Current issue #8, 2016

Rating of most influential subjects of the Russian Pharma market, 2015

Awards in some key industries are not as heavily covered by mass media as Oscar, Grammy or Nobel Prize; however, they are unfailingly under scrutiny of market professionals. The Russian Pharma industry conducts an annual expert opinion poll in order to determine the most influential subjects of the industry. PharmVestnik presents the results of the Influence Rating as of 2015.

[PharmVestnik # 8, 07/03/2016, p. 1, cont’d pp. 4-6]

Fee calculation methods for foreign drug manufacturing site audits have not been canceled

The methods of calculating fees for foreign drug manufacturing site audits had been heavily criticized by the professional community even before they were tested in practice. The fact that the document approving such methods has come into force has not prevented certain experts from insisting on its revision and consequently on changing the audit fee arrangement. The Federal Antimonopoly Service (FAS) held a closed meeting on the issue, but an attempt to calculate fees based on different methods has failed as the cost of the Russian GMP compliance audits has gone up instead of being reduced.

[PharmVestnik # 8, 07/03/2016, p. 2]

FAS cautions MoH

The FAS charged the Russian Ministry of Health with violation the law “On protection of competition” and called on the latter to remedy the violation. According to the FAS, the MoH was overdoing when making amendments to the State Registry of Maximum Drug Sale Prices thus putting obstacles to adequate operations of drug manufacturers.

[PharmVestnik # 8, 07/03/2016, p. 3]

Good cause

A way to preserve cheaper drugs on the market was found back in early February

The Ministry of Industry and Trade (Minpromtorg) maintains that there is no need in heavy regulation of prices for cheaper drugs. This was the ministry’s response to the government’s request for developing actions supporting manufacturers in the low-cost drug segment. The manufacturers themselves asked to deregulate prices. However, it looks like there is no consensus among the relevant ministries.

[PharmVestnik # 8, 07/03/2016, p. 3]

A license controversy

Minpromtorg filed a lawsuit against Pharm-Sintez

On March 9, Moscow Arbitration court will initiate hearings on the Ministry’s of Industry and Trade lawsuit against ...