Appeal brought on 25 September 2023 by Giovanni Frajese against the order of the General Court (Fifth Chamber) delivered on 27 July 2023 in Case T-786/22, Frajese v Commission

(Case C-586/23 P)

Language of the case: Italian

Parties

Appellant: Giovanni Frajese (represented by: O. Milanese and A. Montanari, avvocati)

Other party to the proceedings: European Commission

Form of order sought

The appellant claims that the Court should:

uphold the appeal in its entirety;

declare that the order under appeal is null and void on the basis of grounds of appeal I to IV;

in the alternative, set aside the order under appeal on the basis of grounds of appeal I to IV;

in any event, set aside the point of the operative part ordering the appellant to pay the costs on the basis of the same grounds of appeal;

accordingly, uphold the action under Article 263 TFEU brought at first instance.

Grounds of appeal and main arguments

The appellant puts forward four grounds in support of his appeal brought against the order whereby the General Court declared inadmissible his action seeking the annulment, first, of Commission Implementing Decision C(2022)7163 final of 3 October 2022 granting marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for ‘Spikevax – elasomeran’, a medicinal product for human use, and repealing Decision C(2021) 94 final, and, second, of Commission Implementing Decision C(2022) 7342 final of 10 October 2022 granting marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for ‘Comirnaty – tozinameran, COVID-19 mRNA vaccine (nucleoside-modified)’, a medicinal product for human use, and repealing Decision C(2020) 9598 final.

By the first ground of appeal, he alleges that there has been a serious infringement of Article 254 TFEU, Articles 2, 4 and 18 of the Statute of the Court of Justice of the European Union, and of Article 16 of the Rules of Procedure of the General Court. That infringement stems from the lack of independence and impartiality of the Judge-Rapporteur in Case T-786/22, who previously carried out functions for the other party to the proceedings, the European Commission. That lack of independence also constitutes an infringement of Article 47 of the Charter of Fundamental Rights of the European Union and of the first paragraph of Article 6 of the European Convention on Human Rights, as well as a breach of the general principles of law recognised by civilised nations as sources of universally applicable international law, and entails the absolute invalidity of the order under appeal.

By the second ground of appeal, the appellant alleges that there has been an infringement of procedural rules, since the General Court failed to declare out of time and inadmissible the objection of admissibility lodged by the Commission outside the time limit, determined on pain of the challenge being time-barred, which the General Court itself incorrectly assessed and calculated. That infringement invalidates the order dismissing the action, including as regards the appellant’s being ordered to pay the costs.

By the third ground of appeal, the appellant submits that the General Court failed to rule on the pleas and arguments he put forward concerning whether the conditions referred to in the fourth paragraph of Article 263 TFEU were satisfied. The reasoning of the General Court in that regard is incorrect and contradictory and does not relate to the arguments set out in the application. In particular, the General Court did not take into account the particular status of the appellant as a vaccinating physician and his specific interest in bringing proceedings, given that the information contained in the annexes to the implementing decisions is addressed to medical professionals and doctors are practically responsible for the instructions relating to the administration of the product. In so doing, the General Court acted in breach of the fourth paragraph of Article 263 TFEU, in particular as regards the direct and individual effect produced by the decisions at issue, and provided contradictory and incorrect reasoning, including in the light of the Court’s case-law on the matter.

By the fourth ground of appeal, the appellant argues that the General Court’s finding of inadmissibility equates to a denial of the defence, depriving the appellant – and all citizens of the Union – of any effective judicial protection, in breach of the principles laid down in Title VI of the Charter of Fundamental Rights of the European Union and, inter alia, Article 47 thereof.

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