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Document 62022TN0786
Case T-786/22: Action brought on 18 December 2022 — Frajese v Commission
Case T-786/22: Action brought on 18 December 2022 — Frajese v Commission
Case T-786/22: Action brought on 18 December 2022 — Frajese v Commission
OJ C 63, 20.2.2023, p. 58–59
(BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
20.2.2023 |
EN |
Official Journal of the European Union |
C 63/58 |
Action brought on 18 December 2022 — Frajese v Commission
(Case T-786/22)
(2023/C 63/76)
Language of the case: Italian
Parties
Applicant: Giovanni Frajese (Rome, Italy) (represented by: O. Milanese and A. Montanari, lawyers)
Defendant: European Commission
Form of order sought
The applicant claims that the Court should:
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annul
|
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order the defendant to pay the costs of the proceedings. |
Pleas in law and main arguments
In support of the action, the applicant relies on two pleas in law.
1. |
First plea in law, alleging absence of/incompleteness of efficacy and safety studies, in breach of Regulations (EC) 507/2006 (2) and (EC) 726/2004, Directive 2001/83/EC, (3) the Treaties and Community legislation. In that respect, the following is alleged:
|
2. |
Second plea in law, alleging breach of the precautionary principle. In that regard, it is alleged that the contested implementing decisions breach the precautionary principle, as defined in the 1992 Rio Declaration and transposed by the Treaty on the Functioning of the European Union, which applies where a phenomenon, product or process might have potentially dangerous effects and it is not possible to determine the risk with sufficient certainty. The application of those principles in the field of health and pharmaceutical innovation means that, where there is scientific uncertainty giving rise to the possibility of serious and irreversible risk, the choice between use and non-use of that product must necessarily fall on non-use, as the safeguarding of the health of the individual must prevail. |
(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) 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).
(3) 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).