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.
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.
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?
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.
https://img.youtube.com/vi/zeFP6b3EsPs/maxresdefault.jpg7201280Senator Malcolm Robertshttps://www.malcolmrobertsqld.com.au/wp-content/uploads/2020/04/One-Nation-Logo1-300x150.pngSenator Malcolm Roberts2025-12-30 08:36:192025-12-30 08:36:22Doctors Concerned Over PSRS Report Process
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.
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.
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.
https://img.youtube.com/vi/c3-Ut1EHZXQ/maxresdefault.jpg7201280Senator Malcolm Robertshttps://www.malcolmrobertsqld.com.au/wp-content/uploads/2020/04/One-Nation-Logo1-300x150.pngSenator Malcolm Roberts2025-12-08 18:24:072025-12-08 18:24:13Blood on Their Hands: Victims Still Wait for Answers
During a session with CSIRO at Senate Estimates, I raised serious questions about Australia’s pandemic preparedness and biosecurity.
The Australian Health Management Plan for Pandemic Influenza took a decade to develop, yet it was shelved during COVID. I asked CSIRO whether this plan is being updated and what lessons have been learned.
I also pressed CSIRO on their handling of live viruses—rabies, Ebola, and others—and sought assurances that Australia’s highest-security facility will never repeat the mistakes of Wuhan. CSIRO advised of their world-class biocontainment standards and of their 40-year record without a breach.
Finally, I asked Professor Sutton about his recent comments suggesting future pandemic responses could avoid harsh lockdowns. His view: policy decisions should be “less restrictive” than what we saw during COVID.
Australians deserve transparency and accountability on pandemic planning. I’ll keep asking the tough questions.
— Senate Estimates | October 2025
Transcript
Senator ROBERTS: My questions now go to pandemic preparedness. This is the Australian—
Senator Ayres: We’re off the horses and ferrets now, Senator Roberts?
Senator ROBERTS: Yes, and the rats and the birds.
CHAIR: Senator Roberts, you’ve got three minutes.
Senator Ayres: We’re now going to move on to the main event.
Senator ROBERTS: The Australian Health Management Plan for Pandemic Influenza was developed over 10 years, concluding in 2019, just in time for COVID. But it wasn’t used; it was binned. As your department is pandemic preparedness, Professor Sutton, are you working on updating this plan and correcting whatever reason caused it not to be used?
Dr Hilton: Again, Professor Sutton is not responsible for the ACDP, which is our centre for pandemic preparedness. Professor Sutton is responsible for our research unit, named health and biosecurity.
Senator ROBERTS: Does the CSIRO handle live viruses? Your achievement page mentions lyssavirus— including rabies and Ebola, for example. If you have live viruses, which ones do you have?
Dr Hilton: So are we back to horses and weasels and ferrets?
Senator ROBERTS: Just viruses.
Dr Hilton: Yes; we hold a number of—
Senator ROBERTS: I treat this pretty seriously.
Dr Hilton: So do I.
Senator Ayres: I’m trying, Senator.
Dr Hilton: I just want to make sure we’re going back to your first line of questions.
Senator ROBERTS: I’m just going through whether or not you handle live viruses.
Dr Hilton: I think we’ve established that. We do handle live viruses.
Senator ROBERTS: Thank you. Can you assure the committee that CSIRO will not slip up in the way the Wuhan Institute of Virology did in the escape of their Frankenstein COVID experiment?
Dr Hilton: I would not characterise it in that way. CSIRO takes its responsibility for biosecurity exceptionally seriously in all of its facilities and works closely with regulators to ensure that it maintains the highest standards.
Senator ROBERTS: So you can give me an assurance it won’t escape?
Dr Hilton: What won’t escape?
Senator ROBERTS: Live viruses.
Dr Hilton: Any live viruses? I will give you assurance that we work assiduously to maintain the highest standards of biosecurity as an organisation, across our sites.
Senator ROBERTS: Highest standards—can you give me an assurance that they won’t escape?
Dr Hilton: Senator, we maintain our facility to the highest standards of biosecurity.
Senator ROBERTS: Can you give me an assurance it won’t escape?
Dr Taylor: Senator, I can add that the Australian Centre for Disease Preparedness is one of three facilities in the world that has the highest biocontainment. It is quite unique in its capabilities. Its box-in-a-box design means that, even if the facility fails and if electricity fails, there are triple redundancies in the system. It is world renowned for its secure capabilities. That is why we handle high consequence live viruses there, and that’s its purpose. It’s done that for 40 years without a biosecurity breach.
Senator ROBERTS: Obviously you won’t give me an ironclad guarantee, but that’s fine. In Professor Sutton’s podcast interview, conducted recently, he made the statement that the government could consider not introducing the intrusive COVID social restrictions—lockdowns for instance. Is his opinion based on the work you have done at CSIRO or could you expand on what aspects of the social restrictions should be reconsidered? If Professor Sutton can’t answer it, perhaps you could do it.
Dr Hilton: I think that would be one that Professor Sutton could shed light on—to the interview.
Senator Ayres: He’s been champing at the bit to respond!
Prof. Sutton: That reflection was really based on the fact that it’s a matter for future governments as to the policy settings in response to any future pandemic. It’s not for me to say what the settings could be, but I could certainly imagine a future in which policy decisions could be less restrictive than we’ve experienced historically.
Senator ROBERTS: Thank you very much. See, that wasn’t so difficult.
Prof. Sutton: Not at all.
Dr Hilton: It was a pleasure.
CHAIR: Thank you for your rapid-fire approach, Senator Roberts.
I spoke with the CEO of the National Blood Authority, Adjunct Professor Ms Adriana Platona. She confirmed that the Australian Government owned the Commonwealth Serum Laboratories before it was privatised. She also stated that the National Blood Authority was established in 2003.
I asked her what steps had been taken to ensure the safety of concentrates containing Factor VIII. I did not receive a satisfactory answer—rather, I was given an attempted history lesson. Ms Platona went on to explain that the National Blood Authority was created as a result of the negative issues experienced by recipients of blood products during the 1970s, 1980s, and 1990s. She said that an apology had been issued. I question whether an apology alone is enough to compensate victims who were infected with Hepatitis C and HIV?
Ms Platona stated that there have been no contaminated blood incidents since 2003. I suggested that the Commonwealth Government surely had legacy responsibilities, at which point the Deputy Secretary of the Department, Ms Penny Shakespeare, intervened. She said that these issues were primarily the responsibility of the States and Territories. I pointed out that in March 1953 the WHO recommended that dried plasma should be taken from small pools of 10–20 donors only, for safety reasons. Apparently, by the mid-1980s in Australia, plasma was mass-pooled from large numbers of donors, contrary to WHO recommendations. I asked why this had occurred – which had to be taken on notice.
I then asked whether it was considered an acceptable risk—of high probability—that haemophiliacs would contract Hepatitis Non-A, Non-B, and Hepatitis C during the 1970s, 1980s, and 1990s. Again, I did not receive a satisfactory. I asked whether adequate compensation would be paid to the victims, as has happened in the UK, but was dismissed, and then my session was cut short by the Chair.
I will continue to seek justice for the victims of this terrible blunder by the Commonwealth and their continued denial of responsibility.
— Senate Estimates | October 2025
Transcript
Senator ROBERTS: I’ve got several issues here that I’d like to discuss—National Blood Authority about tainted blood, the pelvic mesh, the Lyme disease, ATAGI following on from Professor Lawler’s comments. So I’ll start with National Blood Authority, please. Is Dr John Rowell here? No. A lot of people are plagued with tainted blood, a heavy burden. At CSL’s 2024 annual general meeting, Chair Brian McNamee stated that, prior to its privatisation, the Australian government was the owner, funder and regulator of the Commonwealth Serum Laboratories. Is that correct?
Prof. Platona: The National Blood Authority was formed in 2003 as a statutory legislative agency. I’m very happy to answer questions about the National Blood Authority’s role and work since 2003.
Senator ROBERTS: I’m wanting to know if you could confirm that before the Commonwealth Serum Laboratories was sold off to the public, the Australian government was the owner, funder and regulator of the Commonwealth Serum Laboratories.
Prof. Platona: I believe that is correct, sir.
Senator ROBERTS: What steps did the Australian government take to regulate the safety of the Factor VIII and IX concentrates manufactured by the Commonwealth Serum Laboratories in the seventies, eighties and nineties?
Prof. Platona: As I said in the first statement, the National Blood Authority was formed in 2003. I’m happy to answer questions about the work of the agency since then. You are referring to matters that precede the formation of the National Blood Authority by several decades.
Senator ROBERTS: Could you tell me—I know it was a long time ago, but a lot of people are severely suffering now. Whose responsibility was it at the time, Ms Platona—is it Professor?—
Prof. Platona: Yes. Ms Platona is fine.
Senator ROBERTS: to ensure the safety of the Factor VIII and XI concentrates? This has relevance to what you’re doing now.
Prof. Platona: Indeed. The National Blood Authority was formed, as I said, as a result of some negatively affected people in the seventies, eighties and nineties. My predecessor provided a lot of context in response to your question in November 2024 on Hansard, as to the steps that led to the formation of the National Blood Authority, the apology, the formation of what is now the national Red Cross Lifeblood organisation, the apology that Red Cross Lifeblood made in 2014, and a number of actions by state and territory governments to deal with, really, the failings of the blood transfusion in the past. I do not want you to think at all that I don’t think about the lives of the people that Haemophilia Foundation, for example, is working to support—not at all. I’m the officer that has got the Public Service Medal for making the direct antiviral medicines available. Those hepatitis C treatments are now considered to be best practice and curative. So I do want to acknowledge the hard circumstances of the people affected by the disease.
Senator ROBERTS: That’s good. Did you want to say any more on that?
Prof. Platona: I’m keen to do a good job, Senator.
Senator ROBERTS: How can you do a good job for people with tainted blood? It was the government’s responsibility.
Prof. Platona: Since the organisation was formed in 2003, to date there has been no contaminated blood incident.
Senator ROBERTS: Do you not have any legacy responsibilities from your predecessors? The Commonwealth government is responsible.
Ms Shakespeare: Prior to 1991, the Commonwealth’s role was largely through providing funding to state and territory governments to operate blood services. States and territories regulated the blood supply system in Australia until, as Ms Platona has explained, the National Blood Authority was established in 2003, and it now provides that national coordination. I think we also had the Therapeutic Goods Act 1989. After that, there were changes to the way that blood was regulated as well. Before that, the regulation largely would have been occurring through state and territory governments.
Senator ROBERTS: But it was overseen by the Commonwealth. Let’s go through the history, and correct me if I’m wrong, Ms Shakespeare. In March 1953, the World Health Organization released a report that recommended dried plasma should be prepared from small pools of no more than 10 to 20 donors. This was ignored, and, by the mid-1980s, factor concentrates were being manufactured using mass pooled plasma from thousands of donors, significantly increasing the risk of hepatitis and HIV. Why were these early recommendations ignored? You weren’t around then, but that was a federal responsibility.
Ms Shakespeare: We can try and take on notice if there’s anything in the archives about what happened in the 1950s, but it is a little bit difficult for us to talk to you about what happened at that time.
Senator ROBERTS: Could you take these on notice then, please. It was in the mid 1980s. Factor concentrates were being manufactured using mass pooled plasma from thousands of donors, which went against the prevailing wisdom. Could you find out, Ms Shakespeare—and I thank you for your attention—if it was considered an acceptable risk that there was a high probability of haemophiliacs using factor concentrates that would be infected with hepatitis Non-A, hepatitis Non-B, hepatitis C in the seventies, eighties and nineties?
Ms Shakespeare: Senator, what I can tell you is that the first specific test for hepatitis C became available in late 1989. Australia was one of the first countries to commence using the test, in November 1989, with implementation completed by February 1990. Similarly, we were one of the first countries to introduce HIV patient screening in May 1985. When tests have become available to make sure that the blood supply was safe and could be monitored for those particular medical issues, we’ve implemented that as early as possible.
Senator ROBERTS: I’m wondering how to help these people.
Ms Shakespeare: I think Ms Platona has spoken about some of the assistance that has been provided, and I can go through some of the help that has been provided. There was a review of the blood arrangements in 2001 that was conducted by a former High Court judge. The recommendations from that review were provided to all Australian Health Ministers and led to the establishment of the National Blood Authority and the centralised coordinated arrangements we have to ensure a safe and adequate blood supply that we still have today. We have haemovigilance—
Senator ROBERTS: Can I interrupt?
Ms Shakespeare: Of course.
Senator ROBERTS: That would assume that, prior to that, the blood wasn’t considered to be safe.
Ms Shakespeare: Decisions will have been made based on the state and territory governments’ delivery of blood products about the introduction of testing when it became available, when those tests were developed. As I said, compared to other countries, Australia was one of the first adopters and introduced those tests at a very early stage. But we didn’t just stop there. We’ve been establishing arrangements to make sure that the blood products that we provide to people today are nationally coordinated, that we’ve got consistent arrangements and that we don’t have differences between regulation and provision in different states and territories. The national haemovigilance program for Australia has been developed. That’s a set of surveillance procedures covering the entire blood transfusion chain, from donation and processing of blood to their provision and transfusion to patients. We have monitoring, reporting, investigating and analysing of adverse events related to donation processing and transfusion, and development and implementation of recommendations to prevent the occurrence or reoccurrence of adverse events. So we’ve got a whole haemovigilance program that now operates that’s been developed and implemented through the National Blood Arrangements. For people that have acquired hepatitis C the direct-acting antivirals, which were listed on the PBS in 2016—at that time that was the largest single PBS listing that had ever been made. We have future-generation directantivirals that are now provided through the PBS. If I can give an example, in 2023-24, we had 9,167 scripts of a drug called glecaprevir and pibrentasvir, which is a current-generation treatment for hepatitis C at a cost to government of $161 million. In the same year, sofosbuvir and velpatasvir, another medicine to treat people with hepatitis C, had 10,953 scripts at a cost to government of $131 million. So we’re providing access to those treatments. Now that covers anybody with hepatitis C. It doesn’t matter how they acquired it, but it would certainly benefit those who acquired it through the blood system before the testing was available.
Senator ROBERTS: For some of these people with tainted blood, their lives have been really shot. Perhaps you could look at the camera—and I’m not trying to put pressure on you, or Ms Platona, or the minister, but what do we do for these people? Where do they go for compensation? Britain compensated their people with tainted blood, long, long, long ago; they admitted it and got on with the job. How do these people recover? How do these people get compensation if they can’t? I know you’ve given a list of drugs. What do we do?
Ms Shakespeare: Those are curative, in many cases, direct-acting antivirals, which will be of significant benefit to people with hepatitis C. I should also say that the Australian government contributes to the hepatitis C litigation settlement schemes, which were set up and are managed by the state governments for people that were infected through the blood supply system before we had the National Blood Authority established. That offers financial settlements for people who contracted hepatitis C between 1985 and 1991. So there has been compensation made available and the Australian government contributes to that.
CHAIR: Senator Roberts, I’m going to have to share the call. We are tight on time.
Senator ROBERTS: Thank you for your interest, Ms Shakespeare.
https://img.youtube.com/vi/So4yc2UKSho/maxresdefault.jpg7201280Senator Malcolm Robertshttps://www.malcolmrobertsqld.com.au/wp-content/uploads/2020/04/One-Nation-Logo1-300x150.pngSenator Malcolm Roberts2025-11-13 16:20:322025-11-13 16:20:35Decades of Neglect: Victims Still Waiting for Justice
The Labor Government is running scared of scrutiny. Their atrocious bill to establish an Australian Centre for Disease Control (CDC) is significant legislation—and I’ll go so far as to say it’s the worst I’ve seen in my nine years in the Senate. It’s dangerous.
There were countless amendments that required answers, and many speakers were denied the opportunity to contribute. Serious questions remain unresolved.
The Albanese Government manipulated the speaking list to push One Nation Senators to the bottom. Just before it was my turn to speak, Labor guillotined the bill, preventing any further speeches from being delivered. I managed to use the debate on the guillotine to deliver part of my speech, which is the video you see here.
This marks a new low for the unscrupulous and arrogant Labor Government. The Greens should be ashamed for supporting the guillotine on such an important bill.
The CDC will provide the government of the day with cover to do whatever it wants. It’s expensive, it will control dangerous research, and the reporting and scrutiny provided in this bill are virtually non-existent. This is unacceptable.
One Nation will repeal this bill.
Transcript
Yet again, a guillotine stops debate immediately before I was scheduled to speak against this bill, and after pushing all three One Nation senators, who were going to speak, to the bottom of the list. One Nation opposed the guillotine. We want to know why the coalition and the Greens join with Labor in supporting big pharma.
Senator Canavan interjecting—
Senator ROBERTS: Except Senator Canavan. Thank you, Senator Canavan. This is significant legislation, and I’ll go so far as to say that it’s the worst legislation I’ve seen in nine years in the Senate. It’s dangerous. There are many, many amendments that need answers, and there are many speakers that missed out. There are many questions.
The first question I have for you is: why are you avoiding scrutiny? This is half a bill! The bill establishes what the CDC director can do. It does not, though, establish what the director cannot do. There’s nothing in this legislation to establish rules around the following, so can you please clarify. What is the process for determining where the CDC will be located and what the site features should be—what protections for the community? What research will be conducted at the CDC, if any? Will that research include gain-of-function research, which was the cause of the COVID outbreak in 2019, which killed millions of people? Who will own the taxpayer funded CDC research? There are no answers to these questions. These are fundamental. What research will be conducted in cooperation with research facilities overseas, and what countries should be excluded on national security grounds? Start with the Wuhan Institute of Virology, and exclude Anthony Fauci’s haunts, the University of North Carolina at Chapel Hill and America’s National Institutes of Health, and Fauci’s colleagues including Ralph Baric and Peter Daszak.
Will live animal testing be conducted, and, if so, on what animals and how? Will research be conducted on behalf of commercial corporations, and, if so, who owns the taxpayer funded research. What annual reporting will be produced to alert the parliament and the Australian people about the risks to which they’re being exposed? If the CDC facility handles sensitive material, what level of containment will be used, and what will be the process for investigating and rectifying breaches? And what is the purpose of and limit to research? Is it just ego—’Look at what we can do!’—or is there a genuine medical outcome they’re working towards?
We know the CSIRO at its Geelong facility is already conducting risky experiments on deadly viruses such as Ebola, and they’re experimenting on animals. Those are my questions. Additionally, what’s happening with taxpayer funds? We know the CSIRO monetises its research, or used to, and we know lately the CSIRO has been publishing the results of their research allowing corporations to piggyback off that research free of charge, saving them years in developing new drugs from which the Australian taxpayers will have no commercial benefit. The taxpayers pay and get no benefit. This is the state of medical research in Australia. What impact will the CDC have on the CSIRO? We don’t know. The bill doesn’t set out these matters. It’s a glaring omission.
The minister says the Australian CDC will undertake technical and advisory functions based on its public health expertise and knowledge and access to relevant information. What expertise? It hasn’t started yet. You’re assuming bureaucrats and health officials actually have the expertise and knowledge to perform these studies, yet there’s nothing in this bill to say they must have that knowledge—nothing. This is a pretence to give ‘thank you’ jobs to COVID era health officials who have a track record of very dangerous, dishonest and inhuman decisions. These bureaucrats will be given powers. The Chief Medical Officer, for example, must be a doctor, but the director of the CDC does not. What could possibly go wrong?
Continuing cover ups from the government and freedom of information—an issue which One Nation senator for Western Australia Senator Whitten has raised is the changes the bill makes to the Freedom of Information Act. The bill amends the Freedom of Information Act 1982 to exempt the CDC from freedom of information applications to which the same documents are currently open. I wonder if this is to cover up information from the COVID years or just to get ahead of the next lab leak.
Finally, I’ve already discussed sensitive biological agents with regard to Ebola. The CDC bill transfers responsibility for the Security Sensitive Biological Agents Regulatory Scheme from the department to the Australian CDC. This scheme regulates certain biological agents that are considered dangerous. Now, let’s take a closer look at this one. Who would decide if a biological agent is sensitive and subject to extra checks? The CDC. Who would be most likely to be importing sensitive biological agents like Ebola and heaven knows what else? The CDC. Who would now be their own regulator? You guessed it, the CDC. This is a recipe for no accountability, a recipe for disaster, a recipe for rampant, unbridled control over the people.
Officially, this bill simply brings together powers spread across several departments into one place. If that’s really the case, why does the bill have a price tag of $250 million for the first three years and $73 million per year after that? Shouldn’t the cost of the CDC be offset through savings in other departments? If that’s all they intend, then that would be true. Clearly the Australian CDC will be doing much, much more. You’re given them the money to do it, and they’ll be doing it away from prying eyes and protected with freedom-of-information blocks and negligible reporting criteria, regulating itself and sending the bill to the taxpayers. In nine years in the Senate, this is one of the worst bills I’ve dealt with. Minister, I’ve given you many questions. I’d like some answers.
