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Russia Proposes Clarifying Rules for Using Patented Medicines in Research

A bill has been submitted to the State Duma that would allow patented medicines to be used for scientific research and experiments before the patent expires. The purpose of such activities would be to prepare for the state registration of generic medicines.

According to the bill’s authors, the initiative could support the development of Russia’s domestic pharmaceutical industry and improve access to medicines for the population.

The draft law establishes the possibility of conducting research and experiments required to obtain authorization for the use of a medicine. Such activities would not be considered an infringement of the patent holder’s exclusive rights.

The proposal is similar to the so-called Bolar provision used in international practice. This rule allows a patented invention to be used for preparations to launch a generic medicine after the patent has expired.

Earlier, Russian Health Minister Mikhail Murashko said that around 6 billion packages of medicines enter civilian circulation in Russia each year, with nearly 72% produced domestically. According to him, about 80% of medicines included in the list of vital and essential drugs are also manufactured in Russia. Over the past 10 years, more than 80 new pharmaceutical production sites have opened in the country, and over 520 companies now hold licenses to manufacture medicines.

Source: GxP News, May 18, 2026.

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