Select Committee on Health Second Report


108. NICE's independence from Government and from the manufacturers, organisations and individuals who have a stake in its processes is clearly essential if it is to carry out its work properly and to maintain its credibility. The particular importance of NICE's independence from Government was emphasised by the Kennedy Report,[151] the Government's response to which committed it to remove the requirement for approval of the Secretary of State for Health and the National Assembly for Wales for the dissemination of NICE guidance, and to give NICE the power to determine its own committee membership and structure.[152] However, while a reduction in government control may represent a theoretical increase in NICE's independence, for NICE to establish itself as truly independent it must demonstrate this in practice.

109. Some witnesses have expressed confidence in NICE's independence. Dr Crayford, for example, described the membership of NICE's committees as "heavyweight and unbiased".[153] NICE's controversial decision not to recommend the use of beta interferon for the treatment of multiple sclerosis in the NHS has also been cited as an example of its independence.[154] However, as we have noted, other contentious decisions, including NICE's revised guidance on Relenza, have led to the concern voiced by Dr Duerden that "maybe NICE had been got at".[155]

NICE's relationship with the pharmaceutical industry

110. Many witnesses in particular questioned NICE's independence in relation to the pharmaceutical industry, a perception which may be compounded by the fact that NICE's Framework Document states: "the Institute will also wish to ensure that, in carrying out its statutory functions, it is sympathetic to the longer-term interest of the NHS in encouraging innovation of good value to patients". The tension between NICE's role in securing clinically and cost-effective treatments for NHS patients and its simultaneous role in supporting the pharmaceutical and other healthcare industries by "encouraging innovation" is perhaps heightened by the fact that the same sponsor branch in the Department of Health is responsible both for NICE and for the pharmaceutical industry.

111. The ABPI felt that these two aims were not irreconcilable, suggesting that if NICE was able to appraise new treatments quickly and promote access for patients, "the interests of industry would follow on behind, and it would be encouraging innovation".[156] NICE argued that, in this context, its remit was to promote clinically innovative practice and end unnecessary 'therapeutic conservatism' by promoting the use of clinically effective and cost-effective new treatments. This type of innovative practice could reach beyond pharmaceuticals to encompass a broad range of treatments and interventions, and could also refer to the innovative use of existing treatments.[157] Lord Hunt, however, seemed to recognise the possible conflict, arguing that "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".[158]

112. Professor Rawlins told us that, where there were doubts about a treatment, NICE aimed to "default in the interests of patients" who might benefit from it, an approach clearly also beneficial to the pharmaceutical industry:

 "There are a number of individual appraisals, which we could go into if you wish, where there has been some doubt - it has not necessarily been beyond reasonable doubt but on the balance of probabilities - that patients would be advantaged by having access to a particular medicine, and so I believe that in encouraging innovation we should encourage that sort of use of treatments."[159]

113. Serving the interests of a particular group of patients who might benefit from a treatment, and by extension, the healthcare industry supplying that treatment, may have an opportunity cost for those NHS patients who will not receive the treatment, but who may suffer from cutbacks elsewhere. The impact of mandatory funding on the NHS is discussed more fully later in this section. However, it is clear that NICE must maintain the confidence of both the NHS and the public more generally that it is serving the interests of NHS patients rather than those of the pharmaceutical industry. We have already recommended that NICE should make improvements to the transparency of its decision-making processes, and that in future these should be governed by a clear, published set of criteria. We recognise that NICE has already made efforts to clarify some of its processes, but we see this as pivotal to NICE's success and would caution against any complacency in this area.

Independence from government and selection of topics

114. Much of our evidence used the concept of independence to comment on the issue of NICE's relationship with the Government more widely. In section IV, we discussed the need to draw a clear distinction between NICE's role in assessing cost-effectiveness and the Government's role in assessing affordability. Another key concern is the selection of topics for NICE's work programme by the Department of Health and the National Assembly for Wales.

115. NICE's work programme is of critical importance because it involves prioritising the assessment of some treatments or clinical areas above others. The implementation of NICE guidance is now mandatory, but without ring-fenced additional funding the provision of treatments NICE has recommended may be at the expense of other equally or perhaps more effective treatments which have not been appraised by NICE. The selection and agreement of topics for NICE's work programme is therefore the process which ultimately determines those treatments and services to which NHS patients may be able to have guaranteed access, and those to which they will not have guaranteed access. This was illustrated by North West Lancashire Health Authority, who told us:

"We are aware of many different types of intervention, which can have a great and sustained effect on the quality of patients' lives, that are forced into a lower priority position as a result of not having been considered (yet) by NICE. Photodynamic therapy for age-related macular degeneration, surgical techniques for the treatment of intractable angina, and neuro-surgical interventions for Parkinson's disease are examples that fall into this category."[160]

116. The critical role of the topic selection process was clearly recognised by NICE, who emphasised the importance of being 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".[161] Some witnesses (including, for example, the BMA) argued that NICE should be able to determine its own work programme, suggesting that this would facilitate a more neutral, rational appraisal of the costs and total health benefits of various treatments, drawing on public and professional concerns, and that it would significantly improve NICE's credibility.[162] However, NICE itself does not ask for this additional responsibility. We feel that this very high-level prioritisation is rightly the job of Government, rather than that of a body which is not publicly or politically accountable for such a function.


117. According to NICE, the Department of Health has made considerable improvements to the topic selection process since it first began, enabling NICE to have "a much more robust say in what counts".[163] Despite this, Professor Rawlins told us that "the process is still somewhat opaque and obscure".[164] This view was endorsed by NICE's stakeholders, many of whom argued that the Department of Health-led Technology Advisory Group needed to be more transparent and inclusive.[165] This was echoed in NICE's own suggestion that its work programme should be "constructed in a more open and inclusive manner", and in its acknowledgement that at present "there is insufficient opportunity for NHS staff to propose either appraisal or clinical guideline topics".[166]

118. During our inquiry, the Department of Health and the National Assembly for Wales published a consultation paper covering the selection of topics for NICE's work programme.[167] The key proposals of this are the establishment of a web-based topic-proposal system, the use of a network of advisers to nominate 'peer reviewers', a wider membership of the Technology Advisory Group, and amended topic selection criteria. We welcome in principle the idea of a web-based topic proposal system, but this needs to be supported by a clear and transparent selection process for the assessment of proposed topics. We feel that current government proposals for widening the membership of the Technology Advisory Group (TAG) still leave the NHS, and in particular patients, under-represented.[168] We therefore recommend that the skills mix of the TAG is further weighted towards these groups, and that the deliberations and decisions of TAG meetings are put into the public domain.


119. As well as shortcomings in the topic selection process, many witnesses gave us useful illustrations of what they felt were problems with NICE's current focus as determined by the topic selection process. Most were in agreement that NICE's focus placed undue emphasis on expensive drug treatments at the margins of healthcare, when it should in fact be considering the treatments which are of the greatest benefit to the population as a whole. We were told by Ealing, Hammersmith and Hounslow Health Authority that:

"a more systematic review of the impact of health care interventions would have resulted in [guidance] having been developed for common conditions such as femoral neck fracture, stroke, depression, hypertension and dyslipideameia."[169]

120. Lambeth, Southwark and Lewisham Health Authority argued that "It would be very helpful if [NICE's] programmes were extended to cover major areas of morbidity and mortality which more reflect the priorities we are all facing locally. It would help us to be able to deal more with the affordability issues because the NICE guidance portfolio would be more relevant to the needs we are facing every day".[170] In its written submission to us, the authority outlined several areas in which, as would seem reasonable, NICE's 'priorities', extrapolated from the areas in which NICE guidance had the potential to lead to the highest NHS spending increases, were different from locally-assessed priorities:

Key health priorities of emerging primary care trusts compared with top NICE priorities





Coronary heart disease (CHD) and stroke

Coronary heart disease and stroke

Coronary heart disease and stroke


Sexual health

Sexual health

Sexual health

Obesity (also prevents CHD)

Older people

Older people

Rheumatoid arthritis

Mental health

Mental health

Mental health

Hepatitis C




Acute CHD


Alzheimer's disease

*priorities derived from proportionate increased NHS spend implied by guidance from March 2000.[171]

121. NICE's work to date has also demonstrated an overwhelming focus on drug treatments, although, as pointed out by Lambeth Southwark and Lewisham Health Authority, "drugs are not necessarily the most important component of treatment and care from a patient's perspective, and should be considered as part of the overall pathway for treatment".[172] Further to this, Professor Walley told us of his impression that: "some of the priorities of NICE, as documented by the issues on which they give guidance, are more priorities for perhaps their commercial sponsors than for the NHS".[173] He cited NICE's appraisal of two drugs used to treat obesity, arguing that a wider framework for managing obesity would be more useful to the NHS than isolated guidance on two drugs. While we hope that NICE's increased focus on broad clinical guidelines rather than individual technology appraisals will begin to remedy this, the basis on which areas are selected is still clearly crucial.

122. The current criteria for the selection of topics for NICE's work programme seem open to wide interpretation.[174] They are as follows:

Technology appraisals
  • Is the technology (or appropriate use of the technology) likely to have a significant impact on patient care?
  • Is the technology (or appropriate use of the technology) likely to have a significant impact on other government health-related policies?
  • Is the technology (or appropriate use of the technology) likely to have a significant impact on NHS resources?
  • Is NICE likely to be able to "add value", eg by resolving uncertainty over the appropriate use of the technology?

Clinical guidelines

  • Is NICE likely to "add significant value", eg by resolving existing uncertainties?
  • Is the proposal likely to have a significant positive health benefit for patients (ie, have good potential to reduce disability, morbidity or mortality)?
  • Is the proposal likely to contribute a significant positive impact to the implementation of government health policies, including the NHS Plan, and NSF and Taskforce priorities?
  • Is there sufficient current evidence to support the development of the proposal?
  • Is the proposal likely to have a significant impact on NHS resources?
  • Will the proposal help resolve an unacceptably wide variation in health outcomes and/or clinical practice?

123. Although some areas of national priority have received significant attention (cancer treatments, for example, constitute ten out of NICE's 31 completed technology appraisals), other priority areas have not (for example, to date only one of NICE's completed technology appraisals has covered a mental health intervention).[175] In the summary table submitted to us by the Department of Health, the second most frequent classification of technology appraisals was 'other' perhaps suggesting an undue focus on treatments outwith clearly defined areas of clinical priority.[176]

124. Although a significant number of the clinical guidelines NICE currently has in progress are within identified government priority areas (ten are in the area of cancer, six in mental health, three in coronary heart disease and two in diabetes), many of NICE's 32 "in progress" guidelines do not fall obviously within the areas outlined as clinical priorities for the NHS, including "pre-operative investigations", "routine antenatal care" and "infertility".[177]

125. The Government's consultation document proposes new, integrated selection criteria for both clinical guidelines and technology appraisals:

  • Is there a need for guidance? In particular:
    • Does the proposed guidance relate to one of the NHS clinical priority areas? and/or
    • Does the proposed guidance address a condition which is associated with significant mortality or morbidity?
    • Does the proposed guidance relate to one or more interventions which could significantly reduce avoidable mortality or avoidable premature mortality, relative to current standard practice, or if used more extensively would do so?
    • Does the proposed guidance relate to one or more interventions which if more extensively used would impact significantly on NHS resources (financial or other)?
    • Does the proposed guidance relate to one or more interventions which could without detriment to patient care be used more selectively, thus freeing up NHS resources for use elsewhere in the NHS?

  • Will NICE be able to add value by issuing guidance, taking into account the following factors:
    • Is the evidence base sufficient to develop robust guidance across most or all of the interventions to be covered by proposed guidance?
    • Is there evidence and/or reason to believe that there is or will be inappropriate practice and/or significant variation in clinical practice and/or variation in access to treatment in the absence of guidance?

126. We welcome the amendments to the selection criteria proposed by the Government in its consultation document, as we feel they offer a clearer, more consistent and more rational framework for the selection of topics. However, we recommend that these criteria are explicitly underpinned by the principle of maximising total health benefit to all patients. The process by which topics are assessed against these criteria must also be inclusive and transparent, and should be backed up by a clear and public explanation of why particular topics have been prioritised for assessment by NICE.

127. So far, NICE has recommended the vast majority (28 out of 31) of the treatments and interventions it has appraised either for routine or selected use.[178] Recent research suggests that the net financial impact on the NHS of NICE technology appraisals to date has been increased costs of between £135.2 million and £154.8 million.[179] Several witnesses have suggested that a more useful approach would be to aim to provide guidance on what treatments the NHS should be cutting back on, selecting topics accordingly. According to Dr Crayford, "there is an infinite number of things in which we could invest. What we need help with is in excluding things from this list, not lengthening it".[180]

128. This is a potentially very sensitive area, as it is even more difficult to withdraw funding for a drug patients are already being treated with than to withhold a new treatment from patients. However, Professor Rawlins agreed on the importance of "getting rid of useless treatments or inferior treatments", and hoped that engaging the NHS in setting NICE's work programme might help identify such treatments.[181] We welcome the fact that this is reflected in the Government's proposed selection criteria, and recommend that the Department of Health gives explicit consideration to devoting a larger

proportion of NICE's clinical guidelines programme to appraising treatments and interventions where the evidence suggests that it may be appropriate for the NHS to reduce rather than expand use.


Beta interferon and independence

129. Several witnesses mentioned NICE's appraisal of beta interferon and the Government's subsequent decision to fund the drug in the context of further research as an issue of contention. Dr Andrew Bamji, a consultant rheumatologist, argued that in the case of beta interferon, "even though the clinical evidence of benefit is weak, patient pressure has forced a change of attitude by the Government which effectively overturns the NICE ruling. If this can happen then NICE's position as an independent body is fatally compromised".[182] Although Lord Hunt told us that the course of action pursued by the Government was, in fact, one of the recommendations of NICE's original guidance, and while this development clearly occurred outwith NICE's processes and as such cannot be argued to have had a direct impact on NICE's independence, it is possible to understand how stakeholders could view this as undermining NICE's role. We recommend that the Government, working together with NICE, should ensure that any subsequent decisions which could appear to run contrary to NICE recommendations are issued in a way that is sensitive to the potential risk such decisions may pose to NICE's credibility. Such decisions should be clearly communicated to stakeholders, and could be issued in collaboration with NICE.

The wider prioritisation debate

130. The final issue that has arisen from our inquiry is the role of NICE in relation to the wider debate on prioritisation in the NHS as a whole. Many of our witnesses felt very strongly that the new mandatory implementation of NICE guidance meant that NICE's work programme now feeds into this prioritisation process in a way not intended when it was originally set up. We have already heard that considerable confusion exists over the separation of the affordability and cost-effectiveness functions, and we have recommended that the Government should attempt to clarify this. However, even with affordability and agenda-setting decisions placed firmly with government, our evidence suggests that there is still a need for further debate and clarification. Professor Walley described the issues in useful theoretical terms:

"Does NICE advice carry with it added resources to the NHS, or as seems to be the case, redistribution of existing resources? If this latter is the case, then all possible alternative uses of the resources need to be considered and a review confined to a single therapeutic area or technology is inadequate. A broader approach is necessary, to cover a wide range of, or even all, NHS activities."[183]

131. Croydon Health Authority offered a more practical perspective:

"Health authorities can only prioritise fairly if all competing demands are considered at once. Because of the way in which it has been set up, NICE does not do this, as it considers new treatments at the margin of healthcare. In contributing to the prioritisation debate in the NHS as a whole, it is therefore flawed. Until NICE has evaluated things like the benefit of funding new nurses for our local A&E department at the Mayday Hospital, then its recommendations to fund certain treatments, which are by default at the expense of this sort of development, cannot be rational for local health economies."[184]

132. For NICE to conduct a full appraisal of the costs and benefits of every possible service improvement in the NHS would clearly be an unworkable aim within its present constitution and funding. However, in establishing NICE and making its guidance mandatory, the Government has provided a centralised valuation system for one area of service provision, namely new and/or controversial drug treatments and health interventions, without balancing this against guidelines for any other elements of service provision. This was illustrated very clearly by Mr Newdick, an academic in the field of health law, who argued that "NICE's recommendation of a treatment for reducing the symptoms of influenza by one day commands the same access to resources as recommended cancer treatments". Concluding his written evidence, Professor Walley argued that "there is a need for a rapidly responsive source of guidance for the NHS, but also for a body to take a broader view of NHS priorities: this seems to be beyond NICE at the moment".[185]

133. As Lord Hunt suggested, weighing competing priorities is inevitable for those who manage NHS budgets.[186] However, NICE raises difficult issues by introducing a systematic process for prioritisation in one area without extending the principles and expertise informing this more widely. In his written evidence, Mr Newdick suggested that primary care trusts need to be given a framework within which to consider new drugs and treatments which are not subject to NICE guidance, a point he developed in oral evidence, and argued for the introduction of "a system for gauging affordability ... according to a systematic series of values and a framework of ethics, which would be vague and imprecise, but would give us some idea about a limit on the demands that can reasonably be made on a cash-limited system".[187]

134. Prioritisation of healthcare spending is an issue of overwhelming importance, and during the course of this inquiry it has become clear to us that a more open debate on healthcare prioritisation needs to take place. Our inquiry has persuaded us that, with so many competing interests vying for attention and funding in an area where resources are finite, it is not sufficient to have implicit healthcare prioritisation. We feel that NICE has been laid open to unfair criticism in respect of the 'rationing' debate, as a consequence of the lack of clarity in policy here.

135. Clearly, it would be beyond the scope of the present inquiry for us to make specific recommendations in this area. We do, however, wish to record our view that the Government must work to achieve a comprehensive framework for healthcare prioritisation, underpinned by an explicit set of ethical and rational values to allow the relative costs and benefits of different areas of NHS spending to be comparatively assessed in an informed way. Such a framework would need to secure the input of the wider population as well as NHS patients and staff, policy makers and academics. Although we are not seeking a detailed response on this point, we would welcome an acknowledgement on the part of the Government that this is a key issue, and we would not be convinced if the Government were to argue that prioritisation were already subject to such a framework.

151   Learning from Bristol: The Report of the Public Inquiry into children's heart surgery at the Bristol Royal Infirmary, 1984-1995, Recommendations 40-41.  Back

152   Learning from Bristol: The Government's Response to The Report of the Public Inquiry into children's heart surgery at the Bristol Royal Infirmary, 1984-1995, para 4.8. Back

153   Ev 71; see also Ev 232 (Royal College of Paediatrics and Child Health). Back

154   Effectiveness, Efficiency and NICE, BMJ 2001 322, 943-944. Back

155   Q33. Back

156   Q284. Back

157   Q320; Q322. Back

158   Q547. Back

159   Q321. Back

160   Ev 227. Back

161   Q313. Back

162   Ev 197-98. Back

163   Q301. Back

164   Q301. Back

165   For example, Ev 50 (CancerBACUP); Ev 46 (National Cancer Alliance); Ev 92 (ABPI). Back

166   Q325. Back

167   Clinical Guidance from the National Institute for Clinical Excellence - Timing and Selection of Topics for Appraisal, Department of Health/ National Assembly for Wales, March 2002. Back

168   Proposed membership includes 12 representatives from the Department of Health/ National Assembly for Wales, 3 representatives from NICE, 4 from the NHS and 2 from patient organisations (Clinical Guidance from the National Institute for Clinical Excellence - Timing and Selection of Topics for Appraisal, Department of Health/ National Assembly for Wales, March 2002, Annex B). Back

169   Ev 205. Back

170   Q148. Back

171   Ev 74. Back

172   Ev 74. Back

173   Ev 24. Back

174   Ev 173. Back

175   NC62 Appendix F (not printed). Back

176   Ev 169. Back

177   NC62 Appendix G (not printed). Back

178   Ev 170. Back

179   From Guidance to Practice - why NICE is not enough, Sadler and Dent, BMJ 2002; 324: 842-845 (6 April). Back

180   Ev 71. Back

181   Q375. Back

182   Ev 193. Back

183   Ev 24. Back

184   Ev 71. Back

185   Ev 25. Back

186   Q508; Q510. Back

187   Q55. Back

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