Information;Judgment — ECLI:EU:T:2020:512
Date: 2020-10-28
Language of the case: English
Court formation: Sixth Chamber
Subject matter: Public health
Procedure: Action for annulment - successful
Origin: Spain

Judgment of the General Court (Sixth Chamber) of 28 October 2020 – Pharma Mar v Commission (Case T‑594/18) (Medicinal products for human use – Application for marketing authorisation for the medicinal product Aplidin – plitidepsin – Commission decision refusing authorisation – Regulation (EC) No 726/2004 – Scientific evaluation of the risks and benefits of a medicinal product – Committee for Medicinal Products for Human Use – Objective impartiality) 1. EU law – Interpretation – Acts of the institutions – Statement of reasons – To be taken into consideration – Decisions based on the opinion of a scientific authority – Incorporation of those opinions into the statement of reasons for such decisions (European Parliament and Council Regulation No 726/2004, recital 23 and Arts 5(2), 10, 56(2) and 87(3)) (see paras 26-31) 2. Acts of the institutions – Administrative procedure – Principle of sound administration – Requirement of impartiality – Scope (Charter of Fundamental Rights of the European Union, Art. 41) (see para. 43) 3. Fundamental rights – Charter of Fundamental Rights of the European Union – Right to sound administration – Requirement of impartiality – Meaning (Charter of Fundamental Rights of the European Union, Art. 41) (see paras 44, 45) 4. Approximation of laws – Uniform legislation – Medicinal products for human use – Orphan medicinal products – Procedure for designating a medicinal product as an orphan medicinal product – Opinion of the Committee for Orphan Medicinal Products – Discretion of the Commission – Limits – Guarantee of impartiality – Scope (European Parliament and Council Regulation No 726/2004, Arts 62(1) and (2) and 63(2)) (see paras 72-74) Re: Application pursuant to Article 263 TFEU for annulment of Commission Implementing Decision C(2018) 4831 final of 17 July 2018 refusing marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ 2004 L 136, p. 1) for Aplidin – plitidepsin, a medicinal product for human use. Operative part The Court: 1. Annuls Commission Implementing Decision C(2018) 4831 final of 17 July 2018 refusing marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, for Aplidin – plitidepsin, a medicinal product for human use; 2. Orders the Commission to pay the costs.