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
Date: 2002-06-29
Institutions: Court of Justice
Subjects: environmental protection, interpretation of the law, interpreting, management, project evaluation, protected area, protection of animal life, protection of plant life, wildlife

C 156/4

EN

Official Journal of the European Communities

29.6.2002

Reference for a preliminary ruling by the Oberverwal-
tungsgericht für das Land Nordrhein-Westfalen by order
of that Court of 14 March 2002 in the case of Kohlpharma
GmbH against Federal Republic of Germany

(Case C-112/02)

(2002/C 156/07)

Reference has been made to the Court of Justice of the
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
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 competent German authority to obstruct the parallel
import of a medicinal product by refusing authorisation under
the simplified procedure, contrary to Article 28 EC, although
on the one hand it accepts that the medicinal product to be
imported (Jumex), authorised for Chiese Farmaceutici S.p.A. in
Italy, is as regards the medically active ingredient (Selegilinhy-
drochloride) identical to the medicinal product (Movergan)
produced by the German authorisation holder Orion Pharma
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.
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?

Action brought on 27 March 2002 by the Commission
of the European Communities against the Portuguese
Republic

(Case C-117/02)

(2002/C 156/08)

The applicant claims that the Court should:

— Declare that, by allowing the approval of a project in the
tourist sector which included construction of housing,
hotels and golf clubs in the Ponta do Abano area, without
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
27 June 1985 on the assessment of the effects of certain
public and private projects on the environment;

— Order the Portuguese Republic to pay the costs.

Pleas in law and main arguments

The Commission takes the view that the correct transposition
of Article 2(1) and Article 4(2) of Directive 85/337/EEC cannot
be relied upon by the Portuguese Republic in order to exempt
from the assessment obligation provided for in Article 2(1) a
specific project which, as in the case of the project relating to
work carried out in the area of Ponta do Abano, although
falling within the scope of Annex II to that directive, is likely
to have a significant impact on the environment by virtue of
their nature, size or location.

(1) OJ 1985 L 175, p. 40.

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

(Case C-127/02)

(2002/C 156/09)

An action against the Portuguese Republic was brought before
the Court of Justice of the European Communities on 27 March
2002 by the Commission of the European Communities,
represented by Anto´ nio Caeiros, acting as Agent, with an
address for service in Luxembourg.

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
Registry on 8 April 2002, for a preliminary ruling 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, Natuur-
beheer en Visserij on the following questions:

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
the habitats directive (1) to be interpreted as also
covering an activity which has already been carried
on for many years but for which an authorisation is
in principle granted each year for a limited period,
with a fresh assessment being carried out on each
occasion as to whether, and if so in which sections
of the area, the activity may be carried on?

b. On the basis of which criteria must it be determined
whether or not a plan or project within the meaning
of Article 6(3) of the habitats directive not directly
connected with or necessary to the management of
the site is likely to have a significant effect thereon,
either individually or in combination with other
plans or projects?

b.

If the answer to question 1a is in the negative, must
the relevant activity be regarded as a ‘plan or project’
if the intensity of this activity has increased over the
years or an increase in it is made possible by the
authorisations?

4.

a. When Article 6 of the habits directive is applied, on
the basis of which criteria must it be determined
whether or not there are ‘appropriate steps’ within
the meaning of Article 6(2) or an ‘appropriate
assessment’, within the meaning of Article 6(3),
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
Article 6(3) of the habitats directive, is Article 6(3)
of the habitats directive to be regarded as a special
application of the rules in Article 6(2) or as a
provision with a separate, independent purpose in
the sense that, for example:

b. Do the terms ‘appropriate steps’ or ‘appropriate
assessment’ have independent meaning or,
in
assessing these terms, is account also to be taken of
Article 174(2) EC and in particular the precautionary
principle referred to therein?

c.

the precautionary
If account must be taken of
principle referred to in Article 174(2) EC, does that
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
or where the absence can be ascertained?

5. Do Article 6(2) or Article 6(3) of the habitats directive
have direct effect in the sense that individuals may rely
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)?

(1) Council Directive 92/43/EEC of 21 May 1992 on the conservation
of natural habitats and of wild fauna and flora (OJ L 206 of
22.7.1992, p. 7).

(i) Article 6(2)

and
Article 6(3) relates to new plans or projects, or

to existing use

relates

(ii) Article 6(2) relates to management measures

and Article 6(3) to other decisions, or

(iii) Article 6(3) relates to plans or projects and

Article 6(2) to other activities?

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?

3.

a.

Is Article 6(3) of the habitats directive to be interpret-
ed as meaning that there is a ‘plan or project’ once a
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?