151. NICE was established as a Special Health Authority in April 1999.[192] NICE is accountable to the Secretary of State for Health in England and to the National Assembly for Wales for its resources, delivery of its work programme and for the guidance it produces for the NHS.[193] In the last financial year its funding was £12, 575, 000. This was set to increase to approximately £13 million this year, and approximately £15 million the following year.[194]

152. The formal aims of NICE, as set out in its Framework Document, are to:

"Promote clinical excellence and the effective use of available resources in the NHS through the development and dissemination of guidelines for the management of certain diseases or conditions, guidance on the appropriate use of particular interventions, audit methodologies and the dissemination of these to support frontline staff and patients ... the Institute will promote the appropriate use of those interventions which offer good value to patients and to discourage the use of those which do not."

153. In reaching its decisions, Annex C to NICE's Framework Document specifies that NICE should have regard to:

• The broad clinical priorities of the Secretary of State and the National Assembly for Wales (as set out for instance in National Priorities Guidance and in National Service Frameworks, or any specific guidance on individual referrals)
• The degree of clinical need of the patients with the condition or disease under consideration
• The broad balance of benefits and costs
• Any guidance from the Secretary of State and the National Assembly for Wales on the resources likely to be available and on such other matters as they may think fit
• The effective use of available resources

154. In addition, the Framework Document states that "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".

155. NICE's technology appraisals are based on a review of evidence of clinical and cost effectiveness for a particular technology, and give recommendations about whether and in what circumstances the technology should be used in the NHS. Although technology appraisals can and have covered a wide range of 'technologies', including surgical procedures, medical devices and screening technologies, the majority have focused on pharmaceuticals.[195] Recent high-profile examples include beta interferon for the treatment of multiple sclerosis (published in February 2002) and zanamivir (Relenza) in the treatment of influenza (published in October 1999, with a revised version published in November 2000). At the time of giving evidence to us, NICE had produced 31 technology appraisals.

156. Clinical guidelines provide wider guidance on the management of whole diseases or clinical conditions, and cover several different treatment options. At the time of giving evidence to us NICE had published four sets of clinical guidelines covering myocardial infarction, fetal monitoring, induction of labour, and pressure ulcers. These guidelines were commissioned by the Department of Health from academic and professional bodies prior to NICE's formation, and were quality-assured by NICE.

157. To date, NICE has been involved in overseeing nine national clinical audit projects and has commissioned a further seven, and is managing four Confidential Enquiries. This function is currently planned to be transferred to the Commission for Health Improvement.

158. In addition to these functions, in April 2002 NICE assumed responsibility for the Safety and Efficacy Register of New Interventional Procedures (SERNIP), a programme which, under NICE, will assess the safety and efficacy of selected new interventional procedures. This was previously managed as a pilot project by the Academy of Medical Royal Colleges.

Structure[196]

159. NICE's Chair and Board of seven non-executive Directors are appointed by the Secretary of State for Health and the National Assembly for Wales. They are supported by four executive members (chief executive, planning and resources director, clinical director and director of communications) who are appointed by NICE subject to the approval of the Secretary of State and the National Assembly for Wales. Board meetings are held in public, at venues throughout England and Wales. NICE relies on a central staff of approximately 40 individuals based in its London office, supplemented by a network of professional relationships with health service, academic and other professional organisations.

160. Reporting to the Board are three advisory Committees - the Appraisals Committee, the Guidelines Advisory Committee and the newly created Interventional Procedures Committee. The size of these Committees ranges from 21 to 43, and their membership is drawn largely from health professionals, NHS managers, patient representatives and academics. These Committees make recommendations to the Board in each of their respective areas.

161. The Partners' Council, chaired by NICE's Chairman, is a body which meets approximately three times a year to advise NICE on a range of issues and provides a forum for exchange of ideas and the formulation of strategy. It currently has 39 members drawn from patient organisations, the NHS, organizations concerned with assuring quality, the healthcare industry, health professionals, and unions. NICE has also recently announced the establishment of a Citizens' Council, which will provide advice to the Institute on topics relating to social, ethical or moral questions arising from NICE's work. The Council will have up to independent 30 members. Although the Partners' Council is a statutory part of NICE, it has an advisory function rather than forming part of the formal governance arrangements for signing off NICE's work.

162. In addition, NICE has created multi-disciplinary National Collaborating Centres (NCCs) to develop clinical guidelines and clinical audit in six broad areas: acute care, chronic disease, nursing and supportive care, mental health, primary care and women's and children's health. The NCCs are based in the Royal Colleges and supported by two cross-cutting units based at academic centres: the National Guidelines and Audit Patient Involvement Unit, based at the College of Health, gives advice on patient and carer involvement and provides support and training to patients and carers who are involved in guideline development groups, and the National Guidelines Support and Research Unit, based at the University of Newcastle, provides advice on methodological issues, and training and education support.

How NICE works[197]

163. Topics are selected for technology appraisals and clinical guidelines by Ministers and the Welsh Assembly.[198] Topic selection is a three-stage process, of which the first stage is the identification of a pool of potential topics NICE might consider. According to the Department of Health, the 'pool' of topics for technology appraisals is influenced by: new technologies identified by the National Horizon Scanning Centre, a unit of the University of Birmingham, which is funded by the NHS R&D programme; topics suggested by professional and patient groups and by the wider NHS; proposals from the National Clinical Directors and other Department of Health (DH) or National Assembly for Wales (NAW) policy branches; and completed research carried out under the auspices of the National Health Technology Assessment programme. Topics for clinical guidelines are informed largely by the needs of the National Service Frameworks.

164. Suggestions for technology appraisals are considered by the Technologies Advisory Group. The membership of this group is not published, but is "mainly staffed by officials in the Department of Health and National Assembly for Wales", with representatives from NICE.[199] Topics for clinical guidelines are considered by the Clinical Priorities Group.

165. The topic lists proposed by the Technologies Advisory Group and the Clinical Priorities Group are then put forward to the Joint Planning Group, a smaller group jointly chaired by the Chair of NICE and by a senior Department of Health official, which considers logistical and capacity issues for NICE's work programme, and 'signs off' a final recommendation to the Minister and National Assembly for Wales.

The technology appraisals process

166. Once a technology is referred to NICE, staff begin the appraisal process by identifying formal consultees. These will include the Department of Health and National Assembly for Wales, the manufacturers or sponsors of the technology, relevant national, professional organisations, and national patient organisations. Consultees will also include the Health Technology Board for Scotland and two health authorities, although these organisations do not have a right of appeal.

167. NICE then conducts a literature search and prepares a draft scope, aiming to identify all the relevant questions and issues the appraisal should address. Prior to publication, a draft version of this is sent to all consultees for comment.

168. On behalf of NICE, the NHS Co-ordinating Centre for Health Technology Assessment (NCCHTA), which is run by the NHS Research and Development Programme, commissions an assessment report based on the final scope, usually from one of a number of academic centres known as Health Technology Assessment Units, which are part of the NHS R&D programme. Once completed, this is sent to all consultees who are given ten working days to comment on it. In tandem with this, all consultees have 16 weeks in which to make submissions to NICE setting out their views on and experiences of the technology under appraisal. NICE staff then compile the evidence, including the assessment report and consultee submissions, into what is known as the 'evaluation report', which is submitted for consideration by the Appraisal Committee.

169. Four patient representatives and two clinical experts, nominated by the formal consultees and selected by the Chairman of the Appraisal Committee, are invited to attend a Committee meeting at which they are 'given the opportunity to make observations about the technology and its use in the NHS'. This is usually followed by questions from the Committee, and if the patient representatives and clinical experts wish they may support their oral contribution with a 'written perspective' on the technology under appraisal. The Appraisal Committee then discusses the evaluation report and the drafting of the Appraisal Consultation Document (ACD) in private.

170. The ACD is then sent together with the assessment report to all consultees for a four week consultation period. Following this period, the Appraisal Committee meets a second time to consider the original evidence and the ACD in the light of any comments made by consultees, and to agree the Final Appraisal Determination (FAD).

171. Following the circulation of the FAD, all consultees except the Health Technology Board for Scotland and the NHS health authorities have a 15 day period in which to lodge an appeal. Appeals may only be made on one or more of the following grounds:

• The Institute has failed to act fairly and in accordance with its published procedures
• The Final Appraisal Determination is perverse in the light of the evidence submitted
• The Institute has exceeded its powers.

172. The decision about whether or not an appeal should be heard is taken by the Chair of NICE. An Appeal Panel constituted of five members is then appointed from NICE's Appeals Committee, all of whom will have had no involvement in the appraisal. The Panel is chaired either by the Chair of NICE or another member of the NICE board.

173. Following the appeal period, guidance on the use of the technology is then issued to the NHS.

The Clinical Guidelines development process

174. When a topic is selected, NICE publicises this and asks potential stakeholders to register their interest via the NICE website. Those that register will be consulted during the guidelines development process.[200] NICE's National Guidelines and Audit Patient Involvement Unit supports the involvement of patients and carers who register.

175. Scoping is then carried out by the relevant National Collaborating Centre (NCC), who propose the patient groups that will be considered, the healthcare setting, the range of treatments to be assessed and how the Centre will assess the clinical and cost effectiveness. The scoping assessment is then circulated for comment to stakeholders and to the

Guidelines Advisory Committee Panel. The NCC then submits a workplan for developing the guideline which, together with the final scope and timetable, is posted on the website.

176. The development of the guideline is the responsibility of the relevant NCC. The NCC will establish a Guideline Development Group which carries out the developmental work, identifying and assessing different types of evidence, and then formulating recommendations for practice on the basis of its evaluation of the evidence.

177. Once the Guideline Development Group has made its recommendations, the National Collaborating Centre prepares draft versions of the full guideline, short form guideline and patient information leaflet. There are two rounds of formal consultation with documents sent for comment to the Guidelines Advisory Committee and to stakeholders. Redrafted versions are posted on NICE's website during the second period of consultation. The final set of documents is signed off by the Guideline Development Group, the Guideline Advisory Committee and finally by NICE itself. There is no procedure for appealing against the recommendations of a Clinical Guideline.

NICE and the wider quality agenda

178. NICE does not operate in isolation, but forms one part of the Government's wider 'quality' agenda. Set out in A First Class Service, this also included the establishment of national clinical standards through National Service Frameworks. The delivery of these standards is effected through the clinical governance programme, and their monitoring is carried out by the Commission for Health Improvement. National Service Frameworks (NSFs) provide a wider framework of standards for service delivery in key clinical areas, sometimes including maximum waiting times, and have so far been issued in the areas of mental health, coronary heart disease, services for older people, and diabetes. NSFs are currently being developed for children's services, renal services and long term conditions.

179. The Commission for Health Improvement was established in April 2000, and has embarked on a programme of reviews of clinical governance in NHS Trusts and Health Authorities, with the aim of having reviewed all NHS organisations by 2004. CHI reviews currently examine the arrangements NHS organisations have in place for implementation and monitoring of NICE guidance, although they do not conduct detailed audit of their implementation.

193   National Institute for Clinical Excellence, Framework Document. Back

194   Q427. Back

195   Ev 128. Back

196   See Figure 1. Back

197   See Figure 2. Back

198   Ev 122. Back

199   Q543. Back

200   Stakeholders will include the Department of Health and National Assembly for Wales, relevant national professional organisations, national patient organisations and manufacturers of medicines and devices used in the clinical area covered by the guideline. Stakeholders also include a number of primary care organisations and trusts who are invited to act as 'NHS stakeholders'.  Back