Legal principles of public administration for the invention of innovative medicines: European experience

Abstract

Formulation of the problem. The creation of innovative medicines is the key to increasing the competitiveness of the pharmaceutical sector of Ukraine’s economy. Going through European integration requires bringing Ukrainian legislation, which regulates various sectors of the economy, in line with European legislation. The study of the European experience of legal regulation of medicines development is characterized by relevance.

The state of the problem research. Problems of innovative activity in the field of medicines creation are investigated in scientific works of such Ukrainian scientists as V. M. Pashkov, S. V. Glibko, Yu. V. Heorgievsky, O. G. Alekseev, and T. A. Kolyada. European authors who have studied scientific activity problems in pharmacy are Philip A. Hines, Rosanne Janssens, Rosa Gonzalez-Quevedo, Ralf Arno Wess, and Constantinos Ziogas, Ivana Silvia.

The purpose of the study is to develop proposals for amendments to Ukrainian legislation governing public administration in the sphere of medicines creation, taking into account the European experience.

Presenting main material. State regulation of the creation of innovative medicines in Ukraine and the European Union is carried out in the following areas. The first is the creation and financial support of research institutions that develop innovative medicines. Second, the identification of research that needs public financial support on a competitive basis. Public administration bodies shall establish the procedure for registration of medicinal products or obtaining a trade license for placing a medicinal product on the market. Legislation and bylaws define the conditions for licensing the production of medicines.

The differences in the legal regulation of the creation of medicines under Ukrainian and European legislation are as follows. First, in the European Union, licenses for marketing medicines are issued by the European Medicines Agency. At the same time, in Ukraine, the registration of medicines is entrusted to the Ministry of Health of Ukraine. Secondly, in the European Union, licenses for medicines production are issued by the national authorities of the EU member states. At the same time, the issuance of such licenses in Ukraine belongs to the competence of the State Service for Medicines Trafficking and Drug Control.

Conclusions and prospects for further research. The implementation of European legislation governing the development of medicines may consist of further amendments to Ukrainian legislation in the field of circulation of medicines. Firstly, to consolidate the medicines registration function to the State Service for Medicines Trafficking and Drug Control of Ukraine. Secondly, to define one of the service’s tasks as providing advice to medicines developers on clinical and preclinical trials and medicines registration. It is also necessary to assess the environmental risk due to the use of a new medicinal product during its registration.