62020TJ0556_INF
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.
(
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)	OJ C 371, 3.11.2020.