Examination of Witnesses (Questions 300
TUESDAY 27 APRIL 1999
DR J PATTERSON,
DR A HESKETH
300. When did you start manufacturing in Ireland?
(Dr Hesketh) I do not have those figures.
301. One of the interesting things is that where
corporation taxes are 10 or 12 per cent it is attractive. Dr Brickwood,
what about your organisation?
(Dr Brickwood) We have manufacturing in Cork. Active
302. Big operation?
(Dr Brickwood) It is not the largest in Europe but
it is sizeable.
303. What was the attraction?
(Dr Brickwood) Tax rates, employment, etcetera. There
are a variety of factors that go into the mix. You consider a
mixture of factors.
304. Nothing to do with the price that you are
able to get out of the British taxpayer for your pharmaceuticals
in the United Kingdom, or was it just cheaper production costs?
(Dr Brickwood) I do not think we took the price we
could get out of the United Kingdom into account.
305. Dr Patterson mentioned how much tax his
company pays for the number of people employed here. How they
are good British citizens. They seem still to be good British
citizens in the sense that they are choosing to invest in the
United Kingdom. I know you are in places like Winchburgh(?) in
my constituency. It seems that this movement has already started
in some of the companies away from Britain to other places, and
it has nothing to do with the prices that the British Government
are trying to negotiate with you for drugs. You move for other
reasons as well.
(Dr Patterson) There is no doubtand I will
answer on behalf of my colleagues on this particular onethat
5 per cent of the world's pharmaceuticals market is in the United
Kingdom. You cannot have all your cost bases in the United Kingdom
as global player, so you have to have some global spread of your
cost bases. There is an attraction of putting capital in the United
Kingdom in relation to how the PPRS operates but that is not the
only factor. There is proximity to markets, and other market places
in other countries do compete for markets, as you would expect.
306. Product labelling and packaging. We have
had some evidence from the Parkinson's Disease Society concerning
a particular drug that was being supplied by Eli Lilly, where
apparently instructions within this drug were written in Spanish,
which perhaps caused some slight difficulty, I suspect, for patients.
Are there any other examples that you would know, where you would
like to flag up instances of that nature.
(Dr Brickwood) We have four examples. John, if you
would like to start with the Zeneca example.
(Dr Patterson) This is Zoladex. This is an injectable
medicine for prostate cancers. This is a pack which was parallel
imported into the United Kingdom a couple of years ago. The packaging,
(I will pass it to you), is a Spanish pack with a very small over-label
with English on it. This depot here, this sterile container, is
placed underneath the skin of the abdomen and it diffuses out
over a month and controls the cancer. They have simply taken a
pair of scissors, cut off our original attachment, and sellotaped
on their own version of the instructions and the product leaflet.
In translating it back from Spanish, the parallel importer has
got the indication and the site of injection wrong. This is a
particularly florid example. It says it is used either in cancer
or premenstrual problems resulting in pain. Actually, it is indicated
for prostate cancer or the treatment of a severe disease called
endometriosis, so not premenstrual problems. It also says: "This
can be injected either into the abdomen or into the chest."
Now, if you start sticking needles into people's chests, you are
in serious trouble. That is an example. I will pass it round to
the Committee. This is one such product, which was parallel imported
from Spain, and we stopped it very quickly. There are many others
which David can talk about.
(Dr Brickwood) This is a lipid lowering agent. What
has happened here is that normally there is a patient information
leaflet, which goes into the pack, that is in English. This one
came from Holland, I think. The importer should take out the Dutch
leaflet and put in an English leaflet, a direct translation of
all the problems associated with Zoladex. There is nothing in
it at all.
307. I can confirm that because I have taken
that drug and had exactly that experience.
(Dr Brickwood) This one is a foil and what happens
is that it is a blister pack. You can see here that you have the
blisters at the front and you have to pop it out. You need the
days of the week on it. In order to do that you have to push it
through. What has happened is that the blister on the front, they
have put the foil on the back with Monday, Tuesday, Wednesday,
Thursday, instead of Lundi, Mardi, Mercredi, and you cannot pop
it out. Again, this is for hypertension. It probably could be
prescribed to elderly patients who are unable to pop out easily
without damaging their tablets. Then the last one we have here
is again a lipid lowering agent. This is what the patient receives.
An English leaflet. One bit [of tablets]. Another bit. Two more
tablets. Two more tablets. This bit has the batch number on it
if you ever need to recall it. This part has the batch number.
These two little bits do not, so you do not know where your batches
have come from, and the recall process is up the Swanee essentially.
They are examples and they bring home to you the problems you
can encounter as a patient.
308. What powers do the Medicines Control Agency
have in this particular area over the licence for importing, and
is there anything you can do with them, as an Association, to
tackle issues of this very nature?
(Dr Brickwood) We work with them. We bring these to
their attention. They have an enforcement section for their responsibility.
They pursue cases like this rigorously in order to try to improve
the quality of products that have come into this country.
(Dr Patterson) There are over 2,000 parallel import
licences existing. It grew by 18 per cent last year. So it is
not that difficult to get a parallel import licence.
309. The pharmaceutical importers claim that
there is this audit process for batch numbers which you can go
back to. Clearly this demonstrates to us that this is a bit pie
in the sky if you have foils being chopped and changed in that
way and there are batch numbers in each section.
(Dr Patterson) And in the rare event we have a recall,
we are going to be going to Spain saying that we sold this in
Spain. Then it has to come back through the Spanish wholesaler,
whoever they sold it to, who is the parallel trader, before we
eventually discover that this product is back in the United Kingdom.
This might take a while.
310. We are led to believe by the Medicines
Control Agency that 10 per cent of products were associated with
parallel trading processes. What is your solution to this? It
could be a potentially dangerous problem for particularly aged
people or people who are not fluent in Spanish, for example.
(Dr Brickwood) A solution is difficult. We have to
work consistently and assiduously with the Medicines Control Agency,
to try to attempt to track down problems like this, and take corrective
action and help them as much as we can.
(Dr Patterson) The solution is part of the bigger
picture, where we have a trading situation whereby the whole distribution
process, which is quite well controlled, is actually not operating
in such a way that a product goes halfway round Europe before
it ends up in the consumer's hands. We have, in a deregulated
open market place, the ability to put it into that market and
watch it to make sure it is properly dealt with.
(Dr Brickwood) We do extensive studies, as part of
the R&D phase, to test the stability of these products at
various temperatures. When it falls out of our channels, again
storage can be critical. Some medicines are temperature sensitive,
need to be held below 8 degrees centigrade. Others will start
to degrade slightly more quickly. So there are issues with regard
to stability and storage as well that need to be monitored carefully.
311. Do you think you can clearly resolve or
assume all is OKpresumably it is in your supply chains
direct to your wholesalersbut beyond them?
(Dr Brickwood) Through normal established wholesale
channels, which are checked by the Medicines Control Agency, that
312. The Association of Pharmaceuticals Importers
state that the entry of counterfeit products into this country
is" almost unknown". Would you agree with that?
(Dr Patterson) I think it is luckily at a relatively
low level. However, there are now increasing numbers of examples,
first of all, of stolen material coming into this country.
313. Stolen but not necessarily counterfeit?
(Dr Patterson) Stolen but then not treated necessarily
in the same way. Stolen and then counterfeit packaging. We have
had this product coming in from Italy where they reboxed it in
a way which was absolutely untrue to bring it back into date,
the date having expired. In the world at large, the WHO estimates
that some 5 per cent of medicines are counterfeit, which are circulating
around the world. So when we get into this whole issue of exhaustion,
which you were bringing in earlier, outside the European Union
there is going to be a significantly increased chance that we
will see counterfeit and stolen goods coming through those channels.
314. I think we accept that counterfeiting does
go on in the world at large and our concern obviously is to protect
United Kingdom consumers. You are saying that there is some evidence
that a small amount of counterfeit drugs are coming in here, is
that what you are saying?
(Dr Patterson) Yes, on the whole that is true, but
as parallel trading increases we are convinced counterfeiting
315. I just want to concentrate on counterfeiting.
The Medicines Control Agency has the duty to check all of this
and monitor it. Is there some loophole that needs to be closed?
Is there something that we need to do to stop even this rather
small amount coming in?
(Dr Hesketh) One of the issues is enforcement. It
is detection of counterfeits. The industry spends a great deal
of time and effort and money in trying to detect, by putting special
marks on packs and so on, preventing counterfeiting. However,
when it occurs, detection and enforcement is often intellectual
property rights, which are going to be enforced, in order to have
a legal right to prevent the counterfeiting. It is a difficult
issue even to detect in the first place.
316. Some of your colleagues, notably SmithKline
Beecham, give us the impression that it is far more widespread
than either you or the ABPI are suggesting. They say: "Concerns
about counterfeits lead to patients stopping taking their legitimate
medicines with serious consequences." Is there any evidence
to support that sort of claim?
(Dr Hesketh) Global certainly.
317. Let us talk about the United Kingdom because
that is what we are here to be concerned with, in the United Kingdom.
(Dr Hesketh) There is evidence in the United Kingdom.
318. Patients are stopping drugs because they
are concerned about counterfeits?
(Dr Hesketh) That is probably a slight over-statement
but there are concerns, and a individual patient who may be concerned
may well take that reaction, yes.
319. Are you sure that this is not a concern
about parallel imports, because the noise you are making about
parallel imports and the suggestion you are making is that they
are not always quite as reliable as they should be. Really, if
there is evidence that patients are stopping taking drugs, this
is because of concerns you may have raised on parallel imports
about genuine counterfeits, which is a contradiction in terms
but you know what I mean.
(Dr Hesketh) We do have a rightful concern that parallel
trading can mask counterfeit products. We do not know the extent
of this. That is the whole problem.
320. You do not think you might be adding to
patient concern by making a fuss about parallel imports, which
is a commercial concern, a legitimate one, which we understand;
but we are worried about the patient's view of this.
(Dr Hesketh) I do not think we exaggerate the problem.
(Dr Brickwood) And we should not.
321. Thank you very much. If there is any other
information that we require we will be in touch with you.
(Dr Brickwood) Thank you very much.