Opinion of the Advocate General — ECLI:EU:C:1998:273
Date: 1998-06-09
Language of the case: English
Based on: Treaty establishing the European Economic Community (1957)
Subject matter: Approximation of laws
Procedure: Reference for a preliminary ruling
Origin: United Kingdom

summary of product characteristics allowed Triazolam to be prescribed in doses of 0.25 mg and 0.125 mg for adults and 0.125 mg for the elderly. The CPMP considered favourably the recommendations of the ad hoc group. The draft summaries of product characteristics were then communicated to the Member States and to the holders of the marketing authorisations concerned. Comments were invited by 1 July 1993 for consideration by the CPMP at its meeting on 13 and 14 July 1993. 21. However, on 9 June 1993 the Licensing Authority communicated to Upjohn its decision revoking, with immediate effect, all marketing authorisations relating to Triazolam. It provided a detailed statement of reasons for that decision and for its rejection of the conclusions of the Persons Appointed. 22. On 15 September 1993 the CPMP adopted the report of the ad hoc rapporteurs' group, which concluded, in particular, that Triazolam should continue to be sold. 23. Meanwhile, on 31 August 1993 Upjohn brought proceedings before the High Court to have the Licensing Authority's decision of 9 June 1993 quashed. It maintained in those proceedings that it was necessary, prior to any examination of the substance of the case, to request the Court of Justice to provide guidance on the way in which the national courts should proceed in examining the case. The High Court held that there was no need to make a reference to the Court of Justice. 24. Upjohn therefore appealed against that decision to the Court of Appeal, which decided to stay proceedings and referred the following questions to the Court of Justice for a preliminary ruling: '1. On the true construction of Council Directive 65/65/EEC as amended and in the light of Community law generally, is it the duty of a national court when ruling upon the compatibility with the aforesaid Community law of a decision of a licensing authority of a Member State to revoke a licence held by the manufacturer of a medicine product to decide whether or not the said decision was the correct decision as opposed to a decision which the licensing authority could reasonably have reached on the material before it? 2. If the answer to Question 1 is that the national court has to decide whether the decision of the competent authority was the correct decision does Community law require it to answer that question solely on the basis of the material before the competent authority or is it obliged to look at any relevant material coming to light after the decision? 3. Was it lawful for the Licensing Authority to revoke the licence when the Committee for Proprietary Medicinal Products (CPMP) was known to the Licensing Authority to be soon to produce an opinion as to continuance of the licence?‘ 25. It is apparent from the proceedings before the High Court and the Court of Appeal that, according to Upjohn, Directive 65/65 and, more generally, Community law require the Member States to establish a procedure for judicial review of decisions taken by the national authorities responsible for marketing authorisations, empowering the national courts to verify, on the basis of a fresh, comprehensive assessment of the issues of fact and of law, whether the decision taken was correct. In particular, the national court seised of the application for an order quashing the decision revoking the marketing authorisations relating to Triazolam should be empowered to decide whether, having regard to the scientific evidence on which it is based, that decision is correct. 26. By contrast, the Licensing Authority has maintained that, according to Directive 65/65, there can be only one national authority competent to take decisions concerning the production and marketing of proprietary medicinal products and, in particular, decisions revoking marketing authorisations. In the United Kingdom, the competent authority in such matters is precisely the Licensing Authority. Thus, the national court seised of the application contesting the decision revoking the marketing authorisations in respect of Triazolam is not empowered to take the place of the Licensing Authority; it may rule only on the question whether the contested decision is vitiated by a defect requiring it to be quashed. The first question 27. By its first question, the national court asks, in essence, whether Directive 65/65 and, more generally, Community law require the Member States to establish a procedure for judicial review of national decisions revoking marketing authorisations for proprietary medicinal products, whereby the national courts and tribunals having jurisdiction are empowered to substitute their assessment of the facts, and, in particular, of the scientific evidence relied on in support of the revocation decision, for the assessment made by the national authorities competent to revoke such authorisations. 28. It is clear that, within the framework of rules governing proprietary medicinal products laid down by the relevant Community legislation, only Article 12 of Directive 65/65 refers to the remedies available against decisions taken pursuant to Article 11 of the directive, that is to say, decisions suspending or revoking marketing authorisations for proprietary medicinal products. As indicated in paragraph 4 of this judgment, the first paragraph of Article 12 merely requires the Member States to provide for such decisions to be open to challenge by way of legal proceedings. 29. It is apparent, therefore, that Article 12 does not lay down detailed rules for the exercise of the right of recourse; it leaves to the Member States the task of organising their own systems of judicial review of decisions refusing, suspending or revoking marketing authorisations for proprietary medicinal products. 30. Upjohn maintains that, since Article 11 of Directive 65/65, as amended, is directly applicable, the national court must be able to review fully the action taken by the administrative authority. Otherwise, the rights enjoyed by Upjohn by virtue of the direct effect of that provision would not be effectively safeguarded. 31. In that connection, it is apparent from the Court's case-law that, in so far as Article 11 of Directive 65/65 lays down the criteria for revocation of a marketing authorisation, it has direct effect, in the same way as Article 21, which provides that a marketing authorisation may be revoked only on the public health grounds expressly mentioned in the directive (Case 301/82 Clin-Midy and Others v Belgium [1984] ECR 251, paragraphs 4 and 10). 32. It is settled case-law that in the absence of Community rules governing the matter it is for the domestic legal system of each Member State to designate the courts and tribunals having jurisdiction and to lay down the detailed procedural rules governing actions for safeguarding rights which individuals derive from Community law, provided, however, that such rules are not less favourable than those governing similar domestic actions (the principle of equivalence) and do not render virtually impossible or excessively difficult the exercise of rights conferred by Community law (the principle of effectiveness) (see, in particular, Case C-312/93 Peterbroeck v Belgian State [1995] ECR I-4599, paragraph 12, and paragraph 18 of the judgment of 1 December 1998 in Case C-326/96 Levez, not yet published in the European Court Reports). 33. As regards decisions revoking marketing authorisations taken by the competent national authorities following complex assessments in the medico-pharmacological field, it does not appear that the only appropriate means of preventing the exercise of rights conferred by Community law from being rendered virtually impossible or excessively difficult would be a procedure for judicial review of national decisions revoking marketing authorisations, empowering the competent national courts and tribunals to substitute their assessment of the facts and, in particular, of the scientific evidence relied on in support of the revocation decision for the assessment made by the national authorities competent to revoke such authorisations. 34. According to the Court's case-law, where a Community authority is called upon, in the performance of its duties, to make complex assessments, it enjoys a wide measure of discretion, the exercise of which is subject to a limited judicial review in the course of which the Community judicature may not substitute its assessment of the facts for the assessment made by the authority concerned. Thus, in such cases, the Community judicature must restrict itself to examining the accuracy of the findings of fact and law made by the authority concerned and to verifying, in particular, that the action taken by that authority is not vitiated by a manifest error or a misuse of powers and that it did not clearly exceed the bounds of its discretion (see, in particular, Joined Cases 56/64 and 58/64 Consten and Grundig v Commission [1966] ECR 299, Case 55/75 Balkan-Import Export v Hauptzollamt Berlin-Packhof [1976] ECR 19, paragraph 8, Case 9/82 Øhrgaard and Delvaux v Commission [1983] ECR 2379, paragraph 14, Case C-225/91 Matra v Commission [1993] ECR I-3203, paragraphs 24 and 25, and Case C-157/96 National Farmers' Union and Others [1998] ECR I-2211, paragraph 39). 35. Consequently, Community law does not require the Member States to establish a procedure for judicial review of national decisions revoking marketing authorisations, taken pursuant to Directive 65/65 and in the exercise of complex assessments, which involves a more extensive review than that carried out by the Court in similar cases. 36. Nevertheless, any national procedure for judicial review of decisions of national authorities revoking marketing authorisations must enable the court or tribunal seised of an application for annulment of such a decision effectively to apply the relevant principles and rules of Community law when reviewing its legality. 37. In the light of the foregoing, the answer to the first question must be that Directive 65/65 and, more generally, Community law do not require the Member States to establish a procedure for judicial review of national decisions revoking authorisations to market proprietary medicinal products, empowering the competent national courts and tribunals to substitute their assessment of the facts and, in particular, of the scientific evidence relied on in support of the revocation decision for the assessment made by the national authorities competent to revoke such authorisations. The second question 38. By its second question, the Court of Appeal asks, in essence, whether Community law requires a national court which is seised of an application for annulment of a decision revoking a marketing authorisation for a particular proprietary medicinal product to take into account, when determining that application, any relevant scientific material coming to light after the adoption of that decision. 39. A system of judicial review whereby the national courts are to determine applications for annulment of decisions revoking marketing authorisations without taking into account relevant scientific material coming to light after the adoption of the contested decision is not such as to render virtually impossible or excessively difficult the exercise of the rights conferred by the directive. 40. As the United Kingdom Government has argued, in the event of new material coming to light following the adoption of a decision revoking a marketing authorisation, the person concerned will still be able to make a fresh application for a marketing authorisation. It will then be for the competent administrative authority to assess, in the light of all the information at its disposal, whether the criteria for the grant of a fresh marketing authorisation are fulfilled. 41. In the present case, this represents an acceptable solution, having regard, first, to the fact that the scientific criteria, especially those concerning the harmful nature of a proprietary medicinal product in respect of which the marketing authorisation has been revoked, are liable to change in the course of time and, second, to the fact that Directive 65/65 does not require the Member States to establish a procedure for judicial review of national decisions revoking marketing authorisations for proprietary medicinal products, empowering the competent national courts and tribunals to substitute their assessment of the facts and, in particular, of the scientific evidence relied on in support of the revocation decision for the assessment made by the national authorities competent to revoke such authorisations. 42. It follows that the answer to the second question must be that Community law does not require a national court or tribunal which is seised of an application for annulment of a decision revoking a marketing authorisation for a particular proprietary medicinal product to take into account, when determining that application, any relevant scientific material coming to light after the adoption of that decision. The third question 43. By its third question, the national court asks, in essence, whether, in the event that the matter has been referred by various Member States to the CPMP following the adoption by the competent national authority of a decision revoking a marketing authorisation and the time-limit for the issue by the CPMP of its opinion has expired, Directives 65/65 and 75/319, as amended by Directive 83/570, preclude that authority from deciding to revoke the marketing authorisation in question without awaiting the opinion of the CPMP. 44. According to the first and second paragraphs of Article 11 of Directive 75/319, as amended by Directive 83/570, where one or more Member States have suspended a marketing authorisation while one or more other Member States have not done so, one of the Member States concerned may refer the matter to the CPMP for application of the procedure referred to in Article 14 of that directive. 45. Article 14 of Directive 75/319 provides that, when reference is made to the procedure described in that article, the CPMP is to consider the matter and issue a reasoned opinion within 60 days of the date on which the matter was referred to it. The CPMP must immediately inform the Member State(s) concerned and the person responsible for placing the product on the market of its opinion or of those of its members in the case of divergent opinions. The Member State(s) concerned must communicate their decision concerning the action to be taken on the CPMP's opinion within 60 days of receipt of the information contained therein. 46. It is unnecessary to rule on the question whether, under the abovementioned provisions, a national authority is empowered to order the revocation of a marketing authorisation within the period of 60 days following the reference of the matter to the CPMP, since it is clear that such an authority is in no way precluded from revoking a marketing authorisation where the CPMP has not produced its opinion within that time-limit. 47. As the Advocate General has stated in points 63 and 64 of his Opinion, the opinion of the CPMP is in no way binding. Moreover, since the issue is one of public health, Article 14 cannot be construed as requiring Member States to await the CPMP's opinion, even after the period of 60 days allowed for its production has expired, before deciding to withdraw a medicinal product that may prove to be harmful to public health, the protection of which constitutes the primary objective of Directive 65/65. 48. Consequently, the answer to the third question must be that Directives 65/65 and75/319, as amended by Directive 83/570, are to be construed as meaning that, where the matter has been referred by various Member States to the CPMP following the adoption by the competent national authority of a decision revoking a marketing authorisation and the time-limit for the issue by the CPMP of its opinion has expired, those directives do not preclude that authority from deciding to revoke the marketing authorisation in question without awaiting the opinion of the CPMP. Costs 49. The costs incurred by the French and United Kingdom Governments and by the Commission, which have submitted observations to the Court, are not recoverable. Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the national court, the decision on costs is a matter for that court. On those grounds, THE COURT (Fifth Chamber), in answer to the questions referred to it by the Court of Appeal (England and Wales) by order of 26 October 1995, hereby rules: 1. 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 and, more generally, Community law do not require the Member States to establish a procedure for judicial review of national decisions revoking authorisations to market proprietary medicinal products, empowering the competent national courts and tribunals to substitute their assessment of the facts and, in particular, of the scientific evidence relied on in support of the revocation decision for the assessment made by the national authorities competent to revoke such authorisations. 2. Community law does not require a national court or tribunal which is seised of an application for annulment of a decision revoking a marketing authorisation for a particular proprietary medicinal product to take into account, when determining that application, any relevant scientific material coming to light after the adoption of that decision. 3. Directive 65/65 and 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, as amended by Council Directive 83/570/EEC of 26 October 1983, are to be construed as meaning that, where the matter has been referred by various Member States to the Committee for Proprietary Medicinal Products following the adoption by the competent national authority of a decision revoking a marketing authorisation and the time-limit for the issue by that Committee of its opinion has expired, those directives do not preclude that authority from deciding to revoke the marketing authorisation in question without awaiting the opinion of the Committee for Proprietary Medicinal Products. Puissochet Moitinho de Almeida Gulmann Edward Wathelet Delivered in open court in Luxembourg on 21 January 1999. R. Grass J.-P. Puissochet Registrar President of the Fifth Chamber 1: Language of the case: English.