CELEX: C2003/070/25
Language: en
Date: 2003-03-22 00:00:00
Title: Case C-39/03 P: Appeal brought on 3 February 2003 by Commission of the European Communities against the judgment delivered on 26 November 2002 by the Second Chamber, Extended Composition, of the Court of First Instance of the European Communities 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 between Artegodan GmbH, Bruno Farmaceutici and Others, Schuck GmbH, Laboratorios Roussel Lda, Laboratoires Roussel Diamant Sàrl, Roussel Iberica SA, Gerot Pharmazeutika GmbH, Cambridge Healthcare Supplies Ltd and Laboratoires pharmaceutiques Trenker SA and Commission of the European Communities

22.3.2003              EN                          Official Journal of the European Union                                            C 70/15
The applicant claims that the Court should:                                Belgian authorities (reliable scale of costs for patients and
                                                                           realities of the market) has to date been identified by the Court
                                                                           of Justice as an overriding requirement capable of justifying a
(a)   Declare that,                                                        measure having an effect equivalent to quantitative restrictions.
                                                                           The Commission is of the view that a period of up to 9 months
                                                                           for including on the list of reimburseable wheelchairs those
      —     by laying down the technical criteria to be met by             bearing EC markings which, accordingly, meet the require-
            wheelchairs in order to be eligible for reimbursement          ments of public health and safety laid down in Directive 93/
            by social security in such a way as to exclude from            42, cannot be considered to be reasonable.
            the list of wheelchairs eligible for reimbursement
            those bearing EC markings but which do not meet
            the relevant criteria, namely, as regards the diameter
            of the front and rear wheels, the cover and filling of         (1 ) Council Directive 93/42/EEC of 14 June 1993 concerning medical
            the seat and back, the dimensions of the flat sections              devices (OJ 1993 L 169, p. 1).
            and crossbars, head rests and/or foot or leg rests;
      —     by laying down more general criteria which the
            economic operator must meet in order to be
            included on the list of reimburseable wheelchairs,
            namely special conditions for manual wheelchairs,
            as well as special conditions for power wheelchairs
            according to which such wheelchairs must be avail-
            able in a minimum number of seat sizes;
      —     by having been too rigid in its updating of the list of        Appeal brought on 3 February 2003 by Commission of the
            equipment eligible for the reimbursement scheme,               European Communities against the judgment delivered on
            the Kingdom of Belgium has failed to fulfil its                26 November 2002 by the Second Chamber, Extended
            obligations under Article 28 EC;                               Composition, of the Court of First Instance of the Euro-
                                                                           pean Communities 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 between
                                                                           Artegodan GmbH, Bruno Farmaceutici and Others,
(b)   Order the Kingdom of Belgium to pay the costs.
                                                                           Schuck GmbH, Laboratorios Roussel Lda, Laboratoires
                                                                           Roussel Diamant Sàrl, Roussel Iberica SA, Gerot Pharma-
                                                                           zeutika GmbH, Cambridge Healthcare Supplies Ltd and
                                                                           Laboratoires pharmaceutiques Trenker SA and Com-
                                                                                        mission of the European Communities
Pleas in law and main arguments
                                                                                                     (Case C-39/03 P)
Wheelchairs are medical devices within the meaning of Council
Directive 93/42/EEC of 14 June 1993 concerning medical                                                (2003/C 70/25)
devices (1). It follows that wheelchairs bearing an EC marking,
provided for in Article 17 of that directive, must be freely
placed on the market in all the Member States. Eligibility for
reimbursement determines to a large extent access to the
Belgian market in wheelchairs, the cost of which is in many
cases considerable and in respect of which eligibility for                 An appeal against the judgment delivered on 26 November
reimbursement is decisive in the choice of the patient.                    2002 by the Second Chamber, Extended Composition, of the
Keeping in place technical criteria conditioning eligibility for           Court of First Instance of the European Communities in Joined
reimbursement of wheelchairs is not justified by public health             Cases T-74/00, T-76/00, T-83/00 to T-85/00, T-132/00,
reasons, since all wheelchairs bearing EC markings are deemed              T-137/00 and T-141/00 between Artegodan GmbH, Bruno
to satisfy the safety criteria laid down by Directive 93/42/EEC.           Farmaceutici and Others, Schuck GmbH, Laboratorios Roussel
Moreover, the Belgian authorities have not shown in what way               Lda, Laboratoires Roussel Diamant Sàrl, Roussel Iberica SA,
making reimbursement for wheelchairs contingent on the                     Gerot Pharmazeutika GmbH, Cambridge Healthcare Supplies
satisfaction of certain technical criteria could contribute to             Ltd and Laboratoires pharmaceutiques Trenker SA and Com-
maintaining the financing of the health insurance system in                mission of the European Communities was brought before the
equilibrium. The requirement that wheelchairs should be                    Court of Justice of the European Communities on 3 February
available in a minimum range of chair sizes is not such as to              2003 by the Commission of the European Communities,
offer greater protection for the health and safety of users and            represented by R. Wainwright and H. Støvlbæk, assisted by
other persons. None of the objectives relied upon by the                   B. Wägenbauer, with an address for service in Luxembourg.
 ---pagebreak--- 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.