Action brought on 1 July 2022 – Fresenius Kabi Austria and Others v Commission

(Case T-416/22)

Language of the case: English

Parties

Applicants: Fresenius Kabi Austria GmbH (Graz, Austria) and 14 other applicants (represented by: W. Rehmann and A. Knierim, lawyers)

Defendant: European Commission

Form of order sought

The applicants claim that the Court should:

declare Commission Decision of 24 May 2022 C(2022) 3591 null and void insofar as it orders the Member States of the European Union to suspend the national marketing authorisations for the medicinal products as referred to in Annex I thereof;

order the Commission to pay the costs of the proceedings;

in the alternative, by way of precautionary motion, declare Commission Decision of 24 May 2022 C(2022) 3591 null and void insofar as it orders Member States of the European Union to suspend the national Marketing Authorisations for the medicinal products of the claimants for the medicinal products as referred to in Annex I thereof.

Pleas in law and main arguments

In support of the action, the applicants rely on four pleas in law.

First plea in law, alleging that the requirements of Article 116 of Directive 2001/83/EC of the European Parliament and of the Council ¹ justifying a suspension of the marketing authorisation for hydroxyethyl starch-containing medicinal products are not met. Consequently, the Commission cannot render a decision requiring that Member States will by way of implementing the decision suspend the respective marketing authorisations.

Second plea in law, alleging that the decision of the Commission is infringing the precautionary principle.

Third plea in law, alleging that the suspension of the marketing authorisation of hydroxyethyl starch-containing medicinal products is neither adequate nor proportionate to address the safety concerns resulting from the Drug Utilisation Study. Off-label use should not lead to suspension of in-label use that has well documented beneficial effects, particularly in the absence of any new adverse safety signals.

Fourth plea in law, alleging that the decision is contradictory in itself and, therefore, lacks sufficient reasoning.

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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 2001 L 311, p. 67).