Case C-353/07: 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)
Date: 2007-10-20
Institutions: Court of Justice
Subjects: health costs, interpretation of the law, medicinal product, pharmaceutical legislation, price freeze, reduced price

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)?

20.10.2007

EN

Official Journal of the European Union

C 247/9

4. May the requirements relating to the indication of criteria
which are objective and transparent, and of such a nature
that the intervention of the relevant competent authorities
(as regards the period up to 31 December 2006) and of the
legislature (as from 1 January 2007) is verifiable be taken to
be fully satisfied by the indication of
the requirements
relating to the ceiling for pharmaceutical expenditure which
each Member State is competent to determine and to the
containment of that expenditure and, in particular, by data
relating to health expenditure overall or, more specifically, to
pharmaceutical expenditure alone?

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?

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,

(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 — IFB Stroder Srl v Agenzia Italiana del
Farmaco (AIFA)

(Case C-354/07)

(2007/C 247/12)

Language of the case: Italian

Referring court

Tribunale Amministrativo Regionale del Lazio

Parties to the main proceedings

Applicant: IFB Stroder Srl

Defendant: Agenzia Italiana del Farmaco (AIFA)

Questions referred

1. After the provisions contained in Articles 2 and 3 (1) [of
relationship

Directive 89/105/EC] which modulate

the

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 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?