Information;Judgment — ECLI:EU:T:2022:111
Date: 2022-03-02
Language of the case: French
Court formation: Eighth Chamber
Subject matter: Public health
Procedure: Action for annulment - unfounded
Origin: France

Judgment of the General Court (Eighth Chamber) of 2 March 2022 – D & A Pharma v Commission and EMA (Case T‑556/20) (1) (Medicinal products for human use – Application for conditional marketing authorisation for the medicinal product Hopveus – sodium oxybate – Decision of refusal by the Commission – Regulation (EC) No 726/2004 – Procedure – Committee for Medicinal Products for Human Use – Request for consultation of a specific scientific advisory group – Impartiality of members of an ad hoc committee of experts – Manifest errors of assessment – Equal treatment) 1. Action for annulment – Jurisdiction of the EU judicature – Claim seeking that directions be issued to an institution – Inadmissibility (Art. 263 TFEU) (see para. 17) 2. Action for annulment – Admissibility criteria – Action against the author of the contested measure – Request for annulment of a measure of the Commission lodged against the European Medicines Agency (EMA) – Inadmissibility (Art. 263 TFEU) (see paras 20-22) 3. Approximation of laws – Medicinal products for human use – Marketing authorisation – Decision of the Commission refusing the placing on the market – Opinion of the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) – Judicial review – Limits (European Parliament and Council Regulation No 726/2004) (see paras 33-35, 37, 183) 4. Approximation of laws – Medicinal products for human use – Marketing authorisation – Discretion of the European Medicines Agency (EMA) – Obligation to follow its advice (European Parliament and Council Regulation No 726/2004) (see paras 49, 231) 5. Approximation of laws – Medicinal products for human use – Marketing authorisation – Procedure for reviewing the opinion of the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) – Request for consultation of a specific scientific advisory group – No consultation of the group requested – Discretion of the Committee for Medicinal Products for Human Use (European Parliament and Council Regulation No 726/2004, Art. 62(1)) (see paras 50, 51, 56) 6. Approximation of laws – Medicinal products for human use – Marketing authorisation – Procedure for reviewing the opinion of the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) – Assessment of the impartiality of the members of an ad hoc expert committee involved (Charter of Fundamental Rights of the European Union, Art. 41(1); European Parliament and Council Regulation No 726/2004, Art. 63(2)) (see paras 88-92, 131-133) 7. Approximation of laws – Medicinal products for human use – Marketing authorisation – Conditional authorisation – Conditions – Scientific evaluation of the quality, safety and efficacy a medicinal product – Insufficient evidence to prove the efficacy of a medicinal product (European Parliament and Council Regulation No 726/2004, Art. 57(1); Commission Regulation No 507/2006, Recitals 1 to 3 and Art. 4(1); European Parliament and Council Directive 2001/83, Art. 1, point 28a) (see paras 160-168, 172) 8. EU law – Principles – Equal treatment – Meaning – Difference in treatment for situations which are factually different and, accordingly, not comparable – No infringement (see paras 177-180) Operative part The Court: 1. Dismisses the action; 2. Orders Debregeas et associés Pharma (D & A Pharma) to pay the costs. 1 OJ C 371, 3.11.2020.