European Court of Justice, Decision C-291/22 P of 14 March 2024

15 mars 2024 – Marketing authorisations for medicinal products: the European Medicines Agency (EMA) must ensure that the experts it consults do not have a conflict of interest. The EMA cannot avoid this obligation of objective impartiality by requiring the applicant to prove the bias of the committee member concerned.

The pharmaceutical company D & A Pharma filed an application with the European Medicines Agency (EMA) for marketing authorisation for Hopveus, a medicinal product derived from sodium oxybate. That active substance is indicated to combat alcohol dependence in the medium and long term. Following a negative opinion from the Committee for Medicinal Products for Human Use (CHMP - which is part of the EMA), D & A Pharma requested re-examination of its application, proposing in particular that the therapeutic indications of the medicinal product be revised and that a scientific advisory group on psychiatry (the SAG on Psychiatry) be convened. That request for re-examination also resulted in a negative opinion, which led the European Commission to refuse, in July 2020, the marketing authorisation for Hopveus. Criticising, among other things, the lack of impartiality of the experts consulted (who allegedly had a conflict of interest) as well as a breach of the principle of adversarial examination, D & A Pharma requested the General Court of the European Union to annul the decision of the Commission. That action having been dismissed, D & A Pharma then turned to the Court of Justice.

The Court sets aside the judgment of the General Court and annuls the decision of the Commission refusing the application for marketing authorisation for Hopveus.

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