“Inpharma”: the “Patent on the Shelf” mechanism will be applied only when a foreign pharmaceutical company leaves the Russian market

The State Duma explained to foreign pharmaceutical companies under what conditions the “Patent on the Shelf” mechanism will operate, allowing Russian companies to develop drugs that are already protected by foreign patents in the country. According to Vadim Kukava, executive director of the Association of Pharmaceutical Companies Infarma, he received confirmation in response to his public request that the mechanism will only be applied if Western companies leave the Russian market. Mr. Kukava stressed that so far there are no such prerequisites.

The Inpharma Association includes drug manufacturers such as AstraZeneca, Bayer, Merck, Phizer, Roche and others.

According to Mr. Kukava, the Ministry of Industry and Trade is preparing to issue a resolution regulating the operation of the mechanism at the end of March – in April. “We analyzed this document, we see certain risks there, we wrote to the government about it. But in response to my public question in the Duma, it was once again confirmed that this mechanism will be applied when and if Western manufacturers start to leave the market,” he said during the conference. “Pharma and healthcare: tasks of the new time”organized by Kommersant.

Vadim Kukava also said that the dialogue between foreign companies and the Russian authorities continues. According to him, the risk that some of them will leave Russia or withdraw their drugs from the market is minimal. At the same time, the expert supported the efforts of the state to develop measures similar to the “Patent on the Shelf”, according to him, this is necessary so that the drugs can be quickly replaced.

The development of an initiative to create analogues of drugs under patent protection became known in the summer of 2022. As stated in project According to the relevant resolution of the Ministry of Industry and Trade, up to 100% of the labor costs of employees involved in the implementation of the project for the development of such drugs, the purchase of equipment and other expenses can be compensated with the help of a subsidy. According to information “Pharmvestnik”they were going to allocate more than 3 billion rubles from the budget.

What other problems with patents were pointed out by foreign pharmaceutical manufacturers – in the material “Kommersant” “Patents do not fit into the registry”.