Federal Law No. 206-FZ dated July 13, 2020, “On Amending Certain Legislative Acts of the Russian Federation on Provision of Citizens with Medicines, Medical Devices, and Specialized Health Food Products,” introduces several significant amendments to Federal Law No. 178-FZ “On State Social Assistance” (hereinafter—the Law on State Social Assistance), Federal Law No. 61-FZ “On the Circulation of Medicines” (hereinafter—the Law on the Circulation of Medicines), and Federal Law No. 323-FZ “On the Basics of Health Protection of Citizens in the Russian Federation” (hereinafter—the Law on the Basics of Health Protection). Federal Law No. 206-FZ enters into force on January 1, 2021, except for certain individual provisions.

The core amendments modify the provision of medicines to privileged categories of citizens, the procedures for introducing medicines into commercial circulation, and specific aspects of state registration for medical devices.

This legal alert provides a detailed overview of the legislative amendments enacted by the new framework.

Refined Provisions on the Scope of Essential Medicines and Medical Devices for Privileged Categories and VED List Formation

Amendments to the Law on State Social Assistance and the Law on the Circulation of Medicines clarify that the volume of essential medicines provided for medical use to certain categories of citizens, in compliance with medical care standards, must not fall below the scope established by the Vital and Essential Drugs List (VED List).

To recap, the categories of citizens entitled to subsidized drug provision include disabled war veterans, participants of the Great Patriotic War, combat veterans under the Federal Law “On Veterans,” residents of besieged Leningrad, family members of deceased disabled war veterans, participants of the Great Patriotic War, and combat veterans, as well as disabled adults and disabled children.

The current VED List was approved by Russian Government Decree No. 2406-r dated October 12, 2019.

Consequently, regional authorities must ensure that regional lists of medicines provided to these categories of citizens free of charge or at a 50% discount fully align in scope with the VED List (and must not be narrower than the federal list).

These provisions take effect on January 1, 2021.

Furthermore, the legislature modified the wording regarding the approval procedure for the VED List. While the Law on the Circulation of Medicines previously stipulated that the list must be approved annually, the new rules establish that the list can be compiled once and must be revised at least once a year. These changes enter into force on the official publication date of Federal Law No. 206-FZ.

Establishment of the Federal Register of Citizens Entitled to State-Funded Medicines, Medical Devices, and Specialized Health Food Products

Amendments to the Law on the Basics of Health Protection and the Law on State Social Assistance mandate that a federal executive body shall maintain the Federal Register of Citizens Entitled to Medicines, Medical Devices, and Specialized Health Food Products funded by the federal budget and the budgets of the constituent entities of the Russian Federation. Concurrently, regional authorities shall manage the regional segments of this register.

The register contains data such as: SNILS (Insurance Number of Individual Ledger Account); full name; date of birth; gender; residential address; passport details; compulsory health insurance (CHI) policy number; citizenship data; the date of inclusion in the register; diagnosis; the category of eligibility for subsidized medicine provision; and information on the prescription and dispensing of subsidized medicines, medical devices, and specialized health food products.

The Government of the Russian Federation will establish other data to be included in the register and specify a more detailed procedure for its maintenance.

The authority maintaining the Federal Register of Persons Entitled to State Social Assistance (the Pension Fund of the Russian Federation) and the operator of the Unified State Social Security Information System (the Pension Fund of the Russian Federation) transfer relevant data to the Federal Register of Citizens Entitled to Medicines, Medical Devices, and Specialized Health Food Products.

These provisions take effect on September 1, 2020.

Amendments to Specific Procedures for Introducing Medicines into Commercial Circulation

The legislature introduced supplements to the Law on the Circulation of Medicines, empowering the Government of the Russian Federation to establish special rules for introducing medicinal products manufactured between July 1, 2020, and October 1, 2020, into commercial circulation. For the purpose of market introduction, medicinal products (excluding those intended for patients with orphan diseases) manufactured outside the Russian Federation before October 1, 2020, may be imported into Russia until January 1, 2021, without identification marks (serialization), subject to the procedure established by the Government of the Russian Federation.

To recap, the Government adopted Resolution No. 955 on June 30, 2020, “On Specific Aspects of Introducing Medicinal Products for Medical Use into Commercial Circulation.” According to this resolution, during the specified transition period, the market introduction of medicines requires approval from an interdepartmental commission established within the Federal Service for Surveillance in Healthcare (Roszdravnadzor).

These changes enter into force on the official publication date of Federal Law No. 206-FZ (July 13, 2020).

Supplements Specifying Medical Devices Exempt from State Registration Under the EAEU Framework

Amendments have been introduced to the Law on the Basics of Health Protection. Previously, state registration was not required for custom-made medical devices manufactured to individual patient specifications under medical prescriptions for exclusive personal use, or for medical devices intended for use within an international medical cluster or innovative scientific and technological centers. Now, exempt medical devices will also include those specified in paragraph 11 of Article 4 of the Agreement on Single Principles and Rules for the Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Eurasian Economic Union (EAEU) dated December 23, 2014.

Specifically, the following medical devices are exempt from registration within the EAEU territory:

• imported by individuals for personal use;

• manufactured within an EAEU member state based on individual patient orders exclusively for personal use;

• imported for use by employees of diplomatic missions and consular offices;

• brought in to provide medical assistance to passengers, crew members, train crews, and vehicle drivers arriving in the EAEU territory;

• utilized for providing medical care to participants of international cultural or sporting events, international expeditions, or for exhibitions;

• designated for conducting research (testing), including for scientific purposes;

• supplied as humanitarian aid in cases defined by the legislation of EAEU member states.

These provisions take effect on September 1, 2020.