EU Judgment in Case C-291/22 P D & A Pharma v Commission and EMA

Thursday 14th March 2024

Judgment in Case C-291/22 P D & A Pharma v Commission and EMA

(Public health)

By its appeal, Debrégeas et associés Pharma SAS (D & A Pharma) seeks the annulment of the judgment of the General Court of March 2, 2022, in CaseT-556/20 D & A Pharma v Commission and EMA.

The contested judgment had dismissed their action seeking, inter alia, to annul Commission’s implementing decision of July 6, 2020, refusing the application for marketing authorisation for the medicinal product for human use Hopveus – sodium oxybate under Regulation (EC) No 726/2004.

The regulation seeks to guarantee high standards of quality and safety of medicines in the EU. It sets out procedures for authorising and supervising medicinal products for human and veterinary use and sets up the European Medicines Agency (EMA), responsible for providing scientific advice to the EU institutions and to the Member States in the field of medicinal products, concerning the authorisation and supervision of medicinal products.

EMA’s Committee for Medicinal Products for Human Use (CHMP) is in charge of preparing opinions on the granting, variation, suspension or withdrawal of a marketing authorisation for a medicinal product for human use, in accordance with the regulation and pharmacovigilance.

On June 26, 2018, , D & A Pharma submitted a conditional marketing authorisation application to the EMA for Hopveus under Commission Regulation (EC) No 507/2006, falling within the scope of Regulation No 726/2004. Hopveus, containing sodium oxybate as an active substance, is intended to combat alcohol dependence.

On October 17, 2019, the CHMP issued an unfavourable opinion on this application.

On October 29, 2019, D & A Pharma lodged a request for reconsideration of the CHMP’s opinion.

For the purposes of that review, the CHMP convened an ad hoc group of experts. Following a further unfavourable opinion of the CHMP dated April 30, 2020, the European Commission, by the contested decision, again refused the application for conditional marketing authorisation, on the ground, inter alia, of the lack of demonstration of the efficacy of the Hopveus medicinal product.

Background Documents C-291/22