Official Journal of the European Union

C series

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C/2025/3312

24.6.2025

(Case T-278/25)

(C/2025/3312)

Language of the case: Italian

Parties

Applicant: Associazione Duchenne Research & Advocacy APS (Parma, Italy) (represented by: V. Salvatore and G. Ragucci, avvocati)

Defendant: European Commission

Form of order sought

The applicant claims that the Court should:

—annul Commission Decision C(2025) 2025 final of 28 March 2025 refusing the renewal of the conditional marketing authorisation for the medicinal product for human use ‘Translarna – ataluren’, granted by Commission Decision C(2014)5619 final, and all other acts which are conditional upon, stem from or are related to that decision, including the acts of which the applicant is unaware, as manifestly lacking any foundation in fact and in law.

Pleas in law and main arguments

In support of the action, the applicant relies on four pleas in law.

1.First plea in law, alleging infringement of the Treaties or any rule of law relating to their application, with particular reference to the inadequate statement of reasons for Decision C(2025) 2025. The applicant alleges, in particular, infringement of the principle of good administration by the Commission and, as such, a failure, by the Commission, to state in detail the reasons underlying the decision refusing to renew the conditional marketing authorisation for Translarna, in infringement of Article 81(1) of Regulation (EC) No 726/2004. (<span class="oj-super oj-note-tag">1</span>)

2.Second plea in law, alleging misuse of powers in relation to the inadequate statement of reasons for Decision C(2025) 2025. The Commission did not carry out any risk-management assessment as to the impact of the decision adopted, thereby failing in the duty inherent to its executive functions, in breach of the precautionary principle, by not taking into account the consequences of the non-renewal of the authorisation for the medicine on patients suffering from Duchenne muscular dystrophy (nonsense mutation).

3.Third plea in law, alleging infringement of the Treaties or any rule of law relating to their application, with specific reference to the statement of reasons set out in Decision C(2025) 2025 in view of the defects affecting the legality of the acts on which it is based and, in particular, the opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on 17 October 2024. The opinion – in which the CHMP recommends that the conditional marketing authorisation should not be renewed, given the negative risk-benefit balance – must be regarded as (i) lacking scientific basis; (ii) insufficient in its assessment of the data available, known to and recognised by the scientific community, and (iii) lacking internal coherence and a proper statement of reasons.

4.Fourth plea in law, alleging misuse of powers regarding the reference to exceptional measures in Decision C(2025) 2025 and, in particular, to Article 117(3) and Article 5(1) of Directive 2001/83/EC. (<span class="oj-super oj-note-tag">2</span>) The exceptional measures referred to are not appropriate to mitigate the adverse impact and damage to patients’ health resulting from the effects of the contested decision. By contrast, the explicit reference to them demonstrates implicit recognition by the Commission of the harm caused to patients by the non-renewal of the conditional marketing authorisation for the medicine.

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Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ 2004 L 136, p.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).

ELI: http://data.europa.eu/eli/C/2025/3312/oj

ISSN 1977-091X (electronic edition)

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