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In brief

On 22 June 2023, the Court of Justice of the European Union (“Court“) ruled in the Joined Cases C-6/21 P and C-16/21 P on the impartiality requirement of the scientific committees’ members and experts involved in the European Medicines Agency’s (EMA) activities.

Key takeaways

According to the EMA’s policy on the handling of competing interests of scientific committees’ members and experts, employment in the pharmaceutical industry is, in principle, incompatible with the involvement in the EMA’s activities.

In the case at hand, the Court had a chance to clarify the notion of “pharmaceutical company”, excluding that a university hospital with a small drug manufacturing entity (which could, in principle, qualify as a pharmaceutical company) can automatically fall under the said notion. In fact, if this was the case, experienced personnel from university hospitals would be prevented from participating in the EMA’s activities, thereby depriving the same EMA of a substantial quota of experts, and this, according to the Court, would be inconsistent with the EU legislation.


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.


Riccardo Ovidi is an Associate in Baker McKenzie Rome office.


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

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