Case C-385/08: Action brought on 2 September 2008 — Commission of the European Communities v Republic of Poland
Date: 2008-09-02
Institutions: Court of Justice
Subjects: Poland, action for failure to fulfil an obligation, market approval, medicinal product, pharmaceutical industry

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.

6.12.2008

EN

Official Journal of the European Union

C 313/13

Furthermore,
in the applicant's submission the marketing of
medicinal products that are generics of the reference product
Plavix could not be covered by the transitional period laid down
in point 1.5 of Annex XII to the Act concerning the conditions
of accession, because the exceptions provided for
therein
concerned exclusively the requirements of safety, quality and
efficacy prescribed in Directive 2001/83/EC, and not
the
10-year period of data protection laid down in Article 13(4) of
Regulation (EEC) No 2309/93 and Articles 89 and 90 of Regu-
lation (EC) No 726/2004.

— in the alternative, refer the case back to the Court of First

Instance for a fresh decision;

— in the further alternative, reduce the fine imposed on the
appellant by Article 3 of the contested Commission Deci-
sion of 27 November 2002 in an appropriate manner, and
in any event by at least EUR 54,51 million;

— order the respondent to pay the costs of the proceedings.

(1) Directive 2001/83/EC of

the European Parliament and of

the
Council of 6 November 2001 on the Community code relating to
medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
(2) Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down
Community procedures for the authorisation and supervision of
medicinal products for human and veterinary use and establishing a
European Agency for the Evaluation of Medicinal Products (OJ L 214,
24.8.1993, p. 1).

(3) Regulation (EC) No 726/2004 of the European Parliament and of the
Council of 31 March 2004 laying down Community procedures for
the authorisation and supervision of medicinal products for human
and veterinary use and establishing a European Medicines Agency
(OJ L 136, 30.4.2004, p. 1).

Appeal brought on 19 September 2008 by Knauf Gips KG
against the judgment of the Court of First Instance (Third
Chamber) delivered on 8 July 2008 in Case T-52/03 Knauf
Gips KG v Commission of the European Commission

(Case C-407/08 P)

(2008/C 313/19)

Language of the case: German

Parties

Appellant: Knauf Gips KG (represented by: M. Klusmann and S.
Thomas, Rechtsanwälte)

Other party to the proceedings: Commission of
Communities

the European

Form of order sought

— Set aside the judgment of the Court of First Instance (Third
Chamber) of 8 July 2008 in Case T-52/03 Knauf Gips KG v
Commission in its entirety;

Pleas in law and main arguments

The appeal against the judgment, by which the Court of First
Instance dismissed the action brought by the appellant against
Commission Decision 2005/471/EC of 27 November 2002, is
based on three pleas in law.

1. By its first plea on appeal, the appellant submits that there
was a breach of the rights of the defence, including a breach
of the right to a fair hearing. The appellant submits that the
Court of First Instance failed to observe the principles that
apply with regard to the legal consequences of a refusal to
grant access to incriminating documents and the withholding
of exculpatory evidence. By the first part of this plea, the
appellant submits that
the Commission's decision should
have been annulled, because the Commission denied the
appellant access to incriminating evidence on which the deci-
sion was subsequently based. By the second part of the first
plea, the appellant submits that the judgment under appeal
involved a separate breach of
the appellant's rights of
defence, given that the Commission also illegally withheld
exculpatory evidence, which likewise should have led to the
annulment of the decision.

2. By its second plea on appeal, the appellant submits that
there was an infringement of Article 81(1) EC, due to funda-
mental breaches of the rules on evidence, namely of the in
dubio pro reo principle, as well as breaches of substantive law,
namely as regards the elements constituting a concerted
led to the
practice, which,
assumption — constituting an error of
law — that
Article 81(1) EC had been breached.

in the judgment under appeal,

3. By its third plea on appeal, the appellant submits that there
was an infringement of the 10 % ceiling under Article 15(2)
of Regulation No 17/62. The appellant submits that the
Court of First Instance wrongly attributed to the appellant
the turnover of undertakings which the appellant does not
control and which do not control the appellant. The appel-
lant submits that it and those undertakings do not form part
of the same economic unit.