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Community Affairs Legislation Committee
19/10/2011
Estimates
HEALTH AND AGEING PORTFOLIO
Department of Health and Ageing

Department of Health and Ageing

[10:16]

CHAIR: We will start with corporate matters.

Senator FIERRAVANTI-WELLS: I begin with answers to questions on notice. Minister, the other day Minister Ludwig was asked questions in this area and there was a debate in the Senate on 13 October around a number of remaining questions on notice. Ms Halton, as you know, a routine area of questioning is the table relating to GP superclinics. I thank you for your cooperation and that of your officers, who have routinely provided this table to us. So it was with some surprise that we noticed that on this occasion it had not been provided. A reference was made to it the other day in the Senate. How long have answers to questions Nos 464 and 465 been sitting in the minister's office? Or perhaps I could ask: when were the questions forwarded to the minister's office?

Ms Halton : I actually do not know that I have that with me. You are asking for?

Senator FIERRAVANTI-WELLS: I am asking for when you sent them to the minister's office. I really want to know how long they have been sitting in the minister's office.

Ms Halton : We will have to take it on notice, if that is what you want.

Senator FIERRAVANTI-WELLS: Senator McLucas, for the record, I lodge a formal complaint in relation to this. It was raised with Minister Ludwig and I am surprised, actually. Since the matter was raised in the chamber on 13 October, I would have thought that one of the officers would be aware of that, Ms Halton. Perhaps inquiries can be made and we can deal with it later this morning.

Ms Halton : I have brought every variety of statistic on how many we have answered and in what time frame, but I do not have that, I am sorry. I have pages of numbers!

Senator FIERRAVANTI-WELLS: That was the one that was most pertinent under the current circumstances.

CHAIR: Would you like to table those numbers, Ms Halton?

Senator FIERRAVANTI-WELLS: Ms Halton has all sorts of numbers.

Ms Halton : Yes, I have all sorts of numbers.

Senator FIERRAVANTI-WELLS: She carries them in her head.

Ms Halton : That is true—I do, actually.

CHAIR: That list is all about questions on notice? We will take what you can give us. It would just be useful for the committee.

Ms Halton : We will give you something. We will just take one teensy bit out of this, which is for my benefit, and we will table it.

Senator FIERRAVANTI-WELLS: Thank you. I will move now to questions in relation to health reform. Ms Halton, so that your officers are aware, I will deal with some general questions on health reform will be looking at areas pertinent to Tasmania, Queensland and other states. I would like to ask some general questions on staffing and bureaucracy, Local Hospital Networks, Medicare Locals and lead clinicians groups and will possibly have some questions on staffing and consultancies in this general area. If not, I will put those on notice. I thought I would mention that up-front.

Ms Halton : I will just make one observation—I have the transition office staff here. Some of these matters are now dealt with in divisions, so some of them may be under the program area. Why don't you barrel away and we will see what we can do with the transition people and then we can make a note—

Senator FIERRAVANTI-WELLS: You have lost Mr Head!

Ms Halton : I know. There is group weep about this.

Senator FIERRAVANTI-WELLS: His sense of humour will be missed.

Ms Halton : His sense of fashion and sartorial elegance will be missed, his sense of humour will be missed, his intellect will be missed and, yes, he will be missed. He was a great colleague and we are very sorry. He has gone to do an important job. That we understand. We are thinking about forgiving him in about 50 years time.

Senator FIERRAVANTI-WELLS: I will start. I note the health agreement or the last reiteration of it was signed I think on 1 August. I have mine dated 1 August.

Mr Maskell-Knight : The date I believe is 2 August.

Senator FIERRAVANTI-WELLS: This has now been going on since 2007. Are we able to detail the costs that have been associated with health reform? Since 2007 is there a sort of global figure, Mr Maskell-Knight, that can be associated with how much the health reform, health reform promotion and stops and starts have cost us? Is that a figure you are able to give us?

Mr Maskell-Knight : I do not think there is a global figure readily at hand and I doubt it will be possible to readily construct one. We could probably—relatively easily—answer questions about communication costs but in terms of staffing costs and associated costs I think it would be very hard.

Ms Halton : Yes, it would be.

Senator FIERRAVANTI-WELLS: All right. I might come to those in more specific detail later. I notice that we now have a new purple book.

Ms Halton : It is called purple but I think it is more aptly described as lavender.

Senator FIERRAVANTI-WELLS: As opposed to the mustard yellow or the other description that you have given it in the past!

Ms Halton : The alternative label for mustard yellow is not a label—

Senator FIERRAVANTI-WELLS: Senator Siewert, I was not going to go there!

Ms Halton : What did Senator Siewert say, Senator, I missed that.

Senator SIEWERT: Baby poo!

Ms Halton : Yes. Now you have said that on the record—I could not possibly have!

Senator FIERRAVANTI-WELLS: I have done a comparison as best I can in relation to these time lines, and this time line here and now—the time line in this book—which starts at page 5. I appreciate that there are some matters which are different and some additional matters in that time line. My question is: are you confident now that the department and the government can meet the delayed time lines? A lot of these appear to be delayed. I have put crosses next to the ones that have not been met and that have been shifted sidewards. Are we confident we are going to be able to meet these delayed time lines—for example, in relation to accessing elective surgery, the funding components and the long-stay older patients?

Ms Halton : I am not aware that there are delays for those. We would have to have a look and compare. Can you tell me where you are reading exactly?

Senator FIERRAVANTI-WELLS: I have done a comparison of the time lines set out in the lavender book as opposed to the mustard yellow book and there appear to be shifts. For example, take access to elective surgery. In this book it is talking about July-September 2011 but now that has shifted to January-March 2012.

Ms Halton : I need Ms Flanagan for this one.

Senator FIERRAVANTI-WELLS: Ms Flanagan to the rescue?

Ms Flanagan : What has occurred with this particular target is that it was agreed in February at the COAG meeting that an expert panel would be set up. I think we talked about the expert panel, and Chris Baggoley, of course, chaired that. The expert panel was asked to look again at the time lines for the achievement of the elective surgery targets and EDs et cetera and came up with a series of recommendations that were incorporated in a revised national partnership agreement that was signed by all governments in August. The reason that those have changed is based on the recommendations of the expert panel.

Senator FIERRAVANTI-WELLS: What about delays in relation to establishing the hospital networks and Medicare Locals, for example? There are revised time lines, if I could put it that way. Are we confident of meeting those time lines. That is really my question, Ms Flanagan.

Ms Halton : Let us talk about Medicare Locals for a second. You know that they are being established in three tranches, the first tranche of which was announced and indeed established on 1 July. I am looking around the room to make sure I am right. Thank you. As you are probably aware, we had an advertising and application process in relation to the next tranche. Those applications are currently being assessed. We expect there to be an announcement about those shortly, with the tranche due at the beginning of next year. The final tranche is due in mid-2012. Again, I would have to get the books out to compare precisely, but I think that is basically what we said we were going to do.

Senator FIERRAVANTI-WELLS: Having started the exercise, what I might do is go through this exercise but on notice. Time precludes me from doing it now. I really want to do a comparison of the times just to make sure of the assurances. We have seen times slipping and I want to get a fix at this point in time: are we going to meet those deadlines?

Ms Halton : The thing I can be quite confident about is, as I said, on Medicare Locals and the process is absolutely well underway. I know because there are people in the department who have been working their way through the next tranche of applications. So that I am completely confident on that.

In terms of the LHNs, the states are well underway with that. Acknowledging that we are not doing that ourselves—it is being done through the states—I have no reason to believe that they will not be up and moving in the timeframe that was agreed.

Senator FIERRAVANTI-WELLS: In relation to Medicare Locals, how many of the contracts were signed by 1 July? Will that be a question specifically in Medicare Locals?

Ms Halton : Yes, but we can give you the timetable for when they were each signed.

Senator FIERRAVANTI-WELLS: Perhaps the officers from Medicare Locals will answer that when they come to the table.

Ms Halton : Yes.

Senator FIERRAVANTI-WELLS: In relation to the deadline for the introduction of Activity Based Funding for 1 July 2012, are you confident that that is going to be met?

Ms Halton : Mr Charles Maskell-Knight might want to give you a fuller answer on this. As you would be aware, the work on ABF—Activity Based Funding—has been underway for quite a long time. The interim pricing authority was stood up on 1 September, with Dr Tony Sherbon, who is I think known to this committee and others, as the interim CEO. That was precisely to ensure that the work that had been commenced in conjunction with state and territory colleagues could be kicked along, noting, as you rightly point to, the timetable, which means that this has to commence at the beginning of the next financial year. Again, recognising that we the department are not doing this, I see no reason why the work that is underway will not be delivered.

Senator FIERRAVANTI-WELLS: You might take this on notice. In relation to how you see activity based funding being introduced, what will be happening and when? Also, how many hospitals will this apply to? Obviously, they will be the ones that remain in block funding. Could you take that on notice so that we get a fix for which hospitals are being identified as what?

Ms Halton : We are happy to give you a slightly longer and more technical answer on notice. What I would remind you of, though, is that the pricing authority itself has to make recommendations in relation to where block funding will apply. You will recall that there has been a lot of public debate and, in some cases, some misinformation put about. Block funding will have to apply in particularly smaller country hospitals and we need the pricing authority to provide a view about that. I suspect that in the time frame of answering these questions that we will not be able to say categorically that it will be 60 or whatever, but we can probably give you an indication of what kinds of facilities may, depending on their work—Mr Broadhead wants to be far more precise.

Mr Broadhead : Essentially, there will be some block funded hospitals and some purely ABF funded hospitals. When I say 'purely', for the majority of their activity there will still be block funding for things like teaching and research, even in those that are predominantly activity based funded. There may be some in the middle, depending on how the pricing authority recommendations to COAG turn out about this. Some will get a mixture, for their treatment activities, of both block and activity based funding. So there may be a band in the middle that have a mixture.

We do not know where the threshold will be set, for example, for smaller country hospitals to be block funded or predominantly block funded, but it is a feature of the Australian hospital system that we have a large number of quite small hospitals. So it is quite possible that there will be some hundreds of small hospitals that are block funded. However, even if there are, that would still be a minor percentage of the total hospital activity. In other words, most of our hospital activity takes place in larger hospitals, but we do have a lot of little hospitals across the country. So you can end up with a situation where you have a significant number of small hospitals block funded but you are still funding on an activity basis by far the majority of hospital activity.

Just to illustrate, this is not to be taken as a position or a value. For example, if you look at hospitals with fewer than 1,800 weighted separations—that is, patient admissions per year or patient discharges and separations per year—that constitutes about 450 hospitals across the country and yet they are responsible for only about seven per cent of the total separations from hospitals.

Senator FIERRAVANTI-WELLS: That is why asked the question. In volume, it might apply to a large percentage of hospitals around the country, but numerically it might not apply to 70 or 75 per cent of our hospitals—I am only plucking those figures out of the air. That is the very reason I asked the question.

Mr Broadhead : The process by which this will be settled is for the pricing authority to come up with what it believes are the appropriate criteria for hospitals to be block funded, those are put to COAG, COAG agrees or does not agree, as it happens, and then whatever criteria are settled are applied and the pricing authority looks at the level of funding that should be provided to those hospitals.

Senator ADAMS: Thanks for that information. What is your definition of a small hospital?

Mr Broadhead : That is the issue in question. We do not have a fixed definition of 'small hospital'. From our point of view, the discussions that we have had—and these are not settled—are really about the volatility of activity in hospitals. In other words, if a small hospital has, from one year to the next, large shifts in the amount of activity it does—and that tends to be the case in small hospitals—it becomes difficult to fund them on an activity basis, because they are rich one year and poor the next. If they have a year in which a number of things happen—therefore they treat a number of people—their throughput is higher and they get a large amount of revenue. Then the next year less happens and they end up with less revenue.

The difficulty that they confront is that often their costs are fixed to a significant degree. So they can end up with more than enough revenue to cover their fixed costs in one year but not enough revenue to cover their fixed costs in the next year. So on that basis you would not fund them on an activity basis because it sets them up, at some point in the future if their activity levels decline in a given year, to be in financial strife. And that is not the intent of all of this.

There will be, I suspect, a number of submissions from a variety of quarters to the pricing authority about what the right level is—what is the right size or type of hospital for block funding to be applied to—but we would expect that one of the key criteria in determining that is stability of funding to ensure that the hospital remains viable over time.

Senator FIERRAVANTI-WELLS: I would like to ask a question in relation to advertising, which I foreshadowed. How much of the $29.5 million that was supposed to deliver the national communication campaign was spent in relation to health reforms prior to the August revised agreement? How much remains unspent, and will the unspent amount be now used to continue to promote—from the lavender book onward?

Ms Palmer : Funding of $29.5 million was originally provided for the campaign and $2.95 million of it was committed to the Consumers Health Forum to provide an active health-consumer role in the health reform process. That has been managed by the transition office. The health reform mass advertising activity ceased on 17 July 2010, which realised $11.2 million in savings towards the government's election commitment to reduce advertising expenditure by $60 million over a four-year period. So the money that was not used for the advertising at that time—$11.2 million—was returned.

Senator FIERRAVANTI-WELLS: So any money for future advertising of health reform—

Ms Palmer : No, there is none.

Senator FIERRAVANTI-WELLS: There is no more money?

Ms Palmer : No.

Senator FIERRAVANTI-WELLS: Not even in your little jar, Ms Halton?

Ms Halton : I wish I had a jar, Senator, or even a magic pudding, but no.

Senator FIERRAVANTI-WELLS: So that is it. There was $29.5 million and $11.2 million was returned.

Ms Palmer : That is correct.

Senator FIERRAVANTI-WELLS: I will put some questions on notice in relation to that. In relation to Tasmania, I have questions about some of the budget cuts. Ms Halton, if we do not get through these can we deal with that through the public hospitals acute program?

Ms Halton : Sure.

Senator FIERRAVANTI-WELLS: Is it best dealt with under acute?

Ms Halton : Ms Flanagan can bounce to the front of the table at whichever point you wish.

CHAIR: Are we going onto acute care? We are particularly tight in this timeframe.

Senator FIERRAVANTI-WELLS: Can we go through them? I am happy to ask those particular questions in those programs. Similarly I have questions about problems in Queensland at the moment. Will I do those in the acute section, as well?

Ms Halton : Which particular problems,?

Senator FIERRAVANTI-WELLS: I am talking about Queensland spending blowouts and the impact that that is going to have in relation to funds from the Commonwealth.

Ms Halton : The short answer is that it will not have any impact on the Commonwealth.

Senator FIERRAVANTI-WELLS: You are obviously aware of the press articles in relation to Queensland.

Ms Halton : Yes, Senator, I am.

Senator FIERRAVANTI-WELLS: 'Health gaffs fuel $600 million spending blow-out'. They say that Queensland is facing cuts in health and, therefore, its failure to meeting conditions in the National Health Reform Agreement. That is the angle that I was coming from.

Ms Halton : I see.

Senator FIERRAVANTI-WELLS: So can I ask those questions in the acute area?

Ms Halton : Yes, I think so, Senator.

Senator FIERRAVANTI-WELLS: Similar issues in other states I should deal with in acute?

Ms Halton : Yes.

Senator FIERRAVANTI-WELLS: In relation to bureaucracy and in effect departmental numbers I think last time, or in answer to a question on notice, you gave me some figures in relation to current staffing numbers and projected staffing numbers. This whole issue of the neutrality of staff numbers as part of the national health reform—is there another area in which I could deal with that?

Ms Halton : No, that is really here—in terms of the numbers in the portfolio.

Senator FIERRAVANTI-WELLS: Perhaps, Ms Palmer, you can assure us that in the end, when all is said and done about health reform, we will have Public Service number neutrality—in other words, maintain the commitment that the then Prime Minister Kevin Rudd made about his health reforms not leading to any increase in bureaucracy around the country.

Ms Halton : Ms Palmer can talk about the Department and indeed probably the portfolio. The colleagues can probably make broader comments but Sam can go first.

Ms Palmer : As part of our strategic review announced in the budget in May, the department will be smaller over the next period of time. It will be about 10 per cent smaller over the next two years than we were at the time of the budget.

Senator FIERRAVANTI-WELLS: When you have the shifts, for example, to the various authorities—and I think in the past we have talked about staff moving et cetera—overall, if I can put it that way, do I read into that an assurance that there will be no extra bureaucracy? Ms Halton, do you understand the question I am getting too?

Ms Halton : I do. Mr Maskell-Knight has got the piece of paper that says we are estimating a reduction of 420 FTE in 2012-13, recognising that the quality and safety commission does not really change in size—it was an existing bureaucracy. And then we have preventive health, pricing and performance, and the aggregate of those will not outweigh the reductions in the department proper.

Senator FIERRAVANTI-WELLS: I will put some questions on notice in relation to that. When should I ask about Local Hospital Networks?

Ms Halton : In acute.

Senator FIERRAVANTI-WELLS: My questions on Medicare Locals?

Ms Halton : Primary care.

Senator FIERRAVANTI-WELLS: And Lead Clinicians Groups?

Ms Halton : The transition office can deal with that.

Senator FIERRAVANTI-WELLS: How many Lead Clinicians Groups have been formed within the Local Hospitals Network?

Mr Maskell-Knight : The National Lead Clinicians Group has been established and we are in discussion with the states about entering into agreements with them to fund a National Clinicians Groups at the local level within their jurisdictions.

Senator FIERRAVANTI-WELLS: Again, this fits into the commitment of no new bureaucracies?

Ms Halton : These are not bureaucracies; this is clinical input to the operation of clinical services, recognising that in a number of instances states already have ways of engaging clinicians and in some cases they will be party to these arrangements. So I think it is not a reasonable thing to say that these are bureaucracies. These are hardly bureaucrats; in fact, most doctors would be deeply offended if they were called bureaucrats.

Senator FIERRAVANTI-WELLS: There might be some costs associated with these bodies but they will not require departmental staffing or secretariat—is that it in a nutshell?

Ms Halton : I think that is right.

Senator FIERRAVANTI-WELLS: I have questions about consultancies which I will put on notice, and I will put some other questions in relation to staffing on notice.

CHAIR: Are those all your questions in general?

Senator FIERRAVANTI-WELLS: Those are all my questions in general but if other senators want to take some time out of population health I am happy for that to happen.

CHAIR: Population Health is always a huge one and I am trying to maintain time for that. Senator Adams do you have other questions in this area, or have they already been asked?

Senator ADAMS: I have one.

CHAIR: Senator Adams, Senator Furner and Senator di Natale have indicated that they have questions in general. Senator Adams.

Senator ADAMS: This is on funding and holding states and territories to account. The Gillard government has an agreement with the states and territories that when the Commonwealth puts extra investment into the health system it cannot replace the states' and territories' investment into health care. Could you explain to me how the Commonwealth ensures that the states and territories keep to their side of the agreement and do not cut back on health funding? What checks and balances does the government have in place to ensure that this happens?

Ms Halton : I think the short answer is that because, as you know, there will be a pool into which moneys will be placed—Commonwealth and state monies—and then those state monies provided to the delivers of the service, I think that transparency is what provides that accountability.

Senator ADAMS: So the pool will actually cope with the—

Ms Halton : Absolutely. The whole point about this is actually being able to see what is being provided. So it is not possible to stick it under a thimble and move it over here and there and then you lose the pea in the process.

Senator ADAMS: So, really, the cost-shifting side of things will be caught?

Ms Halton : Cost-shifting is one of those totemic labels that people like to use. The truth of the matter is that there are always boundaries in between the Commonwealth and the states. What these arrangements do, particularly as we have said that what will be funded will, if it moves, continue to be funded—so if it was in a hospital and it moves out we will continue to fund it—is enable us to have a much clearer view of who is doing what and where, and I think that really helps.

Senator ADAMS: I have some questions on boundaries of local network boards and Medicare Locals, so I will leave that to the other areas.

Senator FURNER: Ms Halton, what has been the consultative process in communicating and in consulting with the stakeholders about the National Health Reform Agreement?

Ms Halton : There is a very long answer to that question. My colleagues can probably give you the headlines. What I can tell you is that one of the last things the sartorially arrayed Mr Head did was actually indulge in a lot of shoe leather exercise across the country. He did how many consultations?

Mr Maskell-Knight : He did 14 meetings in 13 locations across the country in a 15-day period, I think.

Ms Halton : And it was not just in capital cities. So, in addition to the campaign which has already been asked about and in addition to things like the purple-lavender-lilac Jacaranda book and the website, there was a very deliberate attempt to go out and engage with people who are in systems who want to know, and a presentation was done, which, according to Graham, went incredibly well. In a number of cases those presentations included people from state and territory departments. We have a list of where those occurred.

Senator FURNER: Maybe you could provide those 13 locations on notice.

Ms Halton : We are happy to do that.

Senator FURNER: What is the funding in respect of the Commonwealth's investment through health reform in the states and territories this financial year for sub-acute beds, emergency departments and elective surgery?

Ms Flanagan : Sorry, Senator; could you repeat your question?

Senator FURNER: How much funding is the Commonwealth investing through health reforms in the states and territories this financial year for subacute beds, emergency departments and elective surgery? If it is preferable that the question be put on notice, I am happy to do that.

Ms Flanagan : The total funding going out in 2011-2012 is $587.6 million.

Senator FURNER: Can you give me a breakdown in those areas of subacute, emergency departments and elective surgery as well?

Ms Flanagan : In 2011-12 the investment in elective surgery capital is $25 million; the investment in the national emergency access target itself, which is facilitation funding, is $75 million. Sorry; let me start again. The investment in the national elective surgery target in 2011-12 is $95 million, and that is all in facilitation funding. The investment, as I have just mentioned, in capital to go with that is $25 million. The investment in the national emergency access target is $75 million. The investment in capital to go with that for emergency departments is $50 million. The investment in new sub-acute care beds is $317.6 million, and there is a flexible funding pool that is also available for states to use where they wish, of $25 million. That totals the $587.6 million.

Senator DI NATALE: I am interested in the number of freedom of information requests that have been made to the department by tobacco companies in the period since that information was last tabled. Could you perhaps tell me the amount of time in terms of staffing hours that those FOI requests have taken up in terms of the department's time?

Mr Cotterell : We have not done a total calculation of the staff hours, but I can tell you that the department has received 63 FOI requests in total. Eleven of those were transferred from other agencies. As at yesterday, the department had 35 current FOI requests on hand from the tobacco industry.

Senator SIEWERT: Is it possible to provide the updated list you usually give us?

Ms Halton : Here is one I prepared earlier—knowing you would be interested. Senator Di Natale, if I can tell you, I am on the record in relation to this in the past, and I will reiterate this. There is a very deliberate—you can tell—campaign of swamping us with requests. I am on the record in the past as saying that. Acknowledging, accepting and supporting the principle of FOI as I do, because of the way the current FOI laws are written there are huge opportunities for people who wish to abuse process to do so. Essentially the amount that we can charge by way of cost recovery for these requests goes nowhere near meeting our costs. Whilst Mr Cotterell says we have not actually added up all of the hours. One of the claims that we had at one point got over a million dollars when we added it up. On the undercosted costings we were allowed to tell the applicant it would charge and then of course the applicant reduced the scope of the charge. But the process of even working out how long it would take us and how much it would cost on this substandard charging arrangement—we cannot charge for that. So the truth of the matter is: this is a very specific and deliberate attempt to divert resource. There will come a point where we will have to consider what to do about that; but, as I said, I am very happy to table a detailed update for you—which also goes to this costing issue, because it will probably be useful for you to know.

Senator DI NATALE: Do you have any ideas about what you plan to do about what appears to be a fairly deliberate and vexatious campaign?

Ms Halton : That, of course, is the question for us, because as you know there is a provision in the legislation in relation to vexatious requests. That is not well tested, and certainly we are taking some advice in relation to that.

Senator DI NATALE: So you are taking legal advice on that?

Ms Halton : We are intending to take advice on that. But if I can—

Senator DI NATALE: Intending to or currently?

Ms Halton : It is being discussed. I can give you an example. The department can only charge $15 per hour for search and retrieval and $20 per hour for decision-making time. The department is funded between $44.80 and $50.54 an hour for an APS 6, who I think everyone would acknowledge is not going to be a decision maker, so we are hardly talking reasonable recompense for the amount of time and energy that is taken. As I said, I would be very happy to table some information in relation to that.

Senator DI NATALE: Would you have a back-of-the-envelope calculation in terms of how much you think it has cost your department?

Ms Halton : No, we do not. I could use the phrase 'an awful lot', but I think to speculate would probably not be wise. We will have a little think about whether we can provide something on notice.

Mr Cotterell : In some cases the industry is disputing the charges, so I think it is quite difficult for us in front of the committee to attempt to add up the hours and charges.

Senator DI NATALE: If you could take that on notice that would be appreciated.

Senator FURNER: The department listed in the annual report outcomes and figures in respect to Aboriginal employment and strategies. I would like some feedback on the results of those and on any areas of disability as well.

Ms Halton : Absolutely; we would be delighted. I can tell you that we have very active networks—one for our Aboriginal and Torres Strait Islander staff and the other for our staff with disability. Ms Palmer is, I think, acknowledged as a service-wide leader on the issue of disability, which is a testament to her commitment. I have been very pleased to have met myself with both networks quite recently. I can say about the commitment that we have in relation to the target that has been set for the APS, which is 2.7 percent—and we are not at 2.7 percent, but we are not doing too badly—that the certified agreement that we will be putting to staff for their consideration, hopefully very soon, will reiterate our commitment to meeting that target. Ms Palmer can probably give you a little bit more information.

Ms Palmer : Senator, I did not hear your question. Would you mind repeating it for me?

Senator FURNER: I was interested in figures and results through the annual report, in particular employment and strategies for Indigenous people and also areas of disability.

Ms Palmer : As the secretary said, it is something that we have been working quite hard on. We have quite a committed staff, and our people branch are working very closely with both the new staff—with disability network, which was established only this year—and ongoingly with our Indigenous staff network.

We are pleased at the moment to be able to report that, as at 30 August, 4.8 percent of the ongoing employees of the Department of Health and Ageing have identified as having disability, which is well above the APS average of 3.1 percent. This has been an increasing trend in our department since 2008.

We have a disability action plan, which our staff with disability have assisted us to develop, and it has quite a series of activities within it to improve both the disability confidence in our organisation and the capacity of all our staff to work to support staff with disability, whether in fact they choose to identify as having disability or not and remembering that many staff with disability do not find that their disability hampers their work in any way. So we have done quite a bit there.

Our network is very new—it was only established this year. It is of course a volunteer network, as is our Indigenous network, and they are working very hard on improving awareness and support in the organisation.

Ms Halton : I just want to make one point while Ms Palmer turns the page. The staff in our people area won an employer award for their work with people with disability from the ACT government recently, which we are very proud of.

Ms Palmer : We are very proud of it. Regarding Aboriginal and Torres Strait Islander staffing, currently 1.9 per cent of our ongoing staff identify as being Aboriginal or Torres Strait Islander. We have a reconciliation action plan that we have worked with our network which has a number of actions. We have a network meeting with our staff who are Aboriginal and Torres Strait Islander organised for later this year. At that meeting, we expect in our engagement with our staff to talk through that reconciliation action plan and to hear their ideas on other things that we can do to better support our staff within the organisation and improve our recruitment and retention of staff who are Indigenous.

Senator FURNER: Thank you for that.

CHAIR: That concludes questions in the whole of portfolio and corporate areas. We now move on to population health.

[11:01]

CHAIR: We will proceed outcome by outcome and see how we go. We will start with 1.1, Prevention, early detection and service improvement.

Senator ADAMS: My first question is regarding the BreastScreen evaluation 2009 report. Has there been any progress on the recommendations from that evaluation?

Mr Smyth : A number of the recommendations are actually administrative in nature and are being progressed around quality improvements to the programs and workforce enhancements to improve the capacity particularly of mammography technicians and readers. The bulk of the recommendations are still to be considered by all health ministers, but that is under active consideration at the moment.

Senator ADAMS: When do you think that we will hear anything about it?

Mr Smyth : I would not like to give you a time line on that, but it will take a number of months, I suspect, to work through a lot of those issues. Some of the reasons for the delay, of course, have been in relation to the new health reform agreements, because there was at an early stage some consideration of the Commonwealth taking over full funding and policy responsibility for cancer-screening services. So consideration by all jurisdictions was somewhat delayed because of that. But that process is now in train.

Senator ADAMS: I was quite dismayed when I saw Minister Roxon's announcement about the changes in the age limit for mammography and the number of potential invitees. I just want some clarification. The age limit before was 50. People of 45 to 50 years were going to be included with an invitation and they are obviously not going to now.

Mr Smyth : That is not actually correct. Women are not excluded from participating in BreastScreen Australia. The target group is 50 to 69 years of age, but women of 45 to 50 who attend the services are able to be screened. There is currently no exclusion of that age group.

Senator ADAMS: I am fully aware that if they turn up they can be screened, but what worries me is that I felt the government had agreed that the 45 to 50 years would be inclusive.

Mr Smyth : That is part of the consideration of the recommendations and the evaluation of BreastScreen Australia. All ministers will take it into account, Senator.

Senator ADAMS: The 70- to 75-year age group are not invited; they can turn up as well. But a lot of these women—I do a lot of work in this particular area—think that because they are no longer going to be invited they cannot get breast cancer, that they are not in an age group that can. There has been a new evaluation done that has just been published in the Australian medical journal showing, with scientific evidence, that this group does have problems. So this is another area of concern for me. I would like your comments on that. Have you seen that article?

Mr Smyth : I do not have that article in front of me. I am certainly aware that there have been a number of articles recently around BreastScreen. Again, the age groups that are specific to this program will be under active consideration by all governments, all health ministers, in the months ahead.

Senator ADAMS: To help you with this, it is a BreastScreen based mammography screening on women with a personal history of breast cancer. It is a Western Australian study. The other part is, once someone has had breast cancer can they go back? Are they invited to go back every year, still, or is that going to be reduced?

Mr Smyth : It tends to be a different pathway when women have been diagnosed with breast cancer. They go through a different pathway with their medical practitioner. BreastScreen Australia is really about asymptomatic women, a population base screening program. But women who are at high risk, who have a family history of breast cancer or who have had breast cancer, will go through a separate pathway. That is one that they would discuss with their doctor.

Senator ADAMS: There is a problem there with the Medicare rebate because it is very small in comparison. That is something that perhaps the government could look at. It is pretty unfair, especially for rural people. They have huge costs in getting to the city—especially in Western Australia, as an example—and the Medicare rebate, really and truly, is not good enough for them.

CHAIR: Ms Halton I have questions on pregnancy counselling. Is that in 1.1?

Ms Halton : Could you be more specific?

Senator RHIANNON: Counselling services.

Ms Halton : Is it the services or the hotline? They are in two different places.

Senator RHIANNON: It is more about the services: how they are being run, and the standards.

Mr Smyth : There is a program that is about fertility but it is not about pregnancy counselling as such. Twelve organisations are currently funded.

Senator RHIANNON: I want to ask about the providers. We are just trying to work out whether I do it in this section.

Ms Halton : You will have to tell us which providers, Senator.

Senator RHIANNON: I will ask the first question and give you a case. Is there a requirement that all pregnancy counselling providers will provide counselling on the full range of options available to women?

Ms Halton : That is a very general question. It depends on whether the question relates to people we fund. We can make a comment about—

Senator RHIANNON: Specifically to the ones that you fund and then also to try to assess whether there are standards that all providers come under.

Ms Halton : No.

Senator RHIANNON: People can set themselves up to provide counselling on pregnancy and there are no standards by which they have to abide.

Ms Halton : There are professional bodies that regulate the conduct of professionals. There may be consumer issues in relation to how people present themselves but in terms of the things that we have any dealing with they are regulatory activities, which would go through the registration bodies and then funding agreements with bodies that we fund.

Senator RHIANNON: You are not responsible for any standards that would cover providers who do not receive public money.

Ms Halton : No.

Senator RHIANNON: We are just talking about the ones that you do fund. If I could therefore ask that question.

Mr Smyth : We have a family planning grants program, which is about evidence based family planning. It has a national focus and there are three key areas: public education, health promotion and information sharing; professional development, continuing education of professionals involved in family planning activities; and then there is consultation, networking, representation and collaboration across the sector.

The objective is to support evidence based family planning. This is about having couples or individuals achieve the desired number of children. There were 12 organisations that were funded under that program. I am happy to tell you who they are if you like.

Senator RHIANNON: Maybe you could take that on notice.

Mr Smyth : Sure.

Senator RHIANNON: Are you aware of any pregnancy counselling services that receive public funding but fail to provide information on pregnancy termination?

Mr Smyth : I am not aware of that.

Senator RHIANNON: When you say you are not aware does that mean that it does not happen or that the auditing has not been done so you do not know?

Mr Smyth : Our program is not necessarily about that. It is more about fertility advice rather than termination. People may ring the national pregnancy helpline and be directed through that area but—

Ms Halton : I might make a point about this. The then Senator Natasha Stott Despoja would, nearly every estimates—some of our friends and colleagues on that side of the table will remember this—ask questions in relation to the provision of public moneys to organisations who were active in the fertility space. In fact, I think after a certain period the telephone counselling line came about as a consequence of some of those questions. Essentially, some of the organisations we fund have a particular perspective on these issues. They provide advice, as Mr Smyth has told you, in relation to achieving the number of children that people wish. The service that they offer is about fertility and the pregnancy counselling hotline is the service which will provide you with every option et cetera.

Senator RHIANNON: So apart from the hotline there are, as you would be aware, a number of pregnancy counselling services that provide information on the range of options.

Ms Halton : Correct.

Senator RHIANNON: I understood from the answer to a previous question that some of those receive public funding.

Ms Halton : Some of them.

Senator RHIANNON: My question is about those. It was not about the fertility aspect of it. It is about ascertaining whether the services that receive public money are providing the full range of services. I understand from your response, Mr Smyth, that you were not aware of it.

Mr Smyth : We have an agreement with these organisations—the 12 that we fund—to provide a particular focus and service. If they are organisations that do other activities as well that is outside of our funding agreement with them. I am not fully aware of the activities that they may well undertake.

Senator RHIANNON: I am not interested in their other activities. Considering that you are funding them for pregnancy counselling services—

Ms Halton : We are not, necessarily. That is the important point.

CHAIR: This is quite an extensive area and we do not have time to go through the degree of questioning in the allowable time that we have today.

Ms Halton : What I suggest we do is to give you, on notice, the list of organisations we are funding and what we are funding them for.

Senator RHIANNON: Okay.

CHAIR: Senator Rhiannon, what we can do—it is common practice—when you get that information, if you require a briefing, is to go back through Senator McLucas and arrange that. That is the process.

Senator RHIANNON: Thank you.

[11:14]

CHAIR: I intend moving on to communicable diseases. I do apologise—I am putting it on notice now—we will not get to all the questions that I have now been given in this area. We will see what we can do. This is in the program 1.2.

Senator ADAMS: We asked a number of questions last time on the TB problem in the Torres Strait and also with Queensland Health. I am sure that you all know exactly what I am talking about. I would like to know how many times the Torres Strait Cross-Border Health Issues Committee met in the last 12 months.

Ms Holden : We have met two times in the last 12 months. We met recently in September and before that in March.

Senator ADAMS: What have been the committee's three main achievements in that time?

Ms Holden : The main focus in the last two meetings has been around arrangements for the TB clinics that will be ceasing in the Torres Strait and ensuring that appropriate arrangements are set up on the PNG side. That was a lot of the focus of the meeting. They also reviewed their terms of reference as part of that meeting and looked at broader issues around new committees that have been established in the Western Province of PNG.

Senator ADAMS: Could you tell me what is happening in Saibai and Boigu at the moment? Are those clinics being funded by the Commonwealth?

Ms Holden : The primary healthcare clinics in Saibai and Boigu are Queensland Health clinics so they are funded by Queensland. The Australian government makes a contribution towards those clinics for the treatment of PNG nationals.

Senator ADAMS: Queensland were going to remove that funding, so how long does their funding go for?

Ms Holden : The funding you are talking about is in relation to TB specialist clinics, which is an outreach service, not the actual primary healthcare clinic. In relation to that the Australian government has provided funding for three additional TB clinics to be held. The first one was held in October, there will be one held in September and there will be one in February. It is part of a transitional arrangement that has been worked together collaboratively with the PNG government to hand over into PNG care the current TB patients that that clinic is seeing. The first handover was on 13 October last week, when 21 TB patients were handed over from the care of Australian clinicians to care in PNG with the new TB physician they have put in place.

Senator ADAMS: So the patients that are seen at those clinics are not going to Thursday Island anymore, they are going straight back to PNG?

Ms Holden : For the ones that came over for the TB clinics, yes. There was a handover. I think they saw over 60 patients on the day for their general treatment. But 21 of them were handed over into the care of PNG and they will see the new TB physician based at Daru for the continuation of their treatment.

Senator ADAMS: What communication are you having with AusAID's program in PNG?

Ms Holden : They have been quite heavily involved. They are part of the Torres Strait health issues committee. The work that is being done around the TB clinic has been jointly between the Australian government, which includes the Department of Health and Ageing and AusAID; Queensland Health; and the relevant PNG governance. So there is quite a lot of involvement with AusAID's program in PNG.

Senator ADAMS: They have a large amount of money. As far as their drugs go, especially investment into the Mabaduan village, do they have enough drugs there?

Ms Holden : Could you repeat the name of the village?

Senator ADAMS: Mabaduan.

Ms Holden : I do not know the specifics of the AusAID work there. AusAID is doing a lot of work across all of the communities in the Western Province. As part of that, they are looking at the drug supply across the villages. But I do not have any more specifics on their program.

Senator ADAMS: Chair, I have quite a lot of questions that I will put on notice that are to do with the AusAID program and also others on the Commonwealth and Queensland Health involvement with the Torres Strait clinics.

CHAIR: We will now go to program 1.3. We have six minutes. Senator Fierravanti-Wells.

Senator FIERRAVANTI-WELLS: PricewaterhouseCoopers conducted an efficiency review of the Ministerial Council on Drug Strategy and its reporting structures for the department in a report dated 24 January 2011. Why hasn't this report been released publicly?

Ms Krestensen : I will have to take that one on notice.

Senator FIERRAVANTI-WELLS: I have got a copy of the report. Could you also tell me why appendix A, the list of stakeholders consulted, has been redacted? Could you tell me who the consulted stakeholders were and whether they were consulted on the basis of suggestions made by PricewaterhouseCoopers or by the department directing PricewaterhouseCoopers as to who should be consulted? Could you also tell me whether those stakeholders, the various industries, were consulted and again whether that was at the suggestion of PricewaterhouseCoopers or of the department?

Ms Halton : We will have to take that on notice. But because committees are Commonwealth-state creatures, whenever there is an FOI request we have to go to all the parties in the Commonwealth-state arena to ask their permission about what can be released. So we will take it on notice but I think you will probably find that there are a number of parties who object to bits and pieces being released.

Senator FIERRAVANTI-WELLS: There is only one page redacted from the copy I have and that is the stakeholders consulted. I am surprised about that. But please do take that on notice. Could you also take on notice whether in the past three years the department has appointed anyone with alcohol industry experience to any of its advisory bodies to provide advice on alcohol policy? Also in relation to the Blewett labelling review—

CHAIR: Senator, this is the drug strategy. This is program 1.3. I would have thought labelling—

Ms Halton : It depends on which labelling.

CHAIR: Which labelling are you going to, Senator?

Senator FIERRAVANTI-WELLS: I am going to the Blewett review.

CHAIR: That is food. It is FSANZ.

Ms Halton : That is food, and food is not a drug, last time I looked—although for some people—

Senator FIERRAVANTI-WELLS: See, the answer to the question was on population health, food labelling.

Ms Halton : True. Score one you!

Senator FIERRAVANTI-WELLS: Ms Halton, I am raising it particularly in view of some of the things that have been banned and said to be unhealthy.

Ms Halton : Okay.

Senator FIERRAVANTI-WELLS: You know we have had this discussion about chocolate and other things.

Ms Halton : We have.

Senator FIERRAVANTI-WELLS: I will put the rest of my questions on notice.

Senator SINGH: What has been the international response to the government's measures on plain packaging?

Ms Halton : That is a very broad question. It depends on how long you have got.

CHAIR: And you know, Ms Halton, we do not have long.

Ms Halton : What I can tell you is that the government has been commended for the plain packaging initiative by, very prominently, Margaret Chan. In fact, I was with her at the WHO regional committee in Manila last week. Not only has she awarded the minister one of her anti-tobacco awards but she also reiterated at that meeting the importance of Australia's leadership on plain packaging. I could also mention Minister Chen Zhu, China's Minister for Health; the European Commissioner for Health and Consumer Policy; the Indonesian minister; Kathleen Sebelius, the US Secretary of Health—and I could go on.

I can tell you anecdotally that when the UN had its general assembly meeting, where there was a special two-day meeting on noncommunicable diseases, there was a huge amount of interest in our initiative. We met with Michael Bloomberg, the Mayor of New York. He is a very prominent anti-tobacco campaigner. He was very interested and, indeed, very complimentary about the initiative. We met with a series of people. But probably by way of colour and movement I will tell you that when the minister presented to one of the roundtables at that meeting, her presentation was interrupted twice by spontaneous applause and she got a very significant round of applause at the end. For anyone who has done much international work—and I have done a fair amount of international meetings in my time—they will know that that is very unusual. So, yes, I think the short message—without going through the entire cavalcade—is that it has been very well received by people who understand the importance of this from a global health perspective.

Senator SINGH: How many FOIs has the department received from big tobacco?

CHAIR: We have had that question.

Ms Halton : Senator, one of your colleagues has already asked that question. We are going to table some material for you on that.

Senator SINGH: Okay. There was an antismoking social marketing campaign that went out into the community. Out of that, was there any evidence to show that it has reached certain target groups—for example, pregnant women and their partners, those living in disadvantaged areas, those with mental illness, prisoners et cetera?

Ms Halton : It is important to understand that our approach to tobacco advertising does vary depending on the target group. In particular, with the work that we are doing on tackling Indigenous smoking you cannot use general community approaches; you have to be quite targeted. One of the things we are very conscious of with attempting to tackle smoking is that, particularly as the numbers come down, you have to have a very targeted approach.

Mr Cotterell : There was a specific amount of money set aside by the government for a targeted campaign to the groups that you have outlined. That was $27.8 million over four years. I think Mr Davey is going to take us through what has happened in that campaign.

Mr Davey : The measure that Mr Cotterell is talking about, the 'Tobacco Campaign—More Targeted Approach', specifically targets pregnant women, prisoners, people with mental illness, people from culturally and linguistically diverse backgrounds and also people living in socially disadvantaged areas. That campaign has been designed side by side with the national campaign to ensure efficiencies and to more specifically target those groups. We are in the process of evaluating the activity that is run. But as to whether we have reached those groups, we certainly have specific strategies which include things like advertising through targeted media, public relations activities and information materials that have been designed specifically and tested with those target groups to ensure that we are reaching them in the best way we can.

Senator SINGH: So when you are seeing that evaluation or some part of that evaluation being completed?

Mr Davey : It is in the final stages now. With these campaigns, when it is finalised we will publish those results.

Senator WILLIAMS: Ms Halton, officers of the Department of Health and Ageing told the House of Representatives health committee on 4 August that they had legal advice which made them confident that they would win proceedings in the High Court by anyone challenging the bills relating to tobacco plain packaging. How much has been spent obtaining this legal advice?

Ms Halton : We will have to take it on notice.

Senator WILLIAMS: Do you want to take it on notice?

Ms Halton : Yes, sure.

Senator WILLIAMS: Back in 1995, then health minister, Minister Carmen Lawrence, sought to look at plain packaging. As a result of the Attorney-General's advice at the time, Carmen Lawrence reportedly dismissed the proposal, apparently saying, 'It is just not feasible. We would have to buy the tobacco companies' trademarks and that would cost us millions of dollars.' In 1995, how much did your department estimate would have to be paid? You might want to take that on notice. This is a concern I have: the tobacco companies, with millions of dollars behind them, could take a High Court challenge and win. We saw what happened with the Malaysian solution in the High Court. Basically, have you got it covered as far as legal challenges go with property rights? Notice that my only concern about this whole thing is that, if these companies sue Australia through the High Court, we could face billions and billions of dollars of trademark removal compensation, or whatever,. That is why I raise these issues with you. Can you expand on what the department has done in relation to that threat of being sued, basically?

Ms Halton : Regarding those matters, the tobacco companies have pursued us at great length to attempt to retrieve this supposed legal advice and they have lost consistently in relation to the attempt. All I can say is that the supposed view that there was a decision, in theory—and it is all speculative; let's be very clear about that—is, I think, immaterial. The real question here is: is the legislation well founded? Are we confident that the parliament of this country has the authority to take this decision? And is it the right thing to do? Frankly, that is our view. But my colleagues can expand, if you wish.

Mr Cotterell : Senator, on the question you ask in relation to the department's estimate of how much it would cost to pay out the trademarks, we were FOIed on this matter and there was no record of an estimate.

Senator WILLIAMS: You can see my concern: if there is a court case, Australian taxpayers could get hit for billions and billions of dollars for removing a trademark. As a member of the National Party I have seen property rights removed from farmers to farm their land, whether it be land clearing or whatever, with no compensation et cetera. The property right of this product is what concerns me—if they take us through the court and it ends up costing us billions of dollars.

Ms Halton : Let's also be clear: essentially, they are not restrained from using their trademark on correspondence and all sorts of things. Under the proposal, they can use their name. What they cannot do is use their name with any fancy printing or things which make cigarette packets of interest, particularly to young people. There is no restraint on the brand being on the packet. As I think you would be aware, we have done a lot of consumer testing. We have taken a lot of advice about this. In fact, the Senate would be very aware that, because the legislation has not come before the Senate, we will have to think about timetables, implementation et cetera. This has been very, very thoroughly worked through. The truth of the matter is, in my view, that this has been fought so strongly because they actually know it will work. If it was not going to be effective, why would they fight is for this?

Senator WILLIAMS: Chair, I will put a series of questions on notice because of time restraints.

CHAIR: Senator Brown, you have one more question On drug strategy. I am just checking whether there is anything more on drug strategy. Then we will go to NICNAS because we are not sure where it fits.

Senator CAROL BROWN: Following Senator Singh's questions, I just want to note whether you have any information about the nicotine replacement therapies that are now being placed on the PBS—whether you have any figures as to the take-up of those. It might be too early.

Ms Halton : The pharmaceutical people are on later. If you like, we will see whether they can get something by the time they get here.

Senator CAROL BROWN: That would be great.

Ms Halton : We have a little bit of time, so the team will make a phone call. I am sure they are back at the office watching.

CHAIR: We will now go to NICNAS. Senator Waters has questions in this area.

Senator WATERS: When I last spoke with you at the Senate inquiry into coal seam gas in August, I asked a few questions about the chemicals used in coal seam gas hydraulic fracturing fluids. You said at the time that you were still trying to work out which chemicals were being used in those fluids and that you thought there were about 50 or 60 common chemicals in the fluids used by the various companies. Do the companies have to advise you of the chemicals that they are using in the fracturing fluids?

Dr Healy : The companies are not required to notify NICNAS. Chemicals that are listed on the national inventory are available for industry to use without, necessarily, further consultation with NICNAS or notification.

Senator WATERS: You told us that you have assessed about four of those, roughly, 60 chemicals that are used in the fracking fluids, so there are 55 or so that you still have not assessed. You also told me that there is a fast-tracking process and that you are hoping to get through about 3,000 chemicals, which are not yet on the list, in the next few years. Are the coal seam gas chemicals on that list of the ones that you will look at shortly, or what is the time frame for working out if these chemicals are safe to be used?

Dr Healy : Yes, the fracking chemicals are included in the list that we will use the fast-tracking process for, and we are expecting that process to start in 2012-13.

Senator WATERS: If the coal seam gas companies are not obliged to tell you the chemicals that they are using, how do you know which ones to assess?

Ms Halton : We have been consulting with the companies as well as with the states and territories, particularly Queensland and New South Wales, but we have been consulting directly with the relevant companies.

Senator WATERS: If the chemicals are on the list but they have not been used in this manner—that is, in fracking fluids being blasted underground—is there a role for you to assess if this new usage of that listed chemical is appropriate?

Dr Healy : Yes, we can do that assessment, and that is what we are planning to do. The states and territories can also make a decision as they make decisions on the licensing arrangements.

Senator WATERS: So you can and in this instance you will, but you are not obliged to?

Dr Healy : Yes, we will. We have included them in the 3,000 fast-track.

Senator WATERS: But you have just chosen to do that; you are not obligated to do that?

Dr Healy : That is correct.

Senator WATERS: You told me last time that your the budget is about $9 million a year and you have about 60 staff, and that in the last 20 years you have been able to assess 220 chemicals, but you have 38,000 still to go. You mentioned you are implementing a new fast-tracking process that will allow you to get through about 3,000 in the next three years. If you were to assess all 38,000 in, let's say, five years, to a standard that is appropriate to ensure safety for people and the environment, how much additional resourcing would you need to get through that list in five years?

Dr Healy : We would have to consider that a bit further. We have not done the costings for the full 38,000. The initial 3,000 that we are looking at are predicated on certain availability of information, as well as certain tools. We will be using the experience of doing that 3,000 to determine the feasibility and cost for the larger part of the inventory.

Senator WATERS: So you cannot quite answer that question just yet? There is no point in taking that one on notice?

Dr Healy : I do not think so—not with any accuracy, anyway.

Senator WATERS: Good luck with the 38,000. I hope you get to them nice and quickly. Thank you.

Senator FIERRAVANTI-WELLS: I have a couple of questions in relation to plain packaging.

CHAIR: That is not under NICNAS. We just have the chemical group officers at the table. You want to go back to the drug strategy?

Senator FIERRAVANTI-WELLS: I thought that we were still doing 1.3.

CHAIR: No.

Senator FIERRAVANTI-WELLS: We have not moved to 1.4. The last time I looked, the drug strategy was under 1.3.

CHAIR: Senator, we do not have time to go through it, but I actually looked at all the senators and asked if there were any further questions on the drug strategy and then we went to NICNAS. Is it necessary for your questions to be asked today or can you put them on notice?

Senator FIERRAVANTI-WELLS: I will ask the question. On 12 October, the minister made a comment that she needed to reconsider the impact on the implementation frameworks for the plain packaging legislation. What implementation frameworks was the minister referring to? And, following up on your points about the international aspect—there are no international agreed standards in relation to track and trace. What action is the department taking in regard to track and trace since the minister made this comment in her summing up speech on 24 August?

Ms Halton : Unfortunately, the officer has left. What I can tell you in relation to implementation—you will be aware that the bill includes a number of dates that companies have to comply by, and some wash-through dates, in terms of when stock has to be replaced. What needs to be considered—because the bill was not considered by the Senate—is what exactly those dates are. Obviously, there are time frames that are necessary in terms of the implementation, so that is what needs to be considered there. Obviously, depending on timetables, those dates will have to be considered, depending on whether we think the Senate is going to consider the bill.

Senator FIERRAVANTI-WELLS: Can you take on notice the issue about the action that the department has taken in relation to track and trace since the minister made those comments on 24 August?

Ms Halton : Yes.

Senator FIERRAVANTI-WELLS: Thank you.

CHAIR: We will now move to program 1.4, regulatory policy.

[11:41]

Senator FIERRAVANTI-WELLS: You are aware of articles in relation to CSL Biotherapies, and one dated 30 September in relation to rectification of flaws in its laboratory practices. I have two questions. One relates to the deficiencies that were identified by the USFDA. My question is: why are we leaving it to the USFDA to identify deficiencies with CSL, and why isn't the TGA doing that? How many CSL products that have been affected by problems—including Fluvax—have been given to Australians?

Ms Halton : This is a TGA question rather than a vaccine procurement question. In relation to media reporting, it is important to make the point that media reporting does not always accurately reflect the facts, or indeed provide a balanced view. It is fair to say that, yes, the FDA might have been doing its job but so has the TGA.

Dr Hammett : Just to reassure the committee that the TGA has in fact been very active in assessing the compliance of the manufacturing of CSL. Indeed, we have, over the last seven years, been used to auditing their manufacturing facilities on an annual basis. We are in fact currently auditing them on a monthly basis to ensure that they are satisfactorily addressing the issues that both we and the FDA have identified in our manufacturing audits. We are working very closely with the FDA, and the FDA are relying on our monthly audits of CSL to reassure them that CSL is making appropriate progress in identifying issues identified by both the TGA and the FDA. So we are not in any sense relying on the FDA to do the work that the TGA is in fact doing very actively.

Senator FIERRAVANTI-WELLS: What products in the national stockpile or on the national immunisation program are subject to any investigation by the TGA, the FDA or any other regulator?

Dr Hammett : I need to give a bit of background to help the committee understand the process of manufacturing audit. When we go into a manufacturing facility, we look at the processes in place to make sure that the company is able to ensure the final quality of the end products that come out. It is quite normal, whenever we inspect any manufacturing facility, for us to find things that need to be improved, such as record-keeping or tracking of batches or the way they are identifying problems with their own quality control. That is normal. In fact, it is almost unheard of for us to do a manufacturing inspection and not find something that could be improved in the manufacturing process. That has happened with the FDA and the TGA's inspections of the CSL manufacturing process. There are things that do need to be fixed to optimise that manufacturing, but it is important to note that neither FDA nor the TGA have identified any deficiencies that we believe are likely to contribute to unsafe end products. So, while there are things that CSL need to fix about their current processes and their quality control, neither we nor the FDA believe that these are issues of significance for product safety.

Senator FIERRAVANTI-WELLS: We have canvassed in the past the issues in relation to the febrile convulsions and the dark particles in the Fluvax vaccine in 2009. I will not go there again, but it is very clear that it took CSL six months before they actually started to look at that. How can it take a company like CSL six months? What is the TGA doing to make sure that sort of thing does not happen? I was literally howled down in estimates when I last raised these issues about CSL and some of their practices, as if it was some major issue. Well, now we are seeing that there really was an issue and it took CSL six months. Dr Hammett, this is a serious issue.

Dr Hammett : We share your concern that companies respond in a timely manner when issues are identified with their manufacturing process. We have been working very closely oversighting CSL's response to these issues and, indeed, have sought explanations from CSL directly about their timely responsiveness to issues that are identified, and we will continue to make sure that CSL address the issues identified through these manufacturing audits.

Senator FIERRAVANTI-WELLS: And, of course, we had yesterday's little episode. It just keeps going and going.

Dr Hammett : Which episode?

Senator FIERRAVANTI-WELLS: The one referred to in an article in the Australian, copies of which I circulated before.

Ms Halton : Yes.

Senator FIERRAVANTI-WELLS: Are you demanding an explanation? You should be.

Dr Hammett : We are. We have written to CSL.

Senator FIERRAVANTI-WELLS: It emerged that the company knew two years ago about research suggesting a sharp rise in feeders linked to its seasonal flu vaccine but omitted this from information given to doctors. We have canvassed this in these estimates. My question is: when did you and when did the government first know about this? Is this the first you have heard of it? That is really what I would like to know.

Dr Hammett : No, it is not, Senator. In 2009 a study was published which related to clinical trials undertaken in 2005 and 2006. That study was published in peer-reviewed scientific literature. We were advised by CSL of its publication at about the same time as it was actually published. You will recall that that in the years before the Fluvax incident with febrile convulsions—and, indeed, for the last four decades—seasonal flu vaccine has been regarded as an incredibly safe vaccine. In 2009, 2008, 2007, 2006 and 2005 there was no suggestion of safety problems with the flu vaccine.

In retrospect, knowing now what we know in 2010, that there was a problem with the 2010 vaccine, people are going back through clinical trials and saying, 'With the aid of the 'retrospector scope', could we have picked anything?' Indeed, in those earlier clinical trials there were rates of fever for the Fluvax vaccine that were higher than some other comparable vaccines. However, as noted in yesterday's article, most of those fevers were mild or moderate and there was no sign of a febrile convulsion signal. Febrile convulsions were not occurring in those studies that were done.

As I have said, we have written to CSL and made inquiries as to whether there was any delay in notification of us of these issues and have sought to gain a greater understanding of what they knew when. We have not yet received a response, but we are awaiting that.

Senator FIERRAVANTI-WELLS: Can I ask you to take on notice how much money has been paid to CSL? It is an enormous amount of money that you pay them. You obviously must have a very close relationship with CSL—and I mean that simply because of the nature of the work that they do and how much they provide in terms of products to the Commonwealth. Surely, Dr Hammett, you must have been aware of what this company was doing and certainly known about its research in relation to these fevers.

Ms Halton : Let's just back up a second. There are a couple of things. Dr Hammett is the regulator. He does not pay the CSL anything. He has a very clear role, which is as a regulator. He takes that role very responsibly and very seriously. There is a separate part of the government which purchases vaccine, including from CSL. So I think we need to make a distinction here about who is paying what for whom and what the nature of the relationship is, because I do think it is—

Senator FIERRAVANTI-WELLS: I am happy for that to happen, Ms Halton, but the point that I am getting to is, given the close relationship—whether it is on the side of the purchasing arm or on the side of the TGA—this is a serious issue. Two years ago, at a period much earlier than has been previously canvassed in these estimates, there was an issue about fever. My question is: when did the government first become aware of this?

Ms Halton : Again, let's be clear. The regulator, as Dr Hammett has just indicated—

Senator FIERRAVANTI-WELLS: May I ask my question: when did the government and the regulator first become aware?

CHAIR: I will say once—it will not happen again, I know—that when the witness is answering a question, could you wait for the answer to be completed before you give your next question.

Ms Halton : The issue here is, from a regulatory perspective: was there a concern? As Dr Hammett has indicated, the TGA was notified by CSL of the article. In the context of what was known at that point and, as he has already pointed out, the very long history of vaccines and vaccine safety, was this cause for alarm?

Dr Hammett : That is correct.

Ms Halton : And the answer was no.

Dr Hammett : That is right.

Ms Halton : Exactly as he just indicated, if the answer of the regulator is no—I am happy to go back and check, although I expect it would be quite hard to find whether or not this was brought to any minister's or anyone else's attention—I would not expect it to have been. This is the regulator's judgment in the context of many, many years of safety—as we know the black spot issue is quite unusual—but, at the end of the day, as Dr Hammett has said, people might now be making an interpretation of this. But at the time this was not out of the ordinary.

There is a separate question about what information was provided to people, which is exactly the point that he has indicated that letters have been written about, and we are waiting for an answer.

Senator FIERRAVANTI-WELLS: This is my last question. I think it would be worthwhile for your officers to go back over the record.

Ms Halton : Yes.

Senator FIERRAVANTI-WELLS: We have had a lot of discussion in estimates over this. I want tax office make sure, as a consequence of what has now emerged from some of the evidence that all of the evidence that has been given in the past is correct and that nobody needs to correct any previous statement. That is really where I am going. In fairness to those officers, now that this has emerged, I would like an audit done of previous evidence given, as to whether any evidence previously given now needs to be corrected in light of what has emerged. That is really what I would like. I will leave it at that, because I think that is quite an exercise.

Ms Halton : I think that will be quite difficult.

Senator FIERRAVANTI-WELLS: I do not want anyone to have misrepresented to the Senate.

CHAIR: This is quite a serious process and I think that we need to have a discussion outside the Senate estimates on this issue.

Senator FIERRAVANTI-WELLS: I am simply saying, Senator Moore, that I think it would be worthwhile to review this evidence and past evidence to make sure that all previous evidence given in relation to these matters still stands on the record as being correct. That is really my point, Ms Halton. I am not making any accusations or anything; I am simply asking for that to be done.

CHAIR: The department will consider previous statements, but there is no intent in terms of changing evidence or anything of that nature.

Ms Halton : Exactly.

CHAIR: Dr Hammett, as you are at the table I think we will go to TGA questions.

Senator XENOPHON: Dr Hammett, further to Senator Fierravanti-Wells's questions in relation to the CSL vaccine you made reference to the instrument. What was it?

Dr Hammett : The retrospectoscope—a very useful instrument!

Senator XENOPHON: Is that a device that has been approved by the TGA?

Dr Hammett : It has not, yet. You may be able to list it.

Ms Halton : We will think about that one, Senator!

Senator XENOPHON: It sounds like a very dangerous device! Further to Senator Fierravanti-Wells's questioning, Professor Peter Collignon, the professor of infectious diseases and microbiology at the ANU, was critical of the TGA. He said that 'the study that included the more alarming 2006 data had been published in the peer-review journal in 2009'. That is correct. Was there any action at the time of the publication of the 2009 data when that data was made public? How quickly was there action by the TGA from the time that that data was made public in a peer-reviewed journal?

Dr Hammett : Every year there are literally hundreds of thousands of peer-reviewed scientific publications that bear relevance—

Senator XENOPHON: No, that is not—

Dr Hammett : In terms of answering your question it is important to understand the context of how the TGA as the regulator can possibly be aware of the full extent of scientific literature. As it happens, we were made aware in 2009 of the publication of this data. In 2010 we had the fluvax episode. As a result of that fluvax episode, the indication for the use of this vaccine in children under five was removed completely, so the data related to fever rates for children is no longer directly relevant to the use of this vaccine in children because it is not indicated for that.

Senator XENOPHON: Because time is so limited, I will put some questions on notice for you. First, can you provide details of when the TGA first became aware of the peer-reviewed article? Second, at what point was action taken? Third, did the TGA embark on other inquiries as a result of that peer-reviewed article? Fourth, do you agree with Professor Peter Collignon's view? It is:

The TGA should be ensuring companies do update their data—it should be compulsory that the TGA should be informed of any new information, and the TGA should ensure the product information is updated to reflect that.

Dr Hammett : I am happy to take those on notice, and we will—

Senator XENOPHON: Let us go to the issue of DePuy. I asked you at the last estimates whether the TGA was aware that DePuy had paid £4.8 million for bribes to secure contracts in Greece. In 2007, DePuy orthopaedics agreed to pay $84.7 million to the US government to avoid criminal prosecution over financial inducements to pay surgeons. The answers by the TGA were that you were not aware of the case at the time and that it was not applicable as to whether DePuy or DePuy products be subject to additional scrutiny because of this. Aren't you worried about a company that has been convicted of bribes in terms of their medical products and their role in the Australian marketplace? Wouldn't give a heightened level of scrutiny of that company given their convictions in two jurisdictions in respect of bribes?

Dr Hammett : The first time we were made aware of this was when you raised it in Senate estimates last time.

Senator XENOPHON: It worries me that I had to raise it.

Dr Hammett : Under the Therapeutic Goods Act we are responsible for assessing the safety, efficacy and performance of therapeutic goods; we are not responsible for regulating the—

Ms Halton : Purchasing.

Dr Hammett : purchasing and behaviour of company directors and company strategy. So we are limited in terms of our responsibilities under the Therapeutic Goods Act to assess the products.

Senator XENOPHON: So it does not raise any red flags that companies were convicted of bribing surgeons to use their devices? That does not raise a red flag?

Dr Hammett : If the devices are safe and efficacious, it is immaterial how—

Ms Halton : There is a separate question here. For anybody involved in the purchase of devices or the provision of medical services and the oversight of that, including proper professional practice, I agree with you: it is a concern. The TGA's remit goes to the device, so they do not have a remit in relation to those issues.

Senator XENOPHON: Does the department have an issue with it if a company has been convicted of bribes or has received substantial fines in respect of bribing surgeons for the use of their product? Does that indicate a corporate culture that could beg a number of other questions about their devices?

Ms Halton : There are two questions there. One, is any company who behaves in that way likely to raise an eyebrow so that you might turn and have a closer look where you are mandated to so do? Yes, I agree with you absolutely and completely. Two, does it necessarily mean that the various devices per se that they might be promulgating are good bad or indifferent? We take a neutral view; we take an evidence based view, and we have had discussions about this over a period. So, yes, the TGA will undertake its regulatory responsibility in terms of the data and the evidence, including evidence that comes in from around the world about the use of devices, as you know. That work continues and the TGA will do a proper and professional job looking at that information, including revision rates and all those other issues.

As to the people who would be paying for those devices and whether or not any inducements might have been offered for surgeons to use those devices, there are two places—or probably three places—that are relevant in that respect. One is the private insurers because, as you know, they are underwriting for people who are having these procedures done privately. The second is states and territories, who are delivering these devices to public patients. Yes, you are absolutely right: there should be a good, careful look.

Senator XENOPHON: I am running out of time. Would you take on notice whether there are any protocols in place to look at these sorts of issues. I would appreciate it.

Ms Halton : For us, the answer will be no because we do not manage those other issues, but certainly in terms of raising those issues with other people I am happy to do so.

Senator XENOPHON: Thank you.

Senator ADAMS: Dr Hammett, last estimates I asked a number of questions about devices being used for breast examinations. I would like an update on whether any more have been removed from your register.

Dr Hammett : We have awareness of eight non-mammography based devices that may have been promoted for breast screening. Six of them have been cancelled from the register, preventing further supply. One is in the process of being cancelled, and there is a legislated process around how that occurs. The eighth and final device is currently under review by the TGA. So all of them are under review or have been removed from the market. In addition, we have gone to the people who purchased the devices and advised them of the current regulatory status of that equipment and the prohibitions that apply to advertising and promoting those devices for use in breast screening.

Senator ADAMS: Would you provide me a list of those on notice, please?

Dr Hammett : I will have to take some advice about whether we can provide that. I do not see at firsthand that there is any problem with that. I will take that on notice.

Senator ADAMS: Thank you very much.

Senator DI NATALE: The report relating to the transparency of the TGA was released on 20 July this year, but I have not seen any response to the recommendations. Is the TGA providing advice to government? What sort of advice is it providing? Has government indicated when it is likely to respond?

Dr Hammett : You are correct in noting that the report was released publicly on our website and it is currently under active consideration. I do not have a date of response for that report at this time.

Senator DI NATALE: The question was actually about what advice you are providing to government and the nature of the advice on that report.

Dr Hammett : We have certainly provided advice to government about the nature of the recommendations. That advice is under consideration, I understand.

Senator DI NATALE: Can I ask if you are generally supportive of the recommendations?

Ms Halton : No, we are getting into areas he cannot go, Senator.

Senator DI NATALE: For what reason?

Ms Halton : Because it is basically hypothetical and it is something which the government is considering.

Senator DI NATALE: Okay, I am happy to leave it there. In August this year the TGA announced that it was conducting a review of labelling and packaging—a regulatory framework for prescription medicines, over-the-counter medicines and complementary medicines—and stated that the labelling and packaging review consultation paper would be released this month. Are we still expecting it this month? When do we expect to see it?

Dr Hammett : I would be surprised if it was released this month. In fact, there is a working group that brings together the key stakeholders involved in this—consumers, healthcare professionals and industry—that is currently due to meet, I believe, next week to look at a number of options for improvements to current labelling and packaging arrangements. I think, given that next week is the last week of October, it would be unusual for any public consultation document to be ready for release by the end of the month. So I am afraid it is likely that it will be after the end of this month.

Senator DI NATALE: I expect that working group would be separate to the complementary medicines regulatory reform working group—is that correct?

Dr Hammett : That is correct.

Senator DI NATALE: That group, I understand, has put a number of regulatory reforms to government. When do we expect those reforms to be publicly available and when do we expect a response from government?

Dr Hammett : That group was convened by the TGA to provide advice to the TGA about potential improvements to our current arrangements for complementary medicines. That advice has been provided to us and, indeed, in the context of the transparency review and reviews of advertising and recent ANAO reports, government is considering how they might wish to deal with improvements to the complementary medicines framework. Those reforms are all under consideration currently. Because there is such a large piece of work involved in reforming major parts of our regulatory framework, there is very careful consideration being undertaken about how to build a coherent and consistent set of reforms that make sense and will work.

Senator DI NATALE: My final question is about the ANAO report. Your previous answer probably addresses this. I ask about the action that has been undertaken to address issues raised in that report and what further activity is planned. You are grouping that in one project, I imagine?

Dr Hammett : No. We are separating the ANAO report. As you may be aware, there were five recommendations relating largely to the regulation of complementary medicines. Those recommendations have all been accepted and we are moving to implement the recommendations of that report with an expectation that we will have those recommendations implemented by the end of 2012.

Senator DI NATALE: Good. Thank you.

CHAIR: For those who are watching the clock, you will know I have made significant unilateral changes to the program. That is the end of TGA. Thank you very much. I have checked with officers and they have agreed to put 1.5 and 1.6 questions on notice. We now move to the four designated agencies within the portfolio. We have questions on all of them but they will be limited in time. We will start with FSANZ.