Federal Law N 206-FZ of July 13, 2020 “On amendments to certain legislative acts of the Russian Federation on the provision of citizens with medicines, medical devices, and specialized health food products” introduced several important changes to the Federal Law N 178-FZ of July 17, 1999 "On state social assistance" (hereinafter referred to as the Law on state social assistance), the Federal Law of 12 April 2010 N 61-FZ "On the circulation of medicines" (hereinafter referred to as the Law on the circulation of medicines), as well as the Federal Law of 21 November 2011 N 323-FZ "On the fundamentals of health protection of citizens in the Russian Federation" (hereinafter – the Law on the fundamentals of health protection of citizens). Federal Law N 206-FZ of July 13, 2020, comes into force on January 1, 2021, except some of its provisions.
The main changes concerned the provision of preferential categories of citizens with medicines, the procedure for putting medicines into circulation, and some issues of state registration of medical devices.
In more detail, we will give information about the changes made to the legislation.
Provisions on the provision of privileged categories of citizens with necessary medicinal products and medical products, as well as on the formation of the list of vital and essential drugs have been clarified
Amendments to the Law on state social assistance, as well as to the Law on the Circulation of Medicines, clarify that the provision of certain categories of citizens following the standards of medical care with necessary medicines for medical use is carried out in an amount not less than that provided for in the list of vital and essential medicinal products.
Recall that citizens who have the right to preferential drug provision include: war invalids, veterans of the Great Patriotic War, war veterans following the Federal Law “On veterans”, residents of besieged Leningrad, family members of the dead (deceased) disabled war veterans, participants in the Great Patriotic War and war veterans, disabled people, disabled children.
Currently, the List of Vital and Essential Drugs, approved by the Order of the Government of the Russian Federation dated October 12, 2019 N 2406-r, is in force.
Thus, the approved regional lists of medicinal products provided to the indicated categories of citizens free of charge or with a 50% discount, in terms of their volume, must correspond to the VED list (not less than this list).
These provisions come into force on January 1, 2021.
The wording regarding the procedure for approval of the VED list has also been changed. If earlier in the Law on circulation of medicines it was indicated that such a list is approved annually, now it is established that the list can be formed once and revised at least once a year. These changes come into force from the date of the official publication of the Federal Law dated July 13, 2020, N 206-FZ.
The Federal Register of citizens entitled to the provision of medicines, medical devices, and specialized health food products is being established
Amendments to the Law on the fundamentals of health protection of citizens, as well as to the Law on state social assistance, establish that the federal executive body maintains the Federal Register of citizens eligible to provide medicines, medical devices, and specialized health food products at the expense of federal budget and regional budget. At the same time, the authorities of the constituent entities of the Russian Federation maintain the regional segments of this register.
The Register contains such information as insurance number of an individual personal account; full name; sex; date of birth; floor; residence address; passport data; compulsory health insurance policy number; citizenship data; date of inclusion in the Register; diagnosis of the disease; the category of citizens eligible for preferential drug provision; information on the appointment and dispensing of preferential drugs, medical devices and specialized health food products.
Other information on the register and a more precise procedure for its maintenance is subject to the establishment by the Government of the Russian Federation.
The body that maintains the Federal Register of Persons Eligible for State Social Assistance (Pension Agency) is transferred to the Federal Register of citizens eligible for the provision of medicines, medical devices, and specialized health food products, as well as the operator of the unified state information system of social security (Pension Fund of the Russian Federation).
These provisions come into force on September 1, 2020.
Changes have been made regarding the establishment of introduction into civil circulation of medicinal products
Amendments have been made to the Law on the circulation of medicines in the sense that the Government of the Russian Federation is empowered to establish the specifics of the introduction into civil circulation of medicines for medical use produced in the period from July 1, 2020, to October 1, 2020. To bring medicinal products for medical use into civil circulation, except medicinal products intended to provide persons with orphan diseases, manufactured outside the territory of the Russian Federation before October 1, 2020, maybe imported into the Russian Federation before January 1, 2021, in the order established by the Government of the Russian Federation, without applying identification means.
Recall that the Government on June 30, 2020, adopted Resolution N 955 “On the features of putting medicines for medical use into civil circulation”, according to which, during the indicated transition period, medicinal products are introduced into civil circulation based on the approval of the Federal Service for Surveillance in Healthcare interdepartmental commission.
These changes come into force from the date of the official publication of the Federal Law N 206-FZ dated July 13, 2020 (July 13, 2020).
Amendments have been made regarding the designation of medical devices that are not subject to state registration
Amendments have been made to the Law on the basics of health protection If it was previously established that devices that are not subject to state registration are devices that are made according to individual orders of patients, to which special requirements are imposed on the appointment of medical workers and which are intended exclusively for personal use by a specific patient, as well as medical products intended for use on the territory of an international medical cluster or on the territories of innovative scientific and technological centers, then now such medical devices will include medical devices specified in paragraph 11 of Article 4 of the Agreement on uniform principles and rules for the circulation of medical products (medical products and medical equipment) within the Eurasian Economic Union (hereinafter - EAEU) dated December 23, 2014.
Namely, the following medical devices on the territory of the EAEU will not be subject to registration:
• imported by individuals for personal use;
• which are produced in the territory of a member state of the EAEU according to individual orders of patients exclusively for personal use;
• imported for use by employees of diplomatic missions and consular posts; imported for the provision of medical care to passengers and crew members of vehicles, train crews and drivers of vehicles arriving on the territory of the EAEU;
• to provide medical assistance to participants in international cultural, sports events and participants in international expeditions, as well as to hold exhibitions;
• imported for research (testing), including for scientific purposes; imported as humanitarian aid in cases determined by the legislation of the EAEU member states.
These provisions come into force on September 1, 2020.