CELEX: 62003CO0156
Language: en
Date: 2003-06-20 00:00:00
Title: Order of the President of the Court of 20 June 2003. # Commission of the European Communities v Les Laboratoires Servier SA. # Interim relief - Application for suspension of operation of a judgment - Appeal - Medicinal products for human use - Withdrawal of a marketing authorisation - Competence of the Commission - Serotonergic anorectics: dexfenfluramine, fenfluramine - Directives 65/65/CEE and 75/319/CEE - Judgment of the Court of First Instance annulling a decision of withdrawal - Suspension of operation of a judgment of the Court of First Instance - Urgency - None. # Case C-156/03 P-R.

Case C-156/03 P-R Commission of the European CommunitiesvLes Laboratoires Servier SA
            «(Interim relief – Application for suspension of operation of a judgment – Appeal – Medicinal products for human use – Withdrawal of a marketing authorisation – Competence of the Commission – Serotonergic anorectics: dexfenfluramine, fenfluramine – Directives 65/65/EEC and 75/319/EEC – Judgment of the Court of First Instance annulling a decision of withdrawal – Suspension of operation of a judgment of the Court of First Instance – Urgency – None)»
            
               
                  Order of the President of the Court, 20 June 2003  
                     
               I - 0000 
               
            
                   
               
               
            
            Summary of the Order
         
         
                  
                  Interim relief – Suspension of operation of a judgment – Judgment of the Court of First Instance under appeal – Conditions for granting – Prima facie case – Serious and irreparable harm – Judgment annulling a decision to withdraw a marketing authorisation of medicinal products for human use – Absence based on the necessity, as set out in the judgment under appeal, of intervention of Member States for a possible resumption
                     of marketing
                  (Art. 242 EC; Rules of Procedure of the Court, Art. 83(2); Council Directive 65/65)The condition relating to urgency, imposed by Article 83(2) of the Rules of Procedure of the Court of Justice, in order to
         enable that Court, pursuant to Article 242 EC, to order the suspension of operation of a judgment of the Court of First Instance
         annulling a decision of the Commission concerning the withdrawal of a marketing authorisation of medicinal products for human
         use falling within the scope of Directive 65/65 relating to proprietary medicinal products, is not established since the resumption
         of the marketing of the medicinal products in question does not follow automatically from the judgment under appeal, but requires
         a positive decision to that effect and, pursuant to the judgment under appeal, the competence to take any decision relating
         to the marketing authorisations for the medicinal products in question lies with the Member States acting on the basis of
         the requirements essential for public health protection.see paras 41, 43, 46
      

      
      
      
      
      
      
      
      
      
      
      
      
      
      
      
            
            ORDER OF THE PRESIDENT OF THE COURT20 June 2003  (1)
            
            
         
         
            
         
            ((Interim relief – Application for suspension of operation of a judgment – Appeal – Medicinal products for human use – Withdrawal of a marketing authorisation – Competence of the Commission – Serotonergic anorectics: dexfenfluramine, fenfluramine – Directives 65/65/EEC and 75/319/EEC – Judgment of the Court of First Instance annulling a decision of withdrawal – Suspension of operation of a judgment of the Court of First Instance – Urgency – None))
            
         In Case C-156/03 P-R, 
         
         
          Commission of the European Communities,  represented by R. Wainwright and H. Støvlbæk, acting as Agents, with an address for service in Luxembourg,
         
         
         appellant, 
         
         APPLICATION for suspension of operation of the judgment of the Court of First Instance of the European Communities (Second
         Chamber, Extended Composition) of 28 January 2003 in Case T-147/00  
          Laboratoires Servier v  
          Commission  [2003] ECR II-85,
         
         the other party to the proceedings being: 
          Les Laboratoires Servier SA,   established in Neuilly-sur-Seine (France), represented by I. Forrester QC and J. Killick, barrister,applicant at first instance, 
         
         
         
         
         THE PRESIDENT OF THE COURT,
         
         after hearing Advocate General S. Alber, makes the following 
         
         
         Order
         1
            
         By application lodged at the Court Registry on 4 April 2003, the Commission of the European Communities, in accordance with
         Article 225 EC and the first paragraph of Article 56 of the EC Statute of the Court of Justice, brought an appeal against
         the judgment of the Court of First Instance of 28 January 2003 in Case T-147/00  
          Laboratoires Servier  v  
          Commission  [2003] ECR II-85;  
         the judgment under appeal), by which the Court of First Instance annulled Commission Decision C(2000) 573 of 9 March 2000 concerning the withdrawal
         of marketing authorisations of medicinal products for human use which contain the following substances:  
         dexfenfluramine and  
         fenfluramine (
         the decision at issue). In its application, the Commission requested that the appeal be determined pursuant to an expedited procedure in accordance
         with Article 62a of the Rules of Procedure of the Court. 
         
         
         2
            
         By separate document lodged at the Court Registry on the same day, the Commission applied to the Court under Article 242 EC
         for suspension of operation of the judgment under appeal. 
         
         
         3
            
         Les Laboratoires Servier SA (
         Servier) lodged its written observations on the application for interim relief on 5 May 2003. 
         
         
         4
            
         On 8 May 2003, the President of the Court rejected the Commission's application for the appeal in the main proceedings to
         be determined pursuant to an expedited procedure. 
         
         
         5
            
         Since the parties' written submissions contain all the information necessary for deciding the application, there is no need
         to hear oral argument from the parties. 
         
            
               Legal Background
            
         
         6
            
         On 26 January 1965, the Council adopted Directive 65/65/EEC 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). That directive
         has been amended on several occasions, in particular by Council Directive 89/341/EEC of 3 May 1989 (OJ 1989 L 142, p. 11)
         and Council Directive 93/39/EEC of 14 June 1993 (OJ 1993 L 214, p. 22) (
         Directive 65/65). Article 3 of Directive 65/65 lays down the principle that no medicinal product may be placed on the market of a Member
         State unless an authorisation has first been issued by the competent authorities of that Member State in accordance with the
         directive or an authorisation has been granted 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). 
         
         
         7
            
         Article 4 of Directive 65/65 provides in particular that, in order to obtain a marketing authorisation as provided for in
         Article 3, the person responsible for placing the product on the market is to apply to the competent authority of the Member
         State concerned. 
         
         
         8
            
         Article 5 of Directive 65/65 states: The authorisation provided for in Article 3 shall be refused if, after verification of the particulars and documents listed
         in Article 4, it proves that the medicinal product is harmful in the normal conditions of use, or that its therapeutic efficacy
         is lacking or is insufficiently substantiated by the applicant, or that its qualitative and quantitative composition is not
         as declared.Authorisation shall likewise be refused if the particulars and documents submitted in support of the application do not comply
         with Article 4.
         
         
         9
            
         Article 10 of Directive 65/65 provides that the authorisation is valid for five years and is renewable for five-year periods
         after consideration by the competent authority of a dossier containing in particular details of the data on pharmacovigilance
         and other information relevant to the monitoring of the medicinal product. 
         
         
         10
            
         The first paragraph of Article 11 of Directive 65/65 provides: The competent authorities of the Member States shall suspend or revoke an authorisation to place a medicinal product on the
         market where that product proves to be harmful in the normal conditions of use, or where its therapeutic efficacy is lacking,
         or where its qualitative and quantitative composition is not as declared. Therapeutic efficacy is lacking when it is established
         that therapeutic results cannot be obtained with the [medicinal] product.
         
         
         11
            
         Under Article 21 of Directive 65/65, a marketing authorisation for a medicinal product is not to be refused, suspended or
         revoked except on the grounds set out in that directive. 
         
         
         12
            
         Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological
         and clinical standards and protocols in respect of the testing of medicinal products (OJ 1975 L 147, p. 1), as amended by
         Directive 89/341 (
         Directive 75/318), provides, in the first paragraph of Article 1, that the Member States are to take all appropriate measures to ensure that
         the particulars and documents which must accompany an application for authorisation to place a medicinal product on the market
         pursuant to points 3, 4, 6, 7 and 8 of the second paragraph of Article 4 of Directive 65/65 are submitted by the persons concerned
         in accordance with the annex to Directive 75/318. 
         
         
         13
            
         The seventh and eighth recitals in the preamble to Directive 75/318 are worded as follows: [w]hereas the concepts of  
         harmfulness and  
         therapeutic efficacy referred to in Article 5 of Directive 65/65/EEC can only be examined in relation to each other and have only a relative significance
         depending on the progress of scientific knowledge and the use for which the medicinal product is intended; whereas the particulars
         and documents which must accompany an application for authorisation to place a medicinal product on the market [must] demonstrate
         that potential risks are outweighed by the therapeutic efficacy of the product; whereas failing such demonstration, the application
         must be rejected;[w]hereas the evaluation of  
         harmfulness and  
         therapeutic efficacy may be modified in the light of new discoveries and standards and protocols must be amended periodically to take account
         of scientific progress.
         
         
         14
            
         The provisions most directly at issue in the appeal in the main proceedings are described in the following terms in paragraphs
         8 to 13 of the judgment under appeal: 
         
         8
            
         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), amended on several occasions, in particular by [Council]
         Directives 83/570[/EEC of 26 October 1983 (OJ 1983 L 332, p. 1)] and 93/39 (hereinafter, as amended,  
         Directive 75/319), establishes, in Chapter III (Articles 8 to 15c), a procedure for the mutual recognition of national marketing authorisations
         (Article 9), together with Community arbitration procedures. 
         
         
         9
            
         That directive expressly provides for referrals to the Committee for Proprietary Medicinal Products (hereinafter  
         the CPMP) of the European Agency for the Evaluation of Medicinal Products, for application of the procedure governed by Article 13,
         where, in the context of the procedure for mutual recognition established by Article 9, a Member State considers that there
         are grounds for supposing that the authorisation of the medicinal product concerned may present a risk to public health and
         the Member States do not reach agreement within the prescribed time-limit (Article 10 of that directive), where Member States
         have adopted divergent decisions concerning the grant, suspension or withdrawal of national authorisations (Article 11), and
         in specific cases where the interests of the Community are involved (Article 12). In addition, the directive expressly provides
         that the variation, suspension and withdrawal of marketing authorisations granted in accordance with the provisions of Chapter
         III thereof are subject to the procedures laid down in Articles 13 and 14 (Articles 15 and 15a). Finally, Article 15b provides
         that Articles 15 and 15a are to apply by analogy to medicinal products authorised by the Member States following an opinion
         of the CPMP issued prior to 1 January 1995, in accordance with Article 4 of Council Directive 87/22/EEC of 22 December 1986
         on the approximation of national measures relating to the placing on the market of high-technology medicinal products, particularly
         those derived from biotechnology (OJ 1987 L 15, p. 38). The procedures established by Articles 12 and 15a of Directive 75/319
         are of particular relevance in the present case. 
         
         
         10
            
         Article 12 of Directive 75/319 provides: 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 [CPMP] for the application of the procedure laid down
         in Article 13 before reaching a decision on a request for a marketing authorisation or on the suspension or withdrawal of
         an authorisation, or on any other variation to the terms of a marketing authorisation which appears necessary, in particular
         to take account of the information collected under the pharmacovigilance system provided for in Chapter Va. The Member State concerned or the Commission shall clearly identify the question which is referred to the [CPMP] for consideration
         and shall inform the person responsible for placing the medicinal product on the market. The Member States and the aforementioned person shall forward to the [CPMP] all available information relating to the matter
         in question.
         
         
         11
            
         Article 15a of Directive 75/319 states: 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 public health, the
         Member State concerned shall forthwith refer the matter to the [CPMP] for the application of the [procedures] laid down in
         Articles 13 and 14. 2. Without prejudice to the provisions of Article 12, in exceptional cases, where urgent action is essential to protect public
         health, until a definitive decision is adopted a Member State may suspend the marketing and the use of the 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.
         
         
         12
            
         Article 13 of Directive 75/319 governs the procedure before the CPMP, which issues a reasoned opinion. Paragraph 5 of that
         article provides that the European Agency for the Evaluation of Medicinal Products is to forward the final opinion of the
         CPMP to the Member States, the Commission and the person responsible for placing the medicinal product on the market, together
         with a report describing the assessment of the medicinal product and stating the reasons for its conclusions. Article 14 of
         that directive governs the Community decision-making procedure. The first subparagraph of Article 14(1) provides that within
         30 days of the receipt of the CPMP opinion, the Commission is to prepare a draft of the decision to be taken in respect of
         the application, taking into account Community law. Under the third subparagraph of Article 14(1),  
         [w]here, exceptionally, the draft decision is not in accordance with the opinion of the [European] Agency [for the Evaluation
         of Medicinal Products], the Commission shall also annex a detailed explanation of the reasons for the differences. The final decision is adopted in accordance with the regulatory procedure governed by Articles 5 and 7 of Council Decision
         1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission
         (OJ 1999 L 184, p. 23). The Commission is assisted in that procedure by the Standing Committee on Medicinal Products for Human
         Use, set up by Article 2b of Directive 75/318. ... 
         
         
         13
            
         All the directives relating to medicinal products for human use which govern the  
         decentralised Community procedure, in particular Directives 65/65, 75/318 and 75/319, have been recast in Directive 2001/83/EC of the European Parliament and
         of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67;
         hereinafter  
         the Code). Even though the Code was not in force when the decision at issue was adopted, it should be taken into account where appropriate.
         In so far as the Code restates in a more structured corpus, without amending them, the provisions of Directives 65/65 and
         75/319, a systematic analysis of the provisions of Chapter III of Directive 75/319 is part of the scheme of that code.
         
         Background to the dispute
         
         15
            
         Servier is the holder of marketing authorisations, originally issued by the competent national authorities, for medicinal
         products containing dexfenfluramine or fenfluramine, which are serotonergic anorectic agents used in the treatment of obesity.
         
         
         
         16
            
         On 9 March 2000, the Commission adopted, on the basis of Article 15a of Directive 75/319, the decision at issue concerning
         the withdrawal of marketing authorisations of medicinal products for human use which contain dexfenfluramine or fenfluramine.
         In Article 1 of the operative part of that decision, the Commission ordered the Member States to withdraw  
         the national marketing authorisations provided for in the first paragraph of Article 3 of Directive 65/65/EEC concerning the
         medicinal products [containing dexfenfluramine or fenfluramine] listed in Annex I. Article 2 of that decision justified that withdrawal by referring to the scientific conclusions which were appended to the
         CPMP final opinion of 31 August 1999 on those substances and annexed to the decision (Annex II). Article 3 of the decision
         at issue required the Member States concerned to comply with the decision within 30 days of its notification. 
         
         
         17
            
         The decision at issue was adopted following a reassessment of the anorectic substances to which it referred, under Article
         15a of Directive 75/319, after several Member States had notified the European Agency for the Evaluation of Medicinal Products
         of their decisions to suspend the marketing authorisations of medicinal products containing fenfluramine or dexfenfluramine.
         
         
         
         18
            
         The substances in question had already been the subject of Commission Decision C(96) 3608 final/2 of 9 December 1996 concerning
         the placing on the market of the medicinal products for human use which contain fenfluramine or dexfenfluramine (
         the decision of 9 December 1996), subsequent to an opinion of the CPMP to which the matter had been referred under Article 12 of Directive 75/319. The decision
         of 9 December 1996 is expressly based on Articles 12 and 14 of Directive 75/319. By that decision, in line with the CPMP opinion
         of 17 July 1996, the Commission instructed the Member States concerned to amend certain clinical particulars in the summaries
         of product characteristics approved when the marketing authorisations of the medicinal products in question were granted.
         It stipulated that a series of clinical particulars be included, relating in particular to the therapeutic indications, contraindications
         and undesirable effects of those medicinal products. 
         
         
         19
            
         A fuller account of the facts that gave rise to the dispute is to be found in paragraphs 14 to 36 of the judgment under appeal.
         
         The judgment under appeal
         
         20
            
         After setting out, in paragraphs 48 to 52 of the judgment under appeal, various general considerations regarding the application
         of the criteria for withdrawal of marketing authorisations of medicinal products, set out in Article 11 of Directive 65/65,
         in the light of the pleas put forward by Servier in disputing the proper foundation of the decision at issue, the Court of
         First Instance examined of its own motion, in paragraphs 53 to 65 of the judgment under appeal, whether the Commission had
         been competent to take the decision at issue. 
         
         
         21
            
         First of all, the Court of First Instance pointed out that the case before it had been joined, for the purposes of the oral
         procedure, to eight other cases which had then given rise to its judgment of 26 November 2002 in Joined Cases T-74/00, T-76/00,
         T-83/00 to T-85/00, T-132/00, T-137/00 and T-141/00  
          Artegodan and Others  v  
          Commission  [2002] ECR II-4945 in which the same question had arisen regarding the Commission's competence to withdraw the marketing
         authorisations of medicinal products harmonised under Article 12 of Directive 75/319, so that the Commission had been able
         to explain at the hearing its reasoning on that matter. 
         
         
         22
            
         On the substance of the case, the Court of First Instance, applying the reasoning that it had adopted in  
          Artegodan and Others  v  
          Commission , rejected, in the judgment under appeal, the arguments put forward by the Commission and found that that institution did
         not have competence to adopt the decision at issue, which it considered to be without legal basis. 
         
         
         23
            
         In points 58 to 65 of the judgment under appeal, the Court of First Instance explained its reasoning as follows: 
         
         58
            
         In the present case, it is therefore sufficient to find, first, that in the scheme of Chapter III of Directive 75/319, leaving
         aside the decision of 9 December 1996, the management of the purely national marketing authorisations of the medicinal products
         in question came within the residual field of exclusive competence of the Member States concerned (
          Artegodan and Others  v  
          Commission , paragraphs 114 to 116). 
         
         
         59
            
         Moreover, it is clear from the very wording of Article 12 of Directive 75/319 that that article establishes in the field of
         competence of the Member States a purely consultative procedure, which is also optional and can, moreover, be initiated not
         only by the Member States concerned, but also by the Commission, or the applicant or holder of a marketing authorisation.
         In addition, in the system established by Chapter III of Directive 75/319, that article, which is not one of the provisions
         more specifically providing the framework for the mutual recognition procedure, cannot be interpreted in the light of the
         particular objective of that procedure, which is intended ultimately to bring about the adoption of a common decision by the
         Member States concerned, where necessary by way of the Community arbitration procedure established by Article 10 of that directive
         if the Member States fail to reach agreement within the prescribed time-limit (
          Artegodan and Others  v  
          Commission , paragraphs 132 and 133). 
         
         
         60
            
         In the scheme of Chapter III of Directive 75/319, Article 12 of that directive 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. Within that legal framework, the Member States, which have merely an option to consult the
         CPMP, cannot find themselves by implication deprived of their competence if they make use of that option or if the Commission,
         the applicant, or the holder of a marketing authorisation makes a referral to the CPMP under Article 12. In the field of the
         mutual recognition procedure, such a removal of competence would however, if a matter were referred to the CPMP under Article
         12 by the reference Member State, lead to the immediate application of a Community arbitration procedure and the circumvention
         of the preliminary stages of mutual recognition and concertation between the Member States concerned with a view to reaching
         an agreement ─ on the basis of all the documents and information referred to in Article 4 of Directive 65/65 ─, stages which
         are expressly provided for by Articles 9(4) and 10(2) of Directive 75/319. In the field of the exclusive competence of the
         Member States, that removal of competence would also lead to the immediate application of an arbitration procedure, in respect
         of medicinal products which have never been the subject of a preliminary joint examination by the Member States concerned,
         similar to that which distinguishes the mutual recognition procedure (
          Artegodan and Others  v  
          Commission , paragraphs 129, 130 and 142). 
         
         
         61
            
         Against that background, 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
         12 of Directive 75/319 to the effect that it implicitly empowers the Commission to adopt a binding decision under the procedure
         provided for in Article 14 of that directive (
          Artegodan and Others  v  
          Commission , paragraphs 136 to 147). 
         
         
         62
            
         Second, the principle that the Community can only act within the powers conferred on it also militates against an interpretation
         of Article 15a(1) of Directive 75/319 to the effect that, in the absence of any provision providing for such a transfer of
         competence, the optional harmonisation of certain marketing authorisations, in accordance with a non-binding opinion of the
         CPMP under Article 12 of that directive, has the effect of depriving the Member States concerned of their competence in respect
         of subsequent decisions on the amendment, suspension or withdrawal of those authorisations. In the present case, the notion
         that such achieved harmonisation must be maintained ─ which would find its concrete expression in the implementation of a
         Community arbitration procedure ─ is not apparent from either the provisions of Chapter III of Directive 75/319 or the aim
         pursued by that chapter (
          Artegodan and Others  v  
          Commission , paragraphs 149 to 154). 
         
         
         63
            
         In those circumstances, in the system of harmonisation set up by Chapter III of Directive 75/319, which is based specifically
         on the principle of mutual recognition in association with Community arbitration procedures, the concept of a marketing authorisation
         granted in accordance with the provisions of that chapter, referred to in Article 15a(1), covers only authorisations granted
         by way of mutual recognition or arbitration. That concept cannot be interpreted as also including national authorisations
         harmonised following optional consultation of the CPMP under Article 12, which therefore remain within the essentially residual
         field of exclusive competence of the Member States concerned (
          Artegodan and Others  v  
          Commission , paragraphs 149 and 155). 
         
         
         64
            
         It follows that, in the present case, although the marketing authorisations of the medicinal products in question were harmonised
         by the decision of 9 December 1996, which has no legal basis but is no longer open to challenge, they do not come within the
         scope of Article 15a(1) of Directive 75/319. 
         
         
         65
            
         The contested decision, which was adopted under that article, is therefore also without legal basis.
         
         
         
         24
            
         Therefore, in paragraph 66 of the judgment under appeal, the Court of First Instance held that the decision at issue should
         be annulled without examining the pleas raised by Servier in its application. 
         The application for interim relief
         
         25
            
         The Commission submits that the conditions for granting suspension of operation of the judgment under appeal are met. First,
         the appeal in the main proceedings is not prima facie without reasonable substance. Second, compliance with the judgment under
         appeal before the Court delivers judgment on the appeal in the main proceedings would run the risk of causing serious and
         irreparable harm to public health in the Member States concerned. 
         
         
         26
            
         In order to establish a prima facie case for its application for interim relief, the Commission puts forward arguments relating
         to the reasoning of the Court of First Instance on the Commission's lack of competence to adopt the decision at issue. 
         
         
         27
            
         In order to establish the urgency of its application for interim relief, the Commission submits that compliance with the judgment
         under appeal before judgment is delivered in the main proceedings would run the risk of causing serious and irreparable harm
         to public health in the Member States concerned. 
         
         
         28
            
         Servier has not addressed in its observations the question of whether there is a prima facie case. 
         
         
         29
            
         Servier submits that the condition of urgency is not met in the present case, since the Commission has not taken account,
          
          inter alia , of the fact that Servier had voluntarily withdrawn its products from the market well before the decision at issue. 
         
         
         30
            
         It should be recalled that, according to Article 60 of the EC Statute of the Court of Justice, an appeal against a judgment
         of the Court of First Instance is not generally to have suspensory effect. However, pursuant to Article 242 EC, the Court
         may, if it considers that circumstances so require, order that application of the judgment under appeal be suspended. 
         
         
         31
            
         Furthermore, it follows from Article 83(2) of the Rules of Procedure that the grant of interim relief pursuant to Article
         242 EC is conditional on the existence of circumstances giving rise to urgency and of pleas of fact and law establishing a
         prima facie case for such a measure. 
         
         
         32
            
         It is necessary to ascertain whether those conditions are fulfilled in the present case. 
         
         
         33
            
         As regards whether pleas establishing a prima facie case for suspending the operation of the judgment under appeal have been
         put forward, suffice it to state that the appeal brought against that judgment raises fundamental questions, which the Court
         will have to decide in the appeal in the main proceedings, concerning the respective powers of the Commission and the Member
         States in the context of the Community legislation applicable to marketing authorisations for medicinal products for human
         use. 
         
         
         34
            
         The pleas put forward by the Commission on that matter show that there is a major legal disagreement whose resolution is not
         immediately obvious, so that the appeal is not prima facie without reasonable substance. Accordingly, the application for
         interim relief cannot be dismissed on that ground (see, to that effect, the orders in Case C-345/90 P-R  
          Parliament  v  
          Hanning  [1991] ECR I-231, paragraphs 29 and 30; Case C-180/01 P-R  
          Commission  v  
          NALOO  [2001] ECR I-5737, paragraphs 49 and 51, and Case C-39/03 P-R  
          Commission   v  
          Artegodan and Others  [2003] ECR I-4485, paragraph 40). 
         
         
         35
            
         As regards the condition relating to urgency, it is to be remembered that the purpose of the procedure for interim relief
         is to guarantee the full effectiveness of the definitive future decision, in order to ensure that there is no lacuna in the
         legal protection provided by the Court (see, in particular, the orders in Case 27/68 R  
          Renckens  v  
          Commission  [1969] ECR 255; Case C-399/95 R  
          Germany  v  
          Commission  [1996] ECR I-2441, paragraph 46; Case C-393/96 P(R)  
          Antonissen  v  
          Council and Commission  [1997] ECR I-441, paragraph 36, and  
          Commission  v  
          NALOO , paragraph 52). For the purpose of attaining that objective, urgency must be assessed in the light of the need for an interlocutory
         order in order to avoid serious and irreparable damage to the party seeking the interim relief (see the orders in Case C-65/99
         P(R)  
          Willeme  v  
          Commission  [1999] ECR I-1857, paragraph 62, and  
          Commission  v  
          NALOO , paragraph 52). 
         
         
         36
            
         It is for the party claiming serious and irreparable damage to establish its existence (see the orders in Case C-329/99 P(R)
          
          Pfizer Animal Health  v  
          Council  [1999] ECR I-8343, paragraph 75, and  
          Commission  v  
          NALOO , paragraph 53). While it is not necessary for it to be absolutely certain that the damage will occur, a sufficient degree
         of probability being enough, the applicant is none the less required to prove the facts which are considered to found the
         prospect of such damage (order in  
          Commission  v  
          NALOO , paragraph 53). 
         
         
         37
            
         In the present case, it is clear that the Commission has not established that suspending operation of the judgment under appeal
         is necessary for the full effectiveness of the definitive future decision which will be given on the appeal, if the appeal
         is allowed. 
         
         
         38
            
         The urgency claimed by the Commission results exclusively from the alleged risk for public health arising from the fact that,
         in response to the judgment under appeal, the Member States could reactivate the marketing authorisations for the medicinal
         products covered by the decisions at issue, so that those medicinal products could be prescribed to patients and taken by
         them. Those medicinal products run the risk of exposing patients to serious undesirable effects. 
         
         
         39
            
         It should be noted first of all that some of the undesirable effects of the medicinal products in question, referred to by
         the Commission, are mentioned in the summaries of product characteristics as amended by the decision of 9 December 1996 and
         that the case-file shows that those medicinal products are dispensed on prescription under a doctor's supervision. 
         
         
         40
            
         It must further be pointed out that it is clear from Servier's observations that that company voluntarily withdrew its products
         from the market in September 1997, has no longer marketed them in Europe since that date and does not intend to reintroduce
         them on to the market until their safety has been established. It is also clear from those observations that the corresponding
         marketing authorisations have either expired or been suspended at Servier's request. In addition, Servier states that it does
         not intend to request the reactivation of the suspended marketing authorisations and that it is willing to notify the Commission
         in advance of approaching any national authority for that purpose. 
         
         
         41
            
         Finally, it is important to note that it is common ground between the parties that the resumption of the marketing of the
         medicinal products in question does not follow automatically from the judgment under appeal, but requires a positive decision
         to that effect (see, in that respect, paragraph 20 of the judgment under appeal), and that, pursuant to the judgment under
         appeal, the competence to take any decision relating to the marketing authorisations for the medicinal products in question
         lies with the Member States. Accordingly, for the medicinal products in question to be reintroduced on to the market, it would
         be necessary for there to be a favourable decision by the national authorities, which has not so far been taken. 
         
         
         42
            
         In that regard, the Commission does not dispute the capacity of the competent authorities of the Member States to take those
         decisions on the basis of their own assessment. It merely expresses the fear that those authorities may reactivate the marketing
         authorisations of those medicinal products. 
         
         
         43
            
         Without prejudging the reply which the Court might give to the question of competence in the context of the appeal in the
         main proceedings, it must be stated that the Commission has not established that the situation arising from the judgment under
         appeal produces a risk of serious and irreparable harm to public health, since national authorities specialising in public
         health, which they are responsible for protecting, remain empowered to take any decisions relating to the marketing authorisation
         of the medicinal products in question under their own responsibility and on the basis of their own assessment. It should also
         be noted that the Commission has not, in its observations, referred to any obstacle which would prevent it from supplying
         to those authorities any information at its disposal which might prove useful in the assessment of the marketing authorisations
         for the medicinal products in question. 
         
         
         44
            
         Admittedly, that competence of the national authorities, which stems from the interpretation of the Community legislation
         adopted by the Court of First Instance in the judgment under appeal, is the subject of a disagreement which the Court will
         have to resolve in the decision which it will give on the appeal. That situation does give rise to some uncertainty both for
         the national and Community authorities and for the parties concerned. However, this question of competence arises in identical
         terms in Case C-39/03 P  
          Commission  v  
          Artegodan and Others , now pending before the Court, which is being heard by means of an expedited procedure in accordance with Article 62a of
         the Rules of Procedure, which is to put an end to that situation of legal uncertainty as soon as possible. 
         
         
         45
            
         There can accordingly be no question of a risk of serious and irreparable damage if the operation of the judgment under appeal
         is not suspended as requested. 
         
         
         46
            
         In those circumstances, it must be found that the Commission has not succeeded in establishing that the condition relating
         to urgency, imposed by Article 83(2) of the Rules of Procedure, is met in the present case. 
         
         
         47
            
         Since it has been established that the condition relating to urgency is not fulfilled, it is not necessary to examine the
         parties' pleas in law relating to the balancing of the interests at stake (see, to that effect, the orders in Case C-364/99
         P(R)  
          DSR-Senator Lines  v  
          Commission  [1999] ECR I-8733, paragraph 62; Case C-399/02 P(R)  
          Marcuccio  v  
          Commission  [2003] ECR I-1417, paragraph 36, and  
          Commission  v  
          Artegodan and Others , cited above, paragraph 54). 
         
         
         48
            
         It follows from the foregoing that the application for suspension of the operation of the judgment under appeal must be dismissed.
         
         
         On those grounds, 
         
         
         
            
            THE PRESIDENT OF THE COURT
         
         
         hereby orders:
         
            
            1.
             The application for interim relief is dismissed. 
            
            
            2.
             The costs are reserved.
            
            Luxembourg, 20 June 2003. 
         
         
         
                   R. Grass 
               
               
                  G.C. Rodríguez Iglesias  
               
            
         
         
         
                  Registrar
               
               
                  President
               
            
      
      
          1 –
            
             Language of the case: English.