Case C-451/07: Reference for a preliminary ruling from the Tribunale Amministrativo Regionale del Lazio (Italy) lodged on 3 October 2007 — Federfarma v Agenzia Italiana del Farmaco (AIFA), Ministero della Salute
Date: 2007-12-08
Institutions: Court of Justice
Subjects: interpretation of the law, medicinal product, pharmaceutical industry, price freeze, prices policy, public authorities

8.12.2007

EN

Official Journal of the European Union

C 297/27

Reference for a preliminary ruling from the Tribunale
Amministrativo Regionale del Lazio (Italy)
lodged on
3 October 2007 — Federfarma v Agenzia Italiana del
Farmaco (AIFA), Ministero della Salute

(Case C-451/07)

(2007/C 297/43)

Language of the case: Italian

Referring court

Tribunale Amministrativo Regionale del Lazio

Parties to the main proceedings

Applicant: Federfarma

Defendants: Agenzia Italiana del Farmaco (AIFA), Ministero della
Salute

Questions referred

1. After the provisions contained in Articles 2 and 3 [of Direc-
tive 89/105/EC] which modulate the relationship between
the public authorities of a Member State and the pharmaceu-
tical companies — by allowing the pricing of a medicinal
product or the raising of its price to be determined on the
basis of information provided by the [latter], but only in so
far as is acceptable to the competent authority, and thus on
the basis of dialogue between the undertakings themselves
and the authorities competent to supervise pharmaceutical
expenditure — Article 4(1) [of that Directive] concerning
‘price freeze[s] imposed on all medicinal products or on certain cate-
gories of medicinal products’ characterises a price freeze as a
general
instrument, the continuing use of which is condi-
tional upon a review which must be carried out, at least
once a year, with reference to the macro-economic condi-
tions existing in the Member State in question. That provi-
sion allows the competent authorities a period of 90 days in
which to take a final decision, requiring them, on expiry of
that period,
increases or decreases in
prices are being made, if any. On a proper construction of
the reference to ‘decreases in prices … being made,
if any’, is
that provision to be interpreted as meaning that, as well as
the general remedy of freezing the prices of all categories, or
certain specific categories, of medicinal product, another
general remedy may be applied in the form of a reduction in
the prices of all categories, and of certain specific categories,
of medicinal product, or must ‘decreases …, if any’ be inter-
preted as referring exclusively to the medicinal products
which are already subject to the price freeze?

to announce what

be interpreted as meaning that, if the reply to Question I is
that a price reduction is permissible, it is possible to have
recourse to such a measure even more than once in the
course of a single year, and to do that again for many years
(from 2002 until 2010)?

3. Under the terms of Article 4 [of Directive 89/105/EC] —
read in the light of the preamble emphasising that the prin-
cipal aim of measures controlling the prices of medicinal
products is ‘the promotion of public health by ensuring the avail-
ability of adequate supplies of medicinal products at a reasonable
cost’ and preventing ‘disparities in such measures [which] may
hinder or distort intra-Community trade in medicinal products’ —
is it compatible with the Community rules to adopt measures
which refer to economic values attributed to that expenditure
on the basis of ‘predictions’ rather than values which have
been ‘ascertained’ (this question relates to both situations)?

4. Must the requirements relating to compliance with the ceil-
ings for pharmaceutical expenditure which each Member
State is competent to determine be linked, point by point, to
pharmaceutical expenditure alone, or is it within the powers
of the Member States to take account also of data relating to
other health expenditure?

5. Must

the principles,

to be inferred from … Directive
[89/105/EC], of transparency and of shared participation on
the part of the undertakings with an interest in measures
freezing the prices of pharmaceutical products or reducing
them across the board be interpreted as requiring provision
to be made, always and in any circumstances, for the possibi-
lity of derogation from the price imposed (Article 4(2) [of
Directive 89/105/EC]) and for genuine participation by the
applicant company, with the consequent need for the admin-
istrative authorities to state the reasons for any refusal?

Reference for a preliminary ruling from the Bundesgericht-
lodged on 4 October 2007 — Health
shof

(Germany)

Research Inc.

(Case C-452/07)

(2007/C 297/44)

Language of the case: German

Referring court

Bundesgerichtshof

2. In requiring the competent authorities of a Member State to
verify, at least once a year,
in the case of price freezes,
whether the macroeconomic conditions justify continuing
that price freeze, may Article 4(1) [of Directive 89/105/EC]

Parties to the main proceedings

Applicant: Health Research Inc.