Russian Ministry of Health completed its work on the bill to amend the Federal Law “On Circulation of Medicines” which provides, in particular, for the establishment of a register of interchangeable drugs. It may be enacted from January 1, 2019.
The public discussion of the bill will continue until May 14. In addition, it should be approved by the Federal Antimonopoly Service (FAS).
“The bill was received by the FAS of Russia and is under consideration,” said the press service of the antimonopoly agency.
In fact, it was FAS who initiated the establishment of the register. In December 2016, the antimonopoly service prepared its proposals and sent them to the Ministry of Health, which began to work on the bill.
All this was the result of a dispute between Biocad and Teva on interchangeability of their glatiramer acetate medications for the treatment of multiple sclerosis. At that time, FAS took the side of Biocad and demanded that its regional bodies monitor the compliance with the clarifications provided by the agency with regard to interchangeability of drugs during public bidding procedures. However, Teva filed a lawsuit with the Supreme Court of Russia, which limited the ability of FAS to adopt such decisions on medicinal products.