Joined Cases C-6/21 P and C-16/21 P: Judgment of the Court (Third Chamber) of 22 June 2023 — Federal Republic of Germany (C-6/21 P), Republic of Estonia (C-16/21 P) v Pharma Mar SA, European Commission (Appeal — Public health — Medicinal products for human use — Regulation (EC) No 726/2004 — Refusal of a marketing authorisation for the medicinal product for human use — Aplidin — plitidepsin — European Medicines Agency (EMA) — Impartiality of experts from a scientific advisory group (SAG) — Policy of the European Medicines Agency on the handling of competing interests of scientific committees’ members and experts — Concept of ‘pharmaceutical company’ — Scope of the exclusion for ‘research organisations’ — Concept of ‘rival products’)
Date: 2023-06-22
Institutions: Court of Justice
Subjects: European Medicines Agency, drug surveillance, market approval, medicinal product, research body, scientific report, self-employed person








C_2023278EN.01000301.xml










7.8.2023   


EN


Official Journal of the European Union


C 278/3






Judgment of the Court (Third Chamber) of 22 June 2023 — Federal Republic of Germany (C-6/21 P), Republic of Estonia (C-16/21 P) v Pharma Mar SA, European Commission
(Joined Cases C-6/21 P and C-16/21 P) (1)

(Appeal - Public health - Medicinal products for human use - Regulation (EC) No 726/2004 - Refusal of a marketing authorisation for the medicinal product for human use - Aplidin — plitidepsin - European Medicines Agency (EMA) - Impartiality of experts from a scientific advisory group (SAG) - Policy of the European Medicines Agency on the handling of competing interests of scientific committees’ members and experts - Concept of ‘pharmaceutical company’ - Scope of the exclusion for ‘research organisations’ - Concept of ‘rival products’)
(2023/C 278/03)
Language of the case: English

Parties


Appellants: Federal Republic of Germany (C-6/21 P) (represented initially by J. Möller and S. Heimerl, and subsequently J. Möller and P.-L. Krüger, acting as Agents), Republic of Estonia (C-16/21 P) (represented by: N. Grünberg, acting as Agent)

Other parties to the proceedings: Pharma Mar SA (represented by: M. Merola and V. Salvatore, avvocati), European Commission (represented by: L. Haasbeek and A. Sipos, acting as Agents)

Interveners in support of the applicant (C-6/21 P): Kingdom of the Netherlands (represented by: M.K. Bulterman, J. Langer and C.S. Schillemans, acting as Agents), European Medicines Agency (EMA) (represented by: S. Drosos, H. Kerr and S. Marino, acting as Agents)

Interveners in support of the applicant (C-16/21 P): Federal Republic of Germany (represented initially by J. Möller and S. Heimerl, and subsequently J. Möller and D. Klebs, and, lastly, J. Möller and P.-L. Krüger, acting as Agents), Kingdom of the Netherlands (represented by: M.K. Bulterman, J. Langer and C.S. Schillemans, acting as Agents), European Medicines Agency (EMA) (represented by: 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 28 October 2020, Pharma Mar v Commission (T 594/18, not published, EU:T:2020:512);










2.


Refers Case T 594/18 back to the General Court of the European Union;










3.


Reserves the costs.






(1)  OJ C 110, 29.3.2021.

OJ C 148, 26.4.2021.