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
Date: 2003-07-05
Institutions: Court of Justice
Subjects: interpretation of the law, saltwater, stagnant water, tradeable emission permit, water pollution

C 158/18

EN

Official Journal of the European Union

5.7.2003

The Commission considers that no argument justifies the
existence of the prior authorisation procedure at issue. First, it
cannot be justified by concern to ascertain that the medicinal
product has been manufactured according to the good prac-
tices laid down by Community legislation. The imported
medicinal product has been authorised or registered in the
Member State of export, which is responsible for ensuring
compliance with those good practices. Any additional check
carried out in France would be contrary to the principle of
mutual recognition and the objective of ensuring the free
movement of medicinal products. Secondly, with regard to
possible justification on other grounds of protection of health,
it
to distinguish
in the Commission’s view,
between three types of medicinal products:

is necessary,

— medicinal products authorised pursuant

to amended
Directive 65/65, then pursuant to Directive 2001/83/EC,
both in France and in the Member State where they are
purchased (or covered by an authorisation to place them
on the Community market (marketing authorisation)).
The French authorities have acknowledged that an import
authorisation was required in the case of personal import-
ation of medicinal products covered by a marketing
authorisation in France. However, in view of the advanced
state of harmonisation achieved in the pharmaceutical
products sector, in that type of case important guarantees
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
principle pose any risk to health, especially given the fact
that the rules on the manufacture, control and inspection
of that type of medicinal product have been harmonised.
In addition, Directive 92/73/EEC has liberalised patients’
access to the medicinal products of their choice. A prior
authorisation procedure for personal
importation of
registered homeopathic medicinal products is therefore
manifestly unjustified.

— 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
legislation making the
mechanism, since the general
importation of medicinal products to be marketed subject
to prior authorisation, as well as the on-the-spot checks,
imports of medicinal
are sufficient to combat
products. However,
the
protection of public health, the case of imports relating
to medicinal products not authorised in France may
justify a more qualified approach than the case of

from the point of view of

illegal

medicinal products authorised in France or in the Member
State of export or than in the case of homeopathic
medicinal products registered in a Member State. Never-
theless, while acknowledging that a prior authorisation
procedure may be justified, in principle, in the case of
personal imports of such products, that procedure should
be easily accessible, carried out within a reasonable period
and culminate in an authorisation for the importation of
medicinal products not posing any risk to public health.
However, the prior authorisation procedure applied by
France to personal imports of medicinal products does
not comply with those criteria and is therefore dispro-
portionate to the objective to be attained.

(1) Council Directive 65/65/EEC of 26 January 1965 on the approxi-
mation of provisions laid down by law, regulation or administrat-
ive action relating to proprietary medicinal products (OJ, English
Special Edition 1965-1966, p. 20).

(2) Directive 2001/83/EC of the European Parliament and of the
Council of 6 November 2001 on the Community code relating to
medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
(3) Council Directive 92/73/EC of 22 September 1992 widening
the scope of Directives 65/65/EEC and 75/319/EEC on the
approximation of provisions laid down by law, regulation or
administrative action relating to medicinal products and laying
down additional provisions on homeopathic medicinal products
(OJ L 297, 13.10.1992, p. 8).

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

(Case C-213/03)

(2003/C 158/30)

Justice of the
Reference has been made to the Court of
European Communities by order of the Cour de cassation
(Court of Cassation) (France), First Civil Chamber, received at
the Court Registry on 19 May 2003, for a preliminary ruling
in the case of Syndicat professionnel coordination des pêcheurs
de l’Etang de Berre et de la région (Trade association coordinat-
ing fishermen of the Etang de Berre and the area) against
Electricité de France on the following questions:

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
for the protection of the Mediterranean Sea against
pollution from land-based sources (the Barcelona Con-
vention), which has become Article 6(1) in the revised
version, be held to have direct effect, so that any interested
party may rely on it before the national courts in an action
to halt discharges of water which are not authorised in
accordance with the procedure and criteria which it
prescribes?

2. Must the same provision be interpreted to mean that it
prohibits the discharge into a saltwater marsh communi-
cating with the Mediterranean Sea of substances which,
although not toxic, adversely affect the oxygen content
of the marine environment, without an authorisation
issued by the competent authorities of the Member States,
taking into account the provisions of the abovementioned
Protocol and of Annex III C thereto (now Annex II)?

2.

3.

4.

by failing to include in the relevant Austrian legal
provisions (Luftreinhaltegesetz für Kesselanlagen —
LRG-K and LRV-K) (law on air purity for boiler
plants) the definitions of ’new plant’ and ’existing
plant’ as set out in Article 2.9 and 2.10 of the
directive;

in Article 2.6 of

in particular by reason of the
by failing fully,
divergence of the Austrian definition of fuel from
that set out
to
incorporate in the relevant air-purity legislation the
emission limit values for sulphur dioxide, oxides of
nitrogen and dust
laid down in Article 4.1 in
conjunction with Annexes III to VII to the directive;

the directive,

by failing correctly to transpose in the LRG-K
and LRV-K Article 9(2) and (3) of the directive
concerning the calculation of the emission limit
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

(Case C-214/03)

(2003/C 158/31)

An action against the Republic of Austria was brought before
the Court of Justice of the European Communities on 19 May
2003 by the Commission of the European Communities,
represented by Josef Christian Schieferer and Gregorio Valero
Jordana, of the Commission’s Legal Service, acting as Agents,
with an address for service in Luxembourg.

The applicant claims that the Court should:

I.

Rule that:

1.

by laying down in paragraph 22(1) of the Luft-
reinhalteverordnung für Kesselanlagen (regulation
on air purity for boiler plants) (LRV-K) a definition
of ’multi-fuel firing unit’ that departs from Article 2.8
of Council Directive 88/609/EEC of 24 November
1988 on the limitation of emissions of certain
pollutants into the air from large combustion plants,
as amended (1);

The Commission finds that the Republic of Austria has failed
to fulfil its obligations by failing to bring its national law into
line with the directive, which was thus improperly and
incompletely transposed, in so far as:

— 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
20 % and thus restricting the scope of the directive in
that regard;

— it failed to transpose Article 2.9 and 2.10 of the directive
with regard to the definitions of ‘new plant’ and ‘existing
plant’;

— 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
to VII, particularly in light of the definition of fuel,
which in the Austrian legal provisions is confined to
‘conventional fuels’, as a result of which only partial effect
is given to the scope of the directive;

— it failed correctly to transpose Article 9(2) and (3) of the
directive with regard to the calculation of the limit values
for multi-fuel firing units in refineries.

(1) OJ 1988 L 336, p. 1.