The GCEU denies standing to a patients’ association

On 12 January 2026, the Tenth Chamber of the General Court of the European Union (GCEU) delivered an order in Case T-278/25, Associazione Duchenne Research & Advocacy APS v Commission, declaring inadmissible the action for annulment brought against the European Commission’s Implementing Decision C(2025) 2025 final of 28 March 2025. That decision refused to renew the conditional marketing authorisation for the orphan medicinal product Translarna – Ataluren (hereinafter 'Translarna'), intended for the treatment of certain patients with Duchenne muscular dystrophy.

Translarna was granted conditional marketing authorisation in July 2014 and was renewed annually between 2015 and 2024. However, in June 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency issued an unfavourable opinion, finding that the medicine’s efficacy had not been demonstrated and that its risk-benefit balance was not favourable. After reviewing additional data at the Commission’s request, the Committee reiterated its negative opinion in October 2024.

The applicant association was established in Parma (Italy) on 29 March 2025, one day after the adoption of the contested decision, as a non-profit organisation comprising mothers who are the legal representatives of their children affected by Duchenne muscular dystrophy. On 30 April 2025, the association brought an action for annulment of the decision refusing to renew the marketing authorisation for the medicinal product, pursuant to Article 263 of the Treaty on the Functioning of the European Union (hereinafter 'TFEU'), claiming that it was directly and individually affected by the decision. The Commission, for its part, raised a plea of inadmissibility of the action for annulment based on the appellant association’s lack of standing and lack of interest in bringing the action.

The General Court focuses its analysis on determining whether the appellant association was directly and individually affected by the contested decision, in accordance with Article 263 TFEU. The decision was not addressed to it, nor does it constitute a regulatory act, as it lacks general and abstract scope: its sole purpose is to authorise or refuse to authorise the manufacturer to place the medicinal product on the market.

The Court points out that case-law recognises the standing of associations to bring proceedings in only three circumstances: (i) where a provision expressly grants them procedural powers; (ii) where the association acts on behalf of members who, individually, would have standing to bring an action; or (iii) where the association itself is affected in its capacity as such, in particular because its negotiating position in the proceedings leading to the contested act has been prejudiced.

In the case under consideration, the Court ruled out the applicability of all three scenarios. Firstly, the association was established after the contested decision had been adopted; consequently, it could not participate in the administrative proceedings nor benefit from any procedural rights. Secondly, it did not demonstrate that its individual members had standing to bring an appeal, as they are no different from the wider group of parents whose children suffer from the same illness. Thirdly, the association played no negotiating role in the proceedings, in which only the laboratory holding the authorisation and the Commission were involved.

The General Court further clarifies that the recognition of an association’s interest in intervening in ongoing proceedings is subject to a different standard from that required to establish standing as an applicant. It also points out that the right to effective judicial protection cannot be used to circumvent the admissibility requirements laid down in Article 263 TFEU.

Consequently, the General Court declared the action inadmissible.

This ruling is relevant for patients’ associations and organisations representing collective interests that are considering challenging European Commission decisions on the authorisation of medicinal products. The order confirms that merely representing the general interests of a group of affected persons is not sufficient to establish the standing required by Article 263 TFEU.

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