Case T-344/00: Action brought on 13 November 2000 by CEVA Santé Animale against the Commission of the European Communities
Date: 2001-02-10
Institutions: Court of First Instance
Subjects: European Commission, action for failure to act, animal health, hormone, pharmaceutical industry, pharmaceutical legislation

10.2.2001

EN

Official Journal of the European Communities

C 45/19

Action brought on 13 November 2000 by CEVA Santé
Animale against the Commission of the European Com-
munities

— order the Commission to pay the costs of the present

proceedings.

(Case T-344/00)

(2001/C 45/42)

(Language of the case: English)

An action against the Commission of the European Communi-
ties was brought before the Court of First Instance of the
European Communities on 13 November 2000 by CEVA
Santé Animale, having its registered office in Libourne, France,
represented by Denis Waelbroeck and Dirk Brinckman, of
Liedekerke Siméon Wessing Houthoff, Brussels.

The applicant claims that the Court should:

— declare pursuant to Article 232 EC that the Commission
has failed to comply with its obligations under Com-
munity law by failing to take the necessary measures for
the inclusion of progesterone in Annex II to Regulation
No 2377/90 following the issuing of the positive opinion
of the CVMP and in particular to draw up a draft
regulation including progesterone in Annex II and sub-
mitting it to the Standing Committee for approval;

— order the Community, as represented here by the Com-
mission, to repair the damage suffered by the applicant
as a result of its unlawful failure to act and to set the
amount of compensation at EURO 258 453, or at any
other amount reflecting the damage suffered by the
applicant as further established by it in the course of
these proceedings, and especially taking due account of
future damage;

— in the alternative, order the parties to produce to the
Court within a reasonable period from the date of the
judgment figures as to the amount of the compensation
agreed between the parties or, in the absence of agree-
ment, order the parties to produce to the Court within
the same period their submissions with detailed figures in
support;

— order that interest at the annual rate of 8 %, or any other
appropriate rate to be determined by the Court, be paid
on the amount payable as from the date of the Court’s
judgment until actual payment of that amount;

Pleas in law and main arguments

The applicant in the present case is a pharmaceutical company
which markets a veterinary medicinal product containing the
pharmaceutically active ingredient progesterone. The product
marketed by the applicant is used for the purpose of controlling
the period of sexual receptivity in cows and breeding mares. It
can also be used for the therapeutical treatment of fertility
disorders in cows and mares.

The applicant states on this point that in December 1999 the
Committee for Veterinary Medicinal Products (CVMP), after
examining the information forwarded by the Commission,
confirmed its earlier 1996 recommendation for the inclusion
of progesterone in Annex II to Council Regulation (EEC)
No 2377/90, of 26 June 1990, laying down a Community
procedure for the establishment of maximum residue limits
of veterinary medicinal products in foodstuffs of animal
origin (1).Thus there appeared to be no further reason for the
Commission to continue blocking the procedure for the
inclusion of progesterone in the above-mentioned Annex II.
However, despite a renewed oral assurance by the Commission
in October 2000 that a regulation including progesterone in
this Annex II would be adopted without delay, no further
action has been undertaken by the Commission since then.

In support of its claims, the applicant submits as follows:

— In breach of its obligations under Regulation No 2377/90,
especially Article 7(5) and (6) thereof, the Commission
has failed to act;.

— In breach of the general principle of the protection of
legitimate expectations and the general principle of sound
administration, the Commission has failed to act;

— Its failure to act is not consistent with the authorisation
within the Community of the use of progesterone for
therapeutical and zootechnical use or with the recent
initiatives of the Commission confirming that the use of
hormonal substances for these purposes should continue
to be allowed, and constitutes in reality a misuse of
powers;

— The Commission’s failure to act constitutes a breach of
the applicant’s fundamental right to pursue its economic
activity and of the principle of proportionality.

(1) OJ L 224, of 18.8.1990, p. 1.