CELEX: C2003/101/35
Language: en
Date: 2003-04-26 00:00:00
Title: Case C-74/03: Reference for a preliminary ruling by the Østre Landsret by order of that Court of 14 February 2003 in the case of SmithKline Beecham plc against Lægemiddelstyrelsen; interveners being Synthon BV and Genthon BV

26.4.2003               EN                         Official Journal of the European Union                                          C 101/21
The applicant claims that the Court should:                                       much larger amount, against which the Commission had
                                                                                  publicly advised but which was adopted in other Member
                                                                                  States such as France, Germany or Italy. It can in no
—     annul the Commission’s decision of 11 December                              way be maintained that Spanish operators enjoyed an
      2002 ( 1), in so far as it finds that the subsidising of loans              economic advantage to which those of other Member
      and guarantees for owners of agricultural holdings and                      States did not have access.
      the extension of tax benefits to the transfer of agricultural
      land and holdings constitute State aid incompatible with
      the Treaty;                                                          —      (In the alternative) If State aid is found to exist, it is
                                                                                  compatible with the common market in the light of
                                                                                  Article 87(2)(b) EC: neither the objective nor the result of
—     order the Commission to pay the costs.                                      the alleged aid was to cover loss suffered by the farmer:
                                                                                  the intention was to make it easier for him to obtain a
                                                                                  loan from financial institutions so that the loans would
                                                                                  make up for the lack of liquidity brought about by the
                                                                                  disproportionate increase in costs caused by the steep
                                                                                  rises in fuel prices. If, following the Commission’s rec-
                                                                                  ommendation not to reduce the special tax on fuel oils
Pleas in law and main arguments                                                   or value added tax, no alternative measures were adopted,
                                                                                  Spanish farmers would become less competitive in their
                                                                                  trade by comparison with States which implemented
                                                                                  permitted, although not recommended, tax reductions.
(The extension of certain tax benefits to transfers of land)               —      (In the alternative) Compatibility of the measures in the
                                                                                  light of Article 87(3)(c) EC.
—     This does not constitute State aid since certain undertak-
      ings or the production of certain goods are not specifically
      favoured: the measure entails a lower tax burden for the             (1 ) Relating to measures taken by Spain to support agriculture
      seller of the land and has an impact on the owner (farmer)                following the fuel price increase.
      purchasing land: not as to the amount but as to the
      greater availability of land for sale because of the lower
      capital gains tax charge for the seller.
—     (in the alternative) The aid is compatible with the
      Community guidelines for State aid in the agricultural
      sector: A farmer who invests in the acquisition of land,
      and is the owner of a priority holding, by definition
      satisfies the requirements set out in point 4.1 of the
      Community guidelines as regards the economic viability
      of the holding and the occupational skill required for the           Reference for a preliminary ruling by the Østre Landsret
      grant of structural aid cofinanced by the EU under the               by order of that Court of 14 February 2003 in the case of
      Regulation on improving the efficiency of agricultural               SmithKline Beecham plc against Lægemiddelstyrelsen;
      structures in force at the material time.                                    interveners being Synthon BV and Genthon BV
                                                                                                       (Case C-74/03)
(The subsidising of loans and guarantees for owners of
agricultural holdings                                                                                 (2003/C 101/35)
—     This does not constitute State aid within the meaning of
      Article 87 EC since it does not affect trade between
      Member States: The Spanish measure entailing the sub-
      sidising of loans was actually symbolic in the face of a             Reference has been made to the Court of Justice of the
      sector which felt that its economic viability was seriously          European Communities by order of the Østre Landsret (Eastern
      threatened by the exceptional fuel-price increase. It is             Regional Court) of 14 February 2003, received at the Court
      paradoxical that a palliative measure of such a slight               Registry on 19 February 2003, for a preliminary ruling in the
      unitary significance should give rise to a decision of               case of SmithKline Beecham plc against Lægemiddelstyrelsen
      incompatibility with the common market when it was                   (Danish Medicinal Products Administration); interveners being
      adopted as an alternative to a reduction in taxes of a               Synthon BV and Genthon BV on the following questions:
 ---pagebreak--- C 101/22                  EN                          Official Journal of the European Union                                        26.4.2003
Q ues ti o n 1                                                                Pleas in law and main arguments
Is it compatible with point 8(a)(iii) of Article 4 of the                     Article 249 EC, under which a directive shall be binding, as to
First Medicinal Products Directive (Directive 65/65/EEC ( 1), as              the result to be achieved, upon each Member State, carries by
amended) for a product to be authorised under the abridged                    implication an obligation on the Member States to observe the
application procedure when a salt of the active substance in                  period for compliance laid down in the directive. That period
the product is changed from the one used in the reference                     expired on 17 July 2001 without Ireland having enacted the
product?                                                                      provisions necessary to comply with the directive referred to
                                                                              in the conclusions of the Commission.
Q ues ti o n 2                                                                (1 ) OJ L 201 of 17.7.1998, p. 88.
Can the abridged application procedure be used when an
applicant, on its own initiative or at the request of national
health authorities, submits additional documentation in the
form of certain pharmacological or toxicological tests or
clinical trials with a view to demonstrating that the product is
‘essentially similar to’ the reference product?                               Action brought on 20 February 2003 by the Commission
                                                                              of the European Communities against the Federal Repub-
                                                                                                        lic of Germany
( 1) Council Directive 65/65/EEC of 26 January 1965 on the approxi-
     mation of provisions laid down by Law, Regulation or Adminis-
     trative Action relating to proprietary medicinal products (OJ B 22                                  (Case C-77/03)
     of 9.2.1965, p. 369).
                                                                                                       (2003/C 101/37)
                                                                              An action against the Federal Republic of Germany was
                                                                              brought before the Court of Justice of the European Communi-
Action brought on 19 February 2003 by the Commission                          ties on 20 February 2003 by the Commission of the European
         of the European Communities against Ireland                          Communities, represented by Claudia Schmidt, of the Euro-
                                                                              pean Commission’s Legal Service, acting as Agent, with an
                                                                              address for service in Luxembourg at the office of Carlos
                             (Case C-75/03)                                   Gómez de la Cruz, also of the European Commission’s Legal
                                                                              Service, Wagner Centre C 254, Kirchberg.
                            (2003/C 101/36)
                                                                              The applicant claims that the Court should:
An action against Ireland was brought before the Court of                     1.    declare that, by failing to bring into force the laws,
Justice of the European Communities on 19 February 2003 by                          regulations and administrative provisions necessary to
the Commission of the European Communities, represented                             comply with Directive 98/71/EC ( 1) of the European
by Nicola Yerrell, acting as agent, with an address for service                     Parliament and of the Council of 13 October 1998 on
in Luxembourg.                                                                      the legal protection of designs and/or by failing to inform
                                                                                    the Commission of those provisions, the Federal Republic
                                                                                    of Germany has failed to fulfil its obligations under that
The Applicant claims that the Court should:                                         directive;
(1) find that Ireland has failed in its obligations under the EC              2.    order the Federal Republic of Germany to pay the costs.
       Treaty by failing to adopt the laws, regulations and
       administrative provisions necessary to comply with
       Council Directive 98/50/EC of 29th June 1998 amending
       Directive 77/187/EEC on the approximation of the laws                  Pleas in law and main arguments
       of the Member States relating to the safeguarding of
       employees’ rights in the event of transfers of undertakings,
       businesses or parts of businesses (1), or by failing to                The period for transposition expired on 28 October 2001.
       ensure that employers’ and employees’ representatives
       have introduced the necessary provisions by agreement,
       and/or by failing to inform the Commission thereof; and                (1 ) OJ L 289 of 28.10.1998, p. 28.
(2) condemn Ireland to bear the costs of the procedure.