Interventional Clinical and Chemical Studies in Romania, Legal Guarantees

Abstract

The risks of medical treatment are due not only to the patient�s anatomic and physiological state, but also to the scientific and technical level of medicine when providing the medical service, which may progress through interventional clinical studies. In Romania, between 2012-2016 were issued annually between 192 and 221 authorizations for performing interventional clinical studies, the majority being phase III studies and almost half in oncological, respiratory and nervous diseases, although the pathology which represents the main mortality cause is the cardiovascular one. The goal of this study is the analysis of the legal requirements for the patients to participate to these interventional clinical studies, within the ample proceedings that aim to the approval of chemical substances as human use drugs. At present, the legal guarantees for interventional clinical studies are offered by the EU Regulation 536/2014 of the European Parliament and of the Council of 16 April 2014 regarding interventional clinical studies with drugs for human use, which through art. 4-27 of the Regulation settles a preliminary authorization procedure meant to avoid any deviation from public order and good morals, and through art. 28-36 of the Regulation protects the patient�s private interest through a special regulation of his consent when accepting an unusual clinical practice.