Case C-356/07: 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
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 247/11

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?

C 247/12

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 High Court of
Justice
(England & Wales), Queen's Bench Division
(Administrative Court) (United Kingdom) made on 31 July
2007 — The Queen on the application of TNT Post UK Ltd
v The Commissioners of Her Majesty's Revenue &
Customs and Royal Mail Group Ltd

(Case C-357/07)

(2007/C 247/15)

Language of the case: English

Referring court

High Court of
Division (Administrative Court)

Justice (England & Wales), Queen's Bench

Parties to the main proceedings

Applicant: TNT Post UK Ltd

Defendant: The Commissioners of Her Majesty's Revenue &
Customs

b) Is the interpretation of that expression affected by the fact
that postal services in a Member State have been liberal-
ised, there are no reserved services within the meaning of
Council Directive 97/67/EC (3), as amended, and there is
one designated universal service provider that has been
notified to the Commission pursuant to that Directive
(such as Royal Mail in the United Kingdom)?

c) in the circumstances of the present case (which are as set

out in b) above) does that expression include

(i) only the sole designated universal services provider

(such as Royal Mail in the United Kingdom) or

(ii) also a private postal operator (such as TNT Post)?

2. In the circumstances of the present case, is Article 13A(1)(a)
of the Sixth VAT Directive (now Article 132(1)(a) of Direc-
tive 2006/112) to be interpreted as requiring or permitting a
Member State to exempt all postal services provided by ‘the
public postal services’?

3. If Member States are required or permitted to exempt some,
but not all, of the services provided by ‘the public postal
services’, by reference to which criteria are those services, by
reference to which criteria are those services to be identified?

(1) Sixth Council Directive 77/388/EEC of 17 May 1977 on the harmo-
nization of the laws of the Member States relating to turnover taxes
— Common system of value added tax: uniform basis of assessment
(OJ L 145, p. 1).

(2) Council Directive 2006/112/EC of 28 November 2006 on the

common system of value added tax (OJ L 347, p. 1).

(3) Directive 97/67/EC of the European Parliament and of the Council
of 15 December 1997 on common rules for the development of the
internal market of Community postal services and the improvement
of quality of service (OJ L 15, p. 14).

Reference for a preliminary ruling from the Monomeles
Protodikio Kerkyras (Greece) lodged on 2 August 2007 —
Spyridon Vassilakis and Others v Municipality of Corfu

(Case C-364/07)

(2007/C 247/16)

Interested Party: Royal Mail Group Ltd

Language of the case: Greek

Questions referred

1. a) How is the expression ‘the public postal services’

in
Article 13A(1)(a) of the Sixth VAT Directive (Directive
77/388/EEC) (1)
(now Article 132(1)(a) of Directive
2006/112 (2)) to be interpreted?

Referring court

Monomeles Protodikio Kerkyras (Corfu Court of First Instance)