Current issue #7, 2017

MoH promises free drugs for all Russian citizens

Several important statements on the Russian healthcare system were made within the framework of the international investment forum Sochi-2017, one of them – by Health Minister Veronica Skvortsova. She declared that the Ministry of Health was working on a concept of such type of pharmaceutical insurance that would provide for including all Russian citizens into a free drug coverage system. It is planned to reimburse the drug costs partially or fully in the outpatient treatment system.

[PharmVestnik # 07, 07/03/2017, p. 2]

Wording worth a million rubles

API data regarding local drugs to be included into the Federal Drug Register automatically

A bill providing for amendments to the Federal Law # 61 “On drug circulation” was introduced to the State Duma. The deputies proposed to spell out more accurately the MoH’s responsibility to enter the data on the API constituting a medicinal product into the Federal Drug Register, namely, to substitute the wording “must enter” for “must include” in paragraph 3, part 1, article 27 of the above law. Drug manufacturers assert that this new wording will save them millions of rubles.

[PharmVestnik # 07, 07/03/2017, p. 3]

Online drug sales authorization enters final straight

All of a sudden, the Russian MoH published a draft government resolution describing an online drug sales procedure. This brought hope that online pharmacies would be authorized already this year. The MoH’s proposals are well-received by experts overall, however some of them need follow-up revision.

[PharmVestnik # 07, 07/03/2017, p. 4]

On the verge of “colossal changes”

Officials answered pharma players’ questions at breakfast meeting

On February 22^nd, the breakfast meeting hosted by the Russian Chamber of Commerce and Industry brought together representatives of the pharma industry, authorities, and professional public associations. The agenda included pharma regulation issues, and the top speaker was Mikhail Murashko, head of the Federal Service for Surveillance in Healthcare and Social Development. Mr. Murashko declared the beginning of “colossal changes” in the healthcare oversight system that were largely associated with the EAEC regulation coming into force. Businesses were mostly concerned about medical device registration, Drug Master File amendments, speeding up the marketing authorization procedure for subsidized innovative drugs, mandatory licensing, warranties on special investment contracts, GP...