CELEX: C2003/083/56
Language: en
Date: 2003-04-05 00:00:00
Title: Case T-42/03: Action brought on 10 February 2003 by Lurgi AG and Lurgi S.p.A. against the Commission of the European Communities

C 83/26                EN                         Official Journal of the European Union                                        5.4.2003
The applicant claims that the Court should:                               —      The referral covers the entire content of the SPC. This
                                                                                 goes beyond the permissible scope of an Article 30
                                                                                 referral, which must be limited to a ‘clearly identified
—     annul the Contested Decision                                               question’, according to Article 30, second indent, of the
                                                                                 Directive.
—     order the Commission to pay the applicants’ costs                   —      It has not been demonstrated that the contested Decision
                                                                                 is based on public health grounds.
                                                                          (1 ) OJ L 311, of 28.11.2001, p. 67.
Pleas in law and main arguments
The Applicants in the present case are all Marketing Authoris-
ation Holders (MAH) for the product ZOCORD, which,
containing the active ingredient simvastatin, is a lipid-lowering         Action brought on 10 February 2003 by Lurgi AG and
medicine reducing levels of toal cholesterol, LDL-C (low                  Lurgi S.p.A. against the Commission of the European
density lipoprotein cholesterol), Apo B (Apolipoprotein B) and                                       Communities
triglycerides in the blood It also increases the amount of HDL-
C (High density lipoprotein cholesterol) in the blood.                                              (Case T-42/03)
                                                                                                    (2003/C 83/56)
They challenge the decision of the European Agency for the
Evaluation of Medicinal Products to initiate a referral procedure                             (Language of the case: English)
under Article 30 of Directive 2001/83/EC of the European
Parliament and the Council, of 6 November 2001, of the
Community code relating to medicinal products for human
use (the Directive) ( 1), in relation to the aforementioned               An action against the Commission of the European Communi-
product.                                                                  ties was brought before the Court of First Instance of the
                                                                          European Communities on 10 February 2003 by Lurgi AG,
                                                                          Frankfurt am Main, Germany, and Lurgi S.p.A., Milan, Italy,
                                                                          represented by Dr Michael Schütte and Prof Massimo Benedet-
The Applicants sumit that the contested Decision violates                 teli, Lawyers with an address for service in Luxembourg.
Article 30 of the Directive on the following grounds:
                                                                          The applicant claims that the Court should:
—     There are no divergent decisions following decisions in
      accordance with Article 8, 10(1) and 11 of the Directive.           —      annul the notice terminating the THERMIE Contract,
                                                                                 notified by the Commission’s letter of 26 November
                                                                                 2002;
—     The contested Decision is a decision to harmonise the
      summary of product characteristics (SPC) for ZOCORD                 —      declare that the Commission is not entitled to claim
      and associated trade names, and the single proposal of                     reimbursement of the funds paid to the contractors under
      the referral procedure for ZOCORD is to develop and                        the THERMIE contract BM/1007/94;
      impose the EU-wide harmonised SPC. The Article 30
      procedure, however, does not allow for the adoption of a            —      order the Commission to bear the costs of these proceed-
      harmonised SPC.                                                            ings.
—     Before the mutual recognition procedure took effect,
      pharmaceutical companies were under no obligation to                Pleas in law and main arguments
      submit identical marketing authorisation applications to
      different Member States. Applicants could, for example,
      request approval of different therapeutic uses or presen-           The applicants, together with several other contractors, con-
      tations, often to take account of differences in national           cluded a contract (THERMIE contract) on 12 December 1994
      medical practices and customs. Such differences in appli-           with the Commission for activities relating to the promotion
      cations unavoidably result in differences in the approvals,         of energy technology in Europe. The contract was concluded
      but do not qualify as ‘divergent decisions’ for the purposes        under number BM 1007/1994 IT/DE/UK and its object was
      of Article 30. Hence, differences between national                  the funding and implementation of the project ‘Energy farm:
      approvals resulting from different applications are not             an IGCC plant for the production of electricity and heat trough
      covered by Article 30.                                              gasification of SFR biomass’
 ---pagebreak--- 5.4.2003                EN                       Official Journal of the European Union                                       C 83/27
On 30 May 1997 a contract was concluded between one of                   Action brought on 11 February 2003 by Leali S.p.A.
the applicants, Lurgi SpA, and the coordinator of the project,                against Commission of the European Communities
Bioelettrica, relating to the construction of a plant for the
atmospheric gasification of biomass. During the engineering
works, the applicant identified certain technical difficulties.                                    (Case T-46/03)
These difficulties were brought to the attention of the Com-
mission and the other contractors.                                                                 (2003/C 83/57)
On 6 September 2001, the Commission notified Bioelettrica                                    (Language of the case: Italian)
that it was terminating the contract because of the failure to
commence the works under the THERMIE contract. Bioelettrica
contested this termination of the contract before the Court of
First Instance in Case T-287/01, Bioelettrica/Commission.                An action against the Commission of the European Communi-
                                                                         ties was brought before the Court of First Instance of the
                                                                         European Communities on 11 February 2003 by Leali S.p.A.,
On 23 July 2002, the Commission sent a further notice                    represented by Giovanni Vezzoli and Gianluca Belotti, lawyers.
indicating that it would terminate the contract due to non-
performance by the contractors unless they performed their
obligations within 30 days. The Commission mainly criticised             The applicant claims that the Court should:
the delays of the project. In a letter dated 26 November
2002, the Commission stated that it considered the contract
terminated. This termination of the contract is being contested          —     principally, annul the contested decision;
in the present case.
                                                                         —     or, alternatively, reduce the fine imposed,
In support of their application, the applicants invoke an                —     order the defendant to pay the costs.
infringement of the formal requirements in the decision
making procedure of the Commission. According to the
applicants, all acts of the Commission have to be taken under
the principle of collegiality as set forth in Article 219 of the         Pleas in law and main arguments
EC Treaty and Article 1 of the procedural rules of the
Commission ( 1). The applicants submit that the decision termi-
nating the contract had a substantial financial impact for               This action is directed against the same decision as that
the contractors and involves a difficult technical and legal
                                                                         contested in Case T-27/03 S.P. v Commission. The pleas
assessment of the contract and its purpose. Therefore, the
                                                                         in law and main arguments are similar to those in the
applicants claim that the decision to terminate the contract             abovementioned case.
could not be considered as an execution of an act at an
administrative or management level and that the decision had
to be taken by the College of Commissioners.
Furthermore, the applicants invoke the wrongful application
of the THERMIE contract. The applicants submit in this respect
that there is no justification for a termination of the contract
for non-performance by the contractors. According to the                         Removal from the register of Case T-187/94 (1)
applicants, this provision is not applicable when there are
reasonable technical or economic grounds for non-perform-
ance. In the present case, there was a need to make modifi-                                        (2003/C 83/58)
cations to the original technology causing serious economic
risks.                                                                                      (Language of the Case: German)
Finally, the applicants submit that the behaviour of the
Commission prevents the Commission from invoking non-
performance as a ground for termination of the contract. In              By order of 11 December 2002 the President of the First
this respect, the applicants invoke Article 1460 of the Italian          Chamber of the Court of First Instance of the European
Civil Code and the principle inadimplenti non est adim-                  Communities ordered the removal from the register of Case
plentum.                                                                 T-187/94: Theresia Rudolf v Council of the European Union
                                                                         and Commission of the European Communities.
( 1) Rules of Procedure of the Commission [C(2000) 3614] (OJ L 308
     of 8 December 2000, p. 26).                                         (1 ) OJ C 174 of 25.6.1994.