# C_2022073EN.01004702.xml

| 14.2.2022 | EN | Official Journal of the European Union | C 73/47 |
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14.2.2022

EN

Official Journal of the European Union

C 73/47

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Action brought on 5 November 2021 — Agentur für Globale Gesundheitsverantwortung v EMA

(Case T-713/21)

(2022/C 73/60)

Language of the case: German

Parties

Applicant: Agentur für Globale Gesundheitsverantwortung (Elsbethen, Austria) (represented by: A. Steindl, lawyer)

Defendant: European Medicines Agency

Form of order sought

The applicant claims that the Court should:

| — | annul the EMA’s decision of 21 September 2021 (EMA/468888/2021) rejecting the applicant’s appeal of 13 August 2021 against the EMA’s decision of 28 July 2021 (EMA/421922/2021); |
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annul the EMA’s decision of 21 September 2021 (EMA/468888/2021) rejecting the applicant’s appeal of 13 August 2021 against the EMA’s decision of 28 July 2021 (EMA/421922/2021);

| — | grant access to the ‘c4591001-interim-ado-report-body’ study on the basis of which the EMA’s Assessment Report EMA/CHMP/282047/2021 Rev. 1 of 22 July 2021 or Commission Implementing Decision C(2021) 4034 (final) of 31 May 2021 were adopted. |
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grant access to the ‘c4591001-interim-ado-report-body’ study on the basis of which the EMA’s Assessment Report EMA/CHMP/282047/2021 Rev. 1 of 22 July 2021 or Commission Implementing Decision C(2021) 4034 (final) of 31 May 2021 were adopted.

Pleas in law and main arguments

In support of the action, the applicant relies on the following pleas in law.

| 1. | First plea in law, alleging invalidity by reason of an error of law concerning the classification of anonymised data records of study C4591001 in respect of US participants in the study as personal data under Regulation 2018/7125. (1) |
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1.

First plea in law, alleging invalidity by reason of an error of law concerning the classification of anonymised data records of study C4591001 in respect of US participants in the study as personal data under Regulation 2018/7125. (1)

| 2. | Second plea in law, alleging invalidity by reason of an error of law by the EMA in finding that study C4591001 has not been finalised as regards a change in the paediatric indication and is consistent with ‘EMA Policy(0070) on Clinical Data Publication’ (EMA/144064/2019). |
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2.

Second plea in law, alleging invalidity by reason of an error of law by the EMA in finding that study C4591001 has not been finalised as regards a change in the paediatric indication and is consistent with ‘EMA Policy(0070) on Clinical Data Publication’ (EMA/144064/2019).

| 3. | Third plea in law, alleging invalidity by reason of an error of law in the finding that the first indent of Article 4(2) of Regulation No 1049/2001 (2) (‘protection of commercial interests of a natural or legal person, including intellectual property’) is applicable. |
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3.

Third plea in law, alleging invalidity by reason of an error of law in the finding that the first indent of Article 4(2) of Regulation No 1049/2001 (2) (‘protection of commercial interests of a natural or legal person, including intellectual property’) is applicable.

| 4. | Fourth plea in law, alleging invalidity by reason of an error of law in the finding that there is no overriding public interest pursuant to the last sentence of Article 4(2) of Regulation No 1049/2001. |
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4.

Fourth plea in law, alleging invalidity by reason of an error of law in the finding that there is no overriding public interest pursuant to the last sentence of Article 4(2) of Regulation No 1049/2001.

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(1)  Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ 2018 L 295, p. 39).

(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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