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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;

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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.

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.