metadata toggle
R (Eisai Ltd) v NICE
[2007] EWHC 1941 (Admin), (2007) 10 CCLR 368
 
5.44R (Eisai Ltd) v NICE [2007] EWHC 1941 (Admin), (2007) 10 CCLR 368
Since decision-makers had not been advised about their statutory duties, and their consideration of the issues did not disclose an awareness of or consideration of such duties, their formulation of policy and decision-making were unlawful
Facts: NICE granted only limited approval for the use of a drug manufactured by Eisai. Eisai succeeded at first instance in establishing that NICE had failed to comply with anti-discrimination legislation, but not that its consultation process had been unfair (although the Court of Appeal later allowed Eisai’s appeal on that issue).
Judgment: Dobbs J held, on the discrimination issue, that NICE had failed to have due regard to the likely effect of its decision on minority groups, in breach of its duties under the Race Relations Act 1976 and the Disability Discrimination Act 1995:
94. Junior Counsel for NICE was listed as a member of the panel, presumably in the role of independent legal advisor. [7b/33a/178]. It is the more surprising therefore, that there was no discussion or advice given during the hearing about relevant anti-discrimination legislation or even human rights legislation, given that the issue of discrimination had been raised. There is no reference whatever within the body of the decision to any of the duties and obligations of the authority with regard to discrimination. It appears that no consideration was given as to how these duties might impact on the Guidance. Instead of looking at how NICE as a public body could itself promote equal opportunity, having accepted that the Guidance could have a discriminatory effect if applied slavishly, the approach taken was to leave it to others to sort out in the hope and expectation that they would. (Para 4.7). That, in my judgement, is not good enough, particularly given the lack of substance in the justification advanced by Professor Stevens and taking into account the ramifications of the Guidance.
95. The issue of the atypical groups is dealt with in an unsatisfactory way in the Guidance. This creates confusion and the potential for discrimination. In Paragraph 4.3.13 (Para 80) there is reference to the interpretation of the MMSE scores being difficult for the atypical groups. However, this is said not to disadvantage them at entry level. There is then specific reference as to what should happen to those with learning disabilities. The position of those with marked language problems, who the Guidance had previously identified as being ‘different’, is left up in the air. The reference to the discontinuation level does not clarify for the clinician the position with respect to those with marked language difficulties who fall outside the ‘normal’ parameters. [CB/6/167]. There is potential for further confusion with regard to those with learning disabilities. While it is said that learning disability specialists should be responsible for the initiation of treatment, it does not indicate clearly whether such specialists are to use MMSE tests as a guide, or are free to make assessments with no reference to MMSE tests at all or whether only a diagnosis by the specialist of ‘moderate’ AD will attract mandatory funding. Contrast with this the assistance given in the quoted passage from the Guidelines cited in paragraph 81. Given that the 2006 Guidance, in contrast with the 2001 Guidance, excluded those with mild AD from its recommendation, it is particularly important that the Guidance is clear and free from ambiguity.
96. Following the reasoning above, I take the view that the approach of the Appeal Panel was flawed, in that no proper consideration was given to NICE’s duties as a public authority to promote equal opportunities and to have due regard to the need to eliminate discrimination. It was unreasonable and unlawful to overlook that responsibility. A similar view is taken of the Guidance, particularly as there is no evidence that before issuing the Guidance the ‘due diligence’ duties were considered or complied with or that any thought was given to present or imminent obligations under anti-discrimination law. (See 2007 Action Plan [9/44/154]) Despite the publication of the Action Plan in January 2007 and the invitation of the Alzheimer’s Society to NICE in a letter dated 4 January 2007 to consider amendment of the Guidance in the light of its discriminatory impact, nothing was done [15/1/7]. In my judgment the Guidance has failed to avoid discrimination against the relevant groups.
R (Eisai Ltd) v NICE
Previous Next