Case C-472/07: Reference for a preliminary ruling from the Conseil d'État (Belgium) lodged on 24 October 2007 — Association Générale de l'Industrie du Médicament ASBL, Bayer SA, Pfizer SA, Servier Benelux SA, Sanofi-Aventis Belgium SA v Belgian State
Date: 2007-10-24
Institutions: Court of Justice
Subjects: Belgium, fixing of prices, health costs, health insurance, interpretation of the law, medicinal product

C 22/22

EN

Official Journal of the European Union

26.1.2008

Questions referred

1. Is the review of macro-economic conditions referred to in
Article 4(1) of Council Directive 89/105/EEC of 21 December
1988 relating to the transparency of measures regulating the
prices of medicinal products for human use and their inclu-
sion in the scope of national health insurance systems (1) to
be understood as meaning only review as to whether health-
care expenditure is manageable, or must it also extend to
macro-economic conditions in the pharmaceutical industry
sector whose products are liable to be made subject to a
price freeze?

2. May the review of macro-economic conditions referred to in
Article 4(1) of Council Directive 89/105/EEC of 21 December
1988, cited above, be based on a general trend or trends,
such as, for example, ensuring balance in healthcare, or must
it be based on more specific criteria?

(1) OJ L 40 of 11.2.1989, p. 8.

Reference for a preliminary ruling from the Conseil d'État
(Belgium)
lodged on 24 October 2007 — Association
Générale de l'Industrie du Médicament ASBL, Bayer SA,
Pfizer SA, Servier Benelux SA, Sanofi-Aventis Belgium SA
v Belgian State

must Article 4(1) of
directly applicable in the domestic legal systems of
Member States?

that directive be considered to be
the

2. May Article 4(1) of Directive 89/105/EEC of 21 December
1988 be interpreted as meaning that the resumption for one
year, after an absence of 18 months, of a general price freeze
in respect of refundable medicinal products which had lasted
eight years exempts the Member State from carrying out a
review, when the freeze is resumed, of the macro-economic
conditions affected by that freeze?

3. Is the review of macro-economic conditions referred to in
Article 4(1) of Council Directive 89/105/EEC of 21 December
1988, cited above, to be understood as meaning only review
as to whether healthcare expenditure is manageable, or must
it also extend to macro-economic conditions in the pharma-
ceutical industry sector whose products are liable to be made
subject to a price freeze?

4. May the review of macro-economic conditions referred to in
Article 4(1) of Council Directive 89/105/EEC of 21 December
1988, cited above, be based on a general trend or trends,
such as, for example, ensuring balance in healthcare, or must
it be based on more specific criteria?

(1) OJ L 40 of 11.2.1989, p. 8.

(Case C-472/07)

(2008/C 22/41)

Language of the case: French

Reference for a preliminary ruling from the Conseil d'Etat
lodged on 25 October 2007 — Association
(France)
Nationale pour la Protection des Eaux et Rivières — TOS,
Association OABA v Ministère de l'écologie, du développe-
l'aménagement durables — Intervener:
ment

et de
Association France Nature Environnement

Referring court

Conseil d'État

Parties to the main proceedings

(Case C-473/07)

(2008/C 22/42)

Language of the case: French

Applicants: Association Générale de l'Industrie du Médicament
ASBL, Bayer SA, Pfizer SA, Servier Benelux SA, Sanofi-Aventis
Belgium SA

Referring court

Conseil d'Etat

Defendant: Belgian State

Questions referred

Parties to the main proceedings

1. Since the period for transposition of Council Directive of
21 December 1988 relating to the transparency of measures
regulating the prices of medicinal products for human use
and their inclusion in the scope of national health insurance
systems (89/105/EEC) (1) expired on 31 December 1989,

Applicants: Association Nationale pour la Protection des Eaux et
Rivières — TOS, Association OABA

Defendant: Ministère de l'écologie, du développement et de
l'aménagement durables