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Transcript of press conference: 20 August 2009: H1/N1 influenza; extended medicare safety net.

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Subjects: H1/N1 influenza, Extended Medicare Safety Net

NICOLA ROXON: …to give you our weekly update on the situation with the H1N1 pandemic. I'll run through a couple of the standard figures that I provide for you in each of these briefings and give you a little bit of an update and then we're happy to answer any questions that you want to ask us.

Currently there are 460 people hospitalised with H1N1 pandemic flu, 94 of those people are in intensive care units around the country.

We have anecdotal reports that some states are starting see a slight drop in numbers but you can tell from that that that's still a large number of people and putting a substantial amount of pressure on particularly intensive care units in hospitals around the country.

Sadly we now have 121 people who have died with the H1N1 pandemic flu, of course not all of those people died from the flu but that - those figures are, I think, a sobering reminder that whilst this disease is mild for most people it does have that severe edge that we spoke about very early on and that some people do have severe outcomes.

There has been reported in the news today that we will be in receipt, by the end of next week, of two million doses of the swine flu vaccine by the end of next week. That is correct. People would be aware that we have a contract with CSL for the provision of 21 million doses of swine flu. We're pleased that the production has gone smoothly and, of course, over the coming months we will receive extra doses of that vaccine.

What, however, I need to make clear is that we don't currently have full data on the safety and efficacy of the vaccine. The production is occurring at the same time as the human trials, to make sure that as soon as we do have adequate safety and efficacy data we're in the position to be able to start rolling out the vaccine, particularly to those priority people in vulnerable groups.

So we're very pleased. I understand that the safety data that we do have shows that to date it's consistent with the information we have from seasonal flu. I understand, from a discussion with the CEO of CSL last night, that this is actually the first data that's available internationally and so it wouldn't surprise

you that it's not yet complete and it - Jim, I'm sure, will also advise you of this but the Chief Medical Officer has advised me that there's not yet sufficient information from the initial adult trials to draw any conclusions that we should authorise an early rollout of the vaccine.

We are expecting the full report and more data in the coming weeks and because we are receiving the vaccine from the production process, it will start being predeployed to our states and territories. Of course the discussion with the states and territories about the rollout will mean that we are well-placed to be able to particularly target vulnerable groups when Jim is satisfied that the vaccine is safe and effective to be distributed.

I can also announce today, although this has, of course, been covered widely in our comments already to date, that it is agreed that the priority groups for the first doses of the vaccine that will be available are pregnant women in their second and third trimester, people with underlying chronic medical conditions, for example asthma and respiratory diseases, cancers, HIV, heart disease or chronic kidney disease, the morbidly obese, Indigenous people in remote and isolated communities, frontline health care workers and children in special schools.

I should note with that last one, the paediatric data, because the paediatric trials commenced later than the adult trials, will - we're not expecting to have that for some time so we need to wait, of course, until we have that information before we'll be able to roll out the vaccine to any children.

I think that this shows us that we are well-prepared. We have seen overseas that this disease has continued beyond their winter flu season and we do expect that there will still be people that continue to be affected by this disease. Our aim has always been to make sure that we can vaccinate those who are most vulnerable and then in addition, given that we've ordered 21 million doses, as much of the community as possible to be able to help reduce the spread of the disease both currently and in the future.

The only other thing that I would like to just give you a comment on is the surveillance information up to 14 August 2009 indicates that the rate of flu-like illness presenting to GPs are now about 32 cases per 1000 patients seen. That's below the rate at the same time in 2007 which was the highest flu season in recent years so for those of you have been following these figures, that's a bit of a drop-off from the last report.

We have still over just - just over 80 per cent of people testing positive for flu do have pandemic flu so that's using the sampling process that's undertaken so it remains true that the pandemic strain of the flu is the dominant strain of

flu this winter in Australia.

The median age of the deaths associated with H1N1 pandemic flu is 56 years which compares to 83 for those who die of seasonal flu.

So I think there's some good news today. The good news is, of course, that

the production process is going well, that we expect being in receipt of a large number of vaccine doses shortly, that we have good signs from the early safety data but not yet sufficiently comprehensive data to make a decision to give the final tick-off, if you like, for the vaccine to start rolling out, that the first priority groups have been agreed and that the rollout and implementation plans for being able to reach those people quickly are being put in place although further discussions do still need to be undertaken.

I think it's important to remember that this will be the biggest vaccination program in the shortest period of time that the Commonwealth has ever undertaken. It will require some patience and understanding from the public, that when we have the first doses available, subject to the safety and efficacy data, that we will be prioritising those who are most vulnerable first, before we are making this more available to the broader public. So I might open it up to questions, Jim, unless you want to…

JIM BISHOP: No, that's pretty comprehensive.

QUESTION: Could I ask the professor? CSL said that the vaccine was pretty much identical in formulation to the seasonal flu vaccination and they say that is safe. What more data or information are you waiting for?

JIM BISHOP: Well, we've taken the opportunity in Australia to do clinical trials and the good news is, of course, the clinical trial information is coming out and will be available as we start to obtain supplies and this was always planned this way. So we have 30 years of safety with respect to the seasonal flu and that I - we agree with CSL that that process is a safe process but we also have additional information and, as I said, as the Minister said, over the next few weeks we'll have a fairly comprehensive look at this current vaccine as well as the safety data. So we're in a good position, I think, to be able to provide, you know, a good message to the public about this particular vaccine.

QUESTION: Two million doses have already been manufactured. You must be pretty - or CSL must be pretty confident that it's okay.

NICOLA ROXON: Well, the two million doses are due to be delivered to us by the 31 August, which is actually Monday, the week after next. That production process is under way now, and, as you would understand, CSL and other manufacturers have significant contracts around the world for the provision of the vaccine.

It would not be possible to meet the time lines, both of - and fulfil our orders, let alone other countries, if production didn't commence straight away at the same time that the human trials can be undertaken.

There is quite a large logistical challenge, of course, to then get the number of vaccines pre-deployed in each state and territory, and then, of course, out to the service providers, and I think that's just a normal process for us to be doing that at the same time, and part of our contractual arrangements with


QUESTION: Given that we're, sort of, coming to spring time when, I guess, the flu season's sort of reaching its end, is there much point vaccinating so many people?

NICOLA ROXON: Well, Jim might want to comment. I mean, what I mentioned already in my introductory comments, is the evidence from overseas is that the swine flu, in particular, did still have quite a significant tail to it after the northern winter. We don't expect that to be any different here, which means that there'll still be significant numbers of people affected, which means that vulnerable group still can have adverse consequences.

But, of course, the vaccine is intended to provide protection for the future and, Jim, you might want to comment about expectations of how long the protection lasts, how the vaccines work if you want to.

JIM BISHOP: Yes, yes. I think the first thing is, as the minister says, we have got an obligation to deal with the vulnerable groups and that's our first priority for the current arrangements, and remembering that the epidemiology, the flow of this epidemic through our society, we haven't yet said that it's peaked. We hope that it's peaked. We don't know yet. And the second thing is that once we give this protection, we think that will be relatively long lasting, so that this will save us, we hope, against the possibility of the disease coming back in a second wave, either from the Northern Hemisphere this summer or from us in the next winter.

When it does come back, as we've said many times before, we hope it'll be the same, we hope it will be less virulent, but there is also the possibility that it could be more virulent, which is the way these pandemics can go.

So our plan is to be as prudently - prudent as we can about looking after the protection of the people. So the seasons are one aspect, but it's more to do with also just knowing how this virus is going to move around the world.

So, therefore, I think we're in a good position to be able to cover all of those possibilities.

QUESTION: You said that the final order of the trials is going to be out in a few weeks. Does that mean the vaccination process could start as soon as a few weeks?

JIM BISHOP: Well, as soon as we're satisfied with the nature of the information, as soon as we have enough information, those are the sort of decisions that we'll need to make.

NICOLA ROXON: And obviously…

QUESTION: [Indistinct] that is whether it's over [indistinct] months?

NICOLA ROXON: Oh, what I was going to say is, obviously, you would expect the governments to be making provision for us to roll out as quickly as possible. We, however, need to be very conscious of Jim's advice. No government wants to commence a vaccination program before we have the comprehensive data that's required to satisfy Jim that it's appropriate for us to do that. But we are planning and working with the states and territories, as has been speculated, for the vaccination program to commence at some time in September.

We are in the hands of both the clinical trial providers, of course, our negotiations with the states and territories, the advice we need from the Chief Medical Officer.

I don't think people should look for a conspiracy here. What the governments need to do is work to be able to roll it out as quickly as possible, but we do also need to satisfy ourselves that we've got full information from the first trial data to ensure that it's safe for us to do that.

One of the other practical problems, so that people can understand the scale of the challenge, is that the human trials assess what the size dosage is appropriate. So how effective, whether we need one dose or two. As we've said to you all along, this is an issue for how far the 21 million doses will go.

We, ideally, would like to commence the program when we know if it's going to be one or two doses. But there is the potential for us to target vulnerable groups by giving the first dose and being able to recall them for a second dose if that becomes necessary.

But you can see that this sort of complex information needs to be able to be assessed. In the meantime, I'm making sure that from the Government's perspective, that we are working with the states and territories to be ready for the earliest possible dates, particularly for the roll out of targeting those who are most vulnerable. And, importantly, our health workforce who we know not only see and handle a lot of people, but are also most regularly exposed to the virus.

QUESTION: [Indistinct] fall in to that vulnerable category [indistinct]?

JIM BISHOP: Quite a large number of people, so we're going to be asking, obviously, the - some medical support in terms of understanding those, but there's about 4.3 million people that would sort of fit into that vulnerable group of having some form of chronic disease, and they're the sorts of people we'll be going after in the first instance.

QUESTION: Are you confident this will be the first vaccination on the markets in the world?

NICOLA ROXON: I think we've commented previously that, obviously, it's a matter for other jurisdictions what sort of safety and efficacy data they are requiring. I would expect that we're going to see the vaccine being provided in

other countries at a comparable time. Some may actually be prepared to vaccinate with less information than we're seeking to have here. Some have already said they're not necessarily going to wait for human trial data.

I don't expect - we're not aware that any country around the world is providing the vaccination yet. There may be differences of a week or two here and there.

QUESTION: Why hasn't the Health Department or government made some sort of a system of the costings in areas like reproductive medicine and, say, cataracts? Specialists in those areas and elsewhere are claiming the Government has no idea or doesn't seem to of the actual costs they face. Is the Government going to do an assessment [indistinct]?

NICOLA ROXON: Well, it's unlike you, Mark, to necessarily take people's views just at face value. As you would know, with the Medicare safety net, we have made changes that were based on an independent report, which is public. It's been provided, it's been provided to the Senate committee. There's been a Senate committee report about it. The department has provided further advice. It does provide a lot of information about the costs that are charged, about typical cycles of IVF costs, et cetera. That detail is all there.

And I think what the specialists are doing and the Opposition are now jumping on this bandwagon, despite having promised to pass this measure, are trying to use patients to cover up the fact that 78 cents of every dollar from the safety net was going to specialists, not to patients.

We don't believe that was the purpose of the safety net and we think it's time that specialists understood that that was not intended to massively increase their incomes, but was intended to protect patients. And we need to start being prepared to say that some of the exorbitant incomes that are being earned, whether it's millions of dollars in the IVF area, slightly fewer millions, but nevertheless, in the millions for ophthalmologists and others, that the taxpayers cannot be expected to continue to pick up that cost when it is no

longer reasonable to do so.