Drugmakers oppose tightening of requirements for launch of generics in Russia

Leading Russian drugmakers and foreign companies operating in Russia have opposed the introduction of amendments to the existing  rules for registration and examination of drugs in the domestic market which create a single register of patented active ingredients in the market of Russia as well as some other post-Soviet states, reports The Pharma Letter’s local correspondent.

According to producers, the introduction of amendments means that further registration of generics in Russia will depend on the existence of patent rights for the original drug. As producers believe this is considered unacceptable in countries with a developed regulatory system, where only the court can determine whether a patent is breached by a manufacturer of a generic drug.

They also said the adoption of such norms will be within the interests of certain pharmaceutical producers that oppose fair market competition and have strong relations in the Russian federal government.