Appeal brought on 25 February by Debrégeas et associés Pharma (D & A Pharma) against the order of the General Court (Eighth Chamber) delivered on 22 December 2021 in Case T-381/21, Debrégeas & associés Pharma v EMA

(Case C-136/22 P)

Language of the case: French

Parties

Appellant: Debregeas et associés Pharma (D & A Pharma) (represented by: N. Viguié, avocat, D. Krzich, avocate)

Other party to the proceedings: European Medicines Agency

Form of order sought

The applicant claims that the Court should

annul the order of the General Court (Eighth Chamber) of 22 December 2021 in Case T-381/21 Debrégeas & Associés Pharma v EMA;

Accordingly

refer the case back to the General Court of the European Union for the EMA to adduce its observations on the substance and for the General Court to rule on the substance.

If the Court were to hold that the case file was ready and to decide not to refer that case file back to the General Court

grant the forms of order sought by the applicant at first instance.

annul the decision by which the European Medicines Agency (EMA) abolished the ‘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;

In any event,

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

Pleas in law and main arguments

By its first ground of appeal, the applicant maintains that the General Court was not entitled to find, without committing an error of law, compounded by a manifest error of assessment, that D & A would have no legal interest in bringing proceedings in respect of the contested decision, on the ground that any annulment of the contested decision would procure it no advantage, whereas the failure to have due regard to D & A’s situation and in particular its procedural rights is already certain, as is the benefit it would derive from the contested decision being annulled, to the extent that:

D & A brought an action against the decision of 6 July 2020 which rejected its application for a marketing authorisation on the grounds, in particular, of the irregularity of the procedure which led to the decision of the CHMP on account of the failure to consult the SAG on Psychiatry during the review procedure (Req. No T-556-20);

The abolition of the SAG on Psychiatry deprives D & A of a procedural guarantee as an applicant for a marketing authorisation for a psychiatric medicine.

By its second ground of appeal, the applicant argues that the General Court was not entitled to find, without committing an error of law, compounded by a manifest error of assessment, that D & A’s legal interest in bringing proceedings is not present and certain, but only future and hypothetical, whereas D & A brought an action against the decision of 6 July 2020 which rejected its application for marketing authorisation on the grounds, in particular, of the irregularity of the procedure which led to the decision of the CHMP on account of the failure to consult the SAG on Psychiatry during the review procedure (Req. No T-556-20).

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