Науково-методичні підходи до удосконалення системи цін та тарифів на лікарські засоби в Україні

Abstract

У дисертаційній роботі проведено науково-методичне обґрунтування підходів до удосконалення системи цін та тарифів на ЕЛЗ, впровадження яких спрямоване на підвищення їх цінової та фізичної доступності для населення. Соціально-економічна значущість результатів наукового дослідження полягає в тому, що запропоновані методичні рекомендації, затверджені вченою радою НФаУ та узгоджені з МОЗ України, упроваджено в практичну діяльність аптечних закладів, територіальних органів Держлікслужби України, а також у навчальний процес закладів вищої освіти медичного (фармацевтичного) профілю.

В диссертационной работе проведено научно-методическое обоснование подходов к совершенствованию системы цен и тарифов на экстемпоральные лекарственные средства, внедрение которых направлено на повышение их ценовой и физической доступности для населения. Социально-экономическая значимость результатов диссертационного исследования заключается в том, что предложенные методические рекомендации, утвержденные ученым советом НФаУ и согласованы с Министерством здравоохранения Украины, внедрены в практическую деятельность аптечных учреждений, территориальных органов Гослекслужбы Украины, а также в учебный процесс высших учебных медицинских и фармацевтических заведений.

In the dissertation work, a scientific and methodological substantiation of approaches to improving the system of prices and tariffs for extemporaneous drugs (ED) was carried out, the introduction of which is aimed at increasing their price and physical availability for the population. According to the results of the analysis of scientific literature sources, it is established that the domestic system of prices and tariffs, as well as their state regulation has a number of certain problems that need to be addressed. The principles and methods of drug pricing in the European Union, Commonwealth of Independent States and Ukraine are analyzed. The generalization of approaches to pricing for ED in the European Union countries (Germany, Poland, the Czech Republic, Belgium, etc.) is carried out. It was found that in the countries of the world there is no uniform approach to pricing of drugs. Also an assessment of the state of pharmacy manufacturing and the availability of ED was conducted on the basis of a comprehensive survey of pharmaceutical and medical professionals and the public. The results of the study showed that over the last decade there has been a tendency to reduce the number of manufacturing pharmacies on the one hand, and to increase the pharmacy production of drugs on the other. There is also a tendency to increase the prescribed main drugs, especially dermatological, which proves their therapeutic efficacy and necessity. Questionnaire survey of dermatologists and the population of Donetsk region allowed to determine the status and main obstacles to the appointment of extemporaneous dermatological products. According to the results of a survey of pharmaceutical professionals conducted at the national level, it has been established that pharmacy manufacturing has certain problems that need to be solved at three levels - state, regional and microeconomic. The main problems were: imperfection of the legal framework, first of all about 20% of the VAT rate on ED in comparison with 7% on ready; low level of awareness of medical and pharmaceutical workers and the population about the benefits of extemporaneous drugs; lack of active pharmaceutical ingredients and excipients; high requirements for licensing conditions; low profitability of ED manufacturing; unregulated revision of tariffs for the manufacture of drugs. According to the results of the analysis of problems in determining tariffs for ED, it is established that the improvement of the methodology of their calculation should be based on uniform methodological principles of pricing for cost formation, both for drugs of industrial and pharmaceutical production. Based on the correlation and regression analysis a system of regression equations of dependence of costs on the main indicators of production activity was developed separately for pharmacies serving the population, pharmacies serving hospitals and for pharmacies serving the population and hospitals, which allows forecasting the cost of production and justify the level of prices and tariffs for ED. Based on the results of generalization of national and international problems of pharmaceutical production, for the first time a conceptual model of increasing the physical and price accessibility of the population to ED in Ukraine is proposed, which allows to determine the state strategy for extemporaneous formulation development. Legal, organizational and scientific-educational measures have been developed to improve pricing and increase public access to ED. The novelty of the work is that for the first time a comprehensive scientific and methodological substantiation of approaches to improving the system of prices and tariffs for ED, the implementation of which is aimed at increasing their price and physical accessibility for the population. The practical significance of the obtained results is that in the complex all the conducted researches create a solid basis for further improvement of drug pricing, as well as development and standardization of pharmacy manufacturing. Based on the results of the dissertation research, 2 methodological recommendations were developed and approved by the Academic Council of National University of Pharmacy and the Ministry of Health of Ukraine, which were implemented in the work of pharmacies, territorial bodies of the State Medical Service, as well as in the educational process of higher educational medical and pharmaceutical institutions.