Russia. The Government approves the program for Pharmaceutical and Medical Industry Development for 2013–2020

A new edition of the State Program Development of the Pharmaceutical and Medical Industry for 2013–2020 has been approved. The respective Resolution No. 305 dated April 15, 2014 was signed by Prime Minister Dmitry Medvedev.

The goals of the Program are:

• to set up the world-class innovative Russian pharmaceutical and medical industry,
• to organize the production of generic and innovative drugs for treatment of socially significant diseases,
• to organize the production of hi-tech medical devices,
• to harmonize the Russian legislative and regulatory acts with international standards in the area of circulation of pharmaceuticals and medical devices,
• to effect the transition of the pharmaceutical and medical industry to the innovation-based development model.

Unlike the Federal State Program “Development of the Pharmaceutical and Medical Industry of Russia for the Period to 2020 and the Future Perspective”, the new contains more specific development programs for the pharmaceutical industry, in particular, separate sub-programs were developed to regulate the manufacturing of pharmaceuticals, medical devices, and also the legal framework governing the pharmaceutical sector.
The financing targets respect the non-budget funding were reduced as compared to the Pharma-2020 Program.

Some of the industry development KPIs established by Pharma-2020, such as volume of medical devices and pharmaceuticals export, and also the number of pharmaceutical enterprises having upgraded their production facilities, did not change materially.

At the same time, the structure of the KPIs for special-purpose programs was changed, in particular, new targets were introduced, e.g.:

• “total investments in R&D, technology innovations and upgrade of the manufacturing facilities for production of pharmaceuticals and medical devices”,
• “the share of pharmaceutical drugs manufactured in Russia in total consumption volume”,
• “the index of pharmaceuticals production”,
• “the share of medical devices manufactured in Russia in the total consumption volume in Russia in monetary terms”.

The State Program was prepared by the Ministry of Industry and Trade of Russia.

Source: KPMG-Russia