C-152/00
ECLI:EU:C:2002:85
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COMMISSION v FRANCE
O P I N I O N OF ADVOCATE GENERAL GEELHOED delivered on 7 February 2002 1
I — Introduction cared for and that no pain, suffering, distress or lasting harm are inflicted unnecessarily. In particular, the unnecess- ary duplication of animal experiments must be avoided.
1. In the present infringement proceedings the Commission seeks a declaration from the Court that France has failed to imple- ment fully and correctly Council Directive 3. In accordance with Article 25 of the 86/609/EEC of 24 November 1986 on the Directive the Member States should have approximation of laws, regulations and taken the measures necessary to comply administrative provisions of the Member with the Directive by 24 November 1989. States regarding the protection of animals used for experimental and other scientific purposes 2(hereinafter: 'the Directive').
I I — Procedure
2. According to Article 1 the Directive aims to ensure that the provisions laid 4. The French authorities informed the down by law, regulation or administrative Commission on 8 December 1989 of a provisions in the Member States for the number of measures implementing the protection of animals used for experimental Directive. The notified measures concerned or other scientific purposes are approxi- in particular Decree No 87-848 of 19 Oc- mated, so as to avoid affecting the estab- tober 1987 3 and three interministerial lishment and functioning of the common decisions of 19 April 1988 that served to market. According to its recitals, the Direc- implement Decree No 87-848. On 24 April tive aims to ensure that the number of 1998 the Commission sent the French animals used for experimental or other scientific purposes is reduced to a mini- mum, that such animals are adequately 3 — Décret no. 87-848 du 19 octobre 1987 pris pour l'ap- plication de l'article 454 du code pénal et du troisième alinéa de l'article 276 du code rural et relatif aux expéri- ences pratiquées sur les animaux, JO of 20 October 1987 (Decree of 19 October 1987 regarding the application of 1 — Original language: Dutch. Article 454 of the Penal Code and of Article 276(3) of the 2 — OJ 1986 L 358, p. 1. Agricultural Code and relating to animal experiments).
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Government a letter of formal notice to particular Articles 4, 7, 11, 12, 18 and which it received no reply. Subsequently on 22 thereof, the French Republic has 18 December 1998 the Commission issued failed to fulfil its obligations under that a reasoned opinion requesting the French Directive and under the EC Treaty; Government to inform it within two months of the measures to be taken. The application was lodged at the Court Regis- try on 19 April 1999.
— order the French Republic to pay the costs.
5. The Commission puts forward six pleas in law with regard to the non-implemen- tation or incomplete implementation of a number of the provisions of the Directive. 7. The French Republic asks the Court to These relate to the choice of species and of take into account the stringent national experiments, the freeing of animals used in rules regarding animal experiments. experiments, the notification procedure for experiments, the identification marking of animals and also the mutual recognition of the results of experiments carried out on the territory of the Member States. 8. In August and September 2001 the French Government informed the Commis- sion and the Court of the publication of a decree 4and of a decision 5 which in its opinion brought the French rules into conformity with the Directive. 6. The Commission claims that the Court should:
9. On 25 October 2001 an oral hearing took place at which the French Govern- ment and the Commission were repre- — declare that, by failing to implement sented. In the course of this hearing the fully and correctly Council Directive Commission indicated that it did not wish 86/609/EEC of 24 November 1986 on to discontinue proceedings. the approximation of laws, regulations and administrative provisions of the Member States regarding the protec- 4 — Decree No 2001-464 of 29 May 2001 amending Decree tion of animals used for experimental No 87-848 of 19 October 1987, JO of 31 May 2001. 5 — Decision of 20 June 2001 regarding good laboratory prac- and other scientific purposes, and in tices for veterinary medicines, JO of 4 July 2001.
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10. According to settled case-law, the ques- endangered under Appendix I of the Con- tion whether a Member State has failed to vention on International Trade in Endan- fulfil its obligations must be determined by gered Species of Fauna and Flora and reference to the situation prevailing in the A n n e x C.I. of R e g u l a t i o n (EEC) Member State at the end of the period laid No 3626/82 are prohibited unless they are down in the reasoned opinion and the in conformity with the above Regulation Court cannot take account of any sub- and the objects of the experiment are: sequent changes, even where the default has been remedied after the time-limit given in the reasoned opinion has expired. 6In this case the reasoned opinion was served on 18 December 1998. The existence of the alleged failure to fulfil obligations must therefore be determined on the basis of the situation as it stood on 18 February 1999. The decree of 29 May 2001 and the — research aimed at preservation of the Decision of 20 June 2001 notified by the species in question, French Government cannot be taken into consideration.
or I I I— The Commission's pleas in law and the assessment
A — The first plea in law: failure to implement Article 4 — essential biomedical purposes where the species in question exceptionally proves to be the only one suitable for those purposes.' 11. Article 4 of the Directive reads as follows:
'Each Member State shall ensure that experiments using animals considered as 12. The Commission states that the French Republic has failed to prohibit experiments involving endangered species as defined in 6 — See Case C-207/00 Commission v Italy |2001] ECR I-4571, paragraphs 27 and 28. this provision.
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13. The French Government relies notably tice, which can be changed as and when the upon Article 7 of Decree No 87-848, authorities please and which is not pub- which states that all species of animals licised widely enough, cannot be regarded may be used for experiments, subject to the as constituting proper performance of the restrictions laid down in the applicable obligations which, under Article 249 EC, rules regarding endangered species. fall upon the Member States to whom According to the French Government, directives are addressed. 8 under Decree No 87-848 each animal experiment must be either generally or specifically approved, and in every request for permission the competent national authorities take the prohibition in Article 4 of the Directive into account. The species of animals referred to are seldom bred and captured in France, and for species from third countries the authorities competent to approve import rely upon the requirements of Articles 4 and 8 of Council Regulation (EC) No 338/97 of 9 December 1996 on the protection of species of wild fauna and flora by regulating trade therein. 7
15. In the light of this settled case-law, I share the Commission's opinion that the provisions and procedures cited by the French Government do not ensure the full 14. It is well established that Article 249 implementation in national law of Article 4 EC does not necessarily require a literal and of the Directive. Article 7 of Decree formal implementation of a directive and a No 87-848 contains a general reference to general legal context may be sufficient to the legislative restrictions regarding endan- fully and effectively implement a directive gered species. Such a general reference does in the national legal order. Nevertheless, not suffice to implement the Directive. each Member State is bound to implement Neither this nor any other national provi- the provisions of directives in a manner sion provides for a specific and unques- that fully meets the requirements of clarity tionable prohibition on the use of endan- and legal certainty imposed by the Com- gered species for experiments unless the munity legislature. To that end, the provi- conditions set out in Article 4 are met. In sions of a directive must be implemented addition, the argument that for every with unquestionable legal certainty and permit application, the competent auth- with the requisite specificity, precision orities take the requirements of the Direc- and clarity. A purely administrative prac- tive into account, is ineffective. This is a
8 — Sec for example Case C-354/99 Commission v Ireland 7 — OJ 1997 L 61, p. 1. [2001] ECR I-7657, paragraphs 27 and 28.
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purely administrative practice, which is not Experiments on animals taken from the sufficient to properly implement the pro- wild may not be carried out unless experi- hibition under Article 4. ments on other animals would not suffice for the aims of the experiment.'
17. The French Government has claimed that its national legislation provides for an obligation to submit an administrative application requesting permission for the experiment. The competent national auth- orities then examine this request in the light of Article 7(3) of the Directive. B — The second plea in law: incomplete implementation of Article 7(3)
18. Here also I agree with the Commission that such a procedure does not represent an unquestionable and definite implemen- tation. The national legislation does not contain a provision setting out specifically, precisely and clearly the conditions of Article 7(3) regarding the choice of species 16. Article 7(3) of the Directive relates to and serving as a guideline for the compet- the choice of species and of methods and ent authorities when they grant permission states: for any necessary experiments on animals. The French Government essentially invokes an administrative practice. That such prac- tices are insufficient has already been established in the assessment of the first plea in law.
'When an experiment has to be performed, C — The third plea in law: failure to the choice of species shall be carefully implement Article 11 considered and, where necessary, explained to the authority. In a choice between experiments, those which use the minimum 19. Article 11 of the Directive states: number of animals, involve animals with the lowest degree of neurophysiological sensitivity, cause the least pain, suffering, distress or lasting harm and which are most likely to provide satisfactory results shall be 'Notwithstanding the other provisions of selected. this Directive, where it is necessary for the I - 6979
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legitimate purposes of the experiment, the criminal offence, with the exception of authority may allow the animal concerned animals intended for repopulation. Fur- to be set free, provided that it is satisfied thermore, the French Government has that the maximum possible care has been pleaded that according to the 'Code rural' taken to safeguard the animal's well-being, (Agricultural Code) the capture and trans- as long as its state of health allows this to port of wild animals and all the endangered be done and there is no danger for public species is subject to an administrative health and the environment.' approval.
20. The French Government claims that Article 2(b) of Decree No 87-848 imple- ments Article 11 of the Directive. Accord- 22. According to the Commission, ing to this provision the observation of Article 2(b) of Decree No 87-848 cannot animals under conditions that do not cause be regarded as a correct implementation of them any suffering is not to be regarded as Article 11 of the Directive: the freeing of a an experiment within the meaning of the laboratory animal involved in an experi- Decree. ment within the meaning of the Directive is not subject to binding rules. The Commis- sion considers the response of the French Government, that the freeing of animals involved in experiments either never or seldom occurs in France, to be unsatisfac- tory. Article 11 obliges the Member States to adopt legal, regulatory or administrative rules on the basis of which the responsible 21. In addition the French Government has authority may grant permission for the argued that the freeing of laboratory ani- freeing of the animal used in the experi- mals can only be envisaged for animals that ment providing the conditions laid down had previously been taken from the natural are met. The conditions of Article 11 are environment. It seldom occurs that animals absent in the French regulation in question. are taken in this way. The animals used in experiments in France are bred or originate from intra-Community exchange or import, whilst the use of wild animals for scientific purposes is strictly controlled by the French authorities. For animals that have previously been taken from the natu- ral environment Article 13-11 of Law No 76-629 of 10 July 1976 makes the voluntary abandoning of (wild) domes- 23. Finally the Commission has argued that ticated animals that have been captured a the term 'set free' within the meaning of I - 6980
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Article 11 is not limited to just returning D — The fourth plea in law: failure to animals to their natural environment. In implement Article 12(2) view of the broad definition of the term 'experiment', freeing can also be inter- preted as no longer using for experimental purposes, and this can also cover, for example, the return of the animal used in the experiment to its original owner.
25. Article 12(2) states that:
'Where it is planned to subject an animal to an experiment in which it will, or may, 24. Article 11 of the Directive aims to experience severe pain which is likely to be protect the animal used in the experiment prolonged, that experiment must be spe- also after it has been used for experimental cifically declared and justified to, or spe- purposes by attaching a number of con- cifically authorised by, the authority. The ditions to the freeing of the animal con- authority shall take appropriate judicial or cerned. Prior to the freeing, the competent administrative action if it is not satisfied authority must give permission, and in each that the experiment is of sufficient import- case examine, whether the requirements ance for meeting the essential needs of man mentioned in this provision, with regard to or animal.' freeing, are fulfilled. It is therefore obvious that the conditions set out in Article 11 must be apparent in national legislation. Since this was not the case in the French legal order by the deadline established in the reasoned opinion, the Commission's plea in law is already justified on this ground. The argument of the French Gov- ernment that one can only speak of freeing when the animals used in the experiment have in fact ever been removed from the 26. The Commission found that the French natural environment, is not, in my view, Republic had not introduced any regulation convincing. Nowhere does the Directive that would make the experiments men- make such a distinction and, as the Com- tioned in this provision subject to super- mission has stated, it is conceivable that at vision by the competent authority. The the end of the experiment animals are French Government has not denied this. returned to surroundings other than the The plea in law of the Commission must natural environment. therefore be upheld.
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E — The fifth plea in law: incomplete must be maintained by the receiving estab- implementation of Article 18(1) and (3) lishment until it can be so marked.
...'
27. Article 18 reads as follows:
28. In the pre-litigation procedure the French Government pointed out various provisions that oblige the institutions carry- ing out the experiments both to register the ' 1 . Each dog, cat or non-human primate in origin and the identification of the animals any breeding, supplying or user establish- held by them and to mark these animals. ment shall, before it is weaned, be provided These are Articles 9, 25 and 26 of Decree with an individual identification mark in No 87-848, a 1988 Decision regarding the the least painful manner possible except in conditions for the recognition, planning the cases referred to in paragraph 3. and functioning of institutions carrying out animal experiments, the 'Code rural' and a Decision of 25 October 1995, as amended on 26 October 1996.
29. The Commission does not contest that the regulations mentioned implement obli- gations that arise from Article 18 of the Directive. However, it does not consider that the provisions represent a full imple- mentation of Article 18(1) and (3). In particular the marking provisions do not cover animals prior to weaning as is required by Article 18(1). The marking of dogs and cats is covered by a general 3. Where a dog, cat or non-human primate regulation that is not exclusively intended is transferred from one establishment as for animal experiments and does not make referred to in paragraph 1 to another before it obligatory to mark before the animals are it is weaned, and it is not practicable to weaned. Furthermore, the regulations do mark it beforehand, a full documentary not relate to non-human primates. At the record, specifying in particular its mother, same time, the Commission considers that I - 6982
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insufficient attention is given to the excep- generated by experiments carried out in the tional provision in Article 18(3) whereby territory of another Member State unless an animal that has not yet been weaned further testing is necessary in order to may be marked at a later date. Nowhere is protect health and safety.' a provisional registration provided for prior to marking taking place.
30. In this regard the French Government 32. In the pre-litigation phase the French has limited itself in its statement of defence Government referred to Article R. 5118 of to referring to an intended modification of the Public Health Code ('Code de la santé national legislation in order to fully imple- publique'), according to which the Minister ment Article 18. This plea in law must determines the rules and the methods for therefore also be upheld. the testing of medicines and on the basis of which tests must be carried out according to 'good laboratory practices' ('bonnes pratiques de laboratoire').
F — The sixth plea in law: failure to implement Article 22(1)
33. In my opinion the Commission is cor- rect in stating that such a general provision cannot constitute implementation of Article 22(1) of the Directive. That provi- 31. Article 22(1) of the Directive states: sion aims to avoid the duplication of experiments that comply with national or Community legislation, by providing for the recognition of the validity of experi- ments carried out elsewhere. The plea in law is thus valid in its own right. Both in its statement of defence and in the court hearing the French Government has 'In order to avoid unnecessary duplication invoked decisions adopted after 18 Feb- of experiments for the purposes of satisfy- ruary 1999 which aim to transpose ing national or Community health and Article 22(1). However, as already stated safety legislation, Member States shall as the Court cannot take into account amend- far as possible recognise the validity of data ments that have been made after this date.
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IV — Conclusion
34. In the light of the above I propose that the Court should:
— declare that, by failing to implement fully and correctly 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, and in particular Articles 4, 7, 11, 12, 18 and 22 thereof, the French Republic has failed to fulfil its obligations under that Directive and under the EC Treaty;
— order the French Republic to pay the costs.
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