CELEX: C2003/070/26
Language: en
Date: 2003-03-22 00:00:00
Title: Case C-43/03: Action brought on 3 February 2003 by the Commission of the European Communities against the Italian Republic

C 70/16                EN                       Official Journal of the European Union                                           22.3.2003
The appellant claims that the Court should:                             —     Misinterpretation of Article 11 of Directive 65/65/EEC
                                                                              on the approximation of provisions laid down by law,
—     set aside the judgment of the Court of First Instance of                regulation or administrative action relating to medicinal
      the European Communities of 26 November 2002 in                         products (2): By requiring the existence of new ‘scientific
      Joined Cases T-74/00, T-76/00, T-83/00 to T-85/00,                      data or information’ for the suspension or withdrawal of
      T-132/00, T-137/00 and T-141/00;                                        a marketing authorisation, the Court of First Instance
                                                                              relies on a criteria which does not appear in Article 11. By
—     order the defendants to pay the costs.                                  restricting the concept of ‘scientific data or information’
                                                                              to only data concerning medicinal products properly
                                                                              speaking, the Court of First Instance ignores that one of
                                                                              the elements to be taken account of when suspending or
Pleas and main arguments                                                      withdrawing a marketing authorisation is ‘therapeutic
                                                                              efficacy’. The Court of First Instance further ignores that
                                                                              the definition of what is to be understood by ‘therapeutic
—     Misinterpretation of Articles 15a(1) and 12 of Second
                                                                              efficacy’ hinges on an assessment carried out by scientific
      Council Directive 75/319/EEC of 20 May 1975 on
      the approximation of provisions laid down by Law,                       experts, on the basis of a scientific report, so that medical
                                                                              and scientific data concerning the substance cannot be
      Regulation or Administrative Action relating to pro-
      prietary medicinal products (1): The Court of First Instance            artificially separated from the assessment of its efficacy
                                                                              or effects which, by the inextricable nature of the links
      was wrong to refrain from examining the wording of
                                                                              between them, constitute as such scientific data which
      Article 15a(1) of Directive 75/319/EEC. If that article was
      intended to be restricted solely to the procedure for                   cannot be overlooked in the context of Article 11 of
                                                                              Directive 65/65/EEC.
      mutual recognition provided for in Article 10(2), the
      Community legislature would have indicated as much by
      means of specific wording. The effect of the reading of           —     (In the alternative) Breach of the precautionary principle.
      the Court of First Instance is to reduce Chapter III, which
      is none the less composed of Articles 8 to 15c, to a single       —     Breach of the principle of burden of proof: It is not for
      provision of that chapter. The interpretation of the                    the Commission but for the holders of the marketing
      wording of Article 15a(1) as referring to the whole of                  authorisations to show that the medicinal products in
      Chapter III of Directive 75/319 is confirmed by the                     question have the therapeutic efficacy required by the
      purpose of that provision as well as by the division of                 new scientific criteria.
      powers between the Member States and the Community.
      Article 15a (the ‘follow-up’ procedure) and Articles 10,          —     Disregard for the limits of judicial review: The Court of
      11 and 12 of Directive 75/319 share a common purpose,                   First Instance substitutes its assessment of the guidelines
      and it is reasonable to interpret Article 15a as applying               laid down by the Committee for Proprietary Medicinal
      to all the procedures referred to in Chapter III. The                   Products and the national guidelines referred to in the
      misinterpretation, by the Court of First Instance, of the               opinion of that committee of 31 August 1999 for that of
      distribution of powers in connection with Article 15a(1)                the scientists who drew up and assessed the guidelines in
      is the result of a failure to understand the division of                question.
      powers which characterises the whole of the other
      provisions in Chapter III of Directive 75/319. That               —     Distortion of the facts.
      chapter does not lay down an ‘exclusive competence of
      the Commission’ as against an ‘exclusive competence of            (1 ) OJ 1975 L 147, p. 13.
      the Member States’ as the Court of First Instance wrongly         (2 ) OJ, English Special Edition 1965-1966, p. 20.
      claims. Chapter III introduces procedures which are
      intended to attain the common objective, namely that of
      protecting public health and the completion of the
      internal market in medicinal products, by means of the
      instruments in Articles 10, 11 and 12 and of the ‘follow-
      up’ procedure in Article 15a. Each of those provisions
      forms part of the logical framework of shared and
      complementary competences, namely the Member States               Action brought on 3 February 2003 by the Commission
      retain responsibility for marketing authorisation of med-         of the European Communities against the Italian Republic
      icinal products for human use and the Community,
      represented by the Commission, intervenes whenever the                                        (Case C-43/03)
      various circumstances mentioned in the abovementioned
      articles require it. It is the Member States which then                                      (2003/C 70/26)
      implement the decisions adopted by the Commission in
      that context.
—     (In the alternative) Misinterpretation of Article 15a of          An action against the Italian Republic was brought before the
      Council Directive 75/319/EEC: That article does indeed            Court of Justice of the European Communities on 3 February
      apply to national marketing authorisations harmonised             2003 by the Commission of the European Communities,
      by the Member States following the consultation pro-              represented by Luca Visaggio, acting as Agent, with an address
      cedure under Article 12.                                          for service in Luxembourg.
 ---pagebreak--- 22.3.2003               EN                       Official Journal of the European Union                                          C 70/17
The Commission claims that the Court should:                                   b.    a subsequent decision taken on a date unknown to
                                                                                     the United Kingdom in December 2002 or January
—     declare that by failing to adopt the laws, regulations                         2003 to decommit those sums;
      and administrative provisions necessary to comply with
      Directive 2000/77/EC of the European Parliament and of                   c.    any steps taken pursuant to such decisions including
      the Council of 14 December 2000 fixing the principles                          the act of decommitting those sums;
      governing the organisation of official inspections in the
      field of animal nutrition or, in any event, by failing to
      inform the Commission thereof the Italian Republic has                   d.    a Commission decision contained in the letter dated
                                                                                     22 November 2002 to issue a recovery order for the
      failed to fulfil its obligations under Article 2(1) of that
      directive and under the EC Treaty.                                             sum of 9 272 767 Euros of ERDF money already
                                                                                     paid to the United Kingdom in respect of expendi-
                                                                                     ture incurred on MST 2; and
—     order the Italian Republic to pay the costs of the
      proceedings.
                                                                               e.    any steps taken pursuant to such decision.
                                                                         (2) Pursuant to Article 231 EC make a declaration that each
Pleas in law and main arguments                                                of the said measures is void.
                                                                         (3) Pursuant to Article 241 EC make a declaration that in the
Article 249 EC, under which a directive is binding on a                        event that the Commission’s interpretation of
Member State, as to the result to be achieved, entails that the                Article 52(5) of Regulation 1260/99 (1) and/or Article 10
Member States must respect the period for implementation                       of Annex to the Commission Decision C(92)1358/8 is
prescribed by the directive. That period ended on 29 December                  correct, the said measures are inapplicable against the
2001 without the Italian Republic having adopted the necess-                   United Kingdom.
ary provisions to comply with the directive which is the
subject of the Commission’s claims.
                                                                         (4) Make an order that the Commission pay the United
                                                                               Kingdom the costs of and occasioned by this Application
                                                                               and these proceedings.
                                                                         Pleas in law and main arguments
Action brought on 7 February 2003 by the United
Kingdom of Great Britain and Northern Ireland against
                          the Commission
                                                                         1)   T he De c om m it m e n t of 1 1 63 2 6 0 0 E u r os
                           (Case C-46/03)                                     of E R DF A ssi s ta nce
                           (2003/C 70/27)                                The Applicant submits that, in concluding that the United
                                                                         Kingdom had not complied with Article 52(5) of Regulation
                                                                         1260/1999, and in its conclusions as to the effect of any such
                                                                         non-compliance, the Commission erred in law and/or erred in
An action against the Commission was brought before the                  interpretation and/or made a manifest error in assessment.
Court of Justice of the European Communities on 7 February
2003 by the United Kingdom of Great Britain and Northern
Ireland, represented by P. Ormond, acting as agent, assisted by          The Applicant maintains that the sanction imposed by
D. Lloyd Jones QC and S. Lee, Barristers, with an address for            Article 52(5) of the Regulation applies only where an appli-
                                                                         cation for final payment has not been received by 31 March
service in Luxembourg.
                                                                         2001 and that the Regulation requires no more than that an
                                                                         application for final payment has been received by the
The Applicant claims that the Court should:                              stipulated date. The Regulation does not require the submission
                                                                         of an application in any particular form.
(1) Pursuant to Articles 230 and 231 EC make an order
      annulling the following measures:                                  In particular, the Regulation does not require that an appli-
                                                                         cation for final payment must be made in the standard form
      a.    a Commission decision contained in a letter dated            ERDF Certification of Expenditure which is usually employed
            22 November 2002 to decommit the sum of                      for this purpose. The Commission therefore erred in law in
            11 632 600 Euros in respect of expenditure incurred          concluding that failure to make an application for final
            on the Manchester/Salford/Trafford 2 operational             payment in that form led to the imposition of the sanction
            programme, or MST 2;                                         imposed by Article 52(5).