Title Select Committee on Red Tape
Effect of red tape on health services
Database Senate Committees
Date 09-02-2018
Source Senate
Parl No. 45
Committee Name Select Committee on Red Tape
Page 1
Questioner CHAIR (Senator Leyonhjelm)
Paterson, Sen James
Burston, Sen Brian
Responder Mr Pullar
Mr Williams
Ms Aunedi
System Id committees/commsen/f3f44909-3e7f-4584-b6eb-170117895cc5/0001

Select Committee on Red Tape - 09/02/2018 - Effect of red tape on health services

AUNEDI, Ms Helen, Country Head, Country Clinical Operations, Roche Products Pty Ltd

PULLAR, Mr David, Head of Government Affairs and Public Policy, Roche Products Pty Ltd

WILLIAMS, Mr Troy, Chief Executive Officer, Australian Dental Industry Association

Committee met at 9:04

CHAIR ( Senator Leyonhjelm ): I declare open this meeting of the Senate Select Committee on Red Tape for its inquiry into the effect of red tape on health services. These are public proceedings, although the committee may determine or agree to a request to have evidence heard in camera. I remind all witnesses that in giving evidence to the committee they are protected by parliamentary privilege. It is unlawful for anyone to threaten or disadvantage a witness on account of evidence given to a committee and such action may be treated by the Senate as a contempt. It is also a contempt to give false or misleading evidence to a committee. If a witness objects to answering a question, the witness should state the ground upon which the objection is taken and the committee will determine whether it will insist on an answer having regard to the ground which is claimed. If the committee determines to insist on an answer, a witness may request that the answer be given in camera. Such a request may also be made at any other time. I remind those contributing that you cannot divulge confidential, personal or identifying information when you speak. If you wish to supplement your evidence with written information, please forward it to the secretariat after this hearing.

I now welcome representatives from Roche and the Australian Dental Industry Association. Thank you for appearing before the committee today. I invite you each to make a brief opening statement should you wish to do so.

Mr Pullar : On behalf of Roche I would like to thank the committee for the opportunity to present. You've received our submission, so I will simply provide some context to our recommendations. I would like to note that several of these issues were covered in the recommendations of the 2017 Senate Select Committee into Funding for Research into Cancers with Low Survival Rates. Roche's area of expertise is in research and innovation and health care. We invest over $37 million annually in Australia but have a global R&D budget of over US$11 billion—more than Apple or Toyota. There's clearly an opportunity for Australia to take a larger slice of the pie, providing patients with earlier access to medicines and building the skills of our doctors and researchers.

However, there are challenges to our continued investment in Australia, and they are red tape related. At the national level, the Therapeutic Goods Administration's clinical trials notification scheme is recognised as efficient and best practice. However, because trials are conducted in hospitals and clinical practices spread across the states and territories, the ethics approval—is the study appropriate for people to participate in?—and governance review—are the contracts and payments appropriate?—are conducted at a local level. It has long been recognised that there's room to remove duplication of assessments and move to a single national process for ethics and governance review, but we are yet to get there.

Here is just a sample of the reviews and initiatives over the last 16 years that have explored the idea and recommended action: the Pharmaceutical Industry Action Agenda in 2002, the NHMRC streamlining and harmonisation program since 2007; the Pharmaceutical Industry Strategy Group in 2008; the Clinical Trials Action Group in 2011, which led to $9.9 million in the 2012-13 budget; the McKeon review of medical research in 2013; and the COAG Health Council in 2016, which led to additional funding in the 2017-18 budget. Surely it's time to resolve to this issue once and for all.

Australia also has a problem with red tape in our system for reimbursing medicines under the PBS. Our assessment process is generally accepted as one of the fastest in the world: 17 weeks from a company submitting a dossier to a recommendation on whether or not to fund. However, in practice this usually means 17 weeks to being told 'not yet'. An analysis of new cancer drug submissions from 2010 to 2016 found that no more than 50 per cent of recommendations were ever positive, meaning that most medicines required resubmissions and took around two years to list after being approved by the TGA. In the meantime, patients have to pay out of pocket or not access the medicines at all. We're currently ranked 17 out of 20 developed countries for access to new medicines. Because of the fixed assessment cycle, a medicine that's rejected can't be resubmitted for another four months, then recommended another four months after that. Yet in practice, after the first submission price is often the outstanding issue. This could easily be handled by an out-of-session negotiation rather than a comprehensive dossier assessment, which is what's currently required.

As part of the medicines industry's strategic agreement with the government we're working with the Department of Health and an external consultant to co-create frameworks to introduce more flexibility into the system, looking at the budget impact and the level of unmet need before determining the process for assessment. It remains to be seen what will be the result. In an era of personalised medicine, when we recognise that each patient is unique, it's disappointing that our reimbursement process remains one size fits all. Roche wants to be a constructive partner in ensuring that our health system benefits everyone and that Australians can get the best possible care well into the future. We welcome the discussion through the committee.

Mr Williams : If the Australian Dental Industry Association were providing advice to this committee five years ago, it would be a tale where the dental industry was being strangled by red tape. Thanks to a comprehensive reform program, this is increasingly less so. The Therapeutic Goods Administration is in the midst of a root and branch reform of the way that it regulates therapeutic products and the businesses that manufacture and supply them. In 2015 the then Minister for Health received a report from the independent Review of Medicines and Medical Devices Regulation. The dental industry considers this to be a landmark document. It paves the way for cutting red tape. Consistent with its terms of reference, the review that undertook the inquiry identified unnecessary and ineffective regulations. It made recommendations to review and streamline the way medicines and medical devices are approved, the framework that underpins that approval and at the same time maintains the quality, safety and efficacy of the therapeutic goods which are available in Australia. It is an important document, one that ADIA supports, but, more importantly, so too does the Australian government, which has accepted 54 of the 58 recommendations.

We're seeing that transfer into legislative reform. In 2017 the first tranche of reforms to the way the TGA does it work was passed, and there is a current bill before the Senate which will further that work. This makes third party conformity assessment for medical devices much easier. It allows the TGA to work off the decisions of trusted overseas regulators. These makes it easier for small businesses, particularly those in the dental industry, to bring new products to market.

The work of the TGA here is to be commended in bringing this reform to fruition, but also working with industry and small businesses to understand it. Cutting red tape is now arguably part of the TGA's culture. The transformation has come as a result of some exceptional leadership by a deputy secretary within the department, John Skerritt, who in ADIA's view is a world-class regulator. He embodies the APS values of providing advice that is frank, honest and timely. He has worked a lot to make sure that the TGA's decisions are based on sound evidence of business practice and yet continue to maintain patient safety.

Notwithstanding the excellent work of the TGA in cutting red tape, we draw attention to one particular area which will present problems for governments in the years ahead. ADIA, like most stakeholders in the medical devices sector, is very keen to ensure that Australia's regulatory framework aligns with that internationally. For the TGA, this is typified by aligning our regulatory standards with those of Europe. In our submission we have a section dealing with the annexation of European Union regulatory requirements. Based upon the performance of the TGA to date, it's all too clear they are ready to accept these requirements out of Europe without looking at them in the Australian context. This is creating an additional regulatory burden—more red tape for Australian businesses. New European Union regulations, this rather lofty document, were passed by the European Parliament in April 2017. Six months later the TGA confirmed that it was going to set about the task of adopting these. When we asked to see the regulatory impact statement that assessed the cost to Australian business and small businesses—the cost of adopting this rather large monster—the Office of Best Practice Regulation advised that no regulatory statement was required. The rationale, which is faulty, was that the cost of assessing these was considered when the Australian government accepted the Review of Medicines and Medical Devices Regulation. The timing here becomes crucial. The government accepted the report on medicines and medical devices regulation in January 2016. It is on that basis that the Office of Best Practice Regulation is claiming that it has assessed the cost on business. But that wasn't possible. It assessed the cost in January 2016, but this document didn't come into force in Europe until more than a year later. So, we're failing to understand how the Office of Best Practice Regulation could come to the conclusion that the cost of accepting this business has been assessed by the government, when they weren't in force at the time of the regulation.

Please be assured that ADIA is a strong supporter of the TGA; it's made real efforts in cutting red tape for the businesses that manufacture and supply products. But the approach of adopting European regulatory requirements has, to some extent, reduced Australia to a client state of Europe, where we accept what comes out of there without assessing it. Thank you for this opportunity, and we look forward to further engagement.

Senator PATERSON: There are two issues I'm interested in pursuing, one for Roche and one for all of you. Firstly, I was really interested in your comment, Mr Pullar, about having nationally consistent standards. It's particularly important to you, I understand, for ethics approvals. Is that right? Thinking about the status quo as it is today, given there's a variation between states, are there some states that are doing it better or some states that are doing it worse? Are there better places for you to do research and development in Australia, or are there worse ones?

Mr Pullar : Helen can talk to it in more detail, but I think there's variability between states and within states. Some of the states wouldn't necessarily have a statewide consistent approach.

Ms Aunedi : I guess the issue here is the national coordination of human research ethics committees. There are some states where ethics approval is really fast. We can be the first country worldwide to start a study.

Senator PATERSON: Which states would you say—

Ms Aunedi : In New South Wales, recently, we had the first patient globally, through their ethics committee. The Peter MacCullum institute is another really good site in Victoria, and there is Adelaide. So there are pockets where we do this really well. I want to acknowledge that where these committees really focus on that ethics review cycle time, it does work really well, but there's huge variation. For example, we have about 696 trial sites. We activated about 200 last year, so you can see that four being the best out of 200 is a very small percentage. We're supporting the review from the previous inquiry into rare cancers, which is looking to streamline and harmonise these processes around ethics committees, with the view that we're putting patients first: the quicker we can start a trial, the quicker we can get access to treatment for our patients.

Mr Pullar : The big change has been pushing for mutual recognition: the idea that an ethics review should be reasonably universal and recognisable. There's been a lot of push both within states and federally for systems to recognise. I think that does happen sometimes, but, generally, institutions prefer to have their own ethics review.

Senator PATERSON: I ask this because of what he have found in other policy areas. We've got a federal system in Australia and there's differences between states. Sometimes when you attempt to harmonise and have a nationally consistent standard you harmonise to the nationally consistent lower standard, not the higher standard. How do we make sure that doesn't happen, and, if we do harmonise using one model and ditch all the other models, in the future, how do we know that's the best model when we don't have the natural competition and comparison between the states? Is that something that concerns you?

Mr Pullar : It certainly hasn't been the concern in the past. I guess there would be two approaches. One would be: do you have a nationally consistent standard, and that is still implemented in each site? So, you could say that an ethics review needs to be conducted within a certain number of weeks, they need to meet a certain number of times, and these are the processes. But you could still get wildly variable implementations of that. I think what we would hope for would be to eventually have a single committee that would specialise in multicentre trials, which everyone could then just outsource to. They might still conduct the ethics review of what their own institution is doing just within their institution, but if it's a multicentre trial—you could certainly aim to have that be best practice. Do you want to give the Bellberry example?

Ms Aunedi : Yes. There is a private ethics committee—Bellberry Human Research Ethics Committees. They're a not-for-profit organisation. They have some key metrics around how they perform. Regarding your point, with any harmonisation model we would have to be very clear around what the expectation is and what the mandate for these committees is. Certainly, having a single ethical review for multicentre research would eliminate quite a lot of duplication. I think, as David mentioned, the key would be really around framing—saying what this harmonisation would look like, setting some key performance indicators and ensuring that those committees keep to those time lines. I will say that there has been a lot of work done by the NHMRC, which has been fantastic. I think some of the issue that we have is around governance—so around the institutional review around contracts and indemnity—and certainly that's something we need to deal with at a hospital level, both public and private.

Senator PATERSON: The second issue I'm interested in getting both your views on is: you mentioned mutual recognition, and you've both given reasonably positive evidence about the TGA. Is there sufficient mutual recognition of overseas processes for accrediting drugs or medical devices? For example, if a respected institution like the FDA in the United States, or the European Union equivalent, has given a tick-off for a drug or a medical device, is it sufficiently easy to bring that drug or medical device into Australia without having to go through that process again and re-approve it again?

Mr Pullar : Just to give the medicines perspective: because of the recent TGA reforms, it's not a tick-and-flick; it's not automatic. I think generally the review came to the conclusion that we would still like some oversight in Australia. I think that's a community expectation. What they can do is: they can take evaluation reports, they can take some of the critique that has been done overseas, and use that to speed up their own assessment. So we'd still be making a distinct Australian judgement about whether to approve a medicine, but you can learn from some of the process; you're not necessarily doing everything starting from a blank—

Senator PATERSON: Before I move on to Mr Williams, though, is it sufficiently fast now?

Mr Pullar : I would have to say we are happy with it. Particularly, Roche has been fortunate enough to be part of the new priority review process for a couple of products, and we're seeing the TGA being very, very fast with that yet still rigorous, and the standard process, I think, is pretty comparable with other jurisdictions.

Senator PATERSON: Mr Williams?

Mr Williams : In the devices sector—particularly for lower-risk medical devices, which have a very different risk profile from the medicines—the system is actually pretty good. If you're dealing with simple surgical instruments, as long as there has been a certification—a conformity assessment that it meets the relevant standards—it has actually been fairly good. As long as that certification had come out of a well-respected certification body out of, say, North America or Western Europe, the process was pretty good. Where it had become complex was with some of the higher-risk devices. It's a work in progress, but we're comfortable that the TGA is working through it. The government had announced some reforms back in 2013: if it had been approved in a trusted overseas market, it would be available in Australia, and the current legislation before the parliament is putting the infrastructure in place to allow the TGA to do that. What I can tell you is that the level of engagement on this with industry has been first-rate. They've been very happy to say, 'We're not quite sure exactly how this is going to work'—and nor is industry. But what they're dedicated to doing is making sure that, if all of the stakeholders are comfortable that an approval overseas is robust, the TGA would not present any unnecessary roadblocks to making it available in the Australian market. One of the key points of the Review of Medicines and Medical Devices Regulation was to continue the role of the TGA. One of the abstract questions was: did we need a regulator at all? And it made very, very clear—and the Australian government and I think all stakeholders accepted—that the final authority needs to be the TGA. But it has reforms in process; where there had been—blockages is probably not the right word; where the process had been suboptimal and slower, they're certainly working to address that.

Senator PATERSON: Just to play devil's advocate on this issue: are Australians' teeth really that different from the teeth of Americans or Europeans, or do our bodies respond differently to medicines than Europeans' or Americans' do?

Mr Williams : I once asked that question and said, 'Why does an X-ray in Australia seem to be different in Victoria as opposed to Queensland?' And of course the answer is no. There are some—particularly, say, in dental. But there are no changes. And this has been part of the review process. The very act of filling a hole in a tooth, addressing caries, in Australia is identical to that in any developed country. And that was our basic point. Human physiology is identical. The training of the healthcare professionals in Western countries is identical. They have the degree and aptitude to use the medical devices perfectly well in North America or most of Asia or certainly in Western Europe. Why then were the products regulated differently? The risk profile for the patients was the same; the training for the healthcare professionals, for all intents and purposes, was the same. It made sense, in that context, to ensure the regulatory framework was identical.

Mr Pullar : On medicines, I accept the basic premise, and that is why we have harmonisation. Particularly in some of the clinical areas that we're in, there are variabilities in clinical practice in Australia. When you're deciding about a medicine it's not in the abstract; you're looking at it in comparison to what is currently used. Does it offer benefits in safety or efficacy? That's always going to be in comparison to what's available. If that's different in Australia to Europe, you might want to come to a different conclusion.

CHAIR: Mr Williams, on the issue that you raised in relation to the unquestioning acceptance of EU medical devices directives, if I understood your submission correctly you're saying that they're being accepted irrespective of the risk. If that were to be reviewed here, it would be on the basis that they are not as risky as the EU directive assumes. So, for lower risk products, you're saying the TGA should adopt a lower risk approval process?

Mr Williams : I think it's fair. If we use the example that was in the submission, it was a patient implant card.

CHAIR: Say that again.

Mr Williams : The patient implant card. The TGA is proposing that patients receive an information card for a whole range of implantable medical devices. Setting aside the issue of whether it should be a physical card or part of somebody's My Health Record, dental implants were included in that. We simply asked the TGA: what is the benefit and what risk are you trying to identify? The TGA has a very good adverse events incident reporting system. Out of the several hundred thousand dental implants which have gone in, there are about four or five incidents associated with dental implants, and most of those seem to be surgeon errors as opposed to a failure of the device. Globally, the numbers are the same. Upwards of 60 to 80 million dental implants have gone in. On the rate of failure of these devices, the percentage is definitely on the right side of the decimal point.

CHAIR: What should the TGA do differently to avoid this sort of overprecautionary approach based on an EU regulation?

Mr Williams : The same as what is incumbent on any regulator: demonstrate the risk it's trying to do. The approach at the moment is that Europe seems to think that is appropriate.

CHAIR: How would you address the argument that, on the one hand, we're expediting things by saying: if the EU has approved it then we should basically not question it. You're saying that sets the bar too high in some instances; therefore, that requires some local assessment.

Mr Williams : It's the local assessment of whether the regulatory requirement is needed at all, so the decision not to impose it doesn't create an additional regulatory burden for Australia. That's the part. There's a difference between having different regulatory requirements and adopting the European ones in their entirety.

CHAIR: Do you have questions?

Senator BURSTON: Most of them been answered. I'll just go off track a little bit. I notice that dental surgery and so on isn't available on the PBS. I understand that the dental industry resists quite strongly the suggestion that it go on that system, similar to other medical areas. Is there any reason for that? Is that because of additional red tape?

Mr Williams : Mostly respect for the government's bottom line. There's a philosophical debate in the dental industry about whether or not dentistry should be publicly funded, and there has been some good work done on that. Setting aside the philosophical issues, if you believe we have a commitment to universal health care then certainly the dental industry should be part of that. The conservative cost for a denticare, for want of a better term, would run us anywhere between $4 billion to $16 billion in a single year. I know the finance minister. If we went to him with a proposal of $60 billion over the forward estimates—

CHAIR: You'd get a very Germanic response.

Mr Williams : Yes, and I think a very short one, too. There are parts, certainly in the devices space, which are on the Prostheses List, and implants is one of them. But, by and large, we don't have a philosophical problem with that, but it's understood that there are broader dynamics in place, particularly financial ones, at this point in time.

Senator BURSTON: Sure. Thanks.

CHAIR: I've got a number of questions for both Roche and the Dental Industry Association. I confess I am ignorant of the regulatory approvals process for clinical trials. In your issues with ethics and governance, is the approval process legislated, or is it just practice? Where are the problems arising?

Mr Pullar : At a really high level—and Helen can speak to this in more detail—it's essentially devolved. The TGA are your first port of call. They have a scheme called the Clinical Trial Notification scheme. We say, 'We plan to do a clinical trial in this area,' and they accept that, as long as each institution has signed off from a human research ethics perspective. So the ethics and the governance are not necessarily legislated; they are institutional processes. What you see sometimes is that, if it's in the public system, the state department of health probably has some guidelines and some directives which influence then how that institution goes through that process, or it might just come down to that institution's own work practices.

Ms Aunedi : I would say that Australia has a deregulated system for clinical trials. Actually, the CTN scheme is very heavily revered. It's seen as world's best practice. From the TGA perspective, we're extremely happy and comfortable with the review that's happening there.

The next level that we need to deal with is this inconsistency across systems and processes across the states and territories, particularly with the human research ethics review. A lot of that is guided through guidances from the NHMRC, and of course TGA have their own guidances around the operation of clinical trials in Australia.

CHAIR: So you've got a deregulated system, but it's not working as well as you'd like it to work. You're not asking for it to be regulated, are you?

Ms Aunedi : No. What we're asking—

CHAIR: So how will it be fixed?

Ms Aunedi : In our submission we talked about the need to bring the various processes that are happening at the states and territories together so that it's one harmonised approach. What we're seeing at the moment is that the NHMRC might issue a guidance, but every ethics committee might vary it to their own requirements. That introduces more red tape for sponsors of clinical trials who need to put those trials in those centres.

CHAIR: Who's introducing this red tape, though—the institutions?

Mr Pullar : The institutions, predominantly—and we accept the current level of regulation. I think we'd just like it if it were one set of paperwork, one set of reviewers and a kind of predictable outcome.

CHAIR: Unless government regulates that by either legislation or regulation, how could it be achieved?

Mr Pullar : We've looked at a range of options. We've seen this with some other things. With Commonwealth-state, there might be some kind of incentive for states to sign up to a consistent practice so that each department of health would adopt it. It would continue to be state by state; there wouldn't be a new federal regulation, but each state would agree that its processes were not just broadly consistent but identical. They would have the same KPIs, the same committee deadlines et cetera.

CHAIR: Do you have any clear views on how that would be achieved? I'm afraid I'm a bit foggy about it. That sounds like herding cats to me.

Mr Pullar : It is. I think what we struggle with is that it really is a political question in a lot of ways. We can see pros and cons to a range of approaches.

CHAIR: I can imagine a bunch of PhD researchers, all with egos the size of Mount Kosciuszko, all having their own ideas about what's ethical or what a good clinical trial is. What's the fix to that?

Mr Pullar : Well, state governments can direct their institutions. If you are operating within the New South Wales or the Victorian public health system, you are obliged to follow certain protocols and certain processes of your employer. If every institution in those states was directed by its central health authority that it had to recognise the ethics approval of the fastest ethics committee in its state, we think that could be achieved. COAG and the COAG Health Council have looked at this, but then they didn't set any deadlines for when it would be done by or how it would be done. But in principle the directors-general were to look at how they would agree—

CHAIR: You made one suggestion there which resonated, which was that the state health departments issue guidelines that say that the performance of the fastest option has to be the benchmark for everybody else. Is that what you're saying?

Mr Pullar : That is an option, absolutely.

CHAIR: That would be an option.

Ms Aunedi : Clearly, this would need to be worked on with stakeholder engagement, including industry. But I think that's the problem at the moment. There are no set requirements for any of these committees to have a performance standard.

Mr Pullar : We gave the example of Bellberry. You could have the same sort of situation, where there is an ethics committee that sits outside the state system but is recognised by everyone as being acceptable. So every state agrees that it has to, and, if Roche have chosen to go to one of a handful of credible, well-recognised ethics committees—you wouldn't want any operators that weren't equivalent in quality and scrutiny, but if we were able to go outside of the system—the state hospitals would have to recognise that.

CHAIR: Now, Mr Williams, there are a couple of points on yours. You made quite a lot of mention in your submission about the ACCC, and this has come up also in another submission, which we'll be hearing about later. The ACCC seems to have taken an interest in what dentists can and can't do. Would you just go over that for the benefit of the committee, please?

Mr Williams : Certainly. The interest of ADIA in this is dealing with teeth-whitening products. The actual underpinning regulatory framework here is an excellent example of what happens when you do get state and territory consistency. It's the Standard for the Uniform Scheduling of Medicines and Poisons. Its origins go back several decades, where every state and territory did it differently. They've come up with a schedule of products which roughly, in a simple sense, dictates their means of supply, who can supply them and whether they're over the counter or they're prescription.

That framework applies for teeth-whitening products. There's a threshold. If you're at all interested in the details, it's six per cent hydrogen peroxide and 18 per cent carbamide peroxide. Anything less than that is an over-the-counter good; anything more than that can only be sold through a healthcare professional. ADIA is fully supportive of that. In fact, the current entries in that schedule of teeth-whitening products were adopted as a result of some advocacy from ADIA.

What's happened is that the ACCC has had a different interpretation of that state and territory legislation. And, rather than go down the traditional path of either seeking an amendment to the Poisons Standard, which would have the effect of amending state and territory legislation, or indeed creating its own mandatory standard, which it can under the Competition and Consumer Act, it's found a halfway house of publishing basically an information bulletin, which is not consistent with the prevailing state and territory legislation but, by the very nature of who has published it, has become a de facto standard. Nobody wants to reinterpret or go against this ACCC information sheet. So it's being relied on by a number of healthcare professionals, a number of stakeholders—indeed, the Dental Board, the professional body that regulates dental professionals, even references and relies upon this ACCC statement which itself is inconsistent with the state and territory guidelines.

So ADIA's position is quite clear. If the ACCC is uncomfortable with the prevailing regulatory standards, that's fine. Its options are very, very clear: seek an amendment to that state and territory legislation—and that's fine because that is nationally consistent—or override it, as it can, using its powers, effectively via the Commonwealth's corporations power, to set up its own standard. Either is acceptable. Our preference from the industry would be—

CHAIR: Either's acceptable? Both of you have been praising the TGA and its processes, and you're saying it's acceptable for the ACCC to basically come in over the top of the TGA?

Mr Williams : I was about to say that our strong preference would be to allow the state and territory legislation to prevail—just get the ACCC out of this space. If, for whatever reason, they're unable or unwilling to do that, then create a mandatory standard. Yes, it does create another layer of red tape; it's an additional burden, but at least we have clarity. At the moment what we've got is a strong state and territory legislative framework through the Standard for the Uniform Scheduling of Medicines and Poisons, and this ACCC policy statement that's just sitting out there but has the status of a de facto standard.

To address your point, Senator: the worst-case scenario—but it is acceptable—is simply for a mandatory standard. The optimal standard is simply to allow what is a very good regulatory framework to work, and that is to set the requirements for who can sell teeth-whitening products at what concentrations in the states and territories via the Standard for the Uniform Scheduling of Medicines and Poisons.

CHAIR: Have the ACCC's guidelines been tested at all? Has anyone said, 'We don't like your guidelines; we're going to ignore them'? Has there been any testing of that?

Mr Williams : They've not been tested. There have been some recalls, and this is where people have confused it. The ACCC did some mandatory recalls, probably about five years ago now. But these were people selling higher concentrations, beyond the six and 18. But, in terms of simply ignoring the ACCC's policy, no, it hasn't been tested, and it's not immediately clear how they would do that.

CHAIR: No, that's what I was thinking. I wonder where they think they're getting their authority from.

Mr Williams : That's a question we've asked, and they've said, 'Well we'd go through a recall procedure.' The problem is that, even with the recall procedure, the recalls are ultimately signed off by the minister. They can be challenged, but that starts to become a very expensive process. At the end of the day, the businesses that are supplying these are very small businesses. They are not about to spend $100,000 or $200,000 challenging a mandatory recall.

CHAIR: That's very interesting. And they are in effect telling dentists how to run their business?

Mr Williams : And a whole range of other businesses, yes. Dentistry, like most areas of health care, is in a dimension of different regulators. The Dental Board of Australia has its own guidance on who can and can't do teeth-whitening product, which itself is a little inconsistent with the mandatory standard. But that's entirely understandable because it's drawn its wisdom from the ACCC's document.

CHAIR: That's very interesting, and that is absolutely the kind of red tape that we're looking for.

Mr Williams : Dental practices by and large are small businesses. The companies that supply teeth-whitening products are by and large small businesses. I find it interesting that we're spending five per cent of our time on policy advocacy on something as esoteric as teeth-whitening products, but it is red tape running amok.

CHAIR: Yes. That's a good issue for us. The other one that I want to ask you about is the state inconsistencies in relation to X-rays and other radiology things. Could you, for the benefit of the committee, please explain the problem.

Mr Williams : Basically, as with most areas where there is no consistency between the states and territories, they do it very differently. There is increasingly some alignment, but there are different standards as to how you install them, the requirements for the installation, the levels of protection and the physical properties of the building. There are different requirements as to who can sell them. There are different requirements as to who can use them. There are different requirements as to who can interpret the image. In Western Australia, until recently, the only person who could own and operate 3D digital imaging in dentistry was a dentist who had postgraduate degrees in oral maxillofacial radiology. So, as a consequence, while there are about 400 of these machines nationally, there are only six in Western Australia. Now, Western Australia has amended its framework and has now understood that the issue of owning a machine and taking the image is very different from the act of interpreting the image.

But that's the challenge. For the industry that sells this equipment, most of the companies, by the nature of the machines, start to become quite large companies just because of the capital cost. They have to have different compliance obligations because, in some cases, for them to sell it to somebody who's not allowed to use it is an offence. Then of course there are the ethical issues. Even if they can sell it to them, should they really sell it to someone who's not allowed to use it? So they need to have a functional awareness of the eight states and territories' regulations for the supply of it.

The companies that install it have to go through a different framework. It's quite funny that an X-ray machine installed in Albury has to be installed slightly differently than one 100 metres across the road in Wodonga. It is the same problem, of course, in Coolangatta. Somehow—getting to Senator Paterson's earlier point—dentistry must be different in Coolangatta than it is just across the border, because there are different ways that the industry needs to install and own and operate them.

For healthcare professionals—which isn't our area; it's an excellent one for the ADA, the Australian Dental Association, when you hear from them later—it's equally challenging. Who can take the image and who can interpret the image do tend to vary amongst the states and territories, despite the fact that there is national licensing through AHPRA for both radiographers and radiologists and for dentists.

CHAIR: Do you think there are any benefits from one state being more relaxed—New South Wales, for example—and providing a model for the other states? Do you think that that has a positive effect at all?

Mr Williams : The best example is probably in Queensland. I wouldn't call it more relaxed, but it's certainly a more pragmatic approach as to who can own the equipment, who can take the image and who can do the diagnosis. The genesis of that was simply the geographically diverse nature of that state. What they were finding was that you might put one of these digital imaging machines somewhere like Port Douglas, but there simply wasn't the patient load to justify a healthcare professional there all the time. They came up with a framework where the machine could reside in Port Douglas and an appropriately qualified operator could take the image. They weren't the person deciding that the image needed to be taken—that was a dentist or another healthcare professional—but the very act of taking an image could be done by a paraprofessional, and then it could go off to diagnosis.

Queensland was an excellent example and, to some extent, curiously enough, Tasmania and Victoria were very good examples of a pragmatic approach. They understood the risk of the imaging but also needed to understand the access issues. Conversely, until recently in Western Australia, where all of the machines were located in the state's south west, if you needed one these high-resolution images and you were in Broome or Karratha, you were on a plane to Perth. That was the nature of it. That framework has changed. Although the Western Australian regulatory framework has caught up, there are still practical differences from a compliance point of view. Where this has particular issues is for those companies, particularly larger groups of dental practices which operate across multiple states—we're seeing some consolidation in the sector. The regulatory compliance guys have a real battle because one aspect of it is understanding their regulatory compliance for digital imaging—having to do that across six states and two territories.

CHAIR: The question is always: if you do have a nationally consistent approach, will that consistent approach be more like what Western Australia was or more like what Queensland is? You have to get the states to all agree on one way or another. Often, the highest bar is the bar that everybody else has to come to. Are you conscious of that?

Mr Williams : Yes. Now that Western Australia has adopted a framework that is different but more consistent with that of the other states, there is less of a risk that we'd end up taking the highest level of protection and completely making the system unworkable. There are some subtle differences between them. Each have their merit, but none are so restrictive as to limit the legitimate use of this technology. In some ways, it's a bit like the issue of clinical trials. The clinical trial frameworks, individually, are all very good. The problem is that you have seven or eight different systems. Each have their merits—they're all very good—but the problems are all different. That's where we are with the use and ownership of digital imaging equipment. There are variations between the states. Each set of regulations is now fit for purpose. You wouldn't have previously argued that in Western Australia. All of them can do the job. They all have their merits. None of them have a particular downside. The problem is that there are sufficient differences in there to create an additional compliance burden.

CHAIR: Without losing the advantages that you have from, say, what you just described in relation to Queensland, a pragmatic approach, how would you improve the situation without throwing out what's good about the current system?

Mr Williams : It ultimately comes down to where the regulation lies and who the regulator is. The problem here of course is actually, who are the regulators for radiation safety? That is politically a bit of a dicey issue for those of you trying to figure out where you're going to put a low-level-waste repository. It's the same regulator, quite often. The ideal mechanism to do it would be to come up with a set of standards, directions on the use, who can prescribe an image and who can interpret it and then leave it with the relevant national board. Predominantly, in our case, it would be the Dental Board of Australia. The physical requirements as to the room that its in to make sure the radiation can be contained could be readily dealt with by the building code, which of course is largely consistent. It's readily achievable, but it's a bit like the issue of clinical trials. It's like most areas of trying to harmonise state and territory regulation. There's an agreement that it should be done, but the current system isn't broken to the extent that it's not working, so there's just no impetus for reform.

CHAIR: It's a common issue. Your example of Queensland taking a pragmatic approach is an example of where the system sometimes has positive aspects as well. There's always this dilemma of how you can improve the situation and not lose the pragmatism that you're referring to. Thank you very much for coming along today; it is much appreciated.