Case C-291/22 P: Judgment of the Court (Fourth Chamber) of 14 March 2024 – Debrégeas et associés Pharma (D & A Pharma) v European Commission, European Medicines Agency (EMA)
Date: 2024-03-14
Institutions: Court of Justice
Subjects: drug surveillance, market approval, medicinal product








C_202403038EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2024/3038


13.5.2024






Judgment of the Court (Fourth Chamber) of 14 March 2024 – Debrégeas et associés Pharma (D & A Pharma) v European Commission, European Medicines Agency (EMA)


(Case C-291/22 P)
                (1)

(Appeal - Medicinal products for human use - Application for marketing authorisation - Independence of experts consulted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) - Article 41 of the Charter of Fundamental Rights of the European Union - Right to good administration - Requirement of objective impartiality - Criteria for verifying the absence of conflict of interest - EMA’s policy on competing interests - Activities as a principal researcher, consultant or strategic adviser for the pharmaceutical industry - Rival products - Re-examination procedure - Regulation (EC) No 726/2004 - Article 56, Article 62, Article 63 - EMA Guidelines - Consultation of a scientific advisory group (SAG) or an ad hoc expert group)
(C/2024/3038)
Language of the case: French

Parties


Appellant: Debrégeas et associés Pharma (D & A Pharma) (represented by: V. Durget, E. Gouesse and N. Viguié, avocats)

Other parties to the proceedings: European Commission (represented by: A. Sipos and G. Wils, acting as Agents), European Medicines Agency (EMA) (represented by: C. Bortoluzzi, S. Drosos, H. Kerr and S. Marino, acting as Agents)

Operative part of the judgment

The Court:






1.


Sets aside the judgment of the General Court of the European Union of 2 March 2022, D & A Pharma v Commission and EMA (T-556/20, EU:T:2022:111), except in so far as it declared the action inadmissible to the extent that it was directed against the European Medicines Agency (EMA).










2.


Annuls the Commission Implementing Decision of 6 July 2020 refusing the marketing authorisation application for the medicinal product for human use Hopveus – sodium oxybate pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency, as amended by Regulation (EU) 2019/5 of the European Parliament and of the Council of 11 December 2018.










3.


Dismisses the action as to the remainder.










4.


Orders Debrégeas et associés Pharma SAS (D & A Pharma) to pay the costs incurred by the European Medicines Agency (EMA) relating to the proceedings before the General Court of the European Union.










5.


Orders the European Commission to bear its own costs, relating to both the proceedings before the General Court of the European Union and to the appeal proceedings, and to pay those incurred by Debrégeas et associés Pharma SAS (D & A Pharma) in those two sets of proceedings.










6.


Orders the European Medicines Agency (EMA) to bear its own costs relating to the appeal proceedings.






(1)  
            OJ C 237, 20.6.2022.


ELI: http://data.europa.eu/eli/C/2024/3038/oj
ISSN 1977-091X (electronic edition)