Case T-416/22: Judgment of the General Court of 15 May 2024 – Fresenius Kabi Austria and Others v Commission (Medicinal products for human use – Suspension of national marketing authorisations for medicinal products for human use containing the active substance hydroxyethyl starch (HES), solutions for infusion – Action for annulment – Direct concern – Partial inadmissibility – Obligation to state reasons – Error of law – Manifest error of assessment – Precautionary principle – Proportionality – Article 116 of Directive 2001/83/EC)
Date: 2024-05-15
Institutions: General Court
Subjects: EU Member State, drug surveillance, market approval, medicinal product, precautionary principle, principle of proportionality, starch








C_202404085EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2024/4085


8.7.2024






Judgment of the General Court of 15 May 2024 – Fresenius Kabi Austria and Others v Commission


(Case T-416/22)
                (1)

(Medicinal products for human use - Suspension of national marketing authorisations for medicinal products for human use containing the active substance hydroxyethyl starch (HES), solutions for infusion - Action for annulment - Direct concern - Partial inadmissibility - Obligation to state reasons - Error of law - Manifest error of assessment - Precautionary principle - Proportionality - Article 116 of Directive 2001/83/EC)
(C/2024/4085)
Language of the case: English

Parties


Applicants: Fresenius Kabi Austria GmbH (Graz, Austria) and the 14 other applicants whose names appear in the annex to the judgment (represented by: W. Rehmann and A. Knierim, lawyers)

Defendant: European Commission (represented by: M. Escobar Gómez and A. Sipos, acting as Agents)

Interveners in support of the defendant: Ireland (represented by: A. Joyce, M. Tierney, M. Browne and D. O’Reilly, acting as Agents, and by P. McCann, Senior Counsel, and E. O’Callaghan, Barrister-at-Law), European Medicines Agency (represented by: S. Marino, S. Drosos and M. van Egmond, acting as Agents)

Re:

By their action based on Article 263 TFEU, the applicants essentially seek annulment of Commission Implementing Decision C(2022) 3591 final of 24 May 2022 concerning, in the framework of Article 107p of Directive 2001/83/EC of the European Parliament and of the Council, the marketing authorisations of medicinal products for human use which contain the active substance ‘hydroxyethyl starch (HES), solutions for infusion’ following an assessment of a post authorisation safety study (‘the contested decision’), in that it requires the Member States concerned to suspend the national marketing authorisations (‘MAs’) for the medicinal products referred to in Annex I thereto.

Operative part of the judgment

The Court:






1.


Dismisses the action;










2.


Orders Fresenius Kabi Austria GmbH and the other applicants listed in the annex to bear their own costs and pay those incurred by the European Commission, including those relating to the interlocutory proceedings;










3.


Orders Ireland and the European Medicines Agency (EMA) to bear their own costs.






(1)  
            OJ C 340, 5.9.2022.


ELI: http://data.europa.eu/eli/C/2024/4085/oj
ISSN 1977-091X (electronic edition)