EAEU Countries Will Be Able to Recognize Drugs Registered by Other Member States
Authorized agencies of the Eurasian Economic Union (EAEU) member states will have the ability to independently register medicines already introduced to the market in other member states, without the participation of manufacturers. This initiative, prepared by the Board of the Eurasian Economic Commission (EEC), aims to improve the accessibility of medications that manufacturers may find unprofitable to introduce to new markets due to low prices or small consumer bases. Additionally, it could facilitate access in Russia to foreign drugs not registered domestically by certain international manufacturers due to sanctions.
The EAEU, comprising Russia, Armenia, Belarus, Kazakhstan, and Kyrgyzstan, represents a market of over 180 million people. This market size makes it highly attractive to pharmaceutical manufacturers. Since 2017, the five-member states have been working toward creating a unified pharmaceutical market within the EAEU by harmonizing legislation to allow the free circulation of medicines within the union. Initially, the goal was to unify rules for the production and sale of pharmaceuticals and medical devices by 2025. However, this process has faced repeated delays due to difficulties in agreeing on uniform standards.
The proposal approved by the EEC Board this week addresses a specific issue: it allows authorized agencies in EAEU member states to register drugs already available in other member states’ markets on their own initiative.
The registration process will reportedly be conducted without requiring payment of customary fees and based on expert reviews already conducted in a reference state. “The new procedure can be applied at the discretion of the authorized body if no analogs of the drug are registered in the country’s market,” explains the EEC Board.
This change could primarily benefit the availability of medicines that manufacturers are hesitant to introduce to new markets due to their low profitability or limited consumer base.
Sergey Shulyak, head of the marketing company DSM Group, notes that EAEU countries have so far struggled to agree on a unified drug registration system. “The delays stem from a reluctance to lose revenue generated by national clinical trials,” Shulyak explains. However, since 2022, with some international drug manufacturers exiting Russia, the need for progress in this area has become increasingly apparent. “It became clear that if registration in Russia has become ‘toxic’ for global pharmaceutical manufacturers due to sanctions, alternative measures must ensure access to their drugs for Russians if they are already registered in other union countries,” he adds.
Alexey Kedrin, Chairman of the Board of the Eurasian Economic Union Association of Pharmaceutical Manufacturers (AEUAEP), clarifies that EAEU law allows drug registration either with or without specifying the recognizing country. The recognizing country refers to the union member whose expert body validates the reference state’s findings and permits the product’s sale within its territory. “In cases where registration is conducted ‘without specifying’ the country, no simplified registration advantages apply. This is where the authority for agencies to register drugs independently, in cases where manufacturers have not pursued registration, becomes relevant,” Kedrin explains.
Source: Kommersant, December 9, 2024
