# C_2023063EN.01005801.xml

| 20.2.2023 | EN | Official Journal of the European Union | C 63/58 |
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20.2.2023

EN

Official Journal of the European Union

C 63/58

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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:

| — | annul






  (1) | Commission Implementing Decision of 3 October 2022 granting marketing authorisation under Regulation (EC) No 726/2004 (1) of the European Parliament and of the Council for ‘Spikevax — elasomeran’, a medicinal product for human use and repealing Decision C(2021) 94(final), published in the Official Journal of the European Union on 30 November 2022; and |
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annul

(1)

Commission Implementing Decision of 3 October 2022 granting marketing authorisation under Regulation (EC) No 726/2004 (1) of the European Parliament and of the Council for ‘Spikevax — elasomeran’, a medicinal product for human use and repealing Decision C(2021) 94(final), published in the Official Journal of the European Union on 30 November 2022; and

| (2) | Commission Implementing Decision 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), published in the Official Journal of the European Union on 30 November 2022; |
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(2)

Commission Implementing Decision 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), published in the Official Journal of the European Union on 30 November 2022;

| — | order the defendant to pay the costs of the proceedings. |
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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:






  — | Absence of/incompleteness of studies. The obligations imposed with the granting of conditional authorisations have not been complied with and the placebo-controlled, randomised, observer-blind clinical trials were never completed. The annexes to the contested implementing decisions expressly refer to the absence of studies considered to be essential and mandatory by Regulations No 726/2004 and No 507/2006 and Directive 2001/83/EC for the purpose of granting the AIC standard. The authorised pharmaceuticals contain excipients (ALC-0315, ALC-0159 and SM-102) whose use is permitted exclusively for the purposes of research with the express prohibition for human or veterinary use. The safety of the technology used has been neither shown nor tested and the related pharmaco-toxicological aspects have not been studied. |
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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:

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Absence of/incompleteness of studies. The obligations imposed with the granting of conditional authorisations have not been complied with and the placebo-controlled, randomised, observer-blind clinical trials were never completed. The annexes to the contested implementing decisions expressly refer to the absence of studies considered to be essential and mandatory by Regulations No 726/2004 and No 507/2006 and Directive 2001/83/EC for the purpose of granting the AIC standard. The authorised pharmaceuticals contain excipients (ALC-0315, ALC-0159 and SM-102) whose use is permitted exclusively for the purposes of research with the express prohibition for human or veterinary use. The safety of the technology used has been neither shown nor tested and the related pharmaco-toxicological aspects have not been studied.

| — | Failure to complete studies or expected completion of studies as compared to the originally planned schedules. During those two years, it has been found that the authorised pharmaceuticals have neither a sterilizing effect nor an ability to reduce the serious effects of the illness. It appears that it is no longer possible to provide such proof, in the light of the fact that the placebo groups have been vaccinated, thus eliminating the control groups. The safety of the authorised pharmaceuticals is also lacking, as shown by the countless published studies and the pharmacovigilance data themselves, linked to the steep increase in mortality recorded in all EU and non-EU countries in which there was an intensive vaccination campaign, as expressly stated and alleged in the action. |
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Failure to complete studies or expected completion of studies as compared to the originally planned schedules. During those two years, it has been found that the authorised pharmaceuticals have neither a sterilizing effect nor an ability to reduce the serious effects of the illness. It appears that it is no longer possible to provide such proof, in the light of the fact that the placebo groups have been vaccinated, thus eliminating the control groups. The safety of the authorised pharmaceuticals is also lacking, as shown by the countless published studies and the pharmacovigilance data themselves, linked to the steep increase in mortality recorded in all EU and non-EU countries in which there was an intensive vaccination campaign, as expressly stated and alleged in the action.

| — | Absence of any conversion request on the part of the companies. The authorisations were converted into a standard authorisation solely on account of the ‘data submitted’ and in the absence of a specific application for conversion on the part of the pharmaceutical companies, in clear breach of the procedure. |
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Absence of any conversion request on the part of the companies. The authorisations were converted into a standard authorisation solely on account of the ‘data submitted’ and in the absence of a specific application for conversion on the part of the pharmaceutical companies, in clear breach of the procedure.

| — | Absence of a full opinion of the Committee. |
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Absence of a full opinion of the Committee.

| — | Absence of communication to the States, in breach of Article 10 of Regulation (EU) 726/2004. |
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Absence of communication to the States, in breach of Article 10 of Regulation (EU) 726/2004.

| 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. |
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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.

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(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).

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