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You are here: BAILII >> Databases >> Court of Justice of the European Communities (including Court of First Instance Decisions) >> Merck, Sharp & Dohme (Approximation of laws) [2005] EUECJ C-245/03 (20 January 2005) URL: https://www.bailii.org/eu/cases/EUECJ/2005/C24503.html Cite as: [2005] EUECJ C-245/03, [2005] EUECJ C-245/3, [2005] ECR I-637 |
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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-™Ã‰tat (Belgium), by decision of 9 May 2003, received at the Court on 10 June 2003, in the proceedings Merck, Sharp & Dohme BVv
État belge,THE COURT (Second Chamber),
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. 1. Member States shall ensure that a decision on an application submitted, in accordance with the requirements laid down in the Member State concerned, by the holder of a marketing authorisation to include a medicinal product in the list of medicinal products covered by the health insurance systems is adopted and communicated to the applicant within 90 days of its receipt. Where an application under this Article may be made before the competent authorities have agreed the price to be charged for the product pursuant to Article 2, or where a decision on the price of a medicinal product and a decision on its inclusion within the list of products covered by the health insurance system are taken after a single administrative procedure, the time-limit shall be extended for a further 90 days. The applicant shall furnish the competent authorities with adequate information. If the information supporting the application is inadequate, the time-limit shall be suspended and the competent authorities shall forthwith notify the applicant of what detailed additional information is required.
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.
2. Any decision not to include a medicinal product in the list of products covered by the health insurance system shall contain a statement of reasons based upon objective and verifiable criteria, including, if appropriate, any expert opinions or recommendations on which the decision is based. In addition, the applicant shall be informed of the remedies available to him under the laws in force and of the time-limits allowed for applying for such remedies.-™ National rules
-˜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?-™
The indicative or mandatory nature of the time-limit referred to in the first subparagraph of Article 6(1) of the Directive
The consequences of exceeding the time-limit within which the competent authority is to respond
1 - Language of the case: French.