Examination of Witnesses (Questions 911
- 919)
THURSDAY 3 FEBRUARY 2005
LORD WARNER,
DR FELICITY
HARVEY AND
DR JUNE
RAINE
Q911 Chairman: May I welcome you
to this morning's sessions of the Committee and particularly welcome
our witnesses for what will be, hopefully, the final session of
this inquiry which seems to have gone on rather a long time, but
we have found it most interesting. May I first of all thank the
department once again for its co-operation with the inquiry and
perhaps you would like to introduce yourself and your colleagues.
Lord Warner: I am Norman Warner;
I am the Parliamentary Under-Secretary of State in the Department
of Health, responsible for the area covered by the Committee's
inquiry. On my left is Dr June Raine, who is the head of the Post
Licensing Division in the MHRA and on my right is Dr Felicity
Harvey, who is the head of Medicines Pharmacy and Industry Group
in the Department of Health. So we have the regulator on the left
and the department's policy adviser on the right.
Q912 Chairman: May I start by asking
a broad general question? If you have followed some of the developments
in this inquiry, you will be aware that a number of key themes
have come out of the evidence which we have taken over quite a
long period of time. One of them, which in a sense perhaps informed
our reasons for looking at this whole area, is that the over-reliance
on medicines may well be to the detriment of our overall public
health. That has come out in evidence from a range of different
witnesses and organisations. What I wondered, to start off with,
is how the department actually balances concerns with what we
are seeing as, in a sense, the over-medicalisation of society
with your role of sponsoring and encouraging and working with
an industry which needs to be commercially successful?
Lord Warner: Various approaches
have been taken in different countries to this particular issue.
I am very struck, when I go to health minister meetings in Europe,
how they are often quite detached from the industry area. You
can argue whether it is a good thing or a bad thing, but it is
striking that there is that difference. What I would say is that,
give or take, pharmaceuticals represent about 12% of the NHS budget,
that sort of area. So a very large chunk of the NHS budget is
going on things other than pharmaceuticals. We also have in this
country a very strong use of generics by our doctors who are great
users of generics, so there is a balance against what you might
call the research-based industry in this area. That has been developed
over the years with this strong inclination particularly of GPs
to use generics wherever possible. The other thing I think I would
say is that it is the responsibility of all of government to try
to help research-based industries in the UK. We are dealing here
with an industry which has the strongest R&D activity of UK
industries. It is very strong and spends £3.5 billion a year
on research, which provides a lot of high quality jobs in a knowledge-based
industry. There is an important dimension there. I should say
that we have kept the balance pretty well and I am not making
a party political point here. I think that under successive governments,
the balance has been struck between having a health department
which has a responsibility as a sponsor department for the industry
and is also safeguarding the patients' interests and the NHS interests
through both its regulation and, if you like, its purchasing power.
The UK is unique in having a pharmaceutical price regulation scheme
on a voluntary basis; it may not always seem voluntary as you
are going through some of the negotiations, so I am told, but
it is a voluntary agreement. The last one did produce a very substantial
reduction in prices for the NHS which does suggest that we are
actually able to achieve this balance between being a sponsor
of the industry and getting the best value for the NHS.
Q913 Chairman: One of the things
which have struck me, in looking at the health service over very
many years, is that we have focused very much on a curative approach,
on initiatives to do with hospitals and the choice initiative
is a very good example now where it is about where you choose
to go for your treatment. Only very belatedly have we actually
looked seriously at developing a much more radical public health
agenda. Am I wrong in getting the impression that the industry
has perhaps skewed our thinking, our approach to health, because
of its own commercial interests? It is in their interest to create
in society an expectation that we can get a cure for every possible
problem and there is not a lot of money to be made out of preventive
approaches which are implicit within the Public Health White Paper.
Lord Warner: There is a balance
to be struck here because there is a short-term/longer-term issue.
Clearly the public health agenda is extremely important but as
you take forward the public health agenda, and the government's
White Paper on choosing health sets out a very clear and dynamic
strategy for helping deal with many of what I may describe as
the lifestyle choices that people need to make in order to maintain
good health in their communities, we are also faced as a society,
and the government has to respond to that, with the fact that
in the here and now a very large number of people have painful,
deadly, unpleasant conditions where we need the best therapies
we can get to respond to those conditions; we need to help provide
healthcare professionals with, so to speak, the tools to do their
job, so we do need these therapies. We have also seen a growing
flow of therapies which enable you to use medication without becoming
an in-patient; so you can actually make the health response much
less institutional and much more able to enable people to cope
with chronic disease conditions without emergency episodes in
living in their own home with the appropriate professional support.
So there is a balance to be struck, but I would agree with you
that probably historically we have been a bit slow to engage with
the public health agenda.
Q914 Chairman: One of the other themes
which has been within this inquiry quite clearly is the way in
which we have seen a pattern of medicines, which have been initially
hailed as breakthroughs, being widely promoted for their positives,
either being withdrawn or later having had serious questions over
their safety profile. I wonder whether you feel that the controversy
around medicines such as Seroxat, Vioxx and Celebrex indicate
that there is perhaps a problem with the licensing of potential
unsafe medicines.
Lord Warner: Whatever pharmaceutical
we are talking about, most of them have some degree of downside
as well as an upside and the whole point of clinical trials is
to try to get to the bottom of that risk benefit balance on particular
drugs. This country has followed the lead of other countries as
well of having basically a three clinical trial stage system of
licensing and an independent regulator trying to get the best
data that it can before giving licensing approval. It has always
been the case, and it has become more robust, that there is a
degree of post-licensing monitoring and surveillance of particular
products, so that when problems are identified, whether it is
adverse reactions notified through the Yellow Card system, whether
it is new clinical trial data or whatever, there is a process
by which the regulator can conduct further analysis. There is
a good track record on the part of the Committee on Safety of
Medicines of taking seriously that data which shows after licensing
there can be a problem. You could argue that some of the high
profile examples which you have mentioned are demonstrations that
the licensing system does work, that there is a good post-licensing
system for picking up problem areas and dealing with them. What
I should also say is that if we are absolutely frank, we may have
been a bit slow in the past in making sure that the regulatory
system was as transparent as possible in actually bringing information
into the public arena at an early enough stage and I arrived in
this job at the same time, pretty well, as the National Audit
Office report and the PAC report on the MHRA. There were some
pretty valid comments there about transparency, public communication,
whether we had done enough to demonstrate the independence and
effectiveness of the regulatory system. I do not think there was
a fundamental problem, but we have tried to take a number of measures
which I think the Committee is aware of, to try to improve that
transparency. Certainly there is an area on which we shall continue
to need to work away with the industry and that is the whole area
of a public register of clinical trials and publication of all
clinical trials data, so that it is in the public arena when that
information is available in a company or wherever.
Q915 Chairman: One of the underlying
themes of the inquiry has been a rather low opinion of the MHRA
from a number of witnesses consistently expressing concerns. Your
evidence from the department is neutral on that organisation.
You have just referred to transparency and the potential for further
change. Do you feel that other reforms are needed to address a
number of the concerns that we have had put to us about the regulatory
regime?
Lord Warner: It is worth just
going back to the NAO report, because whatever else one may think,
one would not accuse the NAO of being in the pockets of either
government or the industry. They found that the MHRA had made
a significant contribution to public health protection through
its regulation of medicines and they did not find any evidence
that it was too close to the industry. That was the NAO speaking,
not me. Certainly, they made a number of recommendations for improving
the perceptions around whether the regulation was as transparent
as might be. My own frank assessment is that its predecessor body
was very professionally sound, though probably a bit lacking in
communicating and providing information in the public arena which
built public confidence in some of its decision making. That is
why we have taken a very hard look at the committee structure
and, as you know, we shall be creating a new commission on human
medicines which merges the Medicines Commission and the Committee
on Safety of Medicines. We are going to require the chairs and
members of the commission and the new statutory committees to
have no financial interest in the industry, a stronger code of
practice on declarations of interest, we have reviewed the yellow
card scheme where we think patients ought to be given the ability
to report adverse reactions themselves, so we have taken a number
of measures to make this more patient conscious so that patients
can play a bigger part in some of the risk benefit judgments which
actually have to be made in this particular area.
Q916 Mr Jones: The Chairman raised
problems developing, three medicines that he mentioned—Seroxat,
Vioxx and Celebrex. On Vioxx, there is a problem area now in that
you have clear evidence that there are potential risks to some
patients using Vioxx, on the other hand, we have a very large
number of people in the country who have been using Vioxx for
a long period of time without any adverse effects. If the drug
is withdrawn, and presumably these people are then prescribed
a different drug, for those people what we are effectively doing
is increasing their risks because there is a risk inherent with
every drug. They have been using the drug without adverse effect
and now they are going to be told they cannot use that, they have
to use a different one and they do not know whether there is an
adverse effect. That is a very difficult issue, but I should be
interested in what you think. Is there not a case to be made for
saying "We withdraw the drug and we will not prescribe it
to anyone new, but those people who are currently using the drug
should be able to continue to use it".
Lord Warner: This is a very difficult
issue. That in a sense is why we have an independent regulatory
body trying to bring together all the evidence to see where the
balance of advantage lies and the balance of advantage often lies
in a different position on different products. You put the point
very well in the way you described that as the almost perpetual
dilemma for drug regulators, either in this country or in other
countries: how do you get the evidence to strike the right balance?
One could repeat some of your arguments for a number of other
products as well in exactly the same sorts of terms. I saw on
the television the other night with the phased withdrawal from
Co-proxamol that there was a long-term user of Coproxamol who
was not terribly pleased that this was happening. I do think it
is a bit of a dilemma; I do not think there is any easy answer.
There are some issues, which we have begun to think about, about
whether the present system is as sophisticated as it might be
for regulation and whether you talk about some kind of provisional
licensing at a stage after stage three clinical trials or whether
you talk about more robust post-licensing surveillance or some
kind of restrictions around the class of doctors who could prescribe
particular products for a period of time, so that you get a wider
usage. I do not know, but there are issues there which are beginning
to be discussed where we do need to do some more work within a
European framework and with other regulators.
Q917 Mr Bradley: The World Health
Organisation recommends that all countries should have a national
medicines policy. What are your views on introducing one here,
together with a dedicated committee to oversee the quality of
use of medicines?
Lord Warner: We do have pretty
good data and monitoring of the use of medicines. I know, for
example, that there has been some interest in iatrogenic effects
of drugs, where the MHRA actually did their own study in this
particular area. I do not want to appear complacent, but I think
we do have a pretty good system of seeing how drugs are being
used, seeing how prescribing is going, whether the balance is
right between new drugs, research-based drugs and generics and
so forth. We are always going to be in a situation where science
to some extent drives the agenda; there will be new discoveries
which will drive an agenda and will come up out of the science
community for any country. There is a lot in what the WHO are
saying and one of the things which we are going to do is to see
whether we cannot have, what we are calling at the moment, aFutures
Forum, which starts to look ahead, tries to be a bit more anticipatory
about some of the areas where we might try to get the science
applied faster where there is clear human need. What we have in
mind here is that the UK Clinical Research Collaboration (UKCRC),
which was set up by government about a year ago, which brings
together industry, the research community, the charitable sector,
patient interest, we might ask them on a regular basis to discuss
where medicines policy might be directed more and relate it more
to the progress of science in scientific knowledge. I do not know
whether that deals with the kinds of things you have in mind.
Q918 Mr Bradley: Yes. When we were
in Australia, we saw the value of having a national medicines
policy with broadly based interest groups involved in that process,
particularly consumers and users. We were struck that that took
a much more holistic approach to medicines in terms of health
outcomes as well as economic objectives and the World Health Organisation
recommends that looking at it in that way, in the national sense,
is a more effective way of ensuring the value of the medicines
themselves.
Lord Warner: It is a very helpful
suggestion. It is similar to the kind of thinking that has been
going through our own minds and I shall certainly take a closer
look at the Australian experience there and see if we can learn
from that as we take this idea of aFutures Forum further forward.
The idea seems to me a sound one and I should certainly want to
look at it very carefully to see whether we can build on that.
Mr Bradley: I shall come out with you
as I should welcome a return visit.
Q919 Dr Taylor: May I go back to
the question of independence of the regulatory agency, which you
have already talked about? We are told that the MHRA is one of
only two European agencies for whom the operation of the medicines
regulatory system is funded entirely by fees derived from services
to industry and many people have implied to us that it must be
incredibly difficult actually to protect the public from unsafe
medicines when you are being paid by the very people who are producing
those compounds. How do you rate the independence? How do you
ensure it when they are being paid by the very people who they
are trying to regulate?
Lord Warner: Just dealing with
the European situation first of all, virtually all the European
regulatory agencies have a significant contribution in terms of
income from the industry that they are regulating; there is nothing
very unusual about that. If you go to Sweden, I think you will
find it is about 95%, if you go to the Netherlands, you will find
it is 100%, so we are not that out of line.
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