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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.

Author

Roberto Cursano has been a lawyer in Baker McKenzie since September 2007. He focuses on healthcare law and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts. Mr. Cursano is a former administrative officer in the Italian Ministry of Health and helps clients work closely with the Italian Public Administration. He is admitted to the bar before the Italian Supreme Court and the Council of State. As well as training and tutoring in the master’s degree program on clinical trials of pharmaceutical products at the University of Rome Sapienza, Mr. Cursano regularly publishes articles and scientific contributions. He also frequently hosts and participates in seminars and presentations on pharmaceutical and administrative law matters.

Author

Francesca R. Baratta is an Associate in Baker McKenzie Rome office.

Author

Riccardo Ovidi is an Associate in Baker McKenzie Rome office.

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