EU Court of Justice Clarifies Strict Standing Requirement for Challenging Regulatory Decisions

On 10 September 2026, the Court of Justice of the European Union (Eighth Chamber) delivered its judgment in Case C-467/25 P, Debrégeas et associés Pharma (D & A Pharma) v European Medicines Agency (EMA). The judgment clarifies that an EMA refusal to backtrack on historical scientific opinions or alter its online public records does not necessarily constitute a new, challengeable legal act unless it directly alters the applicant's existing legal position.

Facts

D & A Pharma sought marketing authorisation for Alcover granules (containing sodium oxybate for alcohol dependence) in 12 EU Member States via the decentralised procedure in 2014. Disagreement among national authorities led to referral to the European Medicines Agency (EMA), whose Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion in 2017. The European Commission then refused authorisation, and D & A Pharma did not challenge this decision, making it final.

Subsequently, D & A Pharma applied for conditional marketing authorisation for the same product, renamed Hopveus, through the centralised procedure. This application was also rejected. The General Court initially dismissed D & A Pharma’s challenge to the Hopveus decision, but in March 2024, the Court of Justice of the European Union (CJEU) set aside that judgment, finding procedural irregularities: the scientific opinion was prepared by an ad hoc group rather than EMA’s standing Scientific Advisory Group on Psychiatry, and the group’s composition lacked impartiality.

Following the CJEU judgment, D & A Pharma requested EMA to withdraw the earlier CHMP opinion on Alcover, update its website, and publish related correspondence, citing similar procedural defects. EMA refused, stating the Commission’s decision was final, and the CJEU judgment did not apply to the Alcover opinion. D & A Pharma challenged this refusal before the General Court, which dismissed the action as inadmissible, finding no personal interest since the Commission’s decision was definitive and withdrawal of the opinion would not affect D & A Pharma’s legal situation or authorisation status. D & A Pharma appealed to the CJEU.

Court of Justice’s rulings

The CJEU upheld the General Court’s decision, finding that D & A Pharma had not demonstrated a direct and present interest in the annulment of the EMA’s refusal. The Court emphasised that, under Article 263 TFEU, an applicant must show a vested, present, and personal interest in the annulment of a contested act, not merely a hypothetical or future harm. D & A Pharma’s arguments that the continued publication of the CHMP opinion on Alcover damaged its reputation or commercial interests were either not raised before the General Court or were too speculative. The possibility that the opinion could be used in future regulatory proceedings was deemed insufficient to establish standing.

The CJEU also noted that, following its earlier judgment in the Hopveus case, the EMA is already obliged under Article 266 TFEU to avoid repeating the procedural irregularities previously identified. Therefore, the CHMP’s opinion on Alcover cannot be reused in future proceedings, regardless of whether it is formally withdrawn. The Court found no error of law in the General Court’s assessment that the situation was hypothetical and that the actions sought by D & A Pharma would not alter its legal situation or confer any tangible advantage.

Furthermore, the Court disregarded facts and agreements arising after the General Court’s order, as appeals are limited to the legal situation as it stood at the time of the contested decision.

Practical effects of the rulings

• EMA refusals to retract historical scientific opinions or alter public records do not constitute new, challengeable legal acts unless they directly affect the applicant’s legal position.
• The existence or publication of a regulatory opinion does not, by itself, confer standing to challenge it unless a concrete adverse effect is demonstrated.
• EMA must comply with CJEU judgments and avoid relying on opinions tainted by procedural defects, regardless of formal retraction.
• Appeals in EU courts are procedurally disciplined: new arguments or facts not raised before the General Court at first instance cannot be introduced on appeal before the Court of Justice.

Key takeaways

• Final decisions stay final: A party that did not challenge an underlying Commission decision is unlikely to get a second chance to court by asking EMA to retract the CHMP opinion behind it.
• Article 266 TFEU limits reuse anyway: Where a judgment finds expert consultation or impartiality defects, EMA’s duty to comply means an opinion with the same defects should not be relied on again. That duty does not depend on formal retraction.