Case No: C1/2009/0805
Neutral Citation Number: [2009] EWCA Civ 927
IN THE SUPREME COURT OF JUDICATURE
COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM THE HIGH COURT OF JUSTICE
QUEEN’S BENCH DIVISION
ADMINISTRATIVE COURT
(MR JUSTICE HOLMAN)
Royal Courts of Justice
Strand, London, WC2A 2LL

Date: Tuesday, 28th July 2009

Before:

LORD JUSTICE JACOB
and
LORD JUSTICE PATTEN
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Between:

	THE QUEEN ON THE APPLICATION OF 
SERVIER LABORATORIES LTD	
Appellant	
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NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE & ANR	

Respondent	

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(DAR Transcript of 
WordWave International Limited
A Merrill Communications Company
165 Fleet Street, London EC4A 2DY
Tel No:  020 7404 1400  Fax No: 020 7831 8838
Official Shorthand Writers to the Court)

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Mr M Chamberlain (instructed by Messrs Bristows) appeared on behalf of the Appellant.
Mr D Stilitz (instructed by Messrs Beachcroft) appeared on behalf of the Respondent.
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Judgment
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