JUDGMENT OF THE COURT OF FIRST INSTANCE (Fifth Chamber)
31 January 2006 (*)
(Health policy –Veterinary medicinal products – Products containing benzathine benzylpenicillin – Commission decision ordering suspension of marketing authorisations – Competence)
In Case T‑251/03,
Albert Albrecht GmbH & Co. KG, established in Aulendorf (Germany),
AniMedica GmbH, established in Seden-Bösensell (Germany),
Ceva Tiergensundheit GmbH, established in Düsseldorf (Germany),
Fatro SpA, established in Bologna (Italy),
Laboratorios Syva, SA, established in León (Spain),
Laboratorios Virbac, SA, established in Barcelona (Spain),
Química Farmacéutica Bayer, SA, established in Barcelona,
Univete Técnica Pecuaria Comercio Industria, Lda, established in Lisbon (Portugal),
Vétoquinol Especialidades Veterinarias, SA, established in Madrid (Spain),
Virbac SA, established in Carros (France),
represented by D. Waelbroeck, U. Zinsmeister and N. Rampal, lawyers,
applicants,
supported by
French Republic, represented by G. de Bergues and R. Loosli-Surrans, acting as Agents, with an address for service in Luxembourg,
intervener,
v
Commission of the European Communities, represented by H. Støvlbæk and M. Shotter, acting as Agents, with an address for service in Luxembourg,
defendant,
APPLICATION for annulment of Commission Decision C(2003) 1404 of 22 April 2003 ordering suspension of the marketing authorisations of veterinary medicinal products containing benzathine benzylpenicillin intended to be administered by intramuscular and/or subcutaneous means to food-producing animals,
THE COURT OF FIRST INSTANCE
OF THE EUROPEAN COMMUNITIES (Fifth Chamber),
composed of M. Vilaras, President, E. Martins Ribeiro and K. Jürimäe, Judges,
Registrar: K. Andová, Administrator,
having regard to the written procedure and further to the hearing on 13 September 2005,
gives the following
Judgment
Legal context
1 The legislation concerning the marketing of veterinary medicinal products in the European Union has been codified by Directive 2001/82/EC of the European Parliament and the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ 2001 L 311, p. 1, ‘the VET Code’ or ‘VET’). In accordance with Article 97 thereof, the VET Code came into force on 18 December 2001.
2 The VET Code codifies, inter alia, the provisions of Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products (OJ 1981 L 317, p. 1, ‘Directive 81/851’), as amended by Council Directive 90/676/EEC of 13 December (OJ 1990 L 373, p. 15), Council Directive 93/40/EEC of 14 June 1993 (OJ 1993 L 214, p. 31) and Commission Directive 2000/37/EC of 5 June 2000 (OJ 2000 L 139, p. 25) ( ‘Directive 81/851, as amended’).
3 Directive 81/851, as amended, constitutes the transposition, in the veterinary sphere, of the Community legislation relating to medicinal products for human use contained in Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (OJ 1975 L 147, p. 13), as amended by, in particular, Council Directive 93/39/EEC of 14 June 1993 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products (OJ 1993 L 214, p. 22) (‘Directive 75/319, as amended’). This Directive 75/319, as amended, was, like Directive 81/851, as amended, codified, in this case by Directive 2001/83/EC of the European Parliament and the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67, ‘the HUM code’ or ‘HUM’).
4 In particular, Articles 16 to 23c of Directive 81/851, as amended (corresponding to Articles 31 to 43 VET) constitute the counterpart, worded in almost identical terms, in the sphere of veterinary medicinal products, to Articles 8 to 15c of Directive 75/319, as amended (corresponding to Articles 27 to 39 HUM), applicable in the sphere of medicinal products for human use.
5 It follows from Article 5 VET that no medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities of that Member State in accordance with the VET Code, or by the Community in accordance with Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (OJ 1993 L 214, p. 1). In accordance with Article 74 thereof, the essential provisions of Regulation 2309/93 entered into force on 1 January 1995.
Marketing authorisation procedures
6 There are three procedures for marketing authorisation for veterinary medicinal products: the decentralised Community procedure, the centralised Community procedure and the national procedure.
7 The decentralised Community procedure was established by Directive 93/40, with effect from 1 January 1995. It is governed by Articles 32 and 33 VET (corresponding to Articles 17 and 18 of Directive 81/851, as amended) and is based on the principle of mutual recognition.
8 This procedure begins with an application for a national marketing authorisation made to a Member State (the ‘reference Member State’). The issuing of this marketing authorisation takes place at national level, in conditions originally harmonised by Directive 81/851, those conditions having since been codified, essentially, in Chapters 1 (‘Marketing authorisation’) and 3 (‘Procedures relevant to the marketing authorisation’) of Title III VET (‘Placing on the market’).
9 The holder of the national marketing authorisation thus issued then applies for its recognition in one or more other Member States, in accordance with Article 32 VET in Chapter 4 (‘Mutual recognition of authorisations’) of Title III VET (‘Chapter 4 of Title III VET’ or ‘Chapter 4 VET’). That Member State or those Member States may refuse recognition only on grounds of risk to human or animal health or the environment (Articles 32(4) and 33(1) VET). If such a risk is alleged and the Member States concerned do not agree on the action to be taken in respect of the application for recognition, the matter is referred for an opinion to the Committee for Veterinary Medicinal Products (‘the CVMP’), which is part of the European Agency for the Evaluation of Medicinal Products (‘EMEA’) (Articles 33(2) and 36 VET), following which the Commission or the Council is required to take a decision (Articles 37, 38 and 89(2) VET).
10 The centralised Community procedure was instituted by Regulation No 2309/93. Under this procedure, the marketing authorisation application is sent to EMEA and leads to the grant of a marketing authorisation by decision either of the Commission or of the Council, taken on the advice of the CVMP. This procedure is obligatory for medicinal products developed by means of certain biotechnological processes and optional for other innovative medicinal products. It does not concern this action.
11 The national procedure is the result of the approximation of national laws made by Directive 81/851. The only procedure in existence before the entry into force, on 1 January 1995, of the centralised and decentralised Community procedures, it has no longer applied since 1 January 1998 except where the medicinal product is intended to be marketed in only one Member State (Article 8a of Directive 81/851, corresponding to Article 22 VET, as added by Article 1(7) of Directive 93/40). Since then, the lodging, in respect of a medicinal product already authorised in one Member State, of an application for a marketing authorisation in another Member State has automatically set in motion the mutual recognition procedure. The issue of a marketing authorisation as part of the national procedure is carried out in the harmonised conditions referred to in paragraph 8 above.
Provisions at issue in this case
12 Chapter 4 (‘Mutual recognition of authorisations’) of Title III VET (‘Placing on the market’) contains the following provisions:
‘Article 31 [corresponding to Article 16 of Directive 81/851, as amended]
1. In order to facilitate the adoption of common decisions by Member States on the authorisation of veterinary medicinal products on the basis of the scientific criteria of quality, safety and efficacy, and to achieve thereby the free movement of veterinary medicinal products within the Community, a [CVMP] is hereby set up. The [CVMP] shall be part of the [EMEA].
2. In addition to the other responsibilities conferred upon it by Community law, the [CVMP] shall examine any question relating to the granting, variation, suspension or withdrawal of the marketing authorisation which is submitted to it in accordance with this Directive.
…
Article 32 [corresponding to Article 17 of Directive 81/851, as amended]
1. Before submitting the application for recognition of a marketing authorisation, the holder of the authorisation shall inform the Member State which granted the authorisation on which the application is based (hereinafter “the reference Member State”), that an application is to be made in accordance with this Directive and shall notify it of any additions to the original dossier; …
In addition the holder of the authorisation shall request the reference Member State to prepare an assessment report in respect of the veterinary medicinal product concerned, or, if necessary, to update it …
At the same time as the application is submitted in accordance with paragraph 2, the reference Member State shall forward the assessment report to the Member State or Member States concerned by the application.
2. In order to obtain the recognition according to the procedures laid down in this Chapter in one or more of the Member States of a marketing authorisation issued by a Member State, the holder of the authorisation shall submit an application to the competent authorities of the Member State or Member States concerned, together with the information and particulars referred to in Articles 12, 13(1), 14 and 25. He shall testify that the dossier is identical to that accepted by the reference Member State, or shall identify any additions or amendments it may contain. …
3. The holder of the marketing authorisation shall transmit the application to the [EMEA], inform it of the Member States concerned and of the dates of submission of the application and send it a copy of the authorisation granted by the reference Member State. He shall also send the [EMEA] copies of any such authorisation which may have been granted by the other Member States in respect of the medicinal product concerned, and shall indicate whether any application for authorisation is currently under consideration in any Member State.
4. Save in the exceptional case provided for in Article 33(1), each Member State shall recognise the marketing authorisation granted by the reference Member State within 90 days of receipt of the application and the assessment report. It shall inform the reference Member State which granted the initial authorisation, the other Member States concerned by the application, the [EMEA], and the holder of the marketing authorisation.
Article 33 [corresponding to Article 18 of Directive 81/851, as amended]
1. Where a Member State considers that there are grounds for supposing that the marketing authorisation of the veterinary medicinal product concerned may present a risk to human or animal health or the environment, it shall forthwith inform the applicant, the reference Member State, any other Member States concerned by the application and the [EMEA]. The Member State shall state its reasons in detail and shall indicate what action may be necessary to correct any defect in the application.
2. All the Member States concerned shall use their best endeavours to reach agreement on the action to be taken in respect of the application. … However, if the Member States have not reached agreement within the time-limit referred to in Article 32(4) they shall forthwith refer the matter to the [EMEA] for referral to the [CVMP] for the application of the procedure laid down in Article 36.
3. Within the time-limit referred to in Article 28(4), the Member States concerned shall provide the [CVMP] with a detailed statement of the matters on which they have been unable to reach agreement and the reasons for their disagreement
Article 34 [corresponding to Article 19 of Directive 81/851, as amended]
If several applications submitted in accordance with Articles 12, 13(1) and 14 have been made for marketing authorisation for a particular veterinary medicinal product and Member States have adopted divergent decisions concerning the authorisation of that veterinary medicinal product, or suspension or withdrawal of that authorisation, a Member State, or the Commission, or the marketing authorisation holder may refer the matter to the [CVMP] for application of the procedure laid down in Article 36.
The Member State concerned, the marketing authorisation holder or the Commission shall clearly identify the question which is referred to the [CVMP] for consideration and, if appropriate, shall inform the aforementioned holder thereof.
The Member States and the marketing authorisation holder shall forward to the [CVMP] all available information relating to the matter in question.
Article 35 [corresponding to Article 20 of Directive 81/851, as amended]
The Member States or the Commission or the applicant or holder of the marketing authorisation may, in specific cases where the interests of the Community are involved, refer the matter to the [CVMP] for the application of the procedure laid down in Article 36 before reaching a decision on a request for a marketing authorisation or on the suspension or withdrawal of an authorisation, or on any other variations to the terms of a marketing authorisation which appears necessary, in particular to take account of the information collected in accordance with Title VII.
The Member State concerned or the Commission shall clearly identify the question which is referred to the [CVMP] for consideration and shall inform the marketing authorisation holder.
The Member States and the holder shall forward to the [CVMP] all available information relating to the matter in question
Article 36 [corresponding to Article 21 of Directive 81/851, as amended]
1. When reference is made to the procedure described in this Article, the [CVMP] shall consider the matter concerned and issue a reasoned opinion within 90 days of the date on which the matter was referred to it.
...
3. In the cases referred to in Articles 33 and 34, before issuing its opinion, the [CVMP] shall provide the marketing authorisation holder with an opportunity to present written or oral explanations.
In the case referred to in Article 35, the marketing authorisation holder may be asked to explain himself orally or in writing.
...
4. The [EMEA] shall forthwith inform the marketing authorisation holder where the opinion of the [CVMP] is that:
– the application does not satisfy the criteria for authorisation,
or
– the summary of the product characteristics proposed by the applicant in accordance with Article 14 should be amended,
or
– the authorisation should be granted subject to conditions, with regard to conditions considered essential for the safe and effective use of the veterinary medicinal product including pharmacovigilance,
or
– a marketing authorisation should be suspended, varied or withdrawn.
... [T]he holder may notify the [EMEA] in writing of his intention to appeal. ... [T]he [CVMP] shall consider whether its opinion should be revised, and the conclusions reached on the appeal shall be annexed to the assessment report referred to in paragraph 5.
5. Within 30 days of its adoption, the [EMEA] shall forward the final opinion of the [CVMP] to the Member States, the Commission and the marketing authorisation holder together with a report describing the assessment of the veterinary medicinal product and the reasons for its conclusions.
...
Article 37 [corresponding to Article 22(1) of Directive 81/851, as amended]
Within 30 days of receipt of the opinion, the Commission shall prepare a draft of the decision to be taken in respect of the application, taking into account Community law.
...
Where, exceptionally, the draft decision is not in accordance with the opinion of the [EMEA], the Commission shall also annex a detailed explanation of the reasons for the differences.
The draft decision shall be forwarded to the Member States and the applicant.
Article 38 [corresponding to Article 22(2) to (4) of Directive 81/851, as amended]
1. A final decision on the application shall be adopted in accordance with the procedure referred to in Article 89(2).
...
3. A decision as referred to in paragraph 1 shall be addressed to the Member States concerned by the matter and communicated to the marketing authorisation holder. The Member States shall either grant or withdraw marketing authorisation, or vary the terms of a marketing authorisation as necessary to comply with the decision within 30 days of its notification. They shall inform the Commission and the [EMEA] thereof.
Article 39 [corresponding to Article 23 of Directive 81/851, as amended]
1. Any application by the marketing authorisation holder to vary a marketing authorisation which has been granted in accordance with the provisions of this Chapter shall be submitted to all the Member States which have previously authorised the veterinary medicinal product concerned.
...
2. In case of arbitration submitted to the Commission, the procedure laid down in Articles 36, 37 and 38 shall apply by analogy to variations made to marketing authorisations.
Article 40 [corresponding to Article 23a of Directive 81/851, as amended]
1. Where a Member State considers that the variation of the terms of a marketing authorisation which has been granted in accordance with the provisions of this Chapter or its suspension or withdrawal is necessary for the protection of human or animal health or the environment, the Member State concerned shall forthwith refer the matter to the [EMEA] for the application of the procedures laid down in Articles 36, 37 and 38.
2. Without prejudice to the provisions of Article 35, in exceptional cases, where urgent action is essential to protect human or animal health or the environment, until a definitive decision is adopted, a Member State may suspend the marketing and the use of the veterinary medicinal product concerned on its territory. It shall inform the Commission and the other Member States no later than the following working day of the reasons for its action.’
Background to the dispute
13 The applicants are holders of marketing authorisations issued in accordance with the national procedure for veterinary medicinal products containing benzathine benzylpenicillin, an antibiotic used in injectable medicinal products for food-producing animals.
14 By letter of 3 October 2001 the Irish Medicines Board notified the EMEA of a referral to the CVMP under Article 20 of Directive 81/851, as amended (corresponding to Article 35 VET). The reason for this referral was the decision taken by the Advisory Committee for Veterinary Medicines of the Irish Medicines Board to suspend the marketing authorisations for three medicinal products of the abovementioned type on the basis of the fact that the withdrawal period for slaughter of treated animals was inadequate and residues of benzylpenicillin above the maximum residue limits (‘MRLs’) remained in tissues of treated animals beyond the expiry of the withdrawal period. The purpose of the referral to the CVMP was to obtain the EMEA’s opinion as to whether the withdrawal period ought to be extended from the standpoint of the Community interest in protecting consumer safety. The letter from the Irish Medicines Board stated that it was a class action referral, that is to say, a referral applying to all injectable veterinary medicinal products containing the aforementioned substance.
15 By letters of 15 November 2001 the CVMP informed the applicants that a referral procedure had been initiated by Ireland. In those letters, the CVMP requested the applicants to answer certain questions and to pay a fee of EUR 10 000 to the EMEA in accordance with Article 6 of Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the [EMEA] (OJ 1995 L 35, p. 1), as amended by Council Regulation (EC) No 2743/98 of 14 December 1998 (OJ 1998 L 345, p. 3).
16 By application lodged at the Court Registry on 25 January 2002, the applicants brought an action for annulment of the decisions contained in the letters of 15 November 2001 requesting them to answer certain questions and to pay the aforementioned fee. The applicants having, however, by letters of 12, 13, 24 and 31 August 2004, 18 November 2004 and 17 January 2005, withdrawn that action, the case was removed from the register by order of the President of the Fifth Chamber of the Court of First Instance of 8 March 2005 in Case T-19/02 Albrecht and Others v Commission and EMEA (not published in the ECR).
17 On 2 October 2002 the CVMP adopted its reasoned opinion pursuant to Article 36 VET. In that opinion, the CVMP proposed that the marketing authorisations of veterinary medicinal products containing benzathine benzylpenicillin should be suspended.
18 On 21 October 2002 all the applicants lodged an appeal against that opinion before the CVMP pursuant to the final subparagraph of Article 36(4) VET.
19 Having re-examined its original opinion, the CVMP on 15 January 2003 adopted its final opinion, containing the same proposal as the original opinion, namely, suspension of the marketing authorisations of veterinary medicinal products containing benzathine benzylpenicillin.
20 On 22 April 2003 the Commission adopted, pursuant to Articles 37 and 38 VET, Decision C(2003) 1404 ordering suspension of the marketing authorisations of veterinary medicinal products containing benzathine benzylpenicillin intended to be administered by intramuscular and/or subcutaneous means to food-producing animals (‘the contested decision’). By that decision the Commission required the Member States concerned, listed in Article 5 of the decision, to suspend the national marketing authorisations, referred to in Annex I to the decision, that they had granted for the veterinary medicinal products in question.
Procedure and forms of order sought by the parties
21 By application lodged at the Registry of the Court of First Instance on 2 July 2003 the applicants brought the present action.
22 By document lodged at the Court Registry on 14 November 2003 the French Republic sought leave to intervene in these proceedings in support of the forms of order sought by the applicants. By order of 18 December 2003 the President of the Fourth Chamber of the Court of First Instance granted leave to intervene. The intervener lodged its statement in intervention on 16 February 2004.
23 The composition of the Chambers of the Court of First Instance having been altered from 13 September 2004, the Judge-Rapporteur was attached, as President, to the Fifth Chamber to which this case was therefore assigned.
24 Upon hearing the report of the Judge-Rapporteur, the Court of First Instance (Fifth Chamber) decided to open the oral procedure.
25 The main parties presented their oral argument and their answers to the questions put by the Court of First Instance at the hearing of 13 September 2005. The intervener was not present at the hearing, of which fact formal note was taken in the record of the hearing.
26 The applicants claim that the Court of First Instance should:
– annul the contested decision;
– in the alternative, declare the contested decision non-existent;
– order the Commission to pay the costs.
27 The Commission contends that the Court should:
– reject the action as unfounded;
– order the applicants to pay the costs.
28 The French Republic claims that the Court should:
– annul the contested decision;
– order the Commission to pay the costs.
Law
29 The applicants put forward three pleas in law in support of the claim for annulment. The first plea is divided into two parts, one principal and the other subsidiary. The first part is based on the Commission’s lack of competence to adopt a binding decision under Articles 37 and 38 VET, following a referral to the CVMP pursuant to Article 35 VET. The second alleges that, under Article 35 VET, the Commission’s decision-making power is limited to medicinal products authorised in accordance with the mutual recognition procedure alone. The second plea in law alleges that it is unlawful to initiate the procedure provided in Article 35 VET in the form of a class action. The third plea alleges lack of Community interest in this case.
30 The Court of First Instance considers it appropriate to begin by examining the first part of the first plea, which alleges that the Commission lacked competence to adopt a decision pursuant to Articles 37 and 38 VET following a referral to the CVMP under Article 35 VET.
Arguments of the parties
31 The applicants claim that it was not open to the Commission to adopt the contested decision, for Article 35 VET did not confer on it the power to take decisions harmonising, as in this case, national marketing authorisations. That follows from the judgment of the Court of First Instance in Joined Cases T-74/00, T-76/00, T-83/00, T-84/00, T-85/00, T-132/00, T-137/00 and T-141/00 Artegodan and Others v Commission [2002] ECR II-4945 (‘the judgment in Artegodan’), and Case T-147/00 Laboratoires Servier v Commission [2003] ECR II-85 (‘the judgment in Servier’), given in the sphere of medicinal products for human use and in the context of Directive 75/319, as amended (cited in paragraph 3, above).
32 It is in vain that the Commission claims that the judgment in Artegodan is not relevant in the present case, on the grounds, first, that that judgment concerned the procedure laid down in Article 15a of Directive 75/319, as amended (to which, in the veterinary sphere and following codification, Article 40 VET corresponds), and not that laid down in Article 12 of that directive (to which Article 35 VET corresponds), and, second, that the reasoning in that judgment concerning the latter procedure constitutes an obiter dictum which the Court of Justice did not reproduce in its judgment in Case C-39/03 P Commission v Artegodan and Others [2003] ECR I-7885.
33 The applicants challenge the interpretation put forward by the Commission, that Article 35 VET confers on it by implication the power to take decisions on the basis of a general competence of the Community to adopt binding decisions in specific cases where the Community interest is at stake. In the absence of any express provision granting such power to the Commission, they submit that the principle set out in the first paragraph of Article 5 EC precludes an interpretation of Article 35 VET to the effect that it implicitly empowers the Commission to adopt a binding decision under the procedure provided for in Articles 37 and 38 VET.
34 Furthermore, the applicants argue that Article 31(1) VET does not support an interpretation of Article 35 VET to the effect that it establishes an arbitration procedure or that the opinion issued by the CVMP is binding on the Member States. On the contrary, Article 31(1) VET merely states that the CVMP has been set up in order to facilitate the adoption of common decisions by the Member States. It does not support the conclusion that the CVMP’s opinions should automatically be followed by a binding decision by the Commission.
35 The Member States are not indirectly to be deprived of their competence in relation to purely national marketing authorisations just because one of them, or the holder of or applicant for marketing authorisation, or yet the Commission, should decide to initiate the procedure under Article 35 VET. The concept of the interests of the Community in that provision merely provides grounds for a referral to the CVMP, but does not justify any transfer of decision-making power to the Commission.
36 In any case, the consultative nature of the procedure under Article 35 VET does not affect the chief purpose of the VET Code, namely, the protection of public health, which is guaranteed by the obligation of the national authorities to suspend or withdraw marketing authorisations when, in particular, the medicinal product is harmful or the withdrawal period between the last administration of the medicinal product to the animal and the obtaining of foodstuffs from that animal is not long enough.
37 The applicants therefore see no reason to depart from the approach taken in the judgment in Artegodan.
38 The French Republic, though supporting the applicants in declaring that the Commission has no decision-making power in the context of Article 35 VET, has not, however, put forward argument on that point in connection with the first part of the first plea in law but only in connection with the second part of that plea.
39 The Commission states, first of all, that the appeal against the judgment in Artegodan was decided by the Court of Justice in its judgment in Commission v Artegodan and Others, paragraph 32 above, on a point of law concerning the interpretation to be given to Article 15a of Directive 75/319, as amended (to which Article 40 VET corresponds). The Court did not rule on whether the Commission could base a binding decision on Article 12 of that directive (to which Article 35 VET corresponds). The Artegodan case related to a different procedure, with which, in the Commission’s view, the Court of First Instance is not at all concerned in the present proceedings. The reasoning in the judgment in Artegodan concerning the procedure under Article 12 and more generally concerning the scheme of Chapter III of Directive 75/319, as amended, is thus obiter dictum. Moreover, it is clear from paragraph 47 of the judgment in Commission v Artegodan and Others that the Court of Justice was prepared, at the very least, to entertain the assumption that Article 15a of Directive 75/319, as amended, applied to marketing authorisations ‘subject to another harmonisation procedure’, but that the harmonisation brought about by the Commission’s decision of 9 December 1996, referred to in paragraphs 17 and 20 to 25 of the judgment in Artegodan, being only ‘partial’, did not satisfy the requirements of that article. Those comments, whether they are treated as obiter dicta or as an integral part of the judgment of the Court of Justice, serve to highlight the fact that the Court departed from the reasoning employed in the judgment in Artegodan.
40 Next, the Commission notes that the judgment in Servier was given before the judgment in Commission v Artegodan and Others, paragraph 32 above. Inasmuch as it is appropriate to evaluate the weight to be given to the Court of First Instance’s reasoning in the judgment in Artegodan in the light of the judgment on appeal, all reference to the judgment in Servier is quite irrelevant.
41 In addition to those arguments touching the relevance of the judgments in Artegodan and Servier to this case, the Commission invites the Court of First Instance to depart from the approach adopted in the judgment in Artegodan.
42 In that judgment, the Court of First Instance examined the matter of the interpretation of Article 12 of Directive 75/319, as amended, through the prism of competence. Now, such an examination, according to the defendant, must be undertaken only with the greatest care. With the exception of the French Republic, it is not the Member States that have raised this question of competence in the present case, but the holders of marketing authorisations affected by the contested decision. This might be attributable to the fact that Member States have given the Community the power to adopt binding decisions only where the interests of the Community are at stake.
43 According to the Commission, the applicants seek to present the question of competence in terms of black and white: on the one hand, purely national marketing authorisations, which fall within the ambit of the competence of the Member States and, on the other, those marketing authorisations which come under the decentralised or centralised Community authorisation procedures, which are matters within the competence of the Community. However, such a basic distinction is unfounded.
44 In contrast, the Commission considers that the Community is competent even in respect of purely national marketing authorisations once the interests of the Community are at stake. The only question is whether, in each individual case, there exist such interests.
45 Relying on the second and third recitals in the preamble to the VET Code, and on Article 31(1) VET which it describes as the central provision of Chapter 4 VET, the Commission notes that the purpose of the VET Code is not only to safeguard public health but also to achieve the free movement of medicinal products within the Community.
46 The common decisions the adoption of which by the Member States is to be facilitated, as provided in Article 31(1)VET, are not only those taken under the mutual recognition procedure. Nothing in Article 31(1) VET indicates that for certain procedures under Chapter 4 VET (Articles 32, 33, 39 and 40 VET) the Community authorities deemed it necessary to provide for the adoption by the Commission of a binding decision, whereas for other procedures under the same chapter (Articles 34 and 35 VET) a common decision could not be required, but merely aspired to. Quite apart from the fact that the divergent national decisions that might be adopted at the term of a procedure under Article 35 VET not followed by a binding decision by the Commission are not common decisions within the meaning of Article 31 VET, such decisions cannot in any way be said to enable the free movement of medicinal products within the Community. The verb ‘facilitate’, used in Article 31(1) VET, does not, as the applicants suggest, mean that CVMP opinions are not to be followed automatically by a binding decision, but simply reflects the fact that it is not the CVMP that adopts the binding decision.
47 The fact that there is only an option and not an obligation to initiate the procedure under Article 35 VET has no bearing on whether, when such discretion has been exercised, the Commission may adopt a binding decision. Once the procedure under Article 35 VET has been initiated, there needs to be the endorsement that a Community interest is actually involved, which can be provided only by a binding decision by the Commission. That is a question of policy that can be tested and endorsed only within the decision-making process laid down by the VET Code. This interpretation is in keeping with the twofold objective set out in the second and third recitals in the preamble to the VET Code, and also with the legal basis of the VET Code, namely, Article 95 EC. The Commission fails to see how the effectiveness of the procedure under Article 35 VET can be ensured by an interpretation that limits its scope to the consultation of the CVMP, leaving each Member State free to decide what action to take on the basis of the CVMP’s opinion, and therefore making impossible to rule out the possibility that a product might continue to be marketed in some Member States, despite the dangers identified in the CVMP’s opinion.
48 In reliance on considerations relating to the codification mechanism, the Commission suggests that the heading of Chapter 4 VET, viz, ‘Mutual recognition of authorisations’, which replaced the former heading ‘Committee for Veterinary Medicinal Products’, must, like that former heading, be understood in a broad sense, that is to say, as not covering solely the procedure under Article 32 VET, which is no more than a particular mechanism of mutual recognition triggered by the holder of the marketing authorisation, but also the other procedures under Chapter 4 VET, including that under Article 35 VET.
49 Last, the Commission disputes the importance attached by the Court of First Instance in paragraph 146 of its judgment in Artegodan to the differences, with regard to the information required, between the procedures under Articles 11 and 12 of Directive 75/319, as amended, and the procedure under Article 10(2) of that directive. Those divergences do not point to an essential difference between the procedures which would confirm the purely consultative nature of the procedures under Articles 34 and 35 VET.
50 For all those reasons, the Commission takes the view that the practical effectiveness of the procedure under Article 35 VET requires it to be accompanied by a binding decision. The Commission believes that the same may be said, and for the same reasons, of the procedure under Article 34 VET.
Findings of the Court
51 By the first part of the first ground of annulment, the applicants claim that the Commission had no power, following a referral to the CVMP under Article 35 VET, to adopt pursuant to Articles 37 and 38 VET a decision binding on the Member States.
52 It is to be noted that that point was the subject of consideration in the judgments in Artegodan and Servier in proceedings similar to those in the present case, but taking place in the context not of veterinary medicinal products and Directive 81/851, as amended, but of medicinal products for human use and Directive 75/319, as amended.
53 In the judgment in Artegodan the Court of First Instance annulled three decisions of the Commission ordering the withdrawal of marketing authorisations, granted in accordance with the national procedure, for certain anorectic medicinal products.
54 The national marketing authorisations concerned in that case had been amended by the Member States concerned, as a result of a decision of the Commission of 9 December 1996, based on Article 14 of Directive 75/319, as amended (corresponding to Articles 37 and 38 VET) and taken after consultation of the Committee for Proprietary Medicinal Products (‘the CPMP’) under Article 12 of that directive (corresponding to Article 35 VET) (‘the decision of 9 December 1996’) (the judgment in Artegodan, paragraphs 17 and 20 to 25).
55 Taking the view that those marketing authorisations had been harmonised in part by the decision of 9 December 1996 (the judgment in Artegodan, paragraphs 107 and 120), the Commission considered that they no longer fell within the exclusive competence of the Member States and that that decision had had the effect of transferring to the Community competence to decide, henceforth, on their withdrawal, variation or suspension.
56 Thus it was that by several decisions of 9 March 2000 (‘the decisions of 9 March 2000’), which were those at issue in the proceedings giving rise to the judgment in Artegodan, the Commission, acting on the basis of referrals by Member States under Article 15a of Directive 75/319, as amended, and following the procedure governed by Articles 13 and 14 of that directive (to which Article 36 VET and Articles 37 and 38 VET, respectively, correspond), ordered the withdrawal of those marketing authorisations on grounds of public health.
57 The Court of First Instance annulled those decisions in its judgment in Artegodan.
58 The Court noted, first of all, that it was common ground between the parties that the marketing authorisations of the medicinal products referred to by the decisions of 9 March 2000 had been granted, and in some cases renewed, in accordance with the national procedures applicable in the various Member States concerned, and not in accordance with the mutual recognition procedure coupled with arbitration procedures, provided for in Chapter III of Directive 75/319, as amended (the judgment in Artegodan, paragraph 113).
59 The Court concluded therefrom that, ‘leaving aside the decision of 9 December 1996, those authorisations were thus purely national’ and that ‘the suspension, variation or withdrawal of those authorisations therefore came, at the time when the contested decisions were adopted [9 March 2000], within the exclusive competence of the Member States concerned, a competence which, following the introduction of the mutual recognition procedure by Directive 93/39, is essentially residual’ (judgment in Artegodan, paragraph 114). According to the interpretation of the Community legislation given by the Court, ‘since 1 January 1995 that exclusive competence [of the Member States] has been restricted to, first, the grant and management of marketing authorisations for medicinal products marketed solely in a single Member State and, second, the management of purely national marketing authorisations granted before that date or during the transitional period from 1 January 1995 to 31 December 1997’ (judgment in Artegodan, paragraph 116).
60 The Court went on to examine the question whether, following their amendment pursuant to the decision of 9 December 1996, the marketing authorisations for the medicinal products at issue fell within the ambit of Article 15a(1) of Directive 75/319, as amended, which constitutes the legal basis on which the Commission adopted the decisions of 9 March 2000. Finding that that provision referred only to marketing authorisations granted in accordance with the provisions of Chapter III of that directive, that is to say, in accordance with the mutual recognition procedure, the Court interpreted it as meaning that ‘the variation, suspension or withdrawal of such marketing authorisations, on the initiative of a Member State with a view to the protection of public health, falls within the exclusive competence of the Commission, when adopting a decision following a CPMP opinion in accordance with the procedures laid down in Articles 13 and 14 of Directive 75/319[, as amended],’ whereas, ‘[c]onversely, the variation, suspension and withdrawal of marketing authorisations which do not fall within the ambit of Article 15a remain, in principle, subject to the exclusive competence of the Member States’ (judgment in Artegodan, paragraph 121)
61 The Court considered that, the wording of Articles 12 and 15a of Directive 75/319 providing no clear guidance, it was necessary to consider whether, in the scheme of Chapter III of that directive and in the light of the aims of that directive, Article 15a(1), in conjunction with Article 12, could be construed as also applying to national marketing authorisations which had been harmonised under Article 12 (judgment in Artegodan, paragraph 125).
62 To that end, the Court examined the question as to which authority is competent to adopt a decision following an opinion of the CPMP under Article 12 of Directive 75/319, as amended, an article which does no more than provide expressly for the application of the consultative procedure governed by Article 13 of that directive and does not refer to Article 14 of that directive also. It held, in this regard, that Article 12 of Directive 75/319, as amended, ‘is intended to apply in the residual field of exclusive competence of the Member States, or when the initial marketing authorisation of a medicinal product is granted by the reference Member State’ (judgment in Artegodan, paragraph 142), and that it ‘cannot be interpreted as implicitly empowering the Commission to adopt a binding decision under the procedure set out in Article 14’ of that directive (judgment in Artegodan, paragraph 147), unlike Article 10(2) which, although also referring to the consultative procedure laid down in Article 13, nevertheless forms part of a different context, that of the mutual recognition procedure (judgment in Artegodan, paragraphs 130 to 133). The Court reached these conclusions by means of an interpretative approach based, in particular, on the scheme of Chapter III of Directive 75/319, as amended, and on the objectives sought by that directive.
63 Taking notice of the fact that the decision of 9 December 1996 had been complied with by the Member States concerned, the Court considered it necessary nevertheless to establish whether, in the scheme of Chapter III of Directive 75/319, as amended, authorisations harmonised by the Member States following consultation of the CPMP under Article 12 of Directive 75/319 could nevertheless be placed on the same footing as marketing authorisations granted in accordance with the provisions of Chapter III (judgment in Artegodan, paragraph 148).
64 In this connection, the Court found that, ‘in the absence of an express provision, the principle, set out in the first paragraph of Article 5 EC, that the Community is to act within the limits of the powers conferred upon it, precludes an interpretation of Article 15a(1) of Directive 75/319[, as amended,] to the effect that the harmonisation of certain marketing authorisations, in accordance with a non-binding opinion of the CPMP under Article 12 of that directive, can have the effect of depriving the Member States concerned of their powers, by triggering the application of the arbitration procedure provided for in Article 15a in respect of the adoption of any subsequent decision regarding the suspension or withdrawal of such authorisations’ (judgment in Artegodan, paragraph 150). It held therefore that, ‘in the scheme of Directive 75/319[, as amended,] the concept of a marketing authorisation granted in accordance with the provisions of Chapter III of that directive, referred to in Article 15a(1), cannot be interpreted as also including authorisations harmonised following consultation of the CPMP under Article 12’ (judgment in Artegodan, paragraph 155).
65 The Court accordingly concluded that the decisions of 9 March 2000 had no legal basis and that the plea in law alleging that the Commission lacked competence was well founded.
66 In Servier, the Court applied to a similar situation the solution adopted in its judgment in Artegodan (see, in particular, paragraphs 57 to 63, which refer expressly to the judgment in Artegodan).
67 The Commission appealed against the judgments in Servier and Artegodan, complaining that the Court had denied that it was competent to adopt a decision pursuant to Article 14 of Directive 75/319, as amended, following a procedure initiated under Article 12 of that directive.
68 In its judgment in Commission v Artegodan and Others, paragraph 32 above, the Court of Justice, sitting as a full court, dismissed the appeal against the judgment in Artegodan, basing its assessment not on Article 12 of Directive 75/319, as amended, but on Article 15a thereof, which constitutes the legal basis for the decisions of 9 March 2000. The Court held:
‘44 … [I]t should be noted that the decisions at issue were adopted solely on the basis of Article 15a of Directive 75/319.
45 According to its wording, Article 15a of Directive 75/319[, as amended,] applies to marketing authorisations which have been granted in accordance with the provisions of Chapter III of that directive.
46 The Court of First Instance found, and this was not contested by the Commission, that the marketing authorisations whose withdrawal was ordered by the decisions [of 9 March 2000] were initially granted under purely national procedures.
47 Assuming that the purpose of Article 15a of Directive 75/319[, as amended,] is to be interpreted broadly and the provision can thus be held to apply to marketing authorisations which have not been granted under Chapter III but which have been the subject of another harmonisation procedure, it becomes necessary in the present case to determine whether the decision [of 9 December 1996] can be regarded as having brought about such harmonisation.
48 It is common ground that the decision [of 9 December 1996] merely ordered the amendment of certain terms of the initial marketing authorisations, namely the clinical particulars which, along with other data, must be included in the summary of product characteristics in accordance with point 5 of Article 4a of Council Directive 65/65/EEC [of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (OJ, English Special Edition 1965-1966, p. 20)].
49 A partial amendment of that kind cannot amount to an authorisation granted in accordance with the provisions of Chapter III of Directive 75/319[, as amended].
50 It is therefore of no importance whether that partial amendment of the marketing authorisations of the medicinal products in question was the result of compliance with a binding decision or of voluntary harmonisation by the Member States.
51 It follows that Article 15a of Directive 75/319[, as amended,] could not be used as a legal basis for the decisions [of 9 March 2000].
52 In those circumstances, and without its being necessary to rule on the other pleas and arguments put forward by the Commission, the Court finds that the Court of First Instance was right to hold that the Commission lacked the competence to adopt the decisions [of 9 March 2000] and that, accordingly, those decisions had to be annulled.’
69 In its order of 1 April 2004 in Case C-156/03 P Commission v Laboratoires Servier, not published in the European Court Reports, the Court of Justice, following the line of reasoning adopted in its judgment in Commission v Artegodan and Others, paragraph 32 above, dismissed, for the same reasons, the appeal against the judgment in Servier as manifestly unfounded (paragraphs 38 to 48 of the order).
70 The Court of First Instance finds, first, that the judgment in Artegodan has been rendered definitive by the dismissal of the appeal brought against it. It is apparent from the grounds of that judgment, transposed, mutatis mutandis, to the sphere of veterinary medicinal products, that referrals to the CVMP under Article 35 VET cannot lead to a binding decision of the Commission under Articles 37 and 38 VET, but only to an opinion of the CVMP.
71 The Court of First Instance finds, however, that the Court of Justice did not explicitly adopt a position on those grounds of the judgment in Artegodan.
72 That is the context in which the Commission contends that the approach adopted in the judgment in Artegodan is irrelevant to the present case and argues that it is in any event necessary to reverse the position adopted in that judgment.
73 It is appropriate, first, to consider the Commission’s argument that the judgment in Artegodan has no bearing on the instant case – because the procedure at issue in that judgment related to Article 15a of Directive 75/319, as amended, and not to Article 12 thereof – and indeed has been called in question by the Court of Justice.
74 It is, admittedly, true that the decisions of 9 March 2000, challenged in the Artegodan case, were taken on the basis of Article 15a of Directive 75/319, as amended, and that the Court of Justice did not tackle the question of the Commission’s competence to adopt the decision of 9 December 1996 following a referral under Article 12 of that directive.
75 Nevertheless, although that may mean that, for the Court of Justice, the grounds of the judgment in Artegodan relating to the Commission’s lack of decision-making competence in the context of Article 12 of Directive 75/319, as amended, were not essential to the outcome of the dispute in the Artegodan case, but rather constituted obiter dicta, that does not mean that those grounds were regarded by the Court as incorrect or indeed that they are irrelevant to the present case.
76 The fact that in paragraph 50 of the judgment in Commission v Artegodan and Others, paragraph 32 above, the Court of Justice stated that it ‘is therefore of no importance whether that partial amendment of the marketing authorisations of the medicinal products in question (carried out following the decision of 9 December 1996) was the result of compliance with a binding decision or of voluntary harmonisation by the Member States’ does not mean that the Court challenged the Court of First Instance’s reasoning with regard to the Commission’s lack of competence to take a final decision following a referral to the CPMP under Article 12 of Directive 75/319, as amended. That statement by the Court means only that it had not, in examining the appeal, dealt with that issue.
77 The fact that in paragraph 47 of its judgment, the Court of Justice contemplated, beside the marketing authorisations granted under Chapter III of Directive 75/319, as amended, the possibility that a marketing authorisation should be the subject of ‘another harmonisation procedure’ does not imply, as the Commission supposes, that the Court departed from the Court of First Instance’s reasoning. After finding that the marketing authorisations at issue in the case giving rise to the judgment in Artegodan had not been granted under Chapter III of Directive 75/319, as amended (paragraph 46 of the Court’s judgment), the Court confined itself to the pure supposition that the purpose of Article 15a of that directive could be interpreted broadly, which would enable that provision to apply to marketing authorisations which had not been granted under Chapter III but which had been the subject of another harmonisation procedure. By so doing, the Court did not in any way intend to depart from the Court of First Instance’s reasoning.
78 It would therefore appear that the grounds of the judgment in Artegodan, obiter dicta as they may seem to be in the light of the judgment in Commission v Artegodan and Others, paragraph 32 above, are not shaken by the latter judgment and that they are relevant to the instant case.
79 The Commission’s argument that the judgment in Artegodan is irrelevant to this case must therefore be rejected.
80 Second, it falls to be examined whether, as the Commission would have it, Article 35 VET (corresponding to Article 12 of Directive 75/319, as amended) must be interpreted as allowing that institution to adopt, under Articles 37 and 38 VET (corresponding to Article 14 of Directive 75/319, as amended), a decision binding on the Member States concerning purely national marketing authorisations.
81 In its judgment in Artegodan, the Court of First Instance replied that it must not, stating that it was not apparent from the wording or the purpose of Article 12 of Directive 75/319, as amended, or even from the system established by Chapter III of that directive, that the Commission was competent to take a decision following a referral procedure initiated under Article 12. The Court noted that that provision was intended to apply in the residual field of the exclusive competence of the Member States, that is to say, with regard to purely national marketing authorisations, and that consequently it made sense that that article should provide for it to be possible to consult the CPMP (the CVMP in the instant case) only under Article 13 of Directive 75/319, as amended (corresponding to Article 36 VET) (judgment in Artegodan, paragraph 142).
82 The Court of First Instance sees no reason, in the present case relating to the legislation applicable to veterinary medicinal products, to cast any doubt on the interpretation it gave in the similar context of the legislation applicable to medicinal products for human use.
83 First of all, the amendments made by Directive 93/40 to the wording of Article 20 of Directive 81/851, as amended by Directive 90/676, do not permit the inference that that article, thus amended, established an arbitration procedure.
84 In point of fact, the amendments to Article 20 of Directive 81/851 (corresponding to Article 35 VET) consist in particular of the extension of the right of referral to the CVMP to the Commission and to the applicant for or the holder of marketing authorisation, whereas that right was previously limited to the Member States.
85 As to the other amendments made to Article 20 by Directive 93/40 (extension of the option to refer to cases of ‘any other variations to the terms of a marketing authorisation’, the need to identify clearly the question referred for consideration and to inform ‘the person responsible for placing the veterinary medicinal product on the market’ (‘the marketing authorisation holder’ in the version codified in Article 35 VET) and the obligation of the Member States and the person responsible to supply the CVMP with all information available relating to the matter in question), they do not indicate that any transfer of decision-making power has been made in the Community’s favour.
86 Having regard to the foregoing considerations, from which it is clear that the amendments to the wording of Article 20 of Directive 81/851 made by Directive 93/40, as amended by Directive 90/676, do not lead to the conclusion that there has been any transfer of competence to the Community so far as purely national marketing authorisations are concerned, it must be considered, in the same way as in the findings made by the Court of First Instance in the judgment in Artegodan (paragraph 139 of the judgment), that such competence can be given to the Commission only if it is clearly apparent from the purpose of Article 35 VET (corresponding to Article 20 of Directive 81/851, as amended) or is expressly provided for in the system established by Chapter 4 VET (corresponding to Chapter IV of Directive 81/851, as amended).
87 In this connection, the Court considers, as it has earlier indicated in the judgment in Artegodan with regard to Directive 75/319, as amended (paragraph 140 of the judgment in Artegodan), that, unlike Article 33(2) VET (corresponding to Article 18(2) of Directive 81/851, as amended), which relates to the mutual recognition procedure and must accordingly be interpreted in accordance with the purpose of that procedure, as defined in the seventh recital in the preamble to the VET Code, Article 35 VET, just like Article 34 VET, is not one of the provisions providing the framework for the mutual recognition procedure. That procedure is in fact expressly governed by Articles 32 and 33 VET (corresponding to Articles 17 and 18 of Directive 81/851, as amended) on the grant of marketing authorisations, and Articles 39 and 40 VET (corresponding to Articles 23 and 23a of Directive 81/851, as amended) on their management.
88 That finding of the Court in respect of the scope of Article 35 VET is not shaken by the Commission’s argument based on considerations concerning the codification mechanism and the meaning to be given, in this connection, to the title of Chapter 4 VET (see paragraph 48, above).
89 The wording of Chapter 4 VET, of which Article 35 VET forms part, and the fact that that title replaces an earlier title to which it was supposedly accepted that a broad interpretation would be given, in no way compel the conclusion suggested by the Commission, that the procedure under Article 35 VET must lead to the adoption of a binding decision by the Commission. Indeed, it does not follow from the fact that Article 35 VET appears in a chapter entitled ‘Mutual recognition of authorisations’ that that provision is a mechanism for mutual recognition, based on an obligation to recognise where the conditions for such recognition are satisfied. While the procedure under Articles 32 and 33 VET does constitute such a binding mechanism (see paragraph 86 above and paragraph 140 of the judgment in Artegodan), Article 35 VET merely provides a mechanism intended to make it easier for the Member States to adopt common decisions in the sphere of their exclusive competence in respect of purely national marketing authorisations and in specific cases involving the interests of the Community.
90 Nor can the Court’s finding as to the scope of Article 35 VET be put in issue by the Commission’s considerations with regard to the scope of Article 31 VET (corresponding to Article 16 of Directive 81/851, as amended) (see paragraphs 45 and 46 above).
91 On this point the Court considers, first, and as in its findings made earlier in its judgment in Artegodan (in paragraph 141 of that judgment), that Article 31 VET (corresponding to Article 16 of Directive 81/851, as amended) does not support an interpretation of Article 35 VET to the effect that it establishes a Community arbitration procedure or that the opinion issued by the CVMP is binding on the Member States. In point of fact, Article 31 VET does no more than state that the CVMP has been set up in order to make it easier for the Member States to adopt common decisions so far as marketing authorisations for medicinal products are concerned.
92 Second, the Court considers that those submissions of the Commission can detract nothing from the fact that the VET Code, although it does in fact seek to protect public health by means that do not hinder the development of the industry or trade in medicinal products between Member States, cannot for all that, in the absence of express provisions to that effect and having regard to the principle set out in the first paragraph of Article 5 EC that the Community is to act within the limits of the powers conferred on it, deprive the Member States of their exclusive competence as regards marketing authorisations granted under purely national procedures. Thus, in the absence of such express provisions, Article 35 VET is to be understood not to affect the Member States’ exclusive competence but rather to be intended, by means of the consultative procedure which it makes it possible to implement, at Community level, to guide the exercise of the various national competences in a common direction.
93 The Commission also challenges the applicants’ view as regards the optional nature of the procedure under Article 35 VET and the fact that, if a decision by the Commission had been necessary at the end of the procedure, then Article 35 VET would have contained an obligation and not an option to refer the matter to the CVMP. According to the Commission, the effectiveness of the procedure under Article 35 VET cannot be ensured by an interpretation that limits its scope to the consultation of the CVMP, leaving each Member State free to decide what action to take following the CVMP’s opinion (see paragraph 47 above).
94 It is true that the fact that referral to the CVMP is an option (‘may … refer’) and not an obligation does not of itself necessarily determine where subsequent decision-making power is conferred. It is thus possible to suppose that the Commission is competent to take a binding decision even though initiating that procedure is simply an option, and one that may be exercised not only by the Member States but also by the Commission itself, or again by the holder of or applicant for the marketing authorisation at issue.
95 However, having regard to the consequences of that approach, in particular to the circumstance that the procedure under Article 35 VET would lead to the transfer of competence to the Commission in conditions that might completely escape the Member States, the Court of First Instance considers that at the very least express provisions to that effect would be necessary. There being no such provisions, the Member States cannot be divested of their exclusive competence in unforeseeable fashion by the effect of a consultative reference made by the Commission or the holder of or the applicant for the marketing authorisation.
96 That consideration is borne out by the fact that, in the procedure under Article 35 VET and unlike the mutual recognition procedure (see Article 33(2) VET), reference to the CVMP is not preceded by any prior consultation that might enable the Member States to agree amongst themselves and by so doing avoid recourse to the Commission’s binding arbitration.
97 That being so, the circumstance that the Community authorities have provided an option, and have not laid down an obligation, to refer a matter must be interpreted as meaning that through the procedure under Article 35 VET it is open to a Member State, if it considers that a particular case involves a Community interest, to obtain an opinion at Community level before taking a decision. The reference in Article 35 VET to the interests of the Community is not, therefore, in the absence of express provisions to that effect, intended to demonstrate the existence of Community competence but simply to prevent the CVMP from being burdened with questions that do not involve any such interest.
98 In addition, it may to some purpose be noted, as the Court of First Instance did in the judgment in Artegodan in respect of medicinal products for human use (paragraph 143 of the judgment), that the reference to interests of the Community was already included in Directive 81/851 in the versions before the entry into force of the mutual recognition procedure (Article 22 of Directive 81/851 in its original form and Article 20 of Directive 81/851, as amended by Directive 90/676), that is to say, at a time when the Member States possessed general competence with regard to the issuing and management of marketing authorisations and when there was no Community competence. This finding supports the consideration that in the circumstances of this case the concept of interests of the Community cannot legitimise a transfer of competence in favour of the Commission in the absence of express provisions to that effect.
99 With regard to the Commission’s concern that the effectiveness of the procedure under Article 35 VET could not be ensured by an interpretation that limited its scope to the consultation of the CVMP, and would therefore give rise to the danger of the continued marketing of medicinal products in certain Member States in spite of the CVMP’s opinion, it fails to have regard to the fact that the Member States are, in any case and pursuant to Article 83(1)(a) and (d) VET, obliged to suspend or withdraw marketing authorisation from any medicinal product which proves to be harmful in the conditions of use indicated or where the recommended withdrawal period is inadequate to ensure that foodstuffs obtained from the treated animal contain no residues that might constitute a health hazard to the consumer.
100 In addition, the fact that Directive 93/40 and the VET Code were adopted on the basis of the Treaty provisions relating to the approximation of the laws of the Member States and the purpose of which is the establishment and functioning of the internal market, namely, for Directive 93/40, Article 100a of the EC Treaty (now, after amendment, Article 95 EC), added to the Treaty by the Single European Act in 1987, and for the VET Code, Article 95 EC, does not in any way mean, in itself, that the Commission must be recognised to possess decision-making power following a referral to the CVMP under Article 35 VET. The reply to the question whether such power exists depends on the actual wording of the provisions of Directive 93/40 and the VET Code. The Court notes, moreover, that Directive 90/676, while also based on Article 100a of the EC Treaty, has not introduced such Community competence either.
101 Finally, the Court notes that to follow the Commission’s approach and so concede that that institution is competent to take a binding decision at the end of the procedure under Article 35 VET would entail the consequence that the Commission, being itself entitled to make a reference to the CVMP pursuant to that provision, might draw within the sphere of Community competence all those cases of national marketing authorisations which it regarded as specific cases involving the interests of the Community.
102 That approach would infringe the exclusive residual competence of the Member States in the sphere of purely national marketing authorisations.
103 In short, the objective of the VET Code, which is to protect public health by means that do not hinder the development of the industry or trade in medicinal products within the Community, is reconciled with the maintenance, in the absence of express provision to the contrary, of the exclusive residual competence of the Member States in the grant and management of purely national marketing authorisations.
104 In the light of the foregoing considerations, it is to be concluded that Article 35 VET may not be interpreted as impliedly enabling the Commission to adopt a binding decision in accordance with the procedure laid down in Articles 37 and 38 VET.
105 In consequence, it was unlawfully that the Commission, in this case, following a referral to the CVMP under Article 20 of Directive 81/851, as amended (corresponding to Article 35 VET), adopted the contested decision on the basis of Articles 37 and 38 VET.
106 The first part of the first ground of annulment must therefore be upheld, and the contested decision annulled, and there is no need to consider the other grounds of annulment.
Costs
107 Under Article 87(2) of the Rules of Procedure of the Court of First Instance, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Since the defendant has been unsuccessful, it must, in accordance with the form of order sought by the applicants, be ordered to pay the costs.
108 Under the first subparagraph of Article 87(4) the Member States that have intervened in the proceedings are to bear their own costs. The French Republic, having intervened in support of the applicants, must bear its own costs.
On those grounds,
THE COURT OF FIRST INSTANCE (Fifth Chamber)
hereby:
1. Annuls Commission Decision C(2003) 1404 of 22 April 2003 ordering suspension of the marketing authorisations of veterinary medicinal products containing benzathine benzylpenicillin intended to be administered by intramuscular and/or subcutaneous means to food-producing animals;
2. Orders the Commission to bear its own costs and those incurred by the applicants;
3. Orders the French Republic to bear its own costs.
Vilaras | Martins Ribeiro | Jürimäe |
Delivered in open court in Luxembourg on 31 January 2006.