Order of the General Court (Fifth Chamber) of 27 September 2021 –
CNMSE and Others v Parliament and Council

(Case T‑633/20)

(Action for annulment – Public health – Regulation (EU) 2020/1043 – Conduct of clinical trials with medicinal products for human use containing GMOs – Treatment or prevention of the coronavirus disease SARS-CoV-2 (COVID-19) – Concept of legislative act – Concept of regulatory act – No individual concern – Inadmissibility)

1.      Action for annulment – Natural or legal persons – Regulatory acts entailing implementing measures – Concept – Criteria for assessment

(Art. 263, fourth para., TFEU)

(see para. 18)

2.      Action for annulment – Natural or legal persons – Concept of ‘regulatory act’ within the meaning of the fourth paragraph of Article 263 TFEU – Any measure of general application other than legislative acts

(Art. 263, fourth para., TFEU)

(see para. 20)

3.      Acts of the institutions – Legal nature – Legislative acts and regulatory acts – Distinguishing criteria – Procedure for the adoption of the act

(Art. 289(3) TFEU)

(see paras 21, 22)

4.      Action for annulment – Natural or legal persons – Measures of direct and individual concern to them – Regulation 2020/1043 – Conduct of clinical trials with medicinal products for human use containing GMOs – Treatment or prevention of the coronavirus disease SARS-CoV-2 (COVID-19) – Action by an association whose object is the protection of human health, medical safety and the environment – Applicants not individually concerned – Inadmissibility

(Art. 263, fourth para., TFEU; Charter of Fundamental Rights of the European Union, Art. 47; Regulation of the European Parliament and of the Council 2020/1043, Art. 3; European Parliament and Council Directives 2001/18, Arts 6 to 11 and 13 to 24, and 2009/41, Arts 4 to 13)

(see paras 35-47)

Re:

Application based on Article 263 TFEU seeking annulment of Regulation (EU) 2020/1043 of the European Parliament and of the Council of 15 July 2020 on the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease (COVID-19) (OJ 2020 L 231, p. 12).

Operative part

1. The action is dismissed as inadmissible.

2. There is no longer any need to adjudicate on the applications to intervene submitted by the European Commission and the non-profit-making association ‘Groupe de Réflexion et d’Action Pour une Politique Ecologique’.

3. The Coordination nationale médicale santé – environnement (CNMSE) and the other applicants whose names are listed in the annex shall bear their own costs and those incurred by the European Parliament and the Council of the European Union.

4. The Commission and the non-profit-making association ‘Groupe de Réflexion et d’Action Pour une Politique Ecologique’ shall bear the costs relating to their respective applications to intervene.