CELEX: C2000/047/58
Language: en
Date: 2000-02-19 00:00:00
Title: Case T-326/99: Action brought on 19 November 1999 by Nancy Fern Olivieri against the Commission of the European Communities and the European Agency for the Evaluation of Medicinal Products

19.2.2000               EN                     Official Journal of the European Communities                                        C 47/33
     failed to observe the principle of the investor operating in         — order the Commission to pay the applicant’s costs.
     a market economy in considering that the actions of
     Itainvest could not be compared to the conduct of a private
     undertaking since the return on profit was negative from
     the beginning. According to the applicants, that error of            Pleas in law and main arguments
     assessment also concerns the guarantees offered by Itainv-
     est for the performance of individual contracts, as well as
     injections of capital into INMA itself;
                                                                          The applicant in the present case is one of the world’s
                                                                          leading scientists involved in research and clinical trials on
— breach of the obligation to provide a statement of reasons              thalassaemia and its treatment. She has engaged in the
     when adopting the relevant Community measures. In                    principal clinical trials for Ferriprox-Deferiprone (hereinafter
     particular, the Commission did not consider whether at               ‘deferiprone’). According to her, these trials indicate that the
     the time when the decision to give the guarantees to and             drug may have significant adverse effects on human health.
     inject capital into INMA was adopted there were any valid            She claims that, as a result of the contested decision granting a
     economic or financial reasons to justify Itainvest’s course          marketing authorisation for deferiprone, there is a risk of
     of action. The defendant further failed to examine individu-         severe damage to health as well as damaging consequences to
     ally the steps taken and assess their nature in the context          her own professional reputation.
     of the economic situation reigning at the material time,
     preferring instead to rely on mere assumptions.
                                                                          The applicant contends that, contrary to the conclusions of
(1) OJ 1990 L 380, p. 27.                                                 the European Agency for the Evaluation of Medicinal Products
(2) OJ 1998 L 121, p. 1.                                                  (EMEA) and the Commission:
                                                                          — the safety of deferiprone depends first and foremost upon
                                                                              its effectiveness: if it is not effective at removing excess
                                                                              iron from the bodies of patients with thalassaemia, the
                                                                              patients who take it will be at risk of iron overload and
                                                                              premature death from iron-induced cardiac and liver
                                                                              dysfunction;
Action brought on 19 November 1999 by Nancy Fern
Olivieri against the Commission of the European Com-
                                                                          — there is evidence to suggest that deferiprone is toxic to the
munities and the European Agency for the Evaluation of
                                                                              heart and liver and that its use carries considerable dangers
                        Medicinal Products
                                                                              with regard to hepatic fibrosis and the development and
                                                                              progression of cardiac disease;
                          (Case T-326/99)
                                                                          — Further human trials of deferiprone should await the
                           (2000/C 47/58)                                     results of animal toxicity testing.
                    (Language of the case: English)                       The applicant submits that the contested decision and the
                                                                          revised opinion of the EMEA are unlawful because:
An action against the Commission of the European Communi-
ties and the European Agency for the Evaluation of Medicinal              — the Commission and the EMEA committed errors of law,
Products was brought before the Court of First Instance of the                namely by failing to verify material facts in breach of
European Communities on 19 November 1999 by Nancy Fern                        Articles 7 and 11 of Regulation No 2309/93, after they
Olivieri, represented by Philippe Sands and Rebecca Haynes,                   had received evidence from the applicant that Apotex’s
Barristers, with an address for service in Luxembourg at the                  application for a marketing authorisation contained inac-
Chambers of Nathan & Noesen, 18 rue des Glacis, L-1628.                       curate and incomplete information on material issues;
The applicant claims that the Court should:
                                                                          — the Commission and the EMEA committed manifest errors
                                                                              in their assessment of the application for a marketing
— annul in its entirety the Commission’s decision of                          authorisation, which included
     25 August granting marketing authorisation for the med-
     icinal product for human use known as Ferriprox-
     Deferiprone;                                                             — errors of fact and
— annul in its entirety the revised opinion of the European
     Agency for the Evaluation of Medicinal Products dated                    — errors of law by failing to consider information relevant
     23 June 1999;                                                                 to the application;
 ---pagebreak--- C 47/34               EN                      Official Journal of the European Communities                                      19.2.2000
— the Commission and the EMEA committed further errors                   Pleas in law and main arguments
    of law, namely by relying upon ‘exceptional circumstances’
    to justify authorisation of deferiprone pursuant to                  The applicant, a political organisation within the European
    Article 13 of Regulation No 2309/93, when there were no              Parliament, states that on 19 July 1999 the constitution of the
    such ‘exceptional circumstances’ within the meaning of               ‘Groupe Technique des Députés Indépendants (TDI) — Groupe
    Article 13;                                                          mixte’ was communicated to the President of the Parliament,
                                                                         in accordance with Rule 29 of the Parliament’s Rules of
— The Commission and the EMEA failed to take account of,                 Procedure. At the plenary sitting on 20 July all the political
    and properly apply, the principle of proportionality as well         groups opposed the creation of that mixed group. The
    as the precautionary principle.                                      Committee on Constitutional Affairs and the Rules of Pro-
                                                                         cedure was therefore called upon to furnish an opinion on the
                                                                         conformity of that new group with Rule 29(1) of the Rules of
                                                                         Procedure. It proposed an interpretation to the effect that it is
                                                                         not possible, within the meaning of that rule, to accept the
                                                                         constitution of a group which openly denies possessing any
                                                                         political character and the existence of any political affinities
                                                                         between its members. On 14 September 1999 the matter was
                                                                         submitted to a vote of the Parliament, which, by a simple
                                                                         majority, adopted the interpretation proposed by the Com-
Action brought on 19 November 1999 by the Front                          mittee. It is that decision of the Parliament which is contested
         National against the European Parliament                        in the present case.
                        (Case T-327/99)                                  The decision likewise forms the subject-matter of other actions
                                                                         brought by Members of the European Parliament in Cases
                                                                         T-222/99, T-222/99 R (1) and T-329/99.
                         (2000/C 47/59)
                                                                         In support of its action, the applicant pleads as follows:
                   (Language of the case: French)                        Illegality as to form
An action against the European Parliament was brought before             — The nature of the contested measure is such that it amounts
                                                                             to more than a mere interpretation and constitutes a
the Court of First Instance of the European Communities on
                                                                             retroactive decision dissolving a political group. However,
19 November 1999 by the Front National, having its seat at
Saint-Cloud (France), represented by Alain Nivière, of the Lyon              at no time during any previous period of its existence as a
                                                                             legislative body has the European Parliament ever exercised
Bar, 155 Rue Vendôme, Lyon.
                                                                             the slightest control over the existence of political diver-
                                                                             gences within groups.
The applicant claims that the Court should:
                                                                         — The plenary sitting of the Parliament did not vote on
                                                                             the entire text of the opinion of the Committee on
— annul the decision of the European Parliament dated
                                                                             Constitutional Affairs; in particular, it did not deal with
    14 September 1999 announcing the dissolution of the                      matters contained in the specific part of the decision
    Groupe Technique des Députés Indépendants;                               relating to the dissolution of the TDI Group.
— reinstate the Parliamentary members of that group, restor-             — The refusal to allow any spokesperson to speak on behalf
    ing to them all their rights and prerogatives, both material             of the group concerned at the plenary sitting violated the
    and non-material, with effect from 19 July 1999, the date                principles of the right to a fair hearing and the audi alteram
    on which it was declared that their group was constituted;               partem rule.
— order the reinstatement in their careers of the persons                Illegality as to substance
    placed at the disposal of the group, in such a way that
    those persons may be restored to the position which they             — Rule 29 of the Parliament’s Rules of Procedure was
    should have occupied in indexing terms, in accordance                    wrongly applied, inasmuch as that rule does not lay down
    with the grades and steps applicable to them as assistants,              any special procedure concerning the recognition of a
    technical staff and secretaries of a Parliamentary group;                group. Consequently, the constitution of a group cannot
                                                                             be subjected to any scrutiny regarding the substance of
                                                                             political affinities.
— order the payment of the various allowances paid to
    political groups pursuant to the rules applicable to all             — The principle of equality has been infringed, in that to
    other political groups, with effect from the date of the                 accord the status of a non-affiliated Member of the
    declaration made by the Groupe Technique des Députés                     European Parliament is discriminatory by comparison with
    Indépendants, namely 19 July 1999;                                       that of a member of an officially declared political group.
                                                                             Such a distinction does not exist to the same extent under
— order the European Parliament to pay the costs.                            the parliamentary laws of the Member States.