Limited Access for Russians on ADR Usage
In a significant move for the healthcare sector, a new law on dietary supplements has been adopted in Russia. This law, passed during the spring session, is set to have a profound impact on the healthcare system, particularly in the provision of expensive drugs for individuals with orphan diseases.
The implementation of this law is regulated through a coordinated framework involving the Ministry of Health, Rospotrebnadzor, and government resolutions. The key points of this regulation are as follows:
- The Government of the Russian Federation sets criteria for the quality and effectiveness of biologically active supplements, based on their impact on human health and regulates their use and registration procedures.
- The Ministry of Health, in conjunction with Rospotrebnador, establishes official procedures for prescribing these supplements, including approved indications and treatment schemes.
- Medical professionals prescribing dietary supplements must comply with restrictions defined in the Federal Law “On the Fundamentals of Health Protection of Citizens in the Russian Federation.”
- Legal provisions restrict access to certain information on retail sales of dietary supplements, especially those sold remotely, ensuring these sales comply with food safety and quality laws.
- Mandatory labeling and traceability systems have been extended to some groups of dietary supplements by mid-2025, using the Honest Sign scheme, which is part of a broader system for medicines and medical devices.
- The state consumer protection framework, overseen by Rospotrebnadzor, involves stringent control to ensure dietary supplements and associated information meet mandatory requirements, promoting safety and compliance.
Senator Elena Perminova has spoken about this important innovation in healthcare, emphasising the need for prescription-based dietary supplements and the dangers of self-prescription. She stated that while Russians often self-prescribe dietary supplements, it is not always beneficial for their health.
The law also includes a reserve mechanism for providing expensive drugs for individuals with orphan diseases. This reserve mechanism is activated in cases where the region cannot fulfill this obligation.
The medical and patient communities are awaiting clarification on the implementation of these recommendations for dietary supplements. The law on dietary supplements is a topic of interest in the "Parliamentary News" and is considered a significant innovation in healthcare.
In conclusion, the new law on dietary supplements in Russia is tightly regulated via government-established criteria, official medical guidelines for use, legal restrictions on sales and information, and enforced labeling and traceability systems, supporting consumer protection and public health safety. Supplements that do not meet these recommendations will not be allowed into circulation.
- This new law on dietary supplements in Russia will inevitably influence the health-and-wellness sector, as it mandates stringent regulation by the Ministry of Health, Rospotrebnadzor, and government resolutions.
- The new legislation in Russia regarding dietary supplements emphasizes the importance of prescription-based usage to ensure the safety and effectiveness of these supplements in maintaining individual health, particularly in areas like nutrition.
