PHARMACEUTICAL BUSINESS POLICY IN GEORGIA: CHALLENGES AND REFORM OPTIONS

Abstract

The aim of the article was to analyze the legislative and legal norms of the Georgian pharmaceuticals market, their comparison with corresponding international standards, identifying the main challenges in the sector and proposing recommendations. For these purposes, primary desk research was conducted. Legislations, Laws and government orders for improving the supply of medicines to the population served as information bases for the study. During the work, reports from the Agency for the Regulation for Medical and Pharmaceutical Activities, Georgian Representatives of International organizations, the State Statistical Service, and industry experts were used. The study of the issue revealed that the Georgian pharmaceutical sector really needs to improve, revise existing regulations, harmonize with internationally recognized “good practices” (GMP, GDP, GLP, GCP, GVP) and improve financial access to medicines. We will highlight the following challenges: weak regulation of the competitive environment, weak regulation of the pharmaceutical market, quality of medical services provided – polypragmasia. Signs of non-transparent marketing relations and regulation of prices for medicines. The latter is particularly noteworthy because, as it turns out, in recent years “Georgia has been the leader in the European region in terms of total health expenditures on medicines which accounts for 35,5%” (5). “The population of Georgia spent 983 million GEL from own pockets to buy medicines” (5). This is a very large and heavy cost for the population with poor and chronic diseases. We believe that the problem of high prices for medicines is the most tangible, urgent and large scale for our population. Thus, we have made it a priority to work on health policy issues in terms of containment of financial expenditures, both in terms of reducing the total cost of medicines and in terms of direct payments made by the population. To consider all the above, it can be said that the research of the pharmaceutical business policy was selected due to the high public interest, the challenges of the field and the scarcity of study in this regard. In order to highlight the shortcomings and deficits in the regulation, to suggest ways to correct them. Key Words: pharmaceutical market, price regulation, recognition regimen, reference price, generic product, GMP, GDP, GLP, GCP, GVP.