Current issue #2, 2016

Nizhny Novgorod case

Russian regions cannot escape the “odd-man-out” regulation

On February 4, the Federal Arbitration Court of Volga-Vyatka region is to consider a cassation appeal of the Nizhny Novgorod region government and thus put an end to the dispute between the regional governments and the Federal Antimonopoly Service (FAS). At first sight, this is a routine case, but on closer examination this is the moment of truth. The Federal subjects’ governments practice setting up state enterprises authorized to be a unitary drug and medical device providers. As a result, purchasing is performed not pursuant to the Federal Law # 44 but under a rather liberal Federal Law # 223 that allows purchasing both based on trademarks and from a single vendor. The FAS has managed to prove in the court that this is malpractice.

[PharmVestnik # 2, 26/01/2016, p. 1, cont’d p. 2]

Excessive selfness

The Russian FAS has put forward another proposal on how to improve the local Pharma market. This time excessive drug registration requirements got the scolding, namely compulsory local clinical trials. In the FAS’ opinion, the latter have to be excluded from the registration process of the drugs already selling in the USA and the European Union. The Ministry of Health does not share the colleagues’ enthusiasm.

[PharmVestnik # 2, 26/01/2016, p. 3]

They sometimes come back

Roszdravnadzor follow-up calls to pharmacies threaten with license suspension

In January, information agencies spread that news about Health Minister Veronica Skvortsova’s statement regarding license termination for the pharmacies caught for the second time with overpricing the vital and essential drugs (VED). This statement has not come as unexpected for the pharmacy community. Back in October 2015, PharmVestnik already announced a draft regulation providing for new types of offences and sanctions for medical and pharmaceutical workers. No respective amendment has been approved so f...