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In brief

On 3 February, the European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA) and the European Commission launched a public consultation on the establishment of a multi-stakeholder platform to improve clinical trials in the European Union (“MSP“).


Key takeaways

The scope of the MSP is to bring together all the stakeholders in a neutral “forum”, including, by way of example, patient organizations, healthcare professionals, investigators, Clinical Research Organizations, Ethics Committees and regulators, in order to promote innovation and increase mutual trust and understanding, thus improving the EU clinical trials landscape for the benefit of all EU citizens.

The composition of the MSP will be agreed at the end of the public consultation, scheduled for 3 March 2023; the date by which stakeholders can provide their comments on the proposal and possibly express their interest in participating in the platform.

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

Riccardo Ovidi is an Associate in Baker McKenzie Rome office.

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