FAS DRAFTED AMENDMENTS TO SOME ACTS OF SETTING MARK-UPS TO PRICES FOR MEDICINES
The relevant document is published on regulation.gov.ru for public discussion
The Federal Antimonopoly Service has drafted amendments to some acts of the Government of the Russian Federation that regulate prices for vital and essential medicinal drugs. The FAS initiative stems from adopting № 475-FZ Federal Law1. FAS proposals that formed the basis of the draft Governmental Decree concern setting and applying wholesale and retail mark-ups to drug prices and are designed to develop a uniform law-enforcement practice.
In particular, FAS made amendments to the procedure of setting ex-work prices for the drugs on the list of vital and essential medicines by wholesalers and retailers depending on the taxation system they use (the general taxation system and a simplified taxation scheme). The basis of the amendments is the explanation issued earlier by the antimonopoly authority and published on the FAS official web-site.
The antimonopoly body also proposes to delineate the procedure for establishing the maximum wholesale and retail mark-ups to the actual ex-works prices by regional executive bodies and the rules for setting ex-works prices on vital drugs by wholesalers, pharmacies, medical facilities and individual entrepreneurs.
Above all, FAS suggested establishing the procedure for rounding off fractional parts of kopeks by wholesalers and retailers in ex-works prices of drugs on the list of vital and essential medicines.
“It will eliminate legal uncertainty regarding allowed errors when rounding off mark-ups, thus, minimizing the risks of unreasonable fines upon wholesalers and pharmacies”, explains Nadezhda Sharavskaya, Deputy Head of FAS Department for Control over Social Sphere and Trade.
The antimonopoly authority also proposes to make changes to the Rules for maximum wholesale and retail mark-ups to the actual ex-works prices in the part on the specifics of selling drugs on commission agreements.
Reference:
№ 475-FZ Federal Law “On amendments to the Federal Law “On circulation of medicinal drugs” and the Federal Law “On amendments to the Federal Law “On circulation of medicinal drugs”” of 27.12.2019.