CELEX: C2000/233/58
Language: en
Date: 2000-08-12 00:00:00
Title: Case T-141/00: Action brought on 25 May 2000 by Laboratoires Pharmaceutiques Trenker S.A. against the Commission of the European Communities

12.8.2000              EN                     Official Journal of the European Communities                                      C 233/31
Action brought on 25 May 2000 by Laboratoires Pharma-                    (b) Breach of the principle of proportionality, inasmuch as
ceutiques Trenker S.A. against the Commission of the                          the Commission is now ordering the withdrawal of the
                    European Communities                                      marketing authorisations despite the fact that there is no
                                                                              new scientific evidence indicating that the measures taken
                                                                              by the Commission in its previous decision, dated
                         (Case T-141/00)                                      9 December 1996, were incapable of achieving the
                                                                              desired objective.
                         (2000/C 233/58)
                                                                         (c)  Infringement of Directive 75/318/EEC on the approxima-
                                                                              tion of the laws of Member States relating to analytical,
                   (Language of the case: French)                             pharmaco-toxicological and clinical standards and proto-
                                                                              cols in respect of the testing of proprietary medicinal
An action against the Commission of the European Communi-                     products (2), as amended by Commission Directive
ties was brought before the Court of First Instance of the                    1999/83/EC of 8 September 1999 (3), according to which
European Communities on 25 May 2000 by Laboratoires                           the constituents of a medicinal product are deemed to
Pharmaceutiques Trenker S.A., having its registered office in                 have a well established medicinal use, with an acceptable
Brussels, represented by Xavier Leurquin and Lucette Defalque,                level of safety and recognised efficacy, where the marke-
of the Brussels Bar.                                                          ting of the product in question has been authorised for at
                                                                              least ten years.
The applicant claims that the Court should:
                                                                              The approach taken by the contested decision is that the
—     declare null and void the Commission’s decision of                      risk/benefit ratio of amfepramone is negative, having
      9 March 2000;                                                           regard to the new evaluation criteria applied by the
                                                                              Committee for Proprietary Medicinal Products of the
                                                                              European Agency for the Evaluation of Proprietary Medi-
—     order the defendant to pay the costs.                                   cinal Products, although the marketing of the applicant’s
                                                                              medicinal products containing amfepramone has been
                                                                              authorised in Belgium for over ten years and they thus
Pleas in law and principal arguments                                          have a well established medicinal use within the meaning
                                                                              of the directive referred to above, without it being
                                                                              possible to assess their efficacy and their therapeutic
The applicant contests Commission Decision C(2000) 453                        effect in the light of any new evaluation criteria.
of 9 March 2000 concerning the withdrawal of marketing
authorisations of medicinal products for human use which
contain the substance ‘amfepramone’.                                     (d) Violation of the fundamental principles of legal certainty
                                                                              and non-retroactivity, inasmuch as the Committee for
                                                                              Proprietary Medicinal Products, in its findings, and the
In support of its application, the applicant pleads:                          Commission, in adopting those findings, referred to new
                                                                              guidelines and applied them to old medicinal products.
(a)   Infringement of Article 15a of Council Directive 75/319/-
      EEC of 20 May 1975 on the approximation of provisions
      laid down by law, regulation or administrative action              (e)  Infringement of essential procedural requirements,
      relating to proprietary medicinal products (1).                         inasmuch as the contested decision:
      The applicant maintains that, contrary to what is stated in
      the decision at issue, Article 15a of Directive 75/319/EEC              —     does not comply with the obligation to provide a
      cannot constitute the proper legal basis for that decision,                   statement of reasons;
      inasmuch as neither of the two criteria laid down in that
      provision as conditions for its applicability is fulfilled in
      the present case.                                                       —     was adopted without regard for the applicant’s right
                                                                                    to be heard;
      The applicant states in that regard, first, that Article 15a
      concerns marketing authorisations which are granted in                  —     was adopted following an unlawful procedure.
      pursuance of the mutual recognition procedure (whereby
      an authorisation originally granted by one Member State
      is subsequently recognised in another Member State),               (1) OJ 1975 L 147, p. 13.
      whereas the marketing authorisations which have been               (2) OJ 1975 L 147, p. 1.
      granted to the applicant are purely national authorisa-            (3) OJ 1999 L 243, p. 9.
      tions, and, second, that it has not been established in any
      way that the withdrawal of the medicinal product in issue
      was necessary in order to protect public health.