CELEX: C2002/156/09
Language: en
Date: 2002-06-29 00:00:00
Title: Case C-127/02: Reference for a preliminary ruling by the Raad van State by judgment of that Court of 27 March 2002 in the case of Landelĳke Vereniging tot Behoud van de Waddenzee, also acting on behalf of Nederlandse Vereniging tot Bescherming van Vogels against Staatssecretaris van Landbouw, Natuurbeheer en Visserĳ

C 156/4                EN                    Official Journal of the European Communities                                     29.6.2002
Reference for a preliminary ruling by the Oberverwal-                   The applicant claims that the Court should:
tungsgericht für das Land Nordrhein-Westfalen by order
of that Court of 14 March 2002 in the case of Kohlpharma
                                                                        —     Declare that, by allowing the approval of a project in the
         GmbH against Federal Republic of Germany
                                                                              tourist sector which included construction of housing,
                                                                              hotels and golf clubs in the Ponta do Abano area, without
                         (Case C-112/02)                                      an appropriate assessment of its environmental impact,
                                                                              the Portuguese Republic failed to fulfil its obligations
                                                                              under Article 2(1) of Council Directive 85/337/EEC(1) of
                         (2002/C 156/07)                                      27 June 1985 on the assessment of the effects of certain
                                                                              public and private projects on the environment;
Reference has been made to the Court of Justice of the                  —     Order the Portuguese Republic to pay the costs.
European Communities by order of the Oberverwaltungs-
gericht für das Land Nordrhein-Westfalen (Higher Administrat-
ive Court of North Rhine-Westphalia) of 14 March 2002,
received at the Court Registry on 27 March 2002, for a                  Pleas in law and main arguments
preliminary ruling in the case of Kohlpharma GmbH against
Federal Republic of Germany on the following question:
Is it justified under Article 30 EC or other Community law for          The Commission takes the view that the correct transposition
the competent German authority to obstruct the parallel                 of Article 2(1) and Article 4(2) of Directive 85/337/EEC cannot
import of a medicinal product by refusing authorisation under           be relied upon by the Portuguese Republic in order to exempt
the simplified procedure, contrary to Article 28 EC, although           from the assessment obligation provided for in Article 2(1) a
on the one hand it accepts that the medicinal product to be             specific project which, as in the case of the project relating to
imported (Jumex), authorised for Chiese Farmaceutici S.p.A. in          work carried out in the area of Ponta do Abano, although
Italy, is as regards the medically active ingredient (Selegilinhy-      falling within the scope of Annex II to that directive, is likely
drochloride) identical to the medicinal product (Movergan)              to have a significant impact on the environment by virtue of
produced by the German authorisation holder Orion Pharma                their nature, size or location.
GmbH, the medically active ingredient of which is delivered to
the Italian firm by the manufacturer, located in Hungary, on
the basis of a licensing agreement but to the German firm
solely on the basis of a supply agreement with Orion Corp.              (1) OJ 1985 L 175, p. 40.
Finland, either directly or via Finland, if on the other hand the
German authority does not give, as regards the medically
active ingredient or the excipients, which the authorities
consider to differ both qualitatively and quantitatively in the
present case, reasons to show that the two medicinal products
are not identical, and in particular are not manufactured
according to the same formulation and using the same active
ingredient or that they have the same therapeutic effects?
                                                                        Reference for a preliminary ruling by the Raad van State
                                                                        by judgment of that Court of 27 March 2002 in the case
                                                                        of Landelijke Vereniging tot Behoud van de Waddenzee,
                                                                        also acting on behalf of Nederlandse Vereniging tot
                                                                        Bescherming van Vogels against Staatssecretaris van Land-
                                                                                       bouw, Natuurbeheer en Visserij
Action brought on 27 March 2002 by the Commission
of the European Communities against the Portuguese                                              (Case C-127/02)
                             Republic
                                                                                                (2002/C 156/09)
                         (Case C-117/02)
                         (2002/C 156/08)
                                                                        Reference has been made to the Court of Justice of the
                                                                        European Communities by judgment of the Raad van State
                                                                        (Council of State) of 27 March 2002, received at the Court
An action against the Portuguese Republic was brought before            Registry on 8 April 2002, for a preliminary ruling in the case
the Court of Justice of the European Communities on 27 March            of Landelijke Vereniging tot Behoud van de Waddenzee, also
2002 by the Commission of the European Communities,                     acting on behalf of Nederlandse Vereniging tot Bescherming
represented by António Caeiros, acting as Agent, with an               van Vogels against Staatssecretaris van Landbouw, Natuur-
address for service in Luxembourg.                                      beheer en Visserij on the following questions:
 ---pagebreak--- 29.6.2002            EN                      Official Journal of the European Communities                                          C 156/5
1.   a.  Are the words ‘plan or project’ in Article 6(3) of                   b.   On the basis of which criteria must it be determined
         the habitats directive (1) to be interpreted as also                      whether or not a plan or project within the meaning
         covering an activity which has already been carried                       of Article 6(3) of the habitats directive not directly
         on for many years but for which an authorisation is                       connected with or necessary to the management of
         in principle granted each year for a limited period,                      the site is likely to have a significant effect thereon,
         with a fresh assessment being carried out on each                         either individually or in combination with other
         occasion as to whether, and if so in which sections                       plans or projects?
         of the area, the activity may be carried on?
                                                                        4.    a.   When Article 6 of the habits directive is applied, on
     b.  If the answer to question 1a is in the negative, must                     the basis of which criteria must it be determined
         the relevant activity be regarded as a ‘plan or project’                  whether or not there are ‘appropriate steps’ within
         if the intensity of this activity has increased over the                  the meaning of Article 6(2) or an ‘appropriate
         years or an increase in it is made possible by the                        assessment’, within the meaning of Article 6(3),
         authorisations?                                                           in connection with the certainty required before
                                                                                   agreeing to a plan or project?
2.   a.  If it follows from the answer to question 1 that
         there is a ‘plan or project’ within the meaning of                   b.   Do the terms ‘appropriate steps’ or ‘appropriate
         Article 6(3) of the habitats directive, is Article 6(3)                   assessment’ have independent meaning or, in
         of the habitats directive to be regarded as a special                     assessing these terms, is account also to be taken of
         application of the rules in Article 6(2) or as a                          Article 174(2) EC and in particular the precautionary
         provision with a separate, independent purpose in                         principle referred to therein?
         the sense that, for example:
                                                                              c.   If account must be taken of the precautionary
         (i)   Article 6(2) relates to existing use and                            principle referred to in Article 174(2) EC, does that
               Article 6(3) relates to new plans or projects, or                   mean that a particular activity, such as the cockle-
                                                                                   fishing in question, can be authorised where there is
                                                                                   no obvious doubt as to the absence of a possible
                                                                                   significant effect or is that permissible only where
                                                                                   there is no doubt as to the absence of such an effect
         (ii) Article 6(2) relates to management measures                          or where the absence can be ascertained?
               and Article 6(3) to other decisions, or
                                                                        5.    Do Article 6(2) or Article 6(3) of the habitats directive
         (iii) Article 6(3) relates to plans or projects and                  have direct effect in the sense that individuals may rely
               Article 6(2) to other activities?                              on them in national courts and those courts must provide
                                                                              the protection afforded to individuals by the direct effect
                                                                              of Community law, as was held inter alia in Case C-312/
                                                                              93 Peterbroeck (cited above)?
     b.  If Article 6(3) of the habitats directive is to be
         regarded as a special application of the rules in
         Article 6(2), can the two subparagraphs be appli-
         cable cumulatively?
                                                                        (1) Council Directive 92/43/EEC of 21 May 1992 on the conservation
3.   a.  Is Article 6(3) of the habitats directive to be interpret-         of natural habitats and of wild fauna and flora (OJ L 206 of
         ed as meaning that there is a ‘plan or project’ once a             22.7.1992, p. 7).
         particular activity is likely to have an effect on the
         site concerned (and an ‘appropriate assessment’ must
         then be carried out to ascertain whether or not the
         effect is ‘significant’) or does this provision mean
         that an ‘appropriate assessment’ has to be carried
         out only where there is a (sufficient) likelihood that
         a ‘plan or project’ will have a significant effect?