The new draft law "On Circulation of Medicines" will create equal opportunities for both Russian and international producers.
"The main conceptual point of the draft law is to equalise conditions in the market for domestic and foreign producers. The current situation is one of discriminatory access for Russian producers," said the head of the Ministry of Health and Social Development, Tatiana Golikova, after consideration of the bill in the State Duma.
Foreign manufacturers are concerned that if the new law is adopted the process for registering medicines will be delayed, because clinical research in Russia will become mandatory for foreign companies.
Tatiana Golikova has suggested to foreign companies "in the appropriate phases of clinical trials to come to Russia and conduct their research, thereby bypassing the need for additional clinical trials in Russia."
The first reading of the new bill will be considered in the State Duma on 29 January. According to Tatiana Golikova, wide-ranging discussion raises the question of government regulation of prices. "It is essential that our administrative actions do not lead to a deterioration of the situation," the minister said.
The first reading will be followed by a one month break, during which representatives of various departments and regions will discuss the bill in detail.
Tatiana Golikova also hopes that in the near future the issue of selling biologically active additives (BAA) will be resolved. "BAAs are not subject to regulation by the law ‘On Circulation of Medicines’," warned the head of department. "They fall under food products legislation, but, nevertheless, are sold in hospitals and pharmacies.
According to Ms. Golikova, the issue is linked to the new bill and, one way or another, will be presented for discussion at the second reading.