Select Committee on Health Appendices to the Minutes of Evidence


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:

    —  The Government

    —  The taxpayer

    —  The public at large

    —  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.


  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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