In brief
The EU Court of Justice, in its judgment given in Case C-291/22 P, annulled the EMA’s decision denying marketing authorization for a drug, finding that the evaluation process was vitiated by the presence within the Committee for Medicinal Products for Human Use (CHMP) of an expert who was in a situation of conflict of interest.
Key takeaways
In this regard, the Court reiterated that the objective impartiality of the CHMP, and thus of the EMA, is compromised if a conflict of interest on the part of one of the members of the CHMP were to arise even from a mere overlapping of functions, regardless of the personal conduct of that member. Impartiality is equally compromised when an individual who is in a situation of conflict of interest is part of the expert panel that is consulted by the CHMP as part of the review which then leads to the EMA’s opinion.
Moreover, the Court denied that the collegiality of the decision-making process can compensate for this kind of vice.
