Examination of Witnesses (Questions 300
- 319)
WEDNESDAY 30 JANUARY 2002
PROFESSOR SIR
MICHAEL RAWLINS,
MR ANDREW
DILLON AND
PROFESSOR DAVID
BARNETT
300. Can I take you on to the next question,
which is the issue of selection of topics. Clearly one of the
areas where there are suggestions that you are not independent
is the fact that Ministers select the topics that you examine.
(Professor Sir Michael Rawlins) Yes.
301. Are you happy with that arrangement? Are
there areas of selection that cause you problems or where you
may have expressed concern to Ministers about the specific topics
which are being proposed?
(Professor Sir Michael Rawlins) Yes. I mean, I think
the fact that the final decision rests with Ministers is inevitable
in a service which is publicly funded, when NICE's conclusions
could impose very considerable costs to the health service. I
think those powers are appropriate in a publicly funded service.
The proposals that go to Ministers are drawn up by a group that
is called the Joint Planning Group, which is jointly chaired by
myself and Andy McKean, a senior official in the Department, and
we have a lot of input into the agenda setting process and to
what goes forward. That has changed since NICE was first set up.
When NICE was first set up, there was a Departmental committee
that made these decisions and we had very little input into it.
In response to remonstrations from us, the Department, the Government,
changed the process to give us a much more robust say in what
counts. Nevertheless, I think the process is still somewhat opaque
and obscure. I think it could be more open and transparent, I
think it could be more inclusive. As we say in our submission,
I would like the health service generally to have an input into
what we do because I think there are wonderful ideas out there
that we probably have not thought of, where guidance is needed
and would be extremely helpful. I also think that it should be
pro-active. We will no doubt come on to this later, but we should
be appraising new treatments, new technologies around the time
they launch. We have had to do a catch-up programme up to now
but we have got to overcome that catch-up period and become much
more pro-active.
302. Do you detect, in terms of your wish to
have more say in the determination of topics, a willingness by
the Government for a move further in this direction?
(Professor Sir Michael Rawlins) I think so, yes. We
have not had any suggestions that this is not an appropriate way
forward. There is a draft consultation paper, I understand, coming
out shortly. I do not know what the content is, but I understand
it is coming out in the next week or two.
303. That is on your procedures, is it?
(Professor Sir Michael Rawlins) On the topic selection
process.
Chairman: I understand.
Sandra Gidley
304. There have been a number of submissions
that have raised questions about this. I am glad that you have
said that it is opaque and obscure. I think it might be helpful
to us if you could describe what sort of protocols you use to
decide which drugs are going to be prioritised. And, once you
have decided, have there then been ministerial decisions which
have said, "No, we do not think this is appropriate, could
we change it" and what the reason for that has been?
(Mr Dillon) Essentially it is a three-stage process.
The first stage is identification of a pool of potential topics
that NICE might consider. Of course these topics stretch well
beyond pharmaceuticals because the Institute looks at pretty much
any intervention that the NHS might use in clinical practice.
That pool is filled, essentially, from a number of sources, but
primarily from work that is done by what is called the Horizon
Scanning Centre at the University of Birmingham. The Department
of Health and the National Assembly of Wales have a contract with
the people at the University of Birmingham who do what the title
of their unit suggests, which is to look for emerging technologies
and to refer them to a committee, which is the second stage of
the process, called the technologies Advisory Group. That group
consists of people from the Department and the National Assembly
of Wales and also people from the NHS, people from the NHS Research
and Development Programme, and the Horizon Scanning Centre, sitting
together with representatives of NICE, looking at the potential
pool of technologies and selecting out those of particular significance.
There are the criteria which are used to select technologies that
were published by the Department of Health at the time NICE was
established. The third stage is a final review of that topic list
by the group which Professor Rawlins referred to, the Joint Planning
Group, jointly chaired by Mike Rawlins and a senior official from
the Department, a much smaller group with some representatives
from the Department and the Assembly and some from NICE, which
signs off, in effect, a final recommendation to the Minister.
The Minister would consider the topics that have been put forward
and make the final selection decision for publishing and for consultation.
305. If we can go back to the beginning, the
Horizon Scanning Centre, who is actually on that and how are they
appointed?
(Mr Dillon) Those are members of an academic department,
so the arrangements for their appointment would be the responsibility
of the appropriate academic department at the University of Birmingham.
Although I do not know any details, there would be periodically
a bidding process for the contract for Horizon Scanning. The Institute
itself was not involved the first time round the contract was
let, although we would be involved in the future, so I am not
aware of the fine details of the contract specification, but the
individuals, as academics, would be appointed through normal processes
by the University of Birmingham.
(Professor Sir Michael Rawlins) The Horizon Scanning
unit is actually funded by the NHS R&D programme; it is not
part of the virtual institute of NICE.
306. Would there be ministerial input at that
level or not?
(Mr Dillon) No, I do not think so, not in terms of
the Horizon Scanning Centre doing its work I am quite satisfied
that they independently do the scanning work and then they present
that information to the Department and the Assembly.
Chairman
307. Can I come back on the issue of independence.
A number of witnesses have talked about conflicts of interest
on the issue of independence of your body. You may have seen the
evidence that Helen Marlow from Croydon Health Authority presented
to the Committee, in which she talked about conflict of interest
and went on to talk about the absence of a robust procedure for
declarations of interest within NICE. Is this fair comment or
not? Would you care to respond to the concern she has expressed?
(Professor Sir Michael Rawlins) We do actually have
a very clear code of practice that applies to members of all our
advisory committees as well as the staff. (I think it is an annex
in the evidence we submitted to you.) In essence this requires
members of advisory committees to declare their interests annually,
to declare them at the start of each agenda item, and these are
minuted and published in our minutes on our web site. So I think
we are actually pretty open about this and we take very seriously
this whole question of conflict of interest.
308. So you would refute very strongly any implication
that some of your decisions may be influenced by interests within
NICE.
(Professor Sir Michael Rawlins) Very much so. As I
said, we do publish all members' interests, and if they have a
personal specific interest they take no part in the proceedings.
I mean, they are not even present in the meeting.
John Austin
309. There will be a number of interests which
will want to seek to influence your processes. I think we would
all agree that it is important that the voice of patients and
patients' organisations is heard. It is suggested sometimes that
some patient organisations may have a fairly cosy and perhaps
not too healthy relationship with the pharmaceutical companies.
I would like to ask: Do you seek to ensure any declaration from
any patient organisations that are making representations?
(Professor Sir Michael Rawlins) I should explain that
I never go to the Appraisal Committee meetings because I have
to remain independent to hear appeals. Mr Dillon will explain
what happens.
(Mr Dillon) The process that we have for inviting
submissions from all stakeholders asks them to identify any potential
conflicts of interest that they might have. Specifically, and
most importantly, when clinical experts and patient experts are
invited to attend the Appraisal Committees themselves, which they
are for every technology, they are asked before the beginning
of each item to formally declare any interests they consider appropriate
and those interests are recorded in the minutes and published
on the web site.
310. And that is a requirement.
(Mr Dillon) That is a requirement.
311. Since the time that we first met you, have
you learned anything in respect of the way various interest groups
operate? Have you in any way changed your procedures to take account
of this learning process?
(Professor Sir Michael Rawlins) I think so. When we
started out, we produced interim guidance. We were starting out
on a venture, nobody had ever done it before, and we produced
interim guidance for manufacturers and anybody else who was submitting
evidence to us. At that time I do not think we made it quite clear
what sort of evidence would be most helpful to us and, indeed,
professional organisations and so on, as a result of the early
experience, we have now laid out much more clearly the process
and what manufacturers can do, what professional organisations
can do, what patient/carer organisations can do as well. Andrew
Dillon was particularly involved in that and may want to amplify
it.
(Mr Dillon) In order to get the appraisal programme
running rapidly, we wrote very quickly procedures and methodology
in order that we could start. The first people appointed at NICE
arrived in the middle of July. We launched our first programme
at the beginning of August. We had to move very quickly. What
we committed ourselves to almost at the same time as launching
the programme was a formal review of all of our processes for
the appraisal programme and we completed that and published new
process documents and new methodology documents early last year.
In preparing the document that guides patient organisations in
submitting to NICE, we sat down with patient organisations themselves,
both those that had had experience of the Institute's appraisals
and those that had not, talked through with them the best ways
to present to them our thoughts on how they could best contribute
to the appraisal process, and the resulting document was published
in February last year.
Dr Taylor
312. I do not envy you your job at all because
in some way you have to balance clinical effect and cost. In your
submission you say that you should have regard for available resources.
We would like you to expand a bit about what that means and how
you know what resources are available.
(Professor Sir Michael Rawlins) In general terms,
we look at the clinical effectiveness in relationship particularly
to clinical need and other sorts of treatments that are available
and we look at cost effectiveness by methods that are reasonably
well accepted internationally, and we look at each of the technologies
or treatments in that light. The Institute also calculates the
net budget impact; in other words, if this advice is taken up,
how much is it going to cost. This does not play a part in the
appraisal or process itself, but clearly it is of considerable
interest to the Government and the Treasury and Parliament. But
it is not part of the appraisal process. I have often used an
example, and it might be helpful. It might be that at some future
date a company comes along with a treatment for lung cancer that
produces a 95 per cent two year survival, which would be riches
in the context of everything we have got at present. If that costs
£10,000, that would be roughly £5,000 per life-year
gained. That is fine, that would be cost effective of the order
of routine mammography in breast cancer. But there are 50,000
patients a year with lung cancer. The cost to the country would
be £0.5 billion. NICE cannot suddenly commandeer £0.5
billion from the Treasury and quite clearly it becomes an affordability
issue for Government and ultimately for Parliament as to whether
or not they are prepared to fund that sort of thing, and, if they
are, how they are going to find the money, increased taxes, borrowing
or whatever. That seems to me a very clear distinction between
affordability, the £0.5 billion it would have cost the nation,
as opposed to the clear evidence of clinical effectiveness and
cost effectiveness in relationship to what we do. We would go
as far as the clinical and cost effectiveness; ultimately it is
you who have to do the affordability bit—which I do not
think is actually any easier than what we have to do.
313. No. This is not how it is coming across
to health authorities and purchasers. One example that has been
quoted to us which I think is probably one of the best is the
implantable cardiac defibrillators. One of the local trusts knows
that four of those is exactly the same as four extra nurses in
A&E, and for the trust the four extra nurses in A&E is
far, far more important, but they have been faced with this, which
is coming down with pretty considerable power, that this is what
they should do. Is this not skewing local priorities?
(Mr Dillon) But this is a choice that has existed
for years. As Chief Executive of St George's I remember signing
many orders for implantable defibrillators and having to do that
in the knowledge that there were a whole series of local priorities,
local demands for resources, that there simply was not enough
money to meet. The guidance that the Institute gives is guidance
on topics that are important to every local health community but
we know they are not the only important priority, we know they
are not the only demand that is made on local resources in the
NHS. We are aware of that. But the point of establishing NICE
is that, if we are given the right topics, topics that the NHS
collectively regards as important aspects of clinical practice
on which it wants consistent service to be provided for patients,
on which it wants consistency of access, then we are in a position
to give that advice to the service. I think the service that is
looking to deal with these difficult and unacceptable issues of
significant geographical variations, has to take and accept and
has to regard that as a major priority and in effect a first call
on the resources which are available locally. That does not mean
to say that nurses in the Accident and Emergency Department or
Outpatients or on the wards or anywhere else are unimportant;
they are clearly very important, but the fact of NICE existing
and providing guidance at a national level has not created a new
dilemma for local organisations to deal with. What we are doing
is providing clear information that helps to resolve difficult
funding decisions about aspects of clinical practice that would
otherwise be provided variably across the service.
314. It has given them an entirely new dilemma,
because now they are faced with what is in fact coming out as
a directive, that this has to be bought or has to be provided,
and they do not have the funds to do both. The expectation of
patients is: "If NICE has said so, I'm going to get it"
and they will make a tremendous fuss. The comments from patients
who do not get it ... I have got a superb letter—and I am
an Independent, so I can say exactly what I like in this Place.
Some people regard this—and I am not criticising you—as
really a way to ration health care and to be a Teflon coating
for the Government. Is this another example of Mr Milburn devolving
decisions that he ought to have responsibility for?
(Mr Dillon) I remember a discussion I had with cardiologists
at St George's Hospital some years ago, before NICE was announced,
about effectively the rate at which we should be stenting, the
rate of using stents. It was put to me by the cardiologists that
our rate should be around 85 per cent. I asked them for the evidence
for that. It would have meant spending about £60,000, a significant
sum at the margin for even a large organisation. The evidence
they gave me was, "That is what the Royal Brompton does."
In the end we had a long discussion about it, but I was presented
with no better evidence than, "That's what the Royal Brompton
does, and so that is what we should do." When I went to NICE
and we were asked by the Department and the Assembly to look at
the use of stents in CH18 March 2002 and to go through the process
of finding the evidence, of exposing that to extensive appraisal
and consultation and coming up with clear guidance, I remembered
those discussions, and, whatever problems it might create for
the local NHS, if that guidance had been available to me and the
cardiologists of St George's at that time we would have been in
a far better position to make good quality decisions about resource
allocation than we were at that stage.
315. Do not think I am criticising the desire
to get evidence, because that is absolutely essential. What I
am having difficulty with is who is meant to balance four nurses
against four implantable defibrillators and how you square patients'
expectations. Slightly on that, one other thing: several people
have mentioned that they feel that you should have some ethical
input. Is that something that has been raised with you?
(Professor Sir Michael Rawlins) We certainly recognise
that some of our decisions or the basis upon which they are made
requires value judgments. We fully recognise with those value
judgments that we are no more competent than anybody else to make
them. That is why we are in the process of establishing the citizens'
council, composed of ordinary men and women around the country,
to help us make those value judgments, because they are probably
better then the three of us at coming to that sort of conclusion.
I am not quite sure whether that is ethical; at least it is seeing
how out there people think we should be approaching some of these
difficulties.
316. There are well established ethical committees
because every research project—
(Professor Sir Michael Rawlins) Yes, I have chaired
one for a number of years, as you might imagine. This is a rather
different endeavour than the somewhat amateur ethics that we used
to conduct in my ethics committee.
Chairman
317. Can I pursue that question Richard has
raised about the issue of determination and choices at a local
level? Mr Dillon, you had been in a key position in the health
service before you came to NICE. Have your experiences of being
involved in NICE given you any ideas as to how you may make different
arrangements for local choices within the health service? This
is slightly askew from the direction of travel with this inquiry,
but I have asked one or two of our witnesses, when we are talking
about limited resources how best we can ensure that the kind of
choices that Richard has talked about are made with citizens'
councils locally, never mind within NICE or some other body, where
we genuinely reflect the views of the local users of the service.
Have you come up with any brilliant ideas in your time in NICE
which may move us on in this respect?
(Mr Dillon) I think the reality is, certainly my experience
has been, that the opportunity for choice just exists at the margins
for most NHS organisations. Most of what is committed every year
in the NHS is pay. Around 70 per cent of what we spend in the
NHS is on pay. There are choices to be made there. Changes occur
every year in relation to the kind of people that are employed
in the service and the numbers of people that are employed in
particular functions in each local health economy, but essentially
we are stuck with this huge bulk of expenditure long term. Beyond
that, most of the rest of the expenditure is pretty much long-term
as well, in conventional clinical practice. Sometimes that practice
is challenged. NICE provides the NHS with an opportunity to challenge,
to challenge constructively, what we do at the moment, and we
would very much like to get from the NHS, and we are not at the
moment, ideas for topics that look at topics or aspects of clinical
practice where there is a prima facie case for considering
whether or not what we are doing and what we are spending money
on really is the best way to treat patients with that particular
condition. So we would like more of that. If anything, my experience
at NICE has been that if we can start to engage more actively
with the service in topic selection for the Institute, we will
get those proposals coming through, and the NHS will start to
see us less as an entity that is providing us with the sort of
challenges that Dr Taylor referred to. We already have got difficult
decisions, we have very little flexibility and now there is a
national organisation that is effectively reducing that flexibility
by virtue of indicating how we should spend some of the money.
I think if we can move to a position in which we are working with
the NHS on topics that provide the opportunity to redirect investments
to more effective treatments, then we will feel that our contribution
to the service, which we already regard as being substantial,
will increase.
318. Sir Michael, you talked about your citizens'
council. Without going into detail about how you select Citizen
Smith to serve on this, how do you see, in practical terms, this
body operating?
(Professor Sir Michael Rawlins) We would operate it
very much along the lines of citizens' juries, where they meet
for two/three days at a time and they hear witnesses. They are
facilitated, not by me but by experienced facilitators, and they
come out with a report at the end. The citizens' juries that have
been conducted—and the King's Fund have sponsored quite
a number—have produced extraordinarily sensible conclusions
at the end of it. That is the sort of model we hope to get and
we hope to include a real cross-section of people to take part.
319. What kind of issues would they be looking
at?
(Professor Sir Michael Rawlins) Just to give you one
example, when we calculate these quality of life adjusted years,
life-years gained or whatever it is, we multiply the quality of
life by the number of years in which you are going to enjoy them.
That gives a huge advantage to children relative to the elderly
because they have got fewer years left to enjoy. It is actually
mathematically quite simple to change that from a straight line
to any old curve you like. So one of the sort of things is: How
much should we be giving emphasis to children and how can we ensure
that in some way we do not deprive elderly people of the benefits
of modern treatment? It is that sort of broad-based type issue
that we are anxious to pursue with the council.
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