Eisai Ltd. v The National Institute for Health and Clinical Excellence (Nice)

In a structured consultation, fairness requires sufficient information to enable an affected participant to give an intelligent response. It does not ordinarily require disclosure of every document seen by the decision-maker or provide a right to audit an expert model. A public authority issuing guidance must itself address its duties under anti-discrimination legislation. It cannot leave the elimination of discriminatory effects entirely to clinicians or downstream bodies. Guidance must state clearly how general criteria interact with clinical judgment and atypical cases, particularly where funding consequences follow. An appellate or review panel exercising a restricted jurisdiction must not substitute its judgment for that of an expert committee, but must ask whether the committee acted fairly, considered the relevant matters and reached a conclusion open to it on the evidence.

Eisai challenged NICE’s Appeal Panel decisions and the consequential guidance on the use and funding of acetylcholinesterase inhibitors for Alzheimer’s disease. The challenges alleged procedural unfairness in refusing access to a fully executable economic model, unlawful rigidity and discriminatory effects arising from reliance on MMSE scores, and irrationality in aspects of the economic appraisal.

Interested parties supported the challenge. NICE defended the Appeal Panel’s conclusions and relied on the guidance’s context statement, clinical judgment and related dementia guidelines. The central issues were whether the consultation was fair, whether NICE had discharged its public-law equality duties, whether the guidance was sufficiently clear, and whether the Appeal Panel’s conclusions were irrational.

1. Disposition. Grounds one, three, four, five and six failed. Ground two succeeded. NICE was directed to amend the guidance to ensure compliance with its duties and obligations under anti-discrimination legislation, with the extent and method of amendment to be determined after further submissions.
2. Procedural fairness. The appraisal was a highly structured consultation and was subject to fairness, but Eisai was not a litigant facing a case to meet and had no right to quality-assure NICE’s economic model. Applying R v North and East Devon HA ex p Coughlan [2001] QB 213, fairness required enough information for an intelligent and helpful response, not disclosure of every document before NICE. Eisai received the model’s assumptions, analysis and results, and made detailed criticisms and alternative proposals. Refusal of the fully executable model was therefore not unfair. Confidentiality and intellectual-property considerations provided additional support for NICE’s approach.
3. Discrimination and clarity. The Appeal Panel failed to consider NICE’s own statutory duties to promote equality and have due regard to eliminating discrimination. It accepted that rigid use of MMSE scores could disadvantage atypical groups, but wrongly left the risk to practitioners’ common sense. The guidance was ambiguous about the treatment and funding position of patients with language difficulties, learning disabilities and other atypical presentations. The related guidelines could not cure the defect because they served a different purpose and did not impose the same funding obligations.
4. Rationality. The Appeal Panel’s jurisdiction was restricted. It was not to reopen the appraisal or choose between competing experts, but to decide whether the committee’s conclusion was obviously and unarguably wrong, irrational or unsupported by logic. The court upheld the Panel on cumulative benefit, the AD2000 study, carer benefits and care costs. The committee had explained its approach, acknowledged evidential limitations and adopted conclusions within the range of reasonable expert judgment.

The judgment concerns judicial review of decisions of NICE’s Appeal Panel dated 6 October 2006 and the consequent guidance issued on 22 November 2006. The Appeal Panel had rejected the appeals against the Final Appraisal Determination. This court upheld the Panel on most grounds but found the approach to discriminatory effects and equality duties unlawful.