The collaboration among EAEU member states directly influences developments within the Russian pharmaceutical market. The proof of this is the rising number of marketing authorizations being granted, which facilitates drug supply for patients across the Union.
It would be premature to claim that all challenges have been resolved. As elsewhere, the pharmaceutical market is expanding, but this growth is accompanied by complexities. Integration is an ongoing process, and to make it more coherent and dynamic, we must provide clear and well-reasoned explanations to EAEU regulators about the existing barriers. Unfortunately, obstacles persist within the Union that prevent a drug registered under EAEU rules from participating in public procurement tenders in certain member states.
The trend of establishing cooperative projects within the EAEU, for which the Eurasian Economic Commission (EEC) provides interest rate subsidies on loans, has proven to be unviable for the pharmaceutical industry. A key requirement for such projects is participation with the involvement of at least three member states, which is difficult to implement in the drug manufacturing process. It is more efficient and cost-effective to produce pharmaceuticals in a single country rather than across three different ones.
We observe that some countries within the Union are currently actively engaging with foreign companies. Our Association is prepared to provide comprehensive support for the development of a unified EAEU market for the benefit of our patients. We have no disputes with our international colleagues. We share a single market with unified and transparent rules for all. Industry associations, individual companies, and regulators all remain committed to ensuring imported drugs have access to the market.
One of the most pressing issues today remains the lack of reliable drug demand forecasting. There are companies willing to make long-term investments in innovative drug development. However, to commit to such innovation, they require a clear understanding of which types of medicines and for which therapeutic areas will be in demand 5, 10, and 15 years from now. For such a forecast to be given, it is crucial for all market participants – regulatory bodies, the scientific community, and manufacturers – to agree on a unified methodology for its collaborative development.
A highly promising project has recently been launched at the I.M. Sechenov First Moscow State Medical University. They are developing the first Horizon Scanning System (HSS) designed to accelerate the market entry of innovative Russian drugs for treating socially significant diseases. The HSS leverages modern technological platforms, including artificial intelligence and big data analysis. It has the potential to significantly improve the monitoring of emerging technologies, enabling their timely introduction to the market.
Our Association participated in the development of this project, fully supports it, and believes the HSS is of fundamental importance for the Russian pharmaceutical sector. The current priority is to await the initial results, observe how the methodology is formalized, and assess whether this pilot project can evolve into a sustainable and widely adopted pathway.
It is essential for the industry to have a unified methodology capable of producing regular forecasts projecting the structure of the pharmaceutical market 5, 10, and 15 years ahead. This is vital for businesses that assume significant risks by investing in the development of new molecules and drugs. The sector must understand which drugs will be in highest demand and, consequently, which will be the most economically viable.
A significant regulatory shift, the “Second Supplier” mechanism, will come into force in Russia on January 1, 2026. Based on the list of strategically essential medicines, we anticipate that this mechanism will provide substantial state support during procurement tenders. The “Second Supplier” rule will grant preferences to companies with localized production. The objective of this policy is clear: to reduce the dependency of Russian patients on external risks.
Another crucial issue is shifting the dynamics of the Russian active pharmaceutical substance (API) production. A robust domestic API manufacturing base is a guarantee of security for both the pharmaceutical market and patients across Russia and the EAEU. The implementation of a drug traceability system will support companies that have invested in API production. It will protect them having to face unfair competition.
The implementation of both the traceability system and the “Second Supplier” mechanism will serve as a catalyst for the development of the common EAEU pharmaceutical market.
