Stake on transfer: evolution of a regulatory framework for the development of the pharmaceutical industry

Drug technology transfer is one of the ways to provide the country’s population with affordable and effective drugs. The development of the pharmaceutical industry and government initiatives aimed at modernizing healthcare make Russia attractive to international pharmaceutical business, which in turn allows the Russian pharmaceutical industry to obtain modern world-class technologies and equipment, high-tech jobs, and production management methods and enables partners to have a guaranteed sales market. However, despite the importance and priority of drug technology transfer, foreign manufacturers face a variety of economic and legal problems when making strategic decisions on technology transfer. The development of high-tech production of medicines is associated with the technology transfer process. The above process arises from the transition from one stage of the drug life cycle to the next one. The important feature characterizing the transfer process is the regulation of the transfer of knowledge and technologies, which should ensure the stable safety of a drug and its efficacy, and the reproducibility of quality control methods, by taking into account the results of industrial production. The above aspects of drug circulation are laid down at the stage of development. The specificity of the pharmaceutical industry lies in the need to develop technologies in the context of market globalization and intense competition in drug development, production, and sales. In this connection, the export opportunities of states come to the fore, the important part of which is the convenience of registering and launching modern, effective, safe and competitive drugs in terms of price on the international market.