APPENDIX 19
Memorandum by Professor David Haslam,
Chairman of Council, The Royal College of General Practitioners
(NC 80)
I am pleased to offer written evidence on behalf
of the College to the Health Committee's Inquiry into NICE.
The Royal College of General Practitioners is
registered charity and our object is—
". . .to encourage, foster and maintain
the highest possible standards in general medical practice and
for that purpose to take or join with others in taking any steps
consistent with the charitable nature of that object which may
assist towards the same."
We have almost 19,000 GPs as Members, Fellows
or Associates and have been in existence for 50 years this year,
being granted a Royal Charter in 1972. We have pursued our aim
of improving the quality of care in general practice by introducing
various quality markers, the key markers and standards being:
— Examination for Membership of the
College introduced in 1965.
— Fellowship by Assessment (FBA) introduced
in 1989 as a method of recognising by assessment the very highest
standards in general practice (there is also Fellowship by Nomination).
— Membership by Assessment of Performance
(MAP) introduced in April 1999 as a rigorous assessment route
to membership for those who did not or could not take the Examination.
— Quality Team Development (QTD): introduced
in 1999, this assesses practice teams who achieve a satisfactory
level of organisation and care; it is aimed to be within the compass
of most practices.
— Development of the Quality Practice
Award (QPA): through multi-disciplinary groups using self-assessment
and peer review, QPA identifies practices offering a high quality
range of services to their patients.
— The continued development of the
criteria for the appointment and re-appointment of trainers in
training practices, re-assessed on defined criteria at three to
five yearly intervals.
— Accreditation of Professional Development
(APD) currently at an advanced stage of development. The College
has been supportive of revalidation for GPs and APD is just one
of the practical ways in which aim to assist GPs as revalidation
is introduced.
— The development of a Leadership programme
which is intended to bear fruit during 2002-03.
The College is also extremely active in the
fields of GP postgraduate education, not least through a range
of courses and conferences, in clinical guidance and advice and
in primary care research.
The College publishes a number of documents
in the course of a year which publicise its activities, including
standard-setting, educational activities and clinical guidelines.
Its Journal is one of the world's leading academic general practice
publications, as measured by the Journal Citation Report.
The College's work in clinical areas includes
the interface with NICE at a number of points. We have been supportive
of the concepts that led to the establishment of NICE and are
very keen to see it succeed. It has a complex task and inevitably
some things have not proceeded as smoothly as they might have
done.
The College is the host for the National Primary
Care Collaborating Centre which is being commissioned to produce
guidelines for use by GPs throughout England and Wales. This is
one of six such collaborating centres established by NICE. A second
interface is College work commenting on the scope of clinical
guidelines before any of the Collaborating Centres is commissioned
to work on their production. The College also sees a significant
role in the future in the NICE programme of audit work.
The College has contributed very significantly
to the NICE Health Technology Appraisal (HTA) process in the following
ways:
— by nominating members to serve on
the NICE Appraisal Committee;
— by commenting constructively on the
processes adopted by NICE for the HTA process; and
— by providing coherent and comprehensive
submissions and comment at the various HTA stages.
It is in the last of these areas that we have
had the greatest interface with NICE and from where much of the
following evidence has been drawn.
Turning to the four areas highlighted in the
Health Committee's call for evidence:
Is NICE providing clear and credible guidance?
We believe the key word here is credible. Any
new body needs time to demonstrate its credibility and NICE has
a number of key audiences:
— Patients who might benefit from health
technologies under appraisal
— The producers/suppliers of health
technologies under appraisal and potentially to be appraised
— The medical professions—in
our case GPs
We remain unsure whether NICE has achieved the
necessary level of credibility as yet and that may questioned
by a number of the audiences identified above. More time may be
needed for the structures and processes to settle down and prove
themselves.
Some of the guidance produced has lacked clarity
and this confusion has been made worse by the uncertainty caused
by the appeal processes. We feel that credibility has been compromised
by Government control and interference, thus undermining the necessary
independence. We support the Kennedy Report on the Bristol Royal
Infirmary Inquiry that NICE should be made much more independent
of Government.
That NICE's work programme is commissioned by
the Government alone and that there has been confusion over the
question of affordability of new technologies has also been detrimental.
At first NICE appeared to be hailed (wrongly or rightly) as the
way to end "postcode prescribing". NICE distanced itself
from that role and the Government has belatedly made somewhat
unclear arrangements for funding the cost of new treatments.
We have also had concern over the changes in
NICE processes, for example, the early insistence on rigid confidentiality
followed by challenges and changes in procedures. It has to be
accepted that all processes mature and we would hope for greater
stability in the future.
Our view is that the NICE Appraisal Committee
appears to give too great a weight to the views of clinical specialists
and information from pharmaceutical companies rather than the
practical use and impact of new technologies even where the technologies
will be used significantly in primary care.
Having said that, we understand that guidance
from NICE has been welcomed by GPs and has gone some way to achieving
equity within local districts. The guidance is easy to understand
and there is sufficient detail on the process to make it clear
how decisions are reached. The summaries of the condition for
which the technologies are used are also very helpful. This has
helped give GPs more confidence and in that regard, NICE's guidance
is clear and credible.
Has NICE ended confusion by providing a single
national focus?
The national (England and Wales) focus of NICE
has been helpful but, the NICE HTA process is perceived to be
politicised. To suggest therefore, that the whole process is driven
by scientific evidence only is in our view unrealistic.
As far as guidelines are concerned NICE appears
may be in danger of ignoring the work done by others including
the medical Royal Colleges over the years. This means that it
could overlook expertise which is useful to its work and aims.
We were concerned to note the support for this centralising tendency
in the Kennedy report on the Bristol Royal Infirmary Inquiry,
which envisaged NICE being the sole provider of guidelines. This
would lead to a very slow and monopolistic approach which would
be likely to stifle innovation. We can see the need for an authoritative
single voice but one that works more flexibly than appears to
be the case now.
There is also scope for confusion in that NICE
covers England and Wales only but its HTA outcomes might be used
by the relevant bodies in Scotland either modified or unmodified.
This could easily lead to a new form of postcode prescribing opening
up across country borders and further inconsistencies arising
in the delivery of healthcare across the UK.
We are not confident that NICE yet has the necessary
understanding of primary care needs in its HTA processes. Whether
this needs to be reflected in the make up of the Appraisal Committee
might be worthy of consideration given the Committee's broad base
of representation.
Is NICE providing guidance that is locally owned
and acted on in the right way?
We are unsure how a centralised approach such
as through NICE can possibly achieve local ownership—this
is a particularly acute problem for primary care. Unless there
is a further process which helps develop local specific guidance
from the central decisions by NICE then it is probably unrealistic
for NICE to be able to achieve this aim.
NICE is not proactively involved in supporting
the implementation of the guidance it commissions, and sometimes
seems to confuse dissemination with implementation. NICE is not
an appropriate body to engage with the processes of individual
and organisational learning which are required for the guidance
to be "locally owned and acted on".
The ambitious programme of guidelines which
NICE is currently commissioning, all of which will need to be
updated regularly, suggests that there is a danger of overloading
clinicians, particularly generalists, with information. The considerable
level of investment by NICE should be paralleled by local resources
directed at supporting clinicians in implementing the guidance.
There is a growing body of evidence about the factors which lead
to change in clinical practice, and this suggests that credible,
local, clinical leadership is critical and, in primary care, practice
visits are particularly effective. This College's quality awards
encourage the use of NICE guidelines and offer a good model for
introducing change at a local level.
In discussions (eg amongst GPs) "guidelines"
are often referred to as if they were blanket "instructions".
It is important that they are always referred to as "guidelines".
It is the responsibility of the health professional to decide
whether or not the guidance is relevant/appropriate in relation
to an individual patient (who may suffer from conditions additional
to the one which is the subject of the "guidance").
In other words, patients are individuals and professional responsibility
remains with the individual health care professional.
There are problems relating to keeping guidance
up-to-date. Patients read about new drugs/treatments and health
professionals need speedy updates on their value and whether or
not this affects existing guidelines. The other side of this coin
is the need for a speedy reaction from the Department of Health
in letting the public know that "the case is unproven/investigations
are underway/it is hoped to have reliable "evidence"
within xxx (space of time)".
Is NICE actively promoting interventions with
good evidence of clinical and cost-effectiveness so that patients
have faster access to treatments known to work?
We agree that the NICE process is based on evidence.
We are of the view however, that the process for HTAs has placed
too great an emphasis on clinical effectiveness rather than cost-effectiveness
or practical application. We have devised and use extensively
a template for feedback for contributions to our submissions and
comments to NICE HTAs. This gives equal weight to these three
aspects of the appraisal. However, we are not convinced that the
Appraisal Committee has sufficient regard to the cost-effectiveness
or the practical implications particularly for primary care. Its
views tend to be technology/clinical and secondary care biased.
It has to be accepted that the build up of evidence
based care in primary care is happening only slowly and consequently
we fear that it may be a very long time before NICE considers
primary care treatments.
The emphasis on the clinical and technical aspects
of the HTA process has made it extremely difficult for us to find
GPs who have the knowledge and/or experience to analyse the papers
produced by NICE. These are frequently voluminous especially at
the Provisional Appraisal Determination stage and neither this
College nor its individual members is equipped to undertake the
analysis in the time allowed. We fear therefore that many of our
submissions, whilst prepared with great care and consideration,
may lack the rigour that is necessary. We cannot believe that
other commentators are in a significantly better position and
that may distort the appraisal process.
The time needed for proper analysis of the provisional
appraisals is highly significant for medical professionals. Whilst
some compensation is now being offered for this work by NICE,
it was an aspect of the process that was not considered at the
outset. This substantial workload can bring pressures to bear
on the individuals and organisations such as this College who,
effectively subsidise part of the NHS. We would be unhappy if,
because of this, we had to rely on fewer and fewer participants
in the appraisal process as that would be counter to achieving
the level of rigour and credibility that we would like to see.
The two areas where we feel changes could be
made are first, to accept a broader base of evidence, including
qualitative research, and second to take into account in the economic
modelling all the costs involved, not solely those to the NHS.
We suggest that the latter point is of particular importance.
The cost of an illness or disability has much wider implications
for the national economy than beds occupied in NHS hospitals or
operations performed. As social services and the NHS work closer
together it seems perverse not to include the social costs—to
patients, their carers and the State.
This area of the Inquiry's work suggests that
NICE should not only ensure more effective treatment but faster
access to it. Access and effectiveness are not always related,
although the scope of some guidance does include reference to
referral etc decisions. This again suggests the need to look at
the service context of the implementation of guidance.
GENERAL COMMENTS
We suggest that NICE's processes should be much
more clearly aligned to the National Service Frameworks so that
there is "joined up thinking".
Our experience of working with NICE in setting
up structures to develop guidelines has been complicated. As an
organisation it has been forced to set up complex processes within
a short timescale. There has inevitably been uncertainty and change
of direction as the new organisation finds its feet. In retrospect,
it may have been unwise to embark on such a substantial programme
while NICE was not clear about the best way of managing guideline
production. It is also becoming clear that the skills needed to
develop these guidelines are in short supply.
Although NICE has built into its processes a
wide stakeholder involvement, including patients, and has introduced
a requirement to look at cost effectiveness, NICE does not seem
to have processes for considering the impact of guidelines on
patterns of service delivery. Closer links with the NHS Research
and Development programme on service delivery and organisation
might be fruitful.
We suggest that the Inquiry should consider
the impact of NICE on treatment which is not governed by NICE
guidance. It is possible that requirements to fund treatments
which NICE have approved will mean funds are diverted from other
effective treatments which simply happen not to have been reviewed
by NICE. This may actually prevent some patients getting appropriate
treatment.
The long term vision seems to be one in which
much clinical care is governed by NICE guidance. We need a better
understanding of how this guidance will interact with clinical
judgements. Central control of the delivery of care will no doubt
bring considerable advantages and ensure that research is brought
into practice more quickly and effectively. However, what is considered
best practice today may be seen as inappropriate in the light
of new research—we suggest that NICE will need effective
ways of "unpicking" its guidance from time to time.
It is also worth considering what the long term
effects of centrally controlled guidance will be on medical research
and innovation. With clinicians obliged to work within a single
paradigm the opportunities for serendipitous discovery may be
reduced. It may become much more difficult to carry out the research
which would challenge the underlying principles of any particular
set of guidance so that it becomes, in effect, self-confirming.
We trust these comments and observations are
helpful to the Committee and we are very happy to amplify them
if that would be helpful.
January 2002
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