Case C-365/07: Reference for a preliminary ruling from the Tribunale Amministrativo Regionale del Lazio (Italy) lodged on 2 August 2007 — Simesa SpA v Ministero della Salute and 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

20.10.2007

EN

Official Journal of the European Union

C 247/13

Parties to the main proceedings

Applicants: Spyridon Vassilakis and Others

Defendant: Dimos Kerkyras (Municipality of Corfu)

Questions referred

1. Must a national court — as far as possible — interpret its
domestic law in accordance with a directive which was trans-
posed belatedly into its national legal system from

(a) the time when the directive entered into force, or

(b) the time when the time-limit

into
law elapsed without any action having been

for transposing it

national
taken, or

(c) the time when the national measure implementing it

entered into force?

2. Does Clause 5(1) of the Framework Agreement on fixed-
term work concluded by ETUC, UNICE and CEEP, which
constitutes an integral part of Council Directive 1999/70
(OJ 1999 L 175, p. 43 of 10 July 1999) mean that, apart
from reasons connected with the nature, type or characteris-
tics of the work performed or other similar reasons, the
mere fact that the conclusion of a fixed term contract is
required by a provision of
law or secondary legislation
constitutes an objective reason for continually renewing or
concluding successive fixed-term employment contracts?

3. May Clause 5(1) and (2) of the Framework Agreement on
fixed-term work concluded by ETUC, UNICE and CEEP,
which constitutes an integral part of Council Directive
1999/70 (OJ 1999 L 175, p. 43 of 10 July 1999), be inter-
preted to the effect that national provisions which lay down
that fixed-term employment contracts or relationships are to
be regarded as successive only provided a period of at most
three months separates them and, further, that the presump-
tion introduced in favour of the worker that successive fixed-
term employment contracts or relationships should be recog-
nised as of unlimited duration is necessarily based on the
above precondition?

4. Is the prohibition in Article 21 of Law 2190/1994 of the
conversion of successive fixed-term contracts of employment
into contracts of unlimited duration, those contracts having
been concluded for a fixed term in order to cover the excep-
tional or seasonal needs of the employer but in fact for the
purpose of meeting its fixed and permanent needs, compa-
tible with the principle of the effectiveness of Community
law and the purpose of Clause 5(1) and (2), in conjunction
with Clause 1 of the Framework Agreement on fixed-term
work concluded by ETUC, UNICE and CEEP, which consti-
tutes an integral part of Council Directive 1999/70 (OJ 1999
L 175, p. 43 of 10 July 1999)?

5. Is the fact that an independent administrative authority, the
Anotato Simvoulio Epilogis Prosopikou (ASEP — the

Supreme Staff Selection Council) has the final word, under a
national provision, enacted in application of the above direc-
tive, on whether or not
fixed-term contracts can be
converted into contracts of indefinite duration compatible
with the principle of the effectiveness of Community law
and the purpose of Clause 5(1) and (2), in conjunction with
Clause 1 of the Framework Agreement on fixed-term work
concluded by ETUC, UNICE and CEEP, which constitutes an
integral part of Council Directive 1999/70 (OJ 1999 L 175,
p. 43 of 10 July 1999)?

Reference for a preliminary ruling from the Tribunale
Amministrativo Regionale del Lazio (Italy)
lodged on
2 August 2007 — Simesa SpA v Ministero della Salute and
Agenzia Italiana del Farmaco (AIFA) and Others

(Case C-365/07)

(2007/C 247/17)

Language of the case: Italian

Referring court

Tribunale Amministrativo Regionale del Lazio

Parties to the main proceedings

Applicant: Simesa SpA

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

Questions referred

the

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
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.

C 247/14

EN

Official Journal of the European Union

20.10.2007

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?

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
administrative authorities to state the reasons for any refusal?

(1) Council Directive 89/105/EEC of 21 December 1988 relating to the
regulating the pricing of medicinal

transparency of measures

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
2 August 2007 — Abbott Spa v Ministero della Salute and
Agenzia Italiana del Farmaco (AIFA)

(Case C-366/07)

(2007/C 247/18)

Language of the case: Italian

Referring court

Tribunale Amministrativo Regionale del Lazio

Parties to the main proceedings

Applicant: Abbott Spa

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

Questions referred

the

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
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,