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You are here: BAILII >> Databases >> Court of Justice of the European Communities (including Court of First Instance Decisions) >> Glaxosmithkline (Approximation of laws) [2005] EUECJ C-296/03 (20 January 2005) URL: https://www.bailii.org/eu/cases/EUECJ/2005/C29603.html Cite as: [2005] EUECJ C-296/03, [2005] EUECJ C-296/3 |
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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 where a decision refusing entry is annulled)
In Case C-296/03,REFERENCE for a preliminary ruling under Article 234 EC by the Conseil d'État (Belgium) by decision of 27 June 2003, received at the Court on 8 July 2003, in the proceedings Glaxosmithkline SAv
État Belge,THE COURT (Second Chamber),
after hearing the Opinion of the Advocate General at the sitting on 30 September 2004,
gives the following
-˜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
-˜...Where no decision is adopted within 180 days of the date communicated by the Secretariat of the [Commission de remboursement des médicaments] to which the file has been submitted, the decision [relating to the application for entry on the list of reimbursable proprietary medicinal products] shall be deemed to be positive as regards the basis for reimbursement for the medicinal products, the conditions for reimbursement and the category of reimbursement proposed by the applicant -¦-™
-˜Applications seeking a subsidy duly submitted before 1 January 2002 and in respect of which the file has already been deemed to be complete shall continue to be dealt with in accordance with the rules in force before 1 January 2002, provided that they are examined within 90 days from the date of communication of the price, as determined by the Minister whose portfolio includes Economic Affairs, or from the date of communication of the opinion of the Commission de transparence, whichever is later.As regards applications in respect of which the applicant has already communicated by 1 January 2002 the price determined by the Minister whose portfolio includes Economic Affairs and the opinion of the Commission de transparence, the period of 90 days shall be calculated as from 1 January 2002.Where no decision has been taken within the 90-day periods referred to in the first and second subparagraphs, the file shall be transmitted to the [Commission de rembursement des médicaments].The King shall determine the rules concerning such reference and the procedure to be followed.-™
-˜...Where no decision is adopted in respect of those files within the 90-day period referred to in Article 22(3) of the Law of 10 August 2001 -¦, the Chairman of the [Conseil technique des spécialités pharmaceutiques] shall transmit them to the Secretariat of the [Commission de rembursement des médicaments].-¦Where no decision has been taken by the Minister within a period of 90 days from the date of transmission, the official designated by the Minister shall inform the applicants concerned forthwith that no decision has been taken. That notification must be accompanied by the applicant-™s proposal to amend the most recent list and the entry or entries to be amended, with effect from the first day of the month after expiry of a period of 10 days following its publication in the [Moniteur belge].-™
-˜[t]he components of that vaccine are already reimbursed individually. The interministerial conference on public health has stated that it is in favour of a uniform basic vaccination policy to be drawn up between the Communities and the Federal Government. In order to avoid influencing future negotiations, I am not giving a favourable reply to your application ...-™
- first, that the Minister could depart from the CRM-™s definitive proposal only on the basis of social or budgetary factors, or on the basis of a combination of those two factors, - second, that the grounds of the contested decision were materially incorrect in part and, for the remainder, did not constitute sufficient justification based on social or budgetary arguments.
-˜Must the time-limit of 90 days, which may be extended for a further 90 days, referred to 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 prices of medicinal products for human use and their inclusion in the scope of national health insurance systems be considered to be a strict time-limit precluding, upon expiry, the adoption of any decision, even where an initial decision adopted in good time has been annulled?-™
Substance
The indicative or mandatory nature of the time-limit laid down in the first subparagraph of Article 6(1) of the Directive
The consequences of exceeding the time-limit where a previous decision adopted in good time has been annulled
1 - Language of the case: French.