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

A public authority which undertakes consultation must provide enough information to enable consultees to give an intelligent response. What fairness requires depends on the importance, context and practical circumstances of the decision.

Where an economic model is central to a healthcare cost-effectiveness appraisal, fairness may require disclosure of its fully executable version. Consultees must have a meaningful opportunity to test the model’s reliability, including through sensitivity analysis. Extensive disclosure of other material does not cure a restriction which prevents informed representations on a central component of the decision-making process. Confidentiality, administrative cost and delay are relevant but are unlikely to justify withholding material where disclosure is otherwise required for fairness.

NICE appraised drugs used to treat Alzheimer’s disease and issued guidance restricting their recommended use to patients with moderately severe disease. Its cost-effectiveness assessment depended on an Excel economic model. NICE supplied consultees with a read-only version but refused Eisai, the manufacturer of one affected drug, access to the fully executable version needed to alter inputs and undertake sensitivity analyses.

Eisai sought judicial review. Dobbs J, in [2007] EWHC 1941 (Admin), rejected this procedural-fairness ground, although Eisai succeeded on an unrelated ground. Eisai appealed only against the fairness ruling. NICE brought a limited cross-appeal concerning costs.

The central issue was whether withholding the executable model prevented consultees from making an intelligent response on a component central to NICE’s appraisal.

1. Appeal allowed, with the precise relief deferred. Richards LJ, with whom Jacob and Tuckey LJJ agreed, held that procedural fairness required NICE to release the fully executable economic model. Its non-disclosure placed consultees at a significant disadvantage in challenging the model’s reliability and unlawfully limited their ability to make an intelligent response.

2. A consultation, whether legally required or undertaken voluntarily, must be conducted properly. The authority must give sufficient reasons and information for intelligent consideration and response, allow adequate time, and conscientiously consider the consultation’s product. The content of fairness is contextual and should not be determined mechanistically. The significance of undisclosed material is highly material but does not automatically require disclosure.

3. The model was central to NICE’s calculation of cost-effectiveness and cost per quality-adjusted life year. Although the read-only version permitted some analysis and manual checking, it did not permit sensitivity analyses. Consultees could therefore comment on known assumptions but could not identify variables to which the model was particularly sensitive or make fully informed representations about its robustness. NICE’s own responsibility for quality assurance did not remove the consultees’ legitimate role in testing reliability.

4. Confidentiality carried no material weight. The research contract imposed no obligation preventing the requested disclosure, and NICE already released a read-only version containing, on its own case, the same information. Appropriate confidentiality undertakings could protect the executable version. Even a prima facie duty of confidence would yield to a public-interest defence if disclosure were required by procedural fairness.

5. Additional work, cost and a possible delay of two or three months were relevant but insufficient. NICE could impose reasonable conditions governing the form, scale and timing of representations. A court should be slow to permit administrative considerations to prevent disclosure which fairness otherwise requires.

6. Eisai’s application was not defeated by delay under section 31(6)(b) of the Supreme Court Act 1981. An earlier challenge might have been premature because the appraisal’s outcome remained uncertain and an internal appeal on procedural fairness was available. The parties were invited to consider an agreed process for disclosure, representations and a fresh determination. NICE’s costs cross-appeal consequently required no determination at that stage.

1. Court of Appeal (Civil Division): In [2008] EWCA Civ 438, the court unanimously allowed Eisai’s appeal on procedural fairness, subject to determination of the precise relief. NICE’s limited costs cross-appeal was not determined.
2. High Court, Administrative Court: Dobbs J, in [2007] EWHC 1941 (Admin), rejected Eisai’s procedural-unfairness and irrationality grounds, although Eisai succeeded partly on a separate ground concerning anti-discrimination legislation.
3. NICE Appeal Panel: The panel rejected the consultees’ appeals against the final appraisal determination. It found that the read-only model allowed sufficient understanding and meaningful engagement.