Important legal notice

61996C0023

European Court reports 1997 Page I-01221

Opinion of the Advocate-General

1 In these Treaty infringement proceedings the Commission seeks a declaration that, by failing to adopt within the prescribed period the measures necessary to implement Commission Directive 91/507/EEC of 19 July 1991 modifying the Annex to Council Directive 75/318/EEC on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products (1) (hereinafter `the Directive'), the French Republic is in breach of its obligations under the EC Treaty.

2 Under Article 2 of the Directive the Member States were to adopt the measures necessary to comply with the Directive by 1 January 1992 (2) and to inform the Commission thereof forthwith.

Since, when the prescribed period elapsed, the French Republic had not informed the Commission that it had implemented the Directive, on 20 May 1992, by a letter of formal notice, the Commission initiated infringement proceedings pursuant to Article 169 of the Treaty.

By a letter of 20 July 1992 the French Permanent Representation to the European Communities informed the Commission that a draft order was in the course of preparation.

Having received no information regarding implementation of the Directive, on 4 July 1994 the Commission issued a reasoned opinion to the effect that, by failing within the period prescribed to adopt the measures necessary to implement the Directive, the French Republic had not complied with its obligations under the Treaty.

In a letter of 12 September 1994 the French authorities stated that implementation of the Directive required the adoption of orders which were in the course of preparation and that the delay was due to amendments to the relevant Law during the last parliamentary session.

3 In the course of the proceedings the French Republic has not disputed that it is obliged to implement the Directive. In its defence, the Government explained that implementation required five texts - a law, a decree, and three orders, which were all in the course of preparation. In its rejoinder the Government further stated that Law No 96-452 of 28 May 1996 on various health, social and regulatory measures was published on 29 May 1996. That Law amends the law on public health in order to introduce the principle of applications for marketing authorizations in exceptional circumstances which appears in the Annex to the Directive.

4 In its reply, the Commission claimed that the French Republic's defence confirmed the assumption in the application that the Directive has not been implemented. In the circumstances the Commission maintained its claim that the Court should find against the French Republic.

5 I would point out that the French Republic has not disputed the fact that the Directive was not implemented in French law before the expiry of the period laid down in Article 2 of the Directive. The French Republic must therefore be considered to be in breach of its obligations under the EC Treaty, as alleged by the Commission.

6 The Commission has asked the Court to order the French Republic to pay the costs. Under Article 69(2) of the Rules of Procedure the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party's pleadings.

Conclusion

7 In the light of the foregoing, I would suggest that the Court hold as follows:

(1) By failing to adopt within the prescribed period the measures necessary to implement Commission Directive 91/507/EEC of 19 July 1991 modifying the Annex to Council Directive 75/318/EEC on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products, the French Republic is in breach of its obligations under the EC Treaty.

(2) The French Republic is ordered to pay the costs.

(1) - OJ 1991 L 270, p. 32.

(2) - Save Part 2, paragraph A, point 3.3. of the Annex.