Case C-353/08: Reference for a preliminary ruling from the Tribunale Amministrativo Regionale del Lazio (Italy) lodged on 1 August 2008 — A. Menarini Industrie Farmaceutiche Riunite Srl and Others v Ministero della Salute and Agenzia Italiana del Farmaco (AIFA)
Date: 2008-08-01
Institutions: Court of Justice
Subjects: interpretation of the law, medicinal product, pharmaceutical industry, price increase

6.12.2008

EN

Official Journal of the European Union

C 313/11

Order of the Court of 9 July 2008 (reference for a preli-
minary ruling from the Hof van beroep te Antwerpen
(Belgium)) — Gerlach & Co. NV v Belgische Staat

(Case C-477/07) (1)

(Article 104(3), first subparagraph of the Rules of Procedure
— Community Customs Code — Concepts of ‘entry in the
accounts’ and ‘communication’ of the amount of duty to the
debtor — Prior entry in the accounts of the amount of the
customs debt — Recovery of the customs debt)

recovered must have been preceded by the entry in the accounts of
that amount by the customs authorities of the Member State and
that,
in the absence of due notification in accordance with that
provision, that amount may not be recovered by those authorities.
However, those authorities remain entitled to proceed with a new
notification of that amount, in accordance with the conditions laid
down by that provision and the limitation rules in force at the time
the customs debt arose.

(1) OJ C 8 of 12.1.2007.

(2008/C 313/16)

Language of the case: Dutch

Referring court

Hof van beroep te Antwerpen

Parties

Applicant: Gerlach & Co. NV

Defendant: Belgische Staat

Re:

Reference for a preliminary ruling from the Tribunale
Amministrativo Regionale del Lazio (Italy)
lodged on
1 August 2008 — A. Menarini Industrie Farmaceutiche
Riunite Srl and Others v Ministero della Salute and
Agenzia Italiana del Farmaco (AIFA)

(Case C-353/08)

(2008/C 313/17)

Language of the case: Italian

Preliminary ruling — Hof van beroep te Antwerpen — Interpre-
tation of Articles 217 and 221(1) of Council Regulation (EEC)
No 2913/92 of 12 October 1992 establishing the Community
Customs Code (OJ 1992 L 302, p. 1) and Article 6 of Council
Regulation (EEC, Euratom) No 1552/89 of 29 May 1989 imple-
menting Decision 88/376/EEC, Euratom on the system of the
Communities' own resources (OJ 1989 L 155, p. 1)
(now
Council Regulation 1150/2000 (EC, Euratom) of 22 May 2000
implementing Decision 2000/597/EC (OJ 2000 L 130, p. 1)) —
Concepts of ‘entry in the accounts’ and ‘communication’ of the
amount of duty to the debtor — Prior entry in the accounts of
the amount of the customs debt — Recovery of the debt

Operative part of the order

1. Article 221(1) of Council Regulation (EEC) No 2913/92 of
12 October 1992 establishing the Community Customs Code is to
be interpreted as meaning that the ‘entry in the accounts’ of the
amount of the duty to be recovered referred to therein is the ‘entry
in the accounts’ of that amount as defined in Article 217(1) of
that regulation and that that entry in the accounts is to be distin-
guished from the recording of that duty in the accounts of the own
resources referred to in Article 6 of Council Regulation (EEC,
Euratom) No 1552/89 of 29 May 1989 implementing Decision
88/376/EEC, Euratom on the system of the Communities' own
resources.

2. Article 221(1) of Regulation No 2913/92 is to be interpreted as
meaning that the communication of the amount of duty to be

Referring court

Tribunale Amministrativo Regionale del Lazio

Parties to the main proceedings

Applicants: A. Menarini Industrie Farmaceutiche Riunite Srl and
Others

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

Questions referred

1. After the provisions contained in Articles 2 and 3 [of Direc-
tive 89/105/EC (1)] which modulate the relationship between
the public authorities of a Member State and the pharmaceu-
tical 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 pharmaceutical
expenditure — Article 4(1) [of that Directive] concerning
‘price freeze[s] imposed on all medicinal products or on certain

C 313/12

EN

Official Journal of the European Union

6.12.2008

categories of medicinal products’ characterises a price freeze as a
general
instrument, the continuing use of which is condi-
tional upon a review which must be carried out, at least
once a year, with reference to the macro-economic condi-
tions 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,

This Court asks: On a proper construction of the refer-
ence 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 cate-
gories, 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?

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 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?

(1) Council Directive 89/105/EEC of 21 December 1988 relating to the
transparency of measures regulating the prices of medicinal products
for human use and their inclusion in the scope of national health
insurance systems (OJ 1989 L 40, p. 8).

Action brought on 2 September 2008 — Commission of
the European Communities v Republic of Poland

(Case C-385/08)

(2008/C 313/18)

Language of the case: Polish

Parties

Applicant: Commission of the European Communities (repre-
sented by: M. Šimerdová and K. Herrmann, acting as Agents)

Defendant: Republic of Poland

Form of order sought

— declare that, by retaining in force marketing authorisations
for medicinal products that are generics of the reference
product Plavix, the Republic of Poland has failed to fulfil its
obligations under Article 6(1) of Directive 2001/83/EC (1),
in conjunction with Article 13(4) of Regulation (EEC)
No 2309/93 (2) and Articles 89 and 90 of Regulation (EC)
No 726/2004 (3);

— declare that, by placing and keeping on the market after
1 May 2004 medicinal products whose marketing authorisa-
tion was not issued in accordance with Article 6(1) of Direc-
tive 2001/83/EC, the Republic of Poland has failed to fulfil
its obligations under that article;

— order the Republic of Poland to pay the costs.

Pleas in law and main arguments

In the applicant's view, marketing of the medicinal products
which are the subject of decisions of the Minister for Health of
the Republic of Poland that were issued in the period from
January to April 2004 and contain additional recommendations
and requirements for additional investigation cannot be covered
by the transitional period laid down in point 1.5 of Annex XII
to the Act concerning the conditions of accession of
the
Republic of Poland to the European Union, because those deci-
sions of the Minister for Health did not constitute before 1 May
2004 marketing authorisations for the purposes of point 1.5 of
Annex XII. The medicinal products at issue therefore had to be
placed on the market by means of a marketing authorisation
issued in accordance with Directive 2001/83/EC or Regulation
No 2309/93.