Current issue #22, 2015

Isle of luck

Minpromtorg has no doubts about its rights to GMP

According to the Ministry of Industry and Trade (Minpromtorg), in August the Russian Government is to approve draft regulations that will capture the right of the ministry and Federal Budgetary Institution “State Institute of Drugs and Good Practices” (FBI GILS and NP) subordinate to the ministry to inspecting local and foreign manufacturing sites and issuing GMP certificates. This is confirmed, among other things, by the public roundtable discussion hosted by Minpromtorg last week and moderated by FBI GILS and NP Director Vladislav Shestakov. Minpromtorg representatives stated with confidence that it will be GILS that will be responsible for inspecting foreign manufacturing sites starting from January 2016, whereas local sites will be inspected within the framework of license control procedures, which is part of the ministry’s authorities. This means that the attempt by the Federal Antimonopoly Service and Ministry of Health to make the Federal Service for Surveillance in Healthcare and Social Development the “GMP inspector” has failed.

[PharmVestnik # 22, 14/07/2015, p. 1, cont’d p.4]

Virtual pill

A fierce struggle is gaining ground around the drug internet trading. PharmVestnik found out what to expect from legislation on this issue in the nearest future.

[PharmVestnik # 22, 14/07/2015, p. 2]

Ministers’ rally

Moscow hosted the 2^nd meeting of health ministers of Shanghai Cooperation Organization member-states

On the 7^th of July, after a five-year break, Moscow hosted a meeting of health ministers of Shanghai Cooperation Organization member-states who came together again to discuss public health issues. Russia’s Minister of Health Veronica Skvortsova who participated in this meeting observed that “a rather interesting plan for future” had been outlined in the course of discussion.

[PharmVestnik # 22, 14/07/2015, p. 3]

Third party’s secret

May drug manufacturers advertize their products for distributor’s benefit?

Last week, the media went frenzy about a judicial precedent: Astellas Pharma, an international pharmaceutical manufacturer promoting its products on its own, was made to pay an advertizing expenses tax as these expenses were incurred in favor of a third-party exclusive distributor. There are a lot of foreign companies operating in Russia that may be charged with similar taxes. PharmVestnik observer Elena Kalinovskaya asked Pepelyaev Group Senior Partner Rustem AKHMETSHIN for a comment....