Case C-212/03: Action brought on 15 May 2003 by the Commission of the European Communities against the French Republic
Date: 2003-07-05
Institutions: Court of Justice
Subjects: European Commission, France, action for failure to fulfil an obligation, import, market approval, medicinal product

5.7.2003

EN

Official Journal of the European Union

C 158/17

Reference for a preliminary ruling by the High Court of
Justice (England and Wales), Chancery Division, Patents
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
for the United Kingdom

(Case C-207/03)

(2003/C 158/28)

Reference has been made to the Court of Justice of the
European Communities by an order of the High Court of
Justice (England and Wales), Chancery Division, Patents Court
dated 6 May 2003, which was received at the Court Registry
on 14 May 2003, for a preliminary ruling in the case of
1) Novartis AG 2) University College London 3) Institute of
Microbiology and Epidemiology and Comptroller General of
Patents, Designs and Trade Marks for the United Kingdom on
the following questions:

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
to place a medicinal product on the market,
for the
purpose of calculating the duration of a supplementary
protection certificate as provided in Article 13 of Regu-
lation 1768/92 (1) (as amended by the EEA Agreement)?

2)

Is a competent authority within the EEA obliged to rectify
any existing supplementary protection certificates, the
duration of which has been erroneously calculated?

( 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.

The Commission of the European Communities claims that
the Court should:

1.

2.

3.

declare that, by applying a prior authorisation procedure
to personal imports, not effected by personal transport,
of medicinal products lawfully prescribed in France,
amended Directive 65/65/EEC (1)
authorised under
(replaced by Directive 2001/83/EC) (2), both in France
and in the Member State of the European Community
where they are purchased, the French Republic has failed
to fulfil its obligations under Article 28 of the Treaty
establishing the European Community;

declare that, by applying a prior authorisation procedure
to personal imports, not effected by personal transport,
of homeopathic medicinal products lawfully prescribed
in France and registered in a Member State of the
to Directive 92/73/
European Community pursuant
EEC (3) (replaced by Directive 2001/83/EC), the French
Republic has failed to fulfil its obligations under Article 28
of the Treaty establishing the European Community;

declare that, by applying a disproportionate prior author-
isation procedure to personal imports, not effected by
personal transport, of medicinal products lawfully pre-
scribed in France, not authorised in that country but only
in the Member State of the European Community where
they are purchased, the French Republic has failed to
fulfil
the Treaty
establishing the European Community;

its obligations under Article 28 of

4.

order the French Republic to pay the costs.

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)

(2003/C 158/29)

An action against the French Republic was brought before the
Court of Justice of the European Communities on 15 May
2003 by the Commission of the European Communities,
represented by H. Støvlbæk and B. Stromsky, acting as Agents,
with an address for service in Luxembourg.

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
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
Public Health Code relating to the importation into French
customs territory of medicinal products,
including those
having the status of Community goods. In many cases, that
prior authorisation procedure cannot be justified on the basis
of Article 30 EC.

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: