5.7.2021

EN

Official Journal of the European Union

C 263/32

(Case T-267/21)

(2021/C 263/43)

Language of the case: German

Parties

Applicant: Heidi Amort (Jenesien, Italy) and 22 other applicants (represented by: R. Holzeisen, lawyer)

Defendant: European Commission

Form of order sought

The applicant claims that the Court should annul the contested implementing decision as amended and supplemented.

Pleas in law and main arguments

The action against Commission Implementing Decision (C(2021) 1763 final) of 11 March 2021 granting a conditional marketing authorisation under Regulation (EC) No 746/2004 of the European Parliament and of the Council relating to the medicinal product for human use ‘COVID-10 Vaccine Janssen — COVID-19 Vaccine (Ad26.COV2-S [recombinant])’ is based on the following pleas in law.

1.First plea in law: the contested implementing decision infringes Article 2(1) and (2) of Regulation (EC) No 507/2006. (1) It has been scientifically proven that the worldwide panic resulting from the high mortality rate allegedly associated with the SARS-CoV-2 infection is unfounded. In addition, the WHO and the EU should not have duly recognised the emergency situation as a public health threat.

2.Second plea in law: the contested implementing decision infringes Article 4 of Regulation (EC) No 507/2006 on account of:

—the absence of a positive risk-benefit balance under Article 1(28a) of Directive 2001/83/EC; (2)

—the absence of the requirement under Article 4(1)(b) of Regulation (EC) No 507/2006, as it is unlikely that the applicant will be in a position to provide the comprehensive clinical data;

—the absence of the requirement under Article 4(1)(c) of Regulation (EC) No 507/2006, as there is no medical need that can be met by the authorised medication;

—the absence of the requirement under Article 4(1)(d) of Regulation (EC) No 507/2006.

3.Third plea in law: infringement of Regulation (EC) No 1394/2007, (3) of Directive 2001/83/EC and of Regulation (EC) No 726/2004. (4)

4.Fourth plea in law: serious infringement of Articles 168 and 169 TFEU and of Articles 3, 35 and 38 of the Charter of Fundamental Rights of the European Union.

(1) Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ 2006 L 92, p. 6).

(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)

(3) Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ 2007 L 324, p. 121).

(4) 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).