International Legal Standards for the Harmonization of the Criminal Legislation of Ukraine and the Eu and its Implementation to Ensure the Protection of the Pharmaceutical Activity

Abstract

Background: When harmonizing the criminal legislation of Ukraine and the EU and implementing it into the criminal legislation of Ukraine, international legal guidelines (standards) must be taken into account. Aim & Objectives: To investigate international legal standards of harmonization of the criminal legislation of Ukraine and the EU and its implementation to ensure the protection of the pharmaceutical activity. Methodology: Materials: Legislation of Ukraine, European Union, Directives, developed by the European Parliament and the Council of the European Union, recommendations represented by international voluntary group and scientific works. Methods. This article is based on dialectical, comparative, hermeneutic, analytical, synthetic and comprehensive research methods. Results: The construction of a "national model" of criminal-legal protection of pharmaceutical activity should take into account the main international legal standards and be carried out according to the rule: criminal-legal norms should ensure the protection of all types of social values, the violation of which can cause at least minimal damage to public health and the principles of its protection within and outside the circulation of medicinal products. But not selectivity. From the meaning of the Ukrainian "model", some fragments of the circulation of medicinal products fall out (creation, pharmaceutical development, research (testing), advertising and promotion of medicinal products; veterinary medicinal products do not find their criminal legal protection at all, as there are not medicinal products), as well as the existence of criminal law protection of state regulation of pharmaceutical activity is fragmentary. Conclusions: The procedure of harmonization of national criminal legislation with international standards should include norms according to which the prescription of medicinal products is carried out objectively, without the influence of direct and indirect financial incentives; free samples of medicines are provided subject to public restrictions and only for familiarization with new medicines, gaining experience in their use; free access to independent and objective sources of information about medicinal products presented on the market is ensured etc.