Case C-352/07: Reference for a preliminary ruling from the Tribunale Amministrativo Regionale del Lazio (Italy) lodged on 31 July 2007 — A. Menarini Industrie Farmaceutiche Riunite Srl, F.I.R.M.A. Srl, Laboratori Guidotti Spa, Istituto Lusofarmaco d'Italia Spa, Malesi Istituto Farmacobiologico Spa, Menarini International Operations Luxembourg SA v Ministero della Salute, Agenzia Italiana del Farmaco (AIFA) and Others
Date: 2007-10-20
Institutions: Court of Justice
Subjects: health costs, interpretation of the law, medicinal product, pharmaceutical legislation, price freeze, reduced price

20.10.2007

EN

Official Journal of the European Union

C 247/7

Reference for a preliminary ruling from the Tribunale
amministrativo regionale del Lazio (Italy) lodged on 30 July
2007 — CEPAV DUE — Consorzio, ENI per L'Alta Velocità,
Consorzio COCIV, Consorzio IRICAV DUE v Office of the
the Council of Ministers, Ministry of
President of

Transport and Others

(Case C-351/07)

(2007/C 247/09)

Language of the case: Italian

Referring court

Tribunale amministrativo regionale del Lazio

Parties to the main proceedings

Applicants: A. Menarini Industrie Farmaceutiche Riunite Srl, F.I.R.
M.A. Srl, Laboratori Guidotti Spa, Istituto Lusofarmaco d'Italia
Spa, Malesi
Spa, Menarini
Istituto
International Operations Luxembourg SA

Farmacobiologico

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

Parties to the main proceedings

Questions referred

Applicants: CEPAV DUE — Consorzio ENI per l'Alta Velocità,
Consorzio COCIV, Consorzio IRICAV DUE

Defendants: Office of the President of the Council of Ministers,
Ministry of Transport and Others

Question referred

Does Article 12 of Decree-Law No 7 of 31 January 2007,
converted, after amendment, into Article 13 of Law No 40 of
2 April 2007, in so far as it directs that the concessions relating
to construction of the high-speed rail links mentioned in it are
to be revoked, in such a way that the effects of that revocation
extend to the agreements entered into with the general contrac-
tors, and in so far as it limits the compensation available to the
general
conflict with
Articles 43 EC, 49 EC and 56 EC and with the Community
principles concerning legal certainty and the protection of legiti-
mate expectations, as indicated in the grounds set out in para-
graph 5 [of the order for reference]?

paragraph 8q,

contractors

under

the

1. After the provisions contained in Articles 2 and 3 (1) [of
Directive 89/105/EC] which modulate
relationship
between the public authorities of a Member State and the
pharmaceutical 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 phar-
maceutical expenditure — Article 4(1) [of that Directive]
concerning ‘price freeze[s] imposed on all medicinal products or
on certain categories of medicinal products’ characterises a price
freeze as a general instrument, the continuing use of which
is conditional upon a review which must be carried out, at
least once a year, with reference to the macro-economic
conditions existing in the Member State in question.

That provision allows the competent authorities a period of
90 days in which to take a final decision, requiring them, on
expiry of
increases or
decreases in prices are being made, if any.

to announce what

that period,

Reference for a preliminary ruling from the Tribunale
lodged on
Amministrativo Regionale del Lazio (Italy)
31 July 2007 — A. Menarini
Industrie Farmaceutiche
Riunite Srl, F.I.R.M.A. Srl, Laboratori Guidotti Spa, Istituto
Lusofarmaco d'Italia Spa, Malesi Istituto Farmacobiologico
Spa, Menarini International Operations Luxembourg SA v
Ministero della Salute, Agenzia Italiana del Farmaco (AIFA)
and Others

(Case C-352/07)

(2007/C 247/10)

Language of the case: Italian

Referring court

Tribunale Amministrativo Regionale del Lazio

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 interpreted as referring exclusively to
the medicinal products which are already subject to the price
freeze?

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]
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)?

C 247/8

EN

Official Journal of the European Union

20.10.2007

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
administrative authorities to state the reasons for any refusal?

(1) Council Directive 89/105/EEC of 21 December 1988 relating to the
transparency of measures
regulating the pricing of medicinal
products for human use and their inclusion in the scope of national
health insurance systems (OJ L 40, 11.2.1989, p. 8).

Reference for a preliminary ruling from the Tribunale
Amministrativo Regionale del Lazio (Italy)
lodged on
31 July 2007 — Sanofi Aventis Spa v Agenzia Italiana del
Farmaco (AIFA)

(Case C-353/07)

(2007/C 247/11)

Language of the case: Italian

Referring court

Tribunale Amministrativo Regionale del Lazio (AIFA)

Parties to the main proceedings

Applicant: Sanofi Aventis Spa

Defendant: Agenzia Italiana del Farmaco

Questions referred

the

1. After the provisions contained in Articles 2 and 3 (1) [of
Directive 89/105/EC] which modulate
relationship
between the public authorities of a Member State and the
pharmaceutical 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 phar-
maceutical expenditure — Article 4(1) [of that Directive]
concerning ‘price freeze[s] imposed on all medicinal products
or on certain categories of medicinal products’ characterises
a price freeze as a general instrument, the continuing use of
which is conditional upon a review which must be carried
out, at
least once a year, with reference to the macro-
economic conditions existing in the Member State in ques-
tion.

That provision allows the competent authorities a period of
90 days in which to take a final decision, requiring them, on
increases or
expiry of
decreases in prices are being made, if any.

to announce what

that period,

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 interpreted as referring exclusively to
the medicinal products which are already subject to the price
freeze?

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]
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 permissible to adopt measures which refer to economic
values attributed to that expenditure on the basis of ‘predic-
tions’ rather than values which have been ‘ascertained’ (this
question relates to both situations)?