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. (Malcolm Roberts/YT)
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.
- 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.