Order of the President of the Court of 20 June 2003. – Commission of the European Communities v Les Laboratoires Servier SA.

‘The authorisation provided for in Article 3 shall be refused if, after verification of the particulars and documents listed in Article 4, it proves that the medicinal product is harmful in the normal conditions of use, or that its therapeutic efficacy is lacking or is insufficiently substantiated by the applicant, or that its qualitative and quantitative composition is not as declared.

Authorisation shall likewise be refused if the particulars and documents submitted in support of the application do not comply with Article 4.’

‘The competent authorities of the Member States shall suspend or revoke an authorisation to place a medicinal product on the market where that product proves to be harmful in the normal conditions of use, or where its therapeutic efficacy is lacking, or where its qualitative and quantitative composition is not as declared. Therapeutic efficacy is lacking when it is established that therapeutic results cannot be obtained with the [medicinal] product.’

‘[w]hereas the concepts of “harmfulness” and “therapeutic efficacy” referred to in Article 5 of Directive 65/65/EEC can only be examined in relation to each other and have only a relative significance depending on the progress of scientific knowledge and the use for which the medicinal product is intended; whereas the particulars and documents which must accompany an application for authorisation to place a medicinal product on the market [must] demonstrate that potential risks are outweighed by the therapeutic efficacy of the product; whereas failing such demonstration, the application must be rejected;

[w]hereas the evaluation of “harmfulness” and “therapeutic efficacy” may be modified in the light of new discoveries and standards and protocols must be amended periodically to take account of scientific progress’.

‘8Second Council Directive 75/319/EEC of 20 May 1975 on the approximator of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (OJ 1975 L 147, p. 13), amended or several occasions, in particular by [Council] Directives 83/570[/EEC of 26 October 1983 (OJ 1983 L 332, p. 1)] and 93/39 (hereinafter, as amended. “Directive 75/319”), establishes, in Chapter III (Articles 8 to 15c), a procedure for the mutual recognition of national marketing authorisations (Article 9), together with Community arbitration procedures.

9That directive expressly provides for referrals to the Committee for Proprietary Medicinal Products (hereinafter “the CPMP”) of the European Agency for the Evaluation of Medicinal Products, for application of the procedure governed by Article 13, where, in the context of the procedure for mutual recognition established by Article 9, a Member State considers that there are grounds for supposing that the authorisation of the medicinal product concerned may present a risk to public health and the Member States do not reach agreement within the prescribed time-limit (Article 10 of that directive), where Member States have adopted divergent decisions concerning the grant, suspension or withdrawal of national authorisations (Article 11), and in specific cases where the interests of the Community are involved (Article 12). In addition, the directive expressly provides that the variation, suspension and withdrawal of marketing authorisations granted in accordance with the provisions of Chapter III thereof are subject to the procedures laid down in Articles 13 and 14 (Articles 15 and 15a). Finally, Article 15b provides that Articles 15 and 15a are to apply by analogy to medicinal products authorised by the Member States following an opinion of the CPMP issued prior to 1 January 1995, in accordance with Article 4 of Council Directive 87/22/EEC of 22 December 1986 on the approximation of national measures relating to the placing on the market of high-technology medicinal products, particularly those derived from biotechnology (OJ 1987 L 15, p. 38). The procedures established by Articles 12 and 15a of Directive 75/319 are of particular relevance in the present case.

10Article 12 of Directive 75/319 provides:

“The Member States or the Commission or the applicant or holder of the marketing authorisation may, in specific cases where the interests of the Community are involved, refer the matter to the [CPMP] for the application of the procedure laid down in Article 13 before reaching a decision on a request for a marketing authorisation or on the suspension or withdrawal of an authorisation, or on any other variation to the terms of a marketing authorisation which appears necessary, in particular to take account of the information collected under the pharmacovigilance system provided for in Chapter Va.

The Member State concerned or the Commission shall clearly identify the question which is referred to the [CPMP] for consideration and shall inform the person responsible for placing the medicinal product on the market.

The Member States and the aforementioned person shall forward to the [CPMP] all available information relating to the matter in question.”

11Article 15a of Directive 75/319 states:

“1.Where a Member State considers that the variation of the terms of a marketing authorisation which has been granted in accordance with the provisions of this chapter or its suspension or withdrawal is necessary for the protection of public health, the Member State concerned shall forthwith refer the matter to the [CPMP] for the application of the [procedures] laid down in Articles 13 and 14.

2.Without prejudice to the provisions of Article 12, in exceptional cases, where urgent action is essential to protect public health, until a definitive decision is adopted a Member State may suspend the marketing and the use of the medicinal product concerned on its territory. It shall inform the Commission and the other Member States no later than the following working day of the reasons for its action.”

12Article 13 of Directive 75/319 governs the procedure before the CPMP, which issues a reasoned opinion. Paragraph 5 of that article provides that the European Agency for the Evaluation of Medicinal Products is to forward the final opinion of the CPMP to the Member States, the Commission and the person responsible for placing the medicinal product on the market, together with a report describing the assessment of the medicinal product and stating the reasons for its conclusions. Article 14 of that directive governs the Community decision-making procedure. The first subparagraph of Article 14(1) provides that within 30 days of the receipt of the CPMP opinion, the Commission is to prepare a draft of the decision to be taken in respect of the application, taking into account Community law. Under the third subparagraph of Article 14(1), “[w]here, exceptionally, the draft decision is not in accordance with the opinion of the [European] Agency [for the Evaluation of Medicinal Products], the Commission shall also annex a detailed explanation of the reasons for the differences”. The final decision is adopted in accordance with the regulatory procedure governed by Articles 5 and 7 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (OJ 1999 L 184, p. 23). The Commission is assisted in that procedure by the Standing Committee on Medicinal Products for Human Use, set up by Article 2b of Directive 75/318.

...

13All the directives relating to medicinal products for human use which govern the “decentralised Community procedure”, in particular Directives 65/65, 75/318 and 75/319, have been recast in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67; hereinafter “the Code”). Even though the Code was not in force when the decision at issue was adopted, it should be taken into account where appropriate. In so far as the Code restates in a more structured corpus, without amending them, the provisions of Directives 65/65 and 75/319, a systematic analysis of the provisions of Chapter III of Directive 75/319 is part of the scheme of that code.’

‘58In the present case, it is therefore sufficient to find, first, that in the scheme of Chapter III of Directive 75/319, leaving aside the decision of 9 December 1996, the management of the purely national marketing authorisations of the medicinal products in question came within the residual field of exclusive competence of the Member States concerned (Artegodan and Others v Commission, paragraphs 114 to 116).

59Moreover, it is clear from the very wording of Article 12 of Directive 75/319 that that article establishes in the field of competence of the Member States a purely consultative procedure, which is also optional and can, moreover, be initiated not only by the Member States concerned, but also by the Commission, or the applicant or holder of a marketing authorisation. In addition, in the system established by Chapter III of Directive 75/319, that article, which is not one of the provisions more specifically providing the framework for the mutual recognition procedure, cannot be interpreted in the light of the particular objective of that procedure, which is intended ultimately to bring about the adoption of a common decision by the Member States concerned, where necessary by way of the Community arbitration procedure established by Article 10 of that directive if the Member States fail to reach agreement within the prescribed time-limit (Artegodan and Others v Commission, paragraphs 132 and 133).

60In the scheme of Chapter III of Directive 75/319, Article 12 of that directive is intended to apply in the residual field of exclusive competence of the Member States, or when the initial marketing authorisation of a medicinal product is granted by the reference Member State. Within that legal framework, the Member States, which have merely an option to consult the CPMP, cannot find themselves by implication deprived of their competence if they make use of that option or if the Commission, the applicant, or the holder of a marketing authorisation makes a referral to the CPMP under Article 12. In the field of the mutual recognition procedure, such a removal of competence would however, if a matter were referred to the CPMP under Article 12 by the reference Member State, lead to the immediate application of a Community arbitration procedure and the circumvention of the preliminary stages of mutual recognition and concertation between the Member States concerned with a view to reaching an agreement — on the basis of all the documents and information referred to in Article 4 of Directive 65/65 —, stages which are expressly provided for by Articles 9(4) and 10(2) of Directive 75/319. In the field of the exclusive competence of the Member States, that removal of competence would also lead to the immediate application of an arbitration procedure, in respect of medicinal products which have never been the subject of a preliminary joint examination by the Member States concerned, similar to that which distinguishes the mutual recognition procedure (Artegodan and Others v Commission, paragraphs 129, 130 and 142).

61Against that background, in the absence of an express provision, the principle set out in the first paragraph of Article 5 EC that the Community is to act within the limits of the powers conferred upon it, precludes an interpretation of Article 12 of Directive 75/319 to the effect that it implicitly empowers the Commission to adopt a binding decision under the procedure provided for in Article 14 of that directive (Artegodan and Others v Commission, paragraphs 136 to 147).

62Second, the principle that the Community can only act within the powers conferred on it also militates against an interpretation of Article 15a(1) of Directive 75/319 to the effect that, in the absence of any provision providing for such a transfer of competence, the optional harmonisation of certain marketing authorisations, in accordance with a nonbinding opinion of the CPMP under Article 12 of that directive, has the effect of depriving the Member States concerned of their competence in respect of subsequent decisions on the amendment, suspension or withdrawal of those authorisations. In the present case, the notion that such achieved harmonisation must be maintained — which would find its concrete expression in the implementation of a Community arbitration procedure — is not apparent from either the provisions of Chapter III of Directive 75/319 or the aim pursued by that chapter (Artegodan and Others v Commission, paragraphs 149 to 154).

63In those circumstances, in the system of harmonisation set up by Chapter III of Directive 75/319, which is based specifically on the principle of mutual recognition in association with Community arbitration procedures, the concept of a marketing authorisation granted in accordance with the provisions of that chapter, referred to in Article 15a(1), covers only authorisations granted by way of mutual recognition or arbitration. That concept cannot be interpreted as also including national authorisations harmonised following optional consultation of the CPMP under Article 12, which therefore remain within the essentially residual field of exclusive competence of the Member States concerned (Artegodan and Others v Commission, paragraphs 149 and 155).

64It follows that, in the present case, although the marketing authorisations of the medicinal products in question were harmonised by the decision of 9 December 1996, which has no legal basis but is no longer open to challenge, they do not come within the scope of Article 15a(1) of Directive 75/319.

65The contested decision, which was adopted under that article, is therefore also without legal basis.’