Is compulsory licensing of generic medicines coming to the Russian Federation?

As discussed in previous posts, at least twelve countries have issued compulsory licenses for a variety of pharmaceutical pharmaceuticals (See, Part 1 and Part 2 of our series on compulsory licensing in India).  On December 19, 2014, S. Kalashnikov, the Chairman of the Committee of the State Duma for Health Protection, sent to D. Medvedev, the Prime Minister of the Russian Federation, a letter regarding compulsory licensing.  Given the current geopolitical and economic situation, the State Duma Committee for Health Protection is considering implementing compulsory licensing for certain high-tech and biotech medicinal products for the treatment of orphan diseases and disease having the greatest impact on mortality in the Russian Federation.  A translation of the letter is provided below.

To: PrimeMinister of the Russian Federation

D.A. MEDVEDEV

Dear Dmitry Anatolyevich!

Currently, some countries began to actively use the mechanism of compulsory licenses for the production of generic medicines before the expiration of patent protection for the original medicinal product (India, Brazil, Indonesia, Thailand, etc.). The governments of the aforementioned countries are supported by the provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the Doha declaration on the public health. According to these documents, compulsory licensing mechanism is applied in the case of severe social requirements and is used for the production of medicinal products to treat common serious diseases in the country such as AIDS, hepatitis, cancer, and also in the event of an epidemy.

In the current geopolitical and economic situation, the State Duma Committee for Health Protection deems it necessary to consider the implementation of compulsory licensing mechanism for the production of some high-technological and biotechnological medicinal products for the treatment of orphan (rare) diseases and diseases that have the greatest impact on mortality in the Russian Federation.

Sincerely  yours,

Chairman of the Committee

S.V. Kalashnikov

Please watch the BRIC Wall Blog for updates on compulsory licensing in the Russian Federation.

This post was written by Lisa Mueller.

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