Feasibility of Import Substitution for Innovative, Generic and Biological Medicines from the 7 Nosologies Program: Current Conditions, Challenges and Solutions

This work touches upon the practice of import substitution in the sector of public procurement, in particular in «7 nosologies» program. The goal is to study a possibility of import substitution for innovative, generic and biological pharmaceutical products based on the medicines from «7 nosologies»: current status, problems and solutions. The objectives are: 1. to reveal the nature and role of state policy in the sphere of circulation of medicinal products by the example of federal program «7 nosologies»; 2. to analyze the state’s actions aimed at development of import substitution for innovative, generic and biological pharmaceutical products based on the medicines from 7 nosologies program; 3. to study activities of foreign and local manufacturers of innovative, generic and biological pharmaceutical products based on the medicines from 7 nosologies program in the context of import substitution policy; 4. to develop solutions and recommendations to enhance the state’s regulation, control and supervision in implementation of the policy of import substitution on the medicines from «7 nosologies» program in Russia; The major methods of research are qualitative: 9 expert interviews with representatives of foreign and local pharmaceutical companies, oncologists, hematologists, neurologists as well as desk research. The work revealed a number of issues. For example, local manufacturers are still inferior in advanced, knowledge intensive industries and cannot secure proper quality, for example, of biotech products aimed at treating such conditions as oncohematology, mucoviscidose etc. To tighten of product quality control. It seems reasonable to streamline legal and regulatory framework. The issues within «7 nosologies» program the need to be solved are as follows: to consider the possibility of involving second-line therapy products to optimizing the program budget, making it possible to include patients with other severe conditions into this program еtc.