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Community Affairs Legislation Committee - 10/02/2016 - Estimates - HEALTH PORTFOLIO - National Industrial Chemicals Notification and Assesment Scheme

National Industrial Chemicals Notification and Assesment Scheme

[21:49]

Senator RHIANNON: Could you tell us why the delay in releasing the NICNAS national assessment of CSG chemicals has occurred. I understand it was originally to be released at the end of 2013.

Dr Richards : Just by way of initial clarification, this project is being coordinated by the Office of Water Science and the Department of the Environment. In July 2012, NICNAS and CSIRO and some other parts of the Department of the Environment were contracted to do elements of this project. The partners in this project have been providing a series of reports in various draft phases to the Office of Water Science. This is a very complex project that is probably more complex than was initially comprehended when the project started and was first commissioned by the Department of the Environment. The timing of the release, the decisions around the release and, in fact, the form of the final documentation is a matter for the Department of the Environment, and I would respectfully refer the questions—

Senator RHIANNON: Can I just check—it was originally supposed to be out by the end of 2013, is that correct?

Dr Richards : The original contract with NICNAS, CSIRO and the Chemical Assessment Section of the Department of the Environment—the original memorandum of understanding—was a 12 months memorandum of understanding. I cannot comment on when the Department of the Environment intended to release the report, but the original contract was for 12 months work, which has subsequently been extended a number of times.

Senator RHIANNON: So you are saying that it is the Department of the Environment that is ultimately responsible for this time line that I am trying to work out?

Dr Richards : That is exactly what I am saying.

Senator RHIANNON: Have the sections of the work that NICNAS is responsible for been completed on time?

Dr Richards : There have been a number of project slippages at various points of the project. As with any project under any form of contract—whether it is a memorandum of understanding or a formal legal contract—there are usually clauses that allow for unexpected delays to occur and set up mechanisms for how they should be managed. There has been a steering committee that has been managing the process—agreeing or not agreeing, managing and mitigating project slippages and—

Senator RHIANNON: The question was: was NICNAS on time? From that answer, it sounds like it was not on time.

Dr Richards : NICNAS has generally met the time frames. There have been some delays, and there have been other negotiations relating to—

Senator RHIANNON: How long have those delays been?

Dr Richards : There are a whole lot of different inputs into the project. As I say, it is a very complex project. In terms of individual elements of the project and when each one was originally due, when it was ultimately delivered and the number of steps, I would have to take that on notice.

Senator RHIANNON: You can take that on notice, thank you. I understand too that the independent expert scientific committee raised concerns about the delay in delivering the final report in April 2014, and then there was a draft final report completed in October 2014. Is that correct?

Dr Richards : That is a matter for the environment department. The environment department is coordinating this project and it is their expert committee, so that is not a matter I can comment on.

Senator RHIANNON: So the lead agency is the Department of the Environment?

Dr Richards : That is correct.

Senator RHIANNON: So you are subsidiary to them? You just hand your reports over to them?

Dr Richards : That is correct. We have provided a range of technical inputs into the project and the Department of the Environment is responsible for determining how those come together and when they are published.

Senator RHIANNON: When did you send your report to the Department of the Environment?

Dr Richards : We have provided quite a range of reports in various drafts over that period of time, since the project started. As I mentioned before, I am happy to take on notice when the different drafts of the report were provided and when they were due.

Senator RHIANNON: Okay, thanks. I was interested in the predicted environmental concentrations too. Did industry have input into the recalculation of the predicted environmental concentrations of chemicals which informed the health and environmental assessments?

Dr Richards : That is a question for the Department of the Environment. The predicted environmental concentrations were calculated by the Department of the Environment. As you say, they were an input into the human health risk assessments, so NICNAS took figures from the Department of the Environment and plugged them into our risk assessment calculations, but issues around how and when those were calculated, and what the influences were, would be a matter for the Department of the Environment.

Senator RHIANNON: Just t alking about input, did industry have any input into elements of the report?

Dr Richards : As far as NICNAS is concerned, one of the early phases of the work that NICNAS did, as I have mentioned at previous estimates hearings, is that we undertook a survey of companies involved in coal-seam gas work and asked for a range of information so they provided input. This was a voluntary survey so we respectfully and politely asked if they would provide us information. A number of companies wanted to negotiate with us about the way in which any commercially sensitive, confidential information would be managed and protected in that process. So we did have interactions with a number of companies in order to obtain the information that was necessary for that work to go ahead. As far as NICNAS goes, we have engaged with companies—

Senator RHIANNON: Could you take it on notice and provide the list of companies you invited to participate, and which ones did?

Dr Richards : We do expect all of this information to be in the final report when the environment department releases it—

Senator RHIANNON: But considering it has been delayed for so long, could you take that on notice and release that, please?

Dr Richards : I will certainly take the question on notice. As I say, it is not necessarily my information to release.

Senator RHIANNON: But it is a NICNAS decision?

Dr Richards : In terms of which companies NICNAS engaged with, I will certainly take that on notice.

Senator RHIANNON: I understand that at a meeting of the IESC on the 15 March 2014, the following was minuted: discussion on the feasibility of a follow-on stage to the current national chemical assessment project. Were you aware of the discussion of the feasibility of a follow-on stage?

Dr Richards : The Independent Expert Scientific Committee on Coal Seam Gas and Large Coal Mining Development is an expert committee managed by the Department of the Environment. It is not an advisory committee to NICNAS and so any recommendations from that committee go to the Department of the Environment or the Minister for the Environment.

Senator RHIANNON: Does that apply to OWS as well?

Dr Richards : OWS is a division within the Department of the Environment.

Senator RHIANNON: I also want to ask about the communication strategy. I understand this comes up in November 2015 in some of these communications. Have you any resources allocated for a communication strategy about this matter?

Dr Richards : The matter of a communication strategy is a matter for the Department of the Environment.

Senator RHIANNON: Okay, thank you very much. Staying with NICNAS but moving onto cosmetics. Under the reforms to NICNAS that I understand have been rolled out, will NICNAS continue to assess class 3 individual chemicals for use in cosmetics?

Dr Richards : The government announced, in the context of the most recent federal budget, that reforms to NICNAS would proceed and outlined a broad framework in which a more risk-based and proportionate regulatory regime would be established. NICNAS was then given the task of consulting with the wide range of stakeholders who have interests in chemical regulation on the way in which that broad framework would be operationalised. NICNAS did, last year, release the first of a series of four consultation papers proposing a possible way forward for the purposes of consultation and we received a large number of submissions in response. We propose to release the second consultation paper next week, taking note of all the views that were expressed by the wide range of stakeholders, and further refining the proposed implementation approach.

The government announcement in the context of the budget did indicate that in developing a risk based regulatory stance, the risk posed by a chemical is a function of the intrinsic hazards of the chemical—the toxicity of the chemical, which is a property of the actual chemical substance itself—and the exposure of an organism whether it is human, animal or environmental. In looking at risk, it is a function of hazard versus exposure. It has been expressed in the first consultation paper and broadly outlined in the government decision as being a matrix, which, by developing a hazard versus exposure matrix, you can categorise chemicals into one of three class. It is proposed that class 3 chemicals, which are higher hazard and higher exposure, would continue to be assessed by NICNAS, whereas, conversely, those chemicals that are very low hazard or non-hazardous and are very low exposure would be exempt under the new arrangements. So, yes, it is proposed that the so-called class 3 chemicals, the third class of the higher hazard and higher exposure chemicals, which are therefore higher risk, will continue to be—

Senator RHIANNON: Thank you for explaining that. For cosmetics, it is often the ingredients that are coming into the country. Do I take it from that that sometimes cosmetic ingredients may be class 3, but sometimes they are not; therefore, they are assessed in different ways?

Dr Richards : That is right. This regime relates to new industrial chemicals. So new industrial chemicals are defined as those chemicals that are not already listed on the Australian Inventory of Chemical Substances. They are not necessarily chemicals that have never been used in Australia before, but they are chemicals that are not listed. Under current arrangements, a large number of chemicals are exempt from the current scheme and so each year there are close to 10,000 new chemicals—that is, chemicals not listed on the Inventory of Chemical Substances—that are introduced. But each year probably two-thirds of the 10,000 are the same as the year before and the year before that.

Senator RHIANNON: I am interested in the non-animal tested cosmetics. Is it possible for you to say that they are class 3, or would it just be very variable?

Dr Richards : It would depend on where they fell within the matrix in terms of the—

Senator RHIANNON: Right. So I need to have a more specific question, I think.

Dr Richards : At the moment, we are developing a proposal to take to government on how these reforms would be implemented. It is my expectation that the vast majority of chemicals that are used in cosmetics would be either exempt from assessment or reported to NICNAS without assessment. It would only be those chemicals that are very high hazard and a high exposure that might fall into class 3. That is a different question from 'What are the data requirements to conduct an assessment?'

Senator RHIANNON: Is it possible under this system that you could expect the new process to facilitate or encourage non-animal tested validations?

Dr Richards : Yes.

Senator RHIANNON: Can you provide an update on how many cosmetic ingredients have had manufacturers or importers applications to NICNAS to accept overseas non-animal tested substances validated in other jurisdictions?

Dr Richards : I would have to take that on notice. We did an analysis for the 2013-14 year. I am not sure that we have repeated that. It was quite a labour intensive analysis. I am not sure whether we have completed an analysis to allow an updated figure, but I could take on notice whether we have done that analysis.

Senator RHIANNON: I will just add three points, if you could take them on notice. And then I am finished, Chair. In the context of this question, could you provide the categories those ingredients belong to?

Dr Richards : Senator, could you explain. The new system with class 1, class 2, class 3 does not yet exist.

Senator RHIANNON: I see. So that is redundant. How many of those applications were for new ingredients not previously approved in Australia?

Dr Richards : As I said, NICNAS generally only looks at the new chemical ingredients—that is, chemicals not listed on the AICS. So any chemical that is submitted to NICNAS for an assessment is by definition a new chemical.

Senator RHIANNON: Thank you.

CHAIR: Senator Gallagher on NICNAS.

Senator GALLAGHER: In the interests of time, I am going to have to put my questions on notice. We have not even got to hospitals yet. This is just crazy.

CHAIR: So there are no more questions.

Senator GALLAGHER: This is crazy. We have got to sort this out.

CHAIR: It is the standing orders, unfortunately. It is people going consistently over time. That is all from this outcome. Thank you very much.

Dr Richards : Thank you.

[22:04]

CHAIR: We will now move on to population and health.

Senator GALLAGHER: I need to know where all of the money has come from for the ice task force. The government has announced $300 million over four years, the majority of that is to be administered through the PHNs. Where did this money come from? We know that some of it came from the mental health spend. Some of it is from Indigenous health—Indigenous alcohol and other drugs strategies. Where is the balance from?

Dr Southern : The balance was offset from savings in other parts of the department as part of the broader MYEFO process.

Senator GALLAGHER: How much were the broader savings that have come from the department somewhere?

Dr Southern : It is $78.6 million Indigenous-specific funding for the ice strategy. The mental health saving is in the order of $140 million, I believe.

Senator GALLAGHER: Is that all going to ice?

Dr Southern : As I understand it, yes. That is $220 million, so the balance—

Senator GALLAGHER: So you have to find about $20 million from other savings areas?

Dr Southern : Yes, that is right.

Senator GALLAGHER: That money is going to the PHNs. How will that be allocated to the PHNs and when will the money be available?

Dr Southern : It is not all going to the PHNs, although the bulk of it is. $241.5 million will be allocated to the PHNs, from 2016-17, so, from 1 July this year.

Senator GALLAGHER: When will that money be available for programs?

Dr Southern : It will be available in the 2016-17 program year.

Senator GALLAGHER: And then the PHNs will have to go through a commissioning process?

Dr Southern : That is correct. Where we are at the moment is that there is work underway on the allocation of that money to the PHNs, so assessing—

Senator GALLAGHER: How is it being done?

Dr Southern : Part of it is looking at the broad formula for allocation across the PHNs, depending on population size et cetera. But there will be another layer of analysis that goes to assessing need and where there are particular gaps in service delivery—so, balancing that up and then working out that allocation.

Senator GALLAGHER: Will it be known prior to the commencement of this?

Dr Southern : Yes. We are on track to sort out the allocation towards the end of this month.

Dr Studdert : Yes. It is taking some time to do that, in consultation with the PHNs as well.

Senator GALLAGHER: Considering that these savings have to come from one or two disadvantaged groups—from programs supporting people with mental illness and Indigenous Australians—will there be a focus through the ice task force into both of those population groups?

Dr Studdert : Certainly, the Indigenous funding will be specifically for alcohol and drug services, which go to Aboriginal and Torres Strait Islander communities and patients. There is broad recognition that in rolling out the funding for these services we would expect some synergies between the work that the PHNs are doing around the rollout of the mental health funding and the rollout of the alcohol and drug services funding, noting that in some cases we are dealing with similar groups of people.

Senator GALLAGHER: The money will become available in 2016-17. In the government's media release I think it says $300 million over four years, but the financials show it over three years only. I am interested in what happens in that fourth year of the program. What you have said to me tonight is that announcements about the money that is allocated to the PHNs, and the programs that will support, will occur in the second half of this calendar year.

Dr Southern : The funding for the fourth year is outside the forward estimates. Because the announcement—

Senator GALLAGHER: It was a four-year program.

Dr Southern : That is correct. The announcement was made in MYEFO. The four-year budget period was 2015-16 through to 2018-19.

Senator GALLAGHER: So it is $300 million over three years, because there is no expenditure—

Dr Southern : No.

Mr Bowles : No, four years. It is just that the fourth year is outside the current forward estimates, because MYEFO still picks up the forward estimates period for 2015-16, 2016-17, 2017-18, 2018-19—it does not get to that final year.

Senator GALLAGHER: Even though it is not published for that fourth year, what is the fourth year figure?

Dr Southern : It is a similar figure, as I understand it, going forward.

Senator GALLAGHER: It is 63, 40, 38—so it looks like it peaks in the first year and then goes down in the out years. Are you suggesting it is probably in the order of $40 million in the last financial year?

Dr Southern : No. The alcohol and drug treatment services funding line is in the order of $59 million for 2016-17, and $59.9 million for the following year.

Senator GALLAGHER: I was specifically talking about the ice task force, but I will put that on notice, in the interests of time.

Senator DI NATALE: I am interested in the funding that goes to alcohol and other drug services within the Indigenous sector. How do you actually quarantine funding—this is funding that comes out of recommendations from ice task force—giving money to an alcohol and other drugs sector? In reality this is not actually a response to ice. It is a response to alcohol and other drugs, isn't it?

Dr Southern : The recommendation for additional drug and alcohol services was part of the ice task force's recommendations. They talked about those services in the broad, noting that there was a heavy impost at the moment on drug and alcohol services. So there was recognition of what was happening with people who are suffering from ice addiction looking for services. There was a recommendation that there be an expansion of funding for those services. So, while it is a recommendation that has come out of the ice task force, the money will go to services more broadly.

Senator DI NATALE: So it is fair to say that some of the money from the ice task force will go to fund some people who have problems with alcohol dependence, some of the money will go to fund people who have problems with opiates dependence, and some of the money will go to fund people with cannabis dependence?

Dr Southern : The intention is certainly to address the ice problem, but noting that there is—

Senator DI NATALE: I know that is the intention, but the money is going to the alcohol and other drugs services sector.

Dr Southern : That is correct.

Senator DI NATALE: So this is not money that is dedicated to responding to the issue of crystal methamphetamine? This is money that is dedicated to the issue of alcohol and drugs?

Senator Nash: I think it is fairly simplistic to look at them separately, and it is certainly a response—

Senator DI NATALE: It is not simplistic, it is actually factually correct.

Senator Nash: No—I will get to that. You are saying it has got to be alcohol and drugs are not just ice. Obviously, we are responding to the recommendations in the ice task force. One of the issues that became really clear along the way was polydrug use—that you actually could not separate this into silos and just have ice here, alcohol here and other drugs here. So it most certainly is predominantly a response to the ice task force. But taking that into account, it was extremely difficult to just silo ice and say, 'Let's deal with that,' given the nature of the evidence that came out throughout the year when all the work was happening.

Senator DI NATALE: I am not actually being critical of the fact that more money is going to the alcohol and other drugs sector. That is a good thing. But let's be honest about what is happening. We are talking about this as a response to ice, when actually what we are talking about is a chronically underfunded alcohol and other drug sector that is now getting more funding. This is not simply a response to the problem of ice, or crystal methamphetamine; it is a response to the fact that we have an underfunded alcohol and other drugs sector.

Senator Nash: No, that is not correct. That might be your—

Senator DI NATALE: Some of this money will go to people with alcohol dependence—

Senator Nash: You cannot simply block this into silos and say, 'That won't happen.' If you have a better delivery mechanism to look after people with ice than doing it through the alcohol and other drugs sector, it would have been great to hear about it over the last year while we were doing all this work. There is no perfect solution to this. The government recognised that this is a massive problem—the problem of ice—particularly in rural and regional areas. You are well aware of all of this. But, through the work that the task force did and the work that the government did, the AOD sector was deemed as the best way to deliver this.

You are right: it is not going to be 100 per cent completely siloed for ice. Realistically, the response has been, 'Well, that's a good thing, because we can actually deal with the polydrug use in the same way that some of the funding is tied up with mental health.' It is a similar sort of thing: a lot of the time you cannot separate the ice issues from mental health issues. We think it is the most appropriate way to try to deal with that.

Senator DI NATALE: You are not going to get an argument from me about a bigger investment in alcohol and other drugs funding, it is just that this is a funding response to the problem of alcohol and other drugs—not simply to ice. But let's move on.

How is this going to work with the integration of flexible funds?

Dr Southern : The funding that we are talking about here sits outside the flexible funds.

Senator DI NATALE: I know that the funding does, but will it fund some of the same programs that are delivered through flexible funds?

Dr Southern : The proposal at the moment is that alcohol and other drug services, which are currently through two of our funds—one of which is the flexible fund and one which is not but which, as a bucket of money, is directed towards services—will continue. Those services have been advised that there is another 12 months of funding for 2016-17. The funds for those services will come out of the existing buckets of money. As the secretary was explaining earlier today, as part of the process that we are going through at the moment to consolidate funds we would try to bring together the different funding sources we currently have for alcohol and other drugs.

I do not know what we might end up calling it—a drug program or an alcohol and other drug program. That would be the opportunity to bring together funding which currently supports alcohol and other drug services which, as I said, partly comes from a flexible fund and partly from the non-government sector organisation's fund. I cannot remember its full title. It is not actually a flexible fund, but we have already pooled those two sources of funding together to support alcohol and other drug services. Then the funding in response to the ice task force will be brought together with those two other sources.

Senator DI NATALE: With the commissioning process from the PHNs: there is obviously a lot of variability here. How do you ensure that you are getting consistency across all PHNs in terms of the response? One PHN may decide to spend all the money on prevention, with the focus on prevention. Another PHN might decide that detox services need to be prioritised. Others might decide that it is rehab—inpatient beds and therapeutic communities. There are so many different possible responses. So you might be living in an area with a PHN that thinks it is a good idea to pour all their money into one part of the response. How are you going to ensure that there is actually some consistency in terms of the responses across all the PHNs?

Dr Southern : Another piece of implementation work which is underway at the moment is developing the program guidelines for the PHNs in relation to the alcohol and other drugs service funding. That is a piece of work which is underway at the moment, being developed jointly between the Population, Health and Sport Division and our colleagues who are managing the PHN process.

There will be a set of program guidelines around what the funding is intended to do. The PHNs are doing their needs analyses at the moment and you would expect that depending on the population needs of a particular PHN there might be variation in the services they are delivering. But as long as they are within those broad program guidelines and they are meeting the needs of their target populations then you would expect there would be some variation. But we want to be flexible in how it is rolled out.

Senator DI NATALE: I have a few others, but I will put them on notice in the interests of time.

Senator MADIGAN: In October last year I asked about what the Department of Health has done about making doctors aware of tick borne diseases other than Lyme diseases—anaplasma, mycoplasma and rickettsia. I was referred to the Lyme disease page of the department's website, which does not answer the question. Again I ask the question, as I believe two recent research papers, the result of ARC grants, indicate that Australian ticks are carrying significant amounts of known pathogens.

Mr Bowles : The expert is not here, but Professor Baggoley might be able to help a little bit. I meant, Dr Lum is not here.

Prof. Baggoley : As I understand it, the question relates to research from Professor Peter Irwin of Murdoch University and his work on ticks and their content. Is that what you were referring to?

Senator MADIGAN: Yes.

Prof. Baggoley : What he has discovered, as you are aware, is a number of bacteria that have not been discovered previously. And he has found I think one borrelia with the samples that he has taken from quite a range of ticks, and that was taken from an echidna. His point is that he has found these different bacteria, and whether they cause disease or not he cannot tell, and certainly further research needs to be done in that area. He is quite correct in that.

Senator MADIGAN: In October last year I also asked about the Australian diagnostic guidelines for Lyme disease. I was answered that the department's guideline for overseas acquired Lyme disease. What I do not understand is that the department has omitted the single diagnostic sign determined by the CDC in the US for Lyme disease acquired there, that unequivocally diagnoses Lyme disease—that is the, pathognomonic bull's-eye rash. Why has this been omitted from the diagnostic criteria of the Australian guidelines?

Prof. Baggoley : The issue relates to the amount of borrelia. For example in those endemic parts in the US they know they have the borrelia and they have found them, which is associated with that rash. But of course that rash is not found only with Lyme disease. Rash like that can be found with a whole range of diseases. The issue for us here is that the rash is not itself pathognomonic, because of the other conditions. And as you know, and from Peter Irwin's work, we still cannot find the borrelia that causes the rash in the US and parts of Europe and so on. It is not found in this country. We do know with Peter Irwin's work, when he was looking for the ticks in this country, looking for borrelia and was unable to find them, he took as a control group or a comparison group ticks from Germany, where he was readily able to find them. There are a range of conditions that can cause that rash, and that is why in this country, in the absence of borrelia that we have been able to find—and recent research is still backing that up—it is not pathognomonic.

Senator MADIGAN: So can you explain to me then why the Australian diagnostic guidelines differ from the USA? As you said before they have an enormous amount of cases of that. I think it is around 300,000 cases per year.

Prof. Baggoley : Yes.

Senator MADIGAN: And they have a great deal of experience in the diagnosis of Lyme disease. Why are we not using their diagnostic guidelines?

Prof. Baggoley : Well we have just spoken about that pathognomonic rash for example, and that is because they have lots of borrelia and we do not. The key question comes back to your original question. We know our ticks have lots of organisms in them. Is it possible that those organisms are causing a disease from which people are suffering? It is possible, but we have not yet been able to demonstrate cause and effect. But it does not look like it is going to be borrelia.

Senator MADIGAN: So in the case where we have people that have Lyme disease or Lyme-disease-like symptoms, where overseas they are given a course of antibiotics as a safeguard, why then would we not take a proactive approach and give these people who present with a tick bite a course of antibiotics? We take dogs to the vet when they get a tick bite.

Prof. Baggoley : Yes, we take dogs to the vet, and ixodes holocyclus causes dog paralysis. Of course, the treatment for that is not antibiotics. There is rhipicephalus sanguineus and also the kangaroo tick that can cause problems. But on the issue of giving antibiotics for a short period of time, doctors are entitled to treat as they see fit, and for acute conditions and if they are concerned that this might be Lyme disease. Particularly for people who come from overseas, our laboratories do regularly pick them up with serological tests and can help make that diagnosis. So it would make sense to take a blood test, particularly for someone from overseas. They could do the test to help with the diagnosis. If they believe someone has had a bite from which there could be a bacterial infection then there is no reason people cannot do that. The issue, as we were discussing this morning, is the large number of people with chronic conditions and the variety of symptoms and how they are best managed and what might be the cause of their illness. But in the acute setting it is not unreasonable to be doing that.

Senator MADIGAN: It is seared into my memory when I visited people who are suffering, like Amy O’Sullivan in Melbourne, and Alex Fenech, and Lisa Gumieniuk in Sydney. All of this is enhancing their problems. They are suffering as are hundreds of other Australians, possibly thousands, that do not know about what is going on. You say they can go to a doctor; you say they can be treated, but the fact is that they are not getting treated. There are very few doctors who are willing to treat them. They have been to more doctors than they care to count, and here we are, from October last year to February this year, and there are still no answers for these people. There are less doctors who are treating them. What do you say to these people? When are they going to get some answers? Because currently the number of doctors who are prepared to treat them are being knocked off, with conditions placed on them, and they are unable to treat these people.

Prof. Baggoley : We had this discussion this morning, and I have been able—

Senator MADIGAN: But you did not answer the question. These people are sitting at home tonight and they are suffering.

Prof. Baggoley : They are and they need medical help, and—

Senator MADIGAN: Well, they are not getting it. You tell me they can get it—well, point me to where they can get it.

Prof. Baggoley : They can get it. They can go to doctors who can make an assessment and treat as they see fit, which is what they are doing. They are having problems, because there is one doctor for whom you are concerned, who has restrictions placed on his practice—

Senator MADIGAN: No—seven doctors have been knocked out across the country.

Prof. Baggoley : Sorry, Senator—not all seven have restrictions. Some have been reviewed by the Medical Board but they do not have restrictions, and I think you and I both know who they are. The doctor in Melbourne is undergoing an appeal process. The way with this is not to be throwing accusations, one group at the other. The only way that this is going to be sorted out is if people come together. Just as there are doctors who feel that they are unable to treat the patients and have a concern that the Medical Board is after them—and that is an accusation that you have made to them—there are other doctors who, because of the controversy about this, just do not want to have anything to do with this group of patients. This is only going to be solved when the medical profession works together to sort this out, which is what we have been trying to do for the last three years. That is why we had the clinical advisory group on Lyme disease, which I put together. Senator, you cannot insist on a doctor adopting a certain line of treatment if they do not believe that is right for the patient. That is really important. What we are trying to do—and, as I explained this morning—is to have the Department of Health work with the people at Austin Hospital to try to get a multidisciplinary approach for these patients. It is not acceptable that these patients believe they have nowhere to go. The treatment that they get must be based on sound clinical diagnosis, testing and evidence. That is the only way to take this forward, and people working together, not throwing bricks at each other, will make a difference.

Senator RHIANNON: I have a question for the National Health and Medical Research Council. It is about the three baboons. Could you inform the committee on what has happened to the three baboons—I understand they are called Scar, Belvedere and Frazer—who were used in experiments at Westmead Hospital.

Prof. Kelso : I am sorry that in moving to the table I did not hear all of your question.

Senator RHIANNON: I will repeat it: what has been the fate of the three baboons—I understand they were called Scar, Belvedere and Frazer—who were used in experiments at Westmead Hospital.

Prof. Kelso : I am sorry, I do not know the answer to that. The NHMRC is not responsible for monitoring the animals in the baboon facility, so we do not have that information.

Senator RHIANNON: Once the institution is experimenting on the animals, it is no longer under your responsibility?

Prof. Kelso : At no point are the animals themselves under our care or responsibility.

Senator RHIANNON: Thank you.

Senator LEYONHJELM: I would like to ask some questions in relation to the plain packaging tracking survey. I am referring to the plain packaging tracking survey which the department had the Cancer Council of Victoria undertake. Was there a competitive tender for that survey?

Dr Studdert : We will have to take that question on notice.

Senator LEYONHJELM: The chief of the program, I understand, was Professor Melanie Wakefield. Is that correct?

Dr Studdert : Yes, Senator.

Senator LEYONHJELM: Was Professor Wakefield a prior advocate of plain packaging?

Dr Studdert : Professor Wakefield has been involved in a wide range of tobacco related research over many years. I do not think it would be fair to say that she is an advocate. I think she is a researcher who has done a broad range of research in a range of areas related to tobacco control.

Senator LEYONHJELM: I am aware she has done a lot of research in this area, but my question is: has she been a prior advocate of plain packaging?

Dr Studdert : As I said, I do not think we would categorise her as an advocate. She has been a researcher for many years in a range of fields related to tobacco control.

Senator LEYONHJELM: So you are saying no, she is not an advocate, yes, she is, or you do not know?

Dr Studdert : Those are not the terms of our engagement with her over many years in relation to tobacco research.

Senator LEYONHJELM: Yes, I know, but you have done a lot of work with her and she has done a lot of work with you. Are you saying you do not know what her views are?

Mr Bowles : I think that what was said is that she has worked in the field of tobacco control for a long period of time.

Senator LEYONHJELM: I heard that, Mr Bowles. I am still interested in the answer: do you believe she has been an advocate of plain packaging?

Dr Studdert : I think she has been an advocate for supporting the evidence base for good policy measures. Yes, I think many—

Senator LEYONHJELM: Would she consider good policy to be plain packaging?

Dr Studdert : I would say yes, because she has done a lot of research in this area and knows the evidence base that supports that policy.

Mr Bowles : That said, it is probably a question best asked of her.

Senator LEYONHJELM: Yes. It is inconceivable given the longstanding relationship between the department and Professor Wakefield that you do not know what her views are.

Mr Bowles : No-one said the views were not known. She is a long-term researcher in tobacco control, so there will be elements of plain packaging, as there will be other elements of tobacco control. I just make the point that we cannot really talk on her behalf about some of her beliefs and all those sorts of issues.

Senator LEYONHJELM: Nor was I ask you to speak on her behalf; I was asking you what your understanding of her views are. I think Dr Studdert has answered that. Did the contract for this study require only the generation of survey data or did it also require reporting on the data?

Dr Studdert : It required the data and the analysis and reporting.

Senator LEYONHJELM: Was the value of the contract $3 million?

Dr Studdert : I do not think we have that detail with us today. We can certainly take that on notice.

Senator LEYONHJELM: You can take that on notice. Are you able to provide the contract?

Dr Studdert : I would have to get advice on that.

Senator LEYONHJELM: Put that on notice as well, if you can, to please provide it. Your department's website says that the key findings of the survey were that the objectives of tobacco plain packaging were achieved. Given that is a departmental website—we are not referring to Professor Wakefield's here—can you tell me: was there a key finding from the survey that plain packaging improved public health?

Dr Studdert : I will ask my colleague Jackie Davis to answer that. It goes to the mechanisms that the policy measure was established for and the evidence that we have to support the view that those are working.

Ms Davis : The language on the website reflects the broad findings in the BMJ articles published on 19 March last year. They were referencing the proximal objectives as they are referred to in those articles. I think the department ordinarily now refers to them as the mechanisms, which are found in section 3(2) of the Tobacco Plain Packaging Act under the objects of the act.

Senator LEYONHJELM: Yes, that is why I am asking the questions. Was there a key finding that plain packaging improved public health? That is one of the objectives.

Ms Davis : The tracking survey and the BMJ articles that relate to the tracking survey were not designed to measure prevalence and cannot measure prevalence.

Senator LEYONHJELM: So it did not measure whether there was increased giving up of smoking?

Ms Davis : As I said, the design of the tracking survey and the articles in the BMJ that discuss it largely related to the section 3(2) mechanisms—so reducing the appeal of the packet, increasing the effectiveness of graphic health warnings and minimising the pack's ability to mislead. In the long term, those three mechanisms work to reduce prevalence.

Senator LEYONHJELM: How do you know? The post-implementation review is intended to determine whether the objectives of the legislation are being achieved.

Ms Davis : That is correct, and the post-implementation review looks at evidence that goes to both section 3(1), which is the broader public health objectives that you are speaking of—the longer term ones—and also the mechanisms by which those objectives are intended to be achieved, which are the proximal objectives.

Senator LEYONHJELM: The objects of the act are to improve public health, so if we cannot tell from the survey that the introduction of plain packaging improved public health then we have not established whether the act is doing what it is intended to do.

Dr Studdert : I think we have to recognise that there are other surveys that are on track at any point in time that look at the prevalence issue. The tracking survey was to track those proximal indicators in the short to medium term, because we knew it would take some time, as a long-term public health measure, to be able to see those prevalence changes that were, as my colleague said, the primary objective of the legislation.

Senator LEYONHJELM: All right. The most basic of these objectives is an objective to reduce the taking up of smoking, relapsing into smoking or exposure to smoke. Did the survey establish any of those?

Ms Davis : I think we have answered the question. The survey is not designed to look at the long-term objectives of plain packaging. It is a cross-sectional survey that is most suited to looking at the proximal objectives, which are the three mechanisms. Public health studies cannot all achieve every public health objective. This particular study was most suited to measuring the proximal objectives, which are the three mechanisms. There are other research studies that look at the longer term objectives, such as longitudinal studies, or we have the—

Dr Studdert : The National Drug Strategy Household Survey, the survey of children and young people—

Senator LEYONHJELM: Yes, except that your website says:

Key findings:

Reduced appeal of packs, increased health warning effectiveness—

which is what you have mentioned—

some improvement in correcting misperceptions of harms; the objectives of tobacco plain packaging were achieved and sustained among adult smokers up to 12 months after implementation …

The objectives of plain packaging legislation were to improve public health by discouraging people from taking up smoking, encouraging people to give up smoking, discouraging people who have given up smoking from relapsing, and reducing people's exposure to smoke. It did not answer any of those questions.

Dr Studdert : I think we have clarified that there were primary objectives and secondary objectives. The evidence that you have just mentioned goes to supporting those secondary objectives, and we are looking to the longer term tracking surveys to give us the evidence around the primary objectives, and that is starting to become available already.

Senator LEYONHJELM: Did your department see the journal articles that you are referring to that were reported in the British journal Tobacco Control prior to peer review or prior to publication?

Dr Studdert : I believe we would have had reports, but I do not think we saw the articles.

Ms Davis : We did, but we did not comment on them.

Senator LEYONHJELM: One of the articles cited by the department is a report on survey data entitled 'Short-term changes in quitting-related cognitions and behaviours after the implementation of plain packaging with larger health warnings', by Sarah Durkin and others. Even though the article does not seek to report on the rate of giving up smoking, Professor Sinclair Davidson of RMIT argues on the Catallaxy Files website that table 1 of the article indicates that the rate of giving up smoking fell in the first year of plain packaging. Are you familiar with that article? Can you confirm that this conclusion can be drawn from table 1 of the article?

Ms Davis : I am familiar generally with the article, but I would need to have a look at that table.

Senator LEYONHJELM: I will give you some more questions. If you wish to take them on notice, that is fine. Can you confirm that this conclusion can be drawn from table 1 of the article—in other words, that the rate of giving up smoking fell in the first year of plain packaging, based on that article? Does the survey data indicate a fall in the rate of giving up smoking? That is a similar question. There is another related question. Professor Davidson has sought this survey data so that he can independently analyse it. Have you provided that to him?

Ms Davis : The survey data from the tracking survey is available on request. We have had a number of requests for the survey data. All the requests have been answered by providing the underlying data, so, if he has requested it, then, as far as I am aware, it would have been provided. But we can take that on notice.

Dr Studdert : Can I just say that one year is a very short time in the long-term tracking of any measure related to the use of tobacco, so I think we would be cautiously interpreting that.

Senator LEYONHJELM: I think 'caution' is the appropriate word. It is a short period of time, I quite agree, except that some amazing conclusions are being drawn from what seems to be a very flimsy statistical base. Speaking of short terms and flimsy statistics, today I received a reply to a question on notice from Treasury which advised that in period of the 12 months ended November 2013 and the 12 months ended 30 November 2012 there was a 0.8 per cent decline in tobacco clearances, excluding tobacco refund scheme refunds. This is 0.8 per cent in the period of 12 months immediately before plain packaging and 12 months immediately post plain packaging. Your website refers to this as 3.4 per cent. There is an extra month included in your calculation of 2012 and an extra month in your calculation of 2013, the difference being that plain packaging started in that extra month in 2012 and, in 2013, there was an excise increase. So, comparing like with like, and Treasury has confirmed this, the accurate figure of pre and post tobacco clearances was a reduction of 0.8 per cent. Have you looked at that? Are you aware of that calculation? I understand Treasury consulted you in preparing that answer for us.

Ms Davis : Yes. The information on our website, which is quite old now, was in direct response to an article that appeared in The Australian some time ago which quoted a particular figure for the 2012 calendar year. We, at the time, engaged with Treasury and they provided the 3.4 per cent figure as the calendar year response. So that information is directly referable and responsive to an article that was in The Australian some time ago. But the information can vary, depending on what point in time you choose. For example, October was the date when plain packaging was commenced, and it only became fully effective in December 2012.

Senator LEYONHJELM: Do you intend to modify your website to say that, comparing like with like, the reduction was 0.8 per cent? It gives the impression that it had an immediate, substantial impact on clearance rates.

Ms Davis : We have no intention of suggesting that clearance rates are a direct measure of tobacco plain packaging effects. In fact, they are not designed to measure the effects of plain packaging or, indeed, any particular tobacco control measure. They are one indication amongst many of whether plain packaging is working, including the ABS household expenditure data, which has, between September 2012 and September 2013, dropped by a total of 20 per cent. The prevalence data suggests that prevalence has had the most substantial drop in 20 years since plain packaging, together with the behavioural studies that you mentioned earlier in the BMJ. We look at the totality of the evidence, but certainly with the clearance data we would say that since 2012 there has been an 11 per cent drop in total. It is consistent with plain packaging working, but we do not hold out the clearance data as a measure of plain packaging working or, indeed, any other tobacco control measure. It is not designed to measure tobacco control.

Senator LEYONHJELM: Okay. The National Drug Strategy Household Survey is perhaps, I would have thought, the best indicator of smoking levels because, as you say, it is not based just on clearances. Clearance is just one measure. You would expect it to be reliable because it captures not only the legal tobacco market but also the illegal tobacco market. Whatever people think, if they are smoking tobacco, it should capture it. We have looked at the figures since 1991 and there is an almost straight line decline in smoking from 1991 to the period when the most recent data is available, which is 2013. There is absolutely no substantial blips that I can attribute to any particular policy over that period. Do you have any evidence to contradict that?

Ms Davis : Yes, we do. I accept that your modelling may show a straight line, but our modelling suggests that it is a beyond trend drop, especially since plain packaging. As I said, since 2012 it has been the most substantial drop in 20 years. We do not say that is entirely attributable to plain packaging, but it is a beyond trend drop. The other notable thing to take account of, particularly in relation to tobacco control measures, is addiction. You cannot just draw a straight line without interventions assumed that there will be continuing declines because of the addictive nature of tobacco. In the absence of interventions, there is a lot of evidence globally to suggest that prevalence will actually rise rather than continue to drop.

Senator LEYONHJELM: The Chair is winding me up. I would like you to provide that information on notice, if you could please.

Ms Davis : We can certainly provide that.

Senator LEYONHJELM: What I am looking for on notice is what contradicts my graphing of the household drug survey showing a straight line decline since 1991.

Senator LUDLAM: I will try to do this justice in seven minutes. We have still got the NHMRC here—I have some follow-up questions on ME/CFS to those that I put to you last October. it is myalgic encephalomyelitis, or chronic fatigue syndrome. Some of the material that you provided us with—and some came in a bit later on notice. Thank you for that. I asked you about the research investment in ME/CFS since the year 2000. You provided information that said it totalled around $2.4 million. With a bit of assistance I have gone through the research you identified and about two-thirds of the funding appears to be going into research that, however worthy it may be, actually has nothing at all to do with ME/CFS. Can you either correct the record or point out how this research is actually directly relevant to the questions that I asked?

Prof. Kelso : Our latest analysis, which is also going right down into the detail of the grants, identifies four grants which, as far as I understand, really do directly investigate or are related to ME/CFS. One was a grant for 2001 to 2005 to Professor Ian Hickie. Another was a grant for 2003 to 2004 to Helen Kelsall, not Kelso. There were two grants to Professor Andrew Lloyd for 2008 to 2017. These are fellowships, and he has had a longstanding interest in ME/CFS and related syndromes, particularly their relationship to glandular fever and illnesses like that. My understanding of the analysis of those four grants—which come to less than $2.4 million; they come to $1.6 million—is that they are all directly related to ME/CFS.

Senator LUDLAM: So, it is a bit less than we thought last time; it is four grants in 16 years—

Prof. Kelso : That is correct.

Senator LUDLAM: that are directly relevant. Just for backup: looking over a paper from the Griffith University National Centre for Neuroimmunology and Emerging Diseases provided us with some figures that they estimate that between 0.2 per cent and two per cent of the Australian population have the illness. The first thing I found remarkable about that is that there is an order of magnitude in the estimate so that we do not know whether it is 460,000 or 46,000 people, which I found remarkable, but that there has been only that remarkably small amount of funding since the year 2000. Do you know either off the top of your head or from information that you have there at the table whether any of those four research papers were recommending or investigating either cognitive behavioural therapy or graded exercise therapy? Or were they unrelated to that?

Prof. Kelso : I do not have enough information today to answer those directly. I think we can provide that.

Senator LUDLAM: Perhaps I could put these on notice, given how late it is and how close we are to close of play. You also identified that there is no federal funding outside of the NHMRC grants you identified. Actually, I think this came through the secretary rather than from you. I am just wondering: with the other things we have identified, there is no accredited training listed on RACGP that we have been able to find; there is no other dedicated training funded for nurses or allied health staff that we have been aware of. Have you been able to identify anything since last October where anything up to 460,000 people appear to be going without any material support at all? Have you been able to find anything in the system?

Mr Bowles : I have not been able to find anything, but I would need to take it on notice to determine whether anyone else has been able to—

Senator LUDLAM: Well, you did last time, so I presume it would be—

Mr Bowles : Yes, and there was nothing there—nothing at that point.

Senator LUDLAM: So, what do we need to do to fix this? I have not come across, as I said last time—it is a little bit similar to some of the conditions that Senator Madigan is pursuing. A huge cohort of people, and there is not even accurate diagnosis to within an order of magnitude to identify the number of people. Some early research work that I saw identified that up to 46 per cent of these individuals are housebound and six per cent are bedbound. When are we going to start seeing some action? For example, one of the previous witnesses was speaking of a clinical advisory group into Lyme disease. What would it take—maybe through you, if you like, Senator Nash—to get a clinical advisory group established for ME/CFS sufferers? What is the process? I am looking for any suggestions, bright ideas, from anybody at the table or in the room, because there is nothing going on.

Senator Nash: I am happy to take that on notice for you.

Senator LUDLAM: Yes, if you could. What would a clinical advisory group do in the context of what I think Senator Madigan was advised on Lyme disease? What do such entities do?

Mr Bowles : We will take on notice the concept that you are putting around that and get some advice to you on notice.

Senator LUDLAM: Thanks. I am also pretty open to counterproposals. The last time we spoke about advocacy funding, and you did not completely close the door on it, which was good. I am wondering whether the government would consider funding a group like Emerge Australia to continue their work on improving the quality of life?

Mr Bowles : We will take that on notice as well.

Senator LUDLAM: No, but you did last time.

Mr Bowles : And what did we say last time? I cannot remember.

Senator LUDLAM: I do not think I actually got an answer back. You acknowledged that the door was not completely—

Mr Bowles : We answered all our questions, so if that is a specific question—

Senator LUDLAM: Maybe I was not quite as blunt.

Senator Nash: We will revisit that, Senator.

Senator LUDLAM: Would the Commonwealth government be able to find it in its heart—

Mr Bowles : Be blunt this time and we will answer you.

Senator LUDLAM: and we will see you in May—to fund Emerge Australia? They do remarkable work. I have drawn on them pretty heavily, even in the preparation of the research for tonight. Up to 400,000 people, and they are getting by with basically bugger all—a little bit of funding from the Victorian government, which I acknowledge, and that has been valuable. There has been nothing at the Commonwealth level. What do we need to do to jump-start some support for these people? I am really open to proposals.

Mr Bowles : As I said, we will take it on notice.

Prof. Kelso : Perhaps I could tell you something that I think is very encouraging: the Director of the National Institutes of Health in the US announced in October a call for research in the US on ME/CFS. When I was at a meeting in London with him in December he mentioned the fact that this is a very important syndrome that has been poorly recognised and is clearly not understood, and he thought it was time for there to be a significant effort to understand it. I thought that was really excellent news, because we know that the NIH has a budget of more than $30 billion a year for health and medical research, and they have the capability to attract interest to the disease. I think that is going to be a very important stimulus to the field, potentially also in Australia, so of course we hope for great things to come from that research.

Senator LUDLAM: Can we step up the research effort at this end? I want to acknowledge the leading research that goes on at Griffith. It is not that it is a complete wasteland, but there is actually nothing there for patients and for sufferers. The research is good. It is isolated. So, I am just wondering whether you are able to provide us—we talked last time we were here about the possibility of funding some of the more big-picture research. Or you are even proposing to do surveys; I forget the exact process. Do you have any update in that area?

CHAIR: It will have to be very brief.

Prof. Kelso : The process we are looking at is establishing a clear mechanism for determining priorities for targeted funding for particular topics, and ME/CFS could be one of the topics that could be considered for that. I think this will be a new approach on our part as to how we deal with these issues that come up where we are not getting investigator initiated applications.

Senator LUDLAM: How will the public know about when that process starts?

Prof. Kelso : Once this whole process has been developed and has gone through our approval processes—because it is a new mechanism—then we will have, through our website, some form of opportunity to respond. And of course we get many letters about particular issues, and they will feed into our consideration of priorities for targeted funding.

CHAIR: Just before we close, I have been advised by other senators that it is likely that they will be requesting an additional day to cover areas we did not get to cover, particularly acute care, sport and FSANZ. So there will no doubt be some correspondence in due course, once the committee has formally met and resolved such. With that, thank you, Minister, and Mr Bowles and all your officials. We apologise to those we did not get to, but thank you very much for being available.

Committee adjourned at 23 : 02