Servier Laboratories Ltd, R (on the application of) v National Institute for Health and Clinical Excellence & Anor

Article 4(3) of the Directive preserves Member States’ powers over medicinal-product pricing and inclusion in national health-insurance schemes where decisions are based on health, economic and social conditions. Those matters fall outside the Directive’s scope. Decisions of EMEA therefore have no legal relevance to NICE’s exercise of those functions. Permission to appeal on a proposed European Union law ground may be refused where the ground is not seriously arguable, particularly where factual difficulties also arise.

Servier Laboratories Ltd appealed from proceedings in the Administrative Court before Mr Justice Holman against the National Institute for Health and Clinical Excellence and another respondent. The Court of Appeal had granted permission on the so-called reasons grounds. It considered whether permission should also be granted on a proposed new ground raising European Union law, concerning the relevance of EMEA decisions to NICE’s functions. The central issues were whether the ground was seriously arguable and whether factual difficulties affected its viability.

Lord Justice Jacob gave the judgment of the court.

1. Permission on the existing grounds. Permission to appeal had been granted in respect of the so-called reasons grounds. The court made no further determination on those grounds, which were to be considered by the Court of Appeal hearing the appeal.
2. Proposed European Union law ground. Permission was refused on the proposed new ground. The court considered it not seriously arguable that EMEA decisions had any legal role in NICE’s decisions.
3. Article 4(3) of the Directive. The provision preserves the powers of Member State authorities concerning medicinal-product prices and inclusion in national health-insurance schemes, where decisions are based on health, economic and social conditions. Those matters were treated as outside the Directive’s scope. It therefore made no legal sense to separate out an aspect of NICE’s decision as having already been determined by EMEA.
4. Factual difficulty. The court also identified a possible significant difficulty on the facts. It was unnecessary to examine that issue in greater detail at the permission stage.
5. Order. The appeal was allowed in part.

• Court of Appeal (Civil Division): Permission granted on the so-called reasons grounds but refused on the proposed new European Union law ground. The order was that the appeal be allowed in part: [2009] EWCA Civ 927 .
• High Court of Justice, Queen’s Bench Division, Administrative Court: Proceedings before Mr Justice Holman. No citation for the decision is stated in the judgment.