ANALYSIS OF STATE REGULATION OF IMPORT SUBSTITUTION IN THE PHARMACEUTICAL MARKET OF THE RUSSIAN FEDERATION

The purpose of this article is to evaluate the first results of the implementation of the import substitution policy in the pharmaceutical market of the Russian Federation under the conditions of sanctions uncertainty that predetermined a rapid global reorientation towards domestic pharmaceutical manufacturers and manufacturers from the pool of friendly countries. The current state of the Russian pharmaceutical market as of the beginning of 2023 is monitored and the results of the “Pharma-2020” and the goals of the “Pharma-2030” are evaluated. On the one hand, the authors formulate the first positive results of the process of pharmaceutical import substitution associated with an increase in domestic production capacity, an increase in the share of localized drugs, as well as a shift in the structure of public procurement of drugs towards domestic drugs. On the other hand, new challenges are noted facing the industry, and associated primarily with a strong dependence on foreign substances in the production of domestic drugs. An assessment of each of the three possible mechanisms for implementing the import substitution policy localization of the production of medicines, compulsory licensing and own production (full-cycle or generic production) is made. The key problems of the effectiveness of the current normative and legal regulation of the import substitution process in the pharmaceutical industry are identified. The proposals for further development of the legal regulation of pharmaceutical import substitution based on the symbiosis of interests and potential of the key stakeholders of the pharmaceutical industry — pharmaceutical manufacturers, scientific innovation centers, as well as internal and external consumers are formulated. To support legal regulation, it is necessary to intensify the work of institutions, in particular, the development of technology transfer mechanisms and mechanisms for the commercialization and diffusion of innovations in the pharmaceutical sector

pharmaceutical industry, import substitution, localization, economic policy, state regulation, theoretical analysis, innovations, regulatory support, sanctions, strategic development

Kostanyan A. A., Ivleva M. I. Analysis of state regulation of import substitution in the pharmaceutical market of the Russian Federation. Biznes. Obrazovanie. Pravo = Business. Education. Law. 2023;3(64):98—104. DOI: 10.25683/VOLBI.2023.64.727.