C-23/96
ECLI:EU:C:1997:23
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OPINION OF MR ELMER — CASE C-23/96
OPINION OF ADVOCATE GENERAL ELMER delivered on 16 January 1997
1. In these Treaty infringement proceedings By a letter of 20 July 1992 the French Per- the Commission seeks a declaration that, by manent Representation to the European failing to adopt within the prescribed period Communities informed the Commission that the measures necessary to implement Com- a draft order was in the course of prepara- mission Directive 91/507/EEC of 19 July tion. 1991 modifying the Annex to Council Direc- tive 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 Having received no information regarding breach of its obligations under the EC implementation of the Directive, on 4 July Treaty. 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.
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 Commis- sion thereof forthwith. 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 Since, when the prescribed period elapsed, relevant Law during the last parliamentary the French Republic had not informed the session. Commission that it had implemented the Directive, on 20 May 1992, by a letter of for- mal notice, the Commission initiated infringement proceedings pursuant to Article 169 of the Treaty.
The French authorities have not given any notification that the order has been adopted * Original language: Danish. 1 — OJ 1991 L 270, p. 32. and the Commission accordingly brought 2 — Save Part 2, paragraph A, point 3.3. of the Annex. the present proceedings on 26 January 1996.
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COMMISSION ν FRANCE
3. In the course of the proceedings the claim that the Court should find against the French Republic has not disputed that it is French Republic. 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 5. I would point out that the French Repub Government further stated that Law N o lic has not disputed the fact that the Direc 96-452 of 28 May 1996 on various health, tive was not implemented in French law social and regulatory measures was pub before the expiry of the period laid down in lished on 29 May 1996. That Law amends Article 2 of the Directive. The French the law on public health in order to intro Republic must therefore be considered to be duce the principle of applications for mar in breach of its obligations under the EC keting authorizations in exceptional circum Treaty, as alleged by the Commission. stances which appears in the Annex to the Directive.
6. The Commission has asked the Court to order the French Republic to pay the costs. 4. In its reply, the Commission claimed that Under Article 69(2) of the Rules of Pro the French Republic's defence confirmed the cedure the unsuccessful party is to be assumption in the application that the Direc ordered to pay the costs if they have been tive has not been implemented. In the cir applied for in the successful party's plead cumstances the Commission maintained its ings.
Conclusion
7. I n the light of the foregoing, I w o u l d suggest t h a t the C o u r t h o l d as follows:
(1) B y failing t o a d o p t w i t h i n t h e p r e s c r i b e d p e r i o d t h e measures necessary t o i m p l e m e n t C o m m i s s i o n Directive 9 1 / 5 0 7 / E E C of 19 J u l y 1991 modifying t h e A n n e x t o C o u n c i l Directive 7 5 / 3 1 8 / E E C o n t h e a p p r o x i m a t i o n of t h e laws of t h e M e m b e r States relating t o analytical, p h a r m a c o t o x i c o l o g i c a l a n d clinical s t a n d a r d s and p r o t o c o l s in respect of t h e testing of medicinal p r o d u c t s , t h e F r e n c h R e p u b l i c is in b r e a c h of its obligations u n d e r t h e E C Treaty.
(2) T h e F r e n c h R e p u b l i c is o r d e r e d t o p a y t h e costs.
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