Case C-141/07: Action brought on 9 March 2007 — Commission of the European Communities v Federal Republic of Germany
Date: 2007-05-26
Institutions: Court of Justice
Subjects: European Commission, Germany, action for failure to fulfil an obligation, free movement of goods, import, intra-EU trade, medicinal product

26.5.2007

EN

Official Journal of the European Union

C 117/15

Reference for a preliminary ruling from the Bundesverwal-
tungsgericht
lodged on 12 March 2007 —
Hecht-Pharma GmbH v Staatliches Gewerbeaufsichtsamt
Lüneburg

(Germany)

(Case C-140/07)

(2007/C 117/23)

Language of the case: German

Action brought on 9 March 2007 — Commission of the
European Communities v Federal Republic of Germany

(Case C-141/07)

(2007/C 117/24)

Language of the case: German

Referring court

Bundesverwaltungsgericht

Parties to the main proceedings

Applicant: Hecht-Pharma GmbH

Defendant: Staatliches Gewerbeaufsichtsamt Lüneburg

Other party: Vertreterin des Bundesinteresses beim Bundesver-
waltungsgericht

Questions referred

1. Does

the rule of doubt

in Article 2(2) of Directive
2001/83/EC (1) in the version of Directive 2004/27/EC (2)
mean that Directive 2001/83/EC applies to a product which
could possibly be classified as a medicinal product but
whose quality of a medicinal product has not been positively
determined? What degree of probability and hence what
degree of elucidation of the facts may be required in order to
justify the application of Directive 2001/83/EC?

2. Can a product which is not a presentational medicinal
product be regarded as a functional medicinal product within
the meaning of Article 1(2) of Directive 2001/83/EC in the
version of Directive 2004/27/EC because of a component
which can produce physiological changes in a certain dosage
but whose dosage in the product to be assessed — if used as
intended — is too low for that? Is this question to be allo-
‘pharmacological action’ or the
cated to the criterion of
criterion of
functions in human
beings’?

‘modifying physiological

3. Are the characteristics of ‘the manner in which it is used, the
extent of its distribution, its familiarity to consumers and the
risks which its use may entail’ (judgment in Case C-211/03
[2005] ECR I-5141, paragraph 51) stated in the case-law of
the Court of Justice to be relevant, in addition to the phar-
macological qualities, to classification as a medicinal product
still relevant following the new definition of a medicinal
product introduced by Directive 2004/27/EC?

(1) OJ L 311, p. 67.
(2) OJ L 136, p. 34.

Parties

Applicant: Commission of the European Communities (repre-
sented by: B. Schima)

Defendant: Federal Republic of Germany

Form of order sought

— declare that, by providing in Paragraph 14(5) and 14(6) of
the Apothekengesetz (Law on Pharmacies) that a contract to
supply medicinal products is subject to cumulative require-
ments which make it impossible in practice for pharmacies
in other Member States to supply a hospital on a regular
the Federal Republic of
basis with medicinal products,
Germany has
its obligations under
to fulfil
Article 28 EC and Article 30 EC;

failed

— order the Federal Republic of Germany to pay the costs.

Pleas in law and main arguments

Under Article 28 EC, all quantitative restrictions on imports and
all measures having equivalent effect
shall be prohibited
between Member States. All trading rules of the Member States
which are capable of hindering, directly or indirectly, actually or
potentially, intra-Community trade are to be considered to be
measures having an equivalent effect to quantitative restrictions.
The fact that, as Community law currently stands, the rules
relating to the distribution of medicinal products have been
harmonised only in certain limited fields does not release a
Member State from its obligation to comply with the provisions
concerning the free movement of goods.

According to Paragraph 14 of the German Apothekengesetz
(Law on Pharmacies), German hospitals may be supplied with
medicinal products by an external pharmacy instead of setting
up their own pharmacy inside the hospital. According to this
provision, contracts for the supply of medicinal products must
however satisfy cumulative requirements which make it impos-
sible in practice for pharmacies in other Member States to
supply them to a hospital on a regular basis, given that certain
duties stipulated under the contract are capable of being fulfilled
only by pharmacies established in the vicinity of the hospital
which is to be supplied.

C 117/16

EN

Official Journal of the European Union

26.5.2007

According to the case-law of the Court, national provisions
restricting or prohibiting certain selling arrangements do not
fall under Article 28 EC provided that two requirements are
met: first, the provisions concerned must apply to all affected
traders operating within the national territory and, second, they
should affect the marketing of domestic products and those
from other Member States in the same manner, in law and in
fact.
In this case only the first condition is however met,
whereas domestic and foreign products are not affected in the
same manner, in law and in fact, by the legislative requirement
that all duties under the contract be met by a single supplier.
This rule impedes access to the market more for foreign goods
than for domestic products.
is immaterial
according to the case-law of the Court that domestic pharmacies
which are not situated in the vicinity of the hospital are also
confronted by the same problems. A national provision which
does not favour all domestic products and which also adversely
affects domestic and not only foreign products is still capable of
being regarded as a restriction on trade between Member States.

In that regard it

Restrictions on intra-Community trade may be justified on over-
riding grounds of public interest, in particular relating to public
security or public health requirements. The national rules in
question should be suitable, necessary and proportionate. There
is no requirement on grounds of public health for the bundling
mandated by national
the contractual duties
legislation of
referred to. It should on the contrary be possible for a pharmacy
situated at some greater distance from the hospital which is to
be supplied and also in another Member State to supply it with
medicinal products on a regular basis.

a

for

Reference
from the
preliminary
Finanzgericht Hamburg (Germany) lodged on 13 March
2007 — Firma A.O.B. Reuter & Co. v Hauptzollamt
Hamburg-Jonas

ruling

Question referred

Is solely false information supplied by an exporter in its export
declaration liable to sanction under Article 11(1) of Regulation
(EEC) No 3665/87 (1) or is the failure to comply with the mate-
rial requirements for claiming a refund alone the subject of
sanctions?

(1) OJ L 351, p. 1.

Appeal brought on 13 March 2007 by K-Swiss, Inc. against
the order of the Court of First Instance (Third Chamber)
delivered on 14 December 2006 in Case T-14/06: K-Swiss,
Inc. v Office for Harmonisation in the Internal Market
(Trade Mark and Designs) (OHIM)

(Case C-144/07 P)

(2007/C 117/26)

Language of the case: English

Parties

Appellant: K-Swiss, Inc. (represented by: H.E. Hübner, Advocate)

Other party to the proceedings: Office for Harmonisation in the
Internal Market (Trade Marks and Designs) (OHIM)

(Case C-143/07)

(2007/C 117/25)

Form of order sought

The applicant claims that the Court should:

— set aside the order of the Court of First Instance;

Language of the case: German

— order the Office for Harmonisation in the Internal Market

(Trade Marks end Designs) (OHIM) to pay the costs.

Referring court

Finanzgericht Hamburg

Parties to the main proceedings

Applicant: Firma A.O.B. Reuter & Co.

Defendant: Hauptzollamt Hamburg-Jonas

Pleas in law and main arguments

The appellant submits that in declaring its action out of time
the Court of First Instance violated Rules 61, 62 and 68 of
Commission regulation (EC) No 2868/95, of 13 December
1995, implementing Council regulation (EC) No 40/94 on the
Community trade mark (1).

(1) OJ 1995 L 303, p. 1.