Regulation of parallel imports of medicines: international and foreign experience

Abstract

The article comprehensively considers international and foreign legal regulation of the problem of parallel import of medicines. Parallel importation, understood as importing original goods from another jurisdiction without the consent of the right holder, is of particular importance in the field of medicinal products, because the challenge here is to maintain a balance between protecting intellectual property rights and ensuring access to life-saving medicines. Analysis of the international legal framework governing parallel imports, namely the provisions of the agreement on trade-related aspects of intellectual property rights, which enshrines the principle of exhaustion and leaves it to the States parties to determine their own model. In addition, on the basis of a comparative legal method, the regional principle of exhaustion of rights in the European Union, the national approach of the USA and the legal positions of the EAEU countries were examined. In the case of Kazakhstan, parallel imports, although regulated by law, are not fully implemented for medicines. Legal conflicts related to trademark protection, registration procedures and the need for harmonization of legislation within the EAEU are also identified. The author emphasizes the need to improve national legislation taking into account the international experience of Kazakhstan and the development of legal mechanisms that ensure the effective and safe application of parallel imports.