Legal aspects of the clinical trials

Abstract

Clinical trials must be conducted in a way which is in line with the primary principle that clinical trial participants’ rights, safety, health, and welfare override the interest of science and society. The subject matter of the present study is an analysis of the provisions of the criminal law concerning clinical trials, in particular Art. 126 a of the Act of 6 September 2001 – Pharmaceutical Law (Dz.U. 2019, Item 499, 399) and Art. 27 of the Criminal Code. In my view, the criminal aspects of pharmaceutical law are not sufficiently stressed in the ongoing scientific discourse.