44. We were concerned to hear from the MS Society
that during the course of an appraisal "straightforward questions
... were turned aside by the Institute and we were told that the
only way of finding out how that information had been used was
through NICE's formal appeals process, which we did, but we could
not actually make any critique of how that information had been
used because no explanation was given of how it had been used".
Some support for this view can also be drawn from Professor Rawlins'
description of an appeal which had proved a useful mediation exercise:
"This was an opportunity to allow the particular
organisation, which in one case was actually a patient organisation,
to explain what their problem was and we could explain what our
problem was and I think they were reasonably satisfied. Although
the specific appeal was rejected I think they were satisfied that
their point of view had been put and we had explained why we could
not meet their demands."
45. Although we welcome this example of constructive
dialogue between NICE and its stakeholders, we feel that NICE
needs to be able to engage in this type of dialogue within its
routine processes, rather than in the costly and potentially adversarial
setting of a formal appeal. Improvements in the inclusiveness
and transparency of NICE's processes are needed to ensure that
the appeals process is not the only means for stakeholders to
enter into constructive dialogue with NICE.
46. Many memoranda also expressed wider concern that
the Chairman of NICE has sole responsibility for deciding whether
or not an appeal is heard, and that he is also Chair of the Appeals
Committee. The MS
Society argued that "the NICE Appeals Panel has neither the
qualities of independence or impartiality that are required of
a public body exercising an appeals function", without which
it will be unable to maintain the confidence of the public.
The Association of the British Pharmaceutical Industry (ABPI)
agreed with this: "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".
47. NICE gave us assurances that the Chairman maintained
full independence by having no involvement at all in the technology
appraisal process, and told us that they felt this was an appropriate
a perverse consequence of this is that the Chairman may not be
able to keep his finger on the pulse of NICE, and may be prevented
from giving it vital strategic direction. Indeed, there were occasions
during oral evidence when, in response to questioning, Professor
Rawlins excused his lack of knowledge about NICE's processes as
being the result of his need to stay out of the deliberations
of NICE so that he could remain independent for appeals.
48. In an ideal situation, there should be only very
limited recourse to an appeals panel. Professor Rawlins told us
that around 40% of NICE decisions on technology appraisals are
appealed against, and he said that this rate was comparable to
that of the Committee on Safety of Medicines.
However, figures published by the Medicines Control Agency indicate
that between 1995 and 1999, the proportion of decisions that were
the subject of an appeal hearing in fact ranged between 4.6 and
9%, with the proportion subject to independent appeals even smaller.
We recognise that NICE was created to take difficult decisions
about which there will inevitably be disagreement. However, appeals
are meant to resolve any genuine concerns that NICE has not followed
its own processes properly, rather than to act as a means for
stakeholders to question the validity of those processes, or to
enter into dialogue with NICE. There should be the opportunity
for this to take place within normal procedures, so that by the
time NICE reaches a final determination, stakeholders have sufficient
confidence in the technical quality and accuracy of the appraisal
work, and are satisfied that their own evidence and views have
been taken on board and used properly.
49. NICE is currently undertaking a public consultation
into its appeals process, the key proposals of which are that
all hearings will be held in public, and that NHS organisations
who are formal consultees will be given the right to appeal. However,
the current role of the Chair in the appeals system seems to us
to be flawed. We recommend that the Government gives careful consideration
to reforming the appeals system, as it has at least the appearance
of lacking impartiality. We are also concerned that the distance
that this creates between the Chair and the everyday business
of NICE may be to the detriment of the organisation as a whole.