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A step towards compulsory licensing in Russia

A step towards compulsory licensing in Russia

25.11.2019
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The protection of intellectual property rights in the pharmaceutical industry today has gained particular importance. Thus it is not surprising that the question of the application of compulsory licensing has been raised many times over the past few years. It was debated at the VI BRICS Competition Conference and was once again discussed at the V International Scientific and Practical Conference on Antitrust policy: science, practice, education in Skolkovo.


In Russia, the debate had reached its peak when a bill was introduced in the State Duma of the Russian Federation on the introduction of a mechanism for compulsory licensing of medicines by The Federal Antimonopoly Service (FAS). 


It is reported that the Deputy Head of the Legal Department of the Antimonopoly Service, Igor Antonov, spoke about introducing a bill to the State Duma on the introduction of a new version of Art. 1360 of the Civil Code of the Russian Federation on compulsory licensing.


The new changes in the law are supposed to give the Government of Russia the right, "in case of emergency, related to ensuring the defence and security of the state, protecting the life and health of citizens". to decide on the use of an invention, industrial design, etc. without the consent of the patent holder with his notification of this decision of the Government of the Russian Federation as soon as possible and with payment to the patent holder of compensation.


As previously explained by the head of the FAS Igor Artemyev, first of all, the innovation concerns drugs for people with incurable diseases. If a foreign company holding a patent for medicines will "unreasonably" raise prices or directly refuse to supply to the Russian Federation, then the government will be able to issue a permit for its production to the Russian company.
The world already has a practice of compulsory licensing of drugs. Many countries introduced compulsory licensing, but the method of its application varies greatly. For example, in India, patent protection has ceased to affect several drugs, including for the treatment of hepatitis C. In the USA, various forms of compulsory licensing are actively used precisely as a tool to stimulate innovation and an integral element of the system of checks and balances, ensuring the effective operation of the institution of intellectual property.


The Director of the BRICS Competition Law and Policy Centre - Alexey Ivanov agrees that innovation for the society and well-being of the consumer, especially in such critical markets, should be the priority. Thus, compulsory licensing should be adopted more widely and enforced more often in cases that require intervention.


Overall, it is evident that a dynamic competitive environment based on broad access to knowledge and technologies can be achieved through the effective use of antitrust policy tools, including such as compulsory licensing. Many international experts and scientists note that excessive unbalanced protection of intellectual property can impede the development of innovation and scientific and technological progress. In this regard, measures to protect intellectual property must be balanced by appropriate capabilities and must stimulate innovation. The step towards introducing proper compulsory licensing in pharmaceutical markets in Russia is a step towards the new better-balanced market.