Examination of Witnesses (Questions 1000
- 1017)
THURSDAY 3 FEBRUARY 2005
LORD WARNER,
DR FELICITY
HARVEY AND
DR JUNE
RAINE
Q1000 Dr Naysmith: There is a slightly
different angle to all this, which is that this must mean there
is a fairly close relationship between the Department of Health
and the pharmaceutical industry. It is possible that means that
solutions to health problems are sought more quickly and more
readily, from pills and that sort of thing, than other potential
treatments which the department also ought to be considering and
perhaps promulgating more. It is even more important when you
are talking about budgets, because quite often it is cheaper to
prescribe pills than it is to prescribe a course with psychologists
or psychiatrists or physiotherapists. It kind of skews the thinking
about health and public health away from a longer term solution
to a lot of problems. What I am asking is whether there is any
possibility that could be happening.
Lord Warner: The other argument
is: who is doing what? The person in the department who is the
lead official on relationships with the pharmaceutical industry
is Dr Harvey. She is balanced in terms of all the sources of advice
to ministers that feed into public policy decision making by a
raft of other people who are arguing the cases for public health,
particular disease conditions, mental health, acute services and
so forth. At the pinnacle of this is the Secretary of State making
judgments based on a variety of sources of influence. There is
no one person saying that at all costs we actually have to have
a pharmacological solution to this particular health problem.
I should say the arguments increasingly are the other way round,
where people are being encouraged to take more responsibility
for their own health. There is a strong drive in that particular
area, giving people more information about their own health conditions,
encouraging them to find out what are the best ways of responding
to those conditions, a lot more emphasis on choosing lifestyle
options which favour health rather than those which do not. That
is a set of very strong messages going on in the public arena
and the advice which is given to ministers, which is a counter-balance
to any suggestion that we might just want to promote pharmaceutical
products.
Q1001 Dr Taylor: May I go back very
briefly to the cost of adverse drug reactions? I realised rather
belatedly that I did not make my question quite specific enough.
You told us that about 6.5% of admissions to hospital cost £466
million a year. Does that include the cost of treatment in hospital?
Is that a total cost for that?
Lord Warner: I would have to bow
to Dr Raine.
Dr Raine: It was a total cost,
but we can certainly give you a note on the specifics.
Q1002 Dr Taylor: The other thing
which is probably not recognised is the cost of adverse drug reactions
in the community. Is there any measure of that? The loss of work
which a drug reaction causes for a patient who never goes near
hospital. I have only just realised by the mirth which was engendered
by my use of the term "global" that you were thinking
about the whole world. I was thinking about the global cost in
this country, the community and hospital services. Is there any
way you could find out about that?
Lord Warner: We will certainly
look into it. My impression from the study I cited was that it
related to the people who were in that particular hospital, but
we need to look at the evidence.
Q1003 Dr Taylor: Hospital admissions
are easy to collect; it is what is happening in the community
which is more difficult.
Lord Warner: We also have the
GP research database. We will genuinely look into the data we
have and give you the best estimates we have on that basis. I
am afraid I cannot answer in any more detail today.
Q1004 Dr Taylor: Moving on to innovation,
we have heard from several witnesses that really the rate of new
drug discovery is going down and this is almost inevitable because
it obviously becomes more and more difficult to find new answers.
A question which has been put to us: would a stricter regulatory
system encourage more real innovation? If one had got to 12 beta-blockers
and you said enough was enough, 25 non-steroidals and you said
enough was enough, would that in any way encourage drug firms,
force them to go for real innovations? One would cut the beta-blockers
and the non-steroidals well before you got to 12 or whatever the
numbers were.
Lord Warner: The whole area of
innovation is a complex one. It is wider than just stopping particular
pharmaceutical products. I have been involved in that in other
aspects of my work as well as the work on the pharmaceutical industry.
Certainly you have a pharmaceutical industry which has a very
big R&D component; there is no doubt about that. They spend
£3.5 billion a year on medical R&D. We have an NHS which
is putting in over £600 million to R&D and we have the
Medical Research Council and the charitable sector. There is a
very big component of medical clinical R&D in this country
which is driving an agenda of change in this particular area.
What we have found, which is why we set up last year, after a
couple of reviews, one by Sir David Cooksey and one chaired by
Sir John Pattison, was that there were real issues about how fast
we were getting innovation to the bedside from the laboratory.
So there were issues around whether we could do a better job on
what is called translational research in terms of getting clinical
trials off the ground. It is worth bearing in mind that the evidence
shows that patients who are in clinical trials tend to do rather
well compared with people who are not in clinical trials. Whatever
the outcome of the trial, there are benefits for patients. We
found that area is one which needs a great deal of attention and
that is not just in order to benefit the pharmaceutical industry,
it is actually to bring good products faster to the bedside for
a whole range of people. We also think, as I was saying earlier,
why we want to move down the path of aFutures Forum is in some
ways similar to the points that Mr Bradley was making about the
World Health Organisation having a medicines policy. We think
we need to be a bit more holistically looking ahead about the
things we should be concentrating R&D effort on a bit more
than we have done in the past, which is why we want thisFutures
Forum. We do know that generally in the NHS you need to use—this
is not just about pharmaceuticals but things like devices as well—the
purchasing muscle of the NHS to bring some of this innovation
faster to the advantage of patients. This is a complex issue where
it is not just a straightforward matter of stopping one line of
development for a particular range of pharmaceutical products:
it is a complex issue about how you foster innovation, the development
of new therapies and bringing the new therapies to the patient
quickly through a proper trial basis.
Q1005 Dr Taylor: Are there any incentives
which could be offered? It is obviously incredibly expensive to
develop a completely new treatment for something and it is presumably
far cheaper just to develop a minor variant of the drug. Are there
any incentives which could be offered to encourage the real innovation?
Lord Warner: It is not quite true
that some of the me-too drugs have not themselves been of great
benefit to patients. It is not always the case that the first-in-class
product has been the one which has been the winner for patients,
as you probably know from your own clinical practice. We could
certainly send you some evidence. The point I am making is that
there comes a point about when you stop me-too and next-in-class
in a particular class of drugs. Those would not be easy judgments
to make.
Q1006 Dr Taylor: One of our witnesses
felt that three beta-blockers would probably have been enough.
I wondered whether there was any way the regulatory system could
provide an audit and quality control of these sorts of developments
and that would therefore produce some regulation of them and a
push towards major innovation.
Lord Warner: Thinking about this,
particularly in the light of what Mr Bradley was saying earlier,
it seems to me that this is the kind of area you would touch on
in a WHO recommended medicines policy. You would start to take
a picture of where the areas of less involvement were and where
the areas of excess involvement were. It seems to me to fit more
easily into that kind of work rather than using the regulatory
system to try to block entry, if I understand you correctly.
Q1007 Dr Taylor: Yes. I was just
wondering how possible it would be for the MHRA, when there were
six beta-blockers all with slight differences, to say to a firm
which was going to produce a seventh that we do not need it.
Lord Warner: I do not have anything
more to add. The firm would still have to show safety and efficacy
in their product to the MHRA, if they had a new product in that
particular area.
Q1008 Dr Taylor: Back to a point
which has continually been made to us, all that has to be shown
is that a drug is better than a placebo, not better than a standard.
That does seem to me to be a weakness in the system?
Lord Warner: I am not the scientist
here.
Dr Raine: It does depend on the
therapeutic area; there are different approaches depending on
whether comparators are looked at or indeed placebos. We could
perhaps give you a short note on how the regulatory system works
in that regard.
Dr Harvey: The minister referred
to theFutures Forum and the UK CRC. The UK CRC involves all of
the major research funders, the NHS patient groups, scientists
and the pharmaceutical and medical device industries. Is a way
of stimulating research across the board and a way of building
on the original cancer research networks we have had in the NHS
to build research networks around mental health, children, stroke,
Alzheimer's, etcetera, where one is actually engaging with
the major research bodies and the pharmaceutical medical devise,
and biotech industries and patients in the sorts of areas which
are clinical priorities where actually we need the development
of new agents. As the minister was saying the Futures Forum, engaging
with the pharmaceutical and indeed the devices industry with these
major funders and patients does make it clearer to the industry
where the real areas of future priority need are for the NHS.
Q1009 Dr Naysmith: On that, I was
speaking earlier about the PPR scheme and the possibility that
there was an allowance for marketing it. There is also a big allowance
in it for research. Is that ever used as any kind of driver in
this area or could it be?
Dr Harvey: In terms of the 2005
PPRS, you are absolutely correct that in terms of the allowances,
the allowance for research and development was increased within
this particular agreement and that is particularly to stimulate
innovation with development of new active substances.
Q1010 Dr Naysmith: Were the companies
who had innovated rewarded or will they be rewarded or is this
something that everybody gets?
Dr Harvey: No; no. There is a
baseline research and development allowance, but then there is
an additional element for innovation specifically targeted at
the number of new active substances a company has which are in
patent. A small company gets slightly larger allowances; very
large companies get a fixed allowance per new active substance
for up to a maximum of 20 new active substances. This is building
on what was there within the 1999 scheme, but is very much more
around stimulating innovation.
Q1011 Dr Naysmith: What about quality.
Does someone check what has been innovated and say whether it
is a good thing?
Dr Harvey: It is around the development
of new active substances, so they have to be new chemical entities.
Q1012 Dr Naysmith: New in terms of
fulfilling a need or another version of an existing product. Who
will decide that?
Dr Harvey: Technically it could
be another version, but it has to be a new active substance in
its own right. In addition to that there is also an element of
the R&D allowance of up to 3% of NHS sales for the development
of paediatric licenced medicines as well. That is new within this
PPRS agreement and is very much in line with the minister's commitment
around having more licensed treatments available for children
for paediatric use.
Q1013 Dr Naysmith: The minister said
early on—I wrote it down—that one of the aims would
be to get the science applied faster where there is a clear patient
need; or it may have been a clear clinical need, but the rest
of it is accurate. That is what we should be trying to do, is
it not? If we can do it through that mechanism, then we ought
to be looking at it.
Lord Warner: There are various
ways. Paediatric medicine is a good example of where one is trying
to get the incentives all pointing in the correct direction. If
we are frank about it, this has been a rather neglected area in
the past, which is why we will be publishing a British National
Formulary for paediatric medicine later this year—the work
is being done by all the experts in this field—and why we
want to give incentives through the PPRS and negotiations are
going on in Europe over this particular area. Everyone recognises
that one wants to use the mechanisms available to try to get the
incentives where there is clear public benefit and paediatric
medicine is a good example. It is also worth mentioning that the
Chancellor has made available a tax credit for research and development
which the pharmaceutical industry would benefit from, as would
the biotech industries.
Dr Naysmith: We have had evidence in
this Committee that quite a lot of patient groups receive funding
and support from drug companies. I wonder whether you think it
is worth enquiring into such relationships and possibly even considering
legislation to control these groups because they could be acting
as unwitting foot soldiers for the pharmaceutical industry.
Q1014 Chairman: One of the things
we found interesting was the number of all-party groups within
parliament who also have interesting connections, often not known
to their members, with industry.
Lord Warner: This is a difficult
issue. I should just declare to the Committee that before I became
a minister I was the chairman of the National Council for Voluntary
Organisations, so I do feel slightly schizophrenic on this particular
issue. This particular issue is not peculiar just to the taking
of money from pharmaceutical industries for voluntary organisations.
All voluntary organisations are confronted from time to time with
whether they want to take a particular sum of money or types of
funding from a particular source when it may, as they see it,
produce a conflict of interests or compromise their own independence
of judgment. It is ultimately in this area down to the particular
voluntary organisation to consider very carefully whether they
are damaging their own reputations by taking money from a source
which may call in question the arguments they put forward on behalf
of a particular patient group or particular interest. It is not
peculiar to the area of taking money from the pharmaceutical industry.
Q1015 Dr Naysmith: Should some sort
of statement of interest be required, along those lines?
Lord Warner: Absolutely. They
do all have clearly defined charitable purposes in order to be
registered as a charity and the funding should not be in conflict
with their charitable purpose, whatever that is. They do have
to make sure that it is consistent with the benefit to their beneficiaries.
Certainly the Charity Commission offers a range of guidance to
voluntary organisations. I am certainly happy to look into whether
this issue has been raised with them, whether there are particular
areas. I do not know whether the Commission has actually taken
that in.
Q1016 Dr Naysmith: We have the Charities
Bill coming soon which may well be an appropriate route.
Lord Warner: Absolutely. Certainly,
if there is an issue, I think it is to a great extent dealt with
through the charities route.
Q1017 Dr Taylor: You mentioned the
withdrawal of Co-proxamol, which is really quite a milestone,
because I suspect it is the first time that a drug which has been
around for so long has been withdrawn. I can see some of us being
approached in our constituencies at home by long-term rheumatoid
arthritis patients who can see no way that they are going to get
off it. May I just ask what consultation there was, what bodies
were consulted about the withdrawal? Everybody recognises that
even in small overdose it is dangerous, particularly with alcohol,
but what consultation was there before this absolutely drastic
step of getting rid of it altogether was taken, when perhaps it
could have been available under some scheme of limited prescribing?
Dr Raine: Recognising the concerns
which Dr Taylor has expressed about a very well-established medicine,
albeit one without evidence of a favourable risk benefit, that
the withdrawal would pose very major issues for clinical practice
and for patients, for the first time we conducted a public consultation.
We put the evidence base into the public domain and sought comment
about the very question you are asking: are there specific groups
of patients for whom the benefit risk would be favourable. We
asked not just for evidence, but for arguments and opinions. The
results of that consultation are published. In the end the CSM
had to weigh all this up in light of the scientific evidence and
make a very tough decision. What I would say is that we also convened
a pain management working group under the leadership of the CSM
in order to help that change in practice. Quite clearly, if there
is a very small number of patients who do indeed need ongoing
supplies, we could consider a named-patient-basis type of arrangement.
I hope this gives you the perspective on the lengths to which
we went to gauge public opinion in this regard.
Chairman: May I thank you, minister and
your colleagues, for an excellent session. You promised to provide
us with some further information and we should in the near future.
Thank you very much for your help.
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