Appeal brought on 2 May 2022 by Debregeas et associés Pharma (D & A Pharma) against the judgment of the General Court (Eighth Chamber) delivered on 2 March 2022 in Case T-556/20 D & A Pharma v Commission and EMA

(Case C-291/22 P)

(2022/C 237/54)

Language of the case: French

Parties

Appellant: Debregeas et associés Pharma (D & A Pharma) (represented by: N. Viguié, E. Gouesse, avocats)

Other parties to the proceedings: European Commission and European Medicines Agency (EMA)

Form of order sought

The appellant claims that the Court should:

— set aside the judgment of the General Court of 2 March 2022 in Case T-556/20, D&A Pharma v Commission and EMA;

— uphold the action and annul the Commission’s Implementing Decision of 6 July 2020, C(2020) 4694 final refusing the application for marketing authorisation for Hopveus — sodium oxybate, a medicinal product for human use, under Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004;

— order the Commission and the EMA to pay the costs.

Grounds of appeal and main arguments

In support of its appeal, the appellant relies on two grounds of appeal.

By its first ground, the appellant claims, in the first place, that the judgment under appeal contains an error of law in that the General Court held that the Committee on Medicinal Products for Human Use (‘CHMP’) has a broad discretion to decide to rely on the permanent Scientific Advisory Group (‘SAG’) or an ad hoc committee, contrary to the last sentence of the fifth subparagraph of Article 62(1) of Regulation (EC) No 726/2004, (1) to Article 11 of the CHMP Rules of Procedure (2) and to Article 6.1 of the guidelines for the re-examination procedure. (3) That error in law is coupled with an incorrect legal characterisation of the facts, since, in the present case and in any event, only the permanent SAG on Psychiatry could legitimately be consulted.

In the second place, the appellant alleges that the General Court erred in its legal characterisation of the facts in holding that the applicant had not demonstrated the influence that consulting the permanent SAG on Psychiatry could have had on the content of the contested decision, even though, first, Hopveus was in a comparable situation to Selincro (that medication having benefitted from the consultation of the permanent SAG on Psychiatry and obtained a marketing authorisation) and, second, the expertise and working method of the permanent SAG on Psychiatry meant that consulting it could have influenced the content of the decision adopted.

By its second ground, the appellant claims that the judgment under appeal, in the first place, contains an error of law as regards the right to good administration, enshrined in Article 41 of the Charter of Fundamental Rights, in that the General Court held that the appellant had not established that the ad hoc committee convened by the CHMP lacked impartiality on the ground that it had not adduced evidence of personal bias or prejudice on the part of individual members, whereas the appellant relied on the ground of objective impartiality, which does not require the demonstration of statements or views that are subjectively impartial.

In the second place, the appellant alleges that the General Court, misrepresented the facts in holding that the two ad hoc committee members concerned would not have had conflicting interests even though their respective situations were capable of establishing objectively justified doubt and consequently a lack of objective impartiality of that ad hoc committee.

(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) Committee for Medicinal Products for Human Use — Rules of Procedure, EMEA/45110/2007.

(3) Committee for Medicinal Products for Human Use, Procedural Advice on the Re-examination of CHMP Opinions, EMEA/CHMP/50745/2005 Rev. 1.