The Pharmaceutical Sector as a Driver of Technological Independence of the EAEU, BRICS, ASEAN: Issues of Pro-Competitive Legal Regulation (Part 1)

The article was prepared in two parts, the first of which is published in this issue of the journal.

The article examines the current state and problems of legal regulation of the pharmaceutical sector of the Eurasian  Economic Union (EAEU, Union), as well as BRICS and the Association of Southeast Asian Nations (ASEAN) from the point of competition and the impact of such regulation on ensuring the technological independence of these international associations and their member states. Aim. To offer possible ways to develop competition in the pharmaceutical sector of the EAEU, as well as promising areas of interaction between the EAEU, BRICS and ASEAN in this area. Tasks. To assess the current state of legal regulation of the pharmaceutical sector of the EAEU at the supranational level in terms of forming conditions for the development of competition in the common market of medicines. To study the mechanisms of price regulation in the pharmaceutical sectors of the member states of the Union. To analyze national practices of ensuring the availability of medicines for the population. To compare approaches to regulating the pharmaceutical markets of India, China, Brazil, ASEAN. Methods. A combination of general scientific and special scientific methods (including content and comparative analysis of legal texts) are applied, which optimally correspond to the content and structure of the subject of research. Results. Based on the analysis, a comprehensive understanding of the current state of legal regulation of the pharmaceutical sector of the EAEU from the point of view of competition is submitted. An analysis of the actual status of the forming of common market for medicines in the EAEU is conducted, its advantages and disadvantages are highlighted. The mechanisms of price regulation in the pharmaceutical sectors at the national level are studied, proposals for the harmonization of relevant issues at the Union level and the involvement of observer states of the EAEU in this activity are prepared. Compulsory licensing and buying medicines online as tools for increasing the availability of medicines are analyzed. A general overview of the regulation of the pharmaceutical markets of India, China, Brazil, ASEAN is presented. Proposals for possible areas of interaction between the EAEU, BRICS and ASEAN in this area are prepared. Conclusions. Further development of legal regulation of the pharmaceutical sector of the EAEU are associated not only with harmonization of national approaches to price regulation and introduction of effective (“seamless”) and transparent mechanisms for regulating the pharmaceutical sector within the framework of the Greater Eurasian Partnership (EAEU, BRICS and ASEAN), but also with establishment of mechanisms for preventing anti-competitive behavior of market participants, and the involvement of authorized bodies of observer states of the EAEU in this work. The solution of these problems will contribute to the growth of investment activity and technological independence of the region as a whole.

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