Responsibility for circulation counterfeit and unregistered medicines, medical devices, falsified biologically active food additives: problems of law enforcement in the context of the coronavirus pandemic

The subject of the study in the paper was theoretical and applied issues of the responsibility for the circulation of counterfeit and unregistered medicines, medical devices, falsified biologically active food additives in the context of the coronavirus pandemic. The authors analyze the legislative practice of the State Duma of the Russian Federation on amendments and addenda to the legal norm governing this corpus delicti (Art. 238¹ of the Criminal Code of the Russian Federation). The adoption of amendments to the Criminal Code of the Russian Federation is explained by the objectively urgent need to fill the existing gap in the legislation, as well as the difficulties of law enforcement practice in combating crimes in the field of circulation of medicines, medical devices and BAFD. The available statistical data do not fully reflect the real scale of the distribution of counterfeit, substandard, unregistered drugs, medical devices, and falsified BAFD, but they convincingly indicate the severity of the situation in this area and the relevance of developing appropriate criminal law countermeasures. The paper indicates that as a result of the monitoring of the Internet by law enforcement agencies of the Russian Federation more than 600 resources for the sale of medicines, medical devices and BAFD were identified, the legality of which is doubtful. The article discusses the legal content of the objective side of the crime under Art. 238¹ of the Criminal Code. According to the authors, it is necessary to amend it in order to establish the criminal liability of a person previously subjected to administrative responsibility under Art. 6.33 of the Code of Administrative Offenses of the Russian Federation, that is, use the method of administrative prejudice in a criminal law, as well as introduce a qualifying attribute – the commission of a crime by a person previously convicted of a similar crime. In accordance with the requirements of Art. 7, 13 of the Council of Europe Convention “Medicrim”, as well as under the influence of circumstances related to the international distribution of COVID-19, as qualifying signs of an offense under Art. 238¹ of the Criminal Code, it is proposed to consider the commission of a crime by a person using his official position, by deceiving or abusing the confidence of the manufacturer or supplier, in conditions of mass infection of the population, in an epidemic or pandemic.

Keywords: drug; medical device; biologically active food additives (BAFD); qualifying attribute; legislative technique; law enforcement practice; implementation of the rule of law; coronavirus pandemic (COVID-19)