West Law Report

Fairness requires fuller disclosure of model to drug companies

Posted in drug companies, procedural fairness, Times Law Report by mrkooenglish on May 14, 2008

From The TimesMay 7, 2008

Fairness requires fuller disclosure of model
Regina (Eisai Ltd) v National Institute for Health and Clinical Excellence in the Court of Appeal
Court of Appeal

Published May 7 2008

Regina (Eisai Ltd) v National Institute for Health and Clinical Excellence

Before Lord Justice Tuckey, Lord Justice Jacob and Lord Justice Richards

Judgment May 1, 2008

Procedural fairness required the National Institute for Health and Clinical Excellence to release a fully executable version of an economic model to those consulted in the course of an appraisal process and not simply a read-only version. To do otherwise would place drug companies at a significant disadvantage in challenging the reliability of those models.

The Court of Appeal so held in a reserved judgment, allowing an appeal by Eisai Ltd against Mrs Justice Dobbs ([2007] EWHC 1941 (Admin)) who, inter alia, refused its application for judicial review of guidance issued by the National Institute for Health and Clinical Excellence (NICE).

The guidance, issued in 2006, recommended the use of Aricept for NHS patients only with a moderately severe form of Alzhemier’s disease, rather than for those with a mild to moderately severe form for whose use the drugs had previously been recommended.

In its consultation process for the purpose of appraising the clinical benefits and cost-effectiveness of Aricept, NICE made available a read-only version of an economic model, in the form of an Excel spreadsheet, which was used to assess the drug’s cost-effectiveness.

Eisai requested, but was refused, a fully executable version of the model. Eisai’s case was that the nonprovision of that version rendered the consultation process unfair and the decision to issue the guidance unlawful.

Mr David Pannick, QC and Mr Tom de la Mare for Eisai; Mr Nigel Giffin, QC and Mr Daniel Stilitz for NICE; Mr Brian Kennelly for Shire Pharmaceuticals Ltd, as first intervener; Mr Ivan Hare by written submissions for the Association of the British Pharmaceutical Industry, as second intervener.

LORD JUSTICE RICHARDS said that there had been exceptions to NICE’s policy of not releasing the fully executable versions of economic models but that no such exception had been made on this occasion.

NICE’s stance was that there had already been sufficient disclosure and they were not able to go further because of confidentiality, and the delay to the appraisal process that would be caused by releasing the fully executable version of the model.

It was not in dispute that NICE was subject to general principles of procedural fairness in relation to the appraisal process and, in particular, that it had to act fairly in the consultation exercise. Whether or not consultation was a legal exercise, once embarked upon it had to be carried out fairly: R v North East Devon Health Authority, Ex parte Coughlan ([2001] 1 QB 213).

The mere fact that information was significant did not mean that fairness necessarily required its disclosure to those consulted. It was better not to follow the approach of Mrs Justice Dobbs of asking whether Eisai was denied access to significant information. Nevertheless, the degree of significance of the undisclosed material was a highly material factor.

The authorities established that what fairness required depended on the context and the particular circumstances. It was not possible to extract from them a principle that fairness required disclosure of advice obtained from an outside adviser.

There was no express or implied duty of confidentiality restricting the use or disclosure of the model. It would be very surprising if a model commissioned and paid for by the Secretary of State for Health for the purpose of NICE’s appraisal process were subject to obligations of confidentiality preventing disclosure of the fully executable version to those consulted.

The concern raised by NICE as to the adverse practical consequences caused by the provision of the fully executable version of the model was a serious one to which weight should be given.

However, the additional time that would be added to the appraisal process had to be viewed in the context of an already lengthy process. Neither the additional time nor the additional cost to NICE should weigh heavily in the balance in deciding whether fairness required release of the fully executable version.

If fairness otherwise required it, the court should be very slow to allow administrative decisions of that kind to stand in the way of its release.

Notwithstanding NICE’s position to the contrary, procedural fairness required release of the fully executable version of the model. Those consulted would, otherwise, be placed at a significant disadvantage in challenging its reliability.

The appeal would be allowed subject to submissions on the appropriate form of relief.

Lord Justice Jacob and Lord Justice Tuckey agreed.

Solicitors: Arnold & Porter LLP; Beachcroft LLP; Ashurst LLP; Legal Director, ABPI.