The legislation of Italy and the European Union requires a shift in terms of the organisation and national regulation of ethics committees and clinical trials. More generally, this affects the entire sphere of biomedical research. The first part of this article provides a brief review of the history of ethic committees in Italy. We then discuss certain considerations about the current situation and formulate some proposals in terms of the regulatory choices that must be made. There is a vital need for rules that promote efficiency, to guarantee that Italy’s position remains competitive and attractive within the European Union.