Case C-140/07: Reference for a preliminary ruling from the Bundesverwaltungsgericht (Germany) lodged on 12 March 2007 — Hecht-Pharma GmbH v Staatliches Gewerbeaufsichtsamt Lüneburg
Date: 2007-05-26
Institutions: Court of Justice
Subjects: interpretation of the law, medicinal product, pharmaceutical legislation, product quality, public health

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.