Granice ochrony karnej prawa do samostanowienia uczestnika badania klinicznego produktu leczniczego

Abstract

This article addresses the issue of criminal law protection of the right to self-determination in clinical trials of medicinal products. It focuses on establishing the scope of the criminalisation of behaviours violating the right in question under Article 77 points 1–3 of the Act of 9 March 2023 on Clinical Trials of Medicinal Products for Human Use. The method of referring to the EU law applied in statutory features of these offences is, however, affected by obvious legislative deficiencies, seriously hampering the process of interpretation and casting doubt on the rationality of the decision about criminalisation. What can be concluded with certainty is that criminalisation covers the conduct of a clinical trial both when the subject did not express any statement approving their participation in it, and when such a statement lacked the essential features of informed consent. Furthermore, criminal law protection of the right to self-determination does not include minors or incapacitated persons, even to the extent that clinical trial provisions require it to be respected.