State Duma rejects bill for accelerated market entry of generics

0
144

During the plenary session on March 20, State Duma deputies rejected a bill in the first reading that aimed to simplify the market launch of generic drugs produced by companies from unfriendly countries, meaning the existing procedure for introducing these drugs will remain intact. As a result, patients may continue to pay higher prices for medicines, and the government faces potential losses in public procurement.

The bill, developed by parliamentarians Fedot Tumusov and Sergey Kabyshev from A Just Russia — Patriots — For Truth party, proposed amendments to Article 1359 of the Civil Code of the Russian Federation. It aimed to establish that the development, preclinical and clinical research, state registration, production, and setting the maximum selling price for generics would not constitute a violation of the exclusive rights to original medicines. The authors argued that this change would accelerate the introduction of more affordable analogues of imported medicines once their patents expire.

Tumusov noted that the state loses more than 10 billion rubles annually due to the current legislation, highlighting that most developed countries allow generics to be sold immediately after patent protection ends. In contrast, Russia’s process to register and market generics can take up to five years, with foreign companies offering medicines at inflated prices through government procurement.

However, committee member Oleg Ivaninsky countered that the issues raised by the bill’s authors had already been resolved and argued against the need for additional regulation, suggesting that passing the bill could negatively impact Russian pharmaceutical companies with significant patent portfolios. The majority of deputies voted against the adoption of the bill, and it was rejected in the first reading.