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 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.
I was invited to speak at ‘The Misdeeds of AHPRA’ conference held in Sydney on Saturday, 3 May 2025. As it was election day, I couldn’t attend in person and was asked to pre-record a video, which I happily did.
My brief video exposes the many serious conflicts of interest among Australian Health Practitioners Regulation Agency (AHPRA) board members. The conference organisers used it to open the day.
AHPRA faced heavy criticism during the COVID period. Established in 2010, AHPRA was meant to be an independent body overseeing medical practitioners. Yet its board members are deeply intertwined with government and academia, raising questions about its independence.
Recent surveys by the Australian Medical Professionals Society (AMPS) reveal that over 82% of healthcare professionals believe AHPRA lacks fairness and transparency. Investigations drag on for years, causing significant mental and financial strain on practitioners.
AHPRA’s actions during the COVID period, including prosecuting medical professionals for speaking out truthfully to their patients and the public, have eroded public trust and severely crippled our healthcare service.
It’s time for a thorough review and reform to restore confidence in our healthcare system.
Transcript
Hello, I’m Senator Malcolm Roberts, Senator for Queensland with One Nation.
Thank you for the work you’re doing at this conference.
AHPRA (Australian Health Practitioner Regulation Agency) was heavily criticised during the COVID period. And deservedly so. For those at home, I’ll give a quick background to AHPRA.
The national scheme for registration and regulation of medical practitioners that the Australian Health Practitioners Regulation Agency (AHPRA) administers, was implemented in 2010 under the Rudd-Gillard-Labour Government. The so called national law is not a Commonwealth law. Instead it is implemented by each state passing the same legislation, with Queensland acting as the host jurisdiction.
Any proposed amendment to the national law must be approved by the Council of Health Ministers, then passed by the Queensland Parliament, then other states. In 2010 the Federal Government legislated to recognise medical professionals licenced by AHPRA to prescribe under Medicare and the PBS.
AHPRA replaced state based powers with a national independent system of registration and standards for practitioners. AHPRA now hosts fifteen boards, each regulating one area of the medical profession.
AHPRA act as the independent administrator and the boards are the policy makers in their own area. Except that AHPRA is not independent.
AHPRA Chair – Miss Gill Callister – doubles as the Chief Executive Officer of Mind Australia, a commercial operation which provides mental health services, including under the bloated NDIS.
Mind Australia receives additional funding directly from state and federal governments. Board member – Miss Barbara Yo – doubles as Chief of Monash Health, a Victorian government department. In other words, a public servant.
Ari Freiberg is an Emeritus Professor of Law at Monash University, which receives half a billion dollars a year from the federal government. Linton Morris is on the board of Alfred Health, another public servant, as is Geoffrey Moffat, who’s on the board of WA Country Health. And so it goes on and on.
Everyone of the AHPRA board is an academic funded by the government, or is a bureaucrat funded by the government.
How can these people be considered independent? They are NOT independent.
As Kara Thomas pointed out in a January Quadrant article, the recent Bay versus Australian Health Practitioner Regulation Agency court judgement specifically noted that while the pandemic was “an extraordinary period of history,” it did not authorise AHPRA to “abrogate the right of persons to a hearing before an apparently unbiased tribunal.”
Or extend AHPRA’s role to “include protection of government and regulatory agencies from political criticism.”
That’s exactly what AHPRA did.
The spawn of the medical establishment rushed to defend the medical establishment at a terrible cost to the public’s confidence in the medical industry.
The Australian Medical Professional Society (AMPS) recent survey of medical practitioners found 82.6% of healthcare professionals believe AHPRA lacks fairness and transparency in handling complaints and 78.5 percent report unfair treatment.
Unfair treatment!
These numbers reveal and represent AHPRA damning failure. Unfair treatment includes investigations that last for years, career destroying delays and devastating financial and mental health impacts, including suicides.
Many health professionals contemplate leaving the profession entirely.
The acceptance of anonymous complaints and the punitive nature of investigations without proper vetting has created a culture of fear where doctors have said they now practise risk averse defensive medicine, which is not medicine.
This is not incompetent – it’s deliberate. The culture of fear has been created to rob medical professionals of their will to practise medicine in the best interests of the patient.
This is the opposite of care.
Instead, AHPRA has engineered a situation where doctors practise in the best interest of the pharmaceutical industry that AHPRA works for. One example of this is the way in which AHPRA looks the other way when 1500 Australians die every year from an overdose of a medication prescribed by one of Australia’s 88,000 prescribing medical professionals.
In the last 12 months AHPRA prosecuted 31 people. Only two of these relate to prescription drugs of any kind. And yet in Senate estimates, AHPRA advised me they had prosecuted 21 medical professionals for speaking the truth about COVID.
AHPRA prosecuted one practitioner in part for their anti trans position. AHPRA is fighting a rearguard action against the overwhelming shift in public attitude away from invasive medical procedures on children.
Why? Because this will be a billion dollar industry next financial year. If you want the best pronunciation of AHPRA, try this one: cha-ching, cha-ching, cha-ching – the cash registers tune.
During Senate estimates, I asked AHPRA about their cultural safety strategy, which requires all registered health practitioners to acknowledge colonialism and systemic racism.
This is politics, not medicine. Wherever power has been consolidated into a single body, their power has grown.
They become a beacon for every self interested pharmaceutical company, attracting staff prepared to behave in the most egregious way in return for power and a public service salary.
A Senate review in 2022 made fourteen recommendations, including an urgent, in depth review of their processes. That review has never happened. None of the recommendations have been actioned.
Kara Thomas’s article in Quadrant contained a set of sensible recommendations, including devolving these powers back to the States. One Nation supports each of her recommendations.
In short, AHPRA is a failed, corrupting and destructive experiment and must be shut down immediately.
I’ll give the last word to Ms Callister, AHPRA’s Chair, who reposted this tweet in 2018 – “Power comes at a price. Those in the top job have made many compromises to get there”.
Clearly those compromises include absence of professionalism, care, accountability, fairness, decency, transparency, honesty and independence.
President Trump recently called on vaccine manufacturers to support their claims regarding the safety and efficacy of their products. It was these assurances that led him to launch Operation Warp Speed to develop the COVID vaccine and has defended the product in the years since.
It now appears President Trump is open to reconsidering his position on vaccine safety. I hope he does. A critical review of the claims made by vaccine manufacturers is likely to show a very high level of data tampering, misrepresentation, and outright lies.
This will mostly be around vaccine quality, not design. Many of our vaccines are produced as cheaply as possible and contain high levels of heavy metals, such as aluminium, which act as a preservative. These are causing harm to our children.
I hope the President reaches the same conclusion I have – that the mRNA platform is dangerous and should never have been used as the basis for the COVID vaccines developed under Operation Warp Speed.
Transcript
The significance of this is stunning. President Trump has been misled on the safety and efficacy of the COVID vaccines for a very long time. From this post it sounds like he has been kept in the dark and fed lies. I look forward to the president realising that and taking action to defend the health of all Americans by banning the mRNA vaccine platform.
In further developments last week Robert F Kennedy Jr, the United States Secretary of Health and Human Services, announced significant changes to the authorisation of mRNA COVID-19 so-called vaccines. It’s important to understand this was not a banning of mRNA—not yet anyway. It’s important to clarify the new measures. The Food and Drug Administration, the FDA, approved updated COVID-19 shots for the autumn season in America and imposed new restrictions, effectively ending their emergency-use authorisations. This is only a partial victory for mRNA critics such as me. The measures did terminate emergency-use authorisations that had allowed this dangerous, killer product to be given to anyone over six months of age.
What some claiming victory may have missed is that mRNA shots for COVID were given normal approval for a limited range of people. This includes anyone over 65 and anyone from five to 65 with an underlying medical condition. Moderna was approved for children over six months with an underlying medical condition. Is it a massive reduction in approval? Yes. Is it a ban? No. President Trump’s statement overnight suggests there are more developments to come.
Last week I spoke of many new peer reviewed studies which show how this harm is occurring right through the human body. Tonight I will talk about the data, which shows this harm is occurring. We have proof of the harm, and we have the science showing causality. The Defense Medical Epidemiology Database is part of the United States Defense Medical Surveillance System. It enables queries of de-identified medical data coded in the International Classification of Diseases classifications for active duty personnel, filtered on demographics and occupational categories. In 2021 whistleblowers reported significant increases in medical conditions compared to 2016 to 2020 baselines, prompting congressional scrutiny and resulting in a finding of data-handling errors. In 2023 outdated 2021 DMED data confirmed elevated diagnoses, including hypertensive disease up 23 per cent, ovarian disfunction up 35 per cent, pulmonary embolism up 44 per cent, Guillain Barre syndrome up 15 per cent, oesophagus cancer up 13 per cent and breast cancer up seven per cent. Myocarditis was up 151 per cent. Remember the sample set here is millions of people of the United States military. These are—or were—healthy, fit individuals and their families.
The harm is getting worse. Data for 2023 to 2025, using the same pre-COVID baseline, shows persistent elevations, terrifying elevations, over pre-COVID levels. Myocarditis is up 154 per cent; digestive organ cancer up 16 per cent in 2021 and up 43 per cent in 2024; brain cancer up 16 per cent in 2021 and 43 per cent in 2024; and blood coagulation defects up 25 per cent in 2021, 58 per cent in 2022 and then 32 per cent in 2023 as injection rates fell. That’s pretty damning. It shows that those who call this poison the clot shots are not entirely wrong. It gets worse, much worse. Conditions which may be potentially vaccine related and are certainly COVID-response related are up. Suicidal and homicidal ideation was up 46 per cent in 2021 and 86 per cent in 2024. Obesity was up 27 per cent in 2021, 69 per cent in 2022, 162 per cent in 2023 and 262 per cent in 2024. It’s okay though. Novo Nordisk has Ozempic on the market to fix that obesity problem. Who owns Novo Nordisk? Morgan Stanley, BlackRock, Vanguard and Norges. I call them ‘BlackRock Inc.’. This gaggle of rapacious wealth funds invest the wealth of the world’s predatory billionaires.
Who owns Pfizer, the cause of this obesity epidemic? You guessed it, BlackRock. They own the problem and the solution. Did someone say COVID was just a— (Time expired)
https://img.youtube.com/vi/hDtj01FBV-o/maxresdefault.jpg7201280Senator Malcolm Robertshttps://www.malcolmrobertsqld.com.au/wp-content/uploads/2020/04/One-Nation-Logo1-300x150.pngSenator Malcolm Roberts2025-10-28 09:56:102025-10-28 09:56:18Is Trump Finally Seeing the Truth About mRNA Vaccines?
In the July sitting, the Albanese Government introduced the Health Legislation Amendment (Improved Medicare Integrity and Other Measures) Bill 2025. Most of the bill was a tidy-up of poorly drafted health legislation from the previous parliament.
However, one section was slipped in — a new power allowing the Therapeutic Goods Administration (TGA) to declare a drug shortage based merely on the suspicion of a future shortage. This would then enable the approval of drugs that haven’t been properly tested or assessed.
The TGA already has a similar power with a higher threshold for approval. This new legislation appears to be nothing but a pretense to give the TGA sweeping authority to bypass safety testing and scrutiny for new drugs. Even under the current “higher bar,” Section 19(1) has been used to approve 135 current drugs and 600 expired or lapsed ones — a total of 735 approvals of new drugs – or versions of drugs in two years.
I asked the Minister to provide an example of how Australians might be disadvantaged without these new powers. The Minister couldn’t answer. So I must ask — who actually wrote this? It clearly wasn’t the Government.
One Nation will repeal Section 19(1) and ensure that every new drug is subject to proper safety testing and full regulatory oversight.
Watch the video and see for yourself how clueless this Government is.
Transcript
Senator ROBERTS:Minister, the existing wording of section 19(1) already allows the TGA to approve the use of a drug that is not registered or approved in Australia, in the event of a shortage. That power has been used for 135 current approvals, and for 600 expired and lapsed approvals, for a total of 735 approvals of new drugs or versions of drugs in two years. Why do you need new powers when the existing wording is clearly no barrier to approval?
Senator McALLISTER(New South Wales—Minister for the National Disability Insurance Scheme): Thanks for the question, Senator Roberts. The advice that I’ve been provided is that the amendment goes to the ability to act in advance of a shortage arising—knowing that a shortage is coming towards us down the pipeline rather than being required to wait until the shortage actually arises. It will allow the government and the authorities to get ahead of shortages in relation to pharmaceuticals.
Senator ROBERTS: Thank you, Minister. Minister, can you provide an example of a situation where this new power would be needed because the old wording did not provide for that situation?
Senator McALLISTER: Senator Roberts, I think I’ve explained the principle, which is that from time to time we know that shortages of pharmaceuticals do arise. They arise because of interruptions to global supply chains or, sometimes, an interruption in a particular facility’s manufacturing capability. That disruption doesn’t immediately translate into a shortage, but we know, logically, that it will at some moment. These provisions allow us to get ahead of that situation.
Senator ROBERTS: My previous question was theoretical, to understand the process that informed the legislation. This question, Minister, is not theoretical: in what situation has the existing wording of section 19(1) failed to provide a good outcome for everyday Australians? Could you give me a real example, please?
Senator McALLISTER: There are multiple shortages that are managed by the TGA, and we want to be in the best possible position in the future to be able to manage them as they arise.
Senator ROBERTS: Just one example, please, Minister—not a theoretical one, not a hypothetical; just one concrete example of where this has been needed in the past and was not available.
Senator McALLISTER: Senator, it’s not my intention to trawl over previous decisions and circumstances, but it is the case that, from time to time, we can see in advance the potential for a shortfall, and we want to give the TGA the best possible opportunity to be able to intervene and make sure that the medicines that Australians need are available.
Senator ROBERTS: That seems to be confirmation, Minister, that it has not happened in the past. There’s no need for it.
Senator McALLISTER: That doesn’t follow from the advice I’ve provided to you, Senator Roberts. There are shortfalls from time to time in medications that are important for Australians. The TGA presently acts to manage those and works very actively. We want to make sure that, in future, they have all of the tools available to them to be able to do that, and we consider this to be an important amendment that will assist the TGA in that task.
Senator ROBERTS: Minister, thank you. You say that there are examples, but you won’t give me any, so let’s move on. Under this new low bar for approval, a pharmaceutical company would be tempted to avoid applying for a regular approval, which is expensive and time consuming, when they could just have their drug waved through under a spurious scarcity rumour—not fact but pending scarcity. Minister, what safeguards are in this legislation to ensure that big pharma does not create a false scarcity story to avoid making a normal authorisation application?
Senator McALLISTER: The TGA relies on intelligence; the TGA does not rely on rumours. The premise of your question is incorrect. It remains my position, as I’ve explained a number of times now, that it’s really important that we are able to act when we are aware of a forthcoming shortage or the possibility of a shortage of critical medicines. Australians rely on the availability of these, and it’s an important function that the TGA serves in protecting the supply chain.
Senator ROBERTS: Minister, this is getting to be disappointing. You keep telling me there are many examples and it’s concrete, but I don’t get anything. Let’s move on. Minister, under this bill, is there a time limit for the approval, and, if so, can the approval be renewed at the end of that period, creating what is, in effect, a permanent approval where they just keep extending it?
Senator McALLISTER: Senator Roberts, when you’re speaking about an approval, which particular approval are you referring to? Obviously, the legislation canvasses quite a range of different approvals.
Senator ROBERTS: Any temporary approval.
Senator McALLISTER: The advice I am provided is that the approval, by its nature, is temporary and expires as the shortage is resolved.
Senator ROBERTS: So, if the shortage is not resolved, is there a time limit for that approval to be enforced? If there is, can it automatically be renewed—in other words, granting a bypassing of the normal full regulatory approval process?
Senator McALLISTER: I appreciate the senator waiting while I obtain advice. I want to give accurate information to the Senate. The advice I’ve been provided is that these are statutory criteria that need to be met for any approval, and the TGA would need to be satisfied that those statutory conditions were met. However, it is the case that, ordinarily, these circumstances resolve themselves, so we do see shortfalls from time to time, and they are generally resolved over time. Our interest is making sure that any short-term shortages or impacts on Australians can be managed and that the TGA has the tools to do so.
Senator ROBERTS: So, Minister, is there a time limit and is it automatically renewed if the shortage continues beyond that time limit?
Senator McALLISTER: The advice that I have is that the approval would be provided with a time limit. That doesn’t prevent a reconsideration of the same questions, but it would be against the same criteria that I referred to in my earlier answer to your question.
Senator ROBERTS: So it’s highly likely we would just continue. The TGA has already approved certain drugs, including the product Pfizer sells as a COVID vaccine—their word. It’s already been approved for full TGA approval based, according to the TGA, on the safety profile data experienced during emergency use authorisation. Minister, will this legislation provide yet another way big pharma can make an end run around Australia’s longstanding authorisation process?
Senator McALLISTER: No. That’s a very leading question. The purpose of the legislation is set out in the explanatory memorandum and in other documentation around the bill, and there has been a Senate inquiry into the bill. Our objective is to make sure that Australians have the medicine that they need, even when shortfalls arise globally, and that we are in the best position to manage any consequences when we do see interruptions to global supply chains.
Senator ROBERTS: Of the 735 drugs granted authorisation under the existing legislation, how many are now subject to an application for full approval or have been approved based, according to the TGA, on the adverse events profile of the drug during approval under section 19(1) in the same way Pfizer’s Comirnaty was?
Senator McALLISTER: I am not in a position to confirm the numbers that you’ve cited in your question, nor do I have information about the numbers of applications on foot in various processes administered by the TGA. Perhaps you might like to think about another way of getting to the information that you’re interested in.
Senator ROBERTS: I will ask again and will try and break up the question: of the 735 drugs granted authorisation under the existing legislation, how many are now subject to an application for full approval?
Senator McALLISTER: As I indicated to you, Senator, I don’t have that information with me, nor would you expect me to. It’s a very detailed question.
Senator ROBERTS: Okay, I won’t continue with the other breakdowns of the question. Let’s move on to the next question. Does a drug approved under section 19(1) also go on the Pharmaceutical Benefits Scheme and, if so, does the normal negotiation on price still occur, or do we just pay whatever the drug company wants us to pay?
Senator McALLISTER: Thank you for waiting, Senator Roberts. I was seeking advice, again so that I can provide you with accurate information. The advice I have is that the standard process is for a medicine or product to be listed with the ARTG first before being considered by the PBS.
Senator ROBERTS: Thank you, Minister. The TGA have been enjoying unrivalled, unquestioned and unaccountable power since the start of COVID. Minister, why is the government extending the powers of the TGA again, with a bill that provides zero parliamentary oversight of the new powers?
Senator McALLISTER: I don’t agree with many of the propositions that are embedded in your question, Senator Roberts. I think I’ve been really clear about the purpose of the bill, or at least the elements which you’re asking me about now. Your very first question was: why do we need these additional provisions and abilities for the TGA? The answer is: from time to time we see shortages arise, where interventions are required to protect the interests, particularly the health interests, of Australian consumers. We want to make sure that the TGA has the capacity to manage these kinds of shortfalls.
Senator ROBERTS: Thank you, Minister. I appreciate what you just said; I don’t agree with it at all, because the TGA has run roughshod over the people of Australia when it comes to health. They are not held accountable. We need to return, in my opinion, to the days when the department of health approved or did not approve a drug and then the department could be held accountable to the parliament. That’s not the case for the TGA. It completely bypasses the parliament. So I foreshadow my amendment to introduce a provision to the existing legislation that any approval issued under this legislation must be by way of legislative instrument to allow parliamentary scrutiny. We, not the TGA, represent the people. The TGA has so many close contacts and close conflicts of interest with big pharma. It gets 96 per cent of its revenue from big pharma. Minister, why is there so little parliamentary oversight of our health bureaucracy?
Senator McALLISTER: Senator Roberts, I think you and I have different views about the level of oversight. The TGA is part of the department of health. The department of health appears regularly at Senate estimates. There are also a range of forums in which the parliament may ask questions about these issues, including, of course, in this place, in our own question time. Our government is committed to scrutiny, and I simply disagree with the proposition that you have made in your question just now.
Senator ROBERTS: You’re welcome to disagree, Minister. I’m sure that you welcome my disagreement. We saw the previous head of the TGA, Professor John Skerritt, retire from the TGA and, eight months later, get a job on the board of Medicines Australia, the big pharma medical lobby in this country. We also see that the TGA gets 96 per cent of its revenue from big pharma. That is a reason why we need to take the approval of drugs away from the TGA. Big pharma is not trusted, and, by association and due to their COVID mismanagement, we don’t trust the TGA anymore. I move One Nation amendment (1) on sheet 3379 as circulated:
(1) Schedule 2, Part 6, page 22 (line 1) to page 23 (line 22), omit the Part, substitute:
Part 6—Therapeutic goods approvals
Therapeutic Goods Act 1989
52 Subsection 19(1)
Repeal the subsection, substitute:
(1) The Secretary may, by legislative instrument, grant an approval to a person for the importation into, or the exportation from, Australia or the supply in Australia of specified therapeutic goods that are not registered goods or listed goods:
(a) for use in the treatment of another person; or
(b) for use solely for experimental purposes in humans;
and such an approval may be given subject to such conditions as are specified in the instrument.
Note: For variation of an approval for use of the kind referred to in paragraph (1)(b), see subsection (4B).
(1AAA) A legislative instrument made under subsection (1) must set out the reasons for the approval.
53 Subsection 19(4B)
Omit “by notice in writing”, substitute “by legislative instrument”.
Senator RUSTON (South Australia—Deputy Leader of the Opposition in the Senate): I would like to make a couple of comments on the contribution that Senator Roberts has just made in relation to his amendment to this particular bill. I probably would have a great deal of sympathy with Senator Roberts’s position, particularly after the comment made by the government that they’re committed to scrutiny. I don’t think anything could be further from the truth, when we’ve seen the amount of times that transparency has been denied in this place. In fact, this morning we had a half-hour contribution about the refusal of this government to be transparent when it comes to the NDIS. So I certainly have a great deal of sympathy with Senator Roberts in relation to the lack of scrutiny of their actions that the government are largely prepared to allow this parliament and the Australian public over their time in government.
But, in saying that, I understand that one of the most critical issues facing Australia in recent times has been drug shortages, for a number of reasons, of medicines and treatments coming into Australia. As a legislature, whilst safety and efficacy are at the forefront of every decision we make in relation to providing treatments and access to treatments for Australians through the necessary processes that exist within the department of health—and that includes through the TGA—one of the things we must always do is make sure that there is quick access because we know that so many Australians rely on treatments.
When there are shortages, the government must be able to act with some haste to put supplementary or substitute treatments and medications in place to ensure that Australians are not denied the life-saving and life-changing treatments they often rely on. At no time should safety ever be compromised for Australians, but we do understand that many Australians rely on the agility of our health department and its agencies to do that. But we acknowledge the lack of scrutiny and the lack of transparency that have become a hallmark of this government.
Senator McALLISTER: I’d like to indicate the government’s voting position. As I understand it, Senator Roberts’s amendment seeks to essentially require certain decisions to be made by way of a legislative instrument rather than by notice of writing. The government consider that this would be unnecessarily burdensome and would deprive the TGA of the flexibility that is necessary to manage the health interests of Australians, and we won’t be voting in favour of Senator Roberts’s amendment.
The CHAIR: The question before the chair is that amendment (1) on sheet 3379, moved by Senator Roberts, be agreed to.
https://img.youtube.com/vi/HfuEERh_KRQ/maxresdefault.jpg7201280Senator Malcolm Robertshttps://www.malcolmrobertsqld.com.au/wp-content/uploads/2020/04/One-Nation-Logo1-300x150.pngSenator Malcolm Roberts2025-08-19 08:55:112025-09-04 22:49:41Is This a Backdoor for Big Pharma?
Powerful video from America’s national Health Secretary (Minister), Robert F Kennedy Jnr.
RFK Jnr made and sent this video to national health ministers and bureaucrats attending the UN-WHO’s World Health Assembly.
He raises many core issues that when addressed would put the USA and the world on a track back to full health and to freedom from Big Pharma.
He omits one key point: the fact that in addition to CCP funding of Gain-Of-Function research in Wuhan China, the USA National Institutes of Health and Anthony Fauci unlawfully funded and drove such research in Wuhan AND unlawfully initiated and continued to oversee research into the manmade Covid-19 virus at the University of North Carolina under the leadership of Ralph Baric.
RFK Jnr’s 5-minutes video gives the world hope.
Transcript
To my colleagues in public health, I’m Robert F Kennedy Junior, the US Health and Human Services Secretary.
As you know, President Trump has made the decision to withdraw the United States from the World Health Organisation.
I’d like to take this opportunity to offer some background to that decision and more importantly, to chart a future path toward global cooperation on health and health security.
Like many legacy institutions, the WHO has become mired in bureaucratic bloat and trench paradigms, conflicts of interest and international power politics.
While the United States has provided the lion’s share of the organisation funding, historically, other countries such as China have exerted undue influence over its operations in ways that serve their own interests and not particularly the interests of the global public.
This all became obvious during the COVID pandemic when the WHO, under pressure from China, suppressed reports at critical junctures of human to human transmission and then worked with China to promote the fiction that COVID originated from bats or pangolins rather than from a Chinese government sponsored research at a bio lab in Wuhan.
Not only has it WHO capitulated to political pressure from China, it’s also failed to maintain an organisation characterised by transparency and fair governance by and for its member states. The WHO often acts like it has forgotten that its members must remain accountable to their own citizens and not to transnational or corporate interests.
Now, I believe that for the most part, the staff of the WHO are a conscientious people who sincerely believe in what they’re doing. And indeed, the WHO has since its inception accomplished important work, including the eradication of smallpox. Too often, though, the WHO’s priorities have increasingly reflected the biases and interests of corporate medicine. Too often it has allowed political agendas, like pushing harmful gender ideology, to hijack its core mission. And too often it has become the tool of politics and turned its back on promoting health and health security.
Global cooperation on health is still critically important to President Trump and myself, but it isn’t working very well under the WHO, as the failures of the COVID era demonstrate. The WHO has not even come to terms with its failures during COVID, let alone made significant reforms. Instead, it has doubled down with the pandemic agreement, which will lock in all of the dysfunctions of the WHO pandemic response.
We’re not going to participate in that. We need to reboot the whole system, as we are doing in the United States. Here in the United States, we’re going to continue to focus on infectious disease and pandemic preparedness, but we’re also fundamentally shifting the priorities of our health agencies to focus on chronic diseases, which are prevalent in the United States.
It’s the chronic disease epidemic that is sickening our people and bankrupting our healthcare system. We’re now pivoting to make our healthcare system more responsive to this reality.
We’re going to make healthcare in the United States serve the needs of the public instead of industry profit taking. We’re removing food dyes and other harmful additives from our food supply. We’re investigating the causes of autism and other chronic diseases. We’re seeking to reduce consumption of ultra processed foods. And we’re going to support lifestyle changes that will bolster the immune systems and transform the health of our people.
Few of these efforts lend themselves easily to profits or serve establish special interests. These changes can only occur through the kind of systemic overhaul that President Trump has brought to our country.
We’d like to see a similar reordering of priorities on the global stage, especially considering the fact that through the leadership of the United States and funding from our country over the past 25 years, millions of global citizens have seen a reduction in premature death due to HIV, TB and malaria.
Let’s return to the core focus of global health and global health security, back to reducing infectious disease burden and the spread of diseases of pandemic potential.
I urge the world’s health ministers and the WHO to take our withdrawal from the organisation as a wake up call. It isn’t that President Trump and I have lost interest in international cooperation, Not at all. We just want it to happen in a way that’s fair and efficient and transparent for all the Member States.
We’ve already been in contact with like minded countries and we encourage others to consider joining us. We want a free international health cooperation from the straight jacket of political interference by corrupting influences of the pharmaceutical companies of adversarial nations and their NGO proxies.
I would like to take this opportunity to invite my fellow health ministers around the world into a new era of cooperation. We don’t have to suffer the limits of a more abundant WHO.
Let’s create new institutions or revisit existing institutions that are lean, efficient, transparent, and accountable. Whether it’s an emergency outbreak of an infectious disease or the pervasive rod of chronic conditions that have been overtaking not just America but the whole world, we’re ready to work with you.
Thank you and May God bless you, and let’s all pray for the health of our children and our grandchildren.
Produced by the US Department of Health and Human Services.
https://img.youtube.com/vi/toTUNlOlKr4/hqdefault.jpg360480Senator Malcolm Robertshttps://www.malcolmrobertsqld.com.au/wp-content/uploads/2020/04/One-Nation-Logo1-300x150.pngSenator Malcolm Roberts2025-05-22 18:05:142025-05-22 18:05:18US Exits WHO: Let’s Build a Better System Together
One Nation will restore direct oversight, supervision, accountability, and control to Parliament, removing influence from pharmaceutical companies over drug and product approvals.
Recently the head of the Therapeutic Goods Administration (TGA) Professor Skerrit left his role at the TGA and commenced work with Medicines Australia, which is the lobby group for the pharmaceutical industry. In effect, the professor is now working for the companies he recently regulated.
This is entirely unacceptable. The health of everyday Australians and trust in the medical establishment is too important to leave in the hands of a broken system rife with cronyism and self-interest.
We will return the power to authorise drugs and medical devices back to the Minister for Health, who will be responsible for delegating these decisions to his own departmental staff.
This system will ensure that the Minister’s decisions will be subject to rigorous parliamentary scrutiny, prevent conflicts of interest and most importantly remove the direct relationship between the TGA and pharmaceutical companies they are supposed to regulate.
Security of employment in the public service should prevent the revolving door we currently have between the TGA and pharmaceutical companies and ensure the best possible outcome for everyday Australians.
https://i0.wp.com/www.malcolmrobertsqld.com.au/wp-content/uploads/2025/04/ethan-hooson-6U-dmJ7WoDk-unsplash.jpg?fit=1026%2C684&ssl=16841026Senator Malcolm Robertshttps://www.malcolmrobertsqld.com.au/wp-content/uploads/2020/04/One-Nation-Logo1-300x150.pngSenator Malcolm Roberts2025-04-22 18:27:222025-04-22 18:27:54Restoring Parliamentary Oversight and Accountability in Drug and Product Approval
On Wednesday of the last sitting week in November, Senator Shoebridge proposed a bill to legalise cannabis. While support for legalising cannabis is growing strongly across Australia and Queensland, it’s essential to approach the topic with care, data, and diligence. It’s important to understand that despite claims by the TGA and the Lib-Lab UniParty that medicinal cannabis is freely available, the reality is quite different. The plant is artificially expensive and restricted in availability.
In an honest and effective way, we need to make medicinal cannabis easy and affordable to access for millions of Australians. One Nation will continue to lead the way in taking this first, humane step.
While we welcome much of Senator Shoebridge’s bill, there are three key sticking points that One Nation cannot accept:
1. One Nation cannot support home grow at this time. The trial of home cultivation in the ACT has shown it’s not widely adopted. A licensed commercial system would benefit more people than home grow at this stage
2. The fines and jail sentences proposed in the bill are excessively high. One Nation believes in ensuring that the punishment fits the crime, and this bill strangely gets that balance wrong.
3. One Nation does not support creating a new government entity to maintain a cultivar database. Instead, we would work with existing entities to achieve this purpose.
That said, the approach of removing cannabis from the control of pharmaceutical company salespeople at the TGA and establishing a new unit led by people who understand the plant, the industry, and can advance medicinal cannabis—is an excellent idea that One Nation fully supports.
A vote for One Nation is a vote for Australian, whole-plant, natural medicinal cannabis for anyone with a medical need. It would be accessible via a prescription from a doctor, nurse practitioner, or cannabis specialist, and filled by a pharmacist or qualified dispensary under the PBS.
This plan will not increase costs to taxpayers. Evidence from countries that have adopted this model shows that cannabis reduces healthcare spending, as it’s cheaper than many expensive pharmaceutical alternatives—if implemented correctly.
Transcript
There’s much in the Legalising Cannabis Bill 2023 which would make the regulatory environment for cannabis in Australia much, much fairer, so I thank Senator Shoebridge for bringing this bill before the Senate. I feel very pleased to speak, excited about some things and disappointed about others. For too long, the government of the day, both Liberal and Labor, have acted to defend the pharmaceutical state from the competition that medical cannabis represents. Indeed, our regulatory body, the Therapeutic Goods Administration, is funded from the pharmaceutical industry that it purports to regulate. The result is regulatory capture.
In recent years the Therapeutic Goods Administration, the TGA, has taken decisions that defy logic and that breach integrity—decisions that have placed 90 per cent of Australian adults at great risk of harm and death, decisions that have led to excess deaths it refuses to address, because the cause is the TGA and our health authorities. The TGA is a failed experiment; that is abundantly clear. It’s time to shut down the TGA and its apparatus of expert committees and agencies which act in concert to support the pharmaceutical industry to the detriment of the Australian people. It’s time to return control of drug and medical device approvals to the department, where the parliament will be able to exercise oversight and ensure accountability and transparency, which are sadly missing with the TGA.
The department can be downsized. Health is the state responsibility. Centralised regulation of drugs in the hands of the Commonwealth makes sense, and the states should be charged the cost of doing it or do it themselves, as they used to. Cannabis was removed from medical options in Australia following the Menzies government’s passage of the National Health Act 1953. This legislation placed the British Pharmacopoeia as the primary source of standards for drugs in Australia. Cannabis was a stalwart of pharmacopoeia. In 2024 the only pharmacopoeia that still includes medicinal cannabis is the European version. My point is that cannabis was widely used and accepted as a legitimate medical option across a wide range of profiles for a wide range of conditions. Without a doubt, pharmaceuticals have been a boon for modern society in many ways, although for many people modern pharmaceuticals don’t work, or the side effects can exceed the benefit. There’s a simple reason for this: medical cannabis has thousands of versions, with different combinations of cannabinoids, terpenes, flavonoids, steroids and other elements of the plant. There are thousands of elements. The Australian cannabis cultivar repository has almost 1,000 live cultivars of cannabis and is adding more all the time.
The significance of this is that it allows a patient, under the right guidance, to match their strain of cannabis—known as the profile—to the condition that they have. Modern pharmaceuticals employ and promote the opposite approach, matching a pharmaceutical product to a condition—one size fits all, if you like. That’s not the way health should be. But both approaches should be available to the Australian people.
I know the government and the opposition will point to the number of prescriptions written under the pathway scheme for medical cannabis and use that to mislead the public about the success of the current system. Before they make that ill-informed statement, I ask for an answer to the question the TGA refuses to answer: how many people who received a prescription for medical cannabis actually filled it? I’ll ask that again: how many people who received a prescription for medical cannabis actually filled it? My office is hearing from patients who could not afford the prescription, who could not find a chemist to fill it—often because supply was not available—and who paid out big money to get supply that was stale or even mouldy. I want to know how many people who used a medical cannabis product then suffered a side effect. I received a response to a question on notice around this last year. The answer, though, did not differentiate between legal and illegal supply.
So many people have trouble with price or availability and they fill their prescription on the black market. Some of the black-market players run rings around the quality of the legal supply, and many others do not. On the volume of prescriptions written, though not necessarily filled, the rate of harm from medical cannabis is substantially below the rate of harm for many pharmaceutical drugs. Yet cannabis has not been embraced as an alternative treatment. It used to be the leading medicine in the medical almanac in the 1930s in America; it was No. 1. So why hasn’t it been embraced? Why has it been knocked out? Money talks.
Restrictions to medical cannabis are more than directly regulatory. Other subtle hurdles make it difficult to access and use affordably, and that’s to the detriment of Australians’ health. Cannabis will never be approved because the cost of navigating the TGA system is so high that no cannabis supplier can afford it. The Legalising Cannabis Bill 2023 contains a new regulator which could function as a unit with the department. The Cannabis Australia National Agency, CANA, would employ people who know the plant and who know how it should and should not be used. That’s a blessing. CANA would set standards for use, sale, promotion, production and importation without the need for a sponsor. CANA could work with the department to understand the supply needs of the pathway scheme to issue formal guidance on profile and volume until such time as the industry develop the critical mass to do that themselves. This solves the pathways scheme’s biggest hurdle: the supply is patchy and the quality is often rubbish. CANA would license strains of cannabis and issue guidance for use through a new agency. I suggest the Greens could have used the existing Australian cannabis register, although that’s a small point. Regulation is necessary. Some of these insane new varieties of cannabis coming out of the United States have THC levels above 30 per cent. The cannabis that came to Australia during the Vietnam War was only three per cent THC. Over 30 per cent THC is insane, though perhaps useful for palliative care at best.
At this point, One Nation and the Greens diverge. The bill allows home cultivation of six plants. One Nation cannot support home grow. There is a qualification here: our opposition to home grow can exist only if Australians have access to safe, cheap, tested, licensed and accessible product, with a prescription from a doctor or nurse practitioner filled through a chemist or other suitable agent and supplied on the Pharmaceutical Benefits Scheme, the PBS. One Nation introduced a bill which would have done just that, and it was roasted, including by the Greens, can I say. In an interesting example of karma, their bill met the same fate.
The German government tried for two years, through 2022 and 2023, to introduce legislation which was similar to mine—sensible down-regulation of cannabis. They spent two years fighting entrenched interests, their own department and the Bundestag, the German parliament, and then lost patience. In a decision which could be characterised as ‘Stuff the lot of you’, the government simply legalised cannabis. That came into effect on 1 April this year. I’m pleased to inform the Senate that, in a country which is directly comparable to our country, Australia, legalised cannabis hasn’t caused the world to end. In fact, nothing harmful has happened. This was the same result in the Australian Capital Territory, which allowed home grow three years ago with the same result. No harm happened. In fact, nothing happened. And that is a problem. Legalising cannabis is supposed to help people treat medical conditions, reduce drug and alcohol addiction, reduce the presence of organised crime and chill. None of that appears to have occurred. Homegrown appeals to the small number of Australians within the cannabis community who know what they are doing and who have the land to home grow. For most Australians, regulated supply works better. At this point in the development of cannabis in Australia, regulated supply will help more Australians than home grow will. I’ll say that again. At this point in the development of cannabis, which is continuing, in Australia, regulated supply will help more Australians than will home grow.
The cannabis community makes a mistake that I find quite frustrating. They judge the plant on the basis of their experience and knowledge. They advocate for open grow and use like it were nothing more than a herb. It’s not just a herb. As I said earlier, there are 1,000 different profiles, and that number is increasing. How does an average Australian, a typical Australian, with no or limited knowledge know which one is right, how to grow it properly, how to prepare it properly and how to store and use it correctly? A typical Australian doesn’t know that, and that suggests smoking the plant, which One Nation suggests is the worst way to take medicinal cannabis. The most scientific, the most accurate and the safest is to purchase a cannabis vaping solution and vape it. But I won’t go there further today.
The other aspect of the bill One Nation cannot accept is the fines and jail sentences for minor breaches of the regulations. Seriously, six months in jail and 200 penalties earned, which is $36,000? On the other hand, children under 18 get off without a penalty at all. I get that the Greens are trying to raise the age of criminal responsibility, but a 17-year-old who starts a business growing and selling cannabis gets no penalty at all. One Nation questions that. This has not been thought through properly.
Let me finish with a warning and an invitation. Increasingly, One Nation is tending to the German response. If you won’t allow sensible regulation, then no regulation it is. We need sensible regulation. One Nation is prepared to engage with the government and others across the Senate to achieve a sensible regulation of cannabis, including on the PBS. We continue to listen to the community, to the people, Queensland and Australia, because we want to achieve a sensible regulation of cannabis including on the PBS.
https://img.youtube.com/vi/v-EreIqXC8s/maxresdefault.jpg7201280Senator Malcolm Robertshttps://www.malcolmrobertsqld.com.au/wp-content/uploads/2020/04/One-Nation-Logo1-300x150.pngSenator Malcolm Roberts2024-12-12 15:13:502024-12-12 15:13:55Affordable Medicinal Cannabis Needed for Millions of Australians
The World Health Organisation (WHO) has declared Monkeypox a global public health emergency, triggering emergency powers to drive vaccine sales that benefit big pharmaceutical companies with ties to the organisation. This decision serves corporate interests rather than public health. Regulatory agencies that are meant to protect the public fall under undue influence from the industries they regulate. The WHO is a corrupt organisation that is designed to funnel taxpayer money to its billionaire donors. Australian taxpayers gave $30 million to the WHO last year, likely as a show of loyalty.
Transparency is lacking. Major donors include Gavi, a vaccine alliance funded by corporations tied to predatory giants like BlackRock and Vanguard, who also own large shares in pharmaceutical companies. The WHO’s Monkeypox emergency, declared solely by its director-general, Tedros Ghebreyesus, highlights the unchecked power of the position. This decision created a market for four already-approved vaccines linked to companies backed by BlackRock and Vanguard, ensuring massive profits for their shareholders. A new Monkeypox vaccine is expected soon, likely fast-tracked by compromised regulators like Australia’s Therapeutic Goods Administration (TGA).
The WHO previously tried to raise alarm over Monkeypox but found little public concern, so they rebranded it as “Mpox” to push vaccine sales. This benefits the predatory billionaires who control vaccine companies, funnel money to Gavi and the WHO, and fund political parties, including Australia’s Liberal and Labor parties. Recent revelations show Anthony Fauci concealed plans to engineer a more deadly and highly transmissible Mpox virus. This “gain-of-function” research has pandemic potential and should be stopped immediately. It’s troubling that Australia’s CSIRO was involved in gain-of-function research for COVID-19, yet faces no consequences.
The WHO and the TGA have failed in their regulatory duties, serving political agendas rather than public interest. During COVID, the TGA prioritised government control over public health, and there are concerns the same will happen again with Mpox. Every Monkeypox case should be verified through public lab tests, especially as redacted data was used to justify COVID measures that harmed public health.
The time of blind trust in the WHO’s narrative is over; it’s now the age of ‘prove it’.
Transcript
The UN’s World Health Organization, the WHO, has declared monkeypox a public health emergency of international concern. This triggers WHO emergency powers to drive vaccine sales to financially benefit big pharmaceutical companies that donate to the WHO through their other commercial and ownership interests. The first thing a house of review like our Senate should do is ask, ‘Is this a legitimate decision?’ The answer is: it is not, no. The UN WHO has succumbed to regulatory capture—a troubling development in governance. That may plunge Western society into serfdom under large corporations.
Regulatory capture occurs where a regulatory agency mandated to oversee and enforce rules to protect the public interest ends up under undue influence from companies with vested interests such as the entities it’s meant to regulate or special interest groups. This can result in the agency making decisions that prioritise the interests of these parties over the broader public interest. The New South Wales government lists six areas for regulatory capture: adherence to public interest principles; organisational culture; structure; processes; transparency; and staff experience. The WHO fails all six.
I’ve often spoken about the corruption, cronyism and illegal behaviour of the World Health Organization; some of my WHO speeches are on my website. The WHO fails to hold staff accountable for misbehaviour, including rape and sexual assault. Its own investigators conclude the WHO is ‘rotten with rapists’—their words. It is a failure of organisational culture and of staffing quality. The WHO is a corrupt organisation whose decisions benefit its billionaire sponsors with substantial health interests. The scam is simple: take a disease that’s around for generations—firstly the flu, and more recently bird flu and now monkeypox; plant scary stories in a media desperate for clickbait articles; use the media driven fear to declare a pandemic; and then—payday!—mandate vaccines financially benefiting the billionaires that funded the media scare. This betrays the public interest.
The WHO is a con, a fraud and a criminal enterprise designed to transfer wealth from taxpayers into the pockets of their billionaire donors and owners. It is an organisation to which Australian taxpayers gave $30 million last year despite them having $8 billion in financial assets; that donation was likely more about fealty than financing. Identifying the WHO’s donors is difficult since its annual accounts show 32 per cent of donations as ‘other’—another failure of transparency. One of the WHO’s major donors is Gavi, the globalist vaccine alliance of international academics, bureaucrats and pharmaceutical companies funded through corporate donations from companies whose share registers feature investment funds like BlackRock and Vanguard. They feature on big pharma share registries; they own big pharma. If Australia had racketeering laws this arrangement would be illegal. This is a failure in structure.
The monkeypox declaration came from the WHO director-general, Tedros Ghebreyesus, acting alone. The process for making such an important decision is not meaningfully regulated and gives Ghebreyesus too much power to direct a worldwide health response. This is a failure of process, and it’s deliberate. The proclamation is designed to create an international market for new monkeypox vaccines. The WHO already have four approved vaccines for monkeypox: cidofovir, distributed through Pfizer; brincidofovir, manufactured and distributed through Chimerix, whose controlling shareholders include Vanguard and predatory wealth fund cronies; TPOXX, from Siga Pharmaceuticals, with shareholders BlackRock and Vanguard; and ACAM2000 from Emergent Biosolutions, whose largest shareholders are—wait for it—BlackRock and Vanguard. With these drugs the world’s predatory billionaires have decided it’s time for another fundraiser. All four drugs are off-label use—so, any day now, expect a killer new vaccine for monkeypox to be given the hosanna palm frond parade through our disgraced regulators like Canberra’s Therapeutic Goods Administration, the TGA.
The WHO tested this scam a few years ago with a minor media fear campaign that discovered the public didn’t take something called monkeypox seriously. So they rebranded it as mpox. Amusingly, they claimed the name monkeypox was insulting to monkeys; monkeys have feelings too, you know! So mpox is monkeypox rebranded to sell more vaccines from vaccine companies who funnel the profits to the world’s predatory billionaires—those same billionaires who own the corporations that donate to Gavi and the WHO as well as fill the coffers of political parties around the world, including massive donations to both cheeks of the Liberal-Labor uniparty in this country.
Last Tuesday, American congressional investigators revealed that, for nearly nine years, Anthony Fauci concealed plans to engineer a pandemic-capable mpox virus with high transmissibility and a case fatality rate of up to 15 per cent. That’s homicide. The gain-of-function project proposed through NIAID in America from virologist Bernard Moss was to splice genes conferring high pathogenicity from the clade I virus into the more transmissible clade II virus. The new chimeric virus or combined virus could have retained up to a 15 per cent fatality rate and a 2.4 reproductive rate—a measure of transmissibility—meaning, on average, every sick person could infect up to 2.4 other people, giving it pandemic potential. It’s marvellous, what it’s designed to do!
We know gain-of-function research produced the COVID-19 virus. Is this monkeypox outbreak also man-made?
Gain-of-function research serves no useful purpose and should be terminated immediately. It’s deeply troubling that Australia’s CSIRO admitted and bragged about its involvement in gain-of-function research that produced COVID-19. And now an online meme simply says: ‘They’re doing it again because you didn’t punish them last time.’ That’s truth indeed.
The WHO fails all six elements of regulatory capture and so does Australia’s Therapeutic Goods Administration, the TGA. The TGA is not acting in public interest, which former New South Wales deputy ombudsman Chris Wheeler considers fundamental to representative democratic government. The TGA may claim that, during COVID, it was caught between the parliament, its direct employer, and the wider public. It chose to serve the government’s need for air cover for controls decided on political, not medical, grounds. The TGA should have read the findings of the 1990 WA Inc royal commission, which found:
The institutions of government and the officials and agencies of government exist for the public, to serve the interests of the public.
That’s clear. Yet, during COVID, the TGA chose a different path: to support their own agency, to the detriment of the public. What will the TGA do this time, with monkeypox?
Monkeypox is transmitted through direct contact from sexual activity or intravenous drug use. A Philpot scientific study found 98.7 per cent of infections resulted from gay male sexual transmission. Transmission can occur through direct personal contact of the infected site. Infected animals can spread the disease. Asymptomatic spread, though, is, like COVID, an assertion with no evidence. The clade Ia variant of monkeypox can affect children. The clades currently circulating, though, clade Ib and II, have not been proven to infect children.
Australia has two monkeypox vaccines approved for over-18s. Both are off-label repurposed drugs approved for smallpox. JYNNEOS from Bavarian Nordic uses cidofovir, which I mentioned earlier, as the active ingredient. Bavarian Nordic have an application in to America’s Food and Drug Administration to give this vaccine to children aged 12 to 18 and are in early testing to support their application to extend use to children aged two and above—two and above! Why does a child need a vaccine against a disease that’s predominately only transmitted through sexual contact or intravenous drug use? The case for a monkeypox vaccination program must be a very high bar for any person who does not engage in risky sexual activity.
TGA’s website data from the 2022 monkeypox round of vaccinations in Australia shows 3,163 adverse events per 100,000 vaccinations—a staggeringly high three per cent. I note a study published in the journal Frontiers in Medicine, with authors from the University of New South Wales, entitled ‘Autoimmune blistering skin diseases triggered by COVID-19 vaccinations: an Australian case series’. This report found that COVID-19 vaccination either caused the recipient to develop autoimmune blistering disease or made the recipient’s existing condition worse. The cases are extremely rare, and, for once, I can agree with the TGA. I alert Australia to the chance that these outbreaks of a related disease could be mistaken for monkeypox. I note that autoimmune diseases and shingles—that is, herpes zoster—can intersect, and both are side effects of the COVID vaccines. If the Senate is going to be called on to support a monkeypox response, then it’s essential every case is verified through publicly disclosed laboratory testing.
Page after page of redacted data was used to support COVID measures and the damage to public health is undeniable. It’s homicide. ‘Safe and effective’ was not one lie; it was two. People are not believing the UN World Health Organization mpox narrative. The time for blind trust is over. We’re now in the age of ‘prove it’.
