The current state of legal and regulatory framework of the pharmaceutical sector in the healthcare service of Ukraine
Journal Title: Економіка. Фінанси. Право - Year 2018, Vol 11, Issue
Abstract
It is given the extremely high importance and significance of the pharmaceutical industry today, it is quite logical that there is a need for an effective management system capable of carrying out the leading tasks in compliance with the regulatory provisions. A thorough analysis of the legal mechanisms of the pharmaceutical sector makes it possible to formulate a number of suggestions to improve not only special legislation but also the healthcare system as a whole. Improving the legal regulation of pharmaceutical activity in Ukraine is understood as the implementation of a whole range of directives of European legislation aimed at introducing common standards for pharmaceutical activities and forming a single direction for the development of this industry. As a result, the question about the need for a certain harmonization of European stan-dards of legal regulation with the peculiarities of national legislation becomes inevitable. It can be realized on the basis of a detailed analysis and careful study of the regulatory framework of the pharmaceutical sector. Reformation of the healthcare system is one of the most important tasks for Ukraine, the main goal of which is to improve the health of the population and to improve the quality of medical care, which is directly dependent on improving the quality of the phar-maceutical sector. It is not a secret that today in Ukraine there is a rather low level of socio-economic use of the resources of the healthcare and pharmaceutical sector. The level of provision of the population with medication is absolutely not compliant with the international standards. Taking into account the above, as well as global structural processes in the economy, Ukraine’s integration into the world economic community, bringing the regulatory framework of the pharmaceutical sector of Ukraine in compliance with the relevant standards is extremely important today. The research paper deals with determining the urgency and necessity of studying legal mechanisms of pharmaceutical activity. The importance of improving the domestic state regulation of this industry is considered in the paper; the main principles of harmo-nization of European standards with the domestic legal framework are established. The main requirements for establishing effective means of control over quality, production, the system of sales and registration of pharmaceutical products on the territory of Ukraine are outlined. Certain conditions for the next stage of development of the pharmaceutical sector have already been created in Ukraine, but it is to the point to note the fact that one of the key areas for improving the current state of the industry is the implementation of European legislation. The task to be solved in the near future is the introduction in Ukraine of a complex of pharmaceutical directives harmonized with European and international legislation.
Authors and Affiliations
Tetiana Mykhailivna Yamnenko, Iryna Stanislavivna Utiekhina
Keywords
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