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20.10.

2007 EN Official Journal of the European Union C 247/15

On a proper construction of the reference to ‘decreases in Reference for a preliminary ruling from the Tribunale
prices … being made, if any’, is that provision to be interpreted Amministrativo Regionale del Lazio (Italy) lodged on
as meaning that, as well as the general remedy of freezing 2 August 2007 — Baxter Spa v Agenzia Italiana del
the prices of all categories, or certain specific categories, of Farmaco (AIFA) and Others
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 (Case C-367/07)
‘decreases …, if any’ be interpreted as referring exclusively to
the medicinal products which are already subject to the price
freeze? (2007/C 247/19)

Language of the case: Italian


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
Referring court
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)?
Tribunale Amministrativo Regionale del Lazio

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 Parties to the main proceedings
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 Applicant: Baxter Spa
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 Defendant: Agenzia Italiana del Farmaco (AIFA) and Others
on the basis of ‘predictions’ rather than values which have
been ‘ascertained’ (this question relates to both situations)?

Questions referred
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 1. After the provisions contained in Articles 2 and 3 (1) [of
pharmaceutical expenditure alone, or is it within the powers Directive 89/105/EC] which modulate the relationship
of the Member States to take account also of data relating to between the public authorities of a Member State and the
other health expenditure? 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
5. Must the principles, to be inferred from … Directive thus on the basis of dialogue between the undertakings
[89/105/EC], of transparency and of shared participation on themselves and the authorities competent to supervise phar-
the part of the undertakings with an interest in measures maceutical expenditure — Article 4(1) [of that Directive]
freezing the prices of pharmaceutical products or reducing concerning ‘price freeze[s] imposed on all medicinal products or
them across the board be interpreted as requiring provision on certain categories of medicinal products’ characterises a price
to be made, always and in any circumstances, for the possibi- freeze as a general instrument, the continuing use of which
lity of derogation from the price imposed (Article 4(2) [of is conditional upon a review which must be carried out, at
Directive 89/105/EC]) and for genuine participation by the least once a year, with reference to the macro-economic
applicant company, with the consequent need for the conditions existing in the Member State in question.
administrative authorities to state the reasons for any refusal?
That provision allows the competent authorities a period of
90 days in which to take a final decision, requiring them, on
(1) Council Directive 89/105/EEC of 21 December 1988 relating to the expiry of that period, to announce what increases or
transparency of measures regulating the pricing of medicinal decreases in prices are being made, if any.
products for human use and their inclusion in the scope of national
health insurance systems (OJ L 40, 11.2.1989, p. 8).
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
C 247/16 EN Official Journal of the European Union 20.10.2007

in the form of a reduction in the prices of all categories, and Reference for a preliminary ruling from the Vestre
of certain specific categories, of medicinal product, or must Landsret (Denmark) lodged on 6 August 2007 — Danfoss
‘decreases …, if any’ be interpreted as referring exclusively to A/S and AstraZeneca A/S v Skatteministeriet
the medicinal products which are already subject to the price
freeze?
(Case C-371/07)

(2007/C 247/20)
2. In requiring the competent authorities of a Member State to
verify, at least once a year, in the case of price freezes,
Language of the case: Danish
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 Referring court
(from 2002 until 2010)?

Vestre Landsret

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 Parties to the main proceedings
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 Applicants: Danfoss A/S and AstraZeneca A/S
hinder or distort intra-Community trade in medicinal products’ —
is it compatible with the Community rules to adopt measures
Defendant: Skatteministeriet
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)?

Questions referred

4. Must the requirements relating to compliance with the ceil- 1. Is the second subparagraph of Article 17(6) of the Sixth VAT
ings for pharmaceutical expenditure which each Member Directive (1) to be interpreted in such a way that it is a condi-
State is competent to determine be linked, point by point, to tion for the refusal by a Member State of a right to deduct
pharmaceutical expenditure alone, or is it within the powers value added tax on supplies used for the provision of meals
of the Member States to take account also of data relating to to business contacts and staff in a company's canteen in
other health expenditure? connection with meetings that there was, prior to the entry
into force of the directive, authority under national legisla-
tion for the deduction refusal in question and that this
authority was applied in practice by the tax authorities in
such a way that the right to deduct value added tax on these
5. Must the principles, to be inferred from … Directive supplies was refused?
[89/105/EC], of transparency and of shared participation on
the part of the undertakings with an interest in measures 2. Does it have any significance in answering Question 1 that
freezing the prices of pharmaceutical products or reducing company-operated canteens were not subject to VAT under
them across the board be interpreted as requiring provision the national VAT rules in force in the Member State in ques-
to be made, always and in any circumstances, for the possibi- tion before the implementation of the Sixth VAT Directive in
lity of derogation from the price imposed (Article 4(2) [of 1978, that the national deduction exclusion rules were not
Directive 89/105/EC]) and for genuine participation by the changed by the implementation of the Sixth VAT Directive,
applicant company, with the consequent need for the and that it was exclusively as a result of the fact that
administrative authorities to state the reasons for any refusal? company-operated canteens became subject to VAT on the
implementation of the Sixth VAT Directive that the deduc-
tion exclusion rule could become relevant to that type of
(1) Council Directive 89/105/EEC of 21 December 1988 relating to the business?
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). 3. Is an exclusion from the right to deduct ‘retained’ within the
meaning of the second subparagraph of Article 17(6) of the
Sixth VAT Directive if, from the implementation of the Sixth
VAT Directive in 1978 until 1999, as a result of an adminis-
trative practice such as that described in the main proceed-
ings there was a right to deduct VAT on the expenditure in
question?