Official Journal of the European Union

C series

—

C/2024/4485

22.7.2024

(Case T-290/24)

(C/2024/4485)

Language of the case: French

Parties

Applicants: Fresenius Kabi AG (Bad Homburg, Germany), Fresenius Vial (Brézins, France) (represented by: F. Destal, lawyer)

Defendant: European Commission

Form of order sought

The applicants claim that the Court should:

—annul the implied decision of the European Commission of 24 March 2024 considering the decision of the French Agence nationale de sécurité du médicament et des produits de santé, dated 10 July 2023, setting specific conditions for Exelia infusion systems manufactured by the company Fresenius and suspending the advertising of those systems until they have been brought into compliance, to be justified;

—consequently, annul the Commission decision of 16 April 2024 confirming the implied decision of 24 March 2024;

—order the Commission to pay the costs.

Pleas in law and main arguments

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

1.First plea in law, alleging infringement of the obligation to state reasons provided for in the second paragraph of Article 296 TFEU and of Article 41 of the Charter of Fundamental Rights of the European Union (‘the Charter’). The applicants submit that the European Commission did not state the reasons for its decision and failed to provide any information to Fresenius regarding the reasons which led it to consider the decision of the French Agence nationale de sécurité du médicament et des produits de santé (National Agency for the Safety of Medicinal Products and Health Products; ‘the ANSM’) to be justified.

2.Second plea in law, alleging infringement of Fresenius’s rights of the defence as provided for in Article 48(2) of the Charter and of the right to good administration under Article 41 of that charter. The applicants submit, first of all, that Fresenius did not have access to all the documents on which the Commission was able to rely. Next, they maintain that, prior to the Commission decision and to the conclusion of the Commission’s evaluation which resulted in the health surveillance decision adopted on 10 July 2023 by the ANSM being considered to be justified, Fresenius was unable effectively to make known its views on the evidence adduced against it.

3.Third plea in law, alleging infringement of Article 96(1) and (2) of Regulation 2017/745 (1) on account of the lack of evaluation, or inadequate evaluation, carried out by the Commission. According to the applicants, the Commission cannot be considered to have carried out an adequate evaluation of the ANSM’s health surveillance decision.

4.Fourth plea in law, alleging failure to take into account the objection raised by one of the Member States under Article 95(6) and (7) of Regulation 2017/745, on the ground that the Commission did not take account of the disagreement expressed by one of the Member States.

5.Fifth plea in law, alleging that the notification by the ANSM to the Commission under Article 95(4) and (5) of Regulation 2017/745 was insufficient, on the ground that the ANSM did not communicate all the relevant data to the Commission.

6.Sixth plea in law, alleging that the facts and data on which the health surveillance decision is based are incorrect. The applicants submit that it is factually incorrect to claim, first, that any deficiencies in the functioning of the Exelia infusion system are liable to give rise to serious ‘or even fatal’ consequences for the safety of patients and, second, that the number and range of deficiencies in functioning had increased, despite the introduction (at that time) of the software version 1.1.G.

7.Seventh plea in law, alleging that the Commission erred in law by infringing Article 95 of Regulation 2017/745 in respect of the method for evaluating the unacceptable risk to health and safety, on the ground that the Commission did not, when evaluating the risk, take account of the benefits associated with the Exelia system.

8.Eighth plea in law, alleging that the Commission made an error of assessment as regards the absence of an unacceptable risk to health and safety under Article 95 of Regulation 2017/745. First, the applicants submit that any deficiencies in the functioning of the Exelia system cannot, in any event, result in harm to the patient in the light of the safety feature put in place. Next, they allege that no unacceptable risk can be established since the incidents reported up to that point were insignificant and, moreover, complaints in that regard have decreased. Lastly, they argue that consideration of the benefits associated with the Exelia system should have led the Commission to conclude that that medical device did not present an unacceptable risk to health and safety.

(1) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.

ELI: http://data.europa.eu/eli/C/2024/4485/oj

ISSN 1977-091X (electronic edition)

—