ACCC Needs More Power Against Foreign Predatory Billionaires

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I’m concerned about the increasing influence of large, predatory merchant banks on the Australian economy. You’ve heard the names mentioned — Blackrock, First State, State Street, Vanguard and Norges. While their shareholdings may be small, typically 5 – 8% each, when they act together these shareholdings amount to a controlling interest over targeted industries.

These include our retailing duopoly, Coles and Woolworths and our Big-4 banks: Commonwealth, ANZ, NAB and Westpac/St George.

I asked the Australian Competition and Consumer Commission (ACCC) about the way that our banking sector behave like a monopoly — one set of owners with multiple logos. The answers were encouraging but the ACCC needs more power to control these predatory merchant banks.

I also asked about de-banking, which is the process that the Big-4 use their market power to harm or close businesses that compete with them, including cryto exchanges and bullion dealers. The biggest competitor of all though, is actually cash. Physical money competes with more traceable and profitable electronic banking. Banks are closing branches, pulling out ATMs and generally trying to engineer a cash-free society for their profit and control.

These questions were my first to ACCC in quite some time. The answers were sharp and well informed and I look forward to developing these lines of inquiry next estimates.

Transcript

CHAIR: Senator Roberts. 

Senator ROBERTS: We don’t call the ACCC very often because it seems you do a very good job. To improve banking competition—and that’s needed—do we need more regulation or more independent banks providing competition? Which is it? 

Ms Cass-Gottlieb: We want both. 

Senator ROBERTS: Okay! The ACCC refused permission for ANZ to acquire Suncorp bank on competition grounds? 

Ms Cass-Gottlieb: We did. 

Senator ROBERTS: That was a very good decision. Would it improve competition in Australian banking if Suncorp was now purchased by a third party not currently involved in banking? 

Ms Cass-Gottlieb: Firstly, I should note that ANZ and Suncorp have taken an action for review in the tribunal and that decision will come down next week, and so we await that decision. It may or may not be the same decision as the ACCC’s. However, our decision reflected that we were not satisfied that there would not be a substantial lessening of competition and either Suncorp continuing independent, as it is now, or being acquired by another party—one of the possible alternative transactions that was identified was, for instance, merger with an alternative regional bank or smaller bank—or by a party that is not currently a participant in the banking sector, would each retain the independent, competitive constraint. 

Senator ROBERTS: In your progress report on the digital platform services inquiry, you made the point that the ACCC continues to recommend the introduction of new and expanded industry-wide consumer measures, including prohibition on unfair trading practices. What industries or perhaps what context informed that request for more power? 

Ms Cass-Gottlieb: The ACCC is looking for that reform across the economy. We do see that, in terms of digital platforms—for instance, in online trading, subscription traps are a good example—there is a significant capacity to have unfair practices and processes that deprive consumers of the ability to make informed choices. But we do see these problems across the economy. The government is proceeding through a consultation process, which will conclude in November of this year, and we hope this will result in the introduction of an unfair trading practices prohibition across the economy. 

Senator ROBERTS: As to PEXA—I think they’re the conveyancing people? 

Ms Cass-Gottlieb: Yes. 

Senator ROBERTS: Would PEXA’s near-monopoly in electronic conveyancing be an area where you would like more power to keep an eye on their use of market power? 

Ms Cass-Gottlieb: We are hopeful that ARNECC, which is the current regulator, will be in a position to require compliance with the steps towards interoperability, which had been hoped for and planned, so that there will be a capacity to result in meaningful competition. 

Senator ROBERTS: You approved the merger of the Armaguard and Prosegur cash handling businesses—against opposition from the free market, which fears losing the ability to negotiate on price—with the justification of keeping these businesses going. Are you confident the merged entity is viable and capable of holding 90 per cent of the Australian market long-term—let’s say, up to 2030? 

Ms Cass-Gottlieb: It is correct that we did approve that merger on condition of an undertaking. We were particularly conscious of the matters that were put before us relating to the loss of viability for two competing providers of cash-in-transit services, as there was such a significant decrease in the use of cash, particularly brought on during the period of COVID. Under that undertaking, which is effective for three years, the merged entity is required to continue to offer the services to all locations that are currently serviced. It also limits the ability to reduce service levels and raise prices. We do monitor compliance with all undertakings we accept. We do know that the merged entity states that there have been further changes that call into question its continued viability. We have granted an interim authorisation that was sought by 20 members of the Australian Banking Association, the Reserve Bank of Australia, Treasury, Australia Post and suppliers of cash-in-transit services—a whole set—that were seeking to be able to negotiate to try to reach a resolution for continued cash-in-transit services on acceptable terms. As a condition of that interim authorisation, we required that there be public reports monthly in relation to the discussions, because it was quite a significant authorisation that we enabled for those negotiations. We have just this week received the first report, and it’s available on our register. 

Senator ROBERTS: Banks are refusing to accept or issue cash to profitable small players like Commander Security. This company has been de-banked by the big four and now even a customer owned bank. Banks are closing branches, pulling out ATMs and refusing to give cash to their own customers in a situation where identity and use of cash has been established. Cash is, in effect, a competitor to the bank’s dream and the customer’s nightmare of making a fee on every transaction and service every person makes. Are banks misusing their market power to eliminate cash as a competitor to their own electronic payment systems and drive customers to fee-paying services? That’s what it appears to be. 

Ms Cass-Gottlieb: We do currently have a misuse of market power action relating to financial services in the court against MasterCard. We certainly look closely at misuse of market power questions in relation to financial services. There are a series of complex questions in there, including on the closure of branches, which APRA does monitor and report on. We have also reported on our concerns in relation to the manner in which there is muted competition between the banks—for instance, in relation to retail deposit products—and sought recommended regulation that will better inform customers so they can better exercise choice in the products that they acquire. It is difficult to separate what changes are occurring commercially because of the changes in the economy— 

Senator ROBERTS: Yes, it is difficult to know who’s the horse and who’s the cart. 

Ms Cass-Gottlieb: Exactly—what the boundaries are. But we do look at all these questions very carefully, both in terms of enforcement and in terms of monitoring, and we are hoping to continue financial services monitoring because we think they are essential services for Australian families. 

Senator ROBERTS: Are you aware of the Senate inquiry into the closure of rural bank branches? 

Ms Cass-Gottlieb: Yes, we are. 

Senator ROBERTS: It seems quite clear from the one that I’ve taken part in that it’s the banks driving the reduction in cash. It seems very clear to us, but, anyway, that’s a matter for you. Banks are refusing to provide banking services to their customers. It’s not just private cash handling companies; it’s bullion dealers and legitimate cryptocurrencies being de-banked. Last week, Bankwest limited how much their customers could spend on buying crypto. Is this another case of the banks misusing their market power to harm the operation of a competitor, and is it worthy of your scrutiny? 

Ms Cass-Gottlieb: The ACCC participated in a working group and taskforce, together with APRA, the Reserve Bank, AUSTRAC and Treasury, with a concern about de-banking. One of the recommendations from that was that there needs to be better data collection, to be able to better measure and monitor the pattern of and conduct in de-banking, and also that there needs to be more clarity in terms of the anti-money-laundering and counterterrorism financing requirements, which are bases upon which banks say that they need to make risk assessments and, at times, de-bank. So there was a desire to try to reduce that conduct. 

CHAIR: This is your last question. 

Senator ROBERTS: Something that few people seem to be aware of—I’m guessing you are aware of that—is that the major banks, the big four banks, would seem to be one bank with four logos. I say that because their services are similar, their strategies are similar and their modes of operating are similar. They’re largely owned, as I said, by super funds who don’t take an active interest and by mums and dads who don’t take an active interest. That leaves a controlling interest in the hands of four or five major, predatory global companies: BlackRock, Vanguard, State Street, First State and one other. They control, it seems, the big four banks. The banks have enormous power here. They have enormous legal power. They’ve got deep pockets to hire the best lawyers. They’ve got complex regulations that they can hide behind and with which they can really beat up on an individual. They’ve got enormous market power. I think they have 90 per cent of the cash deposits. They have enormous financial power, and, as I said, they hide behind regulations. 

CHAIR: This is a very long last question, Senator Roberts. 

Senator ROBERTS: Is there any thought of giving scrutiny or understanding to the companies that I mentioned—BlackRock, Vanguard, State Street, First State—and their influence over each of the big four banks that they control? 

Ms Cass-Gottlieb: We’ve certainly been contemplating the benefits of continued monitoring, particularly in relation to key services that the banks provide. Also, a part of the Suncorp-ANZ decision looked at concerns in terms of the capacity of the major banks with very similar business models to engage in a problem of what is called ‘concerted effects’. In effect, their responses to competitive signals are similar because of their similar structures. So we are conscious of those risks, and we do seek, both through monitoring and through powers that we have in relation to concerted practices, to watch carefully for these sorts of concerns. 

Senator ROBERTS: We do know that BlackRock, Vanguard and State Street control a lot of major companies around the world and control a lot of companies and a lot of industries. 

CHAIR: Thank you, Senator Roberts. 

Senator ROBERTS: Thank you. 

/5 Comments/by

Is ACMA Biased Towards the Left?

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During recent Senate Estimates I checked with the Australian Communications and Media Authority (ACMA) as to why it did not publicise complaints about the ABC, yet pushed out press releases for similar breaches by the Sky Network.

I also inquired into the Optus outage last year to see whether there is any new information around the failure of emergency 000 calls and whether Starlink (high speed satellite internet) was being considered as a backup in the future.

Transcript

Senator ROBERTS: Thank you for appearing again today. On 26 April 2023, you issued a press release about the Sky News program Outsiders for breaches of industry codes. On 20 March 2023, in relation to the ABC, in response to Senator Henderson, you agreed that the ABC breached the codes during their coverage of a community meeting in Alice Springs. You endorsed the ABC Ombudsman’s finding that there were breaches of the code yet published no press release about that, from what we can see. Why does a conservative news service cop a full press release when you conclude they’ve breached the code but when the ABC breaches a code there’s barely a peep from you publicly? 

Ms O’Loughlin: I might need to refer to my colleagues for the details of that circumstance. 

Senator ROBERTS: Sure. 

Ms O’Loughlin: I would have to say that we put out media releases for pretty much every breach that we look at under the Broadcasting Services Act, be it a national or a commercial broadcaster. I can take it on notice. There are certainly circumstances in the last year where we have put out media releases on the ABC. So it is not our practice to discriminate between types of broadcasters. We like to make transparent our decisions about breaches across the board. I might just see whether or not my colleagues have anything to add. 

Ms Chapman: In the instance of the ABC Alice Springs issue, we didn’t undertake a full formal investigation. We fully considered the matter. We looked at the content. We considered the report by the ombudsman at the time. We didn’t find a formal breach in that instance. That was on the basis that the ABC themselves had found a breach. The ABC themselves conceded that there were issues with the broadcast and that there was considerablemedia attention at the time which highlighted the findings that the ABC made. So we didn’t put out a press release because we didn’t make a formal finding. 

Senator ROBERTS: Thank you. 

Ms O’Loughlin: I will add to that. I just found something in my notes. For example, from the investigation we did on the ABC’s Four Corners program called The Big Lie, we did a media release for that on 21 December 2022 because we had found breach findings in that program. 

Senator ROBERTS: Thank you. I accept your answer from before. I refer to your letter, Ms O’Loughlin, to Senator Henderson on 20 March that is file reference BM11801. You mentioned in the second last paragraph the matter conducted by the ABC about the circumstances attaching to this matter, including any changes to its editorial processes. Did the ABC advise of any changes to its editorial processes? 

Ms O’Loughlin: I don’t have the letter in front of me. 

Senator ROBERTS: I’ll read it. 

Ms Chapman: We did seek a response from the ABC, but I think we need to take on notice whether we received a response. 

Senator ROBERTS: I will read the second last paragraph. However, the ACMA has requested that the ABC keep it informed about the outcome of any further internal investigation conducted by the ABC about the circumstances attaching to this matter (including any changes to its editorial processes) and any additional steps that may be taken by the ABC as a result. 

Ms O’Loughlin: Senator, we will take that on notice for you. I don’t have that in my pack. 

Senator ROBERTS: Thank you. What does it do to the trust of a media company when it has obvious bias? 

Ms O’Loughlin: Senator, I don’t think that’s something on which I can express an opinion. I do think in our experiences broadcasters take very seriously their obligations under the various regulatory codes that they are subjected to, which do come to, in most cases, provisions around bias, impartiality and factual accuracy. 

Senator ROBERTS: It would erode trust if it is done often? 

Ms O’Loughlin: That would probably be a matter for the broadcasters to comment on, Senator. 

Senator ROBERTS: Thank you. I will ask some questions here briefly. If they’ve been covered, just tell me so. I’ve checked with Senator Cadell. He hasn’t covered this one. Could you briefly explain the obligation for carriers to allow network switching for Triple Zero calls and why this didn’t happen during the Optus outage? The second part you’ve already discussed at length, so I’m not interested in that. Could you please explain the obligation? 

Ms O’Loughlin: Certainly, Senator. The obligation is usually referred to as the mobile camp-on provisions. That is a globally standardised arrangement. Where emergency call services can’t be delivered by a particular carrier for a particular reason, those networks allow those calls to camp on to their network for them to be delivered to the emergency call service. That’s what— 

Senator ROBERTS: Free automatic switching? 

Ms O’Loughlin: So it’s an automatic transfer of those particular calls going to emergency call services to camp on to another network. If I have that incorrect, my colleague will let me know. 

Senator ROBERTS: She’s got it. Thank you. Are there any fines applicable for carriers failing to allow switching or failing to make switching work for Triple Zero calls? Would Optus be facing that? 

Ms O’Loughlin: I think part of what we’ll be looking at in our investigation is what was the reason, if in fact that was the reason, some emergency calls didn’t get through. As I mentioned earlier, it’s still not very clear. We’re still in information gathering mode about why that didn’t work. I will ask Mr Fenton to go over some of the potential regulatory responses we may have, if we do, in fact, find any breaches. But it is early days. 

Senator ROBERTS: Thank you. 

Mr Fenton: I will clarify again that these are enforcement options available to the ACMA if it does find breaches of the determination in question—the emergency call determination. The ACMA can issue a formal warning. It can issue a remedial direction to take action to comply. It can accept a court enforceable undertaking. There are infringement penalties available currently set at $18,780 per contravention. It is open to the ACMA to apply to the Federal Court for penalties as well. 

Senator ROBERTS: This is an interesting quirk. Does per contravention mean each phone call?  

Mr Fenton: It would depend on the construct of the particular obligation in question. But it can apply to a specific contravention. Once again, it comes back to the actual structure. 

Senator ROBERTS: Yes. I understand. Thank you. Finally, it strikes me that there is the Starlink service, which covers almost everywhere in Australia. It can access the sky, and that’s pretty much everywhere. Would it be a good back-up for text messages and limited voice conversations and emergency calls to fit into that network? 

Ms O’Loughlin: That’s a really interesting question. I think there’s a lot of interest in Starlink and, indeed, other satellite services, such as low earth orbit satellite services, that may be able to provide direct to handset text or, indeed, calls which are now starting to emerge. There is the potential for that to really benefit particularly people in regional or remote areas or areas of Australia that have trouble getting signals. I think the department is commencing to look at that in more depth to see what that potential is. There has been quite a lot of strong interest internationally as well, as you can imagine, from particularly countries who have the same sort of issues we have in trying to get signals into various areas. The United States recently, from my reading, had come to the conclusion that technology was just not quite mature enough at the moment to be a backstop for emergency calls but could be in the future. I think the department is going to be looking at whether that is a potential in the future. We think that’s a really exciting development in the satellite space. 

Senator ROBERTS: Thank you. I must say that I appreciate the direct answers. 

/2 Comments/by

Labor Dashes Hopes for Murray Darling Basin Community

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The Albanese Labor Government are shifting the goalposts on the Murray Darling Basin Plan. There’s only 42GL left to complete the water acquisitions across the whole basin, so the pain is almost over and there’s still the 450GL of water for South Australia, which means this doesn’t need to be taken from irrigators. And there’s another 3 years to find that water through capital works.

In this Estimates session I asked whether these last few measures would be the end of the nightmare for Basin communities. I was expecting a yes – instead I got a no.

It seems the bureaucracy and the Albanese Government are hell bent on taking everything for themselves, forcing even more farmers off their land. Their answer certainly sounds like they intend to demand more water for the environment when the plan ends in a few years, starting the nightmare over again.

Landholders, including farmers, just want to know what the government is planning so they can adjust. Clearly the Government does not understand farming to know this, or simply don’t care.

The science underpinning the scheme is flawed, which is unsustainable, hurts farmers, fibre producers and the environment.

One Nation would complete the remainder of this plan and then call it done. No more water to be taken off the farmers. We would also sell the 78GL of water over-purchased by the department back to the farmers, to grow food and fibre to feed and to clothe the world.

Anything else is sabotaging the bush. #nofarmersnofood

Transcript

Senator ROBERTS:  With all the numbers flying around, I feel confused sometimes; things don’t seem to change. I would like some clarification. Talk of water buybacks created a lot of anger when the Albanese government came to power. That talk seems to have gone quiet. There was a plan to buy back 44.3 gigalitres immediately, a threat to use buybacks to get another figure to complete the plan—I will raise that in a minute. How much has been purchased so far? Your website is still saying that you need another 38 gigalitres, yet we heard the tender was oversubscribed.  

Ms O’Connell:  In terms of the open tender, we were seeking 44.3 gigalitres for the Bridging the Gap component. I want to be specific here; that was for Bridging the Gap. It was oversubscribed. We had 250 tender responses, which accounted to 90.34 gigalitres in terms of across the catchments.  

Senator ROBERTS:  So double?  

Ms O’Connell:  Yes, just over double. These Bridging the Gap requirements are catchment specific. There is a certain amount of water to be recovered in a certain catchment. It was oversubscribed in total, but specifically we are purchasing to an amount in a particular catchment. It also has to represent the right type of water, and value for money, before we proceed. From that 44.3 gigalitre tender we have agreed to purchase 26.25 gigalitres towards that target. We will, as a result of that, complete the requirements in three of those specific catchments.  

Senator ROBERTS:  So you still have the fourth catchment to do?  

Ms O’Connell:  There are six catchments in total.  

Senator ROBERTS:  You still have three of the six to do.  

Ms O’Connell:  That’s right; to complete the recovery.  

Mr Southwell:  That is correct. There are three catchments that we expect to recover through this tender, subject to all contracts being finalised, and three to go. I might take this opportunity to give an overview of where we are in the process. The tender sought to recover 44.3 gigalitres. When all of those contracts are signed, we expect to have spent around $205 million. Contracts are still being signed. That is important to note in terms of where we are up to. A table on our website provides an outline of each catchment, the volumes we expect to have recovered and the volumes that remain.  

Senator Davey:  That table was only uploaded today.  

Mr Southwell:  It was uploaded yesterday, I think, Senator.  

Senator Davey:  Late yesterday.  

Mr Southwell:  I understood it was later than 9 am yesterday morning.  

Senator ROBERTS:  You will still buy the 90 gigalitres that came in as tenders?  

Mr Southwell:  No.  

Senator ROBERTS:  Just the 26.25?  

Mr Southwell:  That tender process was specifically for Bridging the Gap, and the volumes that we are purchasing are for Bridging the Gap.  

Senator ROBERTS:  That is 26.25?  

Mr Southwell:  Correct.  

Senator ROBERTS:  I note that the Restoring our Rivers Framework, currently under consultation, is for the full 450 gigalitres South Australian flow; your website says 424. Can I have this confirmed: this is the same bucket of water, whether it is 424 or 450—not two buckets?  

Ms O’Connell:  No, there are not two buckets. The requirement is 450 gigalitres, of which 26 gigalitres is contracted, delivered or underway. The remaining component is 424. So it is one lot of 450, with 26 already recovered.  

Senator ROBERTS:  Senator Hanson-Young, in an interview with the ABC last November, said there was a further 300 gigalitres of water to be found to complete the plan, not 38 gigalitres. This was not including the 450 gigalitres. Is that statement correct? If so, can you explain how that figure is arrived at?  

Ms O’Connell:  We would have to see what exactly she was referring to and get that quoted number.  

Chair:  Could you table it? Do you have it with you?  

Senator ROBERTS:  I don’t have it with me, no.  

Mr Fredericks:  We will take that on notice.  

Ms O’Connell:  For us to be able to answer that, would you be able to provide the document as well, so we can make sure we are referring to the right thing?  

Senator ROBERTS:  Yes. By our calculations, if you get the remaining 38 gigalitres on buybacks, you will also have 78 gigalitres of excess purchases in some bailees. Will you sell this back to the farmers?  

Ms O’Connell:  On Bridging the Gap, which is what we have been talking about, it is a catchment-specific amount that we need to recover. We don’t intend to buy more than what is needed. There is a minor amount of incidental overrecovery that happens when you buy water, but that is minor and incidental. Our intention is to bridge the gap through the 44.3 gigalitres.  

Ms Connell:  In relation to the 78 gigalitres of overrecovery you referred to, there are two issues to highlight. The number of overrecoveries won’t be confirmed until New South Wales water resource plans are accredited. A significant proportion of that figure relates to overrecoveries in New South Wales. The other thing to keep in mind is that water is currently held by the Commonwealth Environmental Water Holder and used at the moment.  

Senator ROBERTS:  Minister, once you get that figure, the 38, and the 450, minus what is underway now, is it done? Is there anything else? Can what remains of farming in the Murray Darling Basin get on with growing food and fibre to feed and clothe the world, without this nightmare of the plan hanging over farmers? Is that the end of it?  

Senator McAllister:  I think the best way to describe the government’s intentions is to implement the plan in full. That was the purpose of the legislation that went through the parliament. As you have observed, there is substantial work to do. That work includes the recovery associated with Bridging the Gap, which the officials have been talking about. It also includes establishment of the framework for reaching the 450-gigalitre target. The government is presently consulting on that framework. That document is in the public domain and we are seeking public comment about that approach. There are other elements of the work associated with completing the plan; the officials can talk you through that. Rather than accepting your summary of the work before us, I would prefer to point to the way the government characterises the work that is underway.  

Senator ROBERTS:  What amounts are required to finish the plan? That is what I heard you say: when the plan is finished, that is it—no more buybacks.  

Ms Connell:  In the first instance, the plan doesn’t finish. It is an ongoing instrument, subject to a review by the Murray Darling Basin Authority in 2026. That will be the first review of the Basin Plan. Under the current Basin Plan, there are two key targets.  

Senator ROBERTS:  That means that the plan could change.  

Chair:  Senator ROBERTS, the river is a living thing. The reason why we ended up with the Murray Darling Basin Plan in the first place was over-extraction and the utilisation of the river.  

Senator Davey:  Happy to replace the chair to answer questions from the committee. Thank you, Chair.  

Chair:  Thank you, Senator Davey. Minister, maybe you could help us out here. It is a point of clarification that is worth making.  

Senator McAllister:  I am happy for officials to talk through the approach. The main point is that the government’s commitment is to implement the Basin Plan in full. Under the previous government, insufficient progress was made on some important initiatives. Progress basically stalled for an entire decade. We talked about this a lot during the committee stage of the Senate debate. You are aware of the government’s perspective on this. It is for that reason that we had to change the legislation. We are presently consulting on the key initiatives that are underway. The officials can talk you through all of the important next steps.  

Ms O’Connell:  In terms of the Basin Plan, it is about sustainable river systems long-term management. There are two major components in the plan to be fulfilled that need to be delivered. We have been talking about Bridging the Gap. The remainder is the 450 gigalitres. There are new legislative time frames for delivering those that provide more time, more options, greater flexibility and greater accountability to be able to deliver on those targets. Beyond that, there is a review role for the Murray-Darling Basin Authority in terms of the long-term sustainability and sustainable management of our river systems. That review is not until 2026, which would foreshadow what might be required in the longer-term future.  

Senator ROBERTS:  Let me understand that, Ms O’Connell. The plan as it is—as we have just been told, it’s a living document and a living plan and it could change—the 450 and the 38, that’s it; but it could change in 2026 when the review is done. Because it is a living plan, the plan could grow another arm and leg.  

Ms O’Connell:  Yes.  

Mr Fredericks:  I don’t think we can pre-empt that review.  

Senator ROBERTS:  People’s livelihoods are at stake, Mr Fredericks.  

Mr Fredericks:  I understand that fully. There is a review. It is in 2026. It will be very well conducted by the MDBA. I don’t think that, sitting here in 2024, we, as departmental officials, can really pre-empt that review.  

Senator ROBERTS:  I am thinking of farmers in southern Queensland, New South Wales, Victoria and South Australia who are wondering whether or not to invest in their future and the future of their communities. Businesses in many rural communities have gone downhill, in large part due to the Water Act and the plan. These people want to know that they’ve got something more than two years. They just want to know: is this the end?  

Senator McAllister:  Can I make this point, Senator Roberts? The origin of the plan lay in a recognition across the country that we had overallocated the Murray-Darling Basin system. That had very significant consequences for basin communities. It had very significant consequences for the food and fibre producers in the Murray-Darling Basin, who depend on reliable access to water. It had consequences, of course, for the natural systems in the Murray-Darling Basin, which were under enormous pressure. It’s a while back now, but it really came to a head in the millennium drought. We saw some very severe impacts across the basin at that time. There was a recognition across the country, including within the basin, that we couldn’t go on in this way and that the overallocation needed to be addressed. That is the origin of the plan.  

It matters to farmers and food and fibre producers that these issues are tackled and addressed because there is an interrelationship between the access to water by communities, the access to water by farmers, the availability of water for environmental purposes and, increasingly, the recognition that cultural water matters to First Nations people as well.  

All of these things are interrelated and, at their heart, the success of all of those stakeholders, and the interests of all of those stakeholders, lies in having a healthy, working river that is being appropriately managed. Those are the underlying ideas that drive our government’s commitment to implementing the Basin Plan.  

Senator ROBERTS:  Minister, while we do argue about the science underpinning the Basin Plan, let’s set that aside. Modern civilisation cannot exist without a healthy environment. We get that. A healthy environment cannot be achieved without modern civilisation because it reduces the pressure on the environment. Landholders are the number one protectors of the environment—that means farmers. At the moment, farmers and small businesses in rural communities see a shifting of the goalposts repeatedly. That’s what’s bothering them. They get the point about the need to protect the environment. They’re tired of having the goalposts shifted on them. That’s why my question was: is this the end of it? So far, what we’ve got is: ‘No, it’s not. In 2026 we’ll have a review and see what happens.’ 

Senator McAllister:  The plan has been in place for a very long time, Senator Roberts.  

Senator ROBERTS:  Since 2007.  

Senator McAllister:  Our party has been very consistent in supporting the implementation of that plan. Our view is that the plan should be implemented. For much of that period, that was the stated position of the coalition parties as well. Unfortunately, in the final years of the last government—in fact, really across the period of the last government—the Liberal and National parties undermined and sabotaged the plan’s implementation.  

Senator Davey interjecting— 

Senator McAllister:  That has caused a very significant problem.  

Chair:  That is the minister’s view. She is entitled to answer the question as she sees fit.  

Senator Davey:  I dispute that. The terminology ‘sabotaged’ is absolutely— 

Senator McAllister:  Senator, I think you said— 

Chair:  The minister will finish her— 

Senator Davey:  We might have had a different perspective on how to implement the plan.  

Chair:  Senator Davey, the minister will finish her answer and then you will have a turn.  

Senator McAllister:  I think the core facts are before us. In nine years, that government delivered just two of the 450 gigalitres—two gigalitres, under the 450-gigalitre target— 

Senator Davey:  We were focused on the environment and a sustainable level— 

Chair:  Senator Davey! 

Senator McAllister:  which would have meant that the plan would have been completed at some time around the year 4000. Steps needed to be taken to get the plan on track. We are taking those steps. I think the government’s priorities in terms of implementation are very clear. As I’ve indicated a couple of times now, we’re engaged in consultation with the community about the practical ways that we’re going to take the next steps together. 

/1 Comment/by

TGA and Pharmaceutical Interests Are Too Close

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I questioned the Minister and the Senior Health Department Bureaucrats about the behaviour of former TGA head, Professor Skerritt, who spent 11 years in charge of the TGA before resigning last year and soon after accepted a position on the board of Medicines Australia. This is the peak body representing and lobbying for pharmaceutical companies. The deputy chair for instance is the Head of Pfizer in Australia.

The answers I received in this session highlight that former senior bureaucrats like Professor Skerritt only have one rule to follow—they can’t lobby the Government for 12 months. That’s the only rule applying to former senior health officials. That’s not good enough.

Professor Skerritt and the TGA spent the COVID years dismantling and re-assembling Australia’s drug assessment process to provide drug companies with streamlined approvals, free from the need to provide testing of brand new drugs. Approval has gone from active inquiry to a desktop review of provided literature, before rubber-stamping. This appointment does not pass the pub test.

A Royal Commission must look into the TGA’s behaviour during COVID and the changes made to our drug approval process, without public debate.

Transcript

Senator ROBERTS: Thank you for being here again today. Professor Skerritt’s career includes a period as deputy head of the Department of Health and Aged Care and as head of the Therapeutic Goods Administration. Eight months after leaving the TGA, Professor Skerritt has been appointed to the board of a lobby group, Medicines Australia—in fact, the leading pharmaceutical industry lobby group. The deputy chair of that organisation is the Managing Director of Pfizer. There are other members on the board who are heads of other companies. As head of the TGA, Professor Skerritt introduced the mRNA into Australia and provided authorisation—without testing, as he admitted to me—creating a whole new industry that he is now working in. Does this sound like an appropriate arrangement to you? It sounds like a massive conflict of interest to me. It’s just brazen, like the rules don’t apply to him—or are there no rules?

Mr Comley: I don’t know whether Professor Lawler or Ms Balmanno want to comment. There are rules in terms of former public servants and what they can do, but those rules are largely limited to lobbying activities related to their previous departments. There’s not a broader prohibition on their activity in related areas that they’ve worked in the Public Service.

Senator ROBERTS: He has joined the most significant, powerful lobby group for the pharmaceutical sector, which he was previously regulating.

Mr Comley: As long as he’s not undertaking lobbying activity to us—I think it’s in a 12-month period—that is appropriate.

Ms Balmanno: His obligations in relation to confidentiality of any information gained while in the Public Service continue to apply.

Senator ROBERTS: Let’s unpack that a bit further. This is what Medicines Australia’s latest annual report said about Professor Skerritt: After 11 years leadership of the TGA, Prof John Skerrit retired in April Professor Skerritt has been a cornerstone of our health system for many years. … Medicines Australia and member companies worked closely with his Department during the Medicines and Medical Devices Review, and the rapid registration of COVID-19 vaccines and treatments. On behalf of our industry, members and Board, we thank him for his service and dedication to Australia. Medicines Australia hired him as a thankyou for tearing up years of prudent drug approval and testing while authorising a whole new mRNA drug industry with no testing. How could you read this any other way?

Mr Comley: I’ll allow Professor Lawler to comment first and then I may come back. I do note the point Ms Balmanno made that the obligations for confidentiality and use of information are still retained even when someone has left the service.

Prof. Lawler: Thanks for the question. I recognise that there are a number of underlying elements to your comments around testing and evaluation that I don’t think are necessarily the main thrust of your question. I would highlight that our interaction with Medicines Australia is predominantly through our very well publicised stakeholder engagement processes. We don’t interact directly with the board. We don’t receive lobbying approaches from board members of organisations. We haven’t received any lobbying approaches from Professor Skerritt. The decision—

Senator ROBERTS: With respect, I’m not talking about the board interacting. I’m talking about a former senior member of TGA—the senior member; the head of the TGA—now being on the Medicines Australia board.

Prof. Lawler: Working on the board. As Ms Balmanno and the secretary have highlighted, there are code of conduct provisions that relate to the lobbying activities of former senior employees. We’re not lobbied by Professor Skerritt. We interact with Medicines Australia as we do—

Senator ROBERTS: I’m not talking about that. I’m talking about—

CHAIR: Senator Roberts, you do need to allow Professor Lawler to finish his sentences. Professor Lawler, please continue.

Senator ROBERTS: Sorry.

Prof. Lawler: I may be incorrect in this, but I’m taking that there is undue influence being applied to the decisions of the TGA by a former senior leader of that organisation?

Senator ROBERTS: No, that’s not what I’m—

Prof. Lawler: Sorry. I would ask for clarification then.

Senator ROBERTS: My question is: is his appointment a reward for work he has done in the past?

Prof. Lawler: Thank you for the question. The decisions that are taken by Medicines Australia on who does or does not sit on their board are questions for them.

Senator ROBERTS: It certainly doesn’t look good. It looks like he’s being rewarded for things he’s done for them in the past when he was head of the TGA. The Chief Executive Officer of Medicines Australia is Ms Elizabeth de Somer. Is this the same person who was a member of your Health Technology Assessment Policy and Methods Review reference committee, which is a paid position responsible for: … ensuring that our assessment processes keep pace with rapid advances in health technology and barriers to access are minimised. That’s from your website. Barriers to the entry of her products. Are we paying the pharmaceutical industry to promote pharmaceutical industry agendas to neuter our approval process? This is not looking good.

Mr Comley: I will ask Ms Shakespeare to comment.

CHAIR: Senator Roberts, I do ask that you direct things to the officials as questions. It’s reasonable to ask questions of them.

Senator ROBERTS: I did. I said, ‘Barriers to entry of her products’—

CHAIR: My hearing of it was that it was a statement, given how you finished.

Senator ROBERTS: My last words were a statement, but my question was: are we paying the pharmaceutical industry to promote pharmaceutical industry agendas to neuter our approval process?

CHAIR: Followed by a statement. Please continue; I just remind you to please direct things as questions.

Mr Comley: I will throw to Ms Shakespeare, but I’ll make a general comment that, where we, or other departments within government, are supporting reviews of policy matters that affect a range of stakeholders, it’s not uncommon for those stakeholders to be part of that review process. It’s also not uncommon for those stakeholders to be very clear when people declare what conflicts of interest they have and that people be aware of that. But there is a real balance here in having appropriate expertise in the room, including of what will happen on the ground, with making that policy process. Most of those reviews—almost all that I can think of—are never the final decision-maker. They make an input to government decision-making which is informed by their experience on the ground. Ms Shakespeare may have some further information.

Ms Shakespeare: Ms de Somer, who’s the Chief Executive Officer of Medicines Australia, is a member of the health technology assessment review panel. The membership of the review panel was established under an agreement between the government and Medicines Australia, called a strategic agreement. She’s not paid for the work on that; it’s not a paid position. It’s a review led by an independent chair and it has other experts on it, including the Chair of the Pharmaceutical Benefits Advisory Committee. It has two consumer representatives, a government representative and also experts in health technology assessment.

Senator ROBERTS: So the government has a—I’m sorry, continue.

Ms Shakespeare: As Mr Comley said, the review is currently underway. It’s going to prepare recommendations to the government, but the government will decide whether or not it implements those recommendations.

Senator ROBERTS: So the government has an agreement with Medicines Australia?

Ms Shakespeare: We have a strategic agreement with Medicines Australia. We’ve got strategic agreements with a range of different groups.

Senator ROBERTS: Where is the talk about ensuring safety across long-term use, which used to keep Australia safe for generations? Now it’s all about, it seems, not costing pharmaceutical companies money and approving killer drugs, like remdesivir and molnupiravir, that would never have been approved on a cost-benefit safety analysis before Professor Skerritt rewrote the rulebook. Are you aware of this?

Prof. Lawler: Sorry, I’m struggling. There were two questions there, and I’m not quite clear on what it is that you’re asking. Are we aware of—

Senator ROBERTS: Are you aware of Professor Skerritt’s involvement in approving antivirals molnupiravir and remdesivir, which are killer drugs, it seems—they’ve got very bad records overseas. What I’m saying is: rather than putting safety paramount, are the TGA and the department of health removing barriers to pharmaceutical company approvals?

Prof. Lawler: I see. Thank you for the question, Senator. No.

Senator ROBERTS: The patent cliff is a real problem—I’ll explain what that is in a minute—facing the pharmaceutical industry. Billions of dollars of sales are at risk as patents expire around the same time, producing a loss of revenue totalling $200 billion this decade for the pharmaceutical companies. MRNA technology, which has not been tested, will be the saviour of the drug industry, allowing drugs that are now off patent to be replaced with new mRNA drugs. I understand that in America they’re favouring two companies, one of which is Pfizer. That means the new drugs will be subject to patent, meaning profits all around—wonderful!—except for taxpayers.

Minister, has your government—and the previous government—made a deliberate decision to allow patents on these novel mRNA products to save the profitability of the pharmaceutical industry over considerations of safety and financial cost to taxpayers?

Senator McCarthy: I might start with acknowledging that Professor Skerritt did a commendable job in his previous role, and we certainly wish him all the best in what he’s doing going forward I think your questions place a slur on people’s character, and you might want to have a good look at that. People who move on, whether it’s in political life or in other forms of organisations, deserve the opportunity to move on.

Senator ROBERTS: And I want to protect the taxpayer by making sure there are no conflicts of interest. You didn’t answer my question, Minister.

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

Senator ROBERTS: I will repeat it. Has your government—

CHAIR: Senator Roberts, you don’t need to repeat it. The minister’s taken it on notice.

/2 Comments/by

Pharma Exclusivity in TGA Processes a Barrier to Natural Products

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

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

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

Transcript

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

Senator McCarthy: I will refer to the department. 

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

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

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

CHAIR: We will return to this after the break. 

/4 Comments/by

Anti-depressants Highlight Failure of our Health Policy

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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.

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FSANZ Handling of Lab Grown Meat is a Concern

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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.

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The TGA are Administrators not Regulators

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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.

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Slow Start on Classification System Inquiry

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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. 

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TGA is Rubber Stamping Approvals

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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. 

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