REGULATORY AND LEGAL ISSUES OF ESTABLISHING THE MECHANISM OF MEDICINES’ ONLINE TRADE

The introduction of digital technologies in everyday and professional life has become the inevitability of a natural evolutionary stage in the development of society and the economy. Digital today is a reality in all areas, including the pharmaceutical industry. In this case, of course, it is important to note the objective features of the functioning and development of this sector. The growing role of digital and high‑tech solutions both in the economy as a whole and in relation to the pharmaceutical industry has long been obvious to all entities of the pharmaceutical market. The customer has long been involved in online trading. It is convenient and profitable for him. Accordingly, the pharma stakeholders also go online. However, the pharmaceutical segment of trade remains one of the most regulated by the state in terms of accounting, specifics of sales rules, certification, price levels and other important aspects that ensure the protection of consumers’ life and health. It is not enough to regulate the online space with the existing regulatory framework that provides control of offline trading. With this in mind, the state task is to develop an operating mechanism in the difficult issue of a full‑fledged system of online drug trade. It is important to emphasize that the regulatory framework for providing a Digital‑regime for the sale of pharmaceutical goods should include a system for the circulation of narcotic and psychotropic, radiopharmaceutical drugs, taking into account the particularities established by the legislation of the Russian Federation on narcotic drugs, psychotropic substances and their precursors. When developing a mechanism for online trading in pharmaceutical products, it is necessary to take into account the federal state information system for monitoring the movement of drugs for medical use from the manufacturer to the final consumer using identification tools for medicines for medical use.

pharmaceutical industry, online trading, regulatory framework, digital technologies, digital technologies, pharmaceutical stakeholders, pharmaceuticals, precursors, drug movement monitoring, online space, life and health protection.

Krasilnokova E. A., Nikishin A. F. Regulatory and legal issues of establishing the mechanism of medicines’ online trade. Business. Education. Law, 2019, no. 4, pp. 320–324. DOI: 10.25683/VOLBI.2019.49.450.