Legal Regime for Circulation of High-Tech Medicinal Products: Experience of Interstate Integration Associations

The article analyses the experience of key interstate integration associations in relation to regulating the circulation of high-tech (innovative) medicinal products. Trends in the development of supranational regulation in the area under consideration are identified in order to assess its completeness. The relevance of the study is due to the problems faced by both patients and manufacturers of high-tech (innovative) medicinal products: from the patient community’s perspective, there is a problem of access to such expensive drugs, while from the manufacturers’ side, it is necessary to simplify the process of bringing such products to market and ensuring their cross-border circulation. In order to identify trends that may contribute to solving the problems identified by patients and manufacturers, the international legal and supranational framework for regulating the circulation of high-tech drugs is analyzed. The experience of international organizations (in particular, the World Health Organization), as well as key interstate integration associations (the European Union, the African Union, the Eurasian Economic Union (EAEU)), is considered in terms of regulating the circulation of high-tech drugs. The fragmentary and sporadic regulation of the circulation of high-tech drugs at the global level is largely due to the significant differentiation of economic, organizational, and infrastructural capabilities of individual states in relation to the production of such products. The most detailed legal regulation of the circulation of high-tech medical products is implemented within the framework of the European Union, which serves as a benchmark for other interstate integration associations (in particular, the African Union and Eurasian Economic Union). While lacking a formal partnership arrangement with EU structures, the Eurasian Economic Union is de facto implementing its approaches. However, the harmonization and unification of approaches in the area of high-tech drug circulation is hampered by the transfer of a significant number of issues within the EAEU to the national level.

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