Legal Regulation of Preferential Drug Provision for Patients with Orphan Diseases in the Russian Federation: Current Situation and Possible Ways to Improve Existing Legislation

The purpose of this research was to identify approaches to improving the current legislation of the Russian Federation in the field of legal regulation of preferential drug provision for patients with orphan diseases. The object of the study was the norms of Russian law regulating the provision of drugs for patients with orphan diseases, the provisions of doctrinal research on the problem under study: Putilo N.V., Mironova T.K., Mokhova A.A., Bessarab N.S. Tsomartova F.V. General scientific research methods were used as a methodological basis for the work: general logical (analysis, synthesis, induction), theoretical (historical, generalization), empirical (description, comparison). The regulatory framework of the study was formed by the legislation of the Russian Federation, which regulates relations in the social sphere, health protection and the provision of medical care, the circulation of medicines, the empirical one - the results of studies of domestic and foreign practice in the field of legal regulation of preferential drug provision for patients, including mechanisms for reimbursing drugs for the treatment of rare ( orphan) diseases. The following tasks were solved in the work: - the legal nature of the rights to drug provision has been determined; -the theoretical and applied meaning of the concepts of "drug supply" and "drug assistance" is determined - An analysis of the current legislation of the Russian Federation was carried out and the existing shortcomings in the field of regulation of preferential drug provision for patients with orphan diseases were identified; - a comparative analysis of the current legislation of the Russian Federation and legal regulation of drug provision for patients with disabilities in foreign countries was carried out; - proposals have been developed to improve the legal regulation of preferential drug provision for patients with rare diseases. In this work, for the first time, a comprehensive analysis of the current legislation regulating preferential drug provision for patients with orphan diseases in the Russian Federation, a comparative analysis of Russian and foreign legislation in the field of drug provision for patients with orphan diseases in the Russian Federation was carried out, based on the results obtained, proposals were developed to improve the legal regulation of drug provision for patients. with orphan diseases. The results obtained can be used for further study and can be implemented in real practice.