Eisai Ltd, R (on the application of) v National Institute for Health and Clinical Excellence (NICE) [2008] EWCA Civ 438 (01 May 2008)

Eisai Ltd, R (on the application of) v National Institute for Health and Clinical Excellence (NICE) [2008] EWCA Civ 438 (01 May 2008)

NICE's refusal to provide the fully executable version of the economic model used in its appraisal process was procedurally unfair because it prevented consultees from adequately testing the reliability of a central element in the decision-making process, particularly regarding sensitivity analyses, and thus deprived them of the opportunity to make fully informed representations.

Citation
[2008] EWCA Civ 438
Parties
Claimant/appellant: Eisai Limited; Defendant/respondent: National Institute for Health and Clinical Excellence; Intervener: Shire Pharmaceuticals Limited; Intervener: Association of the British Pharmaceutical Industry
Jurisdiction
England and Wales
Judgment Date
01 May 2008
Procedural Posture
Judicial Review Appeal / Court of Appeal (civil Division)
Outcome
Appeal allowed
Legal Topics
Procedural Fairness, Consultation Requirements, Disclosure of Information, Judicial Review, Healthcare Regulation
Administrative Law Health Law Public Law Procedural Fairness Consultation Requirements Disclosure of Information Judicial Review Healthcare Regulation

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Parties

Eisai Limited

Claimant/appellant

National Institute for Health and Clinical Excellence

Defendant/respondent

Shire Pharmaceuticals Limited

Intervener

Association of the British Pharmaceutical Industry

Intervener

Procedural Posture

Judicial Review Appeal / Court of Appeal (civil Division)

Legal Issues

  1. 1 Whether NICE's refusal to disclose a fully executable version of its economic model to consultees during the appraisal of Alzheimer's drugs constituted procedural unfairness.

Ratio Decidendi

NICE's refusal to provide the fully executable version of the economic model used in its appraisal process was procedurally unfair because it prevented consultees from adequately testing the reliability of a central element in the decision-making process, particularly regarding sensitivity analyses, and thus deprived them of the opportunity to make fully informed representations.

Court Disposition

Appeal allowed

Orders

  • NICE must disclose the fully executable version of the economic model to Eisai and allow representations before making a fresh decision.