Examination of Witnesses (Questions 280
WEDNESDAY 23 JANUARY 2002
280. Moving on to the ABPI, in your summary
of key points you make the point that NICE's own estimates of
the predicted annual addition to the Health Service budget of
£93 million has not been reached and also the savings accruing
have not been realised. Does this damage their credibility? Have
you a comment on that?
(Dr Jones) Again the difficulty is that it is not
the organisation NICE's problem. It is not a criticism of NICE
per se, it is the criticism of our inability to put that
in place. The Minister has been very clear. He says he is going
to put "must do" regulations in place. Of course out
there and certainly overseas, to our company headquarters, it
seemed to be a criticism of NICE. The announcement by the Minister
is very welcome, but we heard earlier that that presents other
problems. We also say in our submission that the great fear we
have is that in what is evidently and always will be I guess a
cash limited situation the danger is that we shall be robbing
Peter to pay Paul.
281. I want to move onto the Pharmaceutical
Price Regulation Scheme. In your evidence you say this affects
NICE's ability to develop guidance and guidelines. Really we should
like a bit of an explanation about this particular scheme. Does
this not have a message for cost effectiveness and does it not
rather negate the work NICE has to do?
(Dr Patterson) You have taken that statement slightly
out of context. It was part of three bullet points which were
trying to say that NICE does not work in a vacuum. There is a
whole series of things, including PPRS, which affects how medicines
are used, what the real price is in the real world and what the
cost effectiveness is to the health system. There is a whole gamut
of things including the licence indications which will affect
282. Can you explain the Pharmaceutical Price
Regulation Scheme a little bit?
(Dr Patterson) How long do you have?
283. Is it not something which allows that if
sales go down you can put the prices up, putting it very simply?
(Dr Patterson) Prices almost never go up on medicines
in this country, as you saw from the report to Parliament in December.
In brief, the PPRS is a scheme which caps profits and profitability
in our industry at a level equivalent to the average return on
capital of the FT100. In other words we are to be average companies
half way up the FT100 scale of activity. It does that by looking
at our expenditure, our sales and putting those all together into
a big pot and looking at return on capital, which is done through
an accounting process with the Department. What that says is that
we are allowed to make profits within a certain range from our
sales, but if our sales go up very high versus our costs or we
were for instance to charge too high a price, the Government then
claws that back at the end of the year through the PPRS scheme.
In fact it is a profit control scheme rather than a pharmaceutical
price regulation scheme. It has the wrong name for what it does.
Dr Taylor: Are we wiser?
Chairman: I understood it earlier on.
284. One pharmaceutical firm which has submitted
evidence, not represented here today, said that NICE could promote
innovation in the pharmaceutical industry. Another one, also not
recognised here today, said in their submission that NICE fails
to reward innovation. What do you think NICE could do? How would
you reconcile these two slightly different views? Should NICE
be doing that sort of thing?
(Mr Fullagar) If I may, the statements are not self-contradictory.
They are saying that if NICE does the job which it was set out
to do, which was to promote more ready and speedy access to the
new treatments for patients, that would be promoting it for the
patients. The interests of the industry would follow on behind
and it would be encouraging innovation. Because of the problems
we have been discussing, the delays and the uncertainties, the
other company is saying that the reality so far is that it is
not doing that promoting/innovating job that we had anticipated.
The theory is that if you get it to work then you are helping
the patient and you are promoting innovation. Right now there
is no evidence it is working.
285. Another drug company has argued in its
submission that in appeals to NICE after recommendations have
been made NICE is both judge and jury in its own court. Do you
subscribe to that view?
(Dr Jones) Very much so.
286. What would you suggest should be done about
it, if you believe that is something which is inhibiting the development
(Dr Jones) We have been used to a process for many
years through the Medicines Control Agency, the Medicines Commission,
whereby if the Committee on Safety of Medicine reaches a view
and there is a genuine disagreement on the basis of science, then
there is an appeals process through the Medicines Commission,
which is independent, has an independent chair person and so on.
You bring witnesses to that. In this process we currently have
with NICE the only person who can decide whether you can appeal
is the Chairman of NICE.
287. Tell me a little more about how the NICE
(Dr Jones) What happens is that if a company believes
that the decision the Appraisal Committee have reached does not
fit their view of the facts, unless they can prove to the Chairman
of NICE that that was done with misfeance or some mistake in the
process, they cannot just appeal on the grounds that they genuinely
disagree with that conclusion. The only reason they can then be
allowed to appeal is if the Chairman accepts and gives permission.
As much as we fully respect Sir Michael Rawlins's independence,
he is the Chairman of the Appeals Commission as well as the Chairman
of NICE. That seems to be, for his benefit and the benefit of
NICE, something which probably ought to change.
288. How often does it happen that a report
is made with which one of your members disagrees, approaches Sir
Michael and then is not given permission.
(Dr Jones) There are examples where that has occurred
289. How often?
(Dr Jones) More often than not there is a tortuous
process where you try to get to appeal on the grounds of some
judicial review of the process rather than a fair and open admission
in life that life is not that simple. We looked at Beta-interferon
earlier. There is a genuine reason for debate. Having got to that
point, then the issue of who is judging it becomes important too.
In the Medicines Control Agency example, a group of independent
people, representing both consumers as well as medicine and others,
reviews the situation again. At the moment you only appeal to
NICE on the basis of judicial review. We think that there are
very good reasons why it should change. So it would appear do
NICE themselves. We understand that at the board meeting on 16
January they did address this. We have not seen their document
yet. We have been invited and have put in our viewsthe
ones I have been putting to youand one hopes that we could
move now to a process which is much more of the measure of what
Government for years have seen as appropriate in our area, which
is through the Medicines Control Agency model.
(Mr Gray) I was going to make that final point. It
is probably also worth noting again, looking at the NICE submission
to this Committee, that because of the appeal rules and the way
in which they define what can be captured under appeal or not,
it is also likely to be that people who do have some concerns
over a recommendation are not making appeals which they might
if it were a more open process because they do not feel under
the current definition of what constitutes an appeal that there
is any point. I believe there is one point in that submission
where the fact that there has been a relatively low number of
appeals is given as support for a particular point. I am not sure
we can necessarily take that as given.
290. In his evidence to the Committee, I think
everyone would agree a fairly eminent commentator on these matters,
Sir Iain Chalmers, speaks of "important data having been
withheld from NICE by companies whose interests would not be served
by submitting it". Is he right to claim that? If he is, can
the public trust the industry to co-operate in this process?
(Dr Patterson) The answer is: absolutely. We submit
all relevant information to NICE. Do we submit every scrap of
evidence? No. If, for instance, a medicine is being looked at
in adults, we do not submit the paediatric data or another indication
which is irrelevant.
291. He uses quite strong language, "information
withheld", "important information withheld". Do
you recognise that at all?
(Dr Patterson) I can only speak on behalf of my company.
We would absolutely refute that.
(Mr Fullagar) I can back that up. I asked my own company
again recently whether there was anything we had felt we had to
withhold from the committee. The answer was: absolutely not. We
have had several products reviewed by the committee.
292. Just thinking above your companies for
a second and thinking of the industry body, has NICE ever contacted
the ABPI to say they were concerned that had happened, that one
of your members has done that? Have you had that kind of contact?
(Dr Jones) No and in my whole experience working in
the Medicines Commission, there were occasions, if the Chairman
of the Commission felt that a company in some way adversely presented
data, or on the other hand had done a super job, they would always
write to the chief executive. That has not occurred on the submission
of relevant data to the committee.
(Mr Gray) We can confirm that we also submit all relevant
data to NICE.
293. Why do you think he makes that claim, then?
It is a big claim to make.
(Mr Gray) I personally have no explanation at all.
294. Presumably it would have been helpful when
he made the allegation if he had given examples of it to back
(Mr Gray) Yes.
(Mr Fullagar) Yes.
295. Presumably he must be referring to the
odd occasion when NICE has asked for further data on something,
which does happen.
(Dr Jones) This is a very regular interaction which
we have with regulatory agencies. Quite frequently in the review,
both in Britain and elsewhere, a regulatory agency will say they
have analysed our data and could have more data then we go back
and do the analysis on our data. What we have to remember is that
the Medicines Control Agency has done its job. It has made its
review on all the data and therefore it would not be appropriate
for NICE to go back and make another clinical judgement of efficacy.
That would be usurping the role of a legitimate competent authority
in that area.
296. If Sir Iain Chalmers would back up that
claim, or if evidence were given to you, what action would the
ABPI take to address concerns of that kind?
(Dr Jones) If it were an isolated example for a company
and it could be shown to be the case, which you are hearing is
not the case, then obviously we would want that company to have
to explain it to NICE. It is very important that industry is seen
to be scrupulously objective in its dealings with these agencies.
It is to its advantage to do so.
Chairman: Gentlemen, may I thank you for a very
helpful session and for your co-operation with our inquiry? Thank
you very much indeed.