Select Committee on Science and Technology Minutes of Evidence


Examination of Witnesses (Questions 240 - 259)

TUESDAY 1 NOVEMBER 2005

Ms Rosie Winterton MP, Dr David Harper and Dr David Salisbury

  Q240  Lord Sutherland of Houndwood: Minister, we understand that the Government has recently ordered over 2 million doses of H5N1 vaccine, and I wonder if we could talk a little bit about this. Firstly, could you explain to us a little bit of the reasoning which led to this decision, and secondly perhaps could you tell us what the vaccine will cost. Is that where the figure of £200 million came from or is it a different number? Finally, how will the vaccine be allocated?

  Ms Winterton: It is true that we are ordering something like 2.5 million doses of the vaccine, and that is a vaccine which can be used against the H5N1 avian influenza strain. In terms of costs, if we based it on what would happen in terms of seasonal flu, that is usually between £5 and £10 per vaccine, so I think it adds up to something like £30 million. That is in the region of; we have to stress in all these matters that if you were to take it from one to the other, that is the cost you would be looking at. But we are obviously in discussions about that. The reason why we have ordered that is so that we know that we can actually protect front-line health workers and perhaps others who might be directly involved in the culling of poultry if that became necessary, if there were an avian flu outbreak. It is also possible that we can use some of the vaccine for research purposes as well. One of the things that we are obviously trying to do is to minimise the amount of time, so that if a virus did develop that could be transmitted from human to human, to make the time that you could develop a vaccine as quickly as possible. So we would be able to use some of it for research purposes as well. As members of the Committee will, I am sure, know, it may be possible that if another virus developed, the H5N1 vaccine might offer some protection, but we just would not know.

  Q241  Lord Sutherland of Houndwood: I find this reassuring, particularly to look at the needs of those working in the front line with the contaminated or sick birds.

  Dr Salisbury: I think the Minister has made most of the points. Clearly, this is an insurance policy, that it seems good to be prepared, and since the assessment of risk is that H5N1 does not look good at the moment, it is timely that we at least have a reserve stock. That will allow us to get some research done. It is particularly important because the mock-up dossiers that may be being used for licensing purposes are quite limited in that they do not include children and they do not include the elderly as being needed for the preparation of a mock-up dossier. So if you already have a candidate vaccine and you have a research infrastructure available, you can at least get some of these policy-related questions answered that may not be necessary in fact for the licence in due course. So we would see this as useful for research. We would also see it as a possible first line if H5N1 emerged, because health workers would be at significant risk and we would want to do our best to minimise those risks. So we see many uses. It also encourages industry, I think, as part of the issue of capacity and helps industry get experience of making some of these vaccines.

  Q242  Baroness Finlay of Llandaff: Can I just ask you to expand a little bit on this group of front-line people you were referring to. Are you including in there people working in the funeral industry and people who are in teaching who may be exposed to large numbers of young people, and people who are involved in food distribution, or are you restricting it to clinical health care staff in your definition of front-line people?

  Ms Winterton: At the moment we have been talking about front-line health workers, for obvious reasons. Also, people who would be involved, as I have said, either in the direct culling of poultry or people who had to be involved in other control measures at that time, but mainly we are talking about health care workers.

  Chairman: We spoke a lot about what the Government is doing to increase the quantity of vaccine should we need it, but I think Lord Winston has a question about regulation.

  Q243  Lord Winston: In the event of a pandemic, what steps might the Government take to speed up the regulatory process to produce vaccines? One of the issues is that some companies feel that vaccines are hardly worth being involved in these days. Is there a process whereby the regulatory framework could be speeded up?

  Ms Winterton: Obviously, many of these issues are dealt with on a Europe-wide level. We obviously have our input into that. I hope the Committee understand that it goes without saying that we would do everything to make sure that safety was not compromised. There is a lot of work that can go on in a sense prior to the development which Dr Salisbury has just set out, and particularly if we are able to use the H5N1 vaccine to do some of that testing. The European Medicines Evaluation Agency (EMEA) has also set out some guidelines for manufacturers involved in manufacture of a virus for a pandemic which should actually help to accelerate the licensing of any vaccine as well. So it is something that happens at European level. There are measures that we can take to help along the process of safety. Obviously, we would not want to compromise safety, but it is important that we work with other international partners on that.

  Dr Salisbury: The EMEA has been extremely forward-looking in preparing so that the process of regulatory business is done as much as possible before there is a pandemic, and that is the purpose of the mock-up dossiers, so the manufacturers already have a whole lot of the package that they would need for a licence already done and approved, and they do that on a mock-up vaccine that they have prepared in advance. When the pandemic emerges and the virus is known and the ultimate vaccine is prepared, it is simply a matter of making a variation to the mock-up package, and that can take two days. So the regulators, I think, should be applauded for what they have already done on a Europe-wide basis to really try to get as far ahead of this issue so that there are not blockages that are simply bureaucratic in getting a licence. One of the important pieces of intervention where I do think we can influence, and I think the Minister was alluding to it, is the piece of time between the identification of a virus that could be causing human to human transmission and then a pandemic, and manufacturers being given material on which they can then base the production processes. That period of time is critical. That is when we know there is a virus and we cannot yet start manufacturing. The National Institute of Biological Standards and Control is looking extremely carefully at how the various regulatory processes that are necessary in that period of time can be brought together and made to run concurrently rather than sequentially so that the interval between having a pandemic virus and having the seed material for production is brought down to the absolute minimum. That would make a huge difference.

  Q244  Lord Winston: I can understand the Minister's reluctance to compromise safety, and that must be right, of course, but if you are dealing with a really deadly virus which is human to human, and you do decide to try and move things forward quickly, are there any steps by which the Government would consider indemnifying manufacturers against adverse consequences of any vaccines produced by a manufacturer?

  Ms Winterton: There are obviously issues around that. I am not sure how feasible some of that would eventually turn out to be. I know that Dr Salisbury has had some discussions around these issues.

  Dr Salisbury: This is something that is certainly being discussed on both sides of the Atlantic, in Europe and, of course, North America, because the manufacturers feel very vulnerable on the issue of preparing a vaccine that is not going through all of the usual steps, although it may go through many of them. Nevertheless, we will have to find a way that is both acceptable to the purchaser and acceptable to the provider so that there is indemnity, and that is currently being discussed and it is part of this bigger package of taking the sleeping contracts through to eventual production. We know that indemnity will have to be resolved one way or another between the industry and those that are buying vaccines.

  Q245  Lord Mitchell: It seems to me these are political decisions that have to be taken. I have a sense from reading through the evidence and in particular the written evidence from some of the manufacturers that they feel that all that should be done has not been done. I just pick up a different degree of urgency from them than I am picking up from the evidence we are receiving today. I just make that observation.

  Ms Winterton: I would hope from the reports that I get back from those who are engaged in the discussions that they are moving things forward. These are issues that are being addressed. It may well be that there are those in industry who wish things to move more quickly and wish for clarity immediately, but it is important that we work through this properly. As Dr Salisbury has said, there are discussions that are taking place on both sides of the Atlantic. I can understand people's anxiety perhaps to be able to have this sorted out. We are not unaware of the problem, but it will take time to resolve. It also needs to be put in the context of some of the other developments that are taking place as well, as we are able to use some of the work that Dr Salisbury has talked about in terms of how we can test certain dossiers, which all have an impact on that.

  Chairman: Shall we move on to antivirals?

  Q246  Lord Patel: My questions relate to antivirals, and particularly inhibitor drugs such as Tamiflu. Based on a fairly conservative model, the UK Government has decided to stockpile 14.5 million doses of Tamiflu, and we understand from previous evidence submitted to us that we will have this stockpile by September of next year. I said based on a fairly conservative model because other countries, such as France, the United States and others, are stockpiling millions more doses. France, we are told, is stockpiling 50 million. You shake your head, so maybe you will tell us the right figure and we will check it. The question is, if that modelling is wrong - and we are told that this drug will be effective in reducing serious complications and deaths if given at a certain time in the early phase of the development of the disease, the first 48 hours - then clearly, it will not be available to everybody who develops early-stage influenza-like illness, in which case there would have to be some form of - and I use the crude word - rationing. Will there have to be some rationing, firstly? If there has to be, how will we manage that? Can we be confident that this drug will be available to all of our citizens who may develop this illness?

  Ms Winterton: I will ask Dr Harper to talk about the modelling, which may be able to give you some reassurance, but first of all, we are certainly almost world leaders in terms of the stocks that we have of Tamiflu. France does have stocks of antivirals but they tend to be Relenza, which comes in powder form. They have some stocks of that as well as some of Tamiflu, but they can be quite difficult to distribute. They are also more difficult for old people and people with asthma to take because they have to be inhaled. In terms of the World Health Organisation recommendations, we are certainly at the top end in terms of the 25 per cent, and that is because the 25 per cent is geared towards the estimate in terms of the modelling of the number of people who might actually suffer during a pandemic. This is for treatment; it is not for prophylactic use of the whole population.

  Q247  Lord Patel: It is a treatment for early phase though.

  Ms Winterton: Yes. It is for treatment, and the estimates in the modelling are that 25 per cent is likely to be the amount of people who would have that. There are those who say why not get it for the entire population and treat people beforehand to prevent it happening? There are a whole range of issues around that, not least to do with the fact that you have to be very careful, if you are talking about prophylactic treatment, how long that would mean somebody taking it for. There can be issues of building up resistance to the drug itself. The best evidence we have - and I do want to emphasize that in terms of the World Health Organisation assessment of what we have done, we really are doing incredibly well to have reached that level of 25 per cent. If you look at many of our European partners, you will find it is nowhere near that, and I think the Americans are something like 1 per cent. We are 25 per cent, and that really is, as I say, very good planning, if I may say so.

  Q248  Lord Patel: I agree that it is for treatment of early phase disease. The question - and I think you answered in the affirmative - is that the amount of drug that we are stockpiling will be enough to meet the demand of every citizen that develops early symptoms of avian flu.

  Ms Winterton: David, can I ask you to say something about the modelling itself?

  Q249  Lord Patel: No, the question  .  .  .

  Ms Winterton: What I am saying is, yes, 25 per cent is based on estimates which have said the numbers in a population which may get influenza  .  .  .

  Dr Harper: There cannot be a guarantee that every person who needs Tamiflu, if Tamiflu indeed is the effective antiviral, would get that, because we have to prepare on the basis of a whole lot of uncertainty and assumptions. The best information that we have at the moment is to work on a 25 per cent clinical attack rate. It could be that, once the virus emerges, there is a much lower clinical attack rate. It could conceivably be a higher clinical attack rate, but the international consensus at the moment is that 25 per cent is a reasonable target figure to have, and that is the basis for our stockpile. But there cannot be a guarantee until the virus actually emerges as to the efficacy of Tamiflu and how many people would actually require it. These are the assumptions that have gone into the preparedness. What I would say is that we are keeping this under review all the time. So we have made our order. This is a limited shelf life product, after all, with a five-year shelf life. We are taking scientific advice also on issues such as the need or otherwise for Relenza, which the Minister mentioned, zanamivir, the drug itself. There is no evidence of any resistance at all associated with zanamivir. The original decision to go for Tamiflu was largely on the basis of ease of administration in a pandemic situation. So we are keeping a very close eye on any emergence of antiviral resistance to oseltamivir, and that alone would mean that we might need to reconsider our antiviral strategy as there are developments and as the science changes.

  Q250  Chairman: There has in fact been one case, has there not?

  Dr Harper: There has been one isolate from a patient in Vietnam of a virus that is resistant to Tamiflu. That is of dubious public health significance but is of great interest and significance scientifically.

  Q251  Lord Patel: We should qualify that that particular case also may not have had full, adequate doses of treatment, which increases the risk of developing a resistance.

  Dr Harper: Absolutely right.

  Q252  Lord Winston: One issue which you raised in answering the question is that, as you mention, a number of our European partners are much less well provided with these antivirals. What will be the policy in the event of one of our European partners faced with a major pandemic, with us untouched, and what will we do about supplying them with drugs that we might or might not need in the future?

  Ms Winterton: The WHO is acquiring a stockpile of 3 million courses of Tamiflu, and at the moment we are obviously working through the WHO on how that might be used in those circumstances, but of course, what we are doing is encouraging countries throughout the world to look very closely at the recommendations of the WHO in terms of the courses of Tamiflu or Relenza that they may be ordering.

  Q253  Chairman: A final question, Minister. Given the fact that this drug has a five-year life, are we committed to maintaining a stockpile of 14.6 million? It is not a one-off purchase?

  Ms Winterton: No, that is exactly the point that Dr Harper was making, that we do keep under review this whole issue, depending on latest information that we have from experts at national and international level. The way that the ordering has been done is obviously very effective because it does mean that you have a continual fresher stock.

  Chairman: Let us move on to issues of NHS reform.

  Q254  Baroness Finlay of Llandaff: You may have seen in this week's BMJ there was a leader on bird flu and pandemic flu. Its final paragraph says, ­Delivering health care would be a considerable challenge, not least because illness among NHS and other essential staff would diminish the work force. During a 15-week pandemic in the UK there would be an estimated additional 1.5 million consultations in Primary Care, 0.75 million visits to accident and emergency departments, and more than 82,000 admissions to hospital", which is a pretty phenomenal load on the system. The NHS itself is going through a period of radical reform. Concerns have been expressed that in the event of a major emergency such as a flu pandemic, initiatives such as the reconfiguring of Primary Care Trusts or the merger of Strategic Health Authorities could undermine the ability to respond effectively. I wonder what steps you are taking to allay these concerns and to make sure that reorganisation does not damage the ability of the clinical service to respond.

  Ms Winterton: I think there are various points to make here, and the first is I think to look at the work of the Chief Medical Officer and the structures that have been set up to ensure that the NHS is prepared, not only in a situation like this but also in other situations, whether that might come from a terrorist attack or a chemical leak or natural disasters. I think we are all very aware of some of the difficulties that may be faced by the NHS. I also think that in terms of the overall planning that has gone on, particularly since 2000-01, we are in a good position to ensure a response. When we talk about NHS front-line workers, that is exactly why we have taken some of the steps that I have just talked about both in terms of vaccine procurement and also Tamiflu antivirals. It is difficult - and you as much as anyone will know this, I know - in terms of planning because so much depends on the severity or otherwise of what occurs. What we have tried to do is to ensure that we are able to communicate with health professionals about what needs to happen, that we have very practical steps that health professionals, PCTs and Strategic Health Authorities should take. I would say when it comes to things like PCT reorganisation, what we want to see, obviously, in any NHS reorganisation is to make sure that the service itself is performing as efficiently as possible. As we have said already, one has very little idea as to, if a pandemic did strike, when exactly it would be, in how many years' time it might be. It would be a slightly curious proposition to say that we could never do anything to the NHS in case this upset planning and took people's minds off the job. I happen to think that is not what will happen and we are keeping a very careful check. As I have said, we have given PCTs and health professionals very specific advice about what we are doing and most recently have sent out a document. I have brought copies of that for the Committee because I thought it would be useful for you to see exactly what we have sent out to all GPs for example and what we are doing with PCTs. They are conducting their own analysis, it is managed through the SHA, so I am confident that any reconfiguration will not get in the way of that, particularly as what we will be looking for from a reorganisation is the ability to offer services even more efficiently than we do at the moment.

  Q255  Baroness Finlay of Llandaff: One of the difficulties with reorganisation is that the relationships that people have worked with, which are personal relationships, can be broken and they find they are relating to a different set of people. What we were wanting to be reassured of was that the framework of central command and control, if you like, is in place which transfers across and which allows for very high sickness rates in some parts of the service which may destabilise the normal pattern, so the service can still respond and shift resources across when perhaps a large tranche of it is knocked out. In some areas that may happen if one general practitioner is unable to function.

  Ms Winterton: Those are absolutely the kind of considerations that we are looking at, and incidentally quite a few of those scenarios are set in terms of when we look at contingency plans in other areas as well for general emergency preparedness. Obviously we are all too well aware of recent incidents where it has been put into practice with exactly the kind of cross-referencing you are talking about. We have some specific groups set up, for example, to look at requirements in terms of intensive care and so on. What we are very clear about as well is that as one would move through the different phases of the WHO's assessment alert state that that is when you would as well disseminate further information to health professionals based on what was actually happening at the time. That is the important thing. We can look at the different scenarios but the practicality is that we have to look at the situation as it develops.

  Q256  Lord Patel: Part of this we have already discussed but it relates to the responsibility of the Health Protection Agency, because the responsibility has been changed, as we understand it, and the funding has been affected on the basis they do not have any further responsibility for frontline management, but now if they are going to be responsible for emergency strategy relating to the pandemic flu we have been told this will create problems for them -

  Ms Winterton: For the HPA?

  Q257  Lord Patel: Yes, the Health Protection Agency.

  Ms Winterton: The HPA at the moment provides a lot of frontline services to the NHS, to local authorities and to others, and it will be very much involved in any efforts to deal with the pandemic. For example, consultants in communicable disease control at the moment with the HPA would continue to be there, and particularly as well the laboratory services for testing. If you wanted to send us any information that you were particularly told that they would not be able to do, please do so. That is certainly not what we are feeling at all, we see this very much as part of not only service delivery at the moment but also in the future.

  Q258  Lord Patel: Exactly, Minister. I think they recognise that, particularly with the situation of pandemic flu developing, they will have a role in emergency planning.

  Ms Winterton: Yes.

  Q259  Lord Patel: The question which came up in the evidence was whether the current funding, which apparently was cut because of the reorgnisation, would be able to meet that requirement.

  Ms Winterton: What is happening following on from the Arm's Length Body review is that they are being merged with the National Institute of Biological Standards and Control. In all those mergers obviously we believe there may well be room for certainly efficiency savings in terms of things like backroom staff or whatever, but the idea of that is to put more resources at the frontline, not to cut funding to organisations.

  Chairman: We will move on now to guidance to GPs.


 
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