Mandatory drug licensing could become a reality in Russia

| By | Drug Registration, Pharmaceutical Industry

Russian economist and the deputy prime minister for social affairs, Olga Golodets, prepared orders a project to develop a law that would give the government the authority to establish the procedure for issuing permits for industrial use of the drug without the permission of the patent holder. This is stated in the draft protocol of instructions following a meeting of the Council under the Government on welfare in the social sphere.

Council meeting will be devoted to issues related to the spread of HIV infection in Russia, is scheduled for Friday, 3 February; “Vedomosti” familiar with a copy of the draft protocol, federal officials confirmed the authenticity of its contents. Initiator of the proposal – the FAS, he knows.

Initially it was about preparation of normative-legal acts, which would have allowed compulsory licensing of antiretroviral drugs only, and the definition of lists of drugs, production of which would be to organize in Russia appropriate.

At the same time the Ministry of Industry considers it possible to introduce a mechanism of compulsory licensing of medicines that are not produced in Russia, if there is no other effective mechanisms to ensure citizens’ access to the drugs, said a ministry spokesman.

Currently, the public debate is already in the bill that allows the use of a patent without the consent of the copyright owner – solely for the purpose of national security. The document prepared by the FAS, stipulates that in the event of an emergency, the government may issue a permission to use a patent without the consent of the patent owner, notifying him about it as soon as possible and to pay adequate compensation to him.

Compulsory licensing may negatively affect the investment climate, and it does not necessarily lead to lower prices for drugs when compared with other alternative mechanisms. An alternative mechanism – it is, for example, price negotiations with manufacturers. A similar approach is used in many developed countries, whose markets are attractive to drug manufacturers. In such cases, at the level of the contract signed between the country’s government and drugmakers fixed supply of drugs in a fixed amount and a fixed price for a specific time period.