Current issue #21, 2016

Experts concerned about slowdown of international clinical trials in Russia

Since the moment of the approval of the Federal Law # 61-FZ “On drug circulation” in 2010, there has been a trend in Russia towards a reduction in the number of international multicenter clinical trials. Companies either fail to receive approvals altogether, or approvals are issued too late. As a result, Russia loses a large number of trials related to new drugs and, together with that, the very opportunity of their launch on the Russian market. Besides, potential investments circumvent the pharma industry.

[PharmVestnik # 21, 28/06/2016, p. 1, cont’d p. 3]

Turning to exports

Import substitution stops being key objective for Russian pharma

The Ministry of Industry and Trade made an official statement that export would become the topic # 1 shortly. The ministry is developing special actions to support the local pharma businesses ready to export. According to Deputy Minister of Industry and Trade Sergey Tsyb, Russian manufacturers already have export-quality products. Therefore the discussion regarding drug registration abroad that took place within the framework of the conference “Regulatory aspects of drug development” (Skolkovo, last week) demonstrated that businesses were interested in getting access to international markets.

[PharmVestnik # 21, 28/06/2016, p. 2]

Specifically for Pharma

The list of violations extended

On June 21, the State Duma approved in the first reading a draft law “On amendments to the Russian Administrative Offense Code in respect of improvement of administrative responsibility in healthcare”. The novelties embrace not only medical aid but also drug sales.

[PharmVestnik # 21, 28/06/2016, p. 3]

Experts discussed state policy regarding drug sales

The pharmaceutical session of the 20^th St. Petersburg International Economic Forum (June 16—18) was the arena for discussion of a number of key industry-specific issues. However, the discussion was full of contradictions.

[PharmVestnik # 21, 28/06/2016, p. 4]

Right there and then

Drug coverage problems require immediate solutions

The conference “Up to date drug coverage of treatment and prevention of socially important diseases — LekPomoshch (Drug Aid) 2016” attracted participation of representatives of more than 40 Russian federal subjects. They focused on drug coverage of specific socially important diseases as well as access of patients to high-cost, innovative, and orphan drugs. The federal subjects presented the...