Problems of criminal responsibility for violation of patient rights in the field of conducting clinacal trials of drugs

Abstract

The article is devoted to the problem of criminal liability for violation of patients' rights in the field of clinical trials of medicines.
 The norms formulated in Articles 141 and 321-2 of the Criminal Code (hereinafter - the CC) of Ukraine are studied. It is established that the name of Art. 141 of the Criminal Code of Ukraine is unfounded in terms of the rules of legislative technique. The ambiguity of the phrase " violation of the patient's rights" does not reflect the content set forth in the disposition of Art. 141 of the Criminal Code of Ukraine prohibition. The list of patient rights is quite wide. However, the disposition of the article prohibits only three types of violations of patients 'rights, which can occur only in one of the possible areas of violations of patients' rights, namely in the field of clinical trials of medicines. In particular, liability is provided for: 1) for conducting clinical trials of drugs without the written consent of the patient or his legal representative; 2) for conducting clinical trials of medicinal products in relation to a minor; 3) for conducting clinical trials of drugs against incapacitated. In this case, liability arises only in the event of socially dangerous consequences (death of the patient or other serious consequences).
 Article 321-2 of the Criminal Code of Ukraine “Violation of the established procedure for pre-clinical studies, clinical trials and state registration of medicinal products” also provides for liability for violation of the procedure for clinical trials of medicinal products, but without causing death, other serious consequences (Part 1 and 2 Article 321-2 of the Criminal Code of Ukraine). However, sanctions under Art. 141 and Part 1 of Art. 321-2 of the Criminal Code of Ukraine are the same, and under Part 2 of Art. 321-2 of the Criminal Code of Ukraine - stricter.
 It is established that in part 3 of Art. 321-2 of the Criminal Code of Ukraine actually provides for liability for the same actions as in Art. 141 of the Criminal Code of Ukraine. However, the punishment under Part 3 of Art. 321-2 is much stricter than under Art. 141 of the Criminal Code of Ukraine. Emphasis is placed on the fact that there is competition between norms, in which more socially dangerous acts (which are provided for in Article 141) are punished less severely.
 Soundly the expediency of removing Art. 141 of the Criminal Code of Ukraine with the Criminal Code of Ukraine, as well as differentiation under Art. 321-2 of the Criminal Code of Ukraine liability for an act that is in gross violation of the order of clinical trials of drugs, led to the death of the patient.