Legal differentiation in the case of domestic legislative default in the field of intellectual property for medicines
Authors: Vishar Iuliia 
Published: March 2021

Within the framework of this article, it is pointed out the importance of legal order in the created domestic regulatory and legalframework of intellectual property for medicines on the basis of international legislation, implemented by approximating national le -gislation to the norms of the European Community law in this area. The disadvantages of the standard approaches of Ukrainian lawmakingin the intellectual pharmaceutical industry to the transformation of legal experience in the pharmaceutical industry of the EuropeanCommunity, which give rise to the domestic legislative default, are presented.Impartially considered the impact of the lack of clarity of the current legislation on intellectual property in pharmaceuticals onthe formation of legally defective, with protective and protective helplessness, intellectual property objects for medicines, which are amanifestation of the legal incompetence of national legislators.The negligent attitude of domestic legislators to the uncertainty in the content of the above changes to the laws that have a directimpact on the definition of the concepts of intellectual property objects for medicines, forms a deformed regulatory and legal basis forpatenting in this area – the ground for possible violations in the form of patent trolling, counterfeit pharmaceutical products, corruptionschemes in medicine, unfair competition, falsification of drugs, and the like, where, first of all, the safety, quality and effectiveness ofdrugs are leveled.The importance of legal differentiation and the need for legal sorting, the renewal of the national legal system to consolidate thesystem of legal regulation of the intellectual pharmaceutical industry by increasing the transparency of the pharmaceutical market andthe responsibility of its participants are noted.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 patentingin this area – the basis for possible offenses in the form of patent trolling, counterfeit pharmaceutical products, corruption schemes inmedicine, unfair competition, falsification of drugs, etc., where, first of all First, the level of safety is leveled, as are the spines andeffectiveness of drugs. At the same time, it should be noted that the lack of results of proper judicial practice in the field of intellectualproperty for medicinal products is an indicator of non-functioning legislative mechanisms for the transformation of the European legalsystem into a national regulatory framework.

The importance and necessity of restoring ecological pharmacies to consolidate the system of legal regulation of the intellectualpharmaceutical 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 contradictionsbased on the implemented system of monitoring, competent legal analytics and control of compliance of Ukrainian legislationwith EU legislation. In turn, a well-functioning, fully documented pharmaceutical quality system must be developed that should includeGood 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) do -cu ments, the State Pharmacopeia of Ukraine, and exclusion of risks for patients, may unreasonably have features patentability, basedon international experience, as a manifestation of relevant medicine.