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Pharma Exclusivity in TGA Processes a Barrier to Natural Products

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Before a drug or natural therapy can be approved by the “regulator” — the TGA — it must have a sponsor whose job is to pay the license fee, fill out the paperwork, and prepare safety and efficacy reports. These can be overseas because we no longer require local trials for new drugs. Drug companies are happy to develop new drugs and sponsor the applications because they have 25 years to get their money back from the patent which gives them exclusive rights to the product’s profits. After that, a product can be ‘generic’ or off-patent and any pharma company can make it.

Natural products such as cannabis and Aboriginal medicine from native plants cannot be patented which means nobody can afford to act as a sponsor. The result is the only thing doctors can prescribe are patented or ‘generic’ pharmaceutical drugs. I asked why there is not an office of the consumer advocate who can sponsor natural therapies like Cannabis and Albicidin (a natural antibiotic). Instead, the TGA chose to speak about their program to re-purpose pharmaceutical drugs that have already been approved for different uses. This answer really shows the pharmaceutical mindset our health administrators have.

The legislation needs to be changed to give natural products a path to market.

Transcript

Senator ROBERTS: Thank you. That leads to another point. It opens it up from this one. We have a system that says that, unless a product has a sponsor, it will never be approved. This isn’t the TGA system. They don’t write policy. This is a department and minister problem. There are multiple studies on the efficacy of medicinal cannabis for some conditions, and yet they’re not listed in schedule 4. There are 150 substances in Aboriginal medicine, yet only two have been commercialised, because natural products, even with postprocessing, can’t be approved by your system, because, without a patent, nobody will sponsor the product. Minister, why is there not a public advocate within the department that can bring natural remedies to the people under poison schedules 2, 3, 4 under the PBS where appropriate? 

Senator McCarthy: I will refer to the department. 

Prof. Lawler : As you highlighted and as we’ve discussed previously, the act does require a sponsor to bring medicines for evaluation. There are a number of reasons for this, and not least among them is the fact that, once a medicine is listed on the Register of Therapeutic Goods, there is a need for postmarket surveillance, pharmacovigilance, and safety and quality assurance, so it’s obviously very important that there be a point of accountability for these medicines. We are undertaking some work in terms of a repurposing initiative, and I will ask Mr Henderson to speak to that. It is about ways in which some of the medicines that are currently on the market can be used in other ways and how that might extend beyond the current sponsorship arrangements. 

Mr Henderson : As part of the last budget, the government approved funding of roughly $10 million over four years for the TGA to initiate a repurposing program for medicines. The context or the objective of that program is to incentivise sponsors—and non-pharmaceutical sponsors as part of that as well—to come forward with submissions to the TGA for medicines that are predominantly used off label. They are registered on the ARTG, the Australian Register of Therapeutic Goods, but for indications for which it may not have been feasible for low-population groups or niche population groups to have had a sponsor come forward in the past, so we’re looking to implement a program where we incentivise through waiving fees associated with the regulatory fees and charges as well as through working closely with our colleagues in the reimbursement space in relation to processes through the PBAC, pharmaceutical benefits and fee waivers. 

Senator ROBERTS: Thank you. So there may be some hope. 

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Australia’s Health System is Failing the Australian People

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During COVID we were forced by the health system into unnecessary and unhealthy lockdowns, away from fresh air, denied proper exercise and social contact. Many Australians have lost faith in the medical system that seems intent on promoting pharmaceutical responses to health issues that are more rightly lifestyle.

The nation’s health survey was released over Christmas and it’s one the health officials will not enjoy reading – “Today … Australians are at significant risk of dying young or living with preventable chronic diseases, with two thirds of us being overweight or obese.”

News Limited observed respondents would rather play video games and eat junk food than exercise. Where was the guidance from health authorities on staying healthy? What happened to the great Australian tradition of promoting “life, be in it”? Of prioritising good food and the great outdoors? Whatever happened to that? Instead we were locked down, fed on fear propaganda and isolated from our loved ones.

In 2024, public health is all about taking a jab or a pill to ‘restore’ health. Public health is no longer about preventative health or natural immunity, it is about promoting drug use. How has this been allowed to happen?

Australians need answers. We also need our public health system to make health all about healthy living once more.

Transcript

The greatest victim of COVID-19 was not the many Australians who, sadly, lost their lives to this man-made virus that Australia helped develop. It was not the many thousands of Australians who, sadly, died from injections and jabs that are proving to be the crime of the century; the greatest victim was public health. Confidence in public health is at an all-time low. Childhood vaccination rates are plummeting. Parents are choosing not to engage with the childcare system and, increasingly, the education system to protect their children from public health. 

The nation’s health survey was released over Christmas, and I thank News Limited for this report, which acts as a second opinion on the performance of our health officials. It’s one the health officials will not enjoy reading. Let me share some of the findings with you: 

Today … Australians are at significant risk of dying young or living with preventable chronic diseases, with two thirds of us being overweight or obese. 

More troubling for our health bureaucrats is that so few respondents were interested in doing anything about it, choosing instead to sit in front of a computer or TV screen for more than eight hours a day, shun exercise and eat junk food. News Limited have taken up the challenge of equipping their readers with simple advice to improve their health. Isn’t that our health authorities’ job? Remember Life. Be in it? Overweight Norm and his family, which started in 1979 and went into hibernation until recently, as it turns out. Public health is supposed to be about preventative medicine, encouraging people to get into life, get into some exercise and fresh air, and interact with others in a sporting, outdoor or otherwise active context. It’s great advice—advice that saves the taxpayer money, correcting conditions that are self-inflicted. 

Saying obesity is self-inflicted will earn you the ire of the woke brigade, who call that ‘fat shaming’. Someone has to. According to the study, Queensland is the third-fattest state in the nation, with 33 per cent of people identifying as obese. That’s one-third. This data is for Australians generally. It does not include the increase in youth depression and suicide that resulted from our failed COVID response and fear campaign. Sedentary lifestyles lead to chronic diseases and illnesses, including cancer, heart disease, diabetes and dementia. 

This afternoon I plan to speak about the 13 per cent increase in Australian mortality. Those deaths occurred largely in the areas of cancer, heart disease, diabetes and dementia. Many, including myself, are blaming the increase in unexplained deaths in Australia on the COVID-19 injections. Many of those are. Yet other reasons may be brought to light in a COVID royal commission that we need. One of those will be the failure of our health authorities to follow the most simple and fundamental pieces of health advice: preventative medicine. 

Everyday Australians were advised to isolate from others and stay inside away from the sun, yet sunshine is a common natural treatment for COVID. The advice to stay out of the sun is the opposite of the advice that should have been provided. We knew right through COVID that those who were obese were the group most at-risk for an adverse reaction to COVID-19. Where was the advice to eat healthy, exercise and lose weight? Nothing. The only advice was to be afraid, be terrified, so as to force a fear-based level of obedience in a country that had always used a mate’s approach to health, like Life. Be in it. 

At the same time, our health bureaucrats have acted to protect their friends in the quit-smoking industry through this recent ban on vapes. They’re protecting the quit-smoking industry, not smokers. One million Australians use a vape, many of whom use it to quit smoking. Australia’s smoking rate is higher than in countries with laws that allow vaping. Vaping stops smoking. Britain’s National Health Service advocate vaping as a quit-smoking medium, and our health authorities ban it. Why do they do that? 

In 2024 public health has changed direction. Preventative health has turned into restorative health. Our health industry is now standing, figuratively, on every street corner hawking the latest drug to correct the very conditions that their failures in public health have made worse. How has this come about? How is this allowed to continue? These are my questions to government and to the media. Will you please start asking those questions? 

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Exactly Who is Calling the Shots in Australia?

I asked Minister Gallagher how many vaccines are provided with an indemnity protection clause by the Australian government whereby those harmed cannot sue the company because the government has taken on the responsibility for harm done. Her answer was that indemnity was put in place due to the emergency nature of COVID response in the early stages. However 14 different COVID products have received indemnity protection from the Australian government, and one of them as recently as the 10th of October 2023.

In response, the minister fell back on confidentiality of agreements between the government and vaccine providers. This is the public’s money – the government is there to serve the people of Australia, not keep secrets from them and coerce them into risky products with mandates that even the Health Secretary, Prof Murphy, has said this year were not justifiable. The risk, from COVID, never justified the risk from the trial injections. After all that has been exposed globally, that the government is still promoting these products is shocking.

In saying that all necessary approvals to ensure its safety were followed through the TGA, Minister Gallagher is not being straight with us. The TGA did not test the Pfizer, AstraZeneca and Moderna COVID shots. It relied on the regulators overseas where these products were made. In the case of Pfizer, these were incomplete and aborted trials. The true magnitude of the harm is being released in the Pfizer papers ordered to be released by a judge in the USA.

Why is the government hiding behind confidentiality and exposing taxpayers to the risk of paying for costly damages for injection injuries as well as paying for products that are turning out to be unsafe and ineffective. Products that the public is no longer taking up and which the Minister appears to be pushing like a pharmaceutical sales rep on commission.

Big Pharma’s Stranglehold on Government Revealed

Senator Katy Gallagher claimed that the COVID product indemnity was put in place to secure product supply in a competitive market during the emergency of the COVID outbreak.

Senator Gallagher is the Minister for Finance overseeing contingent liabilities in the budget. With 14 more indemnities for COVID products and the most recent one last month, I think it’s pretty clear that this has nothing to do with a health emergency. It has everything to do with Labor’s deals with Moderna to get its production plants into Australia and pave the way for the World Health Organisation’s plans for 400 new mRNA vaccines for human and animal use. These are being designed to replace 400 regular vaccines with expiring patents.

Why is the government normalising indemnities? The process removes the incentive on the manufacturer to produce a safe, high quality product since any harm is paid for by the taxpayers. Follow the money and it leads to a patent cliff, not better health. It also explains the ongoing and seemingly frantic messaging of ‘safe and effective’ with every mention of these injections in government. It’s a shame the disinformation legislation does not cover messaging by the Government, so much misinformation originates there.

Transcript | Exactly Who is Calling the Shots in Australia?

Senator ROBERTS: My question is to the Minister representing the Minister for Health and Aged Care, Senator Gallagher. How many vaccines are subject to an indemnity from the Australian government?

Senator Gallagher: Thank you, Senator Roberts. I’ll just see if I can provide you with an accurate answer. I do know that there were indemnity arrangements put in place under the former government for the vaccines that were approved then, in the early stages of the pandemic, and those indemnity arrangements continue. I think we have traversed this a bit at estimates. I’m not sure if there is anything else I can provide. Indemnity arrangements were put in place for the vaccines that the government procured to enable the national vaccine rollout program to be undertaken during the pandemic emergency. That was an important part of ensuring that we could procure the vaccine in the amount that we needed and provide it to the Australian people. I would also say that, whilst the indemnity arrangements were in place, all of the required approvals to ensure the safety of the vaccines—prior to the vaccines being rolled out—were followed, through the TGA processes, which we have also traversed at length in estimates. We also have the COVID-19 Vaccine Claims Scheme, which was established to run alongside the national rollout of the vaccine program. And I would say that it was an important response to the pandemic to ensure that we could get as many people vaccinated as possible in a safe way to ensure that we minimised the impact of significant disease and also, at the very serious end, the deaths that occurred from contracting COVID-19.

Senator ROBERTS: Indemnities have been issued for 14 different COVID products. Each new COVID vaccine or shot has been given an indemnity, the most recent on 10 October 2023. With demand for the booster down to 5½ per cent for those under 65, and with multiple vendors, the argument that indemnities are needed to get stock is a patent nonsense. What is the real reason for these new indemnities, issued only six weeks ago?

Senator Gallagher: I can’t go into the confidential agreements that have been reached in procuring vaccines. These are agreements that are reached between the government and the vaccine provider, and we do so in a way that allows for the rollout of continued vaccination and booster shots to protect people from COVID-19. These are the arrangements that were entered into during the pandemic. Those arrangements are continuing. We think there’s a very important public health reason to ensure that we are procuring vaccines and making them available so people can take their booster. I would say that booster levels remain low—and we do want to see those increase—and that people should go and get their booster if they’re ready for one or if they’re six months past the last COVID-19 bout.

Senator ROBERTS: Minister, you won’t explain to the taxpayers why you’re using their money and putting it at risk, so I’ll ask a second supplementary. This government has offered Moderna an indemnity for every vaccine or shot manufactured in its new Australian factory, currently under construction, including regular non-pandemic vaccines. Why has your government not been honest in telling taxpayers they are paying for new vaccine harm during the COVID period and for all time?

Senator Gallagher: I’m not sure what Senator Roberts is referring to, and I reject the claim that we are somehow using taxpayers’ money and causing vaccine harm. That is not appropriate, and I absolutely categorically reject that. If there is anything further I can provide Senator Roberts around the arrangements with Moderna in particular, I am happy to arrange that. I don’t have that information before me, but I do accept that governments do negotiate agreements with companies around the supply and availability of medicines—and vaccines, in this instance—to ensure that we are able to provide the medicines Australia needs and also ensure that we have enough of the vaccines to provide the appropriate coverage, particularly for COVID-19 protection.

Transcript | Big Pharma’s Stranglehold on Government Revealed

I move: 

That the Senate take note of the answers given by the Minister for Finance (Senator Gallagher) to questions without notice I asked today relating to vaccine indemnities. 

Senator Gallagher is the Minister for Finance and is overseeing contingent liabilities in the budget. Although I prefer the words ‘fake-cine’ or ‘injectable’, what these products are not are vaccines. A vaccine prevents a person getting and transmitting an illness; these COVID ‘fake-cines’ do neither. Australia first provided indemnities in 2015 under the previous Liberal government for mpox and flu vaccines. Those indemnities are still in place. 

Now we have 14 more indemnities for COVID products, and they’ll be permanent. Labor’s deal to get Moderna’s production plant into Australia was revealed last week. Any vaccine manufactured in Moderna’s Australian factory, which is now under construction, will receive an indemnity. The agreement sets out that these vaccines will be indemnified as part of a pandemic vaccine advance-purchase agreement and additionally as part of a routine, non-pandemic vaccine supply agreement. In other words, every vaccine made will be indemnified with no word about testing. The new Moderna indemnity extends to routine vaccine supply, and the minister is not able to claim securing supply in a crisis. 

The World Health Organization has mentioned that there are 400 mRNA vaccines and products under development to replace conventional vaccines with expired patents. The attraction of mRNA is protecting profit from the patent cliff—not protecting better health. Those products will be for humans, livestock and pets. Our health authorities and politicians are promoting experimental mRNA products and, in so doing, risking everyday Australians’ health. I was hoping to hear why in the minister’s answer. Why is the government normalising indemnities, giving foreign multinational pharmaceutical companies blanket indemnities so they can avoid being accountable and encouraging companies to lie in their clinical trials, fudge efficacy data and cover up enduring death, as Pfizer was proven to have done in their COVID ‘fake-cine’ development? This question is not going away. We will relentlessly hound you down. 

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Medicinal Cannabis Overdue for Down Regulation

Proven over thousands of years and once America’s most prescribed medicine – until Pharma realised the profits it could make from patented products – medicinal cannabis has much to offer in terms of health and well-being. With 820 varieties growing in the Australian cultivar database, there’s a cannabis strain for many individual health conditions.

The Therapeutic Goods Authority (TGA) however, insists on tight control of the industry. This inevitably has enabled criminal gangs to provide much of the domestic medicinal supply, leaving the public vulnerable to potentially narcotics-laced products in the black market.

One Nation has advanced legislation to down-regulate medicinal cannabis so that any doctor can prescribe medicinal cannabis for any patient with a medical need and have that prescription filled by a chemist on the PBS. The goal here is to remove the industry’s criminal elements while providing the widest range of quality, whole-plant and natural cannabis for individual patient needs.

The TGA has authorised a range of cannabis products for prescription under its restrictive pathways program, yet there’s no reason not to offer these products in schedule 4, for any doctor to prescribe — truly safe and effective products that have already been prescribed successfully for many years.

By restricting these products using an approval system that has buried the TGA in paperwork they never check, the TGA is just looking out for the pharmaceutical industry and ignoring the needs of everyday Australians.

Transcript

As a servant to the many different people in our one Queensland community, I was pleased to accept an invitation from Isaac Balbin, founder of cannabis.org.au, to attend last Thursday’s national cannabis industry roundtable. What a pleasure it was meeting Isaac, Rhys and their team in Melbourne and speaking with other members of parliament who, like One Nation, believe medicinal cannabis is long overdue for sensible downregulation. Medicinal cannabis is marvellous. Proven over thousands of years, in the 1920s it was America’s most prescribed medicine before Big Pharma realised it could not make as much money from a natural plant. There are now 820 varieties—and growing—in the Australian cannabis cultivar database, many developed to suit specific health conditions or needs. 

Victorian MP David Limbrick made sensible comments about where the line between government regulation for the good of society and personal freedom should be—and it’s nowhere near where it is now. Legalise Cannabis Party MLC from Western Australia Sophia Moermond spoke to the need for some level of personal growth. While we may not agree on personal growing, there was so much commonality in views being expressed. I’m excited for the potential of the cannabis industry uniting behind a sensible cannabis downregulation. 

United Kingdom member of parliament Crispin Blunt updated us on how this is progressing better in the UK than here and provided a framework for evidence-based drug policy. Now, that’s an idea I can get behind: evidence based policy on medicine. 

One of Australia’s leading cannabis doctors, Dr Nic Guimmarra, Vice President of the Society of Cannabis Clinicians, raised his concerns that the current licensing schedule has led to a situation where some disreputable cannabis clinics are pushing patients through so quickly that the resulting prescription and instructions for use are counterproductive for the patient. It’s One Nation’s belief that the heavily regulated and restricted pathway system is burying the Therapeutic Goods Administration in paperwork that it’s not checking, causing suboptimal care and, likely, patient harm as conditions worsen instead of being treated. 

This is why One Nation advanced legislation to downregulate medicinal cannabis so that any doctor can prescribe medicinal cannabis for any patient with a medical need and have that prescription filled by a chemist on the PBS. Our legislation harmonises the THC level below which a planet is hemp, not cannabis, to one per cent. This aligns with changes made in all states. The bill further adds a level of THC and CBD below which a pharmacist could sell the product to an adult without prescription. 

I was pleased to hear Michael Balderstone, President of the Legalise Cannabis Party and a legend of the Australian cannabis industry, warn that new hybrid cannabis strains with THC of up to 35 per cent were a concern needing some regulation. Thirty-five per cent THC is insane. It would suit the treatment of chronic pain and palliative care and very little else. Michael called for some commercial growth activity as otherwise development of new strains will be compromised. This is the problem with free growing without a commercial option. The plant works best when the profile of THC, CBD, terpenes and flavonoids are set to the needs of a person with a specific health condition. Unlike pharmaceuticals, with natural plant cannabis, one size is not expected to fit all. For this development to continue, it needs a commercial market presence. Consensus in the industry may ultimately fall on some level of licensed free growing. One Nation will cross that bridge, in consultation with our members, when we get there. 

Last Thursday I heard an analogy for free growing. It was the belief that, just because people can brew their own beer, it doesn’t mean people will. In fact, almost nobody does, because people can readily buy what’s needed commercially. The challenge is to take out the industry’s criminal elements while providing the widest range of quality Australian whole-plant and natural medicinal cannabis at an affordable price. 

It’s a scandal that regulatory authorities insist on tight volume controls that enable criminal gangs to provide much of the domestic medicinal supply. These are gangs that lace cannabis with narcotics and then deliberately target kids at events like Schoolies. The TGA is driving practices hurtful and dangerous to children. It’s a scandal that the minister could downschedule cannabis today yet has not done so; scheduling is regulatory, not legislative. It’s a scandal that some in the cannabis industry, including pioneers, have developed their business under the current regulatory regime environment and see downscheduling as a threat to their nice little money-earners. 

There’s no reason the entire cannabis product offering that the TGA has authorised for prescription under their restrictive pathways program could not be offered in schedule 4, for any doctor to prescribe—products that have already been prescribed successfully and safely for many years. The minister could use a regulatory instrument to make it happen today, yet he will not, because predatory billionaire owners of pharmaceutical companies pull the strings in Canberra. Australians with a medical need for cannabis don’t get a look-in. This government is saying to everyday Australians, ‘Your needs don’t matter.’  

The TGA monitors impacts of cannabis and has found that medicinal cannabis has a lower adverse event rate than prescribed pharmaceuticals. Sensible downregulation will save lives. It will provide hundreds of tailored strains of medicinal cannabis designed to ease suffering and improve the health of our society, while taking the profit and control away from crime gangs. I look forward to working with cannabis.org.au to make this happen. 

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TGA is Risking Your Health to Act as a Sales Agent for Big Pharma

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A cheap, safe, award-winning, generic medicine, one that has been around for decades and was readily available, was shown to save people’s lives during an outbreak of a virus. Do you think it was a good decision for Australia’s Therapeutic Drug Administration (TGA) to arbitrarily ban its availability and off-label prescription in order to save it for skin conditions? Why not just buy more of it?

Despite substantial bodies of evidence from around the world, Australia did not recognise the available proof supporting Ivermectin’s use because no ‘sponsor’ (read pharmaceutical company) brought it to the TGA. What they did do was convene a Commonwealth-funded Clinical Evidence ‘Kangaroo Court’ which declared Ivermectin had no value in the treatment or prevention of COVID19.

This completely ignored a generation of evidence that Ivermectin was an effective early stage treatment for coronavirus.

The TGA continued to ignore the new data that showed Ivermectin was an effective and safe early treatment for COVID until the jab rate was over 95%, then they allowed its use. Here’s the kicker — the TGA admits in this video they made this decision because they were worried that people would not seek vaccination if they believed Ivermectin could help them.

Regulatory capture by pharmaceutical industries is a well known concept but I’m reassured that this “doesn’t happen at the TGA”. Yet in the same line of questioning, the TGA admits that if a pharmaceutical company sponsor does not promote a drug with them, and pay the fee of course, they don’t bother to show the initiative themselves.

This is purely a transactional process, as the TGA itself admits in this senate estimates. It’s clear that there is something very wrong with the system.

Transcript

Senator ROBERTS: My questions are to the TGA. In the last Senate estimates, I asked Adjunct Professor Skerritt if the TGA was inquiring into the opportunity presented by albicidin, a natural antibacterial derived from a sugarcane virus that does not cause antimicrobial resistance. Dr Skerritt’s response was: We are very closely monitoring the science. In fact, I’m the keynote speaker next Thursday at the Australian Antimicrobial
Congress…We haven’t had a submission relating to that product because it’s still very early days, but we are monitoring…antimicrobial resistance because…it’s a serious threat.

I was concerned that was a non-answer, so I asked the minister about it, in question on notice 1449. His response was: ‘The department of health is not conducting a review into albicidin.’ Can you clear this up, please? Are you treating albicidin as a prospective revelation in the battle against antimicrobial resistance, thoroughly deserving of active research and development?

Dr Langham: The normal manner in which the TGA evaluates and assesses a product for use is through a process whereby a sponsor brings us a product, with all of the relevant research, clinical trials and a dossier of its safety and quality, and that has not happened at this stage. Until someone comes to us with this, we’re not able to do anything in terms of furthering what could potentially be a really important treatment; we’re not able to further that, in terms of making it available to the public.

Senator ROBERTS: Does the department of health have any role, ability or authority to sponsor?

Prof. Murphy: Generally, no. Occasionally, we have taken the role of sponsoring in very difficult circumstances, when there’s a drug that’s registered and available and the sponsor doesn’t want to sponsor it. But
with an experimental new drug, we would never take that role. Occasionally, there are avenues for us to support drug development through MRFF and NHMRC research. There have certainly been programs that have looked at therapeutic advances in that space. But with a new agent or a new molecule, it would be quite inappropriate for us to take a role as a sponsor.

Senator ROBERTS: The TGA is 96 per cent funded by pharmaceutical companies through fees. Albicidin is a naturally occurring substance. Can it be patented? I would say not.

Prof. Murphy: We’d have to take that on notice. It depends on the use, and patent law is quite complicated. I can’t answer that.

Senator ROBERTS: My point is: would it get a sponsor to make an application? Drug companies rely a lot on patents and making excessive profits.

Dr Langham: You would expect so, absolutely.

Prof. Murphy: If it were proven to be highly effective, I would imagine that a drug company would be very interested in pursuing it, but—

Senator ROBERTS: Drug companies have shown that they’re only interested in profits—the major ones.

CHAIR: Please put that as a question, Senator Roberts.

Senator ROBERTS: Yes, it is a question.

CHAIR: What was the question?

Senator ROBERTS: Isn’t that the case?

Prof. Murphy: No. Private companies all make a profit, but profits can often come by sponsoring highly effective new agents; that’s where they make their biggest profits. This is all highly speculative and I don’t know
that we can progress it much further.

Senator ROBERTS: The CSIRO has produced a guide to controlling antimicrobial resistance that assumes massive government power, including close monitoring and regulation of homes, pets, agriculture, waterways, new vaccines against diseases that used to be controlled by antibiotics and, of course, conferences. Antimicrobial resistance is being set up to be a massive government and pharmaceutical company gravy train. Why are you ignoring a probable solution to antimicrobial resistance? Do you want the power to order more vaccines, to wield more intrusive powers and to make more sales for big pharma, which is the history of the last few years?

Prof. Murphy: We reject that assertion. We completely accept the assertion that antimicrobial resistance is a significant problem. One of the ways that we have been, for many years, trying to combat it is to try to encourage prescribers in the use of antibiotics to reduce their use of antibiotics, which is not in the interests necessarily of the pharmaceutical industry. We are very keen to make sure that we limit the use of antibiotics to those situations where they are absolutely essential. There’s a lot of unnecessary prescription of antibiotics, and some of that is a real problem. We certainly have a lot of interest in antimicrobial resistance, and any new agent would be of interest to us. But we are not in a position to sponsor something like that.

Ms Duffy: We are in collaboration with the CSIRO in advancing their work and we have been involved in a number of CSIRO roundtables on this project that they’re going through, so we are working in lockstep with them.

Senator ROBERTS: Let’s turn to medical or medicinal cannabis. My office is getting reports that prescriptions of dried medical cannabis issued under the pathways scheme are being endorsed with the phrase ‘for
vaping’, and that requires patients to also buy and use a vape. A doctor that my office spoke to has advised that this is a TGA instruction; is that correct?

Dr Langham: Medicinal cannabis products, with the exception of two of them, are not regulated as ‘medicinal products’ by the TGA. They are available under a special access scheme, and it’s a condition of the special access scheme that the practitioner who is approved to prescribe adopts all of the undertaking to ‘consent’ patients, to understand the research, to advise on side effects and so forth. The TGA does not regulate any of the medicinal cannabis products in Australia.

Senator ROBERTS: Do you require someone who uses medical cannabis in dried form to purchase a vape— the device?

Dr Langham: It’s not our advice, no, and it would be coming from the medical practitioner, if the medical practitioner felt that there was a substance that was better done as an ointment, a tablet, a spray or a vape. I don’t know whether you’re able to add anything on vaping devices for that.

Ms Duffy: In terms of the method of delivery, it would be up to the treating practitioner to identify the most appropriate method for that patient.

Senator ROBERTS: To list a product under the Australian Register of Therapeutic Goods for prescription under schedule 4, there’s a prescribed process, which is not legislative. The steps, time frames and levels of proof of safety are all in regulation issued by the secretary under delegated powers, and much of the process isn’t even regulatory but administrative. Is that an accurate statement?

Dr Langham: I’d need help on what’s in the act and what’s in the regulations.

Dr Gilmour-Walsh: I didn’t understand all elements of that question.

Senator ROBERTS: Do you want me to repeat it?

Dr Gilmour-Walsh: Yes.

Senator ROBERTS: To list a product under the Australian Register of Therapeutic Goods for prescription under schedule 4, there’s a prescribed process, which is not legislative. The steps, time frames and levels of proof of safety are all in regulation issued by the secretary under delegated powers, and much of the process isn’t even regulatory but administrative. Is that an accurate statement?

Dr Gilmour-Walsh: I don’t know that’s an entirely accurate statement. Some of the process is set out in primary legislation and some of it is set out in delegated legislation. But, yes, there are some administrative
policies that support the administration of the act.

Senator ROBERTS: Does the suspension of these processes by the minister and/or the secretary during COVID prove that the ARTG—the Australian Register of Therapeutic Goods—process is whatever the secretary
or the minister says that it is?

Dr Gilmour-Walsh: That’s simply not the case. The secretary’s powers are bounded by the act and instruments made under the act, including regulations, which are made by the Governor-General.

Senator ROBERTS: COVID vaccines were not manufactured under good manufacturing process, GMP, so even this basic requirement for the approval of a drug is just a preference and not a legislated requirement, is it not?

Mr Henderson: For the provisional approvals of the vaccines, they needed to provide evidence that they were manufactured under good manufacturing practices.

Senator ROBERTS: But they weren’t. Could you get us a copy of that evidence, please?

Mr Henderson: I’ll have to take that on notice.

Senator ROBERTS: Yes, fine. Referencing section 26BF of the Therapeutic Goods Act 1989, this ‘allows the minister to direct the operations of the secretary in respect of the scheduling and listing of products’. Minister, isn’t it true that the minister could down-schedule medicinal cannabis to schedule 4 and move the products approved for prescription under the pathways program onto the Australian Register of Therapeutic Goods right now, if he wanted to? He might not intend doing that, but it is within the minister’s power, isn’t it?

Senator McCarthy: I’ll take that on notice.

Senator ROBERTS: I understand that the minister could regulate right now to move medicinal cannabis to schedule 4. Thank you, Minister.

CHAIR: I believe that the witness is taking that on notice; is that right?

Dr Gilmour-Walsh: Yes. We can take it on notice, but I’ll just add that I don’t believe that power supports that. The usual process is that there has to be a legislative instrument, made under a power much further down in the act, to amend the Poisons Standard.

Senator ROBERTS: The way that I’ve been advised, I’m pretty confident that it’s just a ministerial regulation.

Dr Gilmour-Walsh: We can consider that further, but that’s not my general understanding.

Senator ROBERTS: Minister, my office checked all the state legislation on prescribing and found much commonality. There is the use of a simple statement such as ‘prescriptions can be issued for anything listed in
schedule 4′. There is no separate state list of drugs. If medicinal cannabis were down-scheduled federally, the states would need to introduce legislation to over-rule that decision and then get that legislation through their own parliament; is that correct?

Senator McCarthy: I’ll take that question on notice.

Senator ROBERTS: Thank you. Minister, could the bill introduced by Senator Hanson to down-schedule medicinal cannabis be regulated right now, today, if the minister chose to do so? In other words: the legislation is not needed and the minister could just regulate.

Senator McCarthy: I’ll take that on notice.

Senator ROBERTS: Thank you. Let’s come back to today. Today is a wonderful day to celebrate. Today is 1 June 2023. From 1 June 2023, the prescribing of oral ivermectin for off-label uses will no longer be limited to specialists such as dermatologists et cetera. It’s back and can be used off-label. I must note, to keep the secretary calm, that the TGA says that it does not endorse off-label prescribing of ivermectin for the treatment and prevention of COVID-19. It doesn’t do that, but it can be used for that. Craig Kelly, a former member of parliament, contacted the office of the chief minister in Uttar Pradesh—Uttar Pradesh is a state in India—and
asked for guidance on how Uttar Pradesh had successfully used ivermectin to control the COVID virus in Uttar Pradesh. He received great information on their success. If a member of parliament, at the time, could reach out like that to be better informed, why didn’t the TGA reach out and be better informed on ivermectin?

Prof. Murphy: The TGA relies on the body of scientific evidence. Professor Langham can talk about that. We rely on the published scientific evidence and not the statement of a politician in India. Professor Langham, do you want to comment?

Dr Langham: Thank you. I guess it comes back to my earlier point that a drug, a medicine or a product that is on the ARTG is there for a specific indication. In this case, the specific indication for ivermectin—for which there’s been a dossier provided, evaluated by the TGA as robust, good clinical science—is that it is useful for the treatment of certain parasitic illnesses, be they gastrointestinal or skin based. No evidence has been presented to the TGA by the sponsor to demonstrate in any way, shape or form that ivermectin is useful in treating COVID-19. If the sponsor would like to do so, we’d be happy to consider that, because that’s the only way that the TGA is able to expand that indication.

Senator ROBERTS: Could I table these for discussion, please, Chair.

CHAIR: You can submit them to the committee for consideration. It’s going to take a while to work through them, by the look of it.

Senator ROBERTS: What is being distributed is an affidavit from Dr Pierre Kory in the United States. He has gone through this for many years and he has compiled many references—I think it’s over 96—that praise
ivermectin’s use in treating COVID. It’s been used in many countries and has stopped COVID in its tracks. It has been not only a treatment but also a prophylactic, to prevent the spread of the disease. This is my last question: are you aware of any successful programs overseas that used ivermectin to control the pandemic? Now you’ve got the evidence, Professor Langham.

Dr Langham: Obviously, there’s a very dense article here and a lot of different publications are being referenced. For me to pass judgement on this particular body of evidence, I’d need to take that on notice and get
back to you.

Senator ROBERTS: I’m pleased to hear you say that, because I wouldn’t want it done on the spur of the moment.

Dr Langham: Certainly not.

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What does Big Pharma Have to Gain?

One Nation supports the general principle that students should be able to finish their studies without breaking the bank. The real conversation needed though is the artificial monopoly the medical colleges hold over students in this country.

At a time when Australia is desperate for trained health professionals, medical colleges punitively restrict the amount of places available for students, denying Australians a proper supply and ensuring students have nowhere else to turn. A second look into this practice is needed.

While we’re at it, students that chose not to take the COVID injections need to be allowed to complete their studies or have their HECS debt refunded.

Transcript

One Nation supports the general principle that this MPI proposes, that students should not have to go broke to finish their studies. The medical colleges currently rely on huge numbers of students paying their own out-of-pocket costs and even making thousands of hours of unpaid placements in addition to their studies. The real conversation we need to have, though, is about the artificial monopoly the medical colleges hold over students in this country.

Australia is crying out for health professionals, and the fees to see them are too high for some people. While this is happening, the medical colleges putatively restrict the amount of places available to students, denying Australians a proper supply of trained professionals and ensuring students have nowhere else to turn. We need to have a second look at the medical colleges. And we need to have a look at the universities, who are punishing some people who have completed their academic studies and just need to do their practical courses. The universities are forcing them out because of mandates for COVID injections. That’s inhuman—three to four years work and a contract broken.

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Spike Protein Scandal Should be Referred to Senate Select Inquiry

We know COVID injections contain spike proteins that instruct human cells to make spike proteins for extended periods of time.

I asked these questions in the Senate:

  • What is the biological function of the COVID spike protein?
  • Are COVID injections fundamentally safe?
  • Could the COVID injections be instructing human bodies to make a substance which is making them sicker not healthier?

Moderna has told us that spike proteins are the same whether derived from COVID or the injections. Spike proteins fuse cells together.

Big pharma tried and failed for 20 years to use spike proteins as an antigen so they’re nothing new. COVID was just an excuse to finally use them without the usual safety net of robust regulations and trial data, and make obscene profits.

The spike protein has an unknown impact on the body’s complex mechanisms involving laminin. These large cross-shaped proteins are often called the ‘god molecule’ for their shape. They are part of the body’s healing processes.

Another problem with the spike protein in these injections is that the virus mutates rapidly, making the injection lose any effectiveness very quickly. This is why the so-called ‘vaccine’ was not an immunisation and did not stop infection or transmission.

The COVID injections did not offer protection against new strains. There was no valid independent science to support that statement. That was a lie. The TGA would normally prosecute any pharma company making such claims, and yet it was the TGA itself making that statement!

Spike proteins are also able to trigger cell fusion in brain tissue, possibly causing brain dysfunction and damage leading to ‘long COVID’. As Moderna has revealed, there is no difference between spike proteins from COVID or the COVID injection.

The West has spent the past three years injecting people with the very thing that causes long COVID. Spike proteins.

How this has happened is the scandal that must be investigated immediately.

Transcript

As a servant to the many different people who make up our one Queensland community, I ask a question tonight: what is the biological function of the COVID spike protein? This question asks whether COVID injections are fundamentally safe, because we know that COVID injections contain spike protein that embed into our system a genetic instruction for human cells to make spike proteins for extended periods of time. Could COVID injections be instructing human bodies to make a substance that’s making bodies sicker not healthier? Let’s review the latest data.

First point: spike protein may replace a protein molecule called laminin. Laminin is found in the extracellular matrix, the sheets of protein that form the substrate of all internal organs. Laminin is critical to how our cells hold together. Interfering with laminin can cause our organs to fail. Laminin is shaped like a crucifix and is widely known as the ‘God molecule’. When I met with Moderna in my office a few months ago, they were happy to admit that their spike protein was identical to the spike protein molecule in COVID. So, when studying spike protein, it does not matter what the source is. What matters is that, with the new study on the effects of that spike protein on the body, COVID injections are instructing body cells to produce spike proteins.

What we do know is that the spike protein is fusogenic, meaning its job is to bind cells together—think velcro. It does the same job that laminin does. Big pharma has tried to use spike proteins as an antigen for 20 years, and for 20 years they failed. The COVID injections were not a sudden success. Pharma simply lied and cheated on the clinical trials to use this thing they had spent billions on in an injection arranged to be rushed through approvals, and they made obscene profits in the process.

Now we’re seeing symptoms that can be explained with the discovery that the spike protein replaces laminin in the extracellular matrix. Does the spike protein interfere with laminin? The answer is: we do not know. This is what happens when we do not know yet insist on playing God. The reason using spike proteins as an antigen has failed is because the spike protein mutates in the wild every few weeks. A COVID injection loses any claim to effectiveness very quickly and needs to be updated. This is why the COVID injections are being retired and new ones are being released continually.

Do you remember when we were told that the vaccines offered protection against new strains and to keep taking them? That was a lie—a bloody lie. There was no valid independent science to support that statement. The Australian Therapeutic Goods Administration, the TGA, would normally prosecute a drug maker making misleading comments about their product without proof of the claim. In this case, though, it was the TGA making the misleading claims, so it’s the TGA who should be held to account.

COVID injection effectiveness was knowingly misrepresented, and here’s why. There’s no pathway for an antibody and a serum—blood—to get into the lung. While we can deliver a drug to the lungs and it will get into the serum, it can’t go back the other way, from serum to the lungs. The problem is that, in order to stop infection and transmission, the injections had to get into the lungs and the nose. The COVID injections simply never made it there. People who took the injection had levels of IgG antibody in the nose and lungs that were 1,000 times less than the levels in their blood. This is why the injections did not stop infection or transmission and never could have. The TGA knew, or should have known. This was the science, and they bloody well ignored it to promote injections that failed miserably and killed tens of thousands of people, melting down and exploding the database of adverse events.

Second point: spike proteins cause brain damage, leading to long COVID. Scientists at Macquarie University and the University of Queensland used mini brains infected with the SARS-CoV-2 virus to discover that the spike protein could trigger fusion in cells in both mouse and human brain tissue. The host brain cells are fused, possibly causing brain dysfunction, said Professor Lars Ittner, director of the Dementia Research Centre at Macquarie University. The discovery could explain chronic neurological symptoms such as headaches, brain fog, exhaustion and loss of taste or smell—even long after the initial infection.

Of course, spike protein from the injection was not included in the study, and yet, as Moderna themselves say, there’s no bloody difference. The West has spent three years injecting people with the very thing that’s most likely causing long COVID. Big pharma never researched the effect of their spike protein on the human body yet received approval for their sickening products anyway. How this happened is a scandal that must be referred to a Senate select inquiry immediately.

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How bad is my batch just morphed into how bad is my Minister for Health!

Minister Gallagher seemed to misunderstand the last question on both opportunities to answer it. She did not answer what happens with other medicines. She and others present around her made faces and lipreading Minister Wong would be interesting.

Minister Gallagher’s unguarded expressions give viewers the impression that she felt the question was inappropriate. She only wanted to talk about COVID emergency and repeat the tired pharma marketing messages.

Who does the batch testing? Not the safety testing which is part of vaccine approval.

Who is responsible for testing batches of medicines for quality when they are imported into Australia?

These are questions the Australian public are entitled to know the answers to because our lives depend on it. They are not impositions on ministers. They are part of the job of serving the best interests of the people.

Transcript

Senator Roberts: My question is to the Minister representing the minister for health, Senator Gallagher. Minister, the COVID batch release assessment for each COVID vaccine batch is produced after testing each batch. Who performed the test?

Senator Gallagher: This would have been work led by the TGA, but I will see if I can find further information about whether or not they were assisted by other laboratories. I imagine they were, as part of that work, but I will check and see if there’s anything further I can provide to Senator Roberts.

The President: Senator Roberts, a first supplementary?

Senator Roberts: If an Australian laboratory acting on behalf of the Australian government has not tested the COVID vaccines, we could be buying adulterated product, mislabelled product or
saline. How do the people and how does the Senate know what’s in the vaccines?

Senator Gallagher: It’s because it will go through the TGA’s established processes—that’s why. There would be significant checking of those arrangements with laboratories doing that work. This isn’t something that would be just left to a laboratory saying, ‘I’ve done it,’ and it being ticked off. The quality and safety measures that would be put in place by the TGA in getting those approvals are thorough. As we have seen through the rollout of the vaccine, the vaccine is safe and effective. We’ve seen that over the last three years after it was rolled out and millions and millions of vaccines have been provided through the vaccine rollout program, including the fact that we are now seeing significantly less severe disease or loss of life from— (Time expired)

The President: Senator Roberts, a second supplementary?

Senator Roberts: How many other vaccines or schedule 4 drugs are being imported into Australia in a situation where the safety testing was on the honour system, allowing the drug company or
manufacturer to provide their own safety testing?

Senator Gallagher: For a start, I don’t accept that it was done on an honour system. I do accept that in relation to the COVID vaccine process it was a shortened process because of the urgency and the crisis that the world was in, as the pandemic rolled through. It required the vaccine being created, and then—

The President: Senator Roberts, a point of order?

Senator Roberts: Thank you, President. My question was about other vaccines or schedule 4 drugs, not the COVID vaccines.

The President: I think the minister went to that, but I will remind her of that part of your question.

Senator Gallagher: I guess the point I’m making, Senator Roberts, is it was a highly unusual situation to be in. I think everyone’s acknowledged that the process around the approvals for the COVID vaccine were different and had been shortened, when compared to the approvals for other drugs. That is reflective of the fact that we were in a global pandemic and millions of people were dying from the effects of COVID and that we needed a vaccine in place to protect the community, and that’s actually what happened through the TGA’s approval processes.

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Leave the children alone!

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One Nation attempted to refer “gender affirmation” treatment to a Senate inquiry to expose the harm that is being done to our children.

The gender cult is hell-bent on confusing our kids and leading them down the path of irreversible changes for no medical outcome. We must protect our children from these predators.

Transcript

As a servant to the people of Queensland and Australia, I support Senator Hanson’s motion to refer the issue of treatment options for young people with gender dysphoria to an inquiry. It’s a simple fact that the model of gender affirmation is completely experimental, and that’s at best. More likely, it’s mutilation and debasement of children. Gender affirmation treatment is putting children who feel confusion about their gender at a young age on the pathway to life-altering hormone blockers and irreversible surgery. It’s butchery when children need something else.

People seem to have difficulty accepting this, but some feelings of confusion are completely normal as teenagers make their way through puberty and experience many new changes to their bodies. Left alone or dealt with by counselling and therapy—and love, in the severe cases—these feelings almost always resolve themselves. That is fact. Children need love, compassion, support and respect.

I have a relative who had gender dysphoria much of her life. She contemplated gender surgery. She decided to start the process. She made the decision, and, before doing so, she decided she would not adopt chemicals or surgery. She and her doctor wife came to accept her dysphoria. They are now proud parents of a lovely young child, and we accept and love her regardless of her decision. I have a friend who did change gender the opposite way, from male to female—another lovely person. These people need to be accepted, but children need support, counselling and love, not chemicals and scalpels.

As I said, the alternative to this gender affirmation is leaving kids to work through their issues lovingly, with support, counselling and therapy. The alternative is gender affirmation. Gender affirmation involves telling children that sex is just an arbitrary concept—that’s a lie—and that you can choose to be a boy or a girl whenever you want; with a click of the fingers, you can change teams with little to no consequence. Introducing this idea around the time of puberty and of other feelings of confusion is a dangerous, risky cocktail. Right at the time children are feeling most confused, they’re told that nothing is real and that everything will be fixed if they simply switch teams. The gender affirmation witchdoctors won’t tell children that fully committing to pretending to be a boy or a girl, if they weren’t born that way, simply isn’t simple. Basic biology gets in the way.

The only way to try and eventually effect this change is through a potent, permanent and dangerous cocktail of drugs, they are told, often prescribed off label in addition to permanent, irreversible surgery to lop off bits of people’s bodies. Gender affirmation advocates claim these treatments are reversible. That is a lie. Many children who were pressured into the gender affirmation pathway are coming to regret those choices as adults. De-transitioners are a growing community of adults who now find they will never fully embody their target gender yet are unable to return to the gender they were born due to the irreversible effects of gender affirmation drugs and surgeries. Instead, they’re left dependent on expensive cocktails of gender hormone drugs for the rest of their lives.

The real winner out of the gender affirmation pathway is big pharma, being delivered waves upon waves of medication-dependent consumers for life. It’s worth billions of dollars, despite the small number of people. The victims of the gender affirmation pathway, though, are left destitute, with no accountability for the outcomes that extremists in the gender cult pushed onto them from an adolescent age—extremists like senators in this chamber—for whatever reason.

It’s important to keep in mind the issue that’s trying to be fixed here: feelings of confusion or stress in children going through adolescence. There’s no longitudinal evidence that the gender affirmation pathway leading to gender reassignment fixes the core issue. There’s much evidence that it does not and that it does enormous harm. In fact, the transgender community is at the highest risk of suicide of nearly any community in the world. Why? Because so many young people come to regret their change and are trapped—trapped for life, in being unable to change back to their birth gender, which they’ve come to accept. They are trapped for life, unable to have children themselves, unable to live a normal life and regretting their decision for the rest of their life because they made their decision as an impressionable child. Whether they’re simply predisposed to psychological distress or that distress is created or compounded by the failed gender affirmation pathway is difficult to say. What can be said, however, is that if reassignment surgeries and drugs are meant to be a cure for psychological distress in children, they have absolutely and obviously failed. They’re failing many, many children.

The truth is that putting children on the gender affirmation pathway is a pathway to butchering people for no healthy clinical outcome. Many medical whistleblowers have raised these concerns. I’ll say that again: many medical whistleblowers have raised these concerns, yet have been shouted down by the powerful big pharma and transgender cult that holds power at the moment. The United Kingdom has seen this problem and lived this problem. After whistleblowers blew the lid on medical abuse happening at Tavistock gender clinic, the entire clinic was shut down—the entire clinic that was once held up on a pillar and treated as a god. Now it’s facing class action suits and people are recognising the hideous crimes that they have committed.

At the very least, these issues need to be referred to a committee for inquiry. Those who support the gender affirmation pathway shouldn’t be afraid of the truth through an inquiry. What’s wrong with knowledge? If I’m wrong, then an inquiry will prove you right. Of what are you lot afraid? Greens use labels. Labels are the refuge of the ignorant, the dishonest or the fearful. They support big pharma. Please stop demonising children with gender dysphoria and those who have a different view. I suspect the gender cult knows that the truth is not on their side and that’s why they’re running scared of looking underneath the hood on this issue—an issue affecting children.

One Nation will stand against sending children down a path of drug dependency and body mutilation to appease the gender cult. I’m never caught up in gender, race or national heritage. Every human, regardless of skin colour, for example, and regardless of heritage, has red blood running through their veins—every single human.

We are one. I am very, very pro-human.

Send this to an inquiry and get to the facts and find out what will actually help children. Until then, leave our kids alone.

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Under one flag we stand undivided.

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The politics of today seek to turn Australians against each other. We must resist this division as it only serves the interests of multinational companies and power-hungry politicians.

Transcript

The architect of our Parliament House, Romaldo Giurgola gave the Australian flag pride of place in his design.

A flag the size of a double decker bus, atop an 80m flag pole with supports that bring together the House of Representatives and the Senate.

The symbolism is clear, the Senate and the House of Representatives hold up our flag.

Not the other way around.

Any person who comes into this place, who does not then look up and feel awestruck with where we work, and with the responsibility we have, as Senators has no place being here.

The Australian flag flies above us for direction, not decoration.

We are directed to remember those who were here first and the millions who have come since. Immigrants who have come to this beautiful country to make a better life for themselves and to lift up all Australians in the process.

Including the Italian born architect of Parliament House – which I imagine explains all the marble.

Mr President we are directed to remember that we represent people not corporations.

Yet the winners from 18 months of COVID crony Government are not everyday Australians. The winners from croney govt are foreign multinationals. Big Pharma.

Never in the history of this beautiful country of ours has government policy so comprehensively abandoned those we represent, in favour of those we do not.

When Government needs to deploy the military to maintain control of our own people, to effect a social outcome rather than a medical one, there is only one description for that.

Martial law.

How this government acts in the coming months will decide if a second description should be added.

Treason.

Dividing Australians by any arbitrary measure including vaccination status flies in the face of everything our flag stands for, of everything this nation stands for.

We will not be divided!

We have One flag, we are One Community, we are One Nation.

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