Examination of Witnesses (Questions 760
- 773)
THURSDAY 13 JANUARY 2005
DR RICHARD
BARKER, MR
VINCENT LAWTON,
DR DAVID
CHISWELL AND
MR SIMON
CLARK
Q760 Dr Taylor: Is that MSD advertising
that or is it just the generic makers?
Mr Lawton: It is actually Johnson
& Johnson MSD, which is a consumer part of our company.
Q761 Dr Taylor: So this is one of
the occasions when you make the generic form of this drug?
Mr Lawton: Yes, we manufacturer
it there.
Q762 Dr Taylor: How common is that?
Mr Lawton: We also have another
one called Famotidine. There are other agents of that sort manufactured
by other companies.
Q763 Dr Taylor: Do any of your manufacturers
make simvastatin?
Mr Clark: Yes. We make our own
simvastatin. The simvastatin that is advertised in the press is
nothing to do with the generic prescribed simvastatin. It is purely
the OTC version that is available.
Mr Lawton: It is the low dose
one.
Q764 Mr Jones: Mr Lawton, you have
spoken about the Code of Practice. In our earlier sessions we
have heard a great deal of concern regarding the marketing activities
of companies. This criticism that we have heard so far is particularly
in relation to the time taken for complaints to be handled and
that the sanctions appear to be weak. Do you think the system
could be improved by addressing these issues?
Mr Lawton: Any system, including
this Code of Practice, needs to be reviewed on a regular basis.
Every year or two we do a periodic review and we are doing a fundamental
review now and consulting stakeholders and it is looking at sanctions,
it is looking at everything about the Code of Practice procedures.
Whether or not the sanctions are adequate is something that I
am aware has been raised several times. The sanctions are varied.
They go from, first of all, having to withdraw the materials.
When somebody may have contravened the Code they would have to
stop that promotional activity, withdraw those materials, which
can cost tens of thousands or hundreds of thousands of pounds
in itself for that company and it stops them pursuing that particular
promotional activity. Very often they have to publish a retraction
of this and say what happened and why and this appears every quarter
in our Code of Practice review bulletin which you may have seen.
Q765 Mr Jones: So you would not agree
the sanctions are particularly weak, would you?
Mr Lawton: I do not think the
sanctions are weak. The industry takes it extremely seriously.
Q766 Mr Jones: Dr Chiswell, in your
written evidence you say that biological products slip through
the NICE net, that NICE does not evaluate them because they are
specialised products and not enough patients use them. Have you
raised that point with NICE? Do you or they doubt that "therapeutic
value for money" evaluations would be worthwhile?
Dr Chiswell: We are not saying
that all of our products do not come through NICE. I am associated
with a product called Humira which NICE reviewed for Rheumatoid
Arthritis and recommended. NICE cannot get to everything. I think
there has to be a limit from NICE's point of view as to how much
they can do. Maybe there is another mechanism required whereby
products which work for a few hundred people get into the system
and people get reimbursed. We do have orphan drug regulations
both from the UK and Europe and they will be reviewed in Europe
this year. There are mechanisms where we could see more approvals
of those sorts of products going through.
Q767 Mr Jones: Is there a case for
those orphan products to be evaluated more at the multi-national
level rather than at national level?
Dr Chiswell: Possibly, but in
the end the way the system works is that somebody in a PCT is
going to have to pay for it. Ultimately it is the reimbursement
that counts.
Dr Barker: I wonder if I could
add a point or two on Mr Jones' first question because I think
you raised the point about the speed of evaluation (under the
PMCPA) which Professor Lawton did not address. The average time
is about eight weeks for the Code to investigate the matter. If
it goes to appeal, which is governed by a second panel that is
headed by a QC, that adds a few more weeks to the time. I would
say it is really a pretty rapid process based on my observation
of this over the first few months of my time in the job. By the
way, this is an arm's length entity. It is not one that reports
to me but I have had a chance to review the outcome of some of
these. The embarrassment associated with being found to be in
breach of the Code is not inconsiderable. It comes up to the Board
of Management. These companies really would very much rather avoid
being found in that position. If you take a look at the Code,
it is an extremely detailed and rigorous Code with a great deal
of specificity, but it is fundamentally a reinforcement of the
legal obligation on the MHRA which is already there to regulate
promotion. So we think it is a very important layer above a statutory
requirement on the MHRA and it is itself subject to judicial review,
so we think it is pretty rigorous.
Q768 Dr Taylor: I want to return
to the Clinical Trials Register. Can this be policed? How can
people, patients and the public, be absolutely sure that all trials
are being registered and reported?
Dr Barker: We are actually pretty
proud of the progress that has been made over the last few months
in getting to the stage that we are at. The ABPI started the journey
on this some four years ago and so we have helped to promote a
trend which we think is now internationally accepted. I was at
a meeting earlier this week that involved journal editors, the
American Medical Association, medical informaticists and the industry.
There is now a very good sense that what is being proposed in
terms of a register and a results database is exactly what we
need. The attention is being turned to implementation and monitoring.
A point that is worth remembering is that if this register and
the publication of results is open to the public then it is also
open to the investigators involved in the trial, it is open to
the MHRA and other regulatory bodies and so there would be no
mileage in companies posting information that is misleading or
skewed on that database. Everybody involved in the process will
be able to see it. We think that the peer pressure to comply with
posting and to ensure that what is posted is completely defensible
and objective will be considerable.
Q769 Dr Taylor: I understand that
results from trials only have to be published a year after the
product is marketed. Is that acceptable?
Dr Barker: What the industry has
undertaken to do it to register all clinical trials within a year.
We heard from GlaxoSmithKline that they will publish within 10
months. I do not see any reason why many companies would not be
a lot faster than a year. It was simply setting an outer bound
to the publication.
Q770 Dr Taylor: Should one of our
recommendations be that these should be reported as soon as possible?
Mr Lawton: Yes.
Q771 Dr Taylor: There is one other
item arising from the ABPI evidence and it is trust. Is that a
lack of trust between you and the MHRA or you and the public?
What were you getting at?
Dr Barker: I think we are getting
at the question that the Chairman asked right at the beginning,
which is how do we account for the fact that we are sitting here
this morning talking about these issues and they appear in the
media on a regular basis. We believe that the use of medicines
to promote patient care will only occur in the right way at the
right time and to the right extent if prescribers, regulators
and the general public trust the industry. So this is a statement
about transparency which we think will go a long way to restoring
what we have to recognise has been a loss of trust.
Q772 Dr Taylor: So transparency is
all-important?
Dr Barker: Yes.
Mr Lawton: Transparency is extremely
important to us. Where our image has been tarnished one way or
another then clearly we have to address that very carefully. There
is a lot of baggage which is hanging over from 15, 20, 30 years
ago which keeps coming up. I think the rigours of the processes
of regulation now are such that there are many fewer occurrences
which would bring our industry into disrepute. As far as the public
is concerned, there is not much of a perception of what the pharmaceutical
industry is, we are unable to communicate directly to them and
with them, so they find out through newspapers and they find out
about hopeful stories about medicines which are being developed
in the long term and medicines as they are released and so on
and I think that is absolutely fine. They will find out from us
sometimes because of the work we do in the community with education,
with schools and science education and that sort of thing. I am
not sure that we have one image. The regulators, the politicians,
the health care professionals and so on know us very well and
by and large I think they know us because we are great contributors
to the economy with a £3.6 billion positive balance of trade
and we have 80,000 people employed and 240,000 others get jobs
as a result of our presence in the UK. After 25 years in this
industry I know that everybody that I know well and respect in
this industry wants to do good for patients and I think the people
who know us know that. The public really do not know us. I think
we have a mixed image. Where we have perpetrated a negative image
then we need to sort that out through transparency or whatever,
but we will fix it. Where it is wrongly perpetrated, we will defend
ourselves against that by asserting what our values are, which
are values of ethics, of doing good for patients and trying to
be more transparent and more open.
Dr Taylor: That is very clear. Thank
you. Whatever other problems the pharmaceutical industry has it
is not an orphan industry because within government at least it
is sponsored by the Department of Health, but Sir Richard Sykes
at the session we had with him told us he thought it should be
transferred to the Department of Trade and Industry. Do you all
agree with that?
Mr Lawton: I did actually hear
that statement where he said that it had always been his view
that it should be with another department. Our view as the ABPI
is that we need a sponsoring department which is keen on developing
an R&D-based industry in the UK, and is keen on making the
conditions right for investment in the UK, development of science,
and getting the medicines to the patients as quickly as possible.
It is up to the Government to decide which department is best
qualified to do that. We have a very good relationship with a
number of departments. We work very well with the DTI. We work
with the Treasury and the Home Office because of the animal rights
difficulties which we have. We have a very positive relationship
with the departments we deal with. It is sometimes a bit difficult
but it is usually based upon our core purpose. We have an excellent
relationship with the Department of Health.
Q773 Dr Naysmith: Sir Richard Sykes
did not say this but I imagine he was talking about negotiations
about drug prices as well as lots of other things. So you think
it is still best to keep that where it is?
Mr Lawton: I think we would say
that we are generally well-regulated and well-sponsored but just
like nearly everything else it could be better.
John Austin: If my colleagues have no
other questions, could I thank all of our witnesses for a very
informative session.
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