Posts

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

,

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.

/2 Comments/by

TGA’s Process Patently Not Effective

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.

/6 Comments/by

Medical Professionals Silenced by AHPRA

,

Ten medical professionals have had their registrations suspended by the Australian Health Practitioner Regulation Agency (AHPRA) simply because they spoke out about the COVID injection risks — 4 doctors, 5 nurses and 1 pharmacist.

Even now, AHPRA officials remain in denial about the risks that these injections pose, despite the growing body of evidence that contradicts the marketing slogan of safe and effective.

Australians forced against their will into getting these shots to continue their job, education or see family and loved ones did not have the benefit of ‘honest advice’. Although they should have been able to freely discuss their needs, they were not given this opportunity because the statement AHPRA put out to clarify existing health advice and media coverage around it served to effectively muzzle healthcare providers through fear.

At no time did the agencies involved in providing public health advice reassure medical professionals or their patients that they still had the right to privacy and confidentiality. Patients receiving medical advice before undergoing treatment were entitled to be warned of risk.

Let’s not forget these injections were only provisionally approved due to the experimental nature of the mRNA and vector technology. If our best and brightest medical professionals are feeling silenced by government bodies that will punish any criticism of novel medicines, what have we become?

We now know the jab roll-out is a military/health response which is why it by-passed the usual safety protocols. These were products that were not ready to be injected into the arms of people and yet the only ones protected are the manufacturers.

It’s time for the Health Minister, AHPRA, TGA and ATAGI to loosen the stranglehold they have on our healthcare professionals and let them be free to do their jobs. Australians deserve nothing less.

Transcript

Senator Roberts: Thank you for appearing today, Mr Fletcher. How many health practitioners has AHPRA suspended for being outspoken, contrary to the joint statement of 9 March 2021?

Mr Fletcher: In relation to concerns that we’ve received about any aspect of the conduct of a practitioner related to COVID-19, 31 registered health practitioners have been suspended since the commencement of the pandemic, and 10 of those suspensions were solely with reference to a breach or an alleged breach of the code of conduct related to the vaccination statement. Just to complete that: that’s four medical practitioners, five nurses and one pharmacist.

Senator Roberts: How many health practitioners have had their registration cancelled because of being outspoken contrary to the joint position statement of 9 March 2021?

Mr Fletcher: I might ask the general counsel, Dr Jamie Orchard, to join me, because, just to remind you, neither AHPRA nor the Medical Board nor any of the boards have the power to cancel the registration of a health practitioner. A suspension is an interim measure while we investigate the concerns.

Senator Roberts: Who has the power to cancel it?

Mr Fletcher: That’s done by the independent tribunal within each state and territory. If we have a concern that there is professional misconduct, which is the most serious finding we can make, we then have to refer that to the tribunal, and it’s only the tribunal who can make a decision about cancellation. We’ve got five tribunal outcomes to date, but I’ll just ask Dr Orchard to give you the details.

Dr Orchard: So far a number of matters have been referred to tribunal in respect of practitioners relating to COVID related issues. We have five decisions so far from the tribunals. We can’t go into the details of the other matters because they’re still pending before the tribunals. Those matters relate to one dentist whose registration was suspended and a registered nurse who was disqualified. There was another registered nurse who had been the subject of suspension from the board but was not suspended by the tribunal. There was an enrolled nurse whose registration was suspended for 11 months. There is one final matter, where the tribunal has found professional misconduct but hasn’t yet decided on the sanction.

Senator Roberts: All five are associated with COVID?

Dr Orchard: All related to COVID in some way, but not necessarily solely in relation to making antivaccination statements.

Senator Roberts: How many health practitioners have either been suspended or had their registration cancelled because they made statements that supported the use of ivermectin in the context of treatment of COVID-19?

Dr Orchard: We’d have to take that on notice and have a look.

Senator Roberts: In the 9 March 2021 position statement, it threatens regulatory action for criticising the COVID-19 injections and/or the national immunisation campaign. Is that still in effect?

Mr Fletcher: Senator, the statement you refer to, just to remind you of the context, was issued by all of the 15 national boards with AHPRA.

Senator Roberts: It’s a joint statement.

Mr Fletcher: So it’s a joint statement. Essentially, it was issued in response to queries from practitioners about their obligations in relation to COVID-19 and vaccination, and the statement essentially aims to make clear how existing obligations on a registered health practitioner, through codes of conduct and the like, applied in the context of COVID-19 and vaccination. That statement is still in force.

Senator Roberts: When can we expect this statement to be amended or removed in light of the best available medical scientific advice, which now shows the COVID-19 vaccines, the injections, to be unsafe and not effective? The risk-benefit is undoubtedly terrible.

Mr Fletcher: The statement has always been aligned with the public health advice at the time. We look to jurisdictional health departments, the TGA and ATAGI as the primary sources of public health advice. We will certainly be consulting with them in the near future about the current status of that public health advice and whether any amendment to that statement is needed.

Senator Roberts: Health practitioners like the GPs I’m about to mention—they’ve given me permission to use their names—Dr Mark Hobart, 19 months; GP registrar Dr William Bay, nine months; and emergency department registered nurse Beulah Martin, 11 months, continue to have their health practitioner registration suspended for allegedly engaging in conduct not supportive of the COVID-19 injections. Why are they still being punished?

Mr Fletcher: We’re going to need to be a bit careful about what we say publicly about individual matters, but I’ll just ask Dr Orchard to comment about what we can say publicly about at least two of the practitioners you’ve named there.

Senator Roberts: The context is why they are still being punished in regard to what’s now emerging about the injections?

Mr Fletcher: Let me ask Dr Orchard to explain what we can say publicly.

Dr Orchard: Senator, the action in respect of any practitioners—including those that you’ve mentioned—that was taken by the relevant boards at the time to suspend those practitioners was taken pursuant to the provisions of the national law, either for the purpose of preventing serious risk or in the public interest, and that’s the basis on which they were suspended at the time. Those matters are currently still before the courts because there are appeals going on in respect of each of them, so we can’t really go into further detail while the matters are still being considered by the courts.

Senator Roberts: Let’s come back to national law in a minute. Despite lengthy delays in investigation and AHPRA’s commitment to the Senate to achieve timely investigations and keeping in mind that the section 156 suspension powers under so-called national law are meant to be only an emergency and temporary measure for the most serious of threats to the health and safety of the public, how long can we expect AHPRA to keep maintaining the suspension of doctors, nurses and medical professionals around Australia who have expressed concerns regarding these vaccines, these injections, when now, in light of the best available evidence, those concerns are well justified? You have been suppressing medical professionals giving their honest advice and forcing them to go against the Hippocratic oath or to surrender.

Mr Fletcher: I reject the assertion you made that we have in any way been censoring practitioners. What we have said in that statement is that we expect that people dealing with patients use the best available evidence and their clinical judgement. That is an obligation that has been in the code of conduct for health practitioners that predates COVID-19. There is no change in that. Suspension is an interim measure while we investigate, and it has to meet a legal threshold under that national law. Sometimes one of the reasons that suspension is extended or takes a period of time is because a practitioner exercises the right to appeal their suspension, either to a tribunal or a court. Obviously, while those appeals are underway, we put our work on hold. Essentially, the suspension is there, as I say, on the one hand to allow us to ensure there is appropriate public protection meeting a legal threshold under the national law while we investigate each case.

Senator Roberts: Are you aware that some of the country’s best medical people, best specialists, are telling me that they are silent and changing their behaviour because they are suppressed by AHPRA? Are you aware of that?

Mr Fletcher: I have read the commentary on that, yes.

Prof. Murphy: I’ll make a comment. Senator Roberts keeps asserting that there’s new evidence that the vaccines are not safe or effective. We completely refute that suggestion.

Senator Roberts: I knew you would.

Prof. Murphy: There is no credible scientific evidence that the vaccines, other than—

Senator Roberts: That’s a false statement.

Prof. Murphy: No, I’m going on the best available scientific evidence, and I do not think you should be able to make that statement continually.

Senator Roberts: I will keep making the statement based on science.

Senator Gallagher: It cannot be left unchallenged.

Senator Roberts: He can challenge it, but I’m not going to quit.

Chair: Senator Roberts, I was listening carefully. Before you ask your last question, I am going to remind you that it is important that you put these as questions rather than as statements. I believe you did that with your last question, but the question before was a sentence without a question at the end of it. I think it is appropriate in that case for the witnesses at the table to respond, but the best way is to put questions and then we can hear answers.

Senator Roberts: I am happy to show you my questions.

Chair: Senator Roberts, I was listening carefully. I am happy to have a discussion if I have misheard, but in the question before your last question I didn’t hear a question; I heard a statement. You have a supplementary question, and I remind you that it assists the process of the committee if we frame questions for answers, as I’ve said from the start.

Senator Roberts: Many health practitioners have been suspended under the Health Practitioner Regulation National Law. Is it not true that such a singular national law does not exist, and that the national law is not a Commonwealth law at all but a collection of state based health laws such as the Health Practitioner Regulation National Law (Queensland) and the Health Practitioner Regulation National Law (Victoria)?

Mr Fletcher: I defer to my general counsel to talk about the legal construct of the national scheme.

Dr Orchard: You’re correct in saying that it’s not a Commonwealth law; it’s not. It is a cooperative piece of legislation amongst the various states and territories of Australia. The legislation was initially passed, and any amendments that are passed are passed through the Queensland parliament and then the various states and territories have different mechanisms by which they apply both the original law and any amendments to that law in their own jurisdiction.

Senator Roberts: Thank you for confirming. If so, how can AHPRA accurately and lawfully enforce one national law across Australia, when in fact it is not a national law but many state laws, each with its own amendments, across each state and territory of this Commonwealth? We have state laws being enforced by a national body that’s responsible to the states.

Dr Orchard: I will say, when you talk about the differences, there are very limited differences across the various jurisdictions. It does operate largely as a single national law across the country, subject to some exceptions of course. We ensure that, in the course of our regulatory role in applying that law, we do so consistently across the country so that it operates in a sense in a seamless way and practitioners who operate in one jurisdiction are able to move into another jurisdiction and continue their profession without having to worry about the difference in the state laws that might apply to them.

Chair: Senator Roberts, I’m passing the call to the opposition.

/10 Comments/by

No more indemnity – we will chase you until you are held accountable!

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.

/40 Comments/by

COVID Injection Safety Bungled Badly

In the Senate recently, I remarked on the Therapeutic Goods Administration’s handling of the pharmaceutical products imported as part of the COVID response.

Australia needs to know the Who, Where and How of COVID injection safety.

The Senate hearing held last week demonstrated the endemic level of contempt within pharma. We witnessed both Pfizer and Moderna failing to answer even simple questions and hiding behind pharma execs with scripts written by lawyers to the point that it became farcical.

The TGA took these same pharmaceutical companies word on safety testing. On 409 occasions, the TGA ticked and flicked the COVID injection batches and failed in its duty to safeguard the health and safety of Australians.

We need a COVID Royal Commission to investigate and provide much needed answers and assurances for the future. We need it now.

Transcript

I move:

That the Senate take note of the answer given by the Minister representing the Minister for Health and Aged Care (Senator Gallagher) to a question without notice I asked today relating to COVID-19 vaccinations.

It’s my duty as a senator to ensure the safety of the many different people who make up our one Queensland and Australian community. It’s a duty every senator shares. Yet COVID injection safety was bungled so badly we’re now experiencing tens of thousands of injection related excess deaths, and many more Australians have serious damage to their health.

On four occasions now I have detailed to the Senate peer-reviewed and published papers that show the COVID injections were granted approval under fraudulent circumstances; do not comply with good manufacturing process and were made with a high level of contaminants that should have caused a batch to fail testing; are responsible for fatal adverse events numbering far more than the database has tracked, let alone than the pharmaceutical salesmen at the TGA will admit to; and are causing serious damage at rates that make a tragic joke of TGA guidance.

How did all this get past the TGA safety testing? Simple answer: the TGA took Pfizer’s word about COVID injection safety during application. Then the TGA took Pfizer’s word for the safety of each batch as it arrived. Why? And what do we have the TGA for? That’s 409 times the TGA ticked and flicked the COVID injection vouchers without conducting its own testing. What makes this criminal is that sequencing a vaccine sample takes a few hours and costs very little. These days, this is a routine test.

Last Thursday night, One Nation’s bill to prevent vaccine mandates in the workplace and a similar Liberal-National bill were the subjects of a Senate inquiry hearing. Pfizer and Moderna had the opportunity to address concerns and instead chose to deliver what were apparently lawyers’ scripts that failed to answer a single question that was not already public knowledge. This was foreign multinational pharmaceutical companies showing complete contempt for the Senate and thereby contempt for the Australian people.

Surely now the Senate can see what it will take to get to the truth. Call a royal commission now.

/7 Comments/by

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.

/by

Pharma-Funded TGA Downplays Pfizer Adverse Events

,

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.

/by

Health Dictatorship cemented into Law

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.

/6 Comments/by

Pelvic mesh victims held to ransom by Labor

In a new low for Labor, Health Minister Mark Butler has sneakily attached an amendment to a bill which was designed to support pelvic mesh victims following a 2022 class action.

If successful, the additional measure gives the government unprecedented power to approve overseas substitute medicines that haven’t been through Australia’s regulatory pathway. Sounds pretty familiar, doesn’t it?

Tying this significant change to support for pelvic mesh victims in the Therapeutic Goods Amendment 2022 Measures No 1 Bill 2022 is a disgraceful act and a dangerous precedent. It must be stopped.

/3 Comments/by

TGA admits they didn’t analyse the patient data!

,
The Australian TGA confirmed they NEVER analysed the patient level data from the Pfizer clinical trials.

They just took the word of Big-Pharma and assumed the American FDA had done the work. We never checked the individual patient data here in Australia.
/4 Comments/by