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At the June Senate Estimates I asked several questions of the Therapeutic Goods Association (TGA).

I asked what the TGA was doing to help Australians access a potential new antibacterial to overcome antimicrobial resistance, medicinal cannabis, and off-label Ivermectin. What this trio of medicines has in common is that they are not profitable for pharma because, in the case of the first two, they cannot be patented and patents are how pharma makes its $billions.

Ivermectin is an award-winning drug with a huge body of evidence supporting both its anti-parasitic and anti-viral activity. Because it’s been around for over 70 years, is off-patent and inexpensive, there is little interest from pharma in sponsoring the drug. See how it works? These medications should not be left behind because of pharmaceutical company profit margins.

From the answers provided by the TGA, it’s clear that health products that don’t add to the wealth of pharmaceutical companies have no chance of approval under this Government. The TGA should be acting in the best interests of the Australian people, not the profit margins of big pharma.

Transcript

Senator Roberts: Given the backflip, Mr Fletcher, by the TGA that now allows the prescribing of ivermectin, which can be used off label as treatment for COVID—the TGA makes it clear that it does not endorse
it as a treatment but now allows it as a treatment for COVID—what is the attitude of Ahpra towards those doctors now who were cast aside because they supported ivermectin?

Mr Fletcher: Any regulatory action we have taken or would take in relation to a health practitioner would always take account of the public health advice at the time that the alleged concern occurred.

Senator Roberts: The public advice was wrong.

Mr Fletcher: It would be on the basis of the advice that was in place at the time.

Senator Roberts: Isn’t it strange that ivermectin started off as a highly regarded, very safe drug, given in four billion doses around the world, and then we were told that it was a dangerous drug, and now it’s remarkably safe again with a worldwide profile of being a safe treatment for COVID-19?

Prof. Murphy: Senator, I do have to intervene. There is no change. There is no recommendation that ivermectin be used for COVID. The regulatory changes—

Senator Roberts: I didn’t say that. I said to the contrary. I said the TGA does not endorse them.

Prof. Murphy: No, it’s not—

Senator Roberts: I did not say that there was an endorsement.

Prof. Murphy: No, there isn’t an endorsement. But the change in the regulation has nothing to do with any change in its efficacy or otherwise for COVID simply to reflect the changing circumstances and there’s no need to keep what’s a very unusual restriction on a drug. The TGA as decided it’s no longer proportionate, but there’s still no evidence of any value.

Senator Roberts: So what changed with the TGA?

Prof. Murphy: What changed with the TGA? We’ll get the TGA to address that.

Senator Gallagher: They’re due this evening.

Senator Roberts: Okay. Ahpra never did its own research on the COVID injections and relied on what it was told by the TGA. You said that a little while ago. The TGA never did its own research. In answering a
question that I put to them at the last estimates it relied instead on what it was told by the FDA. It has never assessed the patient-level data.

Prof. Murphy: This is not a question for Ahpra.

Senator Roberts: I’m getting to that.

Chair: Senator Roberts, could you put it as a question?

Senator Roberts: Are you aware that the TGA, which you rely on, has never assessed the patient-level data.

Mr Fletcher: As I said earlier, the sources of public health advice to us are the TGA, ATAGI and the public health officials in each state and territory and the Commonwealth health department.

Senator Roberts: Are you aware that the TGA relied on the FDA and that the FDA itself, in America, never did its own research and relied simply on what Pfizer told it? According to its own records, Pfizer only ever
did limited research and knew the vaccines injections were of limited value and had a significant risk profile. Pfizer lied when it said the vaccines were safe and effective, and Ahpra peddled this lie. You enforced that lie.

Chair: Senator Roberts, this is not a question. It’s very hard for me to maintain order if you don’t put questions.

Senator Roberts: Are you aware of the facts that I’ve just said about Pfizer? Are you aware of those facts?

Prof. Murphy: These are questions for the TGA. It’s not a question for Ahpra.

Senator Roberts: I want to know is he aware of what the TGA based their decision on?

Chair: Senator, if officials at the table indicate that this is not the appropriate place within the program to ask a question, we do need to respect that. My understanding of what Professor Murphy has said is that there is a time for these questions, and that is when we return to the TGA.

Senator Roberts: Thank you, Chair. I notice your silence. Why isn’t Ahpra aware of the false, fraudulent science underpinning the use of the vaccine?

Senator Gallagher: We don’t agree with that.

Senator Roberts: Thank you for answering, Minister. Why does Ahpra still support the use of the injections now that there is a body of respected, peer-reviewed science condemning the use of the so-called
vaccines? Is it because the TGA—

Senator Gallagher: It’s not a matter for Ahpra.

Senator Roberts: How can so many deaths and serious injuries attributed to the vaccines continue to be ignored by Ahpra?

Prof. Murphy: Again, that is not a matter for Ahpra.

Senator Roberts: Ahpra are silent, okay.

Senator Gallagher: It’s not ‘silent’. It’s not a matter they have responsibility for. Witnesses come here to answer questions on areas they have responsibility for.

Senator Roberts: You’ve just taken responsibility for their response. That’s fine. Given that Ahpra—

Chair: Senator Roberts, we have dealt with this issue over the last few days. It is appropriate for the minister to respond to our questions put to the witnesses if that question is not put in the correct place or is not
within that purview. It’s appropriate for Senator Gallagher to respond. Do you have another question, Senator Roberts?

Senator Roberts: Given that Ahpra is a board, I would suggest that board members are jointly responsible for the outcomes of their directions to health practitioners which now include the countless death and serious
injuries that have befallen many otherwise healthy people who took the injections believing they were safe and effective, when they were not. Are you aware that board members will be culpable?

Senator Gallagher: They will not. It’s not their—

Senator Roberts: Can you give me the qualifications of every board member—their medical qualifications?

Senator Gallagher: I reject your assertions. I just want to be very clear. I’m not going to speak for everyone, but my position here is that we do not agree with the assertions you are continuously putting in this hearing.

Senator Roberts: That’s fine, Minister. I hear you. The board members—can you give me their qualifications, Mr Fletcher?

Prof. Murphy: The Ahpra board is a board that regulates the operations of the agency. The decisions around registration standards are made by the national boards, like the Medical Board, which is comprised of community and qualified practitioners. The board of Ahpra is simply a governance board of the bureaucratic operations of Ahpra. The decisions—

Senator Roberts: A governance board?

Prof. Murphy: It does not govern the regulatory decisions. Those decisions are made by the relevant professional national boards, as Mr Fletcher has pointed out on many occasions.

Senator Roberts: State bodies?

Prof. Murphy: National boards. There’s a national Medical Board, a national nursing board—

Senator Roberts: So why do we need Ahpra? They’re not accountable.

Prof. Murphy: Ahpra is the organisation that brings the work of those boards and sets up a national regulation system to enable practitioners to be regulated across the country. It is a means of bringing them together. This is professional registration, so each of those boards—

Senator Roberts: And deregistration. I’d like the qualifications, Mr Fletcher, on notice, of your board members, their qualifications in medicine, specifically what qualifications they have, and I’d like to know who
appointed them. Can you take that on notice?

Prof. Murphy: It’s on the website.

Senator Gallagher: It is on the website, look it up. In relation to profession-specific, as Professor Murphy said, there is the Medical Board, which has representatives; there’s nursing; there’s a whole range of them. They used to be the state and territory boards; they came together to be national boards. They would have different representatives.

Senator Roberts: Can you tell me who appointed each of the members?

Mr Fletcher: The national board members are appointed by state, territory and Commonwealth health ministers.

Senator Roberts: And Ahpra?

Mr Fletcher: The Ahpra board is also appointed by state and territory health ministers and the Commonwealth health minister.

Chair: Thank you very much, Ahpra. We appreciate your favourable response to our request to join us at Senate estimates.

Rapper Zuby, in a very well-delivered address in 2022 at CPAC, observed that most politicians don’t care if people die—and he is correct. Most politicians don’t care if people die.

There’s no royal commission. There’s no Senate inquiry. There’s no access to contracts—they’re commercial-in-confidence we’re told. Years after they were signed, they’re still commercial-in-confidence. Taxpayers paid for the injections, yet we cannot see what we paid for. We can’t even see how much we paid. Censorship. What are they hiding?

Bill Gates paid for censorship in the mouthpiece Big Brother media that is often owned by the same people who own Pfizer. Bill Gates paid for censorship across social media. Gates is an investor in big pharma—a massive investor in big pharma—and a massive contributor to the World Health Organization, the UN’s World Health Organization.

I hold the whole Senate accountable, apart from six senators withstanding the catcalls.

At last Thursday’s Senate inquiry into anti-discrimination bills—one of which was moved by Senator Hanson and another one by Senator Canavan, Senator Antic and Senator Rennick—four of the five senators grilling Pfizer, Moderna and the TGA were from Queensland. Four, plus Senator Antic. Pfizer did not know where to go.

Clearly Pfizer, Moderna and the TGA all disgraced themselves and showed themselves to be inhuman. Clearly none feel accountable for the deaths, the chronic and crippling injuries, the severe injuries—not federal government or its health departments, not the state premiers or their health departments, not employers mandating injections. No-one takes accountability.

We will chase you until you are held accountable.

Transcript

As a servant to the many different people who make up our one Queensland community, I speak in support of the Public Governance, Performance and Accountability Amendment (Vaccine Indemnity) Bill 2023, because with indemnity comes impunity, and this parliament needs huge doses of accountability to change it from exploiting the people and return it to serving the people.

The main process for distributing vaccines in Australia is through the National Immunisation Program. Section 9B of the National Health Act 1953 allows the minister for health to provide, or arrange for the provision of, injections for distribution through the National Immunisation Program. Injections distributed via the National Immunisation Program must be listed on the Pharmaceutical Benefits Scheme. The purchase of injections occurs through the Commonwealth entering into supply contracts with the relevant pharmaceutical companies. These arrangements would include the amount of compensation the Commonwealth is liable to pay in exchange for the injections and are generally subject to the Commonwealth Procurement Rules.

During COVID, the Liberal government, with the full support of the Labor opposition and the Greens, simply tore up the rule book. Pfizer were given a blanket immunity. Pfizer knew, when the injection was being developed and tested, that they had a blanket immunity. What could go wrong? Firstly, accountability is shredded. The outcome of this ill-considered decision was an excess mortality rate in Australia of 27 per cent above normal since the ‘fakecines’ were rolled out. Most likely 30,000 Australians will die this year from side effects of our COVID response, including the injectables. Did they really think Pfizer, a multinational pharmaceutical company with an appalling track record, would suddenly turn into a model corporate citizen when asked to produce the COVID injections? Did you?

Prior to COVID, Pfizer had been fined US$3 billion for criminal acts. They are a habitual offender, persistently engaging in illegal and corrupt marketing practices, bribing physicians and suppressing adverse trial results. We know Pfizer suppressed bad trial data in the COVID trials, fabricated results, excluded test subjects that became sick and failed to test for a full range of adverse effects. They did this knowingly. The ‘fakecines’ were then manufactured in a shoddy fashion and did not use good manufacturing process as they were supposed to and as every other product approved in Australia must.

Live DNA derived from E. coli used in production has been found in large quantities in the Pfizer product—up to a billion strands or parts of strands in every dose. Huge variations between batches suggest huge variations in manufacturing quality. I say ‘suggest’ because we have no idea what is actually in these products, because the TGA accepts batch testing from the manufacturer and has not conducted the testing on each batch as it arrives. It has not conducted the testing. The TGA took the US FDA’s word for the results of the stage 2/3 clinical trials, and the FDA took Pfizer’s word for it. We’re relying on Pfizer’s word for these.

To give a product immunity, the TGA should have thoroughly tested these injections, not looked the other way. We have no idea what harm these products will eventually cause, because there was no long-term safety testing conducted—none. Why would they spend that money when they already had the immunity? That’s what immunity has done to them—more profit for Pfizer, more money in the pocket for CEO Albert Bourla, who banked US$30 million in salary and bonuses last financial year. Overall, Pfizer sold $36 billion in COVID products in 2022, pushing Pfizer to a record $100 billion in sales. I am slightly encouraged to see their share price is down 40 per cent from the peak of 2021, and projected revenue in 2023 is down 80 per cent.

While Pfizer made out like the fraudulent bandits they are, the Australian taxpayers are on the hook for who knows how much. The budget papers are required to show every potential liability the government has. There is an entry for our liability under the COVID products, yet they have not quantified it. You have not quantified it; there’s no figure there. That can’t continue. This liability will run into the billions. Australia needs this bill from Senator Babet to make sure no greedy, dishonest, opportunistic pharmaceutical company is allowed to get away with financial murder again. Australia needs this bill to make sure that no inhuman monster like the former health minister Greg Hunt, like the former prime minister Scott Morrison, like premiers Palaszczuk, McGowan and Andrews, is allowed to get away with malfeasance forcing experimental gene therapy based injections leading to tens of thousands of deaths, tens of thousands of people permanently crippled for life and hundreds of thousands of people injured, and uncounted people in mourning. Those are the nuts and bolts.

Now we go to the morality because governments cannot be trusted. With immunity, comes impunity. The simple reason for lack of accountability is the hiding of government actions through indemnities. Firstly, my position on medications including injections: we all want safe treatment. We are all pro-medicine. We all want that each of us decides what is put into our body—my body, my choice. We all want freedom to make our choice and for our choice to be accepted and respected. We all wholeheartedly support medicines that are fully tested and proven safe, effective, affordable and accessible. I am opposed to untested drugs, forcing untested experimental injections on to people, forcing untested experimental injections on to people with the only alternative being to lose one’s livelihood or let your children starve. How could any human allow this to happen?

How could any human allow this to happen, yet you did. Then in your shame, your cowardice, your guilt, the best you could do to those of us who stood up to this inhuman, monstrous and at times murderous madness was to call us ‘anti-vaxxers’. Pathetic—labels are the refuge of the ignorant, the incompetent, the dishonest, the guilty and the fearful, name-calling as you sling words at us for protecting innocent good people. But your vilification means nothing to us because we go for the truth. I oppose coercion, I oppose mandates, I oppose confidentiality hiding details from taxpayers. These untested injections from Pfizer, Moderna and AstraZeneca were forced on people using lies. Daily for two weeks former prime minister Morrison said, ‘There are no vaccine mandates in Australia.’ That was a lie, a murderous lie killing 30,000 Australians annually in excess deaths above normal. Worse, the Morrison-Hunt duo enabled and drove the injection mandate. Here is how: the Morrison-Hunt duo bought the injections. The Morrison-Hunt duo gave them to the states. The Morrison-Hunt duo indemnified the states. The Morrison-Hunt duo made federal health department data available to the states.

That was the only way the states could enforce their mandates, which really were driven by the Morrison-Hunt duo. State premiers admitted their vaccine mandates were in line with the bogus so-called ‘National Cabinet’, which was headed by Scott Morrison. The Morrison federal government mandated injections in Defence, the Australian Electoral Commission, aged care, the Australian Federal Police and others, but there are no vaccine mandates in Australia, he said. Then on Tuesday, I spoke about the Medical Countermeasures Consortium, which drove the whole lot, the four nations’ defence departments, from Canada, America, Britain and Australia. This was planned and delivered, and Pfizer did the work on behalf of the American Department of Defense. That’s why it bypassed the testing. Now we have 30,000 excess deaths That’s the equivalent to two Boeing 787 Dreamliner crashes every week for a year—every week for a year! Yet we have Queensland nurses still suspended. Foreign nurses are being recruited by Premier Palaszczuk to take their jobs. Then she’s told us repeatedly for the last three years, ‘The health system is crashing.’ Disgraceful, inhuman. The police are mandated, and they’ve lost many. The teachers have been mandated, and, when they finally lifted the mandate, many of them didn’t come back. We found children were crippled, affected. The teachers were fined. Doctors were mandated and many have left the profession. How can Australia put up with that? That’s going to hurt the patients. The pilots were mandated and the Civil Aviation Safety Authority, CASA, cares not a bit. It’s wilfully blind, it’s misfeasance and it’s betraying passenger air safety.

In a shining light, the Australian Firefighters Alliance was formed because their union would not stand up for them. Many unions went rogue and did not stand up for their members. The Australian Firefighters Alliance resisted. They developed, from the very start, a defensive strategy and an offensive strategy and that’s the only one that Premier Palaszczuk did not mandate. It’s based on a false premise. Livelihoods and lives have been destroyed.

We had the absurdity of the drugs failure, the vaccine failure, the injections failure being falsely blamed on the people who didn’t take it. Indemnities encourage impunity and rogue behaviour, irresponsible behaviour, destructive behaviour, cruel, monstrous, inhuman behaviour. Indemnities destroy accountability because everything is hidden, and indemnities are given. There’s no problem disclosed and so there’s no compensation. Millions of people suffer in silence and this Labor government perpetuates the misery, the deceit.

Rapper Zuby, in a very well-delivered address in 2022 at CPAC observed that most politicians don’t care if people die—and he is correct. Most politicians don’t care if people die. There’s no royal commission. There’s no Senate inquiry. There’s no access to contracts—they’re commercial-in-confidence we’re told. Years after they were signed, they’re still commercial-in-confidence. Taxpayers paid for injections, yet we cannot see what we paid for. We can’t even see how much we paid. Censorship. What are they hiding? Bill Gates paid for censorship in the mouthpiece Big Brother media that is often owned by the same people who own Pfizer. Bill Gates paid for censorship across social media. Gates is an investor in big pharma—a massive investor in big pharma—and a massive contributor to the World Health Organization, the UN’s World Health Organization.

I hold the whole Senate accountable, the whole Senate, apart from six senators withstanding the catcalls. At last Thursday’s Senate inquiry into antidiscrimination bills—one of which was moved by Senator Hanson and another one by Senator Canavan, Senator Antic and Senator Rennick—four of the five senators grilling Pfizer, Moderna and the TGA were from Queensland. Four, plus Senator Antic. Pfizer did not know where to go. Clearly Pfizer, Moderna and the TGA all disgraced themselves and showed themselves to be inhuman. Clearly none feel accountable for the deaths, the chronic and crippling injuries, the severe injuries—not federal government or its health departments, not the state premiers or their health departments, not employers mandating injections. No-one takes accountability. We will chase you until you are held accountable.

We’ve had airline employees taken to hospital and then returned and Qantas insisted they be injected. There are too many other stories there; I won’t go into them. But we see people awakening. We see the situation has created heroes: Hoody, Maria Zeee, Chris Spicer and many, many more from the independent people’s media; doctors who formed the Australian Medical Professionals Society; Dr William Bay, and he is a doctor; nurses like Dee; firies like Dan; police like Krystal; paramedics like Peter; doctors like Camillo; pilots like Alan; and thousands of construction workers and other workers. You’ve woken the people up. Thank you so much for being our heroes. Here and globally, you’re wakening people up.

When indemnities are granted, especially in secret, accountability is removed, and you in this Senate, in this parliament, have demonstrated that repeatedly. You’ve confirmed it. All who oppose this bill will be voting to continue the needless deaths and lies. This bill will prevent recurrence. Ending indemnity will end impunity. It will contribute to restoring accountability. Transparency restores trust. I wholeheartedly support this bill and urge all senators to vote in support.

Who got it wrong on ‘vaccine’ side-effects?

World leading virology and pharmacology experts who spent months peer reviewing Pfizer’s own COVID phase III trial data, reaching the conclusion this product was associated with serious adverse events four times higher than any benefit touted such as ‘reduced hospitalisation’?

OR the politically compromised advisory panel that shot the scientific article down within a few weeks of it being published?

I asked the Therapeutic Goods Administration (TGA) this and other important questions as part of a recent Senate Public Hearing.

The author of the TGA 2022 Measures 1 Bill is not a servant of the people, but sees the people as their servants.

It destroys fundamental human rights, removes our tried & true system for authorising new drugs & places the Australian public at the mercy of incompetent bureaucrats.

Transcript

As a servant to the many and varied people making up the amazing Queensland community and Australian nation, I speak to the Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022.

It’s significant in my speech’s opening that I refer to myself as a servant to the Queensland and Australian people. Whoever wrote this bill is not a servant of the people—in fact, the proposer of this bill sees the people as their servants, slaves, serfs. It destroys fundamental human rights, smashes fundamentals of law, removes the tried and true system for authorising new drugs and places the Australian public at the mercy and under the control of unelected bureaucrats. The same bureaucrats proved themselves unfit to exercise their current already disproportionately large power during COVID, all with no accountability.

Let me explain this bill’s provisions. Firstly, introducing a framework for the mandatory reporting of adverse events. One Nation supports this measure. Secondly, it introduces a new marketing approval pathway for biologicals for export only. One Nation supports this. Thirdly, it enables the Secretary of the Department of Health and Aged Care to approve the importation or supply of overseas prescription medicines that are substitutes for existing medicines with no checks and balances on that process. One Nation opposes this measure.

Fourthly, it eliminates the human rights of people to contest decisions on the provision of documents the secretary requires. One Nation totally opposes the removal of common law rights to due process. Next, it enables the secretary to require any person to provide information or documents relevant to a possible contravention of the act. This bill does not do so fairly,

and therefore we do not support this provision.

Next, it permits therapeutic goods advertising. In the absence of justification for making this charge, One Nation opposes this provision.

Finally, it clarifies the secretary is not obliged to observe natural justice. One Nation will defend the rights of everyday Australians to enjoy basic human rights provided across 1,500 years of common law, and so we oppose this provision.

This is a significant bill with new powers and provisions that did not go to committee inquiry. It sums up the arrogance of this Soviet-level government that such a wide ranging bill removing basic human rights, smashing legal principles, containing significant penalties and coercion and with a huge impact on the approval of new drugs will be forced through parliament without being subject to committee inquiry, especially after the separate Scrutiny of Bills Committee in its seven-page report thrashed the Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022.

Here are the main elements of that criticism. 

First is the reversal of the evidential burden of proof:

Item 2 of Schedule 5 seeks to insert proposed section 45AC into the Therapeutic Goods Act 1989 (the Act) to create an offence for failing to comply with a notice from the Secretary requiring the production of information or documents.

Proposed subsection 45AC(3) provides the defence of reasonable excuse, yet the defendant must prove their defence. In simple terms, this bill treats anyone coming to the attention of the secretary of the health department as guilty unless proven innocent. The presumption of innocence dates from Roman Emperor Justinian in the sixth century and, for 15 centuries, has remained a fundamental principle of Western law.

If the bill allowed the normal checks and balances that criminal and civil courts provide, the defence of reasonable excuse would not be necessary.  It would be available automatically.

This bill is extinguishing our defendants’ existing legal rights, all this smashing of legal rights and principles from a Labor government.

Second is strict liability offences:

Item 2 of Schedule 5 proposes to introduce subsections 45AC(2) and 45AD(2) which contain strict liability offences for failure to comply with a notice—

to produce documents. The recipient of a notice does not have to be a large corporation that can afford the compliance cost. It can be any medical professional or administrator. If the recipient fails to produce a notice, as the secretary demands, then a strict liability offence is committed. If the defendant was in hospital the whole time, for instance, it doesn’t matter—here’s the fine, $27,000, pay up, no appeals! Does that sound fair? No.

Third is procedural fairness. Item 1 of schedule 10 to the bill seeks to insert subsection 61(13) into the act so that the secretary is not required to observe any requirements of natural justice in relation to releasing information under the act. What does the secretary think they are?

Fourth is the incorporation of external material. These are all criticisms from the Scrutiny of Bills Committee.

Instruments made under items 12, 15, 16, 20 and 30 of schedule 12 to the bill allow for the later inclusion of any written matter from any suitable source. The material itself is not included, so anyone subject to government action under the bill will have no idea of the full legal position they’re operating in. How can Australians follow the law if we’re not able to determine what the law is? We cannot.

The last time this was used was to remove the reference in the Banking Code of Practice to the international standard for handling customer disputes, which was only available to paying customers from an American company that maintained the code. That document established banking customers had rights they were unaware of. Linking to the document, instead of explicitly setting out the rights, let the banks run riot from 2003 through to the banking royal commission final report in 2019.

The ALP have learned nothing from history, or they have deliberately ignored history. These four criticisms alone from the Senate Scrutiny of Bills Committee are all valid. The Soviet-style government should have addressed all before the bill came to the Senate. I urge all senators to vote this bill down and resist the attack on common law rights and restore principles of law that everyday Australians have held since Western settlement of our beautiful country.

Slipped into the Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022 are provisions that circumvent the approval process for new drugs. The policy direction implicit in schedule 9 should have been set out in a separate bill sent to the committee, widely consulted and properly debated. So extreme is this provision.

In schedule 9, after subsection 19A(2)(2B):

The Secretary may, by notice in writing, grant an approval to a person for the importation into Australia, or the supply in Australia, of specified therapeutic goods (the subject goods) if the Secretary is satisfied:

(a) that there are no registered goods that could act as a substitute for the subject goods; and … … … …

(c)  that all of the following apply:

  • the subject goods are not registered or approved for general marketing in any of the foreign countries specified by the Secretary in a determination under subsection (3);
  • the subject goods are registered or approved for general marketing in at least one foreign country that is not specified by the Secretary …

What? Those statements appear to cancel each other out.

And thirdly:

  • the manufacturing and quality control procedures used in the manufacture of the subject goods are acceptable; and

So not even a good manufacturing process is specified. The minimum required for a supermarket packet of vitamins in Australia, just acceptable. What on earth does acceptable mean? This gives bureaucrats unlimited power with no accountability.

It goes on:

(d)   that the subject goods are of a kind included in Schedule 10 to the Therapeutic Goods Regulations 1990—

Which, for clarity, includes vaccines, and—

(e)   that the approval is necessary in the interests of public health.

That’s in the bureaucrat’s opinion. Let’s take a closer look at this deceit.

The wording of this section is turned around. A drug can be approved if there is no drug already available that can substitute for the new drug. Isn’t that any new drug? Because by definition there will be no existing drug to substitute for it. Isn’t this just a backdoor to allow the secretary to approve new drugs at their discretion without a specified approval process? This is being sold as a measure to combat drug scarcity, yet it’s not how the section was actually written.

This section does not contain any of the following. There’s no explicit binding limitation that this provision can only be used in the case of a drug scarcity. There’s no definition around when the provisions are exercised other than a general statement about the interests of public health, which could be anything that the bureaucrat decides on a whim. There’s no sunset clause. With a wave of the secretary’s magic sceptre, even under the excuse of shortage, drugs and vaccines are approved permanently. There’s no requirement for safety testing.

There’s no suitable requirement for manufacturing quality and consistency.

If powerful multinational pharmaceutical companies have the ability to get a new-generation drug approved with a shiny new patent to replace a drug that’s out of patent and all they have to do is stop making the old drug to create a deliberate shortage, what do you think the drug company will do? Of course this will be rorted. We’ve no protections in place to stop that happening.

Four hundred new mRNA drugs are in development. Two mRNA manufacturing facilities are already under construction in Australia alone. What did the drug companies know last year when they started construction of these plants? This bill is what they knew. This was coming for them.

Schedule 9 will save drug companies billions in regulatory costs. During COVID the TGA approved 23 new drugs under an emergency use authorisation. There was no long-term safety testing, minimal testing of any kind, no testing on progeny and no close monitoring of the Database of Adverse Event Notifications other than to minimise the extent of the harm family doctors reported all over Australia or, rather, doctors were reporting until AHPRA bullied medical professionals into silence.

With the Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022 the Albanese Labor government is setting Australia up to be a paradise for big multinational pharmaceutical companies and to be a killing field.

Separately on today’s Notice Paper is the Work Health and Safety Amendment Bill 2022, which, if passed, will require every business in the country to introduce vaccine mandates for their staff, for their people. Employers who do not will face savage penalties. The Albanese Labor government is not a government of the people. It’s a government of the global elites, for the global elites. And with big pharma’s $500,000 in election campaign donations to Labor, it’s a government under globalist elites—the globalist predators: BlackRock, Vanguard and State Street.

Welcome to the facade that they have in front of them, apparently with the consent and aid of the Greens and with the Liberals-Nationals, who scored big pharma election donations of $500,000, another half a million bucks.

I’m old enough to remember when the Greens campaigned against foreign multinational pharmaceutical companies. Now the Greens actively expand big pharma’s influence. They expand their market share, profit and control over people. Talk about ‘please explain’.

We cannot say with complete certainty whether the 20,000 excess deaths up to October 2022—that’s in just 10 months—were the cause of COVID vaccines or some other factor. Most likely it’s a combination of many factors with medical experts saying quite clearly that excess deaths are directly and indirectly attributable to COVID injections causing heart attacks, blood clots, cancers, Alzheimer’s and many other adverse effects.

What is inexcusable is not knowing the causes and not caring—inhuman. How can 20,000 extra Australians die in a 10-month period and there not be a hue and cry to get to the bottom of it? It’s immoral; it’s inhuman. Yet now Labor wants to give these callous, shifty bureaucrats greater power to work for their big pharma mates. Surely we have to understand why so many people are dying before we make any significant change to the authorisation of new pharmaceutical drugs.

If, as seems highly likely, the extreme level of harm being experienced is confirmed and death is confirmed as being due to the mRNA technology or the spike proteins in these hideous things, and we as a Senate approve a dismantling of the drug approval process, then the very people we are here to represent will rightly damn you all for all time.

I am appalled and disgusted that the Albanese Labor government would even think about introducing this monstrous, inhuman bill.

Is Australia’s COVID response about patients or patents? Did Health bureaucrats make a deliberate decision to wave through new, untested and dangerous vaccines to give pharma companies expanded, patent-protected revenue, against the best interests of the Australian people.

Transcript

In my capacity serving the people of Queensland and Australia, I note that during the last Senate estimate hearings, Adjunct Professor John Skerritt, Deputy Secretary, Health Products Regulation Group within the TGA, commented with clarity previously lacking in three years of health officials’ testimony. Finally the truth. The Therapeutic Goods Administration, our TGA, did not check patient-level clinical trial data for the mRNA vaccines. Instead, it used documents that Pfizer supplied and modified after the United States Food and Drug Administration, the FDA, requested it.

It’s now very relevant to ask how diligent was America’s Food and Drug Administration, the FDA—that’s America’s equivalent of our TGA—in overseeing drug approvals? On 2 November 2021 the British Medical Journal, BMJ, published an article titled ‘Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial’. I’ll quote from this article about whistleblower Brook Jackson reporting on the Texas trial sites: 

A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration. Ventavia fired her later the same day. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails. 

These were provided to substantiate her allegations. Brook Jackson used FDA whistleblower provisions—and a lot of good that did her because the FDA dobbed her in to Pfizer anyway. She was fired, and her complaint was ignored—start of cover-up. 

Minister, on 16 November 2022 the British Medical Journal published an article titled ‘FDA oversight of clinical trials is “grossly inadequate”, say experts’. In recent months a court ordered release of documents surrounding the FDA’s approval of Pfizer’s vaccine confirmed Pfizer’s malfeasance. Known as the ‘Pfizer papers’ the FDA contested the release to the public. It wanted this information kept secret for 75 years. The Pfizer papers show the FDA knew or reasonably should have known at the time of approval that the clinical trials were incapable of supporting an approval. Let me say that again: the Pfizer papers show the FDA knew or reasonably should have known at the time of approval that the clinical trials were incapable of supporting an approval. 

Pfizer then did this: their USA and European trial sites were getting so many adverse reactions that Pfizer had to cheat and at the last moment added 26 new trial sites in Argentina, recruiting 467 doctors almost overnight to create 44,000 new glowing patient records, overwhelming the legitimate bad data. In Argentina some sites and many patients do not appear to exist. Adverse events were hidden, and patients who were harmed or killed were removed from the data. That’s what the United States Food and Drug Administration rubberstamped, and that’s exactly what the TGA rubberstamped. And now every day Australians are dying. 

I know people are tired of this whole thing. One Nation is as well, yet there is a far larger issue that has gone without comment, that is too monstrous to simply let go. It relates to why the TGA refused to have anything to do with an Australian developed conventional attenuated virus vaccine that would have been safe to use. Queensland university discontinued their conventional vaccines on spurious grounds with real conflicts of interest. This opened the door for an entirely new class of drugs and supposed vaccines, mRNA, medicine by gene editing. This was not about Australian patient health; it was about patents. 

Over the last 15 years 47 market-leading drugs have aged out of patent, costing pharmaceutical companies $30 billion a year in lost sales, including drugs that made up to 42 per cent of Pfizer’s drug revenue and 62 per cent of AstraZeneca’s drug revenue. This patent cliff is set to get worse, with another 15 drugs—nine of the world’s 20 top-selling drugs—due to expire this decade. Pfizer will face losing another $15 billion in annual sales. 

The only way to replace so much revenue is with a whole new class of drug: mRNA. Four hundred mRNA drugs are currently in development. The manufacturing plants in Australia are already under construction, before the drugs have been tested. The problem for big pharma was how to get these radical gene-editing drugs accepted. Coincidentally, along came COVID—a miraculous opportunity to use the new, untested mRNA gene editing. The heavens aligned to wave mRNA technology through for humans and animals, untested, with no debate or scrutiny. 

We now have an explosion of patient death reports and patient harm reports on the database of adverse events notifications, including 940 deaths before doctors gave into Ahpra’s blackmail and stopped reporting vaccine or injection deaths. The actual deaths from COVID-19 injections are known to be grossly underreported due to Ahpra’s threats to doctors and nurses. In 2022 there were 22,000 more Australian deaths than usual, and our health bureaucrats can’t tell us why. Half are unexplained, and the other half are supposedly people for whom the mRNA vaccines did nothing—but led to their death. Yet the pharmaceutical industry’s future is now secure for a generation. That, Minister, is a crime this government refuses to investigate. 

Health bureaucrats’ lies and government deceit directly and indirectly killed thousands of people. Thousands of Australians are dead. Bureaucrats’ lies destroyed millions of lives and livelihoods. Unless the Albanese government takes prompt action it will be complicit with the Morrison government’s crime.

One Nation calls on the government to immediately enact a Senate select inquiry to identify the scope and terms of reference for a royal commission into state and federal governments’ gross mismanagement of COVID. 

The TGA and the Morrison Government have failed to exercise duty of care towards vaccine approvals. Double Comirnaty vaccination has been approved for children despite evidence clearly showing a seven fold increase in serious harm between the first and second doses.

Transcript

[Malcolm] Thank you, Mr. President. My question is to the minister representing the Minister for Health, Senator Colbeck. The British Medical Journal has published an article revealing the company that conducted part of the phase three trials of Pfizer’s Comirnaty COVID vaccine. Covering 25,000 people, falsified data, unblinded patients, employed inadequately trained staff, and was slow to follow up on adverse events. Minister, the Morrison-Joyce government failed to conduct an Australian trial of the Pfizer vaccine. And instead, simply took Pfizer’s word for it. Was this a failure in your duty of care to the Australian people?

The minister representing the Minister of Health, Senator Colbeck.

[Richard] Thank you, Mr. President. Senator. I can’t agree with the statement that you make as a question Senator Roberts at all through, through you president. The Australian government took, undertook a comprehensive assessment of each and every vaccine that is being used in this country to ensure Australians had the confidence. That we had a safe and efficacious vaccine for utilisation in the pandemic. And Mr. President, I think the results speak for themselves. If you look at the circumstances in respect of what’s occurred in aged care this year, compared to last year, the impact is profound. Mr. President, it is very clear that we took all steps to ensure that the vaccines that are being used in this country was safe and that they worked. We, we took evidence and advice, yes, from the companies we received the data that they used in their trials, appropriately. But we also had the advantage of being able to use data from other jurisdictions around the world. And we’ve remained in close contact with those agencies that consider vaccines to ensure that they are safe to use. Mr. President. Can I say to all Australians who are still contemplating whether or not they should get a vaccine. Please be assured that our public health system and our authorities, the Therapeutic Goods Administration, recognised as one of the best in the world, has done the, the, the, yes Senator Reynolds, amazing work. To ensure that we have access, Australians have access, anyone living in this country, wants a vaccine has access to a safe and efficacious vaccine

Minister, your time has expired. Senator Roberts, a supplementary question.

Thank you. Prior to the TGA’s approval of Comirnaty vaccine, Steve Anderson, the Director of the US Centre for Biologics Evaluation and Research released data detailing potential Comirnaty adverse outcomes, including Guillain-Barré syndrome, acute myocarditis, auto immune disease, and death. This is exactly what’s happened. In approving Pfizer’s Comirnaty injections, did the TGA fail in it’s duty of care to the Australian people?

Minister.

Thank you, Mr. President. No, it did not. I couldn’t be any firmer than that. And as I indicated in my answer to the primary question, the Therapeutic Goods Administration has considered all data in relation to the vaccine. And in fact, it continues to monitor the data in relation to the vaccines. We’ve, we’ve been extremely open with respect to that. We’ve published reporting on the outcomes of the vaccination programme here in Australia. We’ve published data in relation to adverse reactions, to the vaccines of all types. Mr. President. So I reject any assertion that the TGA has failed in its duty at all. No, it has not. I could not be any firmer, President. We have one of the best and we should be proud of the fact that we have one of the best therapeutic goods assessment, organisations in the world.

Your time has expired. Senator Roberts, a second supplementary question.

Thank you. Latest data from America’s CDC indicates that children aged 12 to 17 are likely to experience mmyocarditis and related conditions at the rate of 9.5 cases per million vaccinations. Yet after the second vaccination, that rate rises sevenfold from 9.5 to 66.7. In approving two doses of Pfizer Comirnaty for our children without testing, are the Minister for Health Greg Hunt and Professor Skerritt at the TGA, risking our children’s lives, health and future.

Minister

There’s a very simple answer to that question, President, it’s no. As I’ve said in my previous answer, the TGA continues to monitor all of the data, not just from Australia, but from around the world, in relation to the impact and the utilisation of the vaccines. Particularly those that we have to be administered here in Australia. We continue to monitor all of the data so that we have the most up-to-date information and that we can continue to assure Australians that the vaccines that they are taking are both safe and efficacious. And all of the data and the advice, continues to demonstrate that Mr. President. Are there contrary indications in relation to the vaccines? Yes, there are. We published the data so that we’re open with that. But we need to make sure that Australians have confidence that the vaccines we have access to a safe and efficacious.

Time has expired.