Examination of Witnesses (Questions 1
- 19)
THURSDAY 9 SEPTEMBER 2004
DR FELICITY
HARVEY, DR
JIM SMITH,
PROFESSOR SALLY
DAVIES, PROFESSOR
KENT WOODS
Dr Naysmith: Good morning, everyone.
It looks as if we have picked on a topic that is of some interest
to the general population. I am Doug Naysmith, MP for Bristol
North West, and the first thing I have to do is apologise for
David Hinchliffe not being here; he has a family commitment that
he wanted to attend. He sends his apologies to the Committee and
to the people who are giving evidence. Can I ask if any members
of the Committee have anything to declare in terms of interests?
AND DR
MONICA DARNBROUGH
Dr Taylor: I would like it put on the
record that I was a shareholder in a major pharmaceutical company
until yesterday. I sold the shares yesterday.
Q1 Dr Naysmith: That was a very wise
thing to do, Richard! In welcoming our witnesses here today, can
I thank you very much for coming and for the submission, which
presumably all five of you contributed to. I will ask you in a
minute to say a word about your role in the Department and the
Agency. When you are asked questions, it is not necessary for
all five to answer every question. Sometimes that happens, and
it can take a long time to go through, but if anyone feels there
is a piece of information that they must get in or that the answer
to the question is going in the wrong direction, then please indicate;
but I will not always call everyone to have a go at every question.
Starting on the left, Dr Smith, would you say a word or two?
Dr Smith: I am Dr Jim Smith; I
am Chief Pharmaceutical Officer in the Department of Health, and
I am responsible for professional pharmacy policy.
Professor Woods: I am Kent Woods,
Chief Executive of the Medicines and Healthcare products Regulatory
Agency.
Dr Harvey: I am Felicity Harvey,
and I am the Head of Medicines, Pharmacy and Industry Group within
the Department of Health; and within the Department of Health
we have the lead co-ordinatory role for sponsorship of the pharmaceutical
industry, but also I cover most medicines issues within the Department
of Health.
Professor Davies: Sally Davies:
I am the new Director of R&D for the Department of Health.
Dr Darnbrough: I am Dr Monica
Darnbrough, Head of the Bioscience Unit in the Department of Trade
and Industry.
Q2 Dr Naysmith: We will be exploring
all these different roles over the next hour or two. Dr Harvey,
we have received a large body of evidence from various sources
with argue that the pharmaceutical industry wields extensive influence
on healthcare policy and systems in this country. Your submission
does not really acknowledge this; it is very much a factual statement
of what you do and your responsibilities. Do you have any opinions
about the influence that the pharmaceutical industry has on healthcare
in this country?
Dr Harvey: Chairman, might I explain
a little about the relationship that government has with the pharmaceutical
industry and some of the main areas that this covers? The pharmaceutical
industry is a major stakeholder for government in general. We
have a multi-faceted relationship, and quite a complex relationship,
in terms of the different areas this relates to. Firstly, and
one of the important reasons why this relationship has a co-ordinatory
focus within the Department of Health, is that the NHS is a major
customer of the pharmaceutical industry. Innovative medicines
and indeed generic medicines are very important in terms of healthcare,
quality of care, and are very much one of the major planks underpinning
the national service frameworks, and indeed NICE guidance that
goes to the NHS, in terms of the drugs that will have most impact
on patient care and patient benefit. Similarly, we have a regulatory
relationship with the pharmaceutical industry, which is led by
the Medicines and Healthcare products Regulatory Authority. As
you know, the MHRA is held in quite high esteem within the European
Union in terms of the quality of the work that it does. Thirdly,
we have a major relationship with the pharmaceutical industry
as a major R&D and innovation industry within the UK. The
pharmaceutical industry invests about £3.5 billion per year
in R&D in the UK, which is incredibly important for the NHS,
particularly in terms of having innovation that we can bring to
patients. That R&D is about a quarter of the R&D for the
manufacturing within the UK. Lastly, but certainly not least,
it is a major industry within the UK and even though it is a global
pharmaceutical industry, and we have exports from the UK of about
£11.8 billion per year, with a £3.1 billion trade surplus.
Therefore, in terms of the relationship that we have with the
pharmaceutical industry as a major stakeholder, it is an important
industry for the UK. However, if you think of public health and
health relationships generally, the relationship the Government
has with the industry is pretty well on an equal basis with the
very key relationship we have in Health with patients and patient
groups, and indeed with NHS professionals and managers.
Q3 Dr Naysmith: We will be exploring
a number of things you have touched on later, obviously. The purport
of my question really was that the National Health Service is
a customer of the pharmaceutical industry and lots of people know,
because it is a fact, that the pharmaceutical industry has quite
a strong influence on formulating the policy of the customer that
it is selling drugs to. I just wonder whether the Department of
Health is the right place for the promotion of the industrial
health of the pharmaceutical industry, which is what that results
in. Is that the right place for it to be? We will be asking more
detailed questions later on as well, but I am asking in a general
way.
Dr Harvey: In terms of the focus
within the Department of Health, it's role is one of co-ordination
across many government departments, as you are aware, it lies
within the Department of Health, because of the importance
of pharmaceuticals, in terms of increasing quality of care and
patient outcome, for example there has been quite a switch between
secondary and tertiary care in recent times, with healthcare now
moving to a more primary care focus. It is important that within
the Department of Health we understand more of the issues around
health, the importance of innovation and research and development,
and obviously the wider UK plc issues.
Dr Darnbrough: Felicity has outlined
the relationship that the Department of Health has with the industry,
and perhaps at this early stage of our discussion I could outline
a little bit of the background to why the Department of Trade
and Industry also has a relationship with the pharmaceutical industry.
As many of you will know, when Mrs Hewitt became Secretary of
State for Trade and Industry, she had a review of the Department,
and at that stage set up a business relations function, outward-looking
towards all important economic sectors of industry in the UK.
One of those sector units is mine, which looks at biotechnology
for all application areas—industrial, agricultural medical,
and so on—as well as working with the Department of Health
in keeping in touch with the pharmaceutical industry. The business
relations side of the Department was encouraged to understand
more about the issues facing companies in terms of productivity
and competitiveness, which is what our Department is really all
about. Therefore, we have quite formalised relationships with
some of the pharmaceutical companies in order to understand the
issues that are of concern to them. However, when we are having
these formal meetings and visiting companies, we very often do
that jointly with people from Felicity's team, and indeed from
other parts of the Department of Trade and Industry, and so on.
Q4 Mr Jones: Every year the pharmaceutical
industry produces a number of innovative drugs, a proportion of
which will have major new therapeutic effects. We have seen evidence
that seems to suggest that the proportion of new drugs that have
major therapeutic effects is declining. Do you collate any information
which looks at innovative drugs being brought in and whether they
are truly therapeutically effective, or whether they bring nothing
new into the drugs market at all?
Dr Harvey: Perhaps I might start,
but it is also relevant to Professor Davies from the R&D perspective.
In terms of innovative medicines being brought to the market,
as the Committee is aware, we set up the National Institute of
Clinical Excellence in 1999. The importance of NICE is that it
looks through its appraisal mechanisms at the clinical and cost-effectiveness
of all new innovations, be they pharmaceuticals or devices. In
terms of the outputs of NICE, which are in most cases underpinned
by a three-month funding direction, they will give advice to the
NHS on how beneficial a particular drug is and in which clinical
indications, very importantly, it is effective—whether it
is right throughout its licensed indications, or whether it is
just for a few of those licensed indications. If you look at about
79 of the last appraisals that NICE has done, only in 24 has it
said this should be used because it is clinically and cost-effective
for all of the specified indications under licence. In the majority,
it is for just part.
Q5 Mr Jones: I understand the role
of NICE in deciding whether or not a drug is clinically effective,
but my question was that you may have a new drug on the market
that is clinically effective, but it is no more clinically effective
than the drugs that exist already. What work does the Department
of Health do to assess that, and does it believe that it should
have a role in making that sort of information public?
Dr Harvey: If I could return to
NICE for a second, when NICE is looking at individual drugs, it
does not necessarily look at just one. On many occasions, and
looking at the work programme at the moment, there are a number
of occasions when it has looked at many drugs within a class.
They might be drugs that have come later to the market that have
a similar effect, and it does look at the clinical and cost-effectiveness
of each of those. In terms of information that is provided for
prescribers around the effectiveness of drugs, whether or not
something has yet found its way to NICE, we also have work that
is done by the National Prescribing Centre, which provides bulletins
and various types of information to clinicians about effectiveness
of individual drugs. Another publication that the Department of
Health provides to doctors is the Drug and Therapeutics Bulletin.
That similarly looks at the clinical effectiveness of ranges of
drugs in the treatment of particular conditions.
Dr Smith: As Dr Harvey has said,
we have a huge range of mechanisms in place to provide information
and advice about drugs within a class. They are NHS-directed services.
They do not resolve the fundamental issue of whether innovation
has taken place in a particular area. For that, we are looking
to the fundamental drivers of the research process, but certainly
in response to the issue of whether there are a lot of "me
too" type drugs coming to the market, they do. We have to
be careful here because "me too" drugs are sometimes
valuable. There are many classes of drugs where the first example
into the market place did not turn out to be the class leader.
The "ulcer healing" drugs are a very good example, and
there are other examples. I take the point. We have a lot of "me
too" drugs and it is very important that we guide and help
doctors and other professionals in choosing the most cost-effective,
and we do that through a range of mechanisms.
Q6 Mr Jones: You say "doctors
and other professionals"—and this is a natural tendency
within professions, but the lay public is also capable of reading
information. It may be useful, you might think—and the Committee
might think—that the general public should be able to acquire
information that is objectively assessed—and no other area
could do it other than the Department of Health—about whether
drugs are bringing in something new or whether the drug is a "me
too" drug that does the same as any other drug.
Dr Smith: I think we agree entirely,
and the Government is very committed to patient education and
the provision of patient advice; and it is doing it in many ways.
NICE also publish a booklet that explains each guideline. This
is aimed specifically at patients and the public, and more widely
than that there is a commitment, a belief, that informing patients
about their medicines will make treatment safer and more effective,
and will make them more likely to take a medicine properly and
get better outcomes. Indeed, as you are suggesting, there is an
intrinsic right of patients to be well informed and to be able
to be partners in that prescribing decision. We are doing a lot
around that. We have a programme called Medicines Partnership,
which is promoting this. We have Ask about Medicines Week, which
is going to run for the second year, encouraging the public to
seek information. We are supporting a programme of tailored information
for patients, which is in its infancy, but the vehicle for that
will be NHS Direct Online. There will be access to an impartial
source of information for the public.
Q7 Mr Jones: As a member of the public,
would I be able to get information in the future about drug X
which has just been introduced, when the Department of Health
says that drug X is—because NICE would have to say it is—clinically
effective, but it is no more effective than Y, Z and Q were; or
that drug X is particularly clinically effective and does things
that the other drugs would not do? Would I be able to get this
information in future?
Dr Smith: I think you would.
Q8 Mr Jones: I cannot now, can I?
Dr Smith: You can for drugs that
NICE looks at, because they are in the public domain. The other
mechanisms that I spoke about are under development, but when
they are developed they are aimed at the public, so you will be
able to log on to NHS Direct Online and look at drugs for blood
pressure or whatever, and see impartial information that will
include value judgments about what is best for a particular disease.
Q9 Mr Jones: The DTI and the DoH
recognise that in the role of promoting the industry and the best
interests of the industry there is a potential conflict because
it is in the industry's interest that any new drug is seen in
the best light possible, but if the DoH were to indicate the usefulness
or new therapeutic value or otherwise of a drug, then many new
drugs coming in to the market would find it very difficult to
be sold.
Dr Darnbrough: It is very much
a question for the companies themselves what lines of research
and development they choose to go down. Obviously, they go down
roads where they think there is a real market for their products.
However, I do not think we should under-estimate the genuine innovations
that are coming out worldwide in the pharmaceutical industry and
also in the UK. They are far from all being "me too".
Q10 Mr Jones: I never suggested they
were. I was trying to look at whether we could distinguish between
what is a "me too" more clearly and what is not.
Dr Darnbrough: If you look at
some of the important drugs that have been developed in the UK
over the last 10 years or so, there are things for prostate cancer,
epilepsy and schizophrenia that are quite novel, as well as the
improved things for hypertension, migraine and diabetes and so
on. Some very innovative things are coming to the market. My colleague
explained the important work of NICE in assessing the cost-effectiveness
of using these new things for healthcare in this country.
Professor Davies: There are a
number of things that I could usefully talk to. Of our national
programme of R&D we spend 115 million through that. We fund
a health technology assessment programme for 18 million and in
that we do work that has a priority for the NHS. For instance,
there is an ongoing trial, head to head, of anti-epileptic drugs.
It is not only about drugs; it is about other methods of treatment,
and other interventions, clearly, as it is technology in the broadest
sense.
Q11 Dr Naysmith: Do you think there
has been enough?
Professor Davies: When you ask
an R&D director like that, I could be a bottomless pit; but
we are doing the top priorities and many more.
Q12 Dr Naysmith: The reason I ask
that is that in comparison with the amount of money that the pharmaceutical
industry can spend on research, that sounds like a rather small
sum.
Professor Davies: We are very
proud of what we do in this country, not only through the Government,
but the public sector research in this country is bigger than
many other countries because of the charity contribution as well,
so that we can build on what pharma has done to provide the best
things for our patients and our society. One of the other areas
I wanted to highlight is our support through technology evaluations
for NICE, but in particular the Cochrane Collaboration work that
goes on in this country, funded by ourselves, to produce systematic
reviews. An individual research study can be misleading on its
own to clinicians, because it comes out with one result, and we
need to put them all together. Through the Cochrane Collaboration
the systematic reviews are done, bringing all the work together
from the perspective of the clinical question. In addition to
doing that, it compares drugs against drugs and looks at side
effects, and also every systematic review has a patient synopsis
that explains it in words satisfactory to the patient. These are
all available for the whole of the international Cochrane collaboration
on the Web, for everyone; so there is access to all of that. We
spend over £7 million a year on the systematic reviews and
evaluations of support on the Cochrane Collaboration, which is
more than any other country.
Q13 Mr Jones: You will understand
that in these questions I am trying to understand the potential
conflicts of interest that there may be between the customers
and the suppliers. Why do you think that the Department of Health
is the best placed organisation, being the major customer, to
co-ordinate the relationship between the Government and the industry?
Professor Davies: It is I think
because the public health interest is very important, and indeed
medicines to the NHS are very important. Through the stakeholder
relationship we have with the pharmaceutical industry and very
much as a result of PICTF, the Pharmaceutical Industry Competitiveness
Task Force, we now have a stakeholder relationship that means
the pharmaceutical industry has a much greater awareness of the
clinical priority areas for the NHS, the areas that we are seeking
to drive up quality of care and better patient outcomes. Through
that better understanding between government, the Department of
Health and the pharmaceutical industry, that has had many gains
for us, in terms of the sort of innovative medicines that have
been brought to market, particularly in the areas for example
of the national service frameworks that are populated by NICE
products like coronary heart disease, diabetes and mental health.
There are many examples, and I know that Professor Woods could
give some examples of where those innovative medicines have had
huge impacts on outcomes for care, and indeed care pathways, for
removing care from secondary and tertiary care more to a primary
care base, which is also facilitated by the importance for the
Department of chronic disease management at the moment.
Professor Woods: I spent 30 years,
up until last year, practising in the NHS as a physician, and
I have seen some very considerable therapeutic steps made during
that time in areas which one has to look back and think about
to realise just how far we have travelled in terms of, for instance,
the management of peptic ulcer disease, which was largely a surgical
condition when I qualified and is now a medical condition. There
have been dramatic changes in the outcome of heart attack, for
instance, due to active management with drugs. It is a change
that took place in the middle to late eighties and onwards. There
was a 40% reduction in the mortality of heart attack in hospital
in my own unit. These are really quite dramatic changes. Nonetheless,
I should like to go back to the question you posed at the very
beginning about the driver to true innovation, as distinct from
small incremental growth within drug classes. It is a very complex
and very important question. The factors that seem to be important
are these. Firstly, as a large customer, can the NHS drive and
stimulate innovation by being a discriminating and demanding customer?
That is something that the NHS has been doing much more critically
and more actively in recent years. However, beneath that is the
problem of where true innovation comes from. Where are the therapeutic
opportunities to be exploited? That is something that is outside
our gift. There is another element, which is the time and cost
of drug development, which, as everybody has been aware, has grown
slowly in recent years—10 or 12 years of developments, and
hundreds of millions of pounds spent on the development of an
individual drug. Therefore, the element of commercial risk is
much higher for a truly innovative compound in a new therapeutic
class than for an incremental development within an established
class, where we know broadly what the drug is going to do. There
are some very complex factors going on here.
Q14 Mr Jones: Does that not depend
upon the size of the market for the drug?
Professor Woods: It does.
Q15 Mr Jones: You can have an innovative
drug that does something marvellously new therapeutically, but
it only does it for a small number of people.
Professor Woods: Absolutely so.
Q16 Mr Jones: Or you can have a "me
too" drug which has a huge market. So that driver is there
in terms of "let us get a slice of this particular cake"
because it is a very big cake.
Professor Woods: Indeed, and the
size of the potential market is a very considerable driver; and
the ability and willingness of the market to pay for the product
is obviously a very important driver. There is a greater concentration
of developmental effort on areas of therapeutics that are large
clinical problems, and it does create problems in some areas where,
by the nature of things the market forces do not drive innovation
equally in relation to need. We have specific examples of that.
We have so-called orphan drugs, which are targeted towards very
small groups of patients. We have issues around drugs for children,
because as a market this is a relatively small part of the clinical
population. Therefore it is necessary to have additional mechanisms
to help encourage innovation in those areas where the market mechanism
itself is not sufficient.
Q17 Dr Taylor: It is the fundamental
drivers that we are desperately trying to get at. It would seem
fairly obvious to the outsider that the driver, if research is
left entirely to the pharmaceutical firms is one of profit. How
do we square that with what the public need? What can the Government
do to force the pharmaceutical industry away from profit motives?
It is a wide, difficult question.
Professor Woods: It is a fundamental
question. We as a country, although we are running a developed
and advanced healthcare system, are a relatively small proportion
of the total pharmaceutical market worldwide. We are talking about
a global industry, and therefore even the influence of the NHS
as a demanding customer is limited. On the other hand, there are
steps that can be taken to at least help support innovation in
areas that would not otherwise be commercially attractive. There
is, within the European regulatory system, which we are closely
integrated with, an orphan drugs mechanism, which has been running
for the last four or five years, which gives certain advantages
in terms of market exclusivity and waiving of regulatory fees
for products that are designated as orphan products. They are
treatments for patient groups which represent fewer than five
in 10,000 of the European population. These in themselves are
not sufficient incentives to completely redirect innovative research,
but they help, in so far as we can, to shape a research and development
strategy that will not be totally discouraged from addressing
relatively rare problems.
Q18 Dr Taylor: We have been told
that the industry has expressed irritation about this Orphan Drugs
Act, which is rather hard to understand because lack of competition
must drive up the prices, which is in their interests really.
Professor Woods: In the European
system the orphan drugs regulation is relatively new and still
to be fully evaluated. I think about 200 compounds have been designated
under that system, and about 12 or 15 have been licensed through
the European route. I think it is going to become more of an issue
as we see the products of biotechnology working through, because
many of these are targeted at quite small groups of people where
we understand the genetic basis of disease and we have the potential
to develop products that will correct that illness. So it is an
area that is a thorny one, a difficult one. The United States
has been working on this a little longer. There was orphan drug
legislation enacted in the early eighties, and that again deploys
a combination of incentives and commercial concessions, in terms
of product exclusivity and tax relief, to encourage development
in these areas. I think you have hit on a really fundamental issue.
Q19 Dr Taylor: You have mentioned
that we are a fairly small player in the world market as it is,
and some of the evidence we have is a little bit confusing. The
ABPI tell us that a quarter of the world's 100 most used medicines
originated in research and development in the UK. The Department
of Health puts it slightly differently—"top-selling
and leading". Is there any significance in these different
descriptions? Do they mean anything, or is it just words?
Dr Harvey: I do not think there
is any significance in the different meaning. It is a fact that
of the top 100 medicines, 25 of those have indeed been developed
through the research and development within the UK, and that puts
us in the UK as second only to the USA in terms of the research
and development basis for development of medicines.
Dr Naysmith: Richard's point is the difference
between leading and top-selling. How do you define "leading"?
Is it the same as the amount of money that the drug firms get
in for particular drugs?
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