Problems of Falsification of Medicinal products in the conditions of the COVID-19 Pandemic: Adaptation of Ukrainian legislation to the norms of the European Union

Abstract

The problem of distribution of low-quality medicinal products in Ukraine has become especially relevant against the background of the spread of the COVID-19 pandemic. The challenge to the national medical system became more tangible, as the fight against the virus and quarantine restrictions became heavy psychological blows for patients who sought appropriate treatment in an unofficial way. The purpose of the article is to analyze the problem of falsification of medicines in the conditions of a pandemic and to develop development models against the background of the study of European legislative norms. General scientific methods (synthesis, analysis, induction and deduction) became the main methods for writing the article. The methods of content analysis, systematic review of scientific literature, SMART and FINER principles were also used. The results highlighted one of the most important problems of the distribution of falsified and unlicensed drugs during the spread of COVID-19 - the semi-legal activity of pharmacies that work exclusively in the field of online sales. The requirements for their activities are quite loyal, and the distribution of low-quality or uncertified medicinal products is punished only administratively. The possibility of using European (primarily German) experience to counter the distribution of falsified medicines was discussed. Attention was also drawn to the geopolitical factor in the fight against COVID-19 – the use of the Russian vaccine “SPUTNIK V”, which in the conditions of Russian aggression can be assessed as a hybrid threat. The problematic nature of using this vaccine has been demonstrated, given the secrecy of the mechanism of conducting experiments. Resolutions of the European regulatory bodies allowed Ukrainian doctors not to use this vaccine either. This episode can be considered a positive moment of using European experience to establish medical rules for work in Ukraine. The conclusions note the need to reform Ukrainian legislation, take into account the European experience and harmonize with European regulations on the circulation of medical drugs. Such a step will make it possible to face modern challenges and significantly complicate the entry of counterfeit medicines into Ukraine.