Order No. b2229-р, dated October 22, 2016. 160 types of medical products have been added to the List of medical products subject to implantation into the human body. Decisions have been adopted to facilitate medical aid within the framework of the program of state guarantees for free medical care of the Russian citizens and provision of social services package.

Background.

Federal Law No. 323-FZ “On Principles of Healthcare for Citizens of the Russian Federation”, dated November 21, 2011 (hereinafter referred to as the Federal Law No. 323-FZ), stipulates that citizens receiving medical aid within the framework of the program of state guarantees are provided with medical products included into the Government-approved List of medical products subject to implantation into the human body.

Federal Law No. 178-FZ “On State Social Assistance”, dated July 17, 1999, stipulates that certain categories of citizens are provided with a social services package, which includes prescription medical products.

By Order No. 2762-р, dated December 29, 2014, the Government approved the list of medical products implanted into the human body and the list of prescription medical products included into the social services package (hereinafter referred to as the lists). These lists contained 202 types of implants, three types of prescription medical products included into the social services package and used for blood glucose control.

According to the Rules for Making Lists of Medical Products (approved by Government Decree No. 968, dated September 22, 2014), lists shall be reviewed as often as once every two years.  By signing the above order revised lists have been approved. 160 types of medical products have been added to the List of medical products implanted into the human body. Three types of medical products, which are not defined as implants per current classification of medical products by type, have been deleted from the list. Two items (“glucose for in vitro diagnostics, reagent” and “lancet tip”) have been added to the list of prescription medical products included into the social services package. Per Federal Law No. 323-FZ, maximum sale prices set by manufacturers and maximum wholesale mark-up to actual sale prices for medical products included into the list of medical products subject to implantation into the human body, shall be subject to government control. Federal Law No. 286-FZ, dated July 3, 2016, stipulates that prices and mark-up on medical products used for preparation for implantation, prevention of surgery complications, delivery, fixation and removal of medical products implanted into the human body, shall not be subject to government control effective January 1, 2017. Therefore, such medical products will be identified by a special mark. Decisions have been adopted to facilitate medical aid within the framework of the program of state guarantees for free medical care of the Russian citizens and provision of social services package.