Research purpose: analysis of the situation in the sphere of healthcare and health condition of the population of the Russian Federation, analysis of system problems of the protection of intellectual property in the Russian pharmaceutical market, research of institutional problems of organization of clinical trials as a barrier for the introduction of innovation drug products to the market
Empirical base of the research: Official statistics of the analytical agencies in the field of drug supply (IMS, DSM-group, COMKON, EFPIA, Frost & Sullivan,data of World Trade Organization (WTO), World Health Organization (WHO), data of the European Parliament (EP&Council) and database of Organization for Economic Cooperation and Development (OECD), data of interview with representatives of foreign expert and business community in the sphere of pharmaceutical provision.
Research results: The research was conducted by three steps. On the first step of the research in the framework of solving the problem of identifying the influence of globalization processes on drug circulation the following tasks were completed:
Health condition of Russia population and availability of the pharmaceutical provision in different subjects of the Russian Federation were researched.
Economic development disparity of the subjects of the Russian Federation was described, which seriously influences the availability of modern drug products for patients.
Forecast analysis of the situation development of some diseases was given.
The comparative analysis of the health of Russia citizens in comparison with population of other countries was provided.
Peculiarities of the pharmaceutical provision system in Russia were described in comparison with main principles of shaping of the National drug policy recommended by the international expert community.
In the second part of the research there were analyzed processes taking place regarding patent discontinuity including extension of the sphere of generics and biosimilars’ application.
In the meantime there were analyzed changes caused by the started speed up of innovation-driven growth and stimulation of R&D in the pharmaceutical sector.
Principles of regulation of the intellectual property were thoroughly analyzed in the sphere of pharmaceutical provision and peculiarities of application of flexible standards of Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) were reviewed.
Mechanisms and consequences of application of TRIPs flexible norms were analyzed in the practice of pharmaceutical provision of foreign countries.
These examples were evaluated from the viewpoint of the possibility of their implementation into the Russian system of pharmaceutical provision.
On the grounds of a wide international analysis there is given the description of the most common practices of pharmaceutical provision’ organization.
On the third step of the research there was conducted the analysis of conditions for the extension of the practice of the conduct of clinical trials to increase the availability of innovation and orphan products for the population of the Russian Federation.
In the framework of solving this problem there were analyzed methodological problems arising at selecting of the site for the conduct of clinical trials by foreign manufacturers of innovational drug products.
There were analyzed positive consequences that follow up the conduct of clinical trials in a recipient country.
There was done a detailed analysis of advantages and disadvantages of the Russian system of clinical trials’ organization.
Implementation of the research results: The results of this study can be used by Public Health Ministry of Russian Federation to establish the regulatory and administrative documents for implementation of the Drug Supply Strategy approved by the Government in December, 2012