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In brief

On 10 June 2024, the Member State Coordination Group on Health Technology Assessment adopted two new HTA guidance on outcomes of joint clinical assessments and reporting requirements.


Key takeaways

In particular, the guidance on outcomes for clinical assessments aims at supporting both Member States authorities in defining the scope of such assessments and those responsible for such assessments in reporting all the elements needed by Member States to properly conduct clinical value-added analysis of health technologies at the national level.

The guidance on reporting requirements identify how assessors should deal with multiplicity issues and complementary analyses in the reporting of joint clinical assessments.

These guidance are an essential tool for health technology developers since they allow the correct identification of the relevant elements within evaluation proposals.

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.