Opinion of the Advocate-General
1 The present case arises from an application made by the Commission pursuant to Article 169 of the EC 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 regarding the protection of animals used for experimental and other scientific purposes (`the Directive'), (1) has failed to fulfil its obligations under the Directive and under the Treaty.
2 Article 1 of the Directive explains the purpose of the Directive in the following terms:
`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 protection are approximated so as to avoid affecting the establishment and functioning of the common market, in particular by distortions of competition or barriers to trade.'
3 At issue in the present case are the provisions required to implement Articles 14 and 22 of the Directive.
4 Article 14 provides:
`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.
In particular, persons carrying out or supervising the conduct of experiments shall have received instruction in a scientific discipline relevant to the experimental work being undertaken and be capable of handling and taking care of laboratory animals; they shall also have satisfied the authority that they have attained a level of training sufficient for carrying out their tasks.'
5 Article 22 provides:
`1. In order to avoid unnecessary duplication of experiments for the purposes of satisfying national or Community health and safety legislation, Member States shall as far as possible recognise the validity of data generated by experiments carried out in the territory of another Member State unless further testing is necessary in order to protect public health and safety.
2. To that end, Member States shall where practicable, and without prejudice to the requirements of existing Community Directives, furnish information to the Commission on their legislation and administrative practice relating to animal experiments, including requirements to be satisfied prior to the marketing of products; they shall also supply factual information on experiments carried out in their territory and on authorisations or any other administrative particulars pertaining to these experiments.
3. The Commission shall establish a permanent consultative committee within which the Member States would be represented, which will assist the Commission in organising the 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.'
6 Article 25 of the Directive provides:
`1. Member States shall take the measures necessary to comply with this Directive by 24 November 1989. They shall forthwith inform the Commission thereof.
2. Member States shall communicate to the Commission the provisions of national law which they adopt in the field covered by this Directive.'
7 As regards Article 14 of the Directive, the 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 not in any event amount to a complete transposition of the provisions of Article 14. In its rejoinder, Belgium states that it is ready to take account of the Commission's comments and to amend the draft accordingly.
8 It follows that Belgium did not in due time take the measures necessary to implement Article 14 of the Directive.
9 As regards Article 22 of the Directive, the Commission contended in the preliminary proceedings that Belgium had not implemented that provision. It was only in its response to the Commission's reasoned opinion that Belgium claimed that Article 22 of the Directive had been implemented, and referred to two royal decrees of 22 and 25 September 1992. (2)
10 In its application, the Commission contends that those decrees were concerned with the implementation of directives other than Directive 86/609. In its defence, which contains only a single sentence on the substance, 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 86/609. It also maintains that Article 6 bis of 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 registration of cases dealt with in another Member State.
11 The Belgian Government's contentions, such as they are, call for the following comments. First, the decrees invoked by Belgium refer in their preambles to various directives but do not refer to Directive 86/609. Secondly, as regards the substantive provisions of the decrees of 22 and 25 September 1992, the Belgian Government has not deigned to identify which provisions of that very elaborate legislation do give effect to Directive 86/609. Thirdly, the Belgian Government seems in any event to be confused in maintaining, with regard to Article 22 of the Directive, that those decrees provide expressly that experiments must be carried out in accordance with Directive 86/609, since Article 22 of the Directive does not concern the way in which experiments are carried out. Finally the decree of 1 February 1996 has to do with the registration of medicinal products and is manifestly designed to implement the directives relating to those products.
12 The Belgian Government's arguments are therefore unfounded in their entirety.
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 obligations under the Treaty;
(2) order the Kingdom of Belgium to pay the costs.
(1) - OJ 1986 L 358, p. 1.
(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 veterinary medicines.
(3) - Royal decree amending the royal decree of 3 July 1969 relating to the registration of medicines.
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