OREANDA-NEWS. September 20, 2013. Stated the Head of FAS Department for Control over Social Sphere and Trade, Timophey Nizhegorodtsev at the 23rd session of the Headquarters for Joint Investigations presenting a Report on the state of competition on the markets of medical drugs in the CIS, drafted together with the antimonopoly authorities of Kazakhstan, Mild ova, Ukraine, Belarus, Kyrgyzstan, Armenia and Tajikistan.

“While generics constitute the most part of a pharmaceutical market in any developed country in the world, in the CIS original drugs took the most expenses. Even after patent protection of original drugs expires, their sales in the CIS often remain the same, or changes insignificantly. In the markets in question generics do not fully compete with original drugs”.

The primary reasons are that the issues of drugs substitutability are not regulated in the CIS; unequal requirements to the quality of all drugs circulating in the markets; inadequate authorization procedures; in sufficient efficiency and poor control over the pharmaceutical industry; incorrect cooperation between pharmaceutical companies and the medical community; unreasonably encouraged across society stereotypes about considerable differences in therapeutic effect and safety between original drugs and generics.

To resolve the problems it is necessary to work out fair, transparent regulatory rules including medicines authorization; reduce administrative barriers for entry of medicines to the market, especially under international non-proprietary names under which only one trade name is registered; introduce a concept and clear criteria of drug substitutability in the national normative legal framework, the GMP standards; increase control over pharmaceutical markets to ensure safety and quality of circulating drugs; improve the practice of public competitive bidding for purchasing medical drugs and harmonize the pharmaceutical markets across the CIS through establishing unified approaches, guidelines, methods, requirements for drug quality, packaging, marking, advertising.

“Reducing prices and saving budgetary funds is impossible without developing competitive conditions on the pharmaceutical markets through approaching the issues of medicines substitutability. The level of drug prices and their availability to the population will depend on how the issue will be resolves in each CIS country”, emphasized Timophey Nizhegorodtsev.