Current issue #4, 2018

Rosta under credit watch

For nearly a decade, Rosta was a TOP4 national pharmaceutical distributor. However, in 2017, the company was quick to fall out from the top ranks. Now, quite a few pharmaceutical manufacturers try to recover their assets as Rosta keeps sinking deeper. Some experts believe that it was the creditors’ impatience that triggered off the snowball effect of the action for debt. PharmVestnik seeks to sort the situation out.

[PharmVestnik # 04, 06/02/2018, p. 1-2]

// Health Strategies

FAS rejects MoH’s Healthy Lifestyle Strategy

The draft Healthy Lifestyle Strategy Until 2025 aimed at a 25% reduction of mortality caused by non-infectious diseases has caught heat one more time. In October 2017, the Federal Antimonopoly Service (FAS) of Russia criticized the previous draft strategy version. Now the FAS states that the observations have not been considered in the finalized document. While being fiercely critical, the antitrust agency proposes mechanisms to implement certain strategic provisions. E.g., the FAS rejects putting a ban on selling alcohol products but proposes a solution through adding emetic agents to such products.

[PharmVestnik # 04, 06/02/2018, p. 3]

// Regulatory & Legal – General

Interchangeable drugs determined in Russia with some matters still outstanding

Since 1 January 2018, the National Drug Register includes a new entry, i.e. interchangeability. Whether this concept puts the record straight is still unclear. The Federal Antimonopoly Service pursues its own research and declines to comment. What the public procurement authorities have to do in the meantime is unclear, too. Finally, the dosage form interchangeability remains an open question.

[PharmVestnik # 04, 06/02/2018, p. 3]

// Regulatory & Legal – Dietary Supplements

Supplements market to undergo revision

In the Healthcare Competition Development Road Map drafted by the Federal Antimonopoly Service and adopted by the Russian Government in January 2018, there is a special focus on the dietary supplements market. Pursuant to this document, before September 2018, the regulatory environment in the dietary supplements area needs to be improved through imposing a ban on marketing authorization of dietary supplements containing pharmaceuticals. However, certain experts consider the development of additional regulations a redundancy and propose granting wider market monitoring powers to the Federal Service for Consumer Rights Protection and Huma...