Examination of Witnesses (Questions 740
- 759)
THURSDAY 13 JANUARY 2005
DR RICHARD
BARKER, MR
VINCENT LAWTON,
DR DAVID
CHISWELL AND
MR SIMON
CLARK
Q740 Dr Naysmith: Do you have any
comments on the points that were made previously about the spend
on marketing compared to research? Presumably as a trade association
you do not necessarily just look at research and the importance
of research, but do you think enough is spent on research?
Mr Lawton: The amount spent on
research is approximately 24 or 25% of what we spend compared
to something like 14% which is spent on marketing and promotional
efforts. The balance between the promotional monies would be more
or less stable over the last few years whereas the expenditure
on research and development is increasing.
Dr Barker: It is approximately
£10 million per day across the industry and £3.5 billion
a year. The other factor, which I think it would be worth the
Committee knowing, is that the promotional efforts of the industry
represent about 11 minutes a week of a GP's time, so the impression
that some people would give you that GPs are overrun with promotional
efforts is very misleading.
Q741 Dr Naysmith: We heard in the
previous session that there are something like between 4:1 and
5:1 personnel employed in marketing as compared with research.
It is quite a lot of personnel.
Dr Barker: I do not think that
is representative at all of the UK.
Q742 Dr Naysmith: I have a question
for Simon Clark in the BGMA but first of all can I take up something
you said way back in your initial remarks. You talked about you
were different from the branded companies in that you promoted
to pharmacists rather than to GPs?
Mr Clark: Correct.
Q743 Dr Naysmith: Have you given
up persuading GPs to prescribe without naming a brand name or
is that just a decision you have made?
Mr Clark: One thing we are fortunate
about within the UK market is that we have seen, as was alluded
to earlier, about 78% of products being written generically by
the INNA, and that is something that we would continue to encourage
for the rest of those products that are appropriate to be written
generically. As a result of that, doctors are putting through
prescriptions to the pharmacists with a generic descriptor, therefore
the role of the generic members and also competing against the
brand is to offer the pharmacist various product prices, the lowest
price being the one that the pharmacist will choose to meet the
needs of that script.
Mr Lawton: If I may add a point
on that. One of my own company's drugs, simvastatin, when it went
off patent was being prescribed 90% as generic simvastatin.
Q744 Dr Naysmith: That is interesting
because that brings us on to the question I was going to ask Simon.
Your submission makes reference to evergreening. Maybe you could
explain this term to us and describe the tactics used by the industry
to limit profit loss when a medicine approaches patent expiry.
In the absence of the Chairman, John Austin
was called to the Chair.
Mr Clark: Evergreening is a term
given where a company may use tactics to extend the commercial
life of the original product at first patent expiry.
Q745 Dr Naysmith: And you would be
against that?
Mr Clark: We would definitely
be against that. What happens here is you will have a product
that enjoys this market monopoly position for a period of in excess
of 10 years and during that time there may be changes in the product
or the product may evolve and that delivers real patient or clinical
benefits to the NHS, and we would absolutely support that without
a doubt. However, we have seen an increase over the last number
of years in cases where one can be sceptical about some of the
changes that are made, in some cases two or three months before
the patent expires on the product. These changes could be a different
form of the product being released, they could be different indications
and a different type of product and, as you see, there are some
examples there. The real issue is that the originating company
would then promote strongly that product to move the position
to start writing scripts in the new form of the product and not
writing prescriptions in the old form, so when the generic comes
to launch there are no generic prescriptions there to be met by
the generic product, and the impact on the generic company is
that it then has to do a new filing and go through a new licence
with the MHRA so we could see a two-year delay before a generic
comes out on the market-place to meet this new form. If you are
dealing with a product that has worth of over £100 million
(which a number of other products have) that are going off patent
that is obviously a significant value to the originator company
but it is also a loss of saving to the NHS. The examples we have
put in the report are not specifically to pull out those or to
dig into those in detail, they are just to illustrate the point.
What we feel the focus should be on is looking forward to make
sure that there is a healthy generic environment. To achieve that,
a number of changes that have been made in the EU Pharmo Regulation
that went through recently are helping us on that progress, but
what the recommendation would be is that the Department has existing
powers to make sure it puts in place a strong generic industry
and has started using those, and we saw some pay-back 12 months
ago with one particular product.
Q746 Dr Naysmith: Is this a fairly
widespread practice? Do all companies do it?
Mr Clark: No, all companies do
not do it. I would not say it is widespread on every single product
but we are seeing a recurring instance of it and we are making
sure that we are sharing that information where we see it with
the various departments as well.
Q747 Dr Naysmith: I am sure Dr Barker
will have something to say about that.
Dr Barker: The process by which
companies bring new variants of products to the market is obviously
one that is controlled by the same regulatory process that we
have heard described in detail before. In other words, the product
has to provide advantages and has to be approved by the regulator.
The advantages could be efficacy advantages. For example, sustained
release formulation could provide control of the use of that medicine
over the day, it could be the ability to take therefore a medicine
once a day rather than twice a day, and so there has to be a therapeutic
benefit for this process to operate and therefore we do not think
there is anything reprehensible about the fact that a company
does that through the life of the patented product.
Q748 Dr Naysmith: Yet in the process
of giving market authorisation the regulatory authority is barred
from considering whether the product holds any clinical advantage
over other established products. Do you think this favours the
industry to the detriment of prescribers and patients?
Mr Clark: No, I do not believe
it does. To set the context here, the UK has been pretty successful
in stimulating a generic industry. As we have heard before, generic
prescribing is widespread through the life of the branded product
and the turnover to generics is really pretty rapid. If you look
at it, as Professor Lawton said in the case of one of his own
products, there was 90% generic writing by the end of the prescription
period. So I think of the problems we have this may not be the
greatest. There is a pretty significant creation of this headroom
for innovation through the use of generics.
Q749 Dr Naysmith: Does anyone else
want to say anything?
Mr Lawton: The product has to
have a therapeutic benefit. If there is an attempt to change the
form it is usually because there is a perceived need for that
form.
Q750 Dr Naysmith: Mr Clark is suggesting
that sometimes this happens just because a drug is getting towards
the end of its patent.
Mr Lawton: I do not know if that
is the case. He has more information than I do about it and certainly
not widespread. The adjustment and development of molecules, whether
it is single molecules or whole classes, is a gradually evolving
thing. This is what we would call "incremental innovation".
If you take the birth pill from 1961 when it first appeared up
until current day, there have been about 18 different developments
either in form, in strength, in tolerability and so on, as a result
of which the medicine now is much more effective, it is much more
tolerable and safer to take than it was when it originally came
out, and there is now less active ingredient in a whole packet
of these medicines than there was in one pill when they first
came out in 1961, so I think these incremental changes do have
a critical role, but I agree that they do need to have a role
and they do need to have proven benefit. Doctors really need to
be able to assess that.
Q751 John Austin: One of the other
issues that has been suggested in evergreening is cosy relationships
between a manufacturer and a generic manufacturer prior to the
expiry of the patent to extend the profitability. It has also
been suggested that some manufacturers may buy up some generic
companies in order to eliminate competition. Is this widespread
and would you regard either of those practices as anti-competitive?
Mr Lawton: Having had a number
of products go off patent over the last five yearsand very
large products including simvastatinI do not know that
cosiness would be a word I would use in terms of the relationship.
I think we respect very much the high-quality generics manufacturers.
A number of pharmaceutical companies used to own their own generics
manufacturers, some still do, but in fact fewer and fewer (rather
than going the other way) own generics companies than was previously
the case.
Mr Clark: Just to build on your
question and answer directly in terms of buying up companies whether
there is a reduction in the number of generic companies in the
UKno, there is not and in fact the generic market now is
more aggressive than it has been, and what you get with the generic
market is a situation where each individual product is a commodity
market in its own right. We see products such as pravastatin which
went off patent during the summer and within 48 hours it was down
60-70% and amlodopine after three or four months was down to 98%
off the original price of the product. So that is not the case;
in fact, the converse is the case. To build on that, we are seeing
an increase in the number of Indian companies that are entering
the UK generic market because of the attractiveness of the generic
market in itself.
Mr Lawton: During the renegotiation
of the PPRS before last we were looking very carefully at the
competitiveness of various sectors and we observed that the UK
generics market was seen as one of the most efficient in the world.
Q752 Dr Taylor: Turning to the provision
of information, I think it was Professor Lawton who talked about
the inadequacy of clinical training of pharmacology students and
now Dr Barker says 11 minutes a week is the GP's contact with
the drug representatives. In the ABPI evidence you have given
us the result of the Taylor-Nelson study showing that of the GPs
surveyed they rated their contact with representatives among their
top three sources of information. This is really getting rather
alarming and certainly we will get advice from our expert advisers
on the degree of training that medical students are having, but
talking about the work that you do in promoting, is it right that
the discoverer, the developer and the supplier of the product
should be the most important adviser?
Mr Lawton: I think that the people
who know most about the medicine right from its inception are
those who discover it and bring it to market. The information
which we develop about it and how to use it and where not to use
it, the benefits versus the risks, and so forth, is carefully
studied and presented. They are subject to external scrutiny and
we also have within our companies a medical legal control procedure
so that all informationwhether it is related to clinical
papers or whether it is a smaller studyhas to be approved
by a medical doctor and legal expertise before it can go out.
Q753 Dr Taylor: Is that an independent
medical doctor?
Mr Lawton: No, it is within the
company, and externally there would be the Code of Practice of
the ABPI which has to be adhered to as well and there are independent
physicians on that and the complaints procedure is open to all
medical practitioners if it is seen to be inappropriate.
Q754 Dr Taylor: With their very limited
training in pharmacology do you think the GPs have enough information
to view your information critically or do you think they just
take it at its face value?
Mr Lawton: That is an extremely
good question which I would hesitate to give a very simple answer
to because it is a very complex issue. The GP is looking for clinical
end points and benefits rather than the clinical pharmacology
relating to how the medicine works, the molecule, the shape of
the molecule, and the potential benefits of any chain in that
molecule. I think they are less able to be critically evaluating
the latter but on the former, in terms of the clinical benefits,
they should be able to see whether or not those clinical benefits,
as they are important to their patients, are properly represented
in materials and also the quality of the discussions they are
having with whether it is the company representative or external
doctors.
Q755 Dr Taylor: Do representatives
concentrate more on GPs than on consultants because they think
they can influence them more?
Mr Lawton: There are 90,000 practitioners
of one sort or another in the UK and general practitioners are
the majority. A large amount of time is spent on general practitioners
because they are the ones who are more likely to be in the prescribing
area, but that is rarely done without consultation with the consultants
who deal with those general practitioners, so that the consultants
have to feel comfortable and they will ask very technical and
difficult questions which we need to be able to answer and satisfy
them on. They will be the advisers to the general practitioner
within a primary care trust but we do visit general practice more.
Q756 Dr Taylor: Information direct
to the public is obviously limited to the non-prescription drugs.
Mr Lawton: Yes.
Q757 Dr Taylor: We gathered at a
week or two ago's session that simvastatin was already being advertised
pretty widely in the ordinary press. Does that come from the generics?
Mr Lawton: Simvastatin went over
the counter last year and that was the only time it has been advertised
in the press. It has not been advertised in the press before that.
Q758 Dr Taylor: No, but it has since
then.
Mr Lawton: Simvastatin over-the-counter
version.
Q759 Dr Taylor: Yes?
Mr Lawton: Yes.
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