Case C-245/03

Merck, Sharp & Dohme BV

v

État belge

(Reference for a preliminary ruling from the Counseil d’État (Belgium))

(Directive 89/105/EEC – Medicinal products for human use – Application for entry on a positive list – Nature of the time-limit for responding – Mandatory nature – Consequences of exceeding the time-limit)

Opinion of Advocate General Tizzano delivered on 30 September 2004

Judgment of the Court (Second Chamber), 20 January 2005

Summary of the Judgment

Approximation of laws – Pharmaceutical products – Directive 89/105 – Medicinal products for human use – Application for entry of a medicinal product on the list of medicinal products covered by the national sickness insurance scheme – Mandatory nature of the time-limit for determining the application – Exceeding of the time-limit – Consequences – No automatic entry on the list

(Council Directive 89/105, Art. 6(1), first subpara.)

The time-limit for determining an application for entry of a medicinal product on the list of medicinal products covered by the national sickness insurance scheme laid down in the first subparagraph of Article 6(1) of Directive 89/105 relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems is a mandatory time-limit which the national authorities are not entitled to exceed.

However, the first subparagraph of Article 6(1) does not impose the automatic entry of a medicinal product on the list of proprietary medicinal products covered by the sickness insurance system where the time-limit laid down in that article is exceeded.

(see paras 24, 34, operative part 1-2)

JUDGMENT OF THE COURT (Second Chamber) 20 January 2005 (1)

(Directive 89/105/EEC – Medicinal products for human use – Application for entry on a positive list – Nature of the time-limit for responding – Mandatory nature – Consequences of exceeding the time-limit)

In Case C-245/03, REFERENCE for a preliminary ruling under Article 234 EC by the Conseil d’État (Belgium), by decision of 9 May 2003, received at the Court on 10 June 2003, in the proceedings

v

THE COURT (Second Chamber),,

composed of C.W.A. Timmermans, President of the Chamber, R. Silva de Lapuerta (Rapporteur), C. Gulmann, R. Schintgen and G. Arestis, Judges,

Advocate General: A. Tizzano,

having regard to the written procedure and further to the hearing on

after hearing the Opinion of the Advocate General at the sitting on 30 September 2004,

gives the following

‘Whereas the objective of this Directive is to obtain an overall view of national pricing arrangements, including the manner in which they operate in individual cases and all the criteria on which they are based, and to provide public access to them for all those involved in the market in medicinal products in the Member States; whereas this information should be public;

Whereas, as a first step towards the removal of these disparities, it is urgently necessary to lay down a series of requirements intended to ensure that all concerned can verify that the national measures do not constitute quantitative restrictions on imports or exports or measures having equivalent effect thereto; whereas, however, these requirements do not affect the policies of those Member States which rely primarily upon free competition to determine the price of medicinal products; whereas these requirements also do not affect national policies on price setting and on the determination of social security schemes, except as far as it is necessary to attain transparency within the meaning of this Directive’.

‘The following provisions shall apply if a medicinal product is covered by the national health insurance system only after the competent authorities have decided to include the medicinal product concerned in a positive list of medicinal products covered by the national health insurance system.

Where a Member State does not permit an application to be made under this Article before the competent authorities have agreed the price to be charged for the product pursuant to Article 2, the Member State concerned shall ensure that the overall period of time taken by the two procedures does not exceed 180 days. This time-limit may be extended in accordance with Article 2 or suspended in accordance with the provisions of the preceding subparagraph.

‘Must the time-limit of 90 days, which may be extended for a further 90 days, mentioned in the first subparagraph of Article 6(1) of Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems, be regarded as a merely indicative time-limit or as a mandatory time-limit and, if the time-limit is mandatory, what are the consequences of exceeding it as regards the response to be given to the application for inclusion of a medicinal product in the list of medicinal products covered by the health insurance scheme?

Must exceeding the time-limit be deemed to constitute inclusion in the abovementioned list?’

On those grounds, the Court (Second Chamber) rules as follows:

[Signatures]