EVALUATION OF THE EFFECTIVENESS OF THE STATE PROGRAM OF IMPORT SUBSTITUTION IN PHARMACEUTICALS

In the context of ongoing external restrictions and changes in the international trade in medicines, state policy in the pharmaceutical industry remains focused on the development of domestic production and the implementation of import substitution measures. This paper provides a comprehensive assessment of the effectiveness of the state import substitution program in pharmaceuticals using the Russian market as an example for the period 2015–2024. The study includes an analysis of the dynamics of production volumes of domestic drugs, changes in the structure of the pharmaceutical market (the share of imported and domestic drugs), an assessment of budget costs, and a study of the impact of the program on the availability of vital drugs for the population. Particular attention is paid to the analysis of the consequences of sanctions pressure, the prospects for the development of the industry and the role of the state in ensuring drug safety. The results of the study showed that during the study period, the production volumes of domestic drugs increased by 53%, and the share of Russian drugs in the domestic market increased from 22% (2015) to 58% (2024). At the same time, complete import substitution in a number of product categories (e. g. oncology drugs, insulins, monoclonal antibodies) has not yet been achieved due to technological barriers and insufficient investment attractiveness of certain areas. The program had a positive effect on the development of the pharmaceutical industry: the number of registered domestic original drugs increased, the infrastructure of manufacturers expanded, and the degree of localization of production increased. However, challenges remain: high dependence on imports of active pharmaceutical ingredients (API), limited competitiveness of some groups of drugs and significant budgetary expenses on supporting the industry. The results obtained can be used to adjust the strategy for the development of the pharmaceutical industry, improve state support mechanisms and form long-term programs to ensure the availability and quality of medicines in the Russian Federation in 2025–2030.