Examination of Witnesses (Questions 480
WEDNESDAY 6 MARCH 2002
HEATH OBE AND
480. So it is only those who would be recommended
who are in the trial?
(Mr McKeon) Yes. It is those who are recommended for
treatment under the ABN guidelines who will be entered into the
481. Can I go back to this transparency and
accountability that you referred to at the beginning, Minister?
The MS Society very clearly said to us that it is not possible
to follow the audit trail of decision-making. You believe that
it is. How would you counter their criticism?
(Lord Hunt of Kings Heath) There is a clear appraisal
process set out which we have sent to you, and I am very happy
to provide further information there, starting from a point where
NICE are asked to review a certain technology. There is then work
that is undertaken in scoping the remit and nature of the exercise
to be undertaken by NICE in which groups who are involved have
an input into that. You then move through to the work that is
being done by consultees who are asked to nominate people who
can have an input into the appraisal committees because the appraisal
committees themselves consist of a broad range of people.
482. One of their specific complaints was that
the stakeholders or the patient interest groups are not allowed
to attend the full hearings of the appraisal committees.
(Lord Hunt of Kings Heath) Yes. That is a decision
that NICE has made, that they feel that their decisions are better
made not in an open forum. There are two reasons for that. One
is the question of the commercial confidential nature particularly
in relation to drugs. The second is perhaps a more general point
that they feel in terms of the discussions that take place that
there might be inhibition on the part of the members of the appraisal
committees in terms of what they said in an open meeting. That
is I think very much for NICE to consider and make a judgement
on. The important point is surely that in the work that they produce,
the provisional appraisal, the final appraisal, the stakeholders,
the people who have a direct interest in a particular appraisal
have an opportunity to comment and to make their views known.
That is something that we would very much want to encourage.
483. When it comes to a decision that is disagreed
with there is an appeals mechanism. Are you satisfied that the
appeals procedure has the qualities of independence and impartiality
that are required for a public body exercising their appeals function?
One of the criticisms has been that whether you have the right
of appeal is determined by the Chairman of NICE who also chairs
the Appeals Committee. That does not seem to be a very open and
(Lord Hunt of Kings Heath) My understanding is that
neither the Chair nor the non-executives take part in the original
appraisal process, so their involvement in relation to an actual
specific appraisal would only come in when they sat as members
of an appeals committee. I think that is a sensible balance. The
Chair and the non-execs are there as guardians of the public interest.
They are there to assure themselves of the overall integrity of
the process. Given that they do not take part in the appraisal
process it seems to me that it is appropriate that they hear the
appeals. Obviously, hearing the appeals also gives them a great
deal of knowledge and information about how well the whole NICE
process is going. There is a very persuasive argument that the
way they run it at the moment is satisfactory.
484. Notwithstanding the fact that the Chairman
may not be involved in the appraisal, the public perception, or
certainly the perception of some stakeholders, is that this is
a cosy arrangement. It is the Chairman of the Committee and he
then does chair the appeal. It does not appear to be transparent.
(Lord Hunt of Kings Heath) I think the proof of the
pudding is in the eating. My understanding is that 13 appeals
have been made so far, four of which have been upheld. It seems
to me that that shows that the Appeals Committee is willing to
uphold appeals which have been made against the appraisal process.
My view is that, provided the Chair and non-execs continue to
have no part in the appraisal process, it is fine for them to
undertake the appeals. The other point I would make
485. In coming to that conclusion that it is
fair and reasonable, have you in that process considered any alternative
(Lord Hunt of Kings Heath) Of course there can be
alternative models where you make the appeals process, I suppose,
quite independent of NICE, but you do run the risk of substituting
one set of experts for another set of experts. You could undermine
the whole NICE process if you went down that path, which is why
it is probably better, I think, to keep appeals within the NICE
family but splitting it so that those involved in the appeal have
had no part in the appraisal process.
486. Can I ask, Minister, about NICE's working
programme and in particular whether you think that NICE has got
the balance right between the development and issuing of clinical
guidelines and technology appraisals and the guidance that flows
from them? I think I am right in saying that they have issued
far more guidance than guidelines. Is that the right balance?
You said earlier that you expect more guidelines in the future.
Does that suggest that there will be a change in that balance?
(Lord Hunt of Kings Heath) The figures I have are
that so far we have had 31 technology appraisals with 43 in development
and four clinical guidelines with another 32 in development. I
would just make two comments. One is that guidelines and appraisals
are both important. They are not mutually exclusive. Guidelines
cover the broader area in a clinical area. Appraisals deal with
specific interventions. You need both. I would like to have seen
more guidelines produced but there are two reasons why that has
not happened. First, NICE, rightly in my view, concluded that
it should give priority at the start to dealing with some of the
most obvious consequences of postcode prescribing. The second
reason is that they took over four guidelines that were being
undertaken by other organisations and that, I gather, took them
much longer because the methodology is different and they had
to pull all that together. We reckon that their current capacity
is around being able to undertake up to about 40 appraisal units
and 15-20 guidelines so that as we go through I would expect many
more guidelines to be produced.
487. Are they getting quicker at doing that?
(Lord Hunt of Kings Heath) Yes, they are taking more.
There is a balance here too. Obviously I would like to see them
do as many as possible but there are some constraints. The first
is, members of the Committee will be aware, that this is a fairly
long and robust process, so that inevitably it takes time. It
is absolutely essential that NICE protects the integrity of the
process. It cannot rush at things at the expense and quality of
its output. The other reason why one has to be slightly cautious
about the numbers it undertakes is the capacity of the NHS to
respond to the guidance. The NHS has quite a few challenges on
it at the moment and clearly the more guidelines, the more appraisals
you do, the more impact it has on the Health Service. We have
to get the balance right. What I can say to the Committee is that
we will do this on an annual basis and part of the performance
framework with NICE is to agree targets and make sure they keep
488. Can I push a little bit further on this
relationship between guidance and guidelines? You mentioned a
moment ago that there was clearly a relationship between the two.
The ABN said to the Committee in its evidence that it sees a sense
that NICE has double vision, that the two separate functions are
not particularly well co-ordinated. Would you accept that they
need better co-ordination of the two processes so that one helps
and informs the other?
(Lord Hunt of Kings Heath) Yes. Certainly we do not
want to, for instance, just target drugs in isolation from the
clinical priorities of the NHS or the guidelines. That would not
be sensible. I have to say that we in the Department are in a
learning process too and I would expect that as we go through
further work programmes (and we are just consulting on the seventh
potential work programme) we too get the integration right and
that there is a consistency of approach. What does inform us over
and above all this is the need to ensure that a lot of NICE's
work is focused round our key priorities: coronary heart disease,
cancer, mental health, because these are the core service priorities
that we set for the NHS.
489. Minister, what is your view on the conflicts
that have arisen between NICE and other organisations, notably
the BNF, from time to time? Do you feel this is perhaps inevitable
or does it represent a broader failure by NICE to engage constructively
with others in the field?
(Lord Hunt of Kings Heath) I do not think it is surprising.
For the UK, and England and Wales in particular, with NICE, this
is very much a developmental concept that we are picking up and
making an integral part of our National Health Service. I do not
think it is surprising in the first two years of its work that
there should be some controversy, that there should be organisations
and people who are looking very closely at the work it does and
seeking to draw criticisms to the attention of NICE. I do not
think we should worry about that. Someone asked earlier, "How
do you quality assure the work that NICE does?" As far as
I am concerned the more people bring criticism out into the open
the more NICE is challenged I believe the more robust it will
come. I am very easy about that. However, I have also said that
in relation to BNF or the Drug and Therapeutics Bulletin that
I would certainly want to encourage NICE to sit down with the
people who produce these two services to discuss where there may
be differences, why there may be differences, and whether that
might lead to any modification of NICE's process. NICE themselves
are a pretty robust organisation and they are well able to take
part in that kind of dialogue. As I have said earlier, I have
encouraged them to do that. I do not think it is appropriate for
me to make any comment on the specifics of either the criticism
or NICE's response to that because I am absolutely convinced that
that has to be left with NICE.
490. You say you encourage them. Have you any
evidence that they are responding to your exhortations?
(Lord Hunt of Kings Heath) Yes. When I conducted their
appraisal of three months ago, and indeed before that, I encouraged
them to meet first of all with the research based drug industry
some more to discuss some concerns that they had. That has happened.
I have also made it clear that I want them to involve the National
Health Service much more in their work. That has happened and,
for instance, in the appraisal committees now there are two health
authority people on each appraisal acting as a kind of proxy for
the rest of the NHS. My experience is that when issues are raised
with NICE they are prepared to go away and consider them and act
upon them. I have not found them an organisation that puts the
blinkers up and says, "No, we are not going to do that".
491. On the question of the progress of NICE
over the years what proportion of health care do you expect to
be covered by NICE guidance in, say, five years and then ten years?
(Lord Hunt of Kings Heath) It is very difficult to
answer and I cannot give you a really quantifiable answer given
the breadth of the NHS and the fact that we are still at a very
early stage in NICE's progress. The kinds of things I would like
to see are that within five years I would expect there to be clinical
guidelines covering most of the current national service frameworks.
Say at the end of ten years I would expect all the NSFs, the ones
that we have already done, the ones that we are working on, to
be covered by clinical guidelines. As far as appraisals are concerned,
I would like to think that in five years' time we would be able
to pick up every significant new development which looked like
there may be some controversy about and that that would have an
early appraisal. Within ten years I hope NICE would have been
able to go back over most of the existing technologies, which
again are significant, and where there may be some controversy.
We will keep it under review on an annual basis. I do not think
I would go much further than that at the moment.
492. What estimates then have been made of the
need for growth in the budget of running NICE to meet that programme?
(Lord Hunt of Kings Heath) NICE's current budget I
think is around £13.6 million for 2001-2002 and it is due
to go up by two million in the next financial year. I do not believe
money is an obstacle to NICE developing its work in the way it
wants to do so. Obviously, if it was decided that some time in
the future that it needed to increase the number of guidelines
and appraisals considerably, then we would have to find the resources
to enable it to do that. Frankly, I do not think at the moment
money is getting in the way of NICE doing its work properly.
493. Experience of NICE, even though it is only
two or three years so far, has that led you to re-evaluate any
part of the initial vision for NICE or is that still achievable?
(Lord Hunt of Kings Heath) I think the vision is achievable.
I am absolutely convinced that the vision is right. Remarkably,
the NHS, after so many years since 1948, one of the most remarkable
things about it is how inconsistent it has been and the fact that
you can get a drug in Birmingham which you cannot get in Solihull,
the fact that high quality services can be available in one part
of the country and not other parts of the country. The big challenge
we have set ourselves is to get a high quality service consistent
throughout the country. NICE is a crucial part of that. It is
not the only part. The national service frameworks are very important
and the role of the Commission for Health Improvement in reviewing
and inspecting the Health Service also has a big role to play.
The vision I am sure is absolutely right. In practice NICE I think
has done well, but of course there are areas in which it can improve.
The Select Committee's inquiry, the consultation that we are having
on timing of an appraisal, all of these activities will help improve
the overall quality of NICE's performance.
494. I wish I could share your optimism because
it strikes me that the progress of NICE is inevitably so slow
that to get to examining enough drugs to really make a difference
is going to take a long time. Can I just check? You said 40 appraisals
and 15-20 guidelines. Is that per annum?
(Lord Hunt of Kings Heath) My understanding is that
it is up to 40 appraisals per year. At the moment we reckon that
NICE can undertake 15-20 guidelines over a two-year period. As
part of the NHS plan to set targets and as part of our annual
appraisal we want to get them up from that so that they can at
least do 20 guidelines a year.
495. In a subsequent answer you almost welcomed
the fact that they were slow because this is a way of limiting
expense because the more they recommend the greater the expense
that falls on the NHS.
(Lord Hunt of Kings Heath) I think you have misunderstood
me. The point I was making about the capacity of the NHS to deal
with appraisal and guidelines was not related to expenditure.
It was more to do with the practicalities of the kind of pressure
being placed on the National Health Service. You will well understand
that in terms of a busy agenda for the NHS one of the considerations
you have to take into account is how many guidelines practically
an individual hospital could implement over a specified period
of time. I share your view that if (I think you implied in your
question) we can step up the number of guidelines and appraisals
in the future the NHS can cope with that and there is enough expertise
around to be able to do it, then that is something we should look
at. At the moment my feeling is that we have to make sure we get
the process right, we have to make sure that every appraisal and
guidance is done in a robust way, which is why we have got the
balance of targets at the moment. We are not being absolutely
doctrinaire about that. We will look at this from time to time.
496. With some of the drug treatments it is
purely and simply a matter of money. The expertise is there and
waiting. Can I go back to appeals? You said that the reason for
leaving them within the NICE framework was that otherwise it would
rather undermine NICE. That rather implies a complete loss of
the opportunity to allow NICE to be really checked by an outside
organisation. I would have thought it would have been possible
on subjects like beta interferon to have an appeal, if there was
going to be an appeal, by an internationally accepted panel of
neurologists rather than just NICE itself.
(Lord Hunt of Kings Heath) There are two things about
that. I am not sure that I would put an appeal in the hands of,
for instance, if you take beta interferon, just the doctors most
intimately involved with a particular drug. I think the benefit
of the kind of appraisal committees NICE has is that you can have
a balance of people who can take a somewhat more rounded view
than maybe doctors intimately concerned with a particular drug.
The second issue is that my inhibition about seeing changes made
or feeling that NICE had not got it right is that I do think you
need to be careful not to establish one group of experts within
the NICE appraisal process and then another group of experts who
meet outwith NICE, substituting their own professional judgement
for each other. I am not sure that that would be particularly
helpful. The other point I would make is that the basis for making
appeals is not really in terms of second-guessing the original
judgement. It is very much around whether the process that has
been undertaken is fair, whether through the whole process there
has been any action which can be regarded as ultra vires
or whether a perverse judgement has been made. In that context
the non-executives and the Chair of NICE are well able to make
that kind of judgement. The proof of the pudding is in the eating.
I think the fact that of the 13 appeals so far held four have
been successful shows that it is working pretty well.
497. Going back to the timing of appraisals,
you have already said that there is a consultation paper coming
out this week.
(Lord Hunt of Kings Heath) Yes.
498. Is that going to be published or just on
the web, and who will that be sent to?
(Mr McKeon) It will be on the web site and we have
sent copies to you, the Committee, already. We will be sending
it to a number of voluntary and professional organisations conducting
the ABPI and the ABHI to give them direct copies.
499. This would be three months for consultation?
(Mr McKeon) Yes.