Examination of Witnesses (Questions 240
TUESDAY 1 NOVEMBER 2005
Ms Rosie Winterton MP, Dr David Harper and Dr David
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
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
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
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
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
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
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