Review of NICE

The establishment of NICE was generally approved since NICE had all the prospects of being an important and valuable agent for change in the NHS (Horton, 1999: 1029).

Until that time the incapacity, at national level, for appraising healthcare interventions, either prior to or following extensive circulation, was creating a number of problems. These

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included a lack of regulation rules for newly imported drugs, dissimilarity in local policies and routine use of non-proven interventions (Dent and Sadler, 2002: 842).

Nevertheless, the introduction of NICE was subject to criticism. Horton (1999:1028) characterised NICE as one of the most important developments in securing the quality of the NHS, since the launch of the Research and Development Strategy in April 1991. However, Horton also said that most of the major steps in NHS progress were not the result of wise planning and noted the coincidence that NICE had started its work after the Kennedy1_enquiry. In addition, it was said that an important step for NICE would have been gaining the early confidence of the health professions as well as the public and Parliament (Rawlins, 1999 quoted in Warden, 1999:416).

On the one hand, there was optimism about what NICE would do, and on the other there were concerns regarding who NICE would work with (Smith 2000; Freemantle 2002; 2004; Maynard and Sheldon, 2002; Kmietovicz 2000; Burke, 2002).

The first appraisal on Relenza treatment for flu was negative and it fired the debate on NICE. The most severe critique, however, seemed to have begun during the beta interferon appraisal. There were discussions on the role of NICE (Dillon, 1999, Horton, 1999, Rawlins, 1999) but before any critique, it was necessary to see the Institute in operation and give it some time. Moreover, the publicity and questioning of NICE had climaxed during the appraisal of interferon for MS as will be discussed in later in this chapter and in Chapter 3. During this appraisal period, most criticism of NICE was coming from patients, organisations lobbying for the pharmaceutical industry and the media.

1_{An enquiry related to the Bristol scandal. A report published in 2001 of the public inquiry into children's heart}

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“The Institute‟s rejection of a second appeal on beta interferon and glatiramer signalled an end to a process which began in August 1999 and attracted an unparalleled amount of criticism of NICE” (http://www.pharmafile.com/pharmafocus /news/story, 2002).

The criticism was focusing mostly on those concerns brought up by the introduction of NICE and concerned, amongst others, the introduction of a new form of rationing, the transparency of the appraisal process, consequences for the pharmaceutical industry investments worldwide, implications for the national economy and NICE‟s political independence. Parallel to the critique were suggestions on how NICE should be restructured (Freemantle 2002, 2004; Maynard and Sheldon, 2002).

2.10.1 The critique of NICE at the appraisal of beta interferon

The beta-interferon appraisal lasted for more than 2 years and during that time, NICE and the appraisal process were exposed to enormous publicity. Furthermore, it could be argued that the media attacked NICE in a very surprising manner. People have often used very negative language about NICE. It was surprising to hear network members such as pharmaceutical industry representatives or patient organisations‟ representatives, expressing their opinions so forcefully i.e. threatening to hold the government responsible for financial consequences and losses(Smith, 2000, ABPI, 1/2002). But this element of actors having bad reactions when their interests are threatened highlights the discussion on the important role of the actors in policy analysis and on the way actors are acting or/and reacting as discussed by researchers such as Walt and Gilson (1994) and Giddens (1984).

Many questions surfaced (Rawlins, 1999; Birch and Gafni, 2003; Maynard, Bloor and Freemantle, 2004; Pearson and Rawlins, 2005) regarding the autonomy of NICE, as an Institute working on clinical excellence and what the role of the state should be. If there are

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key-players who are holding most of the resources or reasons for performing technology appraisals, why should the appraisals be completed in that way, or be completed in the first place? NICE was said to rely heavily on unpaid input in the form of non-executive directors and members of its appraisal committee. It was considered to be a large organisation relying on a small office and a large network, centred on electronic communication, and contracting out specific tasks (Raftery, 2001: 1302). Beyond the bad publicity about NICE, there were other pressures for a review of NICE from the pharmaceutical industry and, more particularly, the Association of the British Pharmaceutical Industry (ABPI) as well as patient organisations.

A formal governmental review of NICE took place in 2001, an investigation on NICE by the House of Commons (parliamentary enquiry on NICE) in 2002 and a review of NICE by the World Health Organisation in 2003. Reviews raised concerns but also made suggestions regarding the operation of the Institute.

The review made by World Health Organisation (WHO) (Hill, et al., 2003) stressed the important role of NICE and of the AC in the operation of the technology appraisal process and made a few key recommendations. Among these were the increase of data available because there was limited access to data due to confidentiality issues, so more information available was needed; the exchange of information and interaction between some of the participants; the reduction of unnecessary duplication of effort in the assessment phase; the collection of data from all relevant stakeholders and, most importantly, the including of pharmaceutical industry‟s membership in the Appraisal Committee.

The recommendations made by the WHO report were also addressed to organisations similar to NICE in other countries “so as to deal with their difficulties and meet their expectations” (Hill et al., 2003:4).

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Nevertheless NICE had also marked an innovation internationally. Other countries had similar bodies providing advice on the use of new technologies but NICE was the first national body issuing guidance covering all aspects of the health service and not only just new treatments or new technologies. Guidance from NICE applied to the NHS in the same way as guidance from other parts of the DoH; health authorities were required to take into account the guidance but not necessarily to follow it while general practitioners had greater discretion (Raftery, 2001:1300).