The legal status of participants who create medicines in the national innovation system

Abstract

Formulation of the problem. Carrying out scientific research in the field of creating innovative medicines is the key to the competitiveness of pharmaceutical enterprises in the internal Ukrainian and world markets. Proper legal regulation of the legal status of business entities and scientific institutions that create medicines should become a guarantee of state support for scientific research in this area. Recent research on the topic. The scientific works of V.M. Pashkova, I.S. Voronina, M.V. Bunyak and other researchers are devoted to certain problems of innovative activity in the sphere of medicine circulation. At the same time, the problems of the legal status of participants in the national innovation system who create new medicines have not found their coverage in the scientific literature. The purpose of this research is to determine the legal status of participants in the national innovation system, who create medicines. Article’s main body. The scientific research is devoted to the determination of the legal status of the participants of the national innovation system who create medicines. Legislative and by-laws, statistical information posted on the official websites of authorities, publications of researchers who studied innovative activities in the field of medicine circulation were studied. It is stated that the development of innovative medicines can be carried out by research institutes, institutions of higher education and pharmaceutical manufacturing enterprises. Medicines productions are created in the organizational and legal form of private and state enterprises, business entities. Research institutes and institutions of higher education have legal form of organization. These institutions are subordinate to either the Ministry of Education and Science, or the Ministry of Health Protection, or the National Academy of Medical Sciences, or the State Service for Medicines and Drug Control of Ukraine. Among the conditions for obtaining a license for the medication production there is no requirement for a laboratory to create new medicines at the enterprise. Requirements for such a laboratory are not provided for in legislative and bylaws. Conclusions and prospects for the development. The author proposes definitions of “medicine developer” and “innovative pharmaceutical organization”. The features of the pharmaceutical enterprise innovativeness, in our opinion, are the presence of a scientific department in the structure of the enterprise and the registration of an innovative project by this enterprise in the prescribed manner. The consolidation of these definitions in the legislation of Ukraine may be important for obtaining state support for scientific research on the new medicines creation.