# C_2023024EN.01004201.xml

| 23.1.2023 | EN | Official Journal of the European Union | C 24/42 |
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23.1.2023

EN

Official Journal of the European Union

C 24/42

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Action brought on 7 October 2022 — SD v EMA

(Case T-623/22)

(2023/C 24/58)

Language of the case: German

Parties

Applicant: SD (represented by: A. Steindl, lawyer)

Defendant: European Medicines Agency (EMA)

Form of order sought

The applicant claims that the Court should:

| — | Annul the decision of the EMA of 21 July 2022 (EMA/254928/2022) by which the applicant’s appeal of 4 May 2022 against the decision of the EMA of 8 April 2022 (EMA/191392/2022) was dismissed; |
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Annul the decision of the EMA of 21 July 2022 (EMA/254928/2022) by which the applicant’s appeal of 4 May 2022 against the decision of the EMA of 8 April 2022 (EMA/191392/2022) was dismissed;

| — | If the applicant is successful, order the EMA to pay the costs and expenses incurred or yet to be incurred by the applicant and, if the applicant is unsuccessful, order the EMA to bear its own costs on the equitable grounds under Article 135(1) of the Rules of Procedure of the General Court. |
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If the applicant is successful, order the EMA to pay the costs and expenses incurred or yet to be incurred by the applicant and, if the applicant is unsuccessful, order the EMA to bear its own costs on the equitable grounds under Article 135(1) of the Rules of Procedure of the General Court.

Pleas in law and main arguments

The action is directed against the decision of the EMA of 21 July 2022 (EMA/254928/2022), by which the applicant was denied full access to three documents. It is alleged that those documents concern ‘specific obligation No. 1(a)’ (‘SO1a’) as part of the obligations relating to Comirnaty specifically provided for in Commission Implementing Decision C(2020) 9598 final of 21 December 2020. (1) In support of the action, the applicant relies on the following pleas in law.

| 1. | First plea in law, alleging that the contested decision infringes, either entirely or at least in part, the first indent of Article 4(2) of Regulation No 1049/2001 (2) as regards the protection of commercial interests
  The redactions infringe additional, parallel legal provisions of the EMA, which were to be taken into consideration for the purposes of interpretation and were disregarded in the contested decision. Further, the decision contains an error in law in so far as it sets out from the premiss that the documents contained commercially confidential information, and there is no comprehensible evidence that harm would be caused to Biontech through the publication of the SO1a documents, which was required to publish them as a condition of authorisation. Accordingly, the EMA is also required, as part of its official function, to grant the applicant complete access to the data without making an error in law. |
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1.

First plea in law, alleging that the contested decision infringes, either entirely or at least in part, the first indent of Article 4(2) of Regulation No 1049/2001 (2) as regards the protection of commercial interests

The redactions infringe additional, parallel legal provisions of the EMA, which were to be taken into consideration for the purposes of interpretation and were disregarded in the contested decision. Further, the decision contains an error in law in so far as it sets out from the premiss that the documents contained commercially confidential information, and there is no comprehensible evidence that harm would be caused to Biontech through the publication of the SO1a documents, which was required to publish them as a condition of authorisation. Accordingly, the EMA is also required, as part of its official function, to grant the applicant complete access to the data without making an error in law.

| 2. | Second plea in law, alleging that the contested decision infringes, either entirely or at least in part, the last sentence of Article 4(2) of Regulation No 1049/2001 as regards the existence of an overriding public interest in disclosure
  The decision contains an error in law because the EMA finds that SO1a is not of public interest, despite the fact that the applicant has established to the requisite degree the relationship between the legal nature of SO1a and access to documents under Regulation (EC) No 1049/2001. |
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2.

Second plea in law, alleging that the contested decision infringes, either entirely or at least in part, the last sentence of Article 4(2) of Regulation No 1049/2001 as regards the existence of an overriding public interest in disclosure

The decision contains an error in law because the EMA finds that SO1a is not of public interest, despite the fact that the applicant has established to the requisite degree the relationship between the legal nature of SO1a and access to documents under Regulation (EC) No 1049/2001.

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(1)  Commission Implementing Decision C(2020) 9598 of 21 December 2020 granting a conditional marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for ‘Comirnaty — COVID-19 mRNA Vaccine (nucleoside modified)’, a medicinal product for human use.

(2)  Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ 2001 L 145, p. 43).

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