Abstract
The purpose of the work was to analyze the terminology and definitions used in the national legislation of developed countries, as well as modern problems of the distribution and detection of drug falsification The object of the study were messages received by the global WHO system – The Global Surveillance and Monitoring System (GSMS), publications on the problems of the distribution of falsified drugs in scientific publications and specialized mass media, regulatory documents of various countries that regulate the circulation of medicinal products. Analysis of scientific and public sources on the falsification of medicines in WHO member countries, as well as data published on the WHO website in the form of warnings, made it possible to establish that falsified medical products are widespread, this problem affects all regions, including highly developed countries, and any – what therapeutic categories of medicines. The most incidents were recorded in Great Britain, China and Nigeria (7 each), the USA and India (6 each), Cameroon (4), Colombia, Ghana, Congo, the Republic of Chad, Israel (3 each), France, Egypt, Turkey, Poland, Bangladesh, Malaysia. Iran, Uzbekistan (2 each), other countries (1 each). Such statistics indicate problems with the regulatory system in the pharmaceutical sector and the effectiveness of counterfeit detection mechanisms. A study of the meaning of the term «counterfeit medicinal product», which is given in the legislation of various countries of the world (Australia, Great Britain, Canada, the USA, China, India), in particular in Ukraine (the current and new version of the Law of Ukraine «On Medicinal Products») and in the EU suggests that this definition is constantly changing, with different countries/organizations offering their own distinctive definitions. With the new version of the Law of Ukraine «On Medicinal Products», the term «falsified medicinal product» was agreed with the definition proposed by the WHO and corresponds to Directive 2001/83/EC. At the same time, it is expedient to implement a new term for drugs that are illegally imported, illegally manufactured, or illegally put into circulation in domestic legislation.
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