Real-world data in legal framework of the Russian Federation

Abstract

The real-world data (RWD) constitute a modern trend in the healthcare system and in the structure of taking decisions. The trend is being actively developed in the Russian Federation. Ethical aspects of these trials and legal regulation of RWD are, however, still unresolved. In this paper, development of the legal field and national regulation of RWD in Russia is discussed during registration, assessment of healthcare technologies, management of patient registries, and development of clinical recommendations. It is shown that the acting regulatory field of the Russian Federation contains no bans on the use of RWD to support regulatory decisions. Nevertheless, the existing legal laws set limited opportunities for practical application and accounting of RWD by the competent authority. In conclusion, recommendations on further development of RWD legal field in Russia are provided.