Are the Italian ethics committees ready for Europe?

Abstract

The Law of 3 January 2018 established in Italy the “National Centre for the Coordination of Regional Ethics Committees for Clinical Trials of Medicines and Medical Devices for Human Use” and reduced the number of ethics committees in the country to 40. This Act should, amongst other things, facilitate Italy’s compliance with the provisions set forth in European Regulation (EU) 536/2014. Hopefully, in addition to the provisions set forth in the Law, the National Centre will strive to foster the harmonisation of ethics committee procedures, in order to reform Italian legislation on the evaluation of clinical trials and, more generally, biomedical studies. Unfortunately, certain organizational and structural conditions do not bode well for the success of the National Centre.