CELEX: C2003/158/30
Language: en
Date: 2003-07-05 00:00:00
Title: Case C-213/03: Reference for a preliminary ruling by the Cour de cassation (France), First Civil Chamber, by order of that court of 6 May 2003 in the case of Syndicat professionnel coordination des pêcheurs de l'Etang de Berre et de la région against Électricité de France

C 158/18                EN                       Official Journal of the European Union                                              5.7.2003
The Commission considers that no argument justifies the                         medicinal products authorised in France or in the Member
existence of the prior authorisation procedure at issue. First, it              State of export or than in the case of homeopathic
cannot be justified by concern to ascertain that the medicinal                  medicinal products registered in a Member State. Never-
product has been manufactured according to the good prac-                       theless, while acknowledging that a prior authorisation
tices laid down by Community legislation. The imported                          procedure may be justified, in principle, in the case of
medicinal product has been authorised or registered in the                      personal imports of such products, that procedure should
Member State of export, which is responsible for ensuring                       be easily accessible, carried out within a reasonable period
compliance with those good practices. Any additional check                      and culminate in an authorisation for the importation of
carried out in France would be contrary to the principle of                     medicinal products not posing any risk to public health.
mutual recognition and the objective of ensuring the free                       However, the prior authorisation procedure applied by
movement of medicinal products. Secondly, with regard to                        France to personal imports of medicinal products does
possible justification on other grounds of protection of health,                not comply with those criteria and is therefore dispro-
it is necessary, in the Commission’s view, to distinguish                       portionate to the objective to be attained.
between three types of medicinal products:
                                                                         (1 ) Council Directive 65/65/EEC of 26 January 1965 on the approxi-
—     medicinal products authorised pursuant to amended                       mation of provisions laid down by law, regulation or administrat-
      Directive 65/65, then pursuant to Directive 2001/83/EC,                 ive action relating to proprietary medicinal products (OJ, English
      both in France and in the Member State where they are                   Special Edition 1965-1966, p. 20).
      purchased (or covered by an authorisation to place them            (2 ) Directive 2001/83/EC of the European Parliament and of the
                                                                              Council of 6 November 2001 on the Community code relating to
      on the Community market (marketing authorisation)).
                                                                              medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
      The French authorities have acknowledged that an import            (3 ) Council Directive 92/73/EC of 22 September 1992 widening
      authorisation was required in the case of personal import-              the scope of Directives 65/65/EEC and 75/319/EEC on the
      ation of medicinal products covered by a marketing                      approximation of provisions laid down by law, regulation or
      authorisation in France. However, in view of the advanced               administrative action relating to medicinal products and laying
      state of harmonisation achieved in the pharmaceutical                   down additional provisions on homeopathic medicinal products
      products sector, in that type of case important guarantees              (OJ L 297, 13.10.1992, p. 8).
      of protection of the health of patients are satisfied. In
      addition, there is the fact that importation will take place
      only following the issue of a lawful medical prescription
      and in quantities not exceeding the needs of the treatment.
      It follows that the prior authorisation procedure at issue
      is not justified.
—     homeopathic medicinal products registered in a Member
      State pursuant to Directive 92/73/EEC, replaced by
      Directive 2001/83/EC. When a homeopathic medicinal
      product is registered in a Member State, it does not in            Reference for a preliminary ruling by the Cour de
      principle pose any risk to health, especially given the fact       cassation (France), First Civil Chamber, by order of that
      that the rules on the manufacture, control and inspection          court of 6 May 2003 in the case of Syndicat professionnel
      of that type of medicinal product have been harmonised.            coordination des pêcheurs de l’Etang de Berre et de la
      In addition, Directive 92/73/EEC has liberalised patients’                        région against Électricité de France
      access to the medicinal products of their choice. A prior
      authorisation procedure for personal importation of
      registered homeopathic medicinal products is therefore                                         (Case C-213/03)
      manifestly unjustified.
                                                                                                     (2003/C 158/30)
—     medicinal products not authorised in France, but author-
      ised in the Member State where they are purchased. The
      prior authorisation procedure at issue does not constitute
      a measure necessary for the purpose of combating the
      risk of fraud or misuse of the marketing authorisation
      mechanism, since the general legislation making the                Reference has been made to the Court of Justice of the
      importation of medicinal products to be marketed subject           European Communities by order of the Cour de cassation
      to prior authorisation, as well as the on-the-spot checks,         (Court of Cassation) (France), First Civil Chamber, received at
      are sufficient to combat illegal imports of medicinal              the Court Registry on 19 May 2003, for a preliminary ruling
      products. However, from the point of view of the                   in the case of Syndicat professionnel coordination des pêcheurs
      protection of public health, the case of imports relating          de l’Etang de Berre et de la région (Trade association coordinat-
      to medicinal products not authorised in France may                 ing fishermen of the Etang de Berre and the area) against
      justify a more qualified approach than the case of                 Electricité de France on the following questions:
 ---pagebreak--- 5.7.2003              EN                          Official Journal of the European Union                                             C 158/19
1.   Must Article 6(3) of the Athens Protocol of 17 May 1980                    2.     by failing to include in the relevant Austrian legal
     for the protection of the Mediterranean Sea against                               provisions (Luftreinhaltegesetz für Kesselanlagen —
     pollution from land-based sources (the Barcelona Con-                             LRG-K and LRV-K) (law on air purity for boiler
     vention), which has become Article 6(1) in the revised                            plants) the definitions of ’new plant’ and ’existing
     version, be held to have direct effect, so that any interested                    plant’ as set out in Article 2.9 and 2.10 of the
     party may rely on it before the national courts in an action                      directive;
     to halt discharges of water which are not authorised in
     accordance with the procedure and criteria which it                        3.     by failing fully, in particular by reason of the
     prescribes?                                                                       divergence of the Austrian definition of fuel from
                                                                                       that set out in Article 2.6 of the directive, to
                                                                                       incorporate in the relevant air-purity legislation the
2.   Must the same provision be interpreted to mean that it                            emission limit values for sulphur dioxide, oxides of
     prohibits the discharge into a saltwater marsh communi-                           nitrogen and dust laid down in Article 4.1 in
     cating with the Mediterranean Sea of substances which,                            conjunction with Annexes III to VII to the directive;
     although not toxic, adversely affect the oxygen content
     of the marine environment, without an authorisation                        4.     by failing correctly to transpose in the LRG-K
     issued by the competent authorities of the Member States,                         and LRV-K Article 9(2) and (3) of the directive
     taking into account the provisions of the abovementioned                          concerning the calculation of the emission limit
     Protocol and of Annex III C thereto (now Annex II)?                               value in multi-fuel firing units which use distillation
                                                                                       and conversion residues from crude-oil refining for
                                                                                       own consumption, alone or with other fuels,
                                                                                the Republic of Austria has failed to fulfil its obligations
                                                                                under Articles 2.6, 2.8, 2.9, 2.10 and 10(4)(1) of Directive
                                                                                88/609, in conjunction with Annexes III to VII thereto
                                                                                and Article 9(2) and (3) of that directive;
                                                                          II.   Order the Republic of Austria to pay the costs of the
                                                                                proceedings.
Action brought on 19 May 2003 by the Commission
of the European Communities against the Republic of
                              Austria                                     Pleas in law and main arguments
                                                                          The Commission finds that the Republic of Austria has failed
                                                                          to fulfil its obligations by failing to bring its national law into
                       (Case C-214/03)
                                                                          line with the directive, which was thus improperly and
                                                                          incompletely transposed, in so far as:
                       (2003/C 158/31)                                    —     it failed correctly to transpose Article 2.8 of the directive
                                                                                relating to the term ‘multi-fuel firing unit’ by restricting
                                                                                the term, in a manner not envisaged in the directive,
                                                                                to units in which the percentage of additional fuels
                                                                                contributing to the thermal input amounts to at least
An action against the Republic of Austria was brought before                    20 % and thus restricting the scope of the directive in
the Court of Justice of the European Communities on 19 May                      that regard;
2003 by the Commission of the European Communities,
                                                                          —     it failed to transpose Article 2.9 and 2.10 of the directive
represented by Josef Christian Schieferer and Gregorio Valero
                                                                                with regard to the definitions of ‘new plant’ and ‘existing
Jordana, of the Commission’s Legal Service, acting as Agents,
                                                                                plant’;
with an address for service in Luxembourg.
                                                                          —     it failed fully to give effect to the emission limit values for
                                                                                sulphur dioxide, oxides of nitrogen and dust in accord-
                                                                                ance with Article 4(1) in conjunction with Annexes III
The applicant claims that the Court should:
                                                                                to VII, particularly in light of the definition of fuel,
                                                                                which in the Austrian legal provisions is confined to
I.   Rule that:                                                                 ‘conventional fuels’, as a result of which only partial effect
                                                                                is given to the scope of the directive;
     1.   by laying down in paragraph 22(1) of the Luft-
          reinhalteverordnung für Kesselanlagen (regulation               —     it failed correctly to transpose Article 9(2) and (3) of the
          on air purity for boiler plants) (LRV-K) a definition                 directive with regard to the calculation of the limit values
          of ’multi-fuel firing unit’ that departs from Article 2.8             for multi-fuel firing units in refineries.
          of Council Directive 88/609/EEC of 24 November
          1988 on the limitation of emissions of certain                  (1 ) OJ 1988 L 336, p. 1.
          pollutants into the air from large combustion plants,
          as amended (1);