EU & Competition news

Hearing Date: 1 May 2008

Court: Court of Appeal, Civil Division

The respondent (NICE) was responsible for appraising the clinical benefits and cost effectiveness of health care interventions notified to it by the Secretary of State for Health and for making recommendations as to their use in the National Health Service. This case was predominantly concerned with were certain drugs for the treatment of Alzheimer's disease (AD), known as acetylcholinesterase inhibitors, which had previously been recommended for use in the treatment of NHS patients with mild to moderately severe AD. In 2006, however, NICE issued fresh guidance recommending the use of these medicines only for patients with moderately severe AD (as determined on a basis laid down in the guidance). The applicant was a pharmaceutical company holding the United Kingdom marketing authorisation for one of the drugs concerned, which was marketed under the name Aricept. The applicant originally brought judicial review proceedings challenging the fresh guidance on a number of grounds, including procedural unfairness. In its consultation process NICE made available to consultees, including the applicant, a read-only version of an economic model, in the form of an Excel spreadsheet, which was used to assess the cost-effectiveness of the drugs. The applicantrequested, but was refused, a fully executable version of the model. The applicant's case was that the non-provision of a fully executable version rendered the consultation process unfair and that the decision to issue the guidance was in consequence unlawful. The judicial review application was dismissed (save on another, unrelated, ground). The applicant appealed.

The applicant contended that the failure to provide the fully executable version (and to do so on a basis that would allow it to be re-run with alternative assumptions and inputs) was unfair. It meant that the applicant was unable to test the reliability of the model by running sensitivity analyses and by tracking the formulae so as to check their accuracy. This prevented it from making informed representations on a central element in the appraisal process. NICE submitted, inter alia, that (i) there had already been sufficient disclosure, including provision of the read-only version of the model on request, to meet the requirements of procedural fairness; (ii) the model was provided to it on terms as to confidentiality which precluded the disclosure of the fully executable version; and (iii) disclosure of the fully executable version and the additional representations that that would generate would be liable to create a great deal of extra work and delay. This in itself would slow down the appraisal process by two to three months, and that that would not be justified by the marginal gain to the consultees of having the fully executable version rather than just the read-only version. It was not in dispute that NICE was subject to the general principles of procedural fairness in relation to the appraisal process and, in particular, that it had to act fairly in the consultation exercise.

The appeal would be allowed.

The court held that procedural fairness required release of the fully executable version of the model.

It was true that there was already a remarkable degree of disclosure and of transparency in the consultation process; but that cut both ways, because it also served to underline the nature and importance of the exercise being carried out. The refusal to release the fully executable version of the model stood out as the one exception to the principle of openness and transparency that NICE had acknowledged as appropriate in the current context. It placed consultees (or at least a sub-set of them, since it was mainly the pharmaceutical companies which were likely to be affected by that in practice) at a significant disadvantage in challenging the reliability of the model. In that respect it limited their ability to make an intelligent response on something that was central to the appraisal process. The reasons put forward for refusal to release the fully executable version were in part unsound and were in any event of insufficient weight to justify the defendant's position.

R v North and East Devon Health Authority, ex parte Coughlan (Secretary of State for Health and another intervening) [1999] All ER (D) 801 applied.

Decision of Dobbs J [2007] All ER (D) 67 (Aug) reversed.

This material first published by the LexisNexis Butterworths. All rights reserved.