For the Purpose of National Safety
Igor Artemiev, Head of Federal Antimonopoly Service at the V International Conference on HIV/AIDS in the Eastern Europe and Central Asia, held in Moscow, Center of International Trade on March 23-25, reported on potential introduction in Russia of obligatory licensing of essential foreign drugs.
Igor Artemiev remarked that it was a compulsory measure and it is used for the purpose of national safety. Russia’s dependence on manufacturers of patent drugs lacking generics, prevents guaranteed supply of population with high quality and accessible drugs. That is the reason why changes determining cases of potential issue of the corresponding compulsory licensing with fair market compensation to patent owner were proposed.
The use of mechanism of compulsory licensing, according to Igor Artemiev, is possible in the following cases, if the drug delivery failed for political motives, because of unprofitability in the territory of the Russian Federation, as well as for shortage of budget in case of epidemics of highly dangerous infections, with treatment impossible without drugs under patent protection.
The head of the Russian FAS also remarked, that Clause 31 of Agreement on Trade Aspects of Intellectual Property Rights (TAIPR) in some cases warrants some countries to use objects of patent without consent of their owners, with corresponding reimbursement to owner. There are corresponding examples in the international practice.
The Institution offers to introduce a scheme where the antimonopoly organ based on commission of the Government will be able to file a lawsuit to a corresponding company, with court taking a decision on issue for a definite term of compulsory patent protection, and after that authorized laboratories may begin synthesis of one or another drug.
Currently the legislation provides issue of compulsory license according to decision of court based on Clause 1362 of the Civil Code of the Russian Federation. “As we analyze as a whole conditions of availability of this drug, we should acknowledge that it is practically not applicable and therefore it has not yet been used in the Russian Federation”, clarified Mr. Artemiev.