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

Lord Justice Jacob:

1. We have given permission to appeal in respect of the so-called reasons grounds, and I need not say any more about that. That will be a matter for the Court of Appeal hearing the case in due course. But we refuse permission to appeal on the proposed new ground of appeal raising a question of European Union law.

2. We do so for two reasons. Firstly, we do not think it is seriously arguable as a matter of European Union law that the decisions of EMEA have any place in the decisions of NICE as a matter of law. Article 4(3) of the Directive reads as follows: “The provisions of this Directive shall not affect the powers of the Member States’ authorities either as regards the setting of prices for medicinal products or their inclusion in the scope of national health insurance schemes, on the basis of health, economic and social conditions. Everything that EMEA does is irrelevant to what Member States’ authorities may do in respect of those specified matters. Those specified matters consist of decisions, so far as this country is concerned, of NICE on the basis of health, economic and social conditions.

3. Mr Lewis on behalf of Servier would seek to break out part of that and say but part of that is something that NICE cannot get involved in because it has been decided by EMEA. But that makes no sense whatever in the context of this specific exclusion. NICE’s job is to make its decision on the basis of health, economic and social conditions, and that is what is excluded from the scope of this Directive and accordingly any decision of EMEA is irrelevant.

4. The second reason is that, so far as one can see at the moment, on the brief argument of Mr Stilitz, there may be real trouble on the facts. It is not necessary to go into that in more detail here.

5. One day plus judgment. A judge with patent experience. Order: Appeal allowed in part