Case C-84/06: Reference for a preliminary ruling from the Hoge Raad der Nederlanden, lodged on  10 February 2006  — Staat der Nederlanden (Ministerie van Volksgezondheid, Welzijn en Sport) v 1. Antroposana, Patiëntenvereniging voor Antroposofische Gezondheidszorg, 2. Nederlandse Vereniging van Antroposofische Artsen, 3. Weleda Nederland NV and 4. Wala Nederland NV
Date: 2006-05-06
Institutions: Court of Justice
Subjects: Netherlands, interpretation of the law, market approval, medicinal product, pharmaceutical legislation

6.5.2006

EN

Official Journal of the European Union

C 108/3

Pleas in law and main arguments

The applicant maintains that:

Reference for a preliminary ruling from the Hoge Raad
der Nederlanden, lodged on 10 February 2006 — Staat der
Nederlanden (Ministerie van Volksgezondheid, Welzijn en
Sport) v 1. Antroposana, Patiëntenvereniging voor Antro-
posofische Gezondheidszorg, 2. Nederlandse Vereniging
van Antroposofische Artsen, 3. Weleda Nederland NV and
4. Wala Nederland NV

1) the CFI infringed Article 15(2) of Regulation No. 17/62/EEC
(‘Regulation 17’) (1) by holding that the Commission lawfully
applied the 10 % turnover cap under Article 15(2) to Britan-
nia's turnover for the business year ending 30 June 1996,
rather than the business year preceding the adoption of the
Decision;

(Case C-84/06)

(2006/C 108/04)

Language of the case: Dutch

2) the CFI infringed the principle of equality:

Referring court

a) by upholding the Commission's discrimination between
undertakings being in essentially the same situation by
applying the 10 % turnover cap, in the case of Britannia,
the Commission considers
to the last year of what
‘normal economic activity’, and, in the case of all other
undertakings to whom the Decision was addressed, to
the business year preceding the Decision; and

b) by upholding the Commission's Decision which discrimi-
nates against Britannia in relation to the year to which
the 10 % turnover cap is applicable in comparison with
its practice in other directly comparable cases;

3) the CFI infringed the principle of legal certainty:

a) by upholding the Commission's use of a year other than
the preceding business year in applying the turnover cap
in Article 15(2) of Regulation 17. Certainty is required as
to the absolute maximum level of penalty that might be
imposed; and

b) by interpreting Article 15(2) Regulation 17 in a way
which imposes a penalty which does not correspond to
the penalty laid down when the infringement was
committed, thereby infringing the fundamental rights of
undertakings.

(1) EEC Council: Regulation no 17: First Regulation implementing Arti-
cles 85 and 86 of the Treaty (OJ 013, 21.02.1962, p. 204-211)

Hoge Raad der Nederlanden (Supreme Court of the Nether-
lands)

Parties to the main proceedings

Applicant: Staat der Nederlanden (Ministerie van Volksgezond-
heid, Welzijn en Sport) (State of the Netherlands (Ministry of
Public Health, Welfare and Sport))

Defendants: 1. Antroposana, Patiëntenvereniging voor Antropo-
sofische Gezondheidszorg, 2. Nederlandse Vereniging van
Antroposofische Artsen, 3. Weleda Nederland NV and 4. Wala
Nederland NV

Questions referred

1. Does Directive 2001/83/EC (1) of the European Parliament
and of the Council of 6 November 2001 on the Community
code relating to medicinal products for human use oblige
Member States to make anthroposophic medicinal products
which are not at the same time homeopathic medicinal
products subject to the requirements in respect of authorisa-
tion as set out in Title III, Chapter 1, of that directive?

2. If the answer to Question 1 is in the negative: is the Nether-
lands statutory provision which makes those anthropo-
sophic medicinal products subject to the aforementioned
requirements in respect of authorisation an exception to the
prohibition under Article 28 EC which is authorised by
virtue of Article 30 EC?

(1) OJ L 311, p. 67.