Key regulatory developments in the Russian pharmaceutical sector in 2021


This video update demonstrates the key regulatory developments in the Russian pharmaceutical sector in 2021, the forecasts for 2022 and the open statistic data on the KPIs of national projects “Healthcare” and “Demography”.

At the level of the Eurasian Economic Commission, the working group on medicines approved a number of positive regulatory proposals aimed at improving the accessibility of breakthrough medicines on the EAEU territory. The working group on medicines also approved the definitions of real-world evidence and real-world data to be introduced to the EAEU regulatory field based on the analysis of the United States experience. The accessibility of certain high-cost innovative therapies was raised after creation of the Fund for Support of Children with Severe Life-Threatening and Chronic Diseases, which is called “Circle of Good”.

At the same time a number of non-ecological regulatory instruments were introduced to the local Russian regulations, such as provisions on the government use of an invention without patentholder’s consent (the requisites of the relevant federal laws are listed on the slide). The import substitution policy as well as regulatory pricing in state procurement has also revealed certain negative trends related to product accessibility.

In 2022 The current unsustainable trends (including those in the sector of IP protection) may be expected to continue. Further, the state procurement reform will come into force. Although the experts do not foresee any specific negative impact on the public purchases of medicines, it is necessary to follow the developments in the law enforcement practice.

Pharma 2030 Strategy (once available) may become the core center of the pharmaceutical industry evolution in the mid-term perspective. Many other legislative developments are expected in 2022, including those at the level of the Eurasian Economic Union.