Eisai Limited v National Institute for Health and Clinical Excellence (NICE) [2007] EWHC 1941 (Admin)

This case is of interest to Local Authorities and other public bodies because it assists in the clarification of duties of public authorities under anti-discrimination legislation, specifically the Race Relations Act 1976 and the Disability Discrimination Act 1995.

The Facts

Eisai Limited manufactures a drug called Donepezil (sold as Aricept), an inhibitor drug, used for the treatment of the early stages of Alzheimer’s Disease. Eisai Limited and two interested parties, the Alzheimer’s Society and Shire Pharmaceuticals Limited, brought judicial review proceedings against a decision by the Appeal Panel of NICE not to recommend the use of Aricept for patients in the mild to moderate phases of the disease, which was based on Guidance published in 2006.

The Decision

Whilst the Court rejected the submissions of procedural unfairness and irrationality, it upheld the appeal on the grounds that NICE had acted unlawfully because its Guidance fell foul of anti-discrimination legislation.

Eisai argued that the Guidance was rigid, ambiguous and discriminatory in relation to certain atypical patient groups, specifically those with language difficulties or learning problems, those patients whose first language was not English and those with high IQs. It was submitted that the Guidance breached the Race Relations Act 1976 (RRA) and the Disability Discrimination Act 1995 (DDA). The Alzheimer’s Society relied on the specific obligations placed on public authorities under section 19B of the RRA and sections 21B and D of the DDA (which it make it unlawful for a public authority to discriminate in carrying out its public functions) as well as the section 71 of the RRA and sections 21E and 49A of the DDA (which impose a duty on public authorities to have due regard to the need to eliminate unlawful discrimination and to promote equality of opportunity).

The Court found that NICE’s Appeal Panel had failed to have regard to the legal duties and obligations placed on a public authority, even though as a public body it was required to ensure that its duties were discharged and its Guidance complied with NICE’s obligations under anti-discrimination legislation. Specifically, the Panel had never tested the reason put forward for not including those with language difficulties or those with English as a second language as exceptions. The Court was critical of NICE because ‘[i]nstead 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 the other to sort out in the hope and expectation that they would.’ (para. 94 of the judgment). The Court concluded that the approach of the Appeal Panel was flawed. It was unreasonable and unlawful to have overlooked NICE’s responsibility as a public authority to promote equal opportunities and have due regard to the need to eliminate discrimination. The same was true of the Guidance because there was ‘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.’ (para. 96 of the judgment). The Guidance, therefore, had failed to avoid discrimination against the relevant groups. The Court ordered the Guidance to be reviewed.

Discussion

This case provides a salutary reminder to Local Authorities (and other public bodies) that they must ensure compliance with anti-discrimination legislation in publishing guidance and similar documents, and must always be mindful of the particular obligations placed on public authorities under that legislation. Public authorities must apply careful consideration to their specific obligations under anti-discrimination legislation and consider potential discriminatory effects in extreme and unusual circumstances.