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EU General Court bars patient association from challenging medicine authorisation refusal

In Case T‑278/25, the EU General Court recently dismissed as inadmissible a challenge brought by a patient advocacy association against the European Commission’s refusal to renew the conditional marketing authorisation for a treatment against Duchenne muscular dystrophy (DMD). The case is significant because it adds to the case law on contesting Commission decisions relating to the marketing of medicinal products. In this blog post, we look at how the Court came to the conclusion that the association lacked standing to litigate and use this as a basis for an informal categorisation of the existing case law.

Factual background

Translarna® (ataluren) is an orphan medicinal product that received a conditional marketing authorisation (CMA) from the Commission in July 2014. The product was indicated for the treatment of a subset of young patients suffering from DMD. The conditional authorisation was renewed annually by the Commission from 2015 to 2024.

In June 2024, however, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued an unfavourable opinion on the renewal. At the Commission’s request, the CHMP reviewed its opinion, but in October 2024 confirmed its negative assessment. The Commission followed that recommendation and, on 28 March 2025, refused to renew the conditional marketing authorisation for Translarna®.

One day later, Associazione Duchenne Research & Advocacy APS was incorporated in Parma, Italy, as a non-profit association of mothers acting as legal representatives of children suffering from DMD. The association subsequently brought an action for annulment of the Commission’s decision before the General Court.

Patient associations are not admissible as applicants in annulment actions (only as interveners)

As noted above, the action did not proceed on the merits because it was declared inadmissible for lack of standing. The association indeed failed to meet the well-established requirement under Article 263(4) TFEU that an applicant must be directly and individually concerned by the contested act. After recalling its settled case law on this dual requirement, the Court examined its more specific jurisprudence on associations seeking annulment of measures not directly addressed to them. The Court identified three scenarios in which such associations may have standing:

• A legal provision expressly grants associations a series of procedural rights;
• The association represents the interests of its members, who would themselves have standing to bring proceedings; or
• The association is individually concerned owing to the impact on its own interests as an association, in particular because its position as a negotiator is affected by the contested act.

 The Court found that none of these three scenarios applied. Nor was it persuaded by the association’s reliance on Case T‑455/24 (Advanz Pharma v Commission), in which a patient association was permitted to intervene in ongoing annulment proceedings. The Court reminded the applicant that the question whether an entity has an interest in the outcome of proceedings — on which the admissibility of an intervention request depends — is distinct from the question of standing as an applicant under Article 263(4) TFEU.

Informal categorisation of existing case law

The Court’s ruling offers a useful opportunity to examine the broader case law on challenges to Commission decisions concerning the marketing of medicinal products in the EU. A wide range of scenarios can arise, many of which have already been tested in practice. The overview below provides a non-exhaustive categorisation of cases, illustrating actions brought by different types of applicant against various Commission decisions, with differing outcomes on both standing and the merits. A key observation is that applicants with a clear economic interest in the outcome are more likely to have standing, whereas actors external to the Commission’s decision and the procedure leading to its adoption are unlikely to do so.

1. The MA applicant/holder challenging the refusal or revocation of its MA(A)

The first category of cases is the most straightforward in terms of standing: a company challenges a decision that adversely affects its marketing authorisation or application (for example, a refusal to grant or a revocation). As the addressee of the decision, the company plainly has standing. Examples include Case T-594/18, Pharma Mar v Commission (refusal of an MAA) and Case T-1182/23, Neuraxpharm Pharmaceuticals v Commission (revocation of an MA). A more ‘exotic’ example is Case T-329/16, Bristol-Myers Squibb Pharma v Commission and EMA, in which the applicant sought annulment of the Commission’s withdrawal of the orphan designation for its product.

2. The MA holder challenging an alteration of its MA

Other regulatory decisions are more subtle. Rather than refusing an application or revoking an authorisation, they alter an authorisation in a way that harms the marketing authorisation holder. For example, in the clopidogrel case (T-539/10 and C-269/13 P), the MAH challenged the suspension of marketing of medicinal products containing clopidogrel manufactured at a specific Indian site, the withdrawal of certain batches from the market, and the subsequent modifications to its marketing authorisations. Similarly, in Case T-483/22, Sanofi sought the partial annulment of a Commission decision granting it a marketing authorisation, in so far as the decision implicitly determined that the active substance was not “new” and stated that the product should not be classified as an orphan medicinal product – thereby denying the company ten years of orphan market exclusivity.

3. Challenging a decision addressed to a competitor

A growing body of case law involves applicants challenging decisions addressed not to themselves but to a competitor. This typically arises where a company considers a decision to be unlawful and detrimental to its own commercial interests.

The Tecfidera® litigation provides a textbook example. From the generics’ side, several companies contested the modification of Biogen’s MA for Tecfidera®, which effectively granted Biogen an additional year of market protection (e.g. Cases T-256/23, T-257/23, T-258/23, and T-351/23). From the originator’s side, Biogen had earlier brought annulment actions (e.g. Cases T‑269/22, T‑278/22, and T‑279/22) against Commission decisions granting MAs to generics of Tecfidera®.

Another example is Laboratoires CTRS v Commission (Case T-452/14), in which the holder of an existing orphan MA challenged a Commission decision granting an authorisation to a competitor’s product, on the ground that it allegedly infringed the holder’s orphan market exclusivity.

4. Challenges brought by private individuals

Private individuals have, on several occasions, tried to challenge Commission decisions granting MAs, often in the context of COVID-19 vaccine authorisations. These have been consistently declared inadmissible for lack of direct and individual concern. Examples include Amort and Others v Commission (e.g. Cases T-136/21, T-165/21 and T-267/21) and UY v Commission (Cases T-109/23 and T-108/23).

5. Challenge brought by a patient association

With its ruling in the above-discussed Case T‑278/25, the General Court has added another informal category to the mix, as the question of the standing of a patient advocacy association had not previously been addressed. While the outcome was not surprising, the decision nonetheless provides further clarity on which actors are likely to have standing to challenge Commission decisions relating to the marketing of medicinal products.

Conclusion

The General Court’s decision in Case T‑278/25 reinforces its restrictive approach to standing under Article 263(4) TFEU. Viewed within the wider case law, the ruling underscores that, while market participants with a concrete economic stake can generally access judicial review, actors representing diffuse or collective interests remain largely excluded. For patient associations in particular, the practical implication is that their influence will continue to be exercised primarily through participation in administrative procedures or as interveners, rather than as direct challengers of Commission decisions.

Written by: Bart Junior Bollen