Perspective and current state of international standards influence on prevention and treatment of diseases through the prism of developing high-quality and safe medicines

Abstract

The aim of the work was to examine international legislation covering the legal responsibility in the pharmaceutical field; to analyze activities of international organizations in the area of combating counterfeit drug distribution. Materials and methods. The study was based on international legal instruments aimed at ensuring legal certainty concerning consideration of drug falsification and similar crimes and imposition of criminal liability for activities related to the falsification of medicines. During the work we used methods of information retrieval, analysis, systematization and generalization. Results. An urgent problem of modern medicine is the use of high-quality drugs for the treatment and prevention of diseases. Compliance with standards, in particular international ones, during the development of drugs is the key to both effective treatment and further research in the field of basic clinical medicine, including obtaining new scientific data, improving methods of prevention, diagnosis and treatment of internal diseases. Transformation processes related to Ukraine’s European integration, development of the pharmaceutical industry market, establishment of additional requirements for the quality and safety of medicines necessitate the implementation of state policy aimed at implementing European Union (EU) legal regulations governing legal liability for offenses. committed in pharmaceutical activities. Special attention is paid to the issues of harmonization of the Ukrainian national legislation with the international legislation on the regional level developed by the Council of Europe and the EU on combating the falsification of medicines, including the imposition of criminal liability. Conclusions. The implementation of the international legislation norms of providing legal liability for offenses in pharmaceutical activity into the national legislation plays a positive role, eliminating the shortcomings of the relevant Ukrainian legislative acts.