
assessments and monitoring were watered down with fast-track approval and emergency-use authorisation for a multitude of drugs. Will you accept that weak approval processes, high-adverse events and blanket denials that anything is wrong have undermined confidence in the entire health system in this country?

Prof. Lawler: There are a couple of things there, if I might comment. We didn’t use emergency-use authorisation. We adopted what is called a provisional pathway—

Senator ROBERTS: It’s equivalent.

Prof. Lawler: It’s not equivalent; it’s quite different. The reason that we undertook it was that, like the rest of the world, we recognised that there were risks that the community was facing, and we worked very closely with other regulators to understand what was emerging. Tonight, you previously mentioned relying on the FDA. It’s really important that, when we talk about reliance, it’s a specific term. It’s not like, if the FDA has approved it, then we automatically register it—

Senator ROBERTS: I’m just using Professor Skerritt’s words.

Prof. Lawler: I wasn’t here when Professor Skerritt gave you those words; I’m just trying to explain where we’re at.

Senator ROBERTS: He said he didn’t do any testing here—

CHAIR: Senator Roberts, can we let Professor Lawler finish his answer, please.

Prof. Lawler: It’s not like, if the FDA hasn’t approved it, we say, ‘You shall not pass.’ What happens is that we look to the information that other regulators have when making our own decisions. I think the important thing as well to note is that we do very much rely on our approvals. We do have, as other regulators have, both pre-market and post-market evaluation and monitoring. But the point that you made about trust is a very important one. We had a presentation at our International Coalition of Medicines Regulatory Authorities earlier this year about trust. There was a very strong driver of trust in institutions, in regulations and in health professionals. The very strong downward driver of it is misinformation and disinformation. Part of the challenge that we have is that, as we hear very frequently, there are a lot of studies, for instance, of very low quality that are being taken up and used as evidence or proof of causal links that just do not exist. Part of the challenge we have is that we do strive to rebuild trust. On two occasions in the last two months, the chief medical officer and I have endeavoured to do that through public statements, and it is a constant battle.

Senator ROBERTS: It’s something we’ve found agreement on. I understand there was a paper in the Lancet a few years ago that said that 50 per cent of medical papers are not valid. Now, we’ve got increasing knowledge coming out and evidence showing that big pharma has heavily influenced the scientific papers and has corruptly done so. This is my last question. Will you monitor the changes in the United States in case the new team under Kennedy is actually right about what has gone before them and right about the changes being necessary?

Prof. Lawler: We monitor all of the developments by our international collaborative partners in regulation.

CHAIR: Thank you.

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The Question TGA Won’t Answer

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The U.S. CDC has changed its guidance on vaccines. The new guidance states that it is not possible to declare vaccines safe because there is no proof that they are. I asked the TGA whether they had changed their own position as a result. The ensuing discussion was pure semantics, as the TGA tried to avoid agreeing with the CDC.

For the record, the theory of logic states: “An outcome that has not been proven impossible may be possible.” To avoid what comes next—a simple question—the TGA had to deny basic logic. That question was: If it MAY be possible, shouldn’t you take a fresh look?

In previous Estimates hearings, I have presented the TGA with peer-reviewed, published papers showing that adjuvants (preservatives) in vaccines can cause autism. These papers actually show causation—the damage to the brain caused by adjuvants used in vaccines.

The testimony from Professor Lawler was simply wrong, and I will revisit this question in the February Estimates.

— Senate Estimates | December 2025

Transcript

Senator ROBERTS: Now, I’d like to turn to vaccines and autism again. In America, the CDC have changed their guidance on vaccines and autism. The guidelines now read:

… there are still no studies that support the claim that any of the 20 doses of the seven infant vaccines recommended for … the first year of life do not cause autism.

The American FDA has accepted that vaccines may cause autism because there is no study to show they are safe. Yet I’ve sat here repeatedly, including earlier tonight, and been told by the TGA over and over again that they are safe. You can’t be right. Either there is proof they are safe, or there is not. Which is it?

Prof. Lawler: I discussed this at length with Senator Antic. The policy decisions and announcements of the FDA are matters for the FDA, and those questions should be directed to them. I would just highlight a couple of your question.

Senator ROBERTS: Correct.

Prof. Lawler: That’s not what they said.

Senator ROBERTS: That’s correct.

Prof. Lawler: They’ve not said that vaccines cause autism.

Senator ROBERTS: They’ve said:

… there are still no studies that support the claim that any of the 20 doses of the seven infant vaccines recommended … do not cause autism.

Prof. Lawler: I think you went on to say at the end of your question—and please correct me if I’m wrong—that the FDA is thereby saying that vaccines cause autism.

Senator ROBERTS: No. I said the FDA, though, has accepted that vaccines may cause autism because there are no studies to show they are safe.

Prof. Lawler: Again, the three-point statement that appeared in November on the CDC’s website, which replaced its previous guidance on vaccines and autism, was of a particular wording. It seemed to me to quite
clearly say that, in its view, it cannot be said that vaccines do not cause autism, because no studies have shown that they do not cause autism. As I mentioned previously in my response to the question by Senator Antic, there is a fundamental scientific challenge in stating that something exists because you haven’t been able to prove that it doesn’t. The scientific process is that an individual or a party that makes a scientific claim holds the onus to provide the evidence that supports that claim. For instance, if you’re claiming that vaccines cause autism, the obligation is on you or another person who’s claiming that to demonstrate the evidence that supports that claim. The challenge that we have in that space is that a significant amount of the initial conversation around vaccines causing autism arose from a 1997 article by then doctor Andrew Wakefield that was published in the Lancet and subsequently retracted and thoroughly debunked because there were personal, professional, ethical and methodological conflicts and flaws. Since then, there have been multiple studies over decades involving millions of children and adults who have received different types of vaccines over different years, and, in that time, there has been no demonstrated causal or associative link between vaccines and autism. So, as I say, if there is a claim there, it has never been substantiated by rigorous and dependable evidence, and all of the evidence that we have is supportive of the view that there is no link between vaccines and autism.

Senator ROBERTS: In my view—and I think this is probably correct—the approver has the onus to say that something’s safe. The approver is you, the TGA. According to FOI No. 1345-01, you had 43 sudden, unexpected deaths reported on your Adverse Event Management System following injection of the Infanrix hexa vaccine. Are none of those caused by the vaccine?

Prof. Lawler: I’ll throw to Dr Dascombe, who’s online, to respond to that. I will just say, initially, as I have said in response to your questions and the questions of others and indeed in the conversation that we had
previously this evening around mesh, the role of the regulator is to ensure that the risks are managed appropriately such that there is an effective balance for the community between access to a therapeutic product and the benefit derived from the product, and the risk that’s presented. As we’ve discussed on a number of occasions, overwhelmingly, for the COVID vaccine and for other vaccines, the risk-benefit profile is positive. Dr Dascombe, I’ll ask you to respond as well.

Dr Dascombe: To go to both of your questions, Senator, Professor Lawler has comprehensively answered on two occasions now tonight questions around the updated guidance from the US CDC. There are a couple of things that I’d reaffirm there, particularly from a post-market regulation of vaccines perspective. The TGA, like our international counterparts, takes an evidence based approach to the regulation of vaccines registered in Australia. This means that our regulatory decisions are based on the weight of available scientific evidence. There are a couple of key points worth confirming. There is no scientific evidence of a causal link between autism and any vaccine or vaccine ingredient. There is a substantial body of scientific evidence to refute the claim that vaccines are linked to autism. Neither the TGA nor any international regulator has detected or confirmed a safety signal for autism in any vaccine. Those are key points to reiterate, to your first question. To your second question, around reported adverse events with the Infanrix hexa vaccine on our Adverse Event
Management System, as you know, this is a system that relies on spontaneous reports from healthcare professionals, consumers, states, public health units and medicine sponsors. The existence of a report in that system and a report made to us doesn’t necessarily confirm that the vaccine has caused that death. We encourage reporting of all adverse events, even if there’s only a small chance that the vaccine is related to that death.

Senator ROBERTS: Thank you.

Prof. Lawler: Thank you for that, Dr Dascombe. I would also just reflect on your comment earlier about the onus on the approver to ensure that something is safe. That is correct. The challenge that every regulator in the world faces is that the only way to ensure that there is no risk in a product is to not approve any product for supply in the country. That’s the only way, and then the public would be quite rightly clamouring for access to goods that are enjoyed by populations around the world. So the role of the regulator here in Australia, as in other countries, is to appropriately assure itself that the evidence indicates that the risk-benefit profile is positive. As Dr Dascombe’s indicated, there’s no identified causal link between vaccines and autism.

Senator ROBERTS: You weren’t here, but I asked Professor Skerritt a question about the testing of the COVID Pfizer shots in Australia. He said, ‘Oh, no, we didn’t do any testing; we relied upon the FDA in America.’
At that time, it had been already been stated that the FDA did no testing itself and relied on Pfizer, and Pfizer cut short its trials because of the number of people who died. So we had a failed study that led to the approval of vaccines—of COVID injections—in this country, and no-one knew about it, yet it was open public knowledge in the United States. Let me continue. A Korean study published in Biomarker Research in September this year followed up 8.4 million Koreans and found as follows: within a 12-month period following their COVID jab, the vaccinated group had a 27 per cent greater chance of being diagnosed with cancer when compared to an unvaccinated group. This was a massive study. This does not prove causation, although many studies I have shared with you prove how these products cause cancer. It does prove correlation. Do you still maintain that COVID vaccines are safe?

Prof. Lawler: I do not recall, Senator, an article that you shared with me that does prove causation between these vaccines and cancer. Also, given the need to analyse the documents, I don’t have the article that you’re
describing in front of me, so I think it would be inappropriate for me to comment on it specifically.

Senator ROBERTS: Okay. I’ll check that. On 28 November 2025, Dr Vinay Prasad, director of the American FDA’s Center for Biologics Evaluation and Research, sent an email first reported by the New York Times. It
described findings from a recent internal FDA review of paediatric deaths reported to the Vaccine Adverse Event Reporting System, VAERS, between 2021 and 2024. According to the memo, an analysis of 96 reported
paediatric deaths among people aged from seven to 18 concluded that at least 10 were causally linked to COVID 19 vaccines, primarily due to vaccine induced myocarditis. Prasad describe this as a ‘profound revelation’. Professor Kidd, do you acknowledge that paediatric vaccines can cause death?

Prof. Kidd: I’m going to have to take that on notice.

Senator ROBERTS: You can’t acknowledge it or you can?

Prof. Kidd: I’m going to take it on notice.

Senator ROBERTS: The FDA analysis—

Prof. Lawler: I’m happy to provide some comment on that if you like, Senator.

Senator ROBERTS: Sure.

Prof. Lawler: We did respond to questions about Dr Prasad’s announcement earlier this evening when questioned by Senator Antic. As far as I’m aware—Dr Dascombe, please feel free to correct me—we have not at
this stage been provided with information regarding that. As we have indicated previously, we rely not only on our own information that comes through our own adverse event monitoring system but also on signals that come from other regulators. This is not a signal that has been replicated, to my knowledge, in other regulators. As I say, we have not had detailed information regarding Dr Prasad’s claim shared with us.
In terms of the question that you posed to Professor Kidd, one of the reasons we have robust postmarket vigilance in place for medicines, devices and, in fact, all therapeutic goods that we regulate is that we recognise
that individuals sometimes react to medicines. To give you an example, we have a number of other medicines—non-vaccine medicines—to which individuals can have allergic reactions. So it would be inappropriate, I think, for either Professor Kidd or me to say that people can’t react to these things. Our role as the regulator is to ensure that appropriate systems are in place to identify safety signals as they arise, to analyse them, to understand them and to respond to them in an appropriate way.

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When Care Turns Into Exploitation

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I spoke with Ms. Liz Hefren-Webb and raised the issue of overcharging by service providers, which is depleting the limited funds available through Aged Care packages.

I highlighted the case of David and Sandra Smith, whose package was debited $3,000 for a small, incomplete gardening job. As a result, they were unable to access certain medical services because they could not afford them. Their complaints to the Commission fell on deaf ears; the Commission provided no explanation for its decision and refused to discuss the matter with the Smiths.

I also raised the case of Mr. Garry Bayliss, who had $14,000 taken from his My Aged Care account simply to replace some timber railings on a fence. Again, the Commission failed to take any action to remedy the situation.

Ms. Hefren-Webb suggested sending the details to the Agency for re-examination. I also raised concerns about the proposed introduction of co-payments into Aged Care packages, which will reduce the actual services provided. Many recipients cannot afford these additional costs, with some services charged at rates of $100 per hour or more. I stated that these shortcomings do not constitute quality care and amount to institutional elder abuse.

– Senate Estimates | December 2025

Transcript

Senator ROBERTS: Thank you for appearing today. Since the introduction of personalised aged-care packages, there has been an abject failure, it seems, of monitoring how funds allocated are actually spent. This is
one of the major failings of the administration of the NDIS that may well bankrupt Australia and be responsible for the death of vulnerable Australians. My question is specifically about the case of David and Sandra Smith. Under their package, they are entitled to some assistance in minor property maintenance. They needed some minor trimming of half a tree and a few branches of another on the property. That was not even completed. They found that $3,000 had been taken out of their package and given to the contractor without discussion between the Smiths and the service administrator of the package. Having raised the issue as a complaint, the Smiths have been ignored. Because of the depleted funds, the Smiths had to cancel some medical appointments they could no longer afford. This issue is gravely affecting their health at an age when they can ill afford such events. The Aged Care Quality and Safety Commission closed off their complaint and refused to even discuss it with the Smiths. They refused to even discuss it, and no explanation was given. To me, this seems like elder abuse by a government agency that is supposed to help older Australians, not abuse them. What is the cover-up, and why was $3,000 paid for next to no work?

Mr Comley: I think the commissioner will provide a response, noting, of course, that it’s difficult for us to talk about individuals in this forum. I will ask Ms Hefren-Webb to comment.

Ms Hefren-Webb: Obviously, I can’t comment on any individual case, and I don’t have any knowledge of the case you’re talking about. We receive around 10,000 complaints a year. Each of them is triaged and assessed, and we do provide a comprehensive response to people. I am not aware that we would ever refuse to provide a response, so I would be very happy to follow up the case you’re talking about.

Senator ROBERTS: So we can put you in touch with them?

Ms Hefren-Webb: That would be great. I’d be very happy to get in touch.

Senator ROBERTS: It does raise issues of accountability, the level of care and the attitude in the department.

Ms Hefren-Webb: It sounds like it’s an issue of pricing that they’re concerned about.

Senator ROBERTS: It might actually be fraud as well.

Ms Hefren-Webb: Potentially. I think the third-most-common complaint we receive around home care is about pricing of services. We do investigate those complaints and we do follow up to see what has driven the
particular pricing. You weren’t here earlier when I said we will compare providers and, if another provider is offering the same service for a lot less, we will ask the provider to explain how they arrived at that price.

Senator ROBERTS: Do you normally get quotes?

Ms Hefren-Webb: We don’t get quotes; we ask the provider how they have come up with their quote.

Senator ROBERTS: So you do not insist on a second quote, but you ask them the source of their quote?

Ms Hefren-Webb: It’s the provider who is managing the package. If there’s a price that the consumer feels is excessive, we will investigate how that’s come about. That’s our role. If we suspect that there is a fraudulent
aspect, we will obviously refer that through to the department, because they’re responsible for fraud and assurance and we’re responsible for compliance with the standards.

Senator ROBERTS: Okay. We will send the contact details.

Ms Hefren-Webb: That would be great.

Senator ROBERTS: Could you check on notice if you have dealt with this or if Aged Care have dealt with this? We would like to know what happened.

Ms Hefren-Webb: Will do.

Senator ROBERTS: This disgrace has badly affected the health of two innocent senior citizens who deserve an answer and money put back into their package. Is that what happens when something is found to be incorrect, wrong or unfair?

Ms Hefren-Webb: I think the department has responsibility for dealing with fraud and how that is dealt with in terms of the individual’s package.

Senator ROBERTS: If there’s something wrong specifically, is the money given back to the aged person?

Ms Snow: I think there would be a range of options. If it’s okay, it might be best to work with the commission really closely to have a look at the case, have a look at what’s been undertaken to date and come back to you.

Senator ROBERTS: Okay. Thank you. I see the caveat, but, if appropriate, can money be put back into their account?

Ms Snow: Yes.

Senator ROBERTS: Thank you. Then there is the case of Mr Gary Bayliss, who had $14,449 taken from his My Aged Care account to replace some worn-out timber rails from a fence. Again the commission failed to take action to remedy the fraud. Now the minister has announced that the concept of co-payments is to be instituted into the aged-care packages. That will mean the cancellation of many services needed by package holders, because they will become unaffordable. Minister, the proposal is that many services will need to be paid for at a rate of least $100 per hour, often at more than twice the market labour rate. An age pensioner cannot afford this. From the absurd to the impossible, this is not care, as I said earlier. It’s abuse. Minister, what can you do to fix this?

Senator McCarthy: Thank you for your questions and the concerns that you’re raising on behalf of your constituents. Clearly, there are many stories there that you’re hearing that really hit at the heart of how people are
feeling in terms of their own care. I will take your questions on notice if that’s okay and get back to you with regard to that particular question.

Senator ROBERTS: Please also take on notice the bigger picture of what can be done.

Senator McCarthy: Sure.

Senator ROBERTS: Commissioner, could you take on the case of Mr Gary Bayliss?

Ms Hefren-Webb: Yes, absolutely.

Senator ROBERTS: Thank you. We’ll be in touch.

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Doctors Concerned Over Report Process

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Doctors have raised with me their concerns about a lack of accountability and a lack of basic understanding that is evident in reports prepared by the Professional Services Review Scheme (PSRS).

During the December 2025 Senate Estimates session, I asked Professor De Dio of the PSRS about the process for drafting Committee Reports. He explained that the reports are written by Committee members with significant assistance from staff lawyers. The lawyers contribute by reviewing the reports and helping with drafts, ensuring the content reflects the concerns of the Committee members.

Professor De Dio noted that the reports are the result of collaborative work, with lawyers playing an important role in production. A draft report is prepared based on the questions asked and the input of members, after which the Committee reviews the draft. He confirmed that this process is standard practice.

My question regarding who signs off on the reports was taken on notice.

– Senate Estimates | December 2025

Transcript

Senator ROBERTS: This is to the Professional Services Review. Who actually writes the draft and final reports on doctors—PSR lawyers or committee members?

Prof. Di Dio: They are the reports of the committee members, and they are assisted in the drafting of those reports by the PSR’s staff.

Senator ROBERTS: Are they lawyers or staff?

Prof. Di Dio: Usually they are lawyers, yes.

Senator ROBERTS: To what extent is legal assistance involved in the authorship of such reports?

Prof. Di Dio: Sorry?

Senator ROBERTS: To what extent is legal assistance involved in authorship of such reports?

Prof. Di Dio: The committee are assisted by the legal practitioners who form part of the support team at the PSR to a significant extent, but, ultimately, the report is their own. They review the report and ensure that the
report contains their views, their opinions and their assessment as to what the outcome should be.

Senator ROBERTS: How much of a final report is written by lawyers and how much by doctors? I know it would vary.

Prof. Di Dio: It varies very much. I can only reiterate that the report is the report of the committee.

Senator ROBERTS: Which parts are written by lawyers?

Prof. Di Dio: I can’t make it clearer. The report is the committee’s report. Legal officers assist with the drafting but the report reflects, at a very granular level, what the concerns of the committee are in both a generic
sense and in the sense of individual services being reviewed.

Senator ROBERTS: The committee members presumably need to collaborate and co-operate if they’re to produce a final report together. What form does this take? Is it emails, phone calls, zoom meetings, face-to-face
meetings?

Prof. Di Dio: It’s something that occurs in a variety of ways. They also have shared access to technology such as SharePoint and other—

Senator ROBERTS: So they might pass the written report around amongst themselves, modifying it, reading it.

Prof. Di Dio: There are a variety of different ways in which they do it. It is their report.

Senator ROBERTS: What’s the justification for lawyers writing drafts and final reports when the act states that they must be prepared by the committee?

Prof. Di Dio: The committee is provided with support services by the agency in order to do their job. The report is their report.

Senator ROBERTS: Do lawyers ever draft a report or write the final report?

Prof. Di Dio: Lawyers have a role to play in the production of that report. The report is created after a committee has sat for however long it sits for. At that committee hearing, questions are asked by the members of
the committee, and the members of the committee present and clarify their findings with the practitioner under review. A process then occurs whereby a draft report is initiated, but that draft report is based upon an extensive review and analysis of what occurs at the committee and what the practitioners who are members of the committee do and say. So there is a role to be played by the PSR team in the preparation of the draft of that report, but the draft of that report is based upon a variety of pieces of data which are initiated by the members of that committee, whether it is what they said contemporaneously, what they asked, the contents of a transcript. It is the committee’s report.

Senator ROBERTS: So a lawyer may write the draft, but it will be after consultation with the committee?

Prof. Di Dio: That is what may occur, yes.

Senator ROBERTS: Are committee members paid for their work in writing the draft and final reports?

Prof. Di Dio: Sometimes. It depends on whether they request to be paid for their work.

Senator ROBERTS: What sort of role does a committee member have? What are they paid for and what are they not paid for?

Ms Weichert: Committee members are entitled to be paid under the Remuneration Tribunal determination for their input into the draft and final reports. It just depends on whether they submit their timesheet to us to process that pay. The Remuneration Tribunal determination is what sets out what they are entitled to be paid for.

Senator ROBERTS: Assuming that lawyers are not trained in clinical medicine, how can they know if what they are writing is a correct summary of the medical evidence canvassed in meetings? How do you make sure that it’s accurate medically?

Ms Weichert: The committee members do that.

Prof. Di Dio: That’s the whole purpose of the committee members; they conduct their committee meeting, and then they review a draft report at various stages, and they continue to review it.

Senator ROBERTS: How long has this practice been in existence?

Prof. Di Dio: What practice?

Senator ROBERTS: Drafting with lawyers.

Prof. Di Dio: I’m not sure. I suspect it’s been many years.

Senator ROBERTS: Thank you.

Mr Comley: Can I just comment. The practice Associate Professor Di Dio is talking about is absolutely common practice throughout probably all parts of public administration, where multidisciplinary teams with
different aspects will have a hand in the preparation of documents, but there is an authorised person or persons actually accountable for the output. In the same way, there are many products that are prepared for me, but,
fundamentally, if I sign them off, I take accountability for those judgements. Or any other area that occurs—when I think about other regulators, that’s very, very common practice. So what has been described is very common. Finally, that person or that body signing off takes accountability for it, but there are many people who actually prepare the raw materials that go into it.

Senator ROBERTS: Thank you, Mr Comley. What we’re concerned about is a number of doctors who have said there doesn’t seem to be any accountability, and quite often the reports are errant medically, and they haven’t been given a fair go. I’m just trying to find out who would sign off on the reports.

Mr Comley: I think it’s been made clear the people signing off on the report are the Professional Services Review board. They take accountability for it. They take responsibility for the report, but they are assisted by
other people in preparing the raw material before they say, finally, ‘Yes, we are comfortable with that output.’

Senator ROBERTS: Just as you sign some reports—I understand you need to have it legally vetted by a lawyer—who signs off on the report for the committee?

Prof. Di Dio: The committee.

Senator ROBERTS: The whole committee? Each of the committee members?

Prof. Di Dio: I believe so. I can take that on notice, but I believe it’s either the chair or whole committee.

Senator ROBERTS: Mr Comley, the reason for my question is we have had a lot of complaints about the PSR reports, and they appear to reflect, in some doctors’ eyes, a lack of understanding of what’s going on. We’re
concerned about accountability. Thank you for your comments.

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Australia Resists Mesh Ban Despite International Restrictions

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I spoke with Dr. Marcelle Noja, who expressed sympathy for those whose health has been compromised by mesh complications.

When asked about the Australian Pelvic Floor Procedure Registry’s failures in following up with patients, she stated that this question would be taken on notice.

I also inquired about the steps the government is taking to assist with the cost of remedial surgeries; this question was likewise taken on notice.

Regarding the differences in approach taken by the UK and New Zealand—where mesh has been banned or severely restricted—I was informed that, because the mesh is used for other treatments, Australia has decided against a total ban on the product.

Due to time constraints, I will submit the remaining unasked questions on notice.

— Senate Estimates | December 2025

Transcript

Senator ROBERTS: Let’s move on to pelvic mesh. Following a Senate inquiry, a formal government apology, overwhelming evidence of harm and international bans in multiple countries, transvaginal mesh
continues to be implanted in Australian women daily. Can you explain why these devices have not yet been banned and what specific evidence would be required for the health department to recommend an immediate hold to their use?

Dr Noja: Thank you for this question and thank you advocating for many of the patients who have had urogynaecological mesh and had negative outcomes as a result of it. The TGA was similarly concerned with the
impacts of urogynaecological mesh. That is why we have taken a number of actions in relation to this. When we look at postmarket activities in relation to mesh, and in fact all products, we undertake a risk analysis, we look at the evidence, and we go to the companies and ask them for information in relation to those products. When it came to these products, we did look at the products and we found that, for many, the evidence was not there to support their ongoing inclusion. Many of those products were actually removed from the Australian Register for Therapeutic Goods. However, for some of the products, we did find that, for some health conditions, there was still benefit for patients. So, for those products, we have continued to include them in the register. However, in support of patients, we have done other activities. We have undertaken a number of reforms. Some of those include increasing information for patients. That means more information about the product, more information about what may occur and working closely with the health professionals to make sure that information does get to consumers. We’ve also recently implemented mandatory reporting regulations for mesh. What we found was that the TGA did not have significant signals to be able to act on doing something. Under this new regulation, it will be mandatory for healthcare facilities to report all adverse events to us. We will then be able to pick up signals sooner and act faster. We continue to monitor this, and this includes undergoing ongoing signal-detection activities. These are critical devices for some Australians, so we really have to be balanced in what we remove from the register versus what we allow to continue, as well as how patients can access it.

Prof. Lawler: I’ll add briefly, as Dr Noja has said, that the role of the regulator is to understand the balance between the risk to patients and the benefits to patients. As we’ve heard, there are certain instances with certain products and certain conditions where there continues to be strong benefit. One of the roles that we take as a regulator is to regularly update product information so that the information that’s necessary for patients to make informed decisions is available to them for conversation with their registered health practitioner.

Senator ROBERTS: Dr Noja, perhaps you can correct me on this, but this is my understanding—I take note of what you said—on the back of the 2018 inquiry, a pelvic mesh registry, the Australian Pelvic Floor Registry, was established. Unfortunately, this registry fails to track long-term health outcomes of mesh affected women, because it only tracks certain women from certain hospitals and only for a period of 24 months. That may have changed. You can correct me if I’m wrong. Will the government amend the failings of the Australian Pelvic Floor Procedure Registry and instead establish a comprehensive, long-term health monitoring program?

Dr Noja: Responsibility for the pelvic floor mesh registry doesn’t sit with the TGA; it sits with my colleagues in another part of the department. I’m not sure if our colleagues from HERD are here. I don’t believe they are. We can take that on notice and talk to our colleagues to provide you with an answer.

Senator ROBERTS: Thank you. The mesh clinics established after the 2018 inquiry are fundamentally failing women by providing only partial medical intervention. Apparently these clinics will remove mesh devices
but categorically refuse to repair the resulting extensive damage, leaving women in a state of severe medical compromise. Can you explain why these clinics are permitted to create additional harm?

Prof. Lawler: We’re not familiar with the practices of those clinics. The regulation of clinics and health practitioners is not a responsibility of the TGA, and, as I mentioned previously, these are largely conversations
between patients and their treating health practitioners. We are not responsible for the management of the operation of those clinics.

Senator ROBERTS: Can you give any advice to women who are still in a lot of pain—not medical advice, but where to go?

Dr Noja: The TGA has established a range of information on our website. We have what’s called the mesh hub, and I’m happy to provide that link to anyone in the committee, if that’s helpful. The mesh hub includes a
range of information for people who have suffered from mesh injury. It includes information about accessing various aspects of our Medicare system as well as treatment options and information about other services that are available to them.

Senator ROBERTS: The mesh hub?

Dr Noja: That’s correct.

CHAIR: Senator Roberts, I’m just flagging that I will need to shift the call shortly.

Senator ROBERTS: I’ll keep sprinting.

CHAIR: You’re in the sprint, yes.

Senator ROBERTS: Every day Australian women are facing an impossible choice due to pelvic mesh complications—and I’m sure you’re aware of that—draining their retirement savings and suffering ongoing
medical trauma. Many women are forced to access their superannuation on compassionate grounds to fund critical mesh removal or repair surgeries, while others completely forgo necessary care due to prohibitive costs. What steps will the government take to establish a comprehensive support system for women that covers the full cost of surgeries and ongoing care that they need from being harmed by a government-approved medical device? Perhaps the minister might want to comment, as well as you, Dr Noja.

Dr Noja: I will allow the minister to comment, but I will just note that our website does include information for patients with respect to what services they can seek support with. There are a number of MBS and PBS items available to them, which they can seek access to, and there are a number of available resources there for them.

Senator Green: For completeness, I’ll take your question on notice so I can provide you with some information about what supports are available. I don’t disagree with you that these women have gone through an
awful ordeal. I’m confident that we’ll be able to give you some fulsome information about what’s available, but you should continue to raise these issues.

Senator ROBERTS: Last question in this sprint—the UK, Scotland and New Zealand have banned or severely restricted transvaginal mesh use, due to unacceptable harm rates, but Australian women continue to
receive these implants daily. That doesn’t seem to make sense to me. What makes Australian women different from British or New Zealand women and justifies continuing a practice that other countries apparently have
deemed too dangerous?

Dr Noja: I will note that the TGA doesn’t tend to ban devices. Our approach is around inclusion versus exclusion of products so that there remain a number of pathways available to clinicians should they deem it
appropriate for a member of the public to have access to a product. The reason we don’t ban products is that it is important that patients get the best appropriate care for their individual circumstance. I really respect your
comments around what we are doing to protect women, and, as I mentioned, we have actually undertaken a number of actions specifically related to these products. As part of our post-market review and our action, we did upclassify some products and remove others, but it is important that these products remain available. They are used for other surgical procedures, apart from urogynaecological conditions, so it is important we make sure that access is available. We just have to have rigour around where access occurs to ensure that the products are fit for purpose in how they’re being used. Part of that, really, is the patient information and making sure that patients are appropriately provided with all the information they need to support them in making sure that it is the right decision for them.

Senator ROBERTS: I hear what you say, and I acknowledge it, but why is the mesh banned in other countries and not banned here?

Dr Noja: I don’t believe it is banned in other countries. Australia has taken the step to upclassify these products. Other countries have not gone as far as Australia has, in terms of its regulatory approach. Some
countries are continuing to look at these products and make decisions about what they do, but they will be making those decisions based on the evidence they have in front of them and the signals and risks that they’ve seen in the patients that are presenting in their jurisdiction.

Prof. Lawler: In your question you did say that in other countries these products have been banned or significantly restricted. As Dr Noja has indicated in her answer, we have also undertaken some actions that have
restricted those devices, through the upscheduling and through the removal of some from the register, and also through the imposition of conditions of inclusion. So we have taken regulatory actions as well.

Senator ROBERTS: So you’re going to send me more information and the minister is going to give me an answer on notice, and I’m going to stay on the treadmill.

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Lyme Disease Denial in Australia

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During this Estimates session, I raised questions regarding the management of Lyme Disease. Unfortunately, my concerns appeared to fall on deaf ears. I was repeatedly told the same narrative—that there is no evidence of Lyme Disease existing in Australia—and it was evident that the so-called “experts” had no interest in exploring this issue further.

There was no substantive response to my request for a comprehensive epidemiological study to be done on tick-borne diseases, nor was there any acknowledgment given of the many individuals living with poorly diagnosed and inadequately treated tick-related illnesses.

The remainder of my questions will be submitted on notice, with the hope of receiving detailed and meaningful responses.

— Senate Estimates | December 2025

Transcript

Senator ROBERTS: I’d like to build on questions from earlier tonight and turn to Lyme disease. For several decades, the risk of harm from tick-borne diseases has been recorded, published, reported and presented to the department of health and the ministers’ offices and advisers at the time. Some of this has even been done through the government’s own infectious disease bulletins. Doctors are verifying Lyme disease—we’ve heard that anecdotally—in Australia. I’m going to talk later about epidemiological studies and records that the department has. In the meantime, could you please specify the dates and events when evidence of the harm of tick-borne diseases has been presented to the department and the actions that have been undertaken to protect Australians historically. You can take it on notice if you like.

Ms Quilty: We’ll take that on notice.

Senator ROBERTS: I acknowledge that in 2016 and 2025 we had very limited Senate inquiries into Lyme disease and tick-borne diseases. The terms of reference were very vague and the recommendations were vague. I’m going to ask about the implementation. But at least the term ‘tick-borne diseases’ was recognised. We still don’t know the full extent and the nature of the entire tick-borne disease problem. Why haven’t these tick-borne disease infections been quantified with a study of the population in the form of a human epidemiological study? There are a lot of people suffering.

Senator Green: We’ve answered quite a lot of these questions before.

Senator ROBERTS: Not these exact—

Senator Green: No, but a study has been done. Anyway, I’ll let the officials answer. We’re just going back over—

Senator ROBERTS: Has an epidemiological study been done?

Senator Green: Not one of those types, but—

Ms Quilty: I’m happy to be corrected, but we’ll take that on notice.

Senator ROBERTS: As far as you know, no studies have been done epidemiologically.

Ms Quilty: Not that I’m aware of.

Senator ROBERTS: Why is the Public Health Laboratory Network’s own diagnosis data being ignored with these diseases when they hold the results of thousands of test results for tickborne disease?

Mr Martin: I’m not aware of the data you refer to being withheld. Some of the tickborne diseases are notifiable, and we do collect information on those. I think one of the challenges is that there are a range of conditions which patients believe may be caused by ticks but, as I’ve mentioned in an earlier answer, there’s not necessarily evidence that the pathogen that would cause that disease is present in Australia. I think that it’s challenging to collect information where we don’t have that causal pathway—

Senator ROBERTS: Have you been given or have you collected samples?

Mr Martin: Samples of?

Senator ROBERTS: Infection.

Mr Martin: There are established diagnostic tests for different tickborne diseases.

Mr Comley: I think the evidence that was tendered earlier was that the bacteria that cause the Lyme disease have not been detected in Australia. It’s not that there aren’t people who contract it overseas and come here. There is also evidence that there are other tickborne diseases that are present in Australia, but not Lyme disease—for the bacteria that’s required to be the cause of the disease.

Senator ROBERTS: I’ll say it again: I don’t understand the exact health system, but why is the Public Health Laboratory Network’s own diagnosis data being ignored with these diseases when they hold the results for thousands of tests for tickborne disease? Why is that being an ignored? What’s been done with it? What’s going to be done with it?

Mr Comley: I think we’re struggling to describe which laboratories you are talking about. Can you provide evidence of that. We’re happy to take on notice whether there is any evidence of that effect in Australia. I think the evidence tendered earlier in this estimate session was that there wasn’t such evidence in Australia, but we’re happy to take that on notice.

Senator ROBERTS: I’m told that there is evidence held by the Public Laboratory Network’s own data.

Mr Comley: We’ll take that on notice, unless the CMO would like to comment.

Prof. Kidd: Senator, there is evidence of tickborne infectious diseases that people have contracted in Australia. There are a number of those infections which are recorded, for which people are tested: some of the Rickettsial infections, Queensland tick typhus, Flinders Island spotted fever, Australian spotted fever, Q fever—due to Coxiella burnetii. There’s data on each of these particular tickborne diseases, which will be in our laboratory systems and which are brought together. The issue about Lyme disease—we’ve talked about that before.

Senator ROBERTS: I am told that hospitals have discharge records, with some stating tickborne illness, Lyme disease, Babesia, rickets, Bartonella et cetera, yet accurate and reliable testing for all these diseases in Australia does not occur. Are you able to provide a quantification of this? This is a public health threat.

Prof. Kidd: I think we’ll need to take that on notice from the PHLN.

Senator ROBERTS: I understand. Why can’t the study of this data for all vector-borne diseases—as part of the responsibility of the Department of Health from the 2016 Senate inquiry—be done to complete an epidemiological study? Can you take that on notice?

Ms Quilty: Yes, we have.

Mr Martin: We can. I think it might take me a moment to find it, but I think the government’s response to the most recent inquiry—

Senator ROBERTS: It’s very vague.

Mr Martin: It does go into the feasibility of—it is not feasible, necessarily, to collect data on everyone who may have been bitten by a tick in Australia. We do have a system around notifiable diseases, where that is nationally collected and reported upon for particular pathogens. I can take it on notice and provide further information on some of those practicalities.

Senator ROBERTS: We’ve got readily available tickborne disease testing panels in Australia for livestock and domestic animals, especially for exports, I’m told. We don’t want to hurt people overseas. Veterinarians know that sometimes it’s necessary for animals that are sick with tickborne disease to be put down. The question raised is: are we doing nothing about humans? Are we going to start putting humans down? That’s pretty far-fetched, of course, but I’m saying that there are lots and lots of people who are sick and crippled a bit and nothing seems to be done.

Senator Green: I understand, but perhaps you could put a question to the officials that they can answer for you.

Senator ROBERTS: On my frustration.

Senator Green: You can express your frustration in the Senate chamber next year.

Senator ROBERTS: I don’t have Lyme disease, but I know people who have, and I know people who’ve got tickborne diseases, and there’s been no epidemiological study done. This has been going on for decades.

Senator Green: I understand. There have been inquiries, responses to those inquiries and the officials have answered your questions.

Senator ROBERTS: I know you, Senator Green. You would not be proud of the studies that have been done in the 2016 Senate inquiry.

Senator Green: I’m very aware of the inquiries. I know that a lot of good senators from this place have been involved in those inquiries and have taken evidence from people who are affected, and the government’s responded to those inquiries.

Senator ROBERTS: I say again: why can’t the study of this data for all vector-borne diseases be part of the responsibility of the department of health and be done to complete an epidemiological study? You’ve taken that on notice.

Senator Green: We’ve taken that on notice.

Senator ROBERTS: Thank you. I’m early this time.

CHAIR: You are early this time. I’m very grateful for that. Senator Liddle.

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Blood on Their Hands: Victims Still Wait for Answers

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At Estimates, I asked Professor Adriana Platona why the Australian Government and CSL took the unacceptable risk of allowing its haemophilia patients to receive a product that would likely infect them with Hepatitis C – as it later became known as. That question was left unanswered.

I asked why, even after safer 80-degree heat-treated products were available in the UK from 1985 for both Factor VIII and Factor IX, Australia continued to allow hepatitis-infected factor concentrates to be used—until 1990 for Factor VIII and 1993 for Factor IX. That question, along with five others, was taken on notice.

I made it clear: a Royal Commission is warranted. The government has failed to deliver justice to victims, unlike the toothless 2004 inquiry that achieved nothing.

Victims of this scandal deserve answers. They deserve to know why they were infected.

— Senate Estimates | December 2025

Transcript

Senator ROBERTS: I’ll start with the National Blood Authority and tainted blood. These questions are from constituents. In the UK, from 1985, factor concentrates began to be heat-treated at 80 degrees for 72 hours. That’s in Britain. Australia, though, chose to go with an alternative heat treatment method of 60 degrees for 72 hours, which at the time was considered to be a method to inactivate HIV, although it was noted that it was not likely that the 60-degree method of heat treatment would inactivate Non-A, Non-B hepatitis, which came to be known as hepatitis C. Why did the Australian government and the Commonwealth Serum Laboratories take the unacceptable risk of allowing its haemophilia patients to receive a product that would likely infect them with Non-A, Non-B hepatitis—hepatitis C?

Professor Platona: Thank you, Senator, for your question. Australia has one of the safest blood systems in the world, and the testing for hepatitis C and HIV was introduced in Australia much sooner than it was in the UK. So the situation between Australia and the UK is not comparable. In 2004, there was an extensive inquiry into hepatitis C and the blood supply in Australia. Many of the questions that you have raised were discussed extensively around April 2004. People have provided submissions, testimonials. There was an extensive inquiry at the time. Many of these issues were discussed extensively at the time.

Senator ROBERTS: Thank you, Professor. We’ll get to those points in a minute. Why did the Australian government and the Commonwealth Serum Laboratories—by the way, you didn’t answer my question as to why the Australian government and the Commonwealth Serum Laboratories took the unacceptable risk of allowing its haemophilic patients to receive a product that would likely infect them. So I’ll move on to the second question. Why did the Australian government and the Commonwealth Serum Laboratories—and these questions, by the way, are from people who have had their lives damaged seriously—continue to allow patients to receive hepatitis infected factor concentrates, all the way up until 1990 for factor 8 and, unbelievably, 1993 for factor 9, when the UK were receiving the safer 80-degree treated product for both factor 8 and factor 9 concentrates since 1985? So we were five years behind and eight years behind.

Professor Platona: That is not my understanding of the fact. I would be very happy to check those facts for you and provide that on notice, with reference to the material submitted in 2004.

Senator ROBERTS: Thank you. I’ve got five questions on notice in the interest of speed. Minister, these questions relate to events that occurred long ago—I acknowledge that—yet they still impact and kill victims today. There are people with their lives damaged seriously. That’s precisely why we need a royal commission into what occurred. The government cannot produce the answers that the victims deserve. These people are deeply upset, deservedly so—not deservedly so, but rightly so. We need a thorough investigation where people are compelled to give evidence and answer questions under oath, unlike the 2004 Senate inquiry which has been described as a toothless inquiry by prominent lawyer Des Collins, who was heavily involved in the UK infected blood inquiry. We don’t accept the 2004 Senate inquiry. Minister, don’t you think the victims of this scandal deserve answers as to what occurred and why they were infected?

Senator Green: I don’t think that’s an appropriate question that I can answer for you other than to say that the constituents’ issues that you raise continually in this committee are valid and that the officials have provided you, I think, very reasonable and factual advice. I don’t have any information that I can give you other than what the officials have given you. You’re very entitled to come here and advocate for your constituents and their concerns, but I don’t have any other advice I can give you.

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