Official Journal of the European Union

EN

C series

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C/2024/5426

16.9.2024

(Case T-373/24)

(C/2024/5426)

Language of the case: French

Parties

Applicant: Debrégeas et associés Pharma (D&A Pharma) (Houdan, France) (represented by: N. Viguié, E. Gouesse and V. Durget, lawyers)

Defendant: European Medicines Agency

Form of order sought

The applicant claims that the Court should:

—annul Decision EMA/174715/2024 of the European Medicines Agency (EMA) of 13 May 2024 refusing the request for retraction of the scientific opinion of the Committee for Medicinal Products for Human Use (CHMP) of 12 October 2017 concerning Alcover granules, for an update on the EMA’s website relating to that matter and for publication of D&A Pharma’s correspondence of 30 January and 12 April 2024;

—order the EMA to pay the costs of the present proceedings.

Pleas in law and main arguments

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

1.First plea in law, alleging an irregularity in the procedure at the end of which the decision was adopted in breach of Article 62(2) of Regulation No 726/2004. (1) The applicant submits that, in the absence of any delegation of power from the Executive Director of the EMA to the signatory of the contested decision, that decision was adopted by an authority which lacked competence to bind the EMA legitimately and to take the decision refusing to retract the CHMP opinion. Moreover, the applicant maintains that the contested decision was not adopted following a procedure consistent with the framework laid down by EMA Policy 72 and its implementing legislation. Lastly, it argues that the involvement of the signatory of the contested decision in the adoption of the opinion delivered by the EMA in 2020 on the same proprietary medicinal product, whereas the Court of Justice annulled the decision refusing a marketing authorisation following that opinion by reason of procedural irregularities, is in breach of the principle of impartiality guaranteed by Article 41 of the Charter of Fundamental Rights of the European Union.

2.Second plea in law, alleging that the EMA made an error of law and a manifest error of assessment relating to the applicant’s requests by incorrectly invoking against it the two-month time limit for bringing proceedings laid down in the sixth paragraph of Article 263 TFEU, which is inapplicable to the request for retraction of a scientific opinion.

3.Third plea in law, alleging that, by refusing to retract the CHMP opinion concerning Alcover granules, which is manifestly vitiated by unlawfulness, on the sole ground that the time limit for challenging the final Commission decision had expired, the EMA also vitiated its decision by an error of law and a manifest error of assessment having regard to the provisions of EMA Policy 1. The applicant submits that, in the present case, the impartiality and integrity of the CHMP during the assessment procedure relating to Alcover granules were undermined due to the consultation of an ad hoc expert instead of the Scientific Advisory Group on Psychiatry, conflicts of interest affecting its members (inter alia its chair) and the lack of an expert on biostatistics, and that all those factors resulted in an incorrect scientific assessment of that medicinal product in respect of which authorisation was sought. It maintains that those factors constitute serious infringements of Regulation No 726/2004, the CHMP’s rules of procedure, Directive 2001/83/EC (2) and EMA Policy 72.

(1) 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).

(2) 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/2024/5426/oj

ISSN 1977-091X (electronic edition)

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