C-268/97
ECLI:EU:C:1998:233
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- 61997CC0268
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OPINION OF MR JACOBS — CASE C-268/97
OPINION OF ADVOCATE GENERAL JACOBS delivered on 14 May 1998 *
1. The present case arises from an application the common market, in particular by distor- made by the Commission pursuant to Arti- tions of competition or barriers to trade.' cle 169 of the E C Treaty for a declaration that the Kingdom of Belgium, by failing to adopt within the prescribed period all the measures necessary to comply with Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States 3. At issue in the present case are the provi- regarding the protection of animals used for sions required to implement Articles 14 and experimental and other scientific purposes 22 of the Directive. ('the Directive'), 1 has failed to fulfil its obli- gations under the Directive and under the Treaty.
4. Article 14 provides:
2. Article 1 of the Directive explains the pur- pose of the Directive in the following terms: 'Persons who carry out experiments or take part in them and persons who take care of animals used for experiments, including duties of a supervisory nature, shall have appropriate education and training.
'The aim of this Directive is to ensure that where animals are used for experimental or other scientific purposes the provisions laid down by law, regulation or administrative provisions in the Member States for their In particular, persons carrying out or super- protection are approximated so as to avoid vising the conduct of experiments shall have affecting the establishment and functioning of received instruction in a scientific discipline relevant to the experimental work being under- taken and be capable of handling and taking * Original language: English. care of laboratory animals; they shall also 1 — OJ 1986 L 358, p. 1. have satisfied the authority that they have
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attained a level of training sufficient for car- will assist the Commission in organising the rying out their tasks.' exchange of appropriate information, while respecting the requirements of confidentiality, and which will also assist the Commission in the other questions raised by the application of this Directive.'
5. Article 22 provides:
6. Article 25 of the Directive provides:
' 1 . In order to avoid unnecessary duplication of experiments for the purposes of satisfying national or Community health and safety leg- islation, Member States shall as far as possible recognise the validity of data generated by experiments carried out in the territory of ' 1 . Member States shall take the measures another Member State unless further testing necessary to comply with this Directive by 24 is necessary in order to protect public health November 1989. They shall forthwith inform and safety. the Commission thereof.
2. To that end, Member States shall where 2. Member States shall communicate to the practicable, and without prejudice to the Commission the provisions of national law requirements of existing Community Direc- which they adopt in the field covered by this tives, furnish information to the Commission Directive.' on their legislation and administrative prac- tice relating to animal experiments, including requirements to be satisfied prior to the mar- keting of products; they shall also supply fac- tual information on experiments carried out in their territory and on authorisations or any other administrative particulars pertaining to 7. As regards Article 14 of the Directive, the these experiments. Commission states that it has not been informed of the adoption by Belgium of the necessary legislation. In its defence, Belgium refers to the preparation of a draft royal decree. According to the Commission's reply, that draft had not yet been adopted and would 3. The Commission shall establish a perma- not in any event amount to a complete trans- nent consultative committee within which the position of the provisions of Article 14. In its Member States would be represented, which rejoinder, Belgium states that it is ready to
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take account of the Commission's comments 86/609. It also maintains that Article 6 bis of and to amend the draft accordingly. the royal decree of 1 February 1996, 3 amending the royal decree of 3 July 1969, provides for a system of mutual recognition within the framework of a system of registra- tion of cases dealt with in another Member State. 8. It follows that Belgium did not in due time take the measures necessary to implement Article 14 of the Directive.
11. The Belgian Government's contentions, such as they are, call for the following com- 9. As regards Article 22 of the Directive, the ments. First, the decrees invoked by Belgium Commission contended in the preliminary refer in their preambles to various directives proceedings that Belgium had not imple- but do not refer to Directive 86/609. Sec- mented that provision. It was only in its ondly, as regards the substantive provisions response to the Commission's reasoned of the decrees of 22 and 25 September 1992, opinion that Belgium claimed that Article 22 the Belgian Government has not deigned to of the Directive had been implemented, and identify •which provisions of that very elabo- referred to two royal decrees of 22 and 25 rate legislation do give effect to Directive September 1992. 2 86/609. Thirdly, the Belgian Government seems in any event to be confused in main- taining, with regard to Article 22 of the Direc- tive, that those decrees provide expressly that experiments must be carried out in accor- dance with Directive 86/609, since Article 22 of the Directive does not concern the way in 10. In its application, the Commission con- which experiments are carried out. Finally the tends that those decrees were concerned with decree of 1 February 1996 has to do with the the implementation of directives other than registration of medicinal products and is mani- Directive 86/609. In its defence, which con- festly designed to implement the directives tains only a single sentence on the substance, relating to those products. Belgium refers to the wrong directive and invokes only a draft royal decree. In its almost equally succinct rejoinder, Belgium maintains in relation to Article 22 of the Directive that the decrees of 22 and 25 September 1992 expressly provide that experiments must be carried out in accordance with Directive 12. The Belgian Government's arguments are therefore unfounded in their entirety. 2 — Royal decree amending the royal decree of 16 September 1985 on the norms and protocols applicable to tests of medicines for human use; royal decree amending the royal decree of 12 March 1985 on the norms and protocols applicable to tests of 3 — Royal decree amending the royal decree of 3 July 1969 relating veterinary medicines. to the registration of medicines.
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Conclusion
13. Accordingly, I am of the opinion that the Court should:
(1) declare that, by failing to adopt within the prescribed period all the measures necessary to comply with Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes, the Kingdom of Belgium has failed to fulfil its obliga- tions under the Treaty;
(2) order the Kingdom of Belgium to pay the costs.
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