CELEX: C2000/149/78
Language: en
Date: 2000-05-27 00:00:00
Title: Case T-76/00: Action brought on 3 April 2000 by Bruno Farmaceutici S.p.A. and seven other companies against the Commission of the European Communities

C 149/42                 EN                     Official Journal of the European Communities                                   27.5.2000
The applicant claims that the Court should:                                Action brought on 3 April 2000 by Bruno Farmaceutici
                                                                           S.p.A. and seven other companies against the Commission
— annul the Commission Decision of 9 March 2000 (K(2000)                                   of the European Communities
     453);
                                                                                                    (Case T-76/00)
— in the alternative, annul the decision in so far as Article 1
     in conjunction with Annex I requires the Federal Republic
     of Germany to withdraw authorisation for the applicant’s                                      (2000/C 149/78)
     preparation containing amfepramon ‘Tenuate Retard’;
— order the Commission to pay the costs.
                                                                                             (Language of the case: German)
Pleas in law and main arguments
                                                                           An action against the Commission of the European Communi-
                                                                           ties was brought before the Court of First Instance of the
The applicant possesses a German authorisation for the                     European Communities on 3 April 2000 by Bruno Farmaceut-
medicinal product containing amfepramon ‘Tenuate Retard’.                  ici S.p.A., of Rome, and seven other companies, represented
By the present application it seeks annulment of the Com-                  by Burkhard Sträter, Rechtsanwalt, Bonn, Germany.
mission’s decision addressed to the Member States on with-
drawal of authorisation for medicinal products for human use
which contain that substance.                                              The applicants claim that the Court should:
The application is based in particular on the following grounds:           — annul Commission Decision K (2000) 453 of 9 March
                                                                               2000;
— The defendant was not entitled to adopt the contested
     decision. It wrongly bases its decision on Articles 14 and            — in the alternative, annul the decision in so far as Article 1
     15a of Directive 75/319 (1). The conditions under Article                 in conjunction with Annex I thereof requires the Member
     15a of the directive are not satisfied.                                   States Austria, Belgium, Denmark, France, Germany, Italy,
                                                                               Luxembourg, Spain and the United Kingdom to withdraw
— The European Agency for the Evaluation of Medicinal                          the authorisations for the applicants’ medicinal products
     Products altered the subject-matter of the procedure under                containing amfepramon;
     Article 15a of Directive 75/319, in breach of the directive.
                                                                           — order the Commission to pay the applicants’ necessary
— The conditions for withdrawal of authorisation under                         costs.
     Article 14 of Directive 75/319 and Article 11 of Directive
     65/65 (2) are not satisfied. Neither the harmfulness nor the
     lack of therapeutic efficacy of amfepramon has been
     established.                                                          Pleas in law and main arguments
— The decision is furthermore disproportionate. The Com-
     mittee for Proprietary Medicinal Products regarded long-              The applicants are pharmaceutical undertakings which market
     term studies of the efficacy and side-effects of amfepramon           medicinal products containing amfepramon in various Mem-
     as necessary. Such studies could, however, also be carried            ber States. By the present application they seek annulment of
     out while the preparations continued, to be marketed.                 the Commission’s decision addressed to the Member States on
     Withdrawal of authorisation, on the other hand, is an                 withdrawal of authorisation for medicinal products for human
     irreparable measure and the one which burdens the holder              use which contain that substance. The application is based in
     of the authorisation most severely.                                   particular on the following grounds:
                                                                           — The initiation of the procedure under Article 15a of
(1) Second Council Directive 75/319/EEC of 20 May 1975 on the                  Directive 75/319/EEC (1) by Belgium was ineffective. The
    approximation of provisions laid down by law, regulation or
                                                                               Committee for Proprietary Medicinal Products and the
    administrative action relating to proprietary medicinal products
    (OJ 1975 L 147, p. 13).                                                    Commission were therefore not entitled to carry out the
(2) Council Directive 65/65/EEC of 26 January 1965 on the approxi-             procedure and adopt the decision.
    mation of provisions laid down by law, regulation or administrat-
    ive action relating to proprietary medicinal products (OJ, English     — The excessive length of the procedure breached essential
    Special Edition 1965-1966, p. 20).
                                                                               procedural requirements.
                                                                           — The procedure on which the decision was based and the
                                                                               decision itself infringe provisions of Directive
                                                                               65/65/EEC (2).
 ---pagebreak--- 27.5.2000                EN                     Official Journal of the European Communities                                      C 149/43
— The evaluation carried out of the safety and efficacy of                 — The Commission based its conclusions on an incorrect
     amfepramon has no valid scientific basis. Criteria were used              analysis of the relevant market, contrary to its own
     for assessment which are applicable only in procedures for                decisional practice.
     new authorisations or extensions. Such procedures are,
     however, within the competence of the Member States.                  — Contrary to the findings in the contested decision, Telecom
     The decision is therefore also void on the ground of misuse               Éireann abused its dominant position by refusing to
     of powers.                                                                provide proper access to the applicant, by offering bundled
                                                                               access conditions on a retail basis and by discriminating
                                                                               between the access conditions granted to the applicant and
(1) Second Council Directive 75/319/EEC of 20 May 1975 on the                  other telecommunications operators.
    approximation of provisions laid down by law, regulation or
    administrative action relating to proprietary medicinal products
    (OJ 1975 L 147, p. 13).                                                — Basing itself on the assumption that the available evidence
(2) Council Directive 65/65/EEC of 26 January 1965 on the approxi-             was insufficient to prove that Telecom Éireann abused
    mation of provisions laid down by law, regulation or administrat-          its dominant position, the applicant submits that the
    ive action relating to proprietary medicinal products (OJ, English         Commission misused its powers by refusing to conduct the
    Special Edition 1965-1966, p. 20).                                         additional proceedings required to establish this evidence.
Action brought on 3 April 2000 by Esat Telecommuni-                        Action brought on 3 April 2000 by Sumitomo Metal
cations Ltd., against the Commission of the European                       Industries Limited against the Commission of the Euro-
                             Communities                                                         pean Communities
                            (Case T-77/00)                                                          (Case T-78/00)
                           (2000/C 149/79)                                                         (2000/C 149/80)
                     (Language of the case: English)                                         (Language of the case: English)
An action against the Commission of the European Communi-                  An action against the Commission of the European Communi-
ties was brought before the Court of First Instance of the                 ties was brought before the Court of First Instance of the
European Communities on 3 April 2000 by Esat Telecom-                      European Communities on 3 April 2000 by Sumitomo Metal
munications Ltd., Dublin, represented by Bernard Amory and                 Industries Limited, Osaka (Japan), represented by Christopher
Alexandre Verheyden of Jones, Day, Reavis & Pogue, Brussels.               Vajda QC and David Aitman, Solicitor.
The applicant claims that the Court should:                                The applicant claims that the Court should:
— declare the defendant’s decision of 18 January 2000 to be                — annul Articles 1 to 5 of the decision in so far as they are
     void;                                                                     addressed to the applicant;
— order the defendant to pay the costs.                                    — alternatively, annul Article 4 of the decision in so far as it
                                                                               imposes a fine of 13.5 million euro on SMI and fix a
                                                                               substantially lower fine;
Pleas in law and main arguments
                                                                           — order the Commission to pay the costs of the proceedings.
The applicant is a licensed provider of telecommunications
services in Ireland. In 1996 it lodged an application for the
                                                                           Pleas in law and main arguments
initiation of a procedure to establish the existence of an
infringement of Article 86 of the EC Treaty (now Article 82
EC) by Telecom Éireann (now called Eircom). The alleged                   According to the applicant, the contested decision finds two
infringement related to the withdrawal by Telecom Éireann of              sets of agreements that infringe Article 81 EC. The first set was
the standard discounts, which it made available to its large-              found to exist between four European producers of seamless
volume end users and to its failure to provide the applicant               standard OCTG and line pipe and four Japanese producers,
with equitable interconnection tariffs. The applicant seeks at             including the applicant (‘EU/Japan agreement’). The second
present the annulment of the Commission decision rejecting                 agreement was found to exist between the European producers
its complaint in particular on following grounds:                          (‘EU Agreement’).