Russia postpones compulsory licensing of imported drugs until December

Source: ThePharmaLetter | May 10, 2016

The Russian government has decided to postpone the introduction of a controversial scheme for the compulsory licensing of drugs imported into Russia, as proposed by some local drugmakers, reports The Pharma Letter’s local correspondent.

According to Alia Samigullina, an official spokesman of Arkady Dvorkovich, (Russia’s first deputy prime-minister, who oversees the development of pharmaceutical industry in the Russian government), a significant part of imported drugs with unexpired periods of patent protection is already produced within the territory of Russia, so there is a no need for the introduction of compulsory licensing scheme.

The initiative of compulsory licensing of drugs in Russia was for the first time put forward by Vikram Singh Puniya, head of Pharmasyntez, one of Russia’s leading drugmakers. According to him, such scheme is widely used in the BRICS (Brazil, Russia, India, China and South Africa) markets, in particular India and Brazil, and could be useful for Russia, which in recent years has faced with a shortage of some vital drugs.

According to the Russian Ministry of Health, the most complex situation is currently observed with the drugs for the treatment of hepatitis C (the number of patients in Russia with this disease is currently estimated at 3 million people), as well as with HIV, the majority of which are traditionally imported from abroad.

According to the Russian Health Ministry, the share of drugs under patent protection in the Russian market is currently estimated at about 15%, the majority of which are drugs from high-priced segment of the market.

Negative impact on investment expected

According to Arkady Dvorkovich, the use of compulsory licensing schemes in the domestic pharmaceutical industry may reduce the investment attractiveness of the industry and may result in the outflow of foreign investments from the Russian pharmaceutical market.

In the meantime, the latest decision of the state has already been criticized by the Russian Federal Anti-Monopoly Service (FAS).

According to Igor Artemyev, head of the Russian Federal Antimonopoly Service (FAS), the introduction of such scheme would help to solve the problem of a shortage of drugs in the domestic market. Mr Artemyev said the current international legislation provides an opportunity to national governments to limit the negative licensing practices used by some right holders.

Mr Artemyev comments: “We believe that antitrust laws may apply to some objects of exclusive rights, if the activities of right holders lead to monopolization of the market, while this monopolization has significant negative consequences on the level of competition in the market and for local consumers.”

It is planned that the Russian government may revise its decision of the suspension of the new scheme in November-December of the current year.

This entry was posted in Compulsory Licensing, Hepatitis C, Uncategorized. Bookmark the permalink.

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