C-354/99

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COMMISSION v IRELAND

it pain, suffering, distress or lasting harm, drugs, foodstuffs and other substances including any course of action intended, or or products: liable, to result in the birth of an animal in any such condition, but excluding the least painful methods accepted in modern prac- tice (i.e. "humane" methods) of killing or marking an animal; an experiment starts when an animal is first prepared for use and ends when no further observations are (i) for the avoidance, prevention, made for that experiment; the elimination diagnosis or treatment of disease, of pain, suffering, distress or lasting harm ill-health or other abnormality or by the successful use of anaesthesia or their effects on man, animals or analgesia or other methods does not place plants; the use of an animal outside the scope of this definition. Non-experimental agricul- tural or clinical veterinary practice are excluded'.

(ii) for the assessment, detection, reg- ulation or modification of physio- logical conditions in man, animals or plants;

5. Article 3 provides that the Directive is to (b) the protection of the natural environ- apply to the use of animals in experiments ment in the interests of the health or which are undertaken for one of the welfare of man or animal.' following purposes:

6. Article 11 provides as follows:

10. The Act sets out inter alia when 8. Article 25 provides: experiments may or may not be held on animals and the conditions under which they may take place. Section 2 thus pro- vides that an experiment calculated to inflict pain may not be performed unless '1. Member States shall take the measures it is covered by one of the exceptions set necessary to comply with this Directive by out in the Act.

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COMMISSION v IRELAND

11. Section 12A(9) of the Act reads almost take part in performing an experiment. The identically to Article 11 of the Directive: maximum penalty for a first offence is IEP 50 and the maximum penalty for a second offence is IEP 100 or imprisonment for a period not exceeding three months.

'Notwithstanding the other provisions of these regulations where it is necessary for the legitimate purposes of the experiment, the animal concerned may be set free, Section 13 provides that a penalty may be provided that the maximum possible care imposed for the obstruction of certain has been taken to safeguard the animal's investigations. The maximum fine which well-being, as long as its state of health can be awarded in such a case is IEP 5. allows this to be done and there is no danger for public health and the environ- ment.'

pain and the amended 1994 version has not Irish legislation corresponding to Article 11 altered the position in that respect. The of the Directive. Section 12A(9) of the Irish Directive, on the other hand, extends not law omits the reference to the authority. No only to experiments calculated to cause provision is therefore made for the require- pain to the animal but also to experiments ment that the authority must satisfy itself, which may cause suffering, distress or before an animal is set free, that a number lasting harm if such experiments are per- of pre-conditions has been met, and so formed for one of the purposes specified in there is a failure to comply with Article 11 Article 3 of the Directive. In other words, of the Directive. the Directive extends to situations in which there is an objective possibility that pain, suffering, distress or lasting harm may be caused, whereas the Irish legislation, according to its wording, only relates to cases in which the experiment in question is calculated to cause pain. 17. The third complaint relates to the fact that even though the Act provides that the Minister is to establish procedures, Ireland has not established those procedures for the purposes of Article 12(1) of the Directive, or at any rate has not informed the Commission of them. The Commission claims further that the definition of 'experiment' contains a num- ber of important elements which may cause legal uncertainty in the absence of an equivalent definition in the Irish legislation. Reference is made to the fact that the scope of the Irish legislation is restricted to experiments on living animals, while the 18. Lastly, the Commission considers that Directive includes also experiments in the the system of penalties in the Irish legisla- pre-natal phase (and from which the animal tion is ineffective. First, the penalties apply suffers the consequences after its birth) and to only a limited number of offences; furthermore that this legislation does not second, the penalties which can be imposed make it clear as to when an experiment do not have sufficient deterrent effect. The begins and when it ends. amounts of the fines have not been adjusted since 1876. Moreover, the Irish Govern- ment does not penalise infringements of the Directive in the same way as infringements of national law that are of comparable nature and importance. The Commission submits that the transposition of a directive into national law without providing for adequate enforcement of those rules, with 16. The second complaint voiced by the appropriate, adequate penalties, conflicts Commission concerns the provision in the with Article 10 EC.

19. The Irish Government recognises the fate of the animals used for the experi- problem concerning the definition of ments. If an animal is to be released or 'experiment' and that the Irish legislation returned to a herd this must be indicated in does not satisfy all requirements, as sub- the application. Moreover, conditions are mitted by the Commission. It also intends attached to the licence. Lastly, the Irish to bring about the desired adjustments by Government states that the vast majority of means of a legislative amendment. animals are killed humanely after an Although it recognises that there may be experiment. uncertainties regarding the scope of the legislation currently applicable, it submits that the current practice, including the application of the definition of 'experi- ment' in the Act, does in fact fulfil the requirements of the Directive relating to distress or lasting harm. Furthermore, it argues that experiments which may cause suffering, distress or lasting harm also fall 21. As regards the procedure, the Irish within the term 'experiments calculated to Government has pointed out that the inflict pain' in the Irish legislation and procedure in Ireland requires applicants to regulations. notify the ministry in advance of details of the experiments and procedures involved. That follows from the general rules applic- able to licencing procedures. According to the Irish Government, a licence application must contain information concerning the nature of the experiment and its objectives and a detailed protocol must be submitted. Applicants must also state where the experiments are to be carried out, what qualifications they have and what position they hold in the research establishment for which they are undertaking the experi- 20. The Irish Government has indicated ments. that it will introduce amendments in its legislation in order to dispel the concerns expressed by the Commission with regard to the implementation of Articles 11 and 12 of the Directive. Nevertheless, the Irish Government has emphasised that the cur- rent Irish system is restrictive with regard to persons who wish to conduct scientific experiments upon animals. It states that 22. As regards the penalties, the Irish Irish legislation prohibits any experiment Government has indicated that it accepts likely to cause pain, except where the the Commission's complaints and will take Minister considers that such experiments that aspect into account in the proposed are necessary for the furtherance of medical amending legislation. It nevertheless takes science. Moreover, it emphasises that in the the view that a licencing system with the application for a licence to carry out associated possibility of revoking an exist- experiments details must be given of the ing licence has an adequate deterrent effect.

23. It must be pointed out first of all that the Member States should, by 24 Novem- ber 1989, have taken all measures neces- sary to implement the Directive. On a number of occasions after that date Ireland 24. The present case concerns individual has had an opportunity to implement it in elements of the Directive. It is settled case- full. An initial letter was sent by the law that the obligations which the Member Commission as long ago as 1990. The Irish States have when implementing directives Government thereupon let it be known that must be strictly construed. Although the the Directive would be implemented by Member States are free to choose the means means of an amendment to the licencing and methods of implementing a directive, and registration procedure. The Commis- that freedom does not alter the fact that a sion found this to be unsatisfactory and Member State is obliged to take all mea- stated that Ireland was in default. The sures in the framework of its national legal Commission then issued a reason opinion. system that are necessary to ensure the full In reaction the Irish Government amended effect of the Directive in accordance with the law through the European Communi- its intended objective. To that end the ties (Amendment to Cruelty to Animals Act Member States must provide a precise legal 1876) Regulations 1994. After studying framework in the field in question, so that that legislative amendment the Commission the national law corresponds with the came to the conclusion that the Directive provisions of the Directive, with wording had still not yet been correctly implemen- that cannot give rise to doubt or ambiguity. ted. The Commission therefore considered that Ireland had failed to fulfil its obliga- tions and gave the Irish Government a period of two months within which to submit its observations. Ultimately a sup- plementary reasoned opinion was issued on 17 December 1998. In that supplementary reasoned opinion the Commission once again set out the points on which it 25. In my opinion, the Commission has considered that there had been a failure to convincingly demonstrated the importance fulfil obligations and invited the Irish of correctly transposing the concept of Government to take the necessary measures 'experiment' into national legislation. That within a period of two months. In its letter concept is, moreover, a key concept which of reply, dated 16 March 1999, the Irish defines the scope ratione materiae of the Government accepted the Commission's Directive. That is why it is of great point of view and also stated that amending importance that the concept be transposed legislation was being prepared and that it exactly into national legislation. The Irish would be submitted to the Commission for Government has ultimately also accepted its opinion by the end of June 1999. this complaint by the Commission.

28. Furthermore, it is settled case-law that 30. All things considered, the Irish Govern- where Community legislation does not ment's defence cannot withstand the Com- specifically provide any penalty for an mission's arguments. Moreover, these pro- infringement, and in the present case the ceedings have been continuing for some Directive does not do so, the Member time and Ireland has had several opportu- States have a general obligation under nities to achieve the correct implementation Article 10 EC to take all measures neces- of the Directive in its national legal system. sary to ensure the effective application of The Commission's application should, in Community law. To that end the Member my opinion, therefore be upheld. States must in particular ensure that infrin- gements of Community law are penalised under the same substantive and procedural 3 — See. inter alta. Case 68/88 Commission v Greece [1989] conditions as infringements of national law ECR 2965 and Case 326/88 Hansen [1990] ECR I-2911.

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OPINION OF MR GEELHOED — CASE C-354/99

31. In accordance with Article 69(2) of the Since the Commission has applied for costs Rules of Procedure, the unsuccessful party and Ireland has been unsuccessful, I con- must be ordered to pay the costs, if they are sider that the application for costs should asked for in the other party's pleadings. be granted.

Conclusion

Having regard to the above, I propose that the Court should declare that: