Legal enforcement of the european union legislation implementation on the creation of innovative medicines

The article's relevance is due to the increasing competitiveness of the pharmaceutical industry of the Ukrainian economy by the creation of innovative medicines. The purpose of the article is to develop proposals for amendments to the Ukrainian legislation governing the creation of innovative medicines in connection with the legal integration of Ukrainian and European law. Such special legal methods as systemic, theoretical-legal, formal-dogmatic methods, comparative-legal methods of cognition as well as the method of state-legal modeling were used to study the selected issues.The processes of European integration require the adaptation of Ukrainian legislation in medicines circulation to the norms of European law. The purpose of the article is to identify proposals for amendments to the Ukrainian legislation governing the creation of innovative medicines connected with the implementation of European law. Legislation and bylaws of Ukraine, directives, and resolutions of the European Parliament and the Council of the EU regulating the medicines circulation have been studied. The positions of Ukrainian and European scientists on the legal regulation of the creation of innovative medicines and the implementation of European law to Ukrainian legislation are clarified. The Ukrainian and the European legislation norms which define the terms innovative, reference, generic, and high-tech medicines have been compared. The powers of the European Medicines Agency to provide advice to developers of medicines have been established. The European Union's innovation support programs have been identified, which can be used by medicines developers from Ukraine. Amendments proposals to the Law of Ukraine "On Medicinal Products" have been formulated. It is necessary to establish the term innovative (original or reference) medicinal product. It is necessary to define the tasks of the medicinal products registration body to provide scientific advice to developers of medicinal products. It is proposed to establish the obligation of the authorities to assist research institutions and manufacturing pharmaceutical companies that create innovative medicines in accessing European programs to support innovative research.

medicines, innovations, implementation, adaptation, European legislation