Criminal and legal evaluation of rules of conducting clinical research of medicinal products violations
The article investigates the two legal components of crime that establish criminal liability for violations during clinical research of medicines. They are Art. 141 of the Criminal Code of Ukraine, which establishes responsibility for conducting clinical trials of medicines without the written consent of the patients or their legal representative, or in cases with minors or legally incapable persons if these actions caused the death of the patient or other grave consequences, and Art. 321-2 of the Criminal Code of Ukraine, which in part 1 envisages responsibility for intentional violation of the established procedure of preclinical study, clinical trials of medicines, falsification of their results, as well as violation of the established procedure of state registration of medicines.
In particular, the article studies the issue of the person under the study (research subject) who is the victim of these crimes. The author notes that there is a disagreement in the regulations concerning the issue of who can be subject of research. In the Law of Ukraine “On Medicines”, such persons are adults, minors, underage persons, persons who are declared incapacitated by the court or whose civil capacity is limited due to mental illnesses. The MoH Decree No. 690 defines subjects of study as legally capable adults, minors, underage persons and incapacitated of persons. The lack of a procedure to include persons with disabilities raises questions about the possibility of involving such persons in clinical trials.
The objective side of the commission of these two crimes was investigated, the subject of these crimes was identified. Both in Art. 141, and in Art. 321-2 of the Criminal Code of Ukraine in the part of conducting clinical research of medicines, the subject is special; it can be a researcher/co-researcher (doctor) or other employee of a medical-prophylactic institution, at the facilities of which - by decision of the central body of executive power which forms and provides implementation of state policy in healthcare - a clinical trial of the medicine is conducted and which is involved in conducting a clinical research.
The author notes that these two articles can correlate as general and special norm, which differ in the main subject of criminal and legal protection. The author proposed to amend these two articles in order to avoid a double criminal prohibition on one act.