Pharma Exclusivity in TGA Processes a Barrier to Natural Products

,

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

Natural products such as cannabis and Aboriginal medicine from native plants cannot be patented which means nobody can afford to act as a sponsor. The result is the only thing doctors can prescribe are patented or ‘generic’ pharmaceutical drugs.

I asked why there is not an office of the consumer advocate who can sponsor natural therapies like Cannabis and Albicidin (a natural antibiotic). Instead, the TGA chose to speak about their program to re-purpose pharmaceutical drugs that have already been approved for different uses. This answer really shows the pharmaceutical mindset our health administrators have. The legislation needs to be changed to give natural products a path to market.

Transcript

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

Senator McCarthy: I will refer to the department. 

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

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

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

CHAIR: We will return to this after the break. 

/4 Comments/by

Anti-depressants Highlight Failure of our Health Policy

,

Australia has the third highest rate of anti-depressant use in the western world. My question on the rate of anti-depressant use was clearly not one the Minister or the Department were expecting. To our health authorities, a positive outcome is getting a pharmaceutical product into someone’s body and calling the job done. Yet non-medical interventions for depression are available—exercise, social interactions and human touch (social dancing being a well-recognised therapy). These therapies are being ignored and high drug use celebrated. I believe this shows a pharmaceutical bias in the Health Department’s approach to depression. It feels like the Department of Health has become the Department of Pharmaceuticals.

Cannabis is used to treat depression overseas, yet this is not available in Australia in a practical way because no pharmaceutical company will sponsor a natural cannabis product. Why? Because the absence of a patent means they can’t get their money back on the cost of the application.

Transcript

Senator ROBERTS: Let’s move to antidepressants. Australia has an antidepressant use of 89 persons per 1,000. That’s the third-highest in the world, not far behind the highest, which is America at 110. The UK has less than we do: 71. Korea is the best at only 13. In other words, we have one of the highest rates of antidepressant use in the world. Isn’t this a failure of public health policy? We’re not treating these issues with a ‘Life. Be in it.’ campaign, knowing that exercise, dancing and group socialising all help with depression. We just write a script and call it done. Minister, what happened to preventive medicine—or is it now just about money for pharmaceutical companies?

Senator McCarthy: Again, your question is loaded with all sorts of accusations which I reject outright. We do our best to inform Australians of all things. In particular throughout COVID, we worked considerably hard to engage with communities remote and regional as well as across cities, so I reject the premise of your question.

Senator ROBERTS: This is not about COVID; this is about our remarkably high antidepressant use—close to the highest in the world.

Mr Comley: Professor Singer, would you like to make any comment on that as the Chief Medical Officer?

Prof. Singer: Clearly, there are different strategies used by different practitioners in relation to depression. A lot of the access to drugs depends on the access this is available as well as cultural factors. For example, you’ve commented that South Korea has a relatively low rate. I would expect that some of that would, in fact, relate to their cultural attitudes to the use of medication to treat depression as well as to attitudes around depression itself. I think one of the things that the use in Australia probably does indicate that people are prepared to be much more open about having depression and needing help. Clearly, prescriptions in some ways do reflect that issue.

Senator ROBERTS: Thank you.

/by

FSANZ Handling of Lab Grown Meat is a Concern

,

I asked questions about the progress of an application by Vow Food for lab-grown quail meat. This is a serious matter that will provide approval for an entirely new industry — an industry that is promoted as being environmentally friendly, while offering a high standard of food, when the truth is the complete opposite.

My questions were based on the timetable for approval published on Food Standards Australia New Zealand’s (FSANZ) own website for this application. A timetable that appears to be out of date. It’s not acceptable that FSANZ would not keep the index page for this most important of applications up to date. I trust the answers provided, which extend the timetable 8 months, are truthful.

While FSANZ are apparently calling for submissions, there has been no attempt to promote the ability of the public and interested groups to do so. This suggests the submission will be curated to provide support for the application. Lab grown meat is a massive threat to public health and safety.

The product is grown in a bioreactor and develops a nutrition profile which is directly related to the fertilizer solution added to the growing medium. Fatal bacteria such as e-coli and salmonella must be controlled. The name of the game here is profit, taking food production away from family farms that produce a healthy natural product and moving it to city-based intensive production facilities owned by foreign corporations operating for profit. I have no confidence under this model that the main input — the nutrition slurry, and the anti-bacterial protections — will not be dialled down so as to dial profits up. I will return to this topic in May.

Transcript

CHAIR: Senator Roberts, you have the call.

Senator ROBERTS: Thank you for appearing today. I’ve got a document that I’m going to try to table later. My questions are about the progress of the Vow company’s lab-grown quail meat. It appears your organisation has recommended that your board approve the lab-grown meat at its next meeting later this month. Is that correct?

Dr Cuthbert: No, that’s not correct. That process goes through two calls for submissions, so we’ve got two processes where we seek comments from any interested stakeholder.

Senator ROBERTS: Any Australian?

Dr Cuthbert: Any stakeholder. It just finished its first call for submissions on, I believe, 5 February. We received approximately 40 submissions on that first round. We’ll then be considering all of the submissions that we’ve received and go out for a second round of consultation once we’ve considered all of those submissions. There will be that second opportunity for people to comment. Only after that will we be putting it forward to the board for consideration.

CHAIR: I’m just going to provide advice on this document. I’m still seeking the source to table, but I’m happy for it to be distributed to witnesses to assist in answering questions. Then we’ll provide advice on tabling.

Senator ROBERTS: Why are there calls for comment?

Dr Cuthbert: Under the FSANZ Act there are models under which we can assess a product. The framework we utilise depends on the product’s complexity and other variables. For this one, because it’s a normal food and because of the complexity that was assessed, we determined that the process that it’s under will include two rounds of public consultation.

Senator ROBERTS: If the board approves a product, which—is that likely?

Dr Cuthbert: We’re still in the process of—

Senator ROBERTS: So it’s too early to say if it’s likely or not. When will you finish your process of consultation and listening, and make a recommendation to the board? When will the board sign off—if it signs off? I’m after rough timing.

Dr Cuthbert: I might seek input from Ms Jenny Hazelton, who’s managing the branch responsible for this piece of work.

Ms Hazelton: The normal process for applications—there are some statutory time frames for completion of that work. At this stage we’re anticipating it will be later this year when we will be putting this to the board. As Dr Cuthbert’s already indicated, we do have another round of public comment, and what comes forward in that second round of public comment will likely then determine when it will actually go to the board.

Senator ROBERTS: So it could go to the board sometime after July or maybe towards the end of the year?

Ms Hazelton: Closer to the end of the year, more likely.

Senator ROBERTS: How long will it take to be gazetted if the board approves it?

Ms Hazelton: The process from there would be that we would notify the Food Ministers Meeting of the outcome.

Senator ROBERTS: That’s federal and state?

Dr Cuthbert: Yes. That’s the representation on the Food Ministers Meeting. They have 60 days to consider that and either ask for us to review that decision or accept, and it would then go on to a gazettal after that time.

Senator ROBERTS: So they’re part of the process of approving or rejecting?

Ms Hazelton: Correct.

Senator ROBERTS: How does that process work? Is it a unanimous vote, or is it just that each state signs up or doesn’t sign up?

Ms Hazelton: It operates through a consensus. Sorry—each state and territory and New Zealand has an opportunity to vote for whether they will accept the approval or whether they will ask for a review.

Senator ROBERTS: Thank you. I referenced your document 273-23 ‘Consumer insights tracker’, which is one of these. There it is; 273-23. Are you familiar with that?

Dr Cuthbert: Our consumer insights tracker?

Senator ROBERTS: Yes. This is a supporting document to consumer literature review application A1269.

Dr Cuthbert: Apologies. Yes; thank you very much.

Senator ROBERTS: It’s available on your website, which concludes, the best name to give this novel food is ‘cell cultured,’ which makes it sound better than ‘lab grown’ or ‘Frankenfood’. I note that your language on subsequent documents uses ‘cell cultured’ or ‘cultured’. Why are you using language that promotes adoption of this product?

Ms Hazelton: We did do a literature review in terms of looking at consumers understanding of what that type of language would be. We are only at the first stage of this process—we’ve just received submissions—so that’s what we have proposed to date. That may not necessarily be what is ultimately in the final approval.

Senator ROBERTS: Your document, which was in that pile there, A1269 hazard and risk assessment, that document references the food safety aspects of cell-based food from the United Nations and the World Health Organization—both organisations I have very little regard for, but nonetheless even they list 53 potential hazards from lab grown meat. That report concludes on page 118: ‘Risk assessment was only the first part of the process of approving lab grown meat for human consumption. What needs to follow are our regulatory authorities cooperating with each other to share information around these potential health risks, which can be pretty severe.’ Rather than doing that and asking for in-depth studies, is FSANZ intending on waving these products through?

Dr Cuthbert: We will continue to do our assessment, and that assessment is quite broad, to determine the safety that needs to be considered through the process.

Senator ROBERTS: Has Vow addressed all your concerns?

Ms Leemhuis: We have received a raft of information from the applicant, Vow, but in addition to that we do look globally at what other evidence is available to inform our assessment.

Senator ROBERTS: Okay. Could you take on notice—I won’t take up the committee’s time now because we’re behind schedule—the approval processes or the steps that you take to consider an application, please? Did you ask Vow for genotoxicity studies in rats, commonly used to ascertain the safety of the product on reproduction and on the growth of cancers or organ damage.

Ms Leemhuis: We regularly ask for toxicity studies for almost all applications that we receive. I’d have to take on notice the specific studies we received for this one, although they will be referenced in the A1269 report online.

Senator ROBERTS: Including genotoxicity?

Ms Leemhuis: Including genotoxicity, yes.

Senator ROBERTS: The approval process seems to be, ‘Well, we can’t find literature that says’—this is casting the net broadly about the approval process, not necessarily yours—’this novel food is dangerous, so we won’t do the work to fill that gap and make sure this product is safe.’ That sounds like malfeasance. Have you done much work with other agencies, including your own, on whether the process is rigorous?

Ms Leemhuis: We work internationally with all of our regulatory partners in this area. We are not alone in looking at these new products coming to market, so, yes, we have regular conversations with a number of agencies globally around this, and the evidence required to assess the safety of these products.

Senator ROBERTS: Could you take it on notice to list those agencies for me, please?

Ms Leemhuis: Yes.

Senator ROBERTS: And would you characterise the exercise in some agencies overseas as just tick and flick, ‘Just approve it’, ‘Might as well do it’?

Ms Leemhuis: I’m not sure we could comment on other agencies processes, just our own.

Senator ROBERTS: Okay. How would you describe your process of assessment and approval? Rigorous?

Ms Leemhuis: Yes.

Dr Cuthbert: Yes.

Senator ROBERTS: These products, these fake meats, are grown in a bioreactor that needs to force cell growth as fast as possible to make money in what is a chemical and energy intensive process. One outcome that many authors have warned about is how the forcing of cell division leads to cancerous cells growing and that people could, in fact, be eating a product that is cancer. I don’t even see that dealt with in your risk assessment. Why not?

Ms Leemhuis: We look at the toxicity of these products and all the evidence provided for that. So, not only do we look at the end product, but we also look at all the inputs into how that product is made. Our view is informed by that.

Senator ROBERTS: Okay. These products have all the nutrition in them that is introduced into the bioreactor. You talk about nutritional value, but it appears no ongoing monitoring will be imposed on Vow to ensure they keep shovelling these nutrients in there at the same rate as the samples they send you. Is that correct? Is there any ongoing monitoring?

Ms Leemhuis: Again, I’d note we’re not finalised with our process yet. In terms of management, that will be in the next call for submission.

Senator ROBERTS: Forget about Vow for a minute. If you authorise or approve this fake meat from some company, then do you monitor the consequences of that in succeeding years?

Ms Leemhuis: FSANZ has an ongoing role in monitoring the food supplies, so, yes. But as part of our assessment process we can also impose conditions that do look to monitor these products if they are of concern or concerns are raised through the assessment that we want to continue to look at into the future.

Senator ROBERTS: I guess there’s a difference between monitoring something in closed conditions and letting it go through a manufacturing process that may or may not be sloppy—who knows what will happen in there? Listeria has been identified as a medium- to high-risk foodborne pathogen that can enter during the final stage of cell growth, meaning it gets into the bioreactor. You have identified potential risks from salmonella and E. coli. Vow have made the claim that lab meats help antimicrobial resistance by using fewer antimicrobial products in production, cleaning and sanitising their factory than natural meat. How accurate is that statement?

Ms Leemhuis: Sorry; I’m not quite sure what statement you’re referring to.

Senator ROBERTS: Vow has made the claim that lab meats help antimicrobial resistance by using fewer antimicrobial products in production, cleaning and sanitising than is the case in natural meat. Is that correct?

Dr Cuthbert: I don’t know that it’s necessary for us to comment on the accuracy of a claim that a company is making. Our job is to ensure that we’re evaluating the safety of the product that’s before us to determine if it’s suitable and safe to be circulated for consumption. Whether it’s more or less than another process is not part of the process.

Senator ROBERTS: So I guess you’ll do that assessment as part of your approval process?

Mr Comley: What’s an absolute assessment?

Senator ROBERTS: Sorry, Mr Comley?

Mr Comley: Sorry; I should leave it to the food authority. I was just saying I think what Dr Cuthbert was saying is it’s an absolute assessment rather than relative assessment against other products that are on the market at the moment.

Dr Cuthbert: Exactly.

Senator ROBERTS: Okay. Thank you for clarifying that. Your documentation, some could say, dresses up this decision as some kind of saviour for the environment. I have circulated an Oxford University article and a peer reviewed paper that finds that very energy intensive bioreactors could have worse long-term environmental consequences than livestock farming in terms of carbon dioxide equivalent emissions—CO2e. Now I don’t think the carbon dioxide production is at all a threat to humanity but, for those who do, recent calculations show that if we wanted to meet the additional demand for meat by 2030 exclusively with cultured meat we would have to build 150,000 bioreactors, which would produce 352 million tonnes of carbon dioxide equivalent as against 150 million tonnes of carbon dioxide equivalent for natural livestock farming. Why shouldn’t people conclude that approving this lab meat is a terrible mistake?

Ms Leemhuis: Just in terms of our roles and responsibilities, it really is about the safety of this product. That’s the act. It says that our role is to assess the safety of the product for human consumption, which is the role we have taken in looking at this application—

Senator ROBERTS: And not just in the lab, but in practical terms.

Ms Leemhuis: rather than the carbon emissions. That’s not within our scope to consider; it’s the safety of the product.

Senator ROBERTS: Okay. Thank you very much.

/by

The TGA are Administrators not Regulators

,

Until a few years ago, new vaccines and drugs were required to have local safety testing and went through a process that took years. This ensured a high degree of safety. During the COVID period, the Therapeutics Goods Administration (TGA) waved approvals through for new technologies (e.g. mRNA injections) and new drugs in a matter of months. Included in this new streamlined approval process were Molnupiravir and Remdesivir.

Remdesivir was refused approval for 20 years owing to serious side effects in trials, including death. Molnupiravir also has a long history of failure. There are multiple studies out recently that show it is simply not effective against COVID, and yet this is the #1 drug on the Pharmaceutical Benefits Scheme. Australia spends $650m a year on Molnupiravir.

I asked why we approved a drug with so much evidence showing negative efficacy and fatal outcomes, including cancer, to replace the Ivermectin + Zinc combo, which costs a fraction of the price and has been proven safe and effective across many years.

I also raised the question of who supervises the supervisor — the TGA. “Nobody” was the response. That answer highlighted the overly cosy relationship between the international pharmaceutical movement and Australian pharmaceutical companies. The TGA requires further inquiry.

A Royal Commission is the only institution in Australia with the powers of inquiry to understand how the TGA has gone from regulator to administrator, seemingly with none of the customary vigilance.

Transcript

Senator ROBERTS: My questions are to the TGA, and these questions go to the approval for molnupiravir. This is a drug developed in 2014 to treat encephalitis. It was then repurposed for influenza but was discontinued after concerns it was mutagenic. Merck then bought the company and used their influence with regulators—such as the TGA, apparently—to have the product approved as a treatment for COVID. This was on the back of a single trial where the preliminary results supported the application but the final results showed that, if anything, it had negative efficacy. Given the weight of evidence, in study after study, that molnupiravir has zero to negative efficacy, why is it still approved?

Prof. Lawler: While one of our medical officers, Dr Kaye Robertson, comes to the table to respond, I would just highlight a couple of things. I take the comment that you made that the drug company used its influence on the TGA. There is a process that we follow, obviously, in the evaluation of all medications. Sponsors bring them for evaluation of safety, quality and efficacy, and that’s the process that is undertaken, rather than one of influence. I think it’s important to note that. In terms of the question you raised around why the medication is still approved for the indication that it has, I’ll ask Dr Kaye Robertson to respond to that.

Dr Robertson: The TGA considered the evidence to support the approval of molnupiravir from the dossier that was submitted by the sponsor, in accordance with our standard processes, and drew the conclusion that, at the time, the benefits outweighed the risks. In terms of the specifics of any subsequent information that has been provided to the TGA, I am actually not in a position to comment with certainty. This is not the area I work in particularly, and I think we would be best advised, if the senator pleases, to take this question on notice and provide you with further detail.

Senator ROBERTS: I appreciate your giving that offer and I will accept your offer for the question to be answered on notice. It does surprise me that approval was given on a single trial where the preliminary results supported the application but the final results showed that, if anything, it had negative efficacy. The weight of evidence, in study after study, shows zero to negative efficacy, so I’m amazed that it’s still approved. The approval required Merck to continue to provide ongoing safety data and testing around mutagenicity and interaction with the mRNA vaccines. Have they done that, and does the data justify retaining approval?

Dr Robertson: I have before me the AusPAR that was published in relation to the studies that assessed the risk of mutagenicity. We can provide that to you in our response. I am reading from that, and it says: ‘Molnupiravir and NHC were mutagenic in the bacterial assay (with and without metabolic activation). Molnupiravir and NHC were not genotoxic in in vitro and in vivo micronuclei tests, and in vivo mutation assay at the cII locus (in Big Blue Transgenic F344 Rats). Equivocal results were obtained in an in vivo Pig-a mutagenicity assay … Carcinogenicity studies are not generally required for drugs for short term clinical use. However, the sponsor has initiated a short-term carcinogenicity in … mice.’ This was put to the clinicians on the ACM and other invited experts regarding this matter. It was considered at the time that, on balance, the drug remained to have a positive benefit-risk balance.

Prof. Lawler: I thank Dr Robertson for that response. I’d also just add, Senator, that, because you’re asking for some quite specific currency and comprehensiveness of ongoing postmarket reporting, we’ll take that on notice and bring that information back to you.

Senator ROBERTS: Thank you. In 2023 molnupiravir was top of the pops, Australia’s No. 1 drug, costing taxpayers $654 million last year, at $1,125 a prescription. Molnupiravir is 26 times more expensive than the out-of-patent ivermectin-plus-zinc combo, which is about $40 per prescription. And that’s what molnupiravir replaced—proven, safe and effective. Why are you spending $654 million—on something that is highly questionable as to its efficacy and its safety—when $25 million would have done?

Prof. Lawler: I can’t speak to the specifics of the amount spent on molnupiravir, but I can certainly indicate that the second amount that you said—I didn’t catch the amount—

Senator ROBERTS: The ivermectin-plus-zinc combo is $40 per prescription, and the total for the year would have been $25 million.

Prof. Lawler: I think that the comparison is flawed, in that there is no credible, supportable evidence that ivermectin and zinc is an effective treatment. So I’m not convinced that you are—

Senator ROBERTS: There is no credible evidence? There are 100 papers.

Prof. Lawler: I’m not convinced that the comparison is sound.

Senator ROBERTS: You based the decision on molnupiravir on one paper, and you’re ignoring 100 papers proving ivermectin’s success. Does anyone question the process—

CHAIR: Sorry, Senator Roberts; I’m going to give Professor Lawler an opportunity to respond to that.

Prof. Lawler: I didn’t hear a question.

Senator ROBERTS: The question is this: does anyone question the TGA’s processes—

Prof. Lawler: Yes.

Senator ROBERTS: for approving drugs? How often do you evaluate them?

Prof. Lawler: Drugs are—

Senator ROBERTS: Who audits them? Is there an independent auditor?

Prof. Lawler: I’m not sure which question you would like me to answer.

Senator ROBERTS: All of them.

CHAIR: Professor Lawler, are you clear on the question placed? There is a mixture of questions and assertions moving around here, so let’s just step back and, Senator Roberts, please place a question.

Senator ROBERTS: The question is: how often do you scrutinise your process, and is there an external auditor who does that who is qualified to do it and to assess the process?

Prof. Lawler: The processes that we follow are continually informed by our international collaboration and also by significant interaction with stakeholders, particularly the advisory committees that we have in respect of the assessments and evaluations that we undertake for products. We also undertake, obviously, the premarket review and evaluation of medicines and other therapeutic goods, and we undertake significant postmarket surveillance of the goods as well. We have outlined in significant detail on previous occasions the postmarket surveillance that we undertake. I might ask Mr Henderson to add to that.

Mr Henderson: Senator, I think you asked about the number of submissions or medicines that we evaluate. Just for context, at the moment there are about 150 applications that the TGA is evaluating for both new medicines and changes to indications to current medicines.

Senator ROBERTS: What is the point of telling me that?

Mr Henderson: Sorry; I thought you asked that as part of your question.

Senator ROBERTS: No, I didn’t ask for the number. Who are your stakeholders? Do they include the sponsors?

Prof. Lawler: As a contemporary regulator, we have a broad stable of stakeholders. They do include industry. As with any regulator, we work to refine our processes to balance the appropriate observance of safety, quality and efficacy with appropriate access and streamlining processes to bring products to market with a minimum of inappropriate regulatory burden. We undertake annual stakeholder engagement surveys to understand the views of the TGA, and the three key stakeholder groups that we survey on an annual basis are industry; health professionals—and obviously it’s important we work with health professionals for a number of ways, in that they both inform us and are informed by our decisions—and the community. It is notable that the responses we get reflect that the TGA, among all groups, comes across as a recognised, understood and valued regulator in the Australian healthcare system.

We have other stakeholders with whom we interact. We obviously interact very closely with the state health jurisdictions, and this is for a number of reasons. Our decisions on a number of elements, such as scheduling, for example, which we’ve already discussed today, have a significant impact on the state and territory poisons legislation and how they’re implemented for the delivery of medicines. We also interact quite closely with expertise across the regulatory sector. We have a number of advisory committees, the membership of which incorporates consumer views and expertise and also those from the academic and research sectors.

It’s also important to note that we obviously have close relationships with our international collaborative regulators. We are part of the International Coalition of Medicines Regulatory Authorities and the International Medical Device Regulators Forum, and we also work closely with individual regulators such as the MHRA and the UK, European Medicines Agency and the FDA.

CHAIR: Senator Roberts, I will shortly rotate the call to Senator Rennick and then can come back to you. Is this a sensible place to pause?

Senator ROBERTS: I’ll make it a short one, and then you’ll come back to me. Spike proteins can enter the body in two ways in the context of COVID: from the virus itself and from the vaccines. What work has the TGA done on the health outcomes of the long-term retention of spike proteins by the body after the mRNA vaccines that you recommended? It’s been four years now, so some good old-fashioned science by the TGA must be available. Is there any assessment?

Prof. Lawler: As has been indicated previously, as with all regulators around the world, we undertake a significant program of post-market surveillance and pharmacovigilance. This includes having a clear and well-communicated preference for adverse events post the vaccine to be reported. Those are reported and entered into our database of adverse event notifications, and, along with examination of that and also in collaboration with partner international regulators, we are very much aware and alive to emerging safety signals and act accordingly.

Senator ROBERTS: But you haven’t done any studies on the retention specifically of the spike proteins? The COVID injections dramatically increased the spike protein. You haven’t done any studies of that?

Prof. Lawler: I’m happy to have any additional response, but what I would highlight is that our role as a regulator is to assess evidence that is brought to us, and we undertake that assessment in the evaluation.

Senator ROBERTS: So you don’t go looking for it?

Prof. Lawler: We utilise that evidence in the assessment and evaluation of products, and we utilise the pharmacovigilance and post-market surveillance exercises that I’ve highlighted.

/by

Slow Start on Classification System Inquiry

,

I have been asking questions about books like ‘The Boys’ and ‘Welcome to Sex’ that expose young children to adult sexual concepts and behaviours. Even worse these books do so in a way that encourages and normalises child sexual behaviour. The rating system for printed works, like these graphic novels, has failed to keep pace with the appearance of the graphic novels more than 20 years ago.

A review of the classification system for written works was promised last year by the Mininster during a meeting with me and I am still waiting for that review to start. At the moment this adult cartoon content is legal to sell to a child of any age because of a loophole in the current system.

After these questions, I hope the Minister with call the review immediately. Sexual material of this nature must be at least rated MA14+, making it illegal to sell to children under 14.

Transcript

Senator ROBERTS: Thank you for appearing, Mr Sharp.  

Mr Sharp: Pleasure, Senator. 

Senator ROBERTS: In response to a question at October Senate estimates relating to the inquiry into the adequacy of the rating system, Senator Brown made this statement. I will quote: “Informal consultation with government stakeholders has commenced. Public consultation will occur early in 2024”. I subsequently received a response to my question on notice which provided the same information. It’s early in 2024 and the Classification Board website does not mention an inquiry. Has public consultation started? If not, when will it? 

Mr Sharp: Senator, I refer you to the department on that. We have been participating in the stage 1 reforms that have been passed. That legislation has been passed. The board has been consulted as part of that. Effectively, the preparation for the implementation of that is occurring. As for the stage 2, the board has no further information on when that will occur. I refer you to the department for further information. 

Senator ROBERTS: When is the review into the classification scheme going to start? Senator Brown said that it would be starting in early 2024. 

Mr Sharp: I don’t have that information, Senator. We are a key stakeholder, but that’s a decision for the minister and the department. 

Senator ROBERTS: So I have to ask the department? 

Mr Sharp: Yes, Senator. 

Senator ROBERTS: Senator Brown, you said it would start in early 2024. 

Senator Carol Brown: And it’s very early 2024. Are we talking about the second stage of the reform? 

Senator ROBERTS: The review into the classification system. 

Senator Carol Brown: The second stage of the reform will clarify the scheme’s purpose and scope and establish fit-for-purpose regulatory and governance arrangements and improve the responsiveness of the scheme to evolving community standards and expectations. I will have to take on notice any particular date. The departmental representative can answer. 

Mr Windeyer: I caught your question. Just to assist, yes, the intention is still that public consultation will kick off early this year. A precise date I don’t have, but that remains the intention. 

Senator ROBERTS: Are we talking a month or so? 

Mr Windeyer: I don’t want to put a time on it. Yes, the intention is still early this year to commence public consultation on the stage 2 reforms. 

Senator ROBERTS: In response to my question regarding the graphic novel Welcome to sex, which I described as targeted to 10-year-olds and up—the author in fact says it’s suitable for eight-year-olds and up—Ms Jolly, who I guess is your predecessor— 

Mr Sharp: Correct, Senator. 

Senator ROBERTS: responded, and I quote: Our understanding is that the book clearly states that it is targeted to teenagers from 13 up. Here is the book, which on the flyleaf identifies the reader as an ‘apprehensive 11-year-old’. Amazon still has the listing at 10 plus. I do note that Hardie Grant, the publishers, have removed reference to an age entirely, so we’re heading in the right direction. It is unhelpful, though, to potential purchasers and where other booksellers have it listed at 14 plus. Can you clarify, on notice please, Mr Sharp, what age is the Classification Board happy with— 10 plus or 14 plus—and why? 

Mr Sharp: Senator, it’s actually not the place of the board to predict what age something should be available other than through the classification process. We’ve had no applications for that book at this time and the board has not reviewed it. 

Senator ROBERTS: It’s now self-classification, I take it, since the legislation was passed. Is that correct? 

Mr Sharp: No, Senator. That’s not correct. The stage 1 reforms did not address anything to do with publications. Publications can either be submitted for classification by the publisher or they can be called in by the director if there’s a belief that it could possibly be a submittable publication. 

Senator ROBERTS: In other words, self-publication is one of the choices or submitted to the board? 

Mr Sharp: Well, it’s not self-classification, Senator. It is the publisher choosing to have the board classify it by making an application for that. Self-classification generally is referred to as them making a choice about what that classification is and publishing it in that way. Senator ROBERTS: I thought the publisher could classify it or ask the board to classify it. I thought that’s what you said. 

Mr Sharp: No. The publisher can put it forward as an application to be classified by the board, or the board can call it in separately. 

Senator ROBERTS: Thank you for clarifying. There seems to be some backside covering going on with the publishers because they’ve started to shift the age upwards slightly. In the last estimates, in response to my question about the options available to the Classification Board for graphic novels, Ms Jolly, your predecessor said, and I quote: “I think the board’s submission to the Stevens review back in 2020 was that we felt there would be benefit in having some greater graduations in classifications”. The Stevens report did not make that recommendation at all. In fact, quoting from page 66 of his report, Mr Stevens said: “On balance, I do not consider that a compelling case has been made for an additional classification category in isolation of a more fundamental look at all the categories”. Mr Sharp and Senator Brown, will you assure the committee that your work in this imminent review will provide that in-depth look at available options that supports a legally binding intermediate classification such as MA14+ or MA15+? 

Mr Sharp: Well, Senator, it’s a good question. The board does not have any input into the scope of that review. However, I can say that on the public record the board in 2020 for the Stevens review made a submission and made recommendations around publications with the idea of harmonising and aligning all the guidelines—the film, computer game and the publication—so that they are more clear in their administering and for the public to understand. Within that, the board did note that it would make sense to abolish the existing unrestricted category 1 and category 2, which really is unclear to the public, and institute possibly an M, an R18+ or an X18+, which would align to those three categories and are well understood by the public within the film classification and computer games classification. That was part of the board’s submission in 2020. The board still has a position. 

Senator ROBERTS: We think the MA14+ or MA15+ are necessary because it’s not suitable for under 14s and it is suitable for 14s and up and 15s and up. That would fit in with your M. Is that correct? 

Mr Sharp: Well, not exactly, Senator. M is not recommended for persons under 15. MA is a legally restricted classification. 

Senator ROBERTS: What does that mean? 

Mr Sharp: It means that people under 15 years cannot purchase the publication and, similarly with a film, cannot view a film unless they have an adult doing that for them. It’s not that they cannot hold it, but they cannot purchase it or buy a ticket to it themselves. So the board’s previous submission was for an M, which is an equivalent to unrestricted. Currently, you may well be aware that unrestricted can also have an additional consumer advice of not recommended for persons under 15 years. R18 would be the equivalent of a category 1 currently, and there is X18. So the intention of the board in that submission, and our position today still, is to use classification designations that the public understands, recognises and trusts very well within the film classification area and the computer game classification area. 

Senator ROBERTS: So would that mean it would not be possible for a 14-year-old or under 14 to buy this? 

Mr Sharp: It would be strongly recommended that it’s not for that age group. But it would not be legally prohibited to do so. It would be advised that a parent make a decision around that. Parental guidance is part of that process. 

Senator ROBERTS: So you are heading in what would be the right direction for me. 

Mr Sharp: I’m pleased to hear that, Senator. 

Senator ROBERTS: But that’s what it sounds like. I’m just checking. 

Mr Sharp: I believe we’re on the same page. 

Senator ROBERTS: I don’t think under 14s should be able to get this, but let’s see what happens with your review, which is imminent. 

Mr Windeyer: Correct. 

Senator ROBERTS: We’ll ask in May. 

Senator Carol Brown: There will be more to say in due course, Senator Roberts.

Senator ROBERTS: Thank you, Senator Brown. 

/by

TGA is Rubber Stamping Approvals

,

The Therapeutics Good Administration (TGA) has been established as an independent body to approve or reject applications for drugs, vaccines and medical devices. For many years, the TGA stood strong against pressure from the USA and pharmaceutical companies to shred our long-established approval processes that protected Australians from drug harm.

Recently that pressure won out and the TGA has adopted the language of pharmaceutical companies, especially as used by their lobby group, Medicines Australia. The result has been the fast tracking of drugs and vaccine-like products that would not have been approved under the old system.

I ask about the rate of approval -vs- rejection of drug applications. In the last 3 years, 140 drugs were approved. The Department dodged the question as to how many were rejected. Most likely this was because drug companies are allowed to withdraw their application rather than face rejection, so they can bring the application again. My information is less than a dozen applications have been “withdrawn”, suggesting the TGA is approving at a much higher rate than they have in the past.

The actions of the TGA may have led to the spike in unexplained deaths and increases in serious harm to Australians. Only a Royal Commission will get to the bottom of their recent shift in process and the harm this may have caused to our health.

Transcript

Senator ROBERTS: I’m stunned that you wouldn’t study the long-term effects of COVID-19 spike proteins, given that the COVID injections cause the body to become a factory for the spike proteins. Let’s move on, though. The TGA website has a page entitled ‘Australian prescription medicine decision summaries’, which displays new drug approvals. 

CHAIR: Before you go on, Senator Roberts, you just made an assertion— 

Senator ROBERTS: I said I was stunned— 

CHAIR: They may not wish to, but I want to check if anyone from the department or the TGA wants to respond to the preamble before your question. 

Prof. Lawler : No, I don’t. Thank you, Chair. 

CHAIR: You’re okay? Alright. Senator Roberts. 

Senator ROBERTS: In terms of new drug approvals for calendar 2022, 2023 and 2024, three years—we’re in the third year—140 drugs were listed as approved. Is there a separate list of rejected applications? 

Mr Henderson : We do publish the medicines that are under evaluation as well as the medicines that are approved. Medicines are either rejected or—a lot of times medicines are withdrawn by the sponsor. 

Senator ROBERTS: Do you publish them? 

Mr Henderson : No, we just publish the number of medicines that have been approved as well as the medicines that are under evaluation. 

Senator ROBERTS: How many were rejected? 

Mr Henderson : I’ll need to take that on notice for those periods. 

Senator ROBERTS: Do you have a rough idea? 

Mr Henderson : I don’t know— 

CHAIR: If he’s taken it on notice, he’s taken it on notice. 

Mr Henderson : I’ll take it on notice. 

Senator ROBERTS: Thank you. Professor Skerritt was in charge of the TGA for most of that period. They approved 140 new drugs, and you don’t know how many have been rejected. Let’s go to plasmidgate. There were questions from several senators, including myself, at the last estimates relating to the scandal known as plasmidgate, which was the contamination of COVID injections with foreign DNA originating from E. coli bacteria used in the production process for making the COVID injections. Your answers on notice to all senators’ questions are essentially the same, which is ‘There’s no contamination,’ and you cast shade on the papers and persons who claim there is. Is this still your position? 

CHAIR: That seemed to be quite a personal reflection in that question. Who particularly were you talking about? 

Senator ROBERTS: There’s no personal reflection. It’s the TGA. 

CHAIR: The TGA? 

Senator ROBERTS: At last Senate estimates—and since, in answers to questions on notice. 

Prof. Lawler : Again, I apologise for having lost track of the question. There were a number of elements there. Could you repeat the question for me, and I can get the best person here to answer it. 

Senator ROBERTS: Sure— 

Mr Comley : Sorry, the essence of the question is, ‘Do you stand by the answers you’ve given to questions on notice related to contamination?’ and the answer is yes, we do. 

Senator ROBERTS: Okay. Have you tested a sample of these products in your own laboratory and have you personally assured yourself that there is no contamination in the COVID vaccines? 

Prof. Lawler : Thank you for the question. All vaccines that have been released have been tested by the TGA and have passed. 

Senator ROBERTS: How did you test the vaccines? Professor Skerritt told me he relied on the FDA, and the FDA said, before Professor Skerritt said that, that they relied upon Pfizer’s testing? What test did you do? 

Prof. Lawler : Could I just clarify that you’re talking about batch-release testing. 

Senator ROBERTS: I’m talking about COVID injections approval. 

Prof. Lawler : I’m trying to clarify whether you’re talking about the release of vaccines for use. 

Senator ROBERTS: I’m talking about the approval of the original COVID injections. Professor Skerritt told me that they were not tested here because you relied upon the FDA. The FDA had previously already stated that they did not do any testing; they relied on Pfizer’s testing, which was broken up. 

Dr Kerr : Thank you for the question. We do do our own testing. 

Senator ROBERTS: Did you test for contamination in the batches? 

Dr Kerr : Yes, we do test for contamination in the batches, including for residual DNA. 

Senator ROBERTS: And E. coli? 

Dr Kerr : The E. coli can be determined through a test called endotoxin testing. We do test for endotoxins, and all of the batches that have been released into the Australia market passed the endotoxin test. 

Senator ROBERTS: Attempts to examine batch-lot testing through freedom of information have resulted in documents that are 100 per cent redacted. I can flick the pages. You have the ability to put plasmid-gate to bed right now by publishing the results of your own testing without redaction. Will you provide to the committee that unredacted proof that there is no contamination? 

Dr Kerr : We publish the summary of our test results on the TGA website. One of those tests is contamination, and I can confirm that the batches are not contaminated with residual DNA or endotoxin. 

Senator ROBERTS: Thank you. Can we have a look at them? They’re on the website? 

Dr Kerr : Yes. 

Senator ROBERTS: I turn to blood clots. There’s an aspect of these injections that just doesn’t go away; in fact, it is becoming more common. Embalmers are reporting that bodies that they are embalming are affected by large blood clots. There are multiple videos and photos online. Dr John Campbell, a British doctor, did an excellent show recently on this. Have you looked at this issue? We know that it’s a problem with some of the injections. 

Prof. Lawler : Taking on board the fact that it’s difficult for us to corroborate or validate some of the comments that you made, I’ll ask Ms Kay to comment. 

Senator ROBERTS: I just want to know if you’ve looked at it. 

Ms Kay : We have not confirmed an association between mRNA COVID-19 vaccines and thrombosis, or blood clots. We have released an extensive list of the safety investigations that we’ve undertaken in response to a question on notice. I can provide that to you again so that you can see which safety signals we have investigated. I can’t tell you off the top of my head right now whether blood clots is one of those. 

Senator ROBERTS: Could you also tell me how you’ve done that evaluation? 

Ms Kay : Right, okay. 

Senator ROBERTS: You can take it on notice. 

Ms Kay : I can tell you now, if you like, how we detect safety signals and investigate them. We have a number of different approaches to detecting safety signals. A key mechanism for detecting safety signals is the statistical analysis of the adverse event reports that we hold in our database, where we look for unusual patterns of reporting that might indicate a new safety signal. We then undertake a medical assessment of those safety signals, and that medical assessment will determine the need for further investigation. That further investigation then takes into account a broad range of different sorts of evidence. We’ll look, in detail, at the adverse event reports within our database, as well as looking at published literature and information released by other regulators. Those investigations assess the strength of the evidence for an association between an adverse event and a vaccine. Where we find a likely association, we’ll take regulatory action, such as updating the product information to make that information available to health professionals. 

Senator ROBERTS: Can you tell me about the medical assessment? 

Ms Kay : The medical assessment of those statistical signals? Certainly. It’s an accepted approach in pharmacovigilance to undertake what’s called a disproportionality analysis, where we look for signals of disproportionate reporting of a particular adverse event with a particular exposure—a medicine or a vaccine. It’s also accepted in pharmacovigilance that those statistical signals need to be put through a medical assessment to understand whether they might have arisen through bias or whether there may be a signal there that needs to be further investigated. There are quite a number of different aspects that are considered in that assessment, and I’d be happy to provide you with that information on notice. 

Senator ROBERTS: Thank you very much. 

/by

Steroid Testing of ADF Athletes

,

Some constituents raised some concerns about the steroid testing of Australian Defence Force athletes.

At Senate Estimates I asked Sports Integrity Australia whether they have received any notifications from the ADF in relation to steroid testing.

Transcript

Senator ROBERTS: My questions go to sports integrity, Mr Sharpe. Could you briefly explain the rules around testing for athletes, as in who is eligible and who is required? 

Mr Sharpe : They’re quite broad. Our focus is on international- and national-level athletes from a testing perspective. We can test lower, but our focus and our policy is that where there’s an absence of education at a lower level, in the first instance, we wouldn’t be testing unless there was specific intelligence that would suggest we need to take a facilitator or someone out of sport. 

Senator ROBERTS: Your focus is on international level? 

Mr Sharpe : And on a national level. 

Senator ROBERTS: Can you explain why athletes that are tested are prohibited from private testing? 

Mr Sharpe : They’re not prohibited from private testing. 

Senator ROBERTS: Can they go and test themselves? 

Mr Sharpe : Absolutely. Sports do have illicit policies, where they all conduct testing around that, which is separate to our agencies. But athletes, if they felt they needed to, would not be prevented from doing that. 

Senator ROBERTS: What is the efficacy of hair follicle testing for steroids? 

Mr Sharpe : We don’t do hair follicle testing. 

Senator ROBERTS: Because it’s not efficacious? 

Mr Sharpe : We just don’t do it because we follow the world Anti-Doping Code and it’s not a part of the code. 

Senator ROBERTS: Are you aware of the Defence Force exemption from their testing regimes for competitive athletes in the Australian Defence Force? 

Mr Sharpe : No, I’m not aware. 

Senator ROBERTS: Should Defence be making you aware of any suspicions of doping? 

Mr Sharpe : I think that’s a matter for Defence. We’d certainly be willing to work with Defence if it related to a sporting event that was under an anti-doping policy. 

Senator ROBERTS: I take it they have not made you aware of any of that. 

Mr Sharpe : No, they have not. 

Senator ROBERTS: How would you action it if they did make you aware? 

Mr Sharpe : It would depend on whether the sport is a registered sport in this country and under an anti-doping policy—whether they participate in those sports or not. 

Senator ROBERTS: Thank you. That’s the end of my questions. 

/by

Smart Meters and Remote Control Air Cons

,

At Senate Estimates I asked the Australian Energy Regulator if they were concerned that there seems to be increasing control over people’s electricity and access to electricity. It seems to be a case of “see no evil” at the Energy Regulator after hundreds of thousands of Queenslanders had their air-cons remotely throttled by the Government.

As the grid gets more unstable because of net-zero policies the government needs more control over electricity use to avoid damage to infrastructure.

One Nation will oppose this WEF inspired control dystopia at every turn.

Transcript

Senator ROBERTS: Thank you for appearing again today. I have a question about the emergency backstop mechanism from the Queensland government’s Department of Energy and Climate. It’s implemented in Queensland and it allows the government to turn off people’s solar panels at will. A lot of people in Queensland were shocked when the government reached into their homes and controlled their air conditioning units 170,000 times in the last two months. Now we’re finding out the government can turn off people’s solar panels as well. I don’t understand why the panels on someone’s house would have to be remotely cut off, even for self-consumption. As the regulator, do you have any data on how many of these generation signalling devices have been installed in Queensland under this emergency backstop mechanism and how many are installed nationally? 

Ms Savage : Is your question about smart inverters? 

Senator ROBERTS: It’s about smart meters that are cutting off air conditioning units and cutting off solar panels. 

Ms Savage : There is a backstop mechanism that’s been put in place through the Energy and Climate Change Ministerial Council, which I don’t know if the department wishes to comment on. Essentially, it’s to avoid situations of what they call minimum demand, where you might have— 

Senator ROBERTS: Minimal demand? 

Ms Savage : Minimum demand problems. It’s where in system operation you might have so much solar in the system— 

Senator ROBERTS: Like the middle of the day. 

Ms Savage : That’s right. South Australia is where it’s been most acute. You might have so much that you can’t keep a stable minimum generation load in place. Solar is turned off during those emergency situations to ensure that you can keep that minimum stable generation load. I’m not aware of the figures that you’ve just quoted around the number of times it’s been done in Queensland, so I’ll look to my colleagues, Ms Jolly or Mr Duggan, to see if they can assist. 

Mr Duggan : I was going to ask if you could give us a sense of where those figures came from, Senator, because I hadn’t heard them before. 

Senator ROBERTS: I can get back to you on that. It was widely reported in the press last week. 

Ms Savage : It’s not consistent with my understanding, so I think we’d need to see the figures. 

Senator ROBERTS: Okay. We’ll get them to you. Under the National Electricity Rules, what remedy or compensation is available to a homeowner if their solar panels are turned off remotely and they suffer some kind of damage because of that? 

Ms Savage : Again, it’s not an area of the AER’s responsibility. I’m not sure whether there are compensation payments in place—I don’t think there are. 

Mr Duggan : I think having access to the information that you’ve got would help us out enormously, but, to me, the direction of the question is more one that goes to AEMO’s management of the grid. I suspect they would be operating that part of the system. If we can get the information from you, we’ll endeavour to work with those— 

Senator ROBERTS: Doesn’t the Australian Energy Regulator oversee the whole lot? 

Ms Savage : Yes, but not necessarily the way in which the system is operated, and that’s a system operation question. We make sure people comply with the rules. One of the things the Australian Energy Regulator is doing is working with the network companies to do what’s called flexible export limits. This is to ensure that you have a greater opportunity to optimise the solar system across the whole grid so that we’re not seeing solar panels being turned off unnecessarily. Did you want to add anything, Mr Cox? 

Mr Cox : No. I think that’s basically right. At the moment, solar panels, as you mentioned, are turned off to preserve the stability of the grid. It’s a fairly rigid arrangement. Perhaps a more flexible arrangement would allow people to export more frequently at times that are convenient to them, and that’s something we’re exploring with the various network businesses. 

Senator ROBERTS: You used the word ‘acute’ and talk about ensuring a stable minimum generation load. These things—solar and wind—have introduced a hell of a lot of management issues, which adds costs and risk to the system. 

Ms Savage : I think they add cost and risk at times through the day, but they’re also at times free. From that perspective, we see a lot of negative prices—in South Australia and Queensland, in particular—through the middle of the day, which lowers overall average prices of the system, but at other times of the day there are costs to manage the system. Ms Jolly has just reminded me that we do have the export services network performance report, which looks at how the networks are and how much solar energy is being exported into the grid. That report might be useful to you too. 

Senator ROBERTS: Okay. Could you send us that, please. 

Ms Savage : Yes. 

Senator ROBERTS: You may not be able to answer this question, but you’re the overseer. How many air conditioners have been installed with remote demand management systems under the PeakSmart program in Queensland? 

Ms Savage : I wouldn’t have access to that data. 

Senator ROBERTS: Would you be able to get it on notice? 

Ms Savage : I don’t think we would have that as an agency; that sounds like a Queensland government program. 

Senator ROBERTS: But you’re overseeing the national. 

Ms Savage : We oversee the bits that are within the national electricity law and rules. State based programs usually are done through state based legislation. 

Senator ROBERTS: So they can operate independently? 

Ms Savage : If the states have their own legislation, there will be elements that will operate through that. 

Senator ROBERTS: Are you concerned that there seems to be increasing control over people’s use of electricity and access to electricity? 

Ms Savage : In Queensland there has been direct load control of air conditioners and pool pumps for a very long time, for more than 20 years. From that perspective, it is not a new thing in Queensland; it has always been a part of the system operation in Queensland. 

Senator ROBERTS: What about other states? Is it increasing? 

Ms Savage : We would have to look at the numbers. I don’t have the numbers in front of me. 

Senator ROBERTS: Could you get them on notice, please. 

Ms Savage : Ms Jolly, would we have those numbers? 

Ms Jolly : I’m not sure. They may come from the distributors who run those programs autonomously. 

Senator ROBERTS: Do you how many smart meters have been installed in Queensland? 

Ms Savage : I probably know how many smart meters there are in Queensland. We are at about 47 per cent in Queensland. Is that right? We’d have to take that on notice. 

Senator ROBERTS: If you could, please. Forty-seven per cent of households have smart metres? 

Ms Savage : We looked at this last week, so I’m trying to remember what the answer to that is. But I think that we’re heading into that territory in most of the jurisdictions now—up towards the high 40 per cents. 

Senator ROBERTS: Is there anything in the National Electricity Rules that enshrines the right of a customer to refuse a smart meter? At the moment many of the programs have opt-out clauses, but my question is whether there is anything in the Electricity Rules that will stop an electricity company if they decide to try to force someone to take a smart meter, to make it mandatory. 

Ms Savage : I think I’ll need take that on notice as well. 

Senator ROBERTS: It seems like there is increasing power over people’s use of electricity. I’ll just ask a few questions; you may not be able to answer these. It is about the emergency backstop mechanism website. The government says that the emergency backstop mechanism ‘is an important step in supporting Queensland’s transition to a more coordinated electricity system’. Is the electricity system becoming more coordinated, controlled? 

Senator McAllister: Senator Roberts, we’ve canvassed this a few times over the course of the day. It’s very difficult for officials to answer questions about documents when we don’t know the provenance of the documents or the dates they were published or we don’t have the document in front of us. Are you able to table that or perhaps provide us with a web link? 

Senator ROBERTS: Sure. It was a website, last updated 12 December 2023, from the Department of Energy and Climate in the Queensland government. 

Senator McAllister: I see. So it’s a Queensland government— 

Senator ROBERTS: Yes. 

Senator McAllister: I’m not sure that the Commonwealth government can answer questions about Queensland government programs. The AER may have information for you, but there are limits on what we can discuss in this forum. 

Senator ROBERTS: I understand that, Minister. I’m just looking at what the Queensland government is saying about the ‘more coordinated electricity system’ and I thought that that might come under the Australian Energy Regulator. 

Ms Savage : I would probably say that an electricity system must be coordinated—it has always been coordinated—because you have to have instantaneous meeting of supply and demand. That’s why you have a system operator to make sure that you’ve got generation resources available when people demand it. That level of coordination is fundamental to ensuring that we can keep a stable voltage waveform in the system. The physics of that demands it. To answer your question, it has always been a coordinated system and it will need to be remain a coordinated system. 

Senator ROBERTS: It says it’s becoming ‘more coordinated’. 

CHAIR: On this notion of the national energy grid and the role of the states, I think what we’re probably tripping over here is the situation where there is a national plan and the states each have a set of responsibilities. How they then roll out those responsibilities is sometimes done in the state and not necessarily part of the purview of— 

Senator ROBERTS: I understand that. I’m trying to find out whether or not you have any role in that or any information about that. 

Ms Savage : I’m happy to try and answer your questions. They’re just not necessarily directly in my patch, but I’ll help you however I can. 

Senator ROBERTS: That’s about all I had. You’ve already answered the last one I had. 

/by

How Do You Fit Big Australia Into Small Housing and Infrastructure?

,

I asked the Treasury Department how they got immigration forecasts for the year so horribly wrong when they were already a third of the way through the year? In October 2022, the Government estimated total net overseas migration for the year July 2022 to June 2023 to be 235,000. The actual arrivals for 2022-23 ended up at 518,000. It’s hard to understand how Treasury was this wrong about those 12 months when they were already 4 months through them.

This is just more proof the government’s immigration program is totally out of control. Minister Gallagher is wrong when she claims this flood immigration is a benefit to Australia. Right now immigration is choking our country, making the housing problem, the cost of living crisis, energy shortages, the crisis in healthcare and other essential services even worse.

Only One Nation will make sure Australians get a roof over their heads first.

Transcript

Senator ROBERTS: Thank you to the officials for being here today. The 2022-23 budget, delivered in October 2022, predicted that net overseas migration would be 235,000 people for the financial year 2022-23. Can I ask whether the Treasury’s definition of net overseas migration differs from the Australian Bureau of Statistics’ definition of overseas migration? 

Ms Reinhardt: Sorry; can you just— 

Senator ROBERTS: Do you have the same definition of net— 

Ms Reinhardt: Yes, we do. 

Senator ROBERTS: I want to go to your department’s immigration forecasts. I notice that in the October 2022 budget papers, four months into that financial year, you were predicting net overseas migration at 235,000 people for the year. Instead, the Australian Bureau of Statistics says Australia had 737,000 migrant arrivals, for a net overseas migration of 518,000—well over double what you said. 

Ms Reinhardt: In the budget, we had a figure for net overseas migration of 400,000. The MYEFO had 510,000, and I recognise that that is a significant miss. I would, however, flag a couple of things around that. The first is that the UK in the period between March and November last year had to double their NOM forecast, and New Zealand had a similar adjustment. There has been a significant uptick in student arrivals post-COVID in most countries—Canada, Australia, UK and New Zealand. There was, I guess, a catch-up that was much faster than any of those countries predicted. We are still below where we would otherwise have been had COVID not occurred. But I think you’re right in saying those forecasts could have been better, if that’s the point you’re making. I would say we are in company. I don’t say it’s good company, but we are in company, and that is something we do need to look at. The other point I’d make is that there have been some really significant changes that have been introduced in the last six months. They’re around closing off the pandemic event visa; introducing really significant integrity changes around student visas; looking at ways of targeting better temporary skilled migration; and indexing theTSMIT, the temporary skilled migration income threshold. We would expect those changes to have quite a substantial impact on arrivals and the NOM numbers. 

Senator ROBERTS: Thank you. I’ll stay with you, Ms Reinhardt. I think you talked about catching up on the pre-COVID-era statistics. My understanding is that we had 1.9 million people on visas before the COVID, and by October 2023 we had 2.3 million—we’d already caught up, well and truly, at the start of that year. I can’t tell you which group of visas— 

Ms Reinhardt: We haven’t fully caught up, but, in terms of visa numbers, I’ll see if my colleague— 

Senator ROBERTS: No, we’ve more than caught up in categories of working visas. 

Ms Horvat: No. 

Ms Reinhardt: No, not in terms of the stock of— 

Senator ROBERTS: In working visas? 

Ms Horvat: We look at net overseas migration in total— 

Senator ROBERTS: I’ve shifted to working visas. 

Ms Horvat: but Ms Reinhardt’s statement is correct, as we have not caught up to pre-COVID for total net overseas migration. 

Senator Gallagher: But Treasury don’t look at what particular visa type you’re on; that would be a matter for Home Affairs. 

Senator ROBERTS: Thank you for pointing that out. Nonetheless, this huge increase in people has a huge impact on the people who are already here. What happens to the prices of houses, rentals, accommodation generally, energy, groceries—cost of living? There’s a huge impact on all of those things when we have so many people flooding into the country. 

Ms Reinhardt: I’m really not best placed to answer the broader inflation questions, but I would say that net overseas migration has really significant positive impacts for Australia. That’s been shown in the analysis year after year. We have maintained a very low unemployment rate in Australia whilst having pretty long-term migration to Australia for several hundred years, and that’s been a really important factor to our economic success. It has also, in recent times, not resulted in any substantial uptick in unemployment, and at the same time we’ve seen really high participation rates for Australians. So I would push back on the idea that that is an absolute negative for Australians, as it’s delivered substantial economic benefit to Australians. 

Senator ROBERTS: It would be, potentially, if it were done in a carefully calculated way and with infrastructure spending to match, but we haven’t build a dam in how many decades for water supply? 

Senator Gallagher: We’re moving into a different area. 

Senator ROBERTS: That’s right. I’m directing my question to you, Minister. This has a huge impact on people’s livelihoods. 

Senator Gallagher: The evidence that you’ve been given is that migration to this country has supported economic growth across the country for many years. We agree that we needed to tighten up some of the arrangements that we’re seeing, particularly around international students and some of the loopholes that were being used—some of the behavioural responses post COVID—and that work is being done. Because of those reforms, there will be 180,000 fewer people over the forward estimates than there would’ve been if we had left the situation unattended to, but there’s a huge amount of work. 

Senator ROBERTS: That’s still a large number. 

Senator Gallagher: It comes down to, I think, 250,000 in the final year of the forward estimates. The work that the Minister for Home Affairs is doing in the migration space has been complex. She inherited a lot of issues in that department—that’s probably putting it politely—and we’re working through them bit by bit. But those reforms are in place. The issues that you raise around infrastructure are real. I don’t think you can blame all of those, again, on overseas migration to this country. Infrastructure requires long-term planning. It involves investments from states and territories. Some of the pressures we’re seeing in housing supply haven’t happened overnight or in the last two years. It’s been a build-up over a much longer period of time, when we weren’t experiencing those high levels of overseas migration that we’ve seen in the last two years. It’s more complex than that. But, yes, we have to work on housing supply; we have to ensure that we’re building infrastructure that’s right for people in cities, towns and regions across Australia; we’ve got to fix the migration system; and we’ve got to make sure that it works for everybody.  

Senator ROBERTS: That’s my point, Minister: just adding more people without doing all the other creates a problem. Sure, it increases economic growth, which looks good in a book or on a whiteboard— 

Senator Gallagher: It supports jobs and incomes in this country, so it is interlinked. What I’m saying is, we will always want to have a migration program. We want to attract people to this country. We want them to live here and come from any country around the world. There are good social and economic reasons to have an approach like that, but, at the same time, you have to be looking after your back garden as well. You have to be making sure the infrastructure is there and that you’re building the housing, and we’re doing all of those things. 

Senator ROBERTS: Thank you, Chair. 

/by

“That’s not my job” Lemmings Driving us Off the Net Zero Cliff

,

No one in government will take responsibility for the net-zero plan going wrong. Mr Parker who heads the Clean Energy Regulator is paid over $630,000 a year, yet he admits that even if catastrophic errors in claims about Net Zero are brought to his attention, he would do nothing about it. No-one on the panel were prepared to answer questions about your right to receive reasonable power bills or to continue to enjoy a standard of living better than a third world country.

Minister McAllister points out that the department is only responsible for the “broad settings” and that other institutions are there to simply follow their tasks under legislation.

Only One Nation is prepared to face up to the UN-WEF Net Zero agenda and pull the plug on the nation killing scam invented by predatory globalists.

Transcript

Senator ROBERTS: Thank you, Chair. First of all, thank you for being here. Can I ask whether you take any responsibility for assessing the cost of trying to run the grid on wind and solar? 

Mr Parker : No, Senator, we don’t do that kind of work. Our job, as defined by statute, is to administer various programs in the climate space, but not that one. 

Senator ROBERTS: Thank you. Do you do any analysis, measuring or modelling on how much wind and solar actually cost once you include the necessary firming or integration costs, the storage and additional transmission? 

Mr Parker : No, Senator. 

Senator ROBERTS: Your job is just to pursue the legislative targets? That’s your statutory job? 

Mr Parker : That’s broadly right. It is in an unofficial space somewhat broader than that, because we have insight, if you like, into industry trends and what’s going on through our liaison with industry, and we are able to feed those views into the policy process. 

Senator ROBERTS: When you say, ‘trends’ what do you mean? They aren’t cost trends. 

Mr Parker : No. We have some information on costs but, as I said, we don’t model those. The sorts of information which we look at are developments in the markets for the relevant carbon instruments, the quantity of investment taking place and so forth. We have an insight into that from our on-the-ground work. 

Senator ROBERTS: You don’t raise the alarm bells over whether chasing net zero for the energy grid is practically feasible or how much it’s going to cost to get to 2035 with solar and wind powering everything? 

Mr Parker : No, that’s a policy question; we don’t get into that. 

Senator ROBERTS: You don’t test AEMO’s Integrated System Plan at all—there are so many acronyms aren’t there?—to see if it has any flaws? You don’t analyse GenCost from CSIRO to see if there are any faulty assumptions? 

Mr Parker : We’re familiar with all of those reports, but it’s not our role to critique them, if you like. 

Senator ROBERTS: As the national regulator for this type of energy, even if it were brought to your attention that there are fundamental flaws in the foundational documents for this whole plan, like the Integrated System Plan or GenCost, you wouldn’t or couldn’t do anything about it. It’s not your responsibility? 

Mr Parker : It’s not our role within our statutory remit to do anything about it. 

Senator ROBERTS: Thank you, Mr Parker. I only ask, because almost every climate related agency I’ve ask, whether it’s supposedly justifying the mad switch to solar and wind or whether it’s actually implementing the policy says, ‘It’s not our job to consider the big picture.’ I’m not arguing that you’re shirking it—I’m not at all. I’m just confirming that you don’t do it. We could be driving off a cliff here and everyone is saying, ‘It’s not my job to think about the cliff, I just drive the car,’ because you’ve been appointed as the driver. Does that terrify you? 

Senator McAllister: Senator Roberts, you’re now— 

Senator ROBERTS: Does it terrify you, Minister? 

Senator McAllister: You’re now asking the official about his feelings and you’re asking me about my feelings. I can explain to you the policy position of the government, the policy arrangements in the government and the responsibilities. The Department of Climate Change, Energy, the Environment and Water is responsible for the broad settings in relation to the energy market. They’ve been here this morning, answering questions from senators about the approach they take to policy development for the settings for the energy system. There are other institutions, as you’ve observed, that have either advisory or regulatory roles. The CER is one of them and they’re here and able to answer your questions about the task that they’ve been given under legislation. 

Senator ROBERTS: Thank you, Minister. Thank you, Mr Parker and your team. Thank you, Chair. 

/by