Case C-355/07: Reference for a preliminary ruling from the Tribunale Amministrativo Regionale del Lazio (Italy) lodged on 31 July 2007 — Schering Plough SpA v 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

C 247/10

EN

Official Journal of the European Union

20.10.2007

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
the
applicant company, with the consequent need for
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 — Schering Plough SpA v Agenzia Italiana
del Farmaco (AIFA) and Others

(Case C-355/07)

(2007/C 247/13)

Language of the case: Italian

Referring court

Tribunale Amministrativo Regionale del Lazio

Parties to the main proceedings

Applicant: Schering Plough SpA

Defendants: Agenzia Italiana del Farmaco (AIFA) and Others

Questions referred

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

the

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,

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
availability of adequate supplies of medicinal products at a reason-
able 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?

20.10.2007

EN

Official Journal of the European Union

C 247/11

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
the
applicant company, with the consequent need for
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 — Bayer SpA v Agenzia Italiana del Farmaco
(AIFA) and Ministero della Salute

(Case C-356/07)

(2007/C 247/14)

Language of the case: Italian

Referring court

Tribunale Amministrativo Regionale del Lazio (Italy)

Parties to the main proceedings

Applicant: Bayer SpA

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

Questions referred

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,

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
in the case of price freezes,
verify, at least once a year,
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
availability of adequate supplies of medicinal products at a reason-
able 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)?

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

the

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?