CELEX: C2003/158/29
Language: en
Date: 2003-07-05 00:00:00
Title: Case C-212/03: Action brought on 15 May 2003 by the Commission of the European Communities against the French Republic

5.7.2003               EN                         Official Journal of the European Union                                            C 158/17
Reference for a preliminary ruling by the High Court of                   The Commission of the European Communities claims that
Justice (England and Wales), Chancery Division, Patents                   the Court should:
Court by order of that court dated 6 May 2003, in the
case of 1) Novartis AG 2) University College London
3) Institute of Microbiology and Epidemiology against
Comptroller General of Patents, Designs and Trade Marks                   1.    declare that, by applying a prior authorisation procedure
                     for the United Kingdom                                     to personal imports, not effected by personal transport,
                                                                                of medicinal products lawfully prescribed in France,
                                                                                authorised under amended Directive 65/65/EEC (1)
                          (Case C-207/03)                                       (replaced by Directive 2001/83/EC) ( 2), both in France
                                                                                and in the Member State of the European Community
                          (2003/C 158/28)                                       where they are purchased, the French Republic has failed
                                                                                to fulfil its obligations under Article 28 of the Treaty
                                                                                establishing the European Community;
Reference has been made to the Court of Justice of the
European Communities by an order of the High Court of                     2.    declare that, by applying a prior authorisation procedure
Justice (England and Wales), Chancery Division, Patents Court                   to personal imports, not effected by personal transport,
dated 6 May 2003, which was received at the Court Registry                      of homeopathic medicinal products lawfully prescribed
on 14 May 2003, for a preliminary ruling in the case of                         in France and registered in a Member State of the
1) Novartis AG 2) University College London 3) Institute of                     European Community pursuant to Directive 92/73/
Microbiology and Epidemiology and Comptroller General of                        EEC (3) (replaced by Directive 2001/83/EC), the French
Patents, Designs and Trade Marks for the United Kingdom on                      Republic has failed to fulfil its obligations under Article 28
the following questions:                                                        of the Treaty establishing the European Community;
1)     Is the date of the granting of a marketing authorisation
       in Switzerland, which is automatically recognised in
       Liechtenstein, to be considered as the first authorisation         3.    declare that, by applying a disproportionate prior author-
       to place a medicinal product on the market, for the                      isation procedure to personal imports, not effected by
       purpose of calculating the duration of a supplementary                   personal transport, of medicinal products lawfully pre-
       protection certificate as provided in Article 13 of Regu-                scribed in France, not authorised in that country but only
       lation 1768/92 ( 1) (as amended by the EEA Agreement)?                   in the Member State of the European Community where
                                                                                they are purchased, the French Republic has failed to
2)     Is a competent authority within the EEA obliged to rectify               fulfil its obligations under Article 28 of the Treaty
       any existing supplementary protection certificates, the                  establishing the European Community;
       duration of which has been erroneously calculated?
                                                                          4.    order the French Republic to pay the costs.
( 1) Council Regulation (EEC) No 1768/92 of 18 June 1992 concern-
     ing the creation of a supplementary protection certificate for
     medicinal products OJ L 182, 02.07.1992, p. 1.
                                                                          Pleas in law and main arguments
Action brought on 15 May 2003 by the Commission of
  the European Communities against the French Republic
                          (Case C-212/03)                                 The Commission alleges the existence of measures having an
                                                                          effect equivalent to quantitative restrictions on imports of
                                                                          medicinal products, consisting of the imposition of a prior
                          (2003/C 158/29)                                 authorisation procedure relating to the personal importation
                                                                          into France, not effected by personal transport, of lawfully
                                                                          prescribed medicinal products, in breach of Article 28 EC.
                                                                          Such authorisation is required by the articles of the French
An action against the French Republic was brought before the              Public Health Code relating to the importation into French
Court of Justice of the European Communities on 15 May                    customs territory of medicinal products, including those
2003 by the Commission of the European Communities,                       having the status of Community goods. In many cases, that
represented by H. Støvlbæk and B. Stromsky, acting as Agents,             prior authorisation procedure cannot be justified on the basis
with an address for service in Luxembourg.                                of Article 30 EC.
 ---pagebreak--- 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: