Case C-452/07: Reference for a preliminary ruling from the Bundesgerichtshof (Germany) lodged on 4 October 2007 — Health Research Inc.
Date: 2007-12-08
Institutions: Court of Justice
Subjects: EU law - national law, interpretation of the law, market approval, medicinal product, pharmaceutical legislation

8.12.2007

EN

Official Journal of the European Union

C 297/27

Reference for a preliminary ruling from the Tribunale
Amministrativo Regionale del Lazio (Italy)
lodged on
3 October 2007 — Federfarma v Agenzia Italiana del
Farmaco (AIFA), Ministero della Salute

(Case C-451/07)

(2007/C 297/43)

Language of the case: Italian

Referring court

Tribunale Amministrativo Regionale del Lazio

Parties to the main proceedings

Applicant: Federfarma

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

Questions referred

1. After the provisions contained in Articles 2 and 3 [of Direc-
tive 89/105/EC] 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 cate-
gories 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 provi-
sion allows the competent authorities a period of 90 days in
which to take a final decision, requiring them, on expiry of
that period,
increases or decreases in
prices are being made, if any. 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 inter-
preted as referring exclusively to the medicinal products
which are already subject to the price freeze?

to announce what

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?

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 admin-
istrative authorities to state the reasons for any refusal?

Reference for a preliminary ruling from the Bundesgericht-
lodged on 4 October 2007 — Health
shof

(Germany)

Research Inc.

(Case C-452/07)

(2007/C 297/44)

Language of the case: German

Referring court

Bundesgerichtshof

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]

Parties to the main proceedings

Applicant: Health Research Inc.

C 297/28

EN

Official Journal of the European Union

8.12.2007

Questions referred

1. Is the ‘date on which the authorisation referred to in
Article 3(b) to place the product on the market as a medic-
inal product was granted’, referred to in Article 7(1) of the
Regulation (1), determined according to Community law or
does that rule refer to the date on which the authorisation
takes effect under the law of the Member State in question?

2. If the Court's answer is that the date referred to in Question 1
is determined by Community law, which date must be taken
into account for that purpose?

(1) OJ L 182, p. 1.

years after leaving school, apart from an alleged single day of
work on a trial basis, he has at no time been in employment,
drops out of all government support schemes designed to
promote the taking-up of employment and does not himself
make serious efforts to take up employment, instead living by
turns on social security benefits,
financial support from his
mother living in Germany and means of unknown origin?

Appeal brought on 9 October 2007 by Ente per le Ville
Vesuviane against the judgment delivered on 18 July 2007
in Case T-189/02 Ente per le Ville Vesuviane v Commission
of the European Communities

Reference for a preliminary ruling from the Verwaltungs-
gericht Giessen (Germany) lodged on 4 October 2007 —
Hakan Er v Wetteraukreis

(Case C-453/07)

(2007/C 297/45)

Language of the case: German

Parties

(Case C-455/07 P)

(2007/C 297/46)

Language of the case: Italian

Referring court

Verwaltungsgericht Giessen

Appellant: Ente per
Soprano, avvocato)

le Ville Vesuviane (represented by: E.

Other party to the proceedings: Commission of
Communities

the European

Parties to the main proceedings

Form of order sought

Applicant: Hakan Er

Defendant: Wetteraukreis

Question referred

Does a Turkish national who, as a member of
the family,
received authorisation to join his father living in Germany who
as a Turkish worker was duly registered as belonging to the
labour force of
the Federal Republic of Germany, and who
acquired, by virtue of previously living together legally with his
father for five years, the legal status as referred to in the second
indent of the first sentence of Article 7 of Decision No 1/80 of
the EEC-Turkey Association Council on the development of the
association (‘Association Council Decision 1/80’), lose that legal
status as a consequence of the fact that, for more than seven

— set aside in part, in accordance with the pleas set out below,
the judgment under appeal and, consequently, declare void
Decision D(2002) 810111, prot. 102504 of 13 March
2002 of the Directorate General for Regional Policy of the
European Commission, and if necessary and in so far as is
reasonable, Memorandum No Gt/SF/MF D(01) 810542,
prot. 109720 of 12 October 2001 of
the Directorate
General for Regional Policy of the European Commission;

— in the alternative, annul

in accordance with the
in part,
pleas set out below, the judgment under appeal and refer the
case back to the Court of First Instance for a ruling on the
substance of the dispute in the light of the directions which
the Court sees fit to give for that purpose;

— order the European Commission to pay the costs of both
the present proceedings and the proceedings at first instance
in Case T-189/02.