22.11.2021

EN

Official Journal of the European Union

C 471/61

(Case T-632/21)

(2021/C 471/86)

Language of the case: German

Parties

Applicants: Karin Agreiter (Merano, Italy) and 33 other applicants (represented by: R. Holzeisen, lawyer)

Defendant: European Commission

Form of order sought

The applicants claim that the Court should annul the contested implementing decision, as subsequently amended and supplemented.

Pleas in law and main arguments

In support of the action against European Commission Implementing Decision of 23 July 2021 amending the conditional marketing authorisation granted by Decision C(2021) 94(final) for ‘Spikevax — COVID-19 mRNA Vaccine (nucleoside modified)’, a medicinal product for human use, the applicants rely on the following pleas in law.

1.First plea in law, alleging that the contested implementing decision infringes Article 2(1) and (2) of Regulation (EC) No 507/2006. (1) If children become infected with SARS-CoV-2, they are at zero risk and, on that ground alone, there can be no positive risk-benefit balance for healthy children. The use of the experimental substance in question, which is based on genetic engineering, therefore constitutes a serious infringement of EU law. Furthermore, neither the WHO nor the EU has duly recognised an emergency situation in the sense of a public health threat.

2.Second plea in law, alleging that the contested implementing decision infringes Article 4 of Regulation (EC) No 507/2006 due to:

—the absence of a positive risk-benefit balance, as defined in point 28a of Article 1 of Directive 2001/83/EC; (2)

—the failure to meet the requirement under Article 4(1)(b) of Regulation (EC) No 507/2006, since the applicant is not in a position to provide the comprehensive clinical data;

—the failure to meet the requirement under Article 4(1)(c) of Regulation (EC) No 507/2006, since there are no unmet medical needs that will be fulfilled by the authorised medicinal product;

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

3.Third plea in law, alleging infringement of Regulation (EC) No 1394/2007, (3) Directive 2001/83/EC and Regulation (EC) No 726/2004. (4) The contested implementing decision infringes, inter alia, the provisions of EU law on the authorisation of ‘advanced therapy medicinal products’ and on the correct designation of product characteristics and a correct package leaflet. The contested implementing decision is also vitiated by a misuse of power by the Commission concerning the infringement of the child protection rules for clinical trials.

4.Fourth plea in law, alleging serious infringement of Articles 168 and 169 TFEU and Articles 3, 35 and 38 of the EU Charter.

(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).