CELEX: C1999/352/65
Language: en
Date: 1999-12-04 00:00:00
Title: Case T-212/99: Action brought on 22 September 1999 by Hoechst Roussel Vet against the Commission of the European Communitie

4.12.1999             EN                     Official Journal of the European Communities                                        C 352/37
Action brought on 22 September 1999 by Hoechst Rous-                    the Standing Committee on Veterinary Medicinal Products to
sel Vet against the Commission of the European Commun-                  enable the substance to be included in Annex III to that
                               itie                                     regulation. For two and a half years, however, the Commission
                                                                        failed to prepare any draft measures for the inclusion of the
                                                                        substance in Annex III and to submit such measures to the
                        (Case T-212/99)                                 Standing Committee for adoption. It was not until 23 April
                                                                        1999 that the Commission, following the applicant’s threats
                        (1999/C 352/65)                                 to initiate legal proceedings, referred the file back to the CVMP
                                                                        for a reassessment of the product. By way of explanation of its
                                                                        inaction, the Commission claims, in its letter of 16 July 1999
                                                                        (the contested letter), that the submission of a draft decision
                  (Language of the case: English)                       concerning the inclusion of ALTRENOGEST in Annex III has
                                                                        been postponed owing to concerns within the Commission
An action against the Commission of the European Communi-               regarding the effects of this substance on public health; it relies
ties was brought before the Court of First Instance of the              in this respect on alleged new scientific findings which surfaced
European Communities on 22 September 1999 by Hoechst                    during the work of DG XXIV’s ‘Scientific Committee on
Roussel Vet, a company having its registered office in Germany,         Veterinary Measures Relating to Public Health’.
represented by Denis Waelbroeck and Dirk Brinckman, with
an address for service in Luxembourg at the Chambers of
Ernest Arendt, 8-10 rue Matthias Hardt.
                                                                        The applicant maintains on the one hand, that the reasons
The applicant claims that the Court should:                             invoked by the Commission for not complying with its
                                                                        obligations and for re-submitting the file to the CVMP
                                                                        manifestly infringe the provisions of Regulation No. 2377/90.
— annul the Commission decision of 16 July 1999 contained
                                                                        Allowing the Commission to re-submit the file to the CVMP,
    in the letter of the same date by which the Commission
                                                                        for reasons entirely unrelated to the applicant’s product, and
    has informed the applicant of its refusal to take the
                                                                        although there is a positive opinion of the CVMP following
    necessary measures to introduce ALTRENOGEST in Annex
                                                                        which the Commission has failed to take any action for more
    III to Regulation No 2377/90;
                                                                        than two years flies in the face of the whole legal framework
                                                                        set up by Regulation No. 2377/90, is not justified by any
— in addition, declare pursuant to Article 232 EC that the              scientific evidence or public health considerations and ignores
    Commission has failed to comply with its obligations                the Commission’s duty of care and of good management in
    under Community law and, more particularly, has failed,             the light of the upcoming deadline of 1 January 2000,
    following receipt of the definitive opinion of the CVMP,            after which the administration to food-producing animals of
    to prepare draft measures including ALTRENOGEST in                  veterinary medicinal products containing pharmacologically
    Annex III to Regulation No 2377/90 and failed to initiate           active substances which are not mentioned in Annexes I, II or
    the procedure under Article 8 of Regulation No 2377/90;             III of the Regulation No. 2377/90 will be prohibited in the
                                                                        European Union. It considers therefore that the decision of the
— order the Commission to bear the costs of the present                 Commission to resubmit the dossier to the CVMP and thus its
    proceedings.                                                        refusal to take the necessary measures to introduce the active
                                                                        substance in Annex III has to be annulled.
Pleas in law and main arguments
The applicant is a pharmaceutical company which has                     The applicant stases, on the other hand, that the Commission
developed a pharmaceutical compound known under the                     has failed to act in violation of its obligations under Com-
name of ‘ALTRENOGEST’ and mainly used in pig breeding.                  munity law, given that it did not take any action whatsoever
On 10 February 1993 it submitted an application for the                 to prepare draft measures following receipt of the opinion of
establishment of maximum residue limits (‘MRL’) for ALTREN-             the CVMP and that it did not forthwith submit such measure
OGEST in conformity with Article 7 of Council Regulation                to the Standing Committee, but only asked for a re-
No 2377/90 laying down a Community procedure for the                    examination more than two years after the positive opinion of
establishment of maximum residue limits of veterinary med-              the CVMP.
icinal products in foodstuffs of animal origin (1). On 23 Februa-
ry 1993 the Commission sent the file to the Committee for
Veterinary Medicinal Products (‘CVMP’). On 16 January 1997,
the CVMP adopted its opinion concerning the MRL application
for ALTRENOGEST; it recommended that ALTRENOGEST be
introduced in Annex III to Regulation No 2377/90, that is to            (1) OJ 1990 L 224, p. 1.
say, that a provisional MRL be fixed, pending the examination
of a number of additional questions.
The applicant points out that under the procedure laid down
in Article 8 of Regulation No 2377/90, the Commission, once
it has received such an opinion, is under a legal obligation to
refer ‘without delay’ the draft of the measures to be taken to