COMPULSORY LICENSING MECHANISM UNDER INTERNATIONAL AND NATIONAL LAW

• Main Authors: Aslan H Abashidze, Vladislav S Malichenko
• Format: Article
• Language: English
• Published: Peoples’ Friendship University of Russia (RUDN University) 2019-12-01
• Series: RUDN Journal of Law
• Subjects: TRIPS; World trade organization; compulsory licensing; pharmaceutical industry; patent protection; medicines
• Online Access: http://journals.rudn.ru/law/article/viewFile/21175/16959

The article highlights the main steps in the formation of compulsory licensing mechanism before the establishment of the World Trade Organization, and analyzes the main provisions of this mechanism implementation under the TRIPS Agreement and the Doha Declaration. Based on the analysis of examples from different regions of the world, the article determines the main advantages of using compulsory licensing with regard to expand of access to medicines, possible impact on quality of the medicinal products being produced and the investment attractiveness of the countries applying this mechanism are assessed. The purpose of this article is to analyze the main approaches to the implementation of compulsory licensing in order to determine the most effective strategy for using this mechanism in the Russian Federation in order to expand the availability of drug therapy for the treatment of life-threatening diseases. Based on the impact of compulsory licensing implementation, the author concludes that it does not correspond to the objectives of the Russian pharmaceutical industry development identified as a priority by Russian Government. Despite a possibility of using compulsory licensing under regulation of many countries, this mechanism is implemented rarely. A possibility of issuing a compulsory licensing is a strong argument in price negotiations with producers. According to the authors position, implementation of compulsory licensing has to be preceded by cost containment mechanism, primarily based on negotiations with producers.