On March 20, deputies of the State Duma rejected in the first reading a bill that proposed simplifying the market entry of generics produced by companies from “unfriendly” countries. The existing procedure for the market release of reproduced drugs will remain in place. This may result in patients continuing to pay higher prices for medications, while the government loses money on state procurement.

The bill was developed by parliamentarians from the “Fair Russia – Patriots – For Truth” party, Fedot Tumusov and Sergey Kabyshev. The document suggested amendments to Article 1359 of the Civil Code of the Russian Federation. It proposed that the development, preclinical and clinical studies, state registration, production, and establishment of the maximum retail price for generics would not violate the exclusive rights to original drugs. According to the authors of the bill, this would accelerate the release of more affordable generic alternatives to imported drugs whose patents have expired.

Tumusov stated that the state loses more than 10 billion rubles annually due to the current legislation. He explained that in most developed countries, generics are available immediately after the patent protection of the original drug expires. In Russia, the process of registering and launching generics can take up to five years. Meanwhile, foreign companies whose patents have expired supply medicines at inflated prices through government procurement.

However, committee member Oleg Ivaninsky noted that the issues raised by the bill’s authors have already been addressed, and no additional regulation is necessary. In his opinion, adopting the bill could negatively impact Russian pharmaceutical companies that hold significant patent portfolios. The majority of deputies voted against the adoption of the bill, and it was rejected in the first reading.

Source: GxP news, March 24, 2025.