Eisai Ltd, R (on the application of) v National Institute for Health and Clinical Excellence (NICE)

Eisai Ltd, R (on the application of) v National Institute for Health and Clinical Excellence (NICE)

Procedural fairness required NICE to disclose the fully executable version of its economic model to consultees. The model was central to the appraisal process, and consultees were significantly disadvantaged in challenging its reliability without the ability to run sensitivity analyses and check formulae. The reasons advanced by NICE for non-disclosure (confidentiality, delay, and additional work) were insufficient to outweigh the requirement of fairness in this context.

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 (administrative Law) / Appeal From High Court to Court of Appeal
Outcome
Appeal allowed
Legal Topics
Procedural Fairness, Consultation Requirements, Disclosure of Information, Confidentiality, Public Decision Making
Administrative Law Health Law Judicial Review Procedural Fairness Consultation Requirements Disclosure of Information Confidentiality Public Decision Making

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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 (administrative Law) / Appeal From High Court to Court of Appeal

Legal Issues

  1. 1 Whether procedural fairness required NICE to disclose the fully executable version of its economic model to consultees during the appraisal process for Alzheimer’s drugs.

Ratio Decidendi

Procedural fairness required NICE to disclose the fully executable version of its economic model to consultees. The model was central to the appraisal process, and consultees were significantly disadvantaged in challenging its reliability without the ability to run sensitivity analyses and check formulae. The reasons advanced by NICE for non-disclosure (confidentiality, delay, and additional work) were insufficient to outweigh the requirement of fairness in this context.

Court Disposition

Appeal allowed

Orders

  • Eisai’s appeal is allowed;
  • The issue of relief is deferred to allow parties to agree on the appropriate form of relief, with the expectation that NICE will provide the fully executable model to Eisai and allow further representations;