16.8.2021

EN

Official Journal of the European Union

C 329/43

(Case T-381/21)

(2021/C 329/57)

Language of the case: French

Parties

Applicant: Debregeas et associés Pharma (D&A Pharma) (Paris, France) (represented by: N. Viguié and D. Krzisch, lawyers)

Defendant: European Medicines Agency

Form of order sought

The applicant claims that the Court should:

—annul the decision by which the European Medicines Agency (EMA) abolished the scientific advisory group ‘Scientific Advisory Group on Psychiatry’ of the Committee for Medicinal Products for Human Use (CHMP), as revealed by the public call for expression of interest for experts to become members of the EMA’s scientific advisory groups (SAGs) of 5 May 2021 and the EMA press release of 5 May 2021;

—order the EMA to pay the costs of the 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 infringement of the principle of equality between candidates for a marketing authorisation, of the principle of consistency in the opinions of the institutions, and of the provisions of Article 56(2) of Regulation No 726/2004. (1) The applicant adds that the abolition of the scientific advisory group ‘Scientific Advisory Group on Psychiatry’ is unlawful, more generally, on the ground that it denies candidates for a marketing authorisation a guarantee of consistency in the opinions expressed in the specific therapeutic field of psychiatry, but also in that it is liable to lead to inconsistencies and unequal treatment of candidates for a marketing authorisation in the context of the re-examination procedure provided for in Article 9 of Regulation No 726/2004, which may be requested by the candidate for a marketing authorisation should the opinion of the Committee for Medicinal Products for Human Use (‘CHMP’) be unfavourable in the initial procedure.

2.Second plea in law, alleging infringement of the principle of impartiality which must guide the marketing authorisation application procedures before the EMA and of Article 56(2) of Regulation No 726/2004. The applicant claims in that regard that the abolition of the above scientific advisory group necessarily creates, for a candidate for a marketing authorisation in the field of psychiatric medicines who has requested a re-examination procedure, a legitimate doubt as to the impartiality of that procedure, in so far as the members of ad hoc expert groups are selected by the CHMP on the occasion of the re-examination and for each candidate.

3.Third plea in law, raising a plea of illegality in respect of Article 56(2) of Regulation No 726/2004, should the Court find that that article authorises the CHMP of the EMA to institute and to abolish, at its discretion, scientific advisory groups, in that this goes against the principles of equality, impartiality and consistency.

*

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).