Forced licensing and price reduction for medicinal drugs will increase coverage of patients under the “AIDS and Hepatitis Programme”

Speaking at the Advisory Council of the VI International Conference on HUV / AIDS in Eastern Europe and Central Asia, Deputy Head of FAS Department for Control over Social Sphere and Trade, Nadezhda Sharavskaya stated that FAS insists on including the mechanisms of forced licensing and measures towards reducing drug prices in the action plan for the “Strategy to counter HIV-infection incidence”.

Executing instructions from the Government of the Russian Federation, the Federal Antimonopoly Service (FAS Russia) drafted a law designed to prevent possible violations by drug patent owners that threaten life and health of the population, support national security and create favourable environment for developing competition. The draft law provides for amendments to the Federal Law “On Protection of Competition” and the Civil Code of the Russian Federation.

“The proposed amendments reduce dependence on foreign patent holders, which, in its turn, will increase the level of national economic security. Apart from the amendments to the Federal Law “On Protection of Competition”, the draft law introduces a new version of Article 1360 of the Civil Code, which provides for the Government to issue permissions for use of patent objects without consent from patent holders not only in the interests of national defence and security but also to protect life and health of the population”, said Nadezhda Sharavskaya.

Apart from high prices for patented drugs, there is an issue of overrates costs of drugs that do not have patent protection. In FAS opinion, to pursue the “Strategy to counter HIV-infection incidence”, there should be mechanisms for looking for suppliers of affordable drugs not only within Russia but also abroad with a possibility of fast-track registration and recognizing international drug registration with post-registration follow up. “FAS insists on including these mechanisms in the plan since it will increase patient coverage with adequate treatment”, emphasized Deputy Head of FAS Department for Control over Social Sphere and Trade.

Following the order from the President of the Russian Federation, FAS is currently conducting the second stage of international comparative analysis of prices for expensive drugs: studying prices for 43 drugs with International Non-Proprietary names on the list of the “AIDS and Hepatitis Programme”  in 39 countries. In Russia 852 drug positions are registered under the above International Non-Proprietary with various presentations, dosages and packaging. The survey findings will expose incidents of overrated drug prices and enable to take the appropriate measures. It is expected that the survey of the drugs on the “AIDS and Hepatitis Programme” will be completed by the end of the year.