Examination of Witnesses (Questions 540
WEDNESDAY 6 MARCH 2002
HEATH OBE AND
540. How do you then reconcile that position
with optimising devolution in the Health Service, if what you
are really going to say to every health authority is, you can
do what you want as long as you produce the same amount of drugs?
(Lord Hunt of Kings Heath) The establishment of NICE
alongside the Commission for Health Improvement and the financial
service frameworks allows us to devolve more. The whole problem
of the NHS, or one of problemsapart from the lack of resource
for many, many years and the lack of capacityis this huge
inconsistency. If through NICE, if through National Service frameworks,
if through the reviews of the Commission of Health and Improvement
we can ensure that when it comes to clinical services there is
a consistency of approach throughout the NHS then you can afford
to devolve many more decisions to the local level. You probably
know the Secretary of State in a speech about three or four weeks
ago spelled out his vision in which, first of all, setting up
these national bodies, then making them independent, as we have
done, you can then allow much more freedom of movement at a more
local level. The fact that we are requiring NHS bodies to finance
the cost of NICE guidance is a small price to pay for that.
Chairman: I should keep off that speech if I
were you, Minister.
Mr Burns: The Chairman is not very keen on it!
541. Those two answers, Minister, raise the
question, how is it that NICE decides on which topic to appraise?
There are some cynics who suggest it must be something to do with
the pressure from drug firms or it may be to do with certain diseases
and certain things that you hear about in the press. Could you
tell us how that is done?
(Lord Hunt of Kings Heath) Let me make it clear that,
first of all, it is the Department of Health and ministers who
decide in the end the work programme of NICE and the particular
technologies that they would appraise or the guidelines they develop.
That was only done after a very careful programme of work. We
have Birmingham University undertaking horizon scanning, which
is trying to pick up new developments and new technologies that
are about to come on stream. Other organisations, as we have heard,
are invited to put forward suggestions. All those are very carefully
considered. We seek expert advice as well to advise us on the
likely impact and actually the practicality of whether in a particular
technique there is enough evidence in order for NICE to make a
decision. A very careful process is gone through before ministers
make the final decisions.
542. You talk about innovations and innovating
techniques, personally I am aware of a number of long existing
techniques, and we have heard on this Committee about the wisdom
of the National Health Service, do they get sufficient push from
somebody to urge that they be appraised, some of them for the
first time ever?
(Lord Hunt of Kings Heath) There is a balance here
in relation to new technologies and existing technologies that
for one or other reason need to be given the NICE Review treatment.
We will try and keep the balance there. I have already intimated
that over the next five to 10 years the expectations that we will
reach a position where any significant new technology where there
was likely to be any doubt or controversy over cost-effectiveness
and clinical effectiveness would be reviewed by NICE after launch
or within a short period of time after launch. I also wish to
see that over that time period we will pick up existing technology
where, again, there is significant concern or a difference of
view and where there is controversy. That is certainly our aim.
The difficulty is we cannot fit everything in in each work programme
and unfortunately some are having to be held back.
543. Do you think process is transparent enough,
the selection process? Is there anything that could be done to
make it more inclusive and more transparent?
(Lord Hunt of Kings Heath) We are consulting at the
moment on the consultation process. There are a number of things
we are doing, we want to make it easier for organisations and
individuals to put forward ideas for possible considerations,
that is the first point towards transparency. We have a Technologies
Advisory Group within the Department, at the moment it is mainly
staffed by officials in the Department and the National Assembly
for Wales, and we want to extend that and bring in more people
from the NHS and patient groups and, indeed, industry. It is bringing
outside people in. We are also suggesting that we give fuller
information on the rationale for the topics that we suggested.
I hope that with those changes which, as I say, are subject to
consultation, people will feel it is a transparent process, with
ministers ultimately making the final decisions.
544. One of the roles of the Institute is to
promote innovation and ultimately is there not some tension between
promoting innovation and maximising health gains at a minimum
cost? One of the bits of evidence we have had is a concern that
when decisions are coming out and when topics are selected by
the Department it is not clear whether that is being done because
of patient issues or whether there is an issue there about promoting
innovation, ie new drugs. Can you comment on that?
(Lord Hunt of Kings Heath) Promoting innovation is
very important. For instance, if we are talking about drugs particularly,
this country has a very strong R&D industry and 23 per cent
of all commercial R&D investment in this country comes from
the drugs companies, so it is clearly a very important issue for
this country that we have a climate in which innovative R&D
takes place. Traditionally, the NHS has been very slow on the
uptake of new medicines. Comparative work that we have done comparing
this country with other countries shows that Britain is particularly
slow in doing so. I think you can argue from that that NHS patients
do not always get the benefits of medicines that might prove to
be both clinically effective and cost effective. We want to get
to a position where any significant new drug where it looks like
there might be doubts about it in the NHS as to whether it is
cost effective or not is appraised at a very early stage. If you
could do thatand that is our aimthen you are likely
to see a much faster uptake of those drugs which are cost-effective
and on which NICE's advice should be taken, so I think we can
get over some of those problems.
545. But it is important that patients see NICE
as independent not only of government but independent of the pharmaceutical
industry. Is there a concern that as long as the promotion of
innovation (which can, equally, be interpreted by some as promoting
pharmaceutical companies) is in there as a role for the Institute,
then patients are going to be suspicious that what is going to
be pushed here is pharmaceutical interests and not the interests
of patients? A physiotherapy treatment, by contrast, is not going
to have much clout and be able to push its way forward in the
way that pharmaceutical companies might.
(Lord Hunt of Kings Heath) But innovation and the
industry's role is not just about drugs. I just used that as an
example. I mean innovation as innovation throughout the whole
546. But you accept that pharmaceutical companies
have much more clout and many more resources to push their case
(Lord Hunt of Kings Heath) I have to do that. I sit
listening to the industry talk to me about these matters and I
have to say they are not enthusiastic exponents of NICE so I guess
NICE has got the balance right. To go back to drugs, we do want
to get good, new drugs which are going to be clinically and cost
effective. We want to get them out into the NHS quicker than we
have been able to do before. I believe patients gain from that.
I also believe that the processes that NICE have should ensure
that they protect patients from drugs coming into the NHS because
NICE would not find them cost effective and clinically effective
unless there was robust evidence to support that. In the end you
go back to the evidence base. The whole point of NICE is to make
judgments on the basis of the best evidence available.
547. Sure, but to make that crystal clear, should
not NICE be under the part of the Department responsible for quality
of care and for public health, rather than the part of the Department
responsible for the health of the pharmaceutical industry?
(Lord Hunt of Kings Heath) Whichever way you cut the
cake, you are always going to have to balance these different
viewpoints and interests. I do not think, frankly, that having
NICE where it is placed in the Department at the moment is any
inhibition or leads to any particular favouritism for the pharmaceutical
industry. If you were to ask the pharmaceutical industry, they
would probably say that they have concerns that their interests
have been suborn to those of NICE. From where I sit, because I
have to deal with both sides (if we are talking about sides) I
believe we can take a very robust, balanced approach.
548. Can I come back to one issue about the
national versus the local tension. We have had the example of
herceptin brought up and health authorities having to decide in
advance of NICE guidance whether or not they should be recommending
to their commissions that it should be prescribed and whether
or not they fund that. If local authorities are having to make
that decision, is there not a case for being more public about
x pounds per QALY? We know herceptin costs £2,600 for the
first 12 weeks and then some on-going costs past that. If they
are trying to mirror what is going to be coming out from NICE
do they not need to have those guidelines in order to make their
(Lord Hunt of Kings Heath) I do not think that is
for the Department or the Government to do. I think methodology
as far as NICE is concerned is very much up to NICE. Obviously
one of the things that we have said to NICE is that we want them
to be more open about their methodology and the kind of factors
that bring them to make such decisions. Perhaps I could ask Mr
McKeon to answer specifically on that.
(Mr McKeon) NICE routinely put their appraisal documentation
in the final documents. We have seen the final cost per QALY or
other relevant measurescost per life gain, or whatever
seems appropriate for the particular drug or treatment concerned.
Also, of course, Sir Michael Rawlins has gone on record with his
own appraisal of NICE's track record. I think he did this at the
NICE conference, which has been quite widely publicised, and talked
about the kind of considerations that NICE have and the sort of
cost per QALYs that were emerging. That has been there for the
NHS to see.
549. These are the ones you have approved so
far but he has not created a situation that says, "this is
the slice point where we think that is worth it, that is not worth
(Lord Hunt of Kings Heath) No, he has very clearly
said that there is not a threshold and that seems to be right,
there is not a clear threshold for saying yes or no. You have
to look at the circumstances of every individual case rather than
saying it "X cost per QALY and it would definitely be no".
He has given an indication that if it goes above a certain level
then serious questions have to be asked about it.
550. That exposes the issue that it is difficult
for people on the ground to make those decisions. There are going
to be those local tensions because some health authorities will
be saying X to one QALY and another will be saying Y to another
QALY, depending on their particular regimes.
(Lord Hunt of Kings Heath) I think we can recognise
there is very much a tension there between a local implementation
and a national one.
551. I apologise for not being able to be here
for the early part of the meeting. Either I have misunderstood
or there is a certain amount of disingenuity here. I thought the
Minister just said that the quality of life and the cost effectiveness
was a NICE decision, but surely if NICE's remit is affordability
(Lord Hunt of Kings Heath) No, it is not.
552. Professor Rawlins said yesterday to a briefing
of MPs that NICE's remit was affordability.it is certainly
in many of our briefing papers that NICE has to look at affordability
(Lord Hunt of Kings Heath) No.
553. You had better tell NICE that because they
are going round with a different story. How can NICE assess affordability
if they do not have any input from the Department of Health?
(Lord Hunt of Kings Heath) Let me make it clear that
their judgment is whether a technology is clinically effective
or cost effective. It is our job to deal with affordability issuesclearly
because it is our job to fund the National Health Service. Obviously
we can write to you further about that but that is the broad principle
that we have agreed.
554. We are not all singing from the same hymn
sheet at the moment, I am afraid. I also have other questions.
I would also like to be pick up on the issue of openness. NICE
itself does seem to be reasonably transparent. Where the whole
process appears to get a bit murky is when you try to assess the
interests of groups that feed in and advise NICE. I was delighted
to see the consultation paper on the Technologies Advisory Group
yesterday. We have been trying to find some information on the
interests of the people who are currently at NICE and it is incredibly
difficult to get hold of. Will the new, more transparent system
make sure that all interests are declared and they are actually
placed on the NICE website so that everyone can see who is influencing
who? We also have a problem at the other end of the scale, where
we have the assessment centres and it is not always clear where
those particular universities and centres are getting their funding
from. Again, where is the transparency round those fringe elements?
Where is that going to be?
(Mr McKeon) TAG, the Department's Committee which
is predominantly comprised of civil servants.
555. That is what I would like to know, who
is on it if they are advising?
(Mr McKeon) There is a registered declaration of interests
of those on the Committee, but you would not find that on NICE's
website. That is the Department of Health. The assessment centres
are effectively funded by the NHS fund and R&D budgets, they
are not funded by NICE, they are funded by us.
556. I realise that, but the same assessment
centres also receive certain pockets of funding from drug companies
and anywhere else, they have to these days because of the under
funding of universities. Where are we going to find out who is
funding those assessment centres? I am told it is usually fairly
obvious which of the six assessment centres the technology is
going to be allocated to?
(Lord Hunt of Kings Heath) I think as far as the assessment
centres are concerned that is very much a matter for the assessment
centres concerned. The whole point about the NICE process, surely,
is this, ultimately, that you need as robust a process as possible,
as we have got, to make sure that their decisions are based on
the evidence that is available. As far as the question of the
selection of topics is concerned that is for ministers to decide.
Of course we seek advice, and that is what the Technologies Advisory
Group is all about, essentially it is an internal group within
the Department which looks at the proposals that come forward
and then makes some judgments and recommendations based on essentially
whether there is likely to be enough information available in
order that an appraisal can be conducted effectively and then
based on decisions to do with priorities within the Department
and looking at the shape of the whole programme to see whether
there is a balanced programme. I think that in terms of the priorities
of the process I am satisfied that it is a perfectly appropriate
process and one which, at the end of the day, these ministers
decide on which appraisals should be done by NICE.
557. Yesterday's consultation document says,
"We propose to re-establish TAG so that it includes wider
representation for NHS frontline bodies, patients, professional
groups and industry". What I am asking you is how the public
and how politicians know exactly where those people are coming
from and what onus will be put on those people to declare their
interests so that the process is transparent?
(Lord Hunt of Kings Heath) That is clearly a matter
which we need to consider in relation to the consultation process.
We put this out to consultation and will be seeking views, and
we will be considering issues like that as we come to conclusions.
Obviously we want this to be a process in which people have confidence.
Where it is right that people should declare interests obviously
we will want those to be declared. The Department has its own
clear rules on declarations of interest. I do not think that should
be a problem, it is certainly something that we will look at.
558. We will all know where to find those interests
should we wish to?
(Lord Hunt of Kings Heath) We need to see the end
of the consultation to see what we are going to do and the way
we are going to prepare this. We will look at the issue of the
declaration of interests. Again, I would say that it is in all
of our interests to make sure that the process has as much integrity
as possible because so much is riding on this being a thorough,
Dr Naysmith: It is very difficult to find any
scientist or a laboratory in which the work is not getting some
sort of funding from some market or organisation or other, not
necessarily pharmaceutical. The point I wanted to pick up was
what Sandra said when she started asking questions, I was at the
same meeting and I do not believe the reference was to afford
ability, I think he said cost-effectiveness.
Sandra Gidley: I was talking about the lung
Chairman: There we are!
559. Certainly talking about cost-effectiveness
is very much part of the process.
(Lord Hunt of Kings Heath) On the other point that
you raised in relation to the number of experts who one way or
another have connections with the industry, that is a feature
which is apparent. NICE has, I think, described to you the way
in which that is dealt with within the Committee process, which
seems to me be an acceptable practice.
Dr Naysmith: On that topic, attributing it to
where it came from, it came from Mrs Thatcher's government, when
she insisted that independent institutions, of which we had a
great number, all had to seek grants in the same sort of way as
other institutions, often from commercial sources, which means
there is no such thing as a truly independent scientific government
and scientific institution.
Chairman: Who sponsors you, Doug?
Dr Naysmith: Nobody sponsors me.