On legislative interoperability in civil law protection of intellectual property rights for medicinal products
Authors: Vishar Iuliia 
Published: March 2020

In the framework of this article, attention is drawn to the importance of legal ordering in the created domestic regulatory framework of intellectual property for medicines on the basis of international law, implemented by approximating national legislation to the norms of the European Community law system in this area. The shortcomings of the standard approaches of Ukrainian lawmaking in the intellectual pharmaceutical industry to the transformation of legal experience in the pharmaceutical industry of the European Community, generating domestic legislative eclecticism, are presented.

The effect of omitting the clarity of the definitions of the basic concepts in the regulatory legal acts of the national legislation, namely: «homeopathic medicines», «confidential registration information», «independent expert», «reference medicinal product», «original (innovative ionic preparation)», «unlawful use of natural information on the safety and efficacy of a medicinal product», «a similar biological preparation (biosimilar)», on intellectual property in the pharmaceutical industry on the education of legally inferior, with protective and protective helplessness, intellectual property objects for medicines, which is a manifestation of the legal incompetence of national legislators.

Indicated on the negligent attitude of domestic lawmakers to the uncertain classification of inventions in pharmaceuticals, which, like the above definitions of the concepts of intellectual property for medicines, forms a deformed regulatory framework for patenting in this area - the basis for possible offenses in the form of patent trolling, counterfeit pharmaceutical products, corruption schemes in medicine, unfair competition, falsification of drugs, etc., where, first of all First, the level of safety is leveled, as are the spines and effectiveness of drugs. At the same time, it should be noted that the lack of results of proper judicial practice in the field of intellectual property for medicinal products is an indicator of non-functioning legislative mechanisms for the transformation of the European legal system into a national regulatory framework.

The importance and necessity of restoring ecological pharmacies to consolidate the system of legal regulation of the intellectual pharmaceutical industry by increasing the transparency of the pharmaceutical market and the responsibility of its participants is indicated.

In our opinion, the legislation in this priority for the state strategy area should be reviewed to eliminate recurrences and contradictions based on the implemented system of monitoring, competent legal analytics and control of compliance of Ukrainian legislation with EU legislation. In turn, a well-functioning, fully documented pharmaceutical quality system must be developed that should include Good Manufacturing Practices (GMPs) with quality control and risk management for quality at the stage of intelligent product creation. Thus, the underestimated pharmacy business, where extracorporeal medicines created in the conditions of individual production (manufacturing) with ensuring compliance with their purpose, the requirements of regulatory (analytical, technical, technological) documents, the State Pharmacopeia of Ukraine, and exclusion of risks for patients, may unreasonably have features patentability, based on international experience, as a manifestation of relevant medicine.