Senate Community Affairs Legislation Committee, , 8:06:50 to 9:15:45
Senators inquire about women's health safety regarding Asherman syndrome and TGA regulatory actions concerning sunscreen recalls and vaccine safety.
Topics: Health, Manufacturing, Procurement
Speakers: Hon Anne Ruston, Prof Anthony Lawler, David Pocock, Malcolm Roberts, Dr Marcelle Noja, Blair Comley PSM, Dorinda Cox, Dr Liz Develin, Honexia Jin, John Jamieson, Mark Roddam, Natalie Bekis, Nick Henderson, Nita Green, Penny Shakespeare, Prof Robyn Langham, Speaker 62, Speaker 64, Steph Hodgins-May
I've got some questions about Asherman syndrome and what the government is doing to minimize harms caused by uterine cures.
any clues as to where this would be. >> Okay. Someone's appeared.
>> Uh the TGA set up the women's health products working group in 2022 after the pelvic mesh inquiry. The group was supposed to improve communication between women's health stakeholders including RANSCOG. Um, what role did Ransco play on the working group and how many meetings did Ransco members attend in 2025?
>> Thank you, Senator. Um, Professor Robyn Langham, chief medical adviser of the therapeutic goods administration. I would have to take that uh question on notice and check on our specific attendance list of the Women's Health Product Working Group. Uh, but you're absolutely right. The working group has been established to improve stakeholder engagement, to improve discussion of important issues to uh a number of uh not only community groups but also uh um research and clinical groups that are involved in the uh delivery and evaluation of women's health products. Uh and we've we've done so uh uh in meetings that are conducted three times a year. As to specific attendance, I would need to take that one on notice.
So do are you suggesting there were perhaps three meetings though in 2025? Is it
>> there were three meetings of the women's health product working group? Yes.
>> Okay. And you yeah take on notice who is involved. Um what is the process for raising issues for discussion? Um are all members encouraged to put issues on the agenda or does the secretariat manage the agendas of that group?
>> Uh thank you Senator. We have a process whereby we invite me our members to uh to fill agenda items for discussion and where we think there are uh specific items as to changes in regulation then the TGA will uh bring an agenda to that item to the table as well. And where we do have an issue being raised by one of our stakeholders, then we will endeavor to have a a uh u one of the uh TGA um representatives that's working in that area to present alongside to perhaps explain some of the regulatory touch
>> And are you able to tell me now how many consumer representatives are formal members of this working group
>> currently or? Uh we we have a number of representatives. One of which comes from the Consumers Health Forum. We also have uh and I'm I'm I'm going to mess up the name of the group I'm sure. But um the National Women's Health something rather. >> I'll I'll I'll get back to you on that one as well. So we we do have a number of uh large um consumer-based groups with broad interests across the women's health products. We also have uh the breast cancer research network of Australia BC BCNA. >> Yeah. >> Uh and there might be another one. We have uh research organizations. We have uh peak clinical bodies such as ranscog uh the college of surgeons. Um yeah
>> yeah maybe just take on notice to get those those ones correct and um did Ransco or any other member ask the working group to consider the harm caused by uterine curettes?
>> So the issue of Ashmans was brought to us by uh an independent group um at the request of one of our consumer
>> Okay. Um the ABC did detailed reporting on Ashman syndrome caused by um uterine curettes in October 2023. Um given media interest in the pelvic mesh inquiry just a year earlier, do you have any sense of why it took an additional 12 months to be brought up for discussion by the working group?
>> Senator, I'm going to have to take that on notice when it was first discussed. Um again we rely heavily on our on our um stakeholders to bring uh items of concerns uh to us with that. Perhaps if I could ask um um um uh my colleague here who um heads up our um postmarket devices section to comment on the processes that were used.
>> Yeah, thank you. And I think it yeah it is um on the public record that it was first discussed in October 2024.
>> Thank you Senator Dr. Marcelle Noja medical device and product quality division. That is correct. The first time the working group did discuss this matter was on the 30th of October 2024 meeting. It was subsequently discussed again in March of 2025 and again in October of 2025. Um further to uh Professor Langham's in information, there is a full list of the uh attendees and um there's often communicators and information put out on our website. So, I'd strongly recommend um we can provide that information to you. Uh when it does come to reviewing these matters in the postmarket space for medical devices, we do regularly review any adverse events and information brought to us both by consumers as well as through other clinical information that may arise and be provided to the TGA. Uh in respect to sharp curettes uh we have undertaken a lot of work in this space including talking to Ransco who have published a position statement in respect to the use of these products and uh what is best practice when it comes to treating women uh for interuterine issues.
>> Thank you. So sorry can you just confirm those dates? Was it um October 2023 or 2024 that it first made it on
>> 30th of October 2024. So it did still
take a year from that first.
>> So it was spoken on three separate occasions at each of those occasions,
>> but a year on from when the the first reporting public reporting happened in October 2023.
>> So for it to Yeah, I I can't we'd need to check the dates on when the first public reporting occurred. Uh with uh medical devices, there are a number of reports that occur, but uh the reports don't necessarily represent a signal that requires full investigation. We do look at the information holistically and make an assessment on whether additional action is needed. Unfortunately, with this condition, there are a number of um factors that come into play when it comes to the condition. So, various aspects of instrumentation can cause the condition to occur. And because of that wide variety, when we do look at our reports, what we find is they're not just related to sharp cures, they're related to a variety of um health conditions that might have been treated as well as a variety of instruments that women may have had used on them.
>> Thank you. Would you would I ask that you table attendance of each of those meetings that you've just referenced and what was discussed in those meetings? Thank you. Um women have told us that they've been advised not to expect TGA action to regulate the use of uterine curettes because it is a clinical issue and the responsibility of um ranscog. Is
>> If I could clarify the TGA does regulate curettes. Uh the TGA does uh have a responsibility in terms of demonstrating quality, safety and efficacy as part of a registration on the Australian register of therapeut therapeutic goods. uh what and perhaps again Marcel if you're happier to to talk about um the
>> I might complement that senator when it comes to sharp curites they have a wide variety of clinical use so uh when it comes to the use from interuterine perspective ranskog and their position is very clear that that is not the preferred treatment and so there is a real role here for the clinical application of these products and what is and isn't an appropriate use We are doing some work to update our website, but generally we wouldn't ban a product such as a sharp curette because it can be used in all different settings. They're often used for dermalological reasons. For example, the cutting off skin cancers. There's a whole variety. Um sometimes we do find with devices that the use is not necessarily um in line with the approval of the product and that off label use is really a clinical matter which whilst we send out advice and and we try and work with clinical groups wherever we can there is still a level of decision making that is made by the healthcare provider in how they use a product
>> and I think Senator if I may professor Anthony Lawler um health products regulation group deputy secretary. Um this indicates the importance of the collaboration that we undertake with other regulators including uh including the um Australian health practitioners regulatory a regulation agency but also um standards bodies such as the commission of safety court and healthcare and also the medical colleges who in large part provide clinical guidance for their members on um on the most appropriate standard of clinical
>> Thank you. Thank you. And um perhaps to the minister um acknowledging this context that we've just heard um the vaginal [clears throat] mesh inquiry found evidence of the medical profession failing to manage and avoid risks or disclose those risks to patients. Um if ransog fails to act, do you think there is a role for government to step in early to fully inquire into the scale of harm caused by uterine curettes and I suppose consider policy responses to these guidelines?
>> Um thanks for the question. Um and thanks for raising the issue because I
need to listen to Australian women and As you know, the Labor government is doing that more broadly. Um but I will um have to take your question on notice if there's a particular position or an approach from the government. I think
the officials have stepped you through exactly how they're approaching the issue at the moment. um and we'll keep a
>> Okay. Thanks. So, um yeah, if you could take that on notice, that'd be good. But I suppose but to to what the officials were saying just now, the World Health Organization has actually had guidelines in place since 2012 advising against the you use of sharp curettes wherever possible in favor of suction curettes um because of the significant risk of harm posed by sharp curettes. To clarify, does Australia have similar guidelines um to that?
>> Thank you for the question, Senator. So the ranscock guidance does also recommend the use of suction curette
>> So
>> so the TGA doesn't issue the clinical guidance that that happens outside of us and Ransco as the primary group responsible for those services has issued those um for those clinicians rather has issued that guidance.
>> Okay. Okay. But despite the clear risks prevented by uh presented by sharp curettes, the TGA lists most sharp curettes as a class one low risk. Is
>> Again, I think if I may, Senator, it goes very much to the fact that the the sharp cures are used um for a broader set of indications as well. Uh and so that is kind of largely how it goes to the the the process of um of um classification. We do um as Dr. that was highlighted um have a a fairly robust postmarket um um surveillance um process in place. So if there's problems with the curette, if there's um if there is any um propensity to to be infected or or to be unable to be sterilized um if they if they deform or bend and snap when they're being used, we we are able to pick up these safety signals and respond to them with appropriate market
>> Thanks. So, I'm just trying to understand. One woman was told by the um TGA that sharp cures cannot be higher a higher class than class one because they are not long-term implants. Um by that logic, you know, any sort of tool could be used in surgery. Uh used in surgery could also be classified as uh class one because it's not implanted. uh we might bring someone else to the
>> Yes. So, so while while Mr. Jamieson is is is is approaching the table, just to clarify that um we have um separate areas within the TJ that go to market authorization uh and postmarket surveillance. We're in constant conversation because obviously we need to balance the risk of devices across the life cycle. But in terms of the classification medical devices, I ask I'll ask Mr. Jamieson to comment.
>> Uh thank you uh John Json uh medical devices and product quality division. Um, Senator, uh, to your question around the classification of medical devices, we have a principles-based set of classification rules in the legislation. [clears throat] So, it's established in law. Um, you are quite right. The principles for the classification uh rely on things like the uh level of invasiveness of the device, the duration of use of the device. So under that basis, that's the that's the um that's what's behind that
>> So by that logic, a chainsaw used in surgery could be considered could be classified um as class one because it's not implanted. Seems a bit.
>> Yeah, I think um thank you Senator. I think the other part of uh the classification of a of a device is not a measure of um its level of significance in the in the health system. Um it is um the level of scrutiny applied before the product is approved. Um it's not a measure of the level of significance or scrutiny applied after the product is um approved for sale.
>> Senator, if I may jump in, um in the postmarket space, uh when we receive signals, sometimes when we assess the information around the device, we do look at the classification and assess if it's still fit for purpose. Um as we know with eurog gynecological mesh part of what we did there was actually upclassify those products because we found that the classification for those products wasn't appropriate relative to the risk of using those products. So classifications can change if we feel that the evidence is showing that that is necessary to do so. When it comes to these uh sharp curettes, we've not seen as yet that there is evidence to suggest that because of the significant impact of clinical practice on women who have Asherman syndrome.
>> Okay. And um do you expect that this will be kept on the agenda of the advisory group?
I can't comment on the advisory group, but in respect to what the TGA is doing more broadly, we do continue to monitor and check for signals in respect to Ashman's. Uh we do have a very robust postmarket system. We receive over 20,000 signals that we regularly assess and we ensure that we are directing our resourcing to where the highest risk is for the Australian public.
And in answer to your question about the advisory group, we do absolutely undertake to report any changes back to members uh as they happen. Uh and uh occasionally we'll get uh specific uh external um uh groups in to to uh to speak to us again about any of their changes that they may have had so that the uh the whole of the working group can keep up to date with any changes.
>> Okay. Thank you. And um back to the minister. Um, speaking of listening to women, um, as you've said that you're doing, um, women affected by Asherman syndrome have been calling for years for public and clinical guidelines on when uterine cures may be used, um, risks and alternative treatment options. Uh, Ransog finally released updated miscarriage guidelines in May 2025 that included this advice. Um however they have not provided any public guidelines or guidelines for clinicians as far as we are aware on the use of uterine curettes in the post-apartum period. Um experts say that women 2 to four weeks postpartum are 25 to 30% more likely to develop ashman syndrome hemorrhage or suffer uterine perforation as a result of cure misuse. Um would you say that that is enough evidence I suppose to prompt the government to step in and require um or develop clinical and public guidelines?
>> Um well thank you for raising it. We we certainly do listen to women and we we also listen to the experts around the issue of clinical guidance. Um I'm certainly not a clinical expert at all and so I um uh can't give you advice about what the next steps would be. Um but as the officials have stepped you through the process that is being undertaken and the continual monitoring of any devices that might be considered
Okay. Um so just see if I've got anything else. Yeah, look I have no further questions. Thank you for your
>> Thank you Senator Hodgins May. Uh Senator Ruston,
>> thank you very much. Just quickly before we move on from the share on to other topics. Can I um just when we finished the last uh I got the call taken from you last time um Mr. Comley, you'd made the comment that um I'd sort of taken the prime minister's letter to the states in relation to the requirement about reducing hospital growth as a requirement for additional funding out of context. Um, I sort of just wondering whether it's possible for the prime minister's letter to be tabled so we can get the context in which it was. Um,
>> I'll take that on notice, Senator. Obviously, it's not for me to table the prime minister's letter. I don't think it's ever been published.
>> Okay. Um well, if you could you could take that on notice because I mean you made a comment that I'd taken it out of of context and yet in the public um the the press release that the prime minister has has put his name to um it it actually has that line in it about the fact that [clears throat] um that the comm funding was contingent on states and territories reducing hospital growth. So yeah, if if you could take that on notice so that we can get that context if you believe that I am. Um and also um on the basis of the understanding that the commonwealth funding was contingent on states of territory reducing hospital growth. Um therefore, you know, one assumes that the $25 billion was contingent on
>> So that's not true, Senator.
>> Okay. So there's something's changed.
>> No, no, no, no, no, no. As I've explained previously, the [clears throat] it's not contingent um the funding is not contingent on the um volume or price growth in the states and territories. The outcome of the CCR of that additional funding is related to the price and volume growth in hospital
>> Okay. Well, if in some way you could try and um reconcile the comments from the prime minister about that growth because it it was quite a matter of some public debate at the time. We've substantly got the $25 billion has been made available. Um so if you can try and in whatever context or capability you have clearly not being able to reveal the prime minister's correspondence without his permission how those two statements or those two actions the statement and the action of the $25 billion. So so I suppose in a sense what I'm trying to understand from the $25 billion is what what undertakings did we get for just handing over $25 billion of taxpayers money to the states and territories? Were there particular requirements on the states and territories for that? It appears all the way through that the prime minister has sort of like even back as early as 2023 when the first discussions on the grand bargain on um the NDIS was part of the negotiations in [clears throat] your 42.5% that seems to have gone out the window. So what were the conditions that were put on the $25 billion? If you could provide them that
would be great. Um well Senator I mean as you're right there was a there was a grand bargain so a significant um significant requirement from the states and territories was to take on a larger uh higher share of the increase in NDIS funding. So for the last three years of the agreement they were previously capped at a 4% growth rate on the state's NDIS contribution. They will be now capped at 8%. Mhm. >> So that is a significant um change. They've also committed to work with the Commonwealth to try and achieve an overall growth rate in the NDIS of 5 to 6%. Uh and within the NH um there are there are obviously the headline funding arrangements attract the most attention, but it is actually a very large document that includes a range of of commitments and things that will drive reform in the in the health system. Um now the NH um hasn't been published yet but we >> and so that will provide significant further detail of the reform requirements >> but it was not in any of those reform requirements was a requirement for the states and territories to uh reduce their growth rate in hospital volume but it was a consequence of the combination of price and growth would affect what the ultimate CCR would be for states and
territories. Okay. So, two things there. I'll wait and we can have a look once the hopefully we've got the agreement by the time we get to estimates next time. Uh and also if you can someone work out what the reconciliation is of the prime minister's statements in the process of the negotiation and what the final outcome how you actually reconcile then because accepting that that was what the final decision was but that certainly wasn't the commentary in the
>> well even at the time of the prime minister's letter it wasn't the condition it was just an observation
about what the >> I haven't seen the prime minister's letter all I can see is what's been reported in the media which is you know and you've made the comment I'm taking it out of context I don't know whether I am >> I'm not taking the media out of context because I've got all that. So let's see what the letter says. Um can I just ask uh in relation to this uh the workforce scope of practice review um is the government intending to provide a formal response to the unleashing the potential of our health workforce scope of
>> I'll ask the officers to come to the
Penny Shakespeare, Deputy Secretary of Health Resourcing Group. Uh so at this stage there is no formal response. However, uh the department has been getting on with work uh to uh reform scope of practice where that's going to uh provide benefits to Australian patients. So, a lot of the work so far that has been discussed with our our colleagues in states and territories and uh we're operationalizing now through working groups with them uh relates to group uh to look at um any changes that need to be made to harmonize who can prescribe medicines across Australia. That started with ADHD medications uh and making sure that we've got uh patient uh access improved through GPS able to undertake prescribing of those medicines because there were significant patient blocks in terms of access uh due to needing to see a psychiatrist for for access to those medicines. Uh that group will uh look at other uh reforms to ensure that people can get access to medicines. uh and as far as possible that's happening in a nationally harmonized way. So uh we've got work underway at the moment to implement uh designated registered nurse prescribing. Um so health ministers have approved uh standards for uh nurses to to prescribe.
>> So can I just ask you what um what's the process of authority for that to happen? So um the the government has done this review. You've said that they haven't responded to the review, but you haven't sat back and waited. You've got on with the implementation. So, you know, like what is the authority for doing that? Is it just the department thinks it's a good idea, so off they go or um I mean like how I'm not criticizing you for doing it, but what's the process here? We've got a review hasn't been responded to and yet you're still going ahead with it. What what how
does that work? I think the the review has um made recommendations uh that are not just directed to the Commonwealth government. There are significant um reform recommendations that relate to uh education uh of of health professionals. Uh it's a bit like the National Medical Workforce Strategy. It's not just a Commonwealth document. It's something that's been developed with recommendations and and recommended approaches uh for a whole range of stakeholders who are involved in uh the education, the employment, um the the funding of of uh doctors and the way that they work in Australia. So I think you know if you look at the recommendations in the scope of practice review, they're very broad ranging. They're not just directed at the Commonwealth government. So, I'm not ruling out that there may be a formal Commonwealth government response to the review at some point, but it's not going of the recommendations in that review because they're not all directed at the
>> Yeah. Okay. No, that's absolutely fine. It's just that sort of I think there's sort of an expectation that if you if the government you know um commissions a review that there will be some sort of followup in relation to well first of all um is it the intention of the public release of that response?
within the department that's working
>> No understand that entirely. Um I'm just trying to understand when when the public release of these documents because there sort of I mean there was a there's been a lot of interest in the the scope of um practice review um and so I'm just interested to understand when the promised sort of review cor you know response etc when are you aware of when that's to be released or maybe the minister might know released >> yes but the response to it
>> I think what Shakespeare is saying is that at this [clears throat] stage and we're ruling out that the government may not consider it at the point. We are not for example preparing for government a comprehensive review to all the respon all the recommendations partly because as M Shakespeare said not all the recommendations are solely the purview of the commonwealth. We have a task force that's operating within the department and it is progressively developing advice actually instilling consultation with external stakeholders and then putting recommendations to government. So that's the current process.
>> Sure. Okay. Um, recommendation 12 um was directly um I won't read the whole lot of it out, but it was it was around um referral pathways for consumer access to specified non-general practice um specialist MBS items. Is that something you've been working on?
>> Uh so I'm I might get our scope of he's here to come up and talk about that. So yes, we've been discussing that that recommendation as well as a range of others with external stakeholders. So
>> Is is would that require legislation to enact if you chose to pursue that?
>> Uh my understanding is yes that there would need to be changes to um certainly Medicare legislation.
>> Yeah. So sort of interested, we've just had the um the health legislation amendment prescribing a pharmaceutical benefit bill in 2025. Interested as to why that wouldn't have been included in that legislation or we haven't done enough work to get there or
>> So I'm sorry, what was the the bill you reference, Senator?
>> The the health legislation amendments prescribing pharmaceutical benefits bill 2025.
>> Yeah. I mean I think that we have not finalized advice on that particular recommendation as to which referral pathways would ultimately be recommended to government.
>> I think there would be different
>> Okay. So require legislation but it
would it may also be I'd have to check
whether it's uh head legislation or regulations that would need to be
>> Okay that's fine. I mean that I don't need the details of it. I've obviously read the recommendations. Um S I was
just going to add in terms of some of the Oh, sorry. Um Natalie Beas, assistant secretary um in the health workforce division. Um if it might be helpful. Um I thought I just might add u scope of practice absolutely understand the expectations from stakeholders. I think one of the things that needs to be considered and definitely a topic for our national boards at the moment is how to expand scope of practice within the regulation. Um so that is live. Um and so that needs to happen first. Uh the requirement of that is for health ministers to sign that off. there are various professions at various stages um and obviously the what you've raised in terms of the PBS legislation that also needs to be considered um in time but those regulatory steps need to be done first um the designated iron prescribing as you've raised that has been a 10-year journey for the nursing and midwifree profession to bring that standard forward and for to have that endorsed and so now it's at that point where we need to consider how is that implemented and what are those considerations both for states territories under the drugs and poisons law but also for the commonwealth should we want or a decision for government as to grant PBS access for example.
>> Yeah sure. So um is the government also considering in terms of the extension of the PBS prescribing rights to other allied health professionals than you know like I don't know podiatrists or
>> Yes. Yes. So the podiatrist podiatrist. Yes. So podiatrists have requested access to the PBS a number of times. I think it's on the public record and through peback. >> Um again that's an independent process. Um there there was a review into the podiatry and there were some concerns particularly around education standards. So that is the immediate work that health ministers have asked the podiatric board in particular to take forward and that is something that's being considered. but they already have access to some prescribing through uh for podiatry in particular.
>> Okay, great. Thank you. Um could I get an update on what's happening with the access in Australia?
>> Senator Russen, I do need to share the call. Um really is this a short block?
>> I haven't said one word since afternoon.
>> You had 75 minutes. >> I [laughter] timed it. >> I know. But now that's why we're going to shorter blogs. So um I'm happy for you.
>> How are you? >> Um in response to a question um taken on notice um by Senator Mccarthy and the chair um around um what was actually happening in relation to alternative approaches, alternative technologies, what was actually happening around providing proon therapy access to Australians, particularly Australian children. Um uh my answer was the South Australian government has investigated potential alternative technology vendors who may be able to deliver a proton beam therapy system which did seem like a rather inadequate answer in terms of we've been talking about this in estimates since I've been coming here um about the fact that Australia still does not have a proton beam therapy um facility particularly for children um and we or we don't need to go into the consequences of that either meaning children have to travel or the potential damage of alternative um treatments for children um who need this therapy. So um first of all what alternative technology vendors have been engaged in the process in relation to proton therapy access in Australia.
>> Uh good afternoon Senator Liz Develin, deputy secretary of the primary and community care group. So, um, just to fill you in on the timelines, uh, as you're aware, South Australia wrote to us with a significant request for additional funding for a proton beam therapy center in South South Australia in the middle of last year. Uh, the Commonwealth Minister wrote back and said we would require further information about their plans and particularly to think about the funding request. At the same time, the minister wrote to other jurisdictions, that's New South Wales, Queensland, and Victoria because they have been identified in the national strategy for Proton as being appropriate locations. So, the minister did want to assess those jurisdictions interest in providing uh that service to Australia. We are yet to hear formally back from those jurisdictions. We are we are yet also to hear back from the South Australian government formally about the request for funding that they have put to the Commonwealth and their plan. So we are still waiting for that information from uh both South Australia and to see if any of the other jurisdictions are interested in providing this service.
>> Okay. So in terms of being able to provide a service like this so that I mean obviously the federal government has previously been very generous with the amount of money that was made available circumstances that were less than ideal prevailed. We are now in 2026 and it seems like this is just being punted around the place and you're like we hear from like Peter Mack as an example that they're really keen to do this and yet they haven't responded to you. So um you know the South Australian government was hellbent on delivering this facility for them and they haven't responded to you. So I the question is so so when did you la when did you write to the states the other states um in order to ascertain their um sort of applica appetite for the provision of this service
>> the minister wrote in December at the same time he wrote to the South Australian government requesting
>> so the South Australian government wrote to the minister in the middle of the year requesting significant additional funding to enable the Adelaide service to go ahead. Was that still the original um full gantry um proposal that was sent through from the South Australian government in terms of the funding application?
>> I understand their plan was to use the facility and the bunker that they had um invested in to date. I'd have to check whether it was exactly the same sorts of equipment because there are slightly different um
>> very different sorts of equipment
point. >> That's right.
>> Yeah. So um so as we're sitting here some sort of eight years since Australia was promised prom beam therapy particularly for children. We sort of are in no man's land aren't we? I mean South Australian government's asked for money. Obviously the feds have gone back and asked for more detail. You know you've gone to the to the state. I mean when's somebody actually going to make this happen? So do I don't know minister what what's going on? When is this going to happen?
>> Um thanks um Senator for the question. Um look I think the government recognizes the impact that the delay is having um on establishing um this type of therapy in Australia and that the impact that that's having on patients. So I think that that is why the minister sought to vote to other jurisdictions in December. Um we would obviously continue to work closely with the South South Australian government um to explore um uh how we can move the project forward. Uh but in the meantime, we are looking at alternatives because we know that this is an important um uh therapy that's worth investing in.
So, sounds to me like the the minister's lost confidence in the South Australian government's ability to be able to not that I'm expecting you to necessarily answer that. So, I suppose the question has got to be, I mean, how committed is the federal government to make this particular therapy available in Australia? Um and what sort of timeline is the government prepared to put on providing a uh a therapy that quite frankly um not only saves lives but can in you know hopefully allow children not to be permanently disabled as a result of alternative treatments. I mean it really it really is a a terribly sad indictment on the South Australian government that they haven't been able to get their act together. What do you think the federal government can do to try and break this impass? I mean, just writing letters, I mean, to be fair, in December, I've been asking about this for 4 years. Um, and I accept the fact that it's been going on even longer than that, but here we are, and we're having the same conversation. It's like Groundhog
>> What I can say to you, Senator, is um I'm not going to traverse all the reasons that we've we're in this situation now in terms of the delays. So there's a variety of reasons um other than to say that the minister's taken proactive steps.
>> Okay. Could I maybe put on notice that probably not going to accept that answer as easily at the next estimates, but it would be fabulous if we could >> get this moving. Thank you, Chair.
>> Thank you, Senator Ruston. Uh Senator
>> Thank you, Chair. And uh I'll continue with the TGA, please. As more and more harm emerges from the co jabs and I note the TGA is now talking about harm exceeding benefit for young people. The long process of scientific inquiry into the clinical trials has started with the purpose of to establish how the results from the clinical trial could vary so badly from actual results. I've provided you with one copy of a very long document titled the assessment of methodolog methodological practices implemented in FISA's CO 19 mRNA vaccine trials with respect to good clinical practice. I've also sent the secretariat an electronic copy. I'm not seeking to table it. The paper shows quote multiple methodological bias and major violations to good clinical practice. End of quote. When was the last time you revisited your processes that saw a product approved that should never have been
>> Um, thank you very much for that uh for that question, Senator. Uh, obviously as a contemporary regulator, we are constantly um reviewing not only our our processes but the uh therapeutic goods that we've approved and authorized. uh we've had conversations here on a number of occasions around the um the phco vigilance and the postmarket surveillance activities that we undertake. I I think it is important to highlight um and I think you and I have both said the same thing that it's that it's important that as um as robust and reliable evidence and scientific advancement comes up as we understand more and more around the process that um governs vaccination um the human's body response the human body's response to infection and the human body's response to vaccination um as our understanding evolves so should our regulatory decision-m that I think it's important though and you know we've had the conversation previously around around the difference between science and pseudocience that when uh information is published uh it is important to view that in the appropriate context. Um and the the article that you've provided I think it's really important to understand where where that sits. Um it is challenging to draw strong scientific conclusions from the article you provided. Um it has um invalid epidemiological comparisons. Uh it uses evidence selectively. Um the toxicology and it is speculative and not supported by evidence. Um this article would not survive peer review in a mainstream journal. Uh what we do in our um scientific assessment is we look to the rigor of the science. We don't look to the outcomes. We look to the rigor. There are a number of issues with this article. Um the methodology itself is flawed. It doesn't um contain independent peer review. It doesn't contain conflict of interest disclosures which themselves would disqualify it from publication in a mainstream credible review. Um it was released by uh an organization called the children's self-defense which we know is a political advocacy organization with an explicit antivaccination uh agenda. Um the challenge also is that the authors themselves don't have expertise in vaccine pharmarmacology or regulatory toxicology or clinical imun immunology. So these are really hard things to reconcile. One of the greatest challenges is and I know you introduced the document by saying that it has 200 peer-reviewed papers but the challenge is that they are selectively uh chosen uh on the basis of satisfying a predetermined outcome. And if I can give you one example, in 2025, a large Danish nationwide cohort study of 1.3 almost 1.3 million children found no evidence supporting an increased risk for autoimmune attopic or allergic or neurodedevelopmental disorders in early childhood. If I sorry Senator this this is actually important to the document that you've highlighted from cumulative exposure to vaccines containing aluminium. This article does not mention it. Now, it may not agree with it, but it does not mention a study that had one
>> question about when was the last time you revisited your processes that saw a product approved that should never have been approved. When was the last time?
>> And I and I I I answered at the beginning of the the processes that we are continually reviewing our processes
um in terms in terms of >> products that were that have failed in the marketplace.
>> Um can I have an example because I'm not sure what you mean by that, Senator?
>> Your infallible processes failed when it came to sunscreen, didn't it? A choice investigation, and I must compliment Choice, found 16 of the 20 sunscreens tested failed, only delivering an SPF of four or five instead of 50. Did the TGA actually test these products before you licensed them, or did you take the manufacturers's word for it again?
>> Well, thank you very much for that question, Senator. I'm just asking Mr. Mr. Arby Clark, who heads up our complimentary over-the-counter medicines uh branch to join us. Uh we've highlighted to you previously that um that we uh regulate um proportionately based on the risk presented by the product. Um and so there are different requirements on products and that goes to pre and postacceptance testing. Um as you've uh mentioned we have uh uh we have taken on board the findings of the choice article. We've been in conversations um with sponsors and other regulators and we are revisiting our processes. I'll ask my colleagues.
>> I'll just I'll just point out there's a list of 16 here. >> The first one I won't go through the names because it'll take me all all day to go through the names. Voluntarily recalled all batches listing cancelled from the register. Second, also recalled. Cancelled. Third, voluntarily recalled. Cancelled from register. Fourth, voluntarily recalled. Another voluntary recalled. Recalled. Recalled. Recalled or paused. Recalled or paused. Recalled or paused. Recalled or paused. Recalled. Sales paused voluntarily for retesting. Sales paused or removed. Sales paused, linked and affected. 16.
>> So you've asked us, Senator, when we last revisited a decision that we've made, and you've just given us a list of 16 times, and we have. So what we've done is we've responded to market issues. We've responded to
>> We approved these products.
>> Senator, you've asked us when we have uh gone back and uh reviewed decisions that we've made, and you've read us out a list of 16 times when we have our process. Senator, you've asked us, sorry, I I I you have asked us when uh we have last made a decision and we've reviewed that and then you've read out for us a list of the times that we have. Part of the process that we undertake as any regulator does undertake is that we have a complimentary pre and postmarket process so that when concerns uh arise, we respond with appropriate regulatory actions. We have a regulatory, if you like, pyramid or regulatory triangle where we work through education and guidance all the way up to compliance and we review our processes. That's what we're currently doing. If you have an interest in what we're doing with that, I'm more than happy to throw to my colleagues.
>> Well, you acknowledge choice. So, would you have done it without choice sticking
>> As I've said, Senator, if you're interested in what we're doing in response to that, I'm happy to call my
I appreciate the outcome was 12 products being removed or recalled with SPF as low as four advertised five. Which shows choice was correct? Was 12 the final tally of products withdrawn or recalled and did inquiries extend to other brands having failed to correctly supervise something parents used to protect their children? I'm wondering how far the inquiries went. Now maybe they can talk.
>> Uh thank you for the question, Senator. So um I might just also clarify just based on the previous line of questioning. So sunscreens are are captured under our list of medicines framework. So they do not undertake a pre-market assessment by the TGA. However, we do have in place postmarket compliance activities that we look for and identify where there are concerns or issues with those listed medicines such as adverse events being reported to the TGA, but importantly also um signals that we've received from research organizations um consumers um or generally social media. So um we have
treated this this outcome from choice
investigations as one of those signals.
>> We can just let the witness finish his evidence please.
>> Um so we have um taken these choice findings very seriously and as as you have pointed out senator we have focused in on the sunscreens that were identified through that choice testing that had what we um considered serious potential for harm and adverse events for consumers. Um and that that that was that sunscreen um ultraviolet that had tested um had SPF claims of 50 um that had tested by um choice to have SPF claims of four below four. Um so we have focused our investigations initially on that sunscreen and potent particularly that formula um associated with that sunscreen and those 16 sunscreens that you mentioned are sunscreens that contain the same base formula as that ultraviolet sunscreen and we have moved to have have those sunscreens canled or >> Thank you. But um I can uh assure you, Senator, as well, our investigations are ongoing and we continue to investigate um not only those sunscreens that were identified by Choice, but a number of different sunscreens.
>> So, Professor Lawler told me you're retesting products even after they're out in the marketplace after they've been approved, but you relied on Choice to bring this your attention to it. I >> So, is there is there any on monitoring of schedule two products to ensure the product you licensed is still the product on the shelf shelf? Do you do
that? So Senator, if if I might I I I if if I misspoke, I I do apologize. What I believe I I I indicated was that we are monitoring, we assess products before and after. So the process of assessment includes some of the device um postmarket assessment and includes medicine's postmarket assessment and as Mr. Henderson's highlighted, it includes incorporating all relevant safety signals, including those that that that that are reported in the media. I think it's entirely appropriate that when there are elements supported in the media that we that we respond in an appropriate regulatory fashion.
>> So we're paying so pharmaceutical companies and other other agencies are paying you money to approve things and and then you sit back and watch as choice comes in and says hang on a minute not. So let's come to my question again. Do you ensure the product you approved is still the same product on the shelf now years later? Do you do
>> Can I clarif I mean what I might um I might ask um uh I think um in terms of the process that we undertake uh in ensuring uh manufacturing quality. Uh I I think it's important to note that that the uh manufacturers of products are are regularly um inspected and and that we have controls in place there. I might ask Miss Jin from our um from our manufacturing quality branch to comment.
>> Thank you professor Lola. Um Jin, assistant secretary medical device and product quality division. Um just expand on what professor Lola mentioned earlier. The TGA does have an ongoing uh program to um um inspect uh manufacturers regularly. Um we do look at uh a number of elements. So the manufacturers assessed based on uh international recognized uh good manufacturing uh practice standards and that has a lot of requirements. One of which is to ensure that the manufacturers release products that meeting the uh marketing authorization. Um senator you asked earlier about what the TGA does once the product is been approved. Um when the product is approved it comes with a set of requirements. One of which is the marketing authorization of formulation details. That's all verified on site when we u inspect manufacturers to ensure the manufacturers continues to release products meeting what's been approved by the TGA what's on the Australian register of therapeutic >> Thank you. Um I could if I could add to that as well. Um Avina Clark, assistant secretary uh medicine's regulation division. Uh in our compliance work
related to sunscreen, one of the things we look specifically at is is the product on the shelf what has actually been tested for. So really looking at whether the evidence that a sponsor hold is contemporary for the product that's on the shelf.
>> Thank you. That's what I was getting at. What penalty was taken against the manufacturers that deceived the TGA on
Sorry, which manufacturers do you mean? Sorry, I s
>> sunscreen manufacturers. >> Did you take any action against them? They they deceived you. They've got a SPF of four or five when they're advertising 50.
>> Senator Oh. So, Senator, as we outlined, um the we have taken immediate action and we have cancelled or removed um from the um ARTG listings of those sunscreens that we have investigated that have that same base formula as the SPF 4 um ultra.
>> What penalty did did you levy with them? >> Did you give them any penalty?
>> If I could add our our compliance uh is proportionate and sequential. So there
are a range of there are a range of actions we can take. In the first instance if we have cor
>> what action did you take with these people?
>> Well so in in this specific instance for these specific sunscreens they were recalled but if there tends to be persistent behavior uh of misleading conduct for example that we would have other options uh available in terms of uh infringement notices or taking uh a sponsor to court. Uh but generally those are escalated actions if we find the behavior is repeated um uh and and um there isn't a willingness for a sponsor to bring their product in line.
>> So in this case you simply got a recall, took them off the shelves, no penalty.
>> Senator, um again I may um if if I could add um the TGA's regulatory decisions are also based on evidence. Um so in this instance um as Mr. Clark has mentioned that we've taken immediate actions to recall those goods that um have the low SPF results that inconsistent with the label claim. We've also conducted the inspection of the manufacturer. Um we could not find the manufacturing processes could explain the low SPF. As Mr. Henderson um had mentioned earlier, the TGA investigation is ongoing. We're still looking at the cause to the uh the variability of the SPF results. We're still looking at for the reason for certain formulation producing low SPF results. Now, the outcome of those investigations certainly will guide TGA to further strengthen our regulatory framework.
>> So, there's no penalty at the moment. Okay. Uh, on notice, could you provide me with how much the TGA has received in funding from the companies that produce these products in calendar 2025 across all products you license from those companies where a recall was required? >> Can I get that on notice?
>> Uh, we'll take that on notice. Thank
>> Thank you, Minister. We saw figures a few years ago that that TGA receives 96% of its funding from pharmaceutical companies or purveyors of of proposers for for approval. It's one nation's position that I'm going to look for your opinion here. One nation's position that the TGA is too close to the companies they regulate calling reg called regulatory capture and your expert committees are even closer to the pharmaceutical industry. One Nation would return approvals to the Department of Health and restore parliamentary oversight and accountability to what is a $22 billion line item. We propose tighter testing and regulation and accountability, not the mates rates deals that I'm seeing in things like the co products. Minister, >> Minister
um if there's a question uh in relation to
>> I'd like to know the minister's
>> to directly to the minister um because I will seek to shift the call.
>> That's what I directed it to the minister. I'd like to know the minister.
>> Okay. But there was a lot of preamble and I'm not sure that >> um yeah
>> had to set up the context. >> Yes. So, Minister, what's your um view on the TGA receiving funding from the people it regulates supposedly? >> Well, my initial view >> accountable because we need to get it back to the Department of Health.
>> I mean, my initial view, Senator, is we certainly wouldn't support any one nation policy when it comes to health care. I think you've demonstrated particularly over the CO 19 pandemic a real lack of [sighs] um judgment when it comes to ensuring that um Australians are safe. Um we need to um uh provide the TGA with the support and funding that they need to do their job. They are part of the department. Um so your your um your policy idea would simply change the letterhead but the role that they play is important and we will support them instead of coming here and to Senate estimates every time and trying to undermine the work that they do.
>> Why did you why did you uh go against your recommendation to have a co royal
commission? Oh, Senator, I'm I'm not going to get into a culture war with you about CO 19 in 2026.
>> people are still dying from some of the
>> Thanks.
>> Thanks, Chair.
>> Thank you, Senator Roberts. Senator
questions about ACT U bulk billing
>> tomorrow. So, now come
>> bulk billing clinics.
>> I think well I think we're going to do all the Bing tomorrow and outcome two. >> Okay. Sorry. Apologies.
>> It is now is it?
>> Yeah.
>> Yeah.
>> Okay.
>> The incentive payment is kind of a gray area. The 12.5% the clinics is different because it's a direct expenditure.
>> All right.
>> Would have been better in cost portfolio.
Um I was asking you to get an update on the government's announcement to establish three fully bulk build clinics in the ACT which minister I again acknowledge and and thank the government for. Um understand that Capital Health Network uh was running the tender. I'm interested if there's been a result of that tender that the department is aware of.
>> Mark Roddam first assistant secretary primary care division. Uh the Capital Health Network is in the very final stages of negotiations with the three providers uh successful through their uh through their grant process. So we're very close to those being announced.
>> Is it three different providers or one provider doing all three clinics?
>> Uh I'd need to take that on notice, Senator. I believe it's not three the same. I'm not sure if there are two the
>> Okay. Thank you. That would be great on um notice. When are the clinics supposed
to be up and running? We expect uh the middle of this year, Senator.
and uh to clarify with the with the the funding, the the 10.5 million is in addition to Medicare billings or is the
>> That's correct. It's for workforce incentives for for minor capital works etc. Senator, >> so it's to salary GPS. No, it's uh to uh attract to the uh act senator. So u potentially relocation costs etc. Things like that
>> for GPS.
>> Yes.
Okay. Um maybe on notice, could you just provide a bit of an overview of what that what the 10.5 can and can be used for?
>> What I can do on notice, Senator, is um that's very clear in the tender documentation. So I can provide that on
notice. and and um like what do you mean 10 million for relocation of GPS
>> senator? So I believe the grant funding will include funding for recruitment activities, retention activities, accommodation ancillary costs but not
Um how many how many GPS are we expecting at these three clinics?
>> 10 approximately 10 at each. So 30 in
>> total full-time.
>> Yes.
>> Yeah. FTE.
>> Uh I'm not sure if we can be specific about full FT full-time Senator, but certainly 30 GPS.
>> 30 GPS. Okay. Maybe just on notice if there's an expectation about what what that load actually comes out at.
>> We can do that, Senator.
>> Okay. Thank you. Um can you turn to the Interchange um health co-op? Um and as I understand it, the four health group acquired Interchange Health Co-op and is continuing to deliver services. Um I think last time I asked the 3rd of September last year no commonwealth funding had been provided to for health. I'm interested if funding has been delivered to for health after the the election commitments.
>> So uh similarly senator that is um the contracting process is being finalized at the moment. I expect funding would flow to four health soon.
>> Is there a date on that?
>> Not a specific date senator but I would expect soon.
And did the did the department put any conditions on that funding?
>> Yes, that uh the clients of the interchange co-op continue to be served or that client group continue to be served under these arrangements.
>> And do you do you specifically around um opiate dependence treatments? okay, I'll wait till that's finalized and I'll I'll have I'll have some more um uh questions. The the my understanding is that the the clinic currently has two doctors. Um uh before it's collapse, it had four to five doctors um on a full-time equivalent so the numbers of doctors is h haveved. Do you know what sort of level of service it's providing and will they have to step it up to actually meet the conditions to to service those um
>> I'd need to take on notice the detail. Senator.
>> Okay. Thank you. Um got someone on the Wen Urgent Care Clinic. Um uh which provider or entity runs that
door who will have that information
>> Maybe maybe
>> Uh Sarah Sinclair, assistant secretary of primary care division. Can I please trouble you to repeat your question? Um
which uh provider or entity is running the Medicare urgent care clinic in Woden?
>> Uh the four health group.
>> Four health. Okay. So for health will be running um Woden uh as as well as I saw um uh Minister Gala say on uh Instagram that the urgent care clinic in Woden is seeing around 120 patients um asked a Camber GP how many patients they would see in a week and um granted that they're they're I think exceptional GP they're seeing about 100. So I'm interested how many doctors are currently at the urgent care clinic if they're if they're seeing 120 patients
>> Uh Senator, I'd need to take that detail
>> Okay. And maybe on notice if that is just the totality of the demand or if that's just how many they can actually
establishing Medicare urgent care clinics and this clinic opened in December of last year, it does take a little bit of time for community to to ramp up. So we would expect that that would continue to grow for that service based on previous experience.
>> Okay. So maybe just notice if there's spare capacity and how that's how that's working out and is is there's no >> Okay, I'll put in a quan to them then. Um and then just on bulk billing um more broadly, I saw the minister's media release earlier today about the bulk billing rate um uh titled record jump in bulk billing for Australians. Um and and to quote those who haven't seen it, uh in just 3 months the bulk billing rate for all Australians has jumped to 81.4% 4% for 16 to 64 year olds. Uh there's been a 6.9 percentage point increase in the block building rate, the largest quarterly increase on record. Um and really just wanted to acknowledge uh the government and um secretary and the whole department on your exceptional work um on this. It really is a big effort and very welcome for for um Australians. I was interested if you have the rate for the ACT, please.
Uh we were going to cover this tomorrow, but we do have this in front of us. I
>> we've got headline.
>> Yeah, headline.
>> yes. So the bulk billing rate for the ACT is 53.8% and that's a 1.3 percentage point increase since the new initiatives
>> 53.8. That's is that December quarter?
>> Uh it's not a quarterly figure as such. So it goes from the 1st of November to the 31st of January.
and you said what's that increase you you mentioned there?
>> Uh that's uh 1.3 percentage points to 53.8%.
>> And do you have the rate for concession card holders?
>> Uh we'd need to take that further detail on notice or we may be able to provide that tomorrow in outcome too.
>> Thank you. if if you have if you have that would be good. Um and then just on the new um sorry, now I'm jumping around here a bit. Um Secretary, on the new um hospital agreement, will uh we get to 42.5% in 2030 for HD
Look, it it depends on what the volume and price growth over that period is. um you know, the intuitive thing is um the first year of the cap uh is 10.25%, it's 8% every year afterwards. So, so every year you're below that in total volume ter volume and price the CCR goes up. So, it's just a question whether the the combined price and volume growth is is low enough to deliver enough of a gap between those caps to deliver you a CCR of 42.5
>> and and so you you're pretty confident that we will get there or what?
>> Just flagging um final question.
>> Can I can I Okay.
>> Yeah, I look I think um it's the reason I'm I'm we would do different scenarios. there is a scenario in which you get there. Um if you take a scenario of price and volume growth that's similar to that has been the case over the last 10 years, >> you you you don't get to 42.5%, you get to more like 40%.
>> Okay. And just f finally the we've we've discussed um at previous estimates this uh I think dire need for a um small jurisdiction loading and you said that you're undertaking um some work. circumstance said what
>> so the deal the the the agreement actually has a small state loading um for act Northern Territory and Tasmania it's it's for one year and that's because I hackper is doing further work on whether there are such significant cost disadvantages in those things that national efficient price is not fully reflecting that so the idea is that that um small state loading bridges until that work would be available which will then potentially feed into recalculating the efficient price for those jurisdictions.
>> And so what is that loading for the first year
>> uh >> For the ACT, it's $75 million.
>> Okay. Thank you. Thanks, Joe.
>> Thank you. Um we are in a position to before we go to dinner uh release some uh witnesses. The Australian Commission on Safety and Quality in Health Care, uh, Cancer Australia and the National Health Funding Body are released from, uh, this hearing. So, thank you. We will reconvene after the dinner break at