Status of Legal Regulation of Pharmaceutical Relations in Ukraine: National Realities and International Experience
The article is focused on the analysis of the status of legal regulation of pharmaceutical relations in Ukraine. It has been stated that pharmaceutical law is a new entity in the legal system of Ukraine, the subject matter's boundaries of which are being formed, standing out of other branches of law. Pharmaceutical law being a complex branch of law, regulates various groups of social relations, which are united by the pharmacy. It has been emphasized that a significant number of current bylaws indicates a satisfactory status of legal regulation of the medicinal products' circulation, but complicates the understanding of law and the application of uniform regulatory practice by the relevant entities. It has been emphasized that there is a lack of special documents among the current regulatory acts aimed at minimizing corruption risks related to the medicinal products' circulation in Ukraine, as well as to prevent the influence of pharmaceutical market entities on lobbying for inclusion of their pharmaceutical products in the registers and lists of medicinal products that are subjects to reimbursement. It has been noted that there are currently processes in Ukraine aimed at strengthening the effectiveness of administrative and legal regulation of public relations in the pharmacy. The key areas of qualitative changes are attempts to regulate relations within the forensic pharmacy, the circulation of generic medicinal products and the reimbursement mechanism. The author has indicated insufficient legal regulation of the status of biologically active additives, generic medicinal products and anti-corruption mechanisms in the field of medicinal products. It has been clarified that there is no normative enshrinement of a number of international terms in the national pharmaceutical legislation. The necessity of adaptation of the legislation of Ukraine to international norms within the pharmacy has been proved. It has been established that, despite the positive tendencies, the status of legal regulation of relations in ...