C-205/01
ECLI:EU:C:2002:549
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OPINION OF MR TIZZANO — CASE C-205/01
OPINION OF ADVOCATE GENERAL TIZZANO delivered on 26 September 2002 1
1. In the present action, brought by the ing of drugs, foodstuffs and other sub- Commission under Article 226 EC, the stances or products and the protection of Court of Justice is called upon to determine the environment. The primary objective of whether the Kingdom of the Netherlands the harmonisation intended by the Direc- has failed to adopt the measures necessary tive, as expressly declared by the preamble in order to implement in national law (first recital) and Article 1, is to eliminate Articles 11 and 22(1) of Council Directive disparity between the relevant laws in 86/609/EEC of 24 November 1986 on the Member States so as to avoid affecting the approximation of laws, regulations and functioning of the common market, administrative provisions regarding the especially by causing distortion in compe- protection of animals used for experimental tition and obstacles to trade. and other scientific purposes (hereinafter: 'Directive 86/609' or 'the Directive') (OJ L 358, p. 1).
3. According to the preamble (second recital), harmonisation is to be pursued by Legal background reducing the number of animals used for the abovementioned purposes to a mini- mum, and in any case by ensuring that such animals are adequately cared for and that no pain, suffering, distress or lasting harm is inflicted unnecessarily, or, if unavoid- able, that they be restricted to the mini- Community law mum.
2. Directive 86/609 establishes minimum standards of protection of animals used for experimental or scientific purposes relating to the development, manufacture and test-
4. As regards the specific provisions whose 1 — Original language: Italian. implementation in the national law of the
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Netherlands is in dispute in the present 6. Lastly, Article 25 of the Directive pro- case, it should be noted that Article 11 of vides: 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. 'Notwithstanding the other provisions of this Directive, where it is necessary for the legitimate purposes of the experiment, the authority [responsible for checking experi- ments] may allow the animal concerned to be set free, provided that it is satisfied that 2. Member States shall communicate to the the maximum possible care has been taken Commission the provisions of national law to safeguard the animal's well-being, as which they adopt in the field covered by long as its state of health allows this to be this Directive.' done and there is no danger for public health and the environment.'
National law
5. Article 22(1) of the Directive provides: 7. The principal measures aimed at imple- menting the Directive which the Kingdom of the Netherlands notified to the Com- mission are the Wet op de dierproeven (Law on animal experiments) of 12 January 1977, 2 as amended by the Law of 12 September 1996, 3and the Dierproeven- besluit (Animal experiments order) of 'In order to avoid unnecessary duplication 31 May 1985, as amended, which gives of experiments for the purposes of satisfy- effect to certain provisions of that law. 4 ing national or Community health and safety legislation, Member States shall as far as possible recognise the validity of data 2 — Wet van 12 januari 1977, houdende regelen met betrekking generated by experiments carried out in the tot het verrichten van proeven op dieren (Stbl. 1977, 67). 3 — Wet tot wijziging van de Wet op de dierproeven (Stbl. 1996, territory of another Member State unless 500). further testing is necessary in order to 4 — Besluit van 31 mei 1985 tot uitvoering van de artikelen 3, tweede lid, 9, 12, 14 en 15 van de Wet op de dierproeven protect public health and safety.' (Stbl. 1985, 336).
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Facts and procedure Netherlands informed the Commission of a series of measures amending the Order on animal experiments.
8. By letter of 9 June 1998 the Commission informed the Kingdom of the Netherlands that it considered that the notified measures did not constitute a full and proper trans- position of certain provisions of the Direc- 10. On the basis of the above information, tive and invited the latter to submits its the Commission withdrew some com- observations within two months. The Gov- plaints but maintained those relating to ernment of the Netherlands replied by Articles 8(2), 11, 18(1) and 22(1) of the letter of 29 July 1998, denying that it had Directive. It commenced the present pro- failed to fulfil its obligations. However, ceedings on 18 May 2001. Subsequently, at examination of the arguments advanced by the hearing before the Court of Justice on the Netherlands did not lead the Commis- 11 June 2002, in view of the adoption of sion to change its position. On 1 August the amendment to the Order on animal 2000 the Commission therefore issued a experiments 7and of the Nadere regeling reasoned opinion requiring the Kingdom of merken proefdieren (Additional standards the Netherlands to comply with its obli- of identification marking of animals used gations under Articles 4, 5, 7(3), 8(2),(3) for experimental purposes), 8the Commis- and (4), 11, 18(1) and 22(1) of the Direc- sion dropped the claims relating to tive within two months. Articles 8(2) and 18(1) of the Directive but maintained those in respect of Articles 11 and 22(1) as well as its position on costs. 9
9. By letter of 3 October 2000 the Govern- ment of the Netherlands submitted its observations in response to the reasoned opinion. By letter of 14 March 2001 the Netherlands informed the Commission of further measures it had adopted and pub- Legal analysis lished subsequent to the reasoned opinion in order to implement the Directive, namely the Beleidsregels ontheffingen Wet op de dierproeven (Orders relating to derogations from the Law on animal experiments) 5and the Regeling huisvesting en verzorging 11. As we have seen, the Commission proefdieren (Regulation on the housing claims that the Kingdom of the Netherlands and welfare of animals used for experi- mental purposes). 6 At the same time the 7 — Besluit van 26 Juni 2001 tot wijziging van het Dierproeven- besluit (Stbl. 2001, 310). 8 — Stert. 2001, 119. 5 — Stert. 2000, 507. 9 — The Commission confirmed the withdrawal of some of its 6 — Stert. 2001, 27. claims by letter to the Court Registry on 12 June 2002.
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has not ensured the full and proper imple- 13. Thus, in order to assess the complaints mentation of the Directive, albeit now only brought by the Commission, it has to be in respect of Articles 11 and 22(1). The determined whether the above conditions Government of the Netherlands argues have been satisfied and, in particular, that, while those provisions of the Directive whether the national law relating to animal have not been literally transposed into the experiments meets the requirements of national law on animal experiments, the Articles 1 1and 22(1) of the Directive. It achievement of the objectives which they should be noted from the outset that this is set is nevertheless ensured by that law and far from straightforward since in effect, as in general by the national rules in force. will be seen later, the national law in According to the Kingdom of the Nether- question appears for the most part to lands, that is in line with the criteria comply with the Community provisions, outlined by the Court of Justice for veri- and where it does fall short it does so in fying whether Member States have fulfilled ways which are of little or merely formal their obligations in transposing directives. significance. Nevertheless, the fact remains that, to the extent that these shortcomings continue to exist, they justify the Commis- sion's action, especially where they jeop- ardise the complete achievement of the objectives contained in the above provi- sions of the Directive.
12. In this regard I also note first of all that, Article 11 of the Directive according to the case-law of the Court, the transposition of a directive into national law 'does not necessarily require the provi- sions of the directive to be enacted in precisely the same words in a specific express provision of a law or regulation, 14. As has been seen. Article 11 of the [but] the general legal situation may be Directive establishes the conditions by sufficient if it actually ensures the full which the authority responsible for check- application of the directive' provided in ing experiments on animals can authorise particular that it 'is sufficiently precise, an animal to be set free during an experi- clear and transparent for the persons con- ment. For that purpose the competent cerned to know the full extent of their authority must be satisfied that the maxi- rights and obligations'. 10 mum possible care has been taken to safeguard the animal's well-being, that its health allows this to be done and that there 10 — Settled case-law; the citation is from Case C-214/98 Commission v Greece | 2 0 0 0 | FCR I-9601, paragraphs is no danger for public health and the 49 and 50. environment. According to the Commis-
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sion, Netherlands law does not ensure the public health and the environment. All of exact implementation of that provision. In that, in the view of the Government of the particular, it does not agree with the Netherlands, ensures compliance with the Government of the Netherlands' argument conditions laid down by Article 11 of the that the conditions laid down by that Directive, without it being necessary to provision are ensured by Articles 10a, 12 reproduce those conditions in national law and 13 of the Law on animal experiments. in a literal and specific way. Those articles in fact are of general scope and do not deal with the specific situation of freeing the animals.
16. I must confess that I do not find the arguments advanced by the Government of the Netherlands convincing. Article 11 of the Directive requires compliance with precise conditions whose continuing exist- ence, as is clear from the wording of the provision, has to be the subject of a specific 15. The Government of the Netherlands, assessment in each particular case where it for its part, insists that it is precisely the is proposed to set an animal free. 1 1 It is application of the above articles of the Law only where such conditions are met that the on animal experiments which achieves the competent authority can allow the animal result intended by Article 11 of the Direc- to be set free. Even in this respect, I tive. In its view, the freeing of animals therefore doubt whether the preventive envisaged by that provision is but one stage assessment of the experiment undertaken in the experiment and as such it is subject by the commissions for animal experi- to the preventive checking of the competent ments, as envisaged by national law, con- national authorities which ensures that the stitutes an adequate means of ensuring that conditions laid down by the Directive are the above conditions are fully complied complied with. The Netherlands emphasise with. in particular that, according to Article 10a of the Law on animal experiments, in order to carry out an experiment it is necessary to obtain the favourable opinion of a com- mission authorised by the Centrale Com- missie dierproeven (Central commission for 17. Even if, as the Government of the animal experiments) or of the Central Netherlands argues, the commissions also commission itself, which is issued subject form a view as to the setting free of the to a research plan which shows the various animal in assessing research plans, it is in stages of the experiment. In this context, any case logical to presume that the animal under Articles 12 and 13 of the national is freed at the end of a stage of the law, the relevant bodies must take into experiment (for example the administration account the requirements to protect the of a pharmaceutical product) in which well-being and the health of the animal problems for the animal and risks for the used for experiments. Moreover, and more protection of public health and the environ- generally, those bodies must ensure that the experiment complies with all existing legis- 11 —See on this point Case C-1 52/00 Commission v France lative obligations, especially with regard to [2002] ECR 1-6973, paragraphs 41 and 42.
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ment referred to by Article 11 of the 19. The same can be said of the further Directive could arise. In this regard, an condition imposed by Article 11 of the assessment ex ante of the experiment con- Directive according to which an animal ducted solely on the basis of the research used for experimental purposes can be set plan does not seem to me sufficient to free only if 'there is no danger for public enable the competent authority to establish health or the environment'. In this regard that the maximum has been done to also the Government of the Netherlands safeguard the animal's well-being, that its places general reliance on a rather hetero- state of health allows it to be set free and genous variety of legislative provisions in that there is no danger for public health different sectors from which, it maintains, and the environment, as specifically compliance with the above conditions can required by Article 11. be deduced. In my view, however, it is precisely this kind of argument which confirms that in reality Netherlands law does not offer a response which is as unequivocal as the clear and precise imperative of Article 11 of the Directive.
20. I therefore find the Commission's com- plaint in respect of Article 11 of the 18. Aside from that however, it certainly Directive to be well-founded. does not seem sufficient as a way of ensuring compliance with Article 11 of the Directive to refer to the requirements to safeguard the well-being and health of the animals which the national authorities should meet under Articles 12 and 13 of the Law on animal experiments. Even if the Netherlands legislation is to be interpreted in this sense, the fact remains that Article 11 Article 22(1) of the Directive of the Directive specifies that the require- ments in a particular case in which an animal is set free can only be met where the competent authority 'is satisfied that the maximum possible care has been taken to 21. The Commission further claims that safeguard the animal's well-being' and 'its the Kingdom of the Netherlands has failed state of health allows this to be done'. On to transpose Article 22( 1 ) of the Directive, the basis of the measures adopted by the which, as has been seen, requires the national government, however, it does not mutual recognition of data generated by appear at all that the relevant legislation experiments carried out in other Member requires the competent authorities, when States for the purposes of satisfying deciding whether to free an animal, to national or Community health and safety adhere to conditions of equivalent rigour legislation in order to avoid unnecessary and clarity. duplication of experiments.
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22. The Government of the Netherlands 24. It is true that the requirement imposed argues t h a t the r e q u i r e m e n t s of by the Directive for Member States to Article 22(1) are fully reflected in recognise 'as far as possible' the validity Article 10(1)(a) of the Law on animal of data generated by experiments is not an experiments in which, in its view, a clause absolute obligation. This can be under- of mutual recognition can be implied. By stood from the fact that, in order to avoid prohibiting direct experiments on animals the duplication of experiments, the desired for obtaining data which, according to data from experiments must not only be prevailing and generally accepted expert available but also usable, in the sense that it opinion, can be produced by other means, derives from an experiment with an ident- the national provision also covers the case ical or comparable object. 12 Nevertheless, where the desired data has already been even taking this into account, I am of the obtained in other Member States and is view that the conditions laid down by the available to researchers concerned. As is Netherlands law do not fully comply with apparent from the various working drafts, the requirements of the Directive since the it is precisely this latter situation which is at mutual recognition of the validity of data the origin of the provision. The Govern- generated by experiments, although not ment of the Netherlands submits finally excluded, is not imposed in the clearer that Article 10(1) of the Law on animal and more strict terms set out in experiments does not prevent the compet- Article 22(1) of the Directive. ent national authorities from authorising an experiment where, in accordance with Article 22(1) of the Directive, further research is necessary for the protection of public health and safety.
25. In my view, this is indicated by the fact that, according to the Government of the Netherlands, the prohibition laid down by Article 10(1)(a) of the national Law on animal experiments ensures both the imple- mentation of the obligation of mutual recognition in Article 22(1) of the Directive and also the exception to that obligation. The prohibition on animal experiments laid down in Article 10(1)(a) in cases where the desired results can be obtained by other 23. In my opinion the Government of the means gives rise simultaneously not just to Netherlands' argument cannot be accepted the obligation on the part of the competent on this point either. Even if Article 10(l)(a) authorities in the Netherlands to recognise of the Law on animal experiments had the the validity of data generated by experi- scope which the national government attributes to it, the obligation of mutual recognition is not in any event as strict as 12 — Even though, in my opinion, it is legitimate to presume that required by Article 22(1) of the Direc- that the object is identical or comparable in respect of experiments for the purposes of satisfying Community tive. health and safety legislation.
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ments in other Member States but also to health and safety legislation' with specific the possibility for those authorities to provisions intended to avoid the dupli- derogate from that obligation where cation of experiments. In my opinion, it is further experiments are necessary 'to pro- therefore the structure of the Directive itself tect public health and safety' as indicated in which indicates that full compliance with the Directive. However, in my opinion, it is Article 22(1) cannot be ensured, as the precisely this ambivalence, which, far from Netherlands Government seeks to do, by supporting the argument of the Govern- means of the prohibition set out in the ment of the Netherlands, shows instead abovementioned Article 7(2) of that Direc- that the national law does not clearly tive. c o r r e s p o n d to t h e r e q u i r e m e n t s of Article 22(1) of the Directive.
27. Therefore, in respect of this point also, the Netherlands law cannot be considered to be in compliance with the Directive.
28. I therefore conclude that this claim and consequently the Commission's action in its entirety are well founded. 26. On the other hand, that should not come as a surprise when one considers that Article 10(l)(a) of the Law on animal experiments relied on by the Netherlands G o v e r n m e n t does not reproduce Article 22(1) but rather Article 7(2) of the Directive, which prohibits experiments on animals 'if another scientifically satisfac- tory method of obtaining the result sought, Costs not entailing the use of an animal, is reasonably and practically available'. There is no question that the obligation of mutual recognition in Article 22(1) of the Directive has the same objective as that prohibition, 29. Under Article 69(2) of the Rules of namely to limit the use of animal experi- Procedure the unsuccessful party is to be ments to those which are absolutely necess- ordered to pay the costs if they have been ary. However, this does not alter the fact applied for. In view of what I have that the prohibition is separate and inde- concluded as to the merits and of the fact pendent inasmuch as it envisages the par- that the Commission did so apply, the ticular case of 'experiments for the pur- Kingdom of the Netherlands should pay the poses of satisfying national or Community costs.
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Conclusion
30. In the light of the above I propose that the Court should:
— declare that, by failing to adopt within the prescribed time-limit all the measures necessary to comply with Articles 11 and 22(1) of 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 the Netherlands has failed to fulfil its obligations under that Directive;
— order the Kingdom of the Netherlands to pay the costs.
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