In a judgment dated March 12, 2024, the Court of Justice of the European Union (the “Court of Justice“) was asked to clarify the scope of the principles that must be respected in the procedure conducted by the European Medicines Agency (EMA) for the evaluation of medicinal products.

Background

The appeal to the Court of Justice follows an application for a conditional marketing authorization submitted to the EMA on June 26, 2018, for Hopveus, a drug for the treatment of alcohol dependence.

On October 17, 2019, the Committee for Medicinal Products for Human Use (CHMP), which is part of the EMA, issued a negative opinion on this application.

In response, the applicant submitted a request for re-examination, for which the CHMP convened an ad hoc expert group, which included an expert who was also an investigator for another medicine also intended for the treatment of alcohol dependence (AD 04). Following a new unfavorable opinion dated April 30, 2020, the European Commission rejected the conditional marketing authorization.

To challenge this rejection, the applicant brought an action against the Commission and the EMA before the General Court of the European Union (the “General Court“), seeking annulment of the [...]

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