June 11, 2021, Moscow – Representatives of the Eurasian Economic Commission (EEC) and the Association of International Pharmaceutical Manufacturers (AIPM) held the working meeting on the development of the single market of medicines in the EAEU.
The attendees included: Viktor Nazarenko, Member of the EEC Board (Minister) in charge of Technical Regulation; Dzhanyl Dzhusupova, Deputy Director of the Technical Regulation and Accreditation Department; Dmitry Rozhdestvensky, head of the Section of Coordination of Work in the Area of Circulation of Medicines and Medical Devices; and other designated Commission members. The Association was represented by Vladimir Shipkov, Executive Director, by Oxana Monge, General Manager of Sanofi Eurasia and Chair of the AIPM Board of Directors, by top executives of the several member companies, and by the chairs of committees and working groups at the Association.
The meeting was dedicated to the state and prospects for the development of the Eurasian medicines market, specifically in light of the transition of all member states to the EAEU rules. The discussion also covered the importance of ensuring effective interaction of all stakeholders as they enforce the Eurasian regulatory documents, the further optimization of regulatory procedures, and the efforts to improve the competitiveness and attractiveness of the single Eurasian pharmaceutical market.
A more detailed opinion exchange touched upon the specifics of transitioning to single rules for the registration and circulation of medical products under EAEU laws; improving the capabilities of the Union's information system; introducing GxP practices; T&T for medicines; improving the unified mechanisms for putting products into civil circulation; protecting intellectual property rights and data exclusivity; and more.
In particular, one of the most acute problems discussed was the procedure of making the registration dossiers for various medicines compliant with the Union's laws. Instead of a reasonable idea of confirming the EAEU standards, in reality, it has turned into a bureaucratic total re-registration with inevitable risks to ensure the uninterrupted supply of medicines that have been circulating in the markets of the Union member states for a long time. As a result of the discussion, both sides confirmed their readiness to seek additional mutually acceptable solutions.
Viktor Nazarenko, Member of the Board (Minister) in charge of Technical Regulation, assured the industry representatives that, if there are proposals for optimizing the procedures, the Commission is ready to organize the discussion with the authorized bodies of the member states on its site. "The Eurasian Economic Commission welcomes cooperation with business associations, as they represent the consolidated stance of this particular market segment; we are always ready to consider initiatives aimed at increasing the availability, quality, and effectiveness of medicines offered to the public in the EAEU member states," said Mr. Nazarenko.
AIPM Executive Director Vladimir Shipkov, for his part, thanked the Commission for the high assessment of the association's activities, emphasized the need for further consolidation of efforts to sustain the functioning of the single pharmaceutical market and reaffirmed the readiness of the international industry to make a comprehensive contribution to the development of Eurasian integration. "The stage of practical implementation of the decisions has come and everyone will have to reformat their activities to meet modern Eurasian and international requirements," notrd Vladimir Shipkov.
Among other issues, the discussion participants pondered the prospects of potentially creating a single regulator in the EAEU, similar to the European Medicines Agency, as well as the need to protect patent holder rights and ensure the integrity of data on the results of preclinical and clinical drug trials in the EAEU, while simultaneously taking into account the member states' individual obligations within the WTO (which includes recommendations to ensure the transparency of information on applications submitted for registration under the rules of the Union). At the same time, the inviolability of the national obligations of the member states of the Union in terms of data exclusivity protection was emphasized.
The attendees agreed that the discussion was constructive and expressed the need for regular expert dialog exchanges in the interests of both the industry and the regulator.
The Association of International Pharmaceutical Manufacturers (AIPM) was established in 1994 and represents in the Russian Federation the leading international pharmaceutical companies - producers and developers of modern effective, safe and high-quality medicines. Today, AIPM unites more than 60 international companies that provide over 80% of the world’s pharmaceutical products and over 60% of medicines imported to the Russian Federation.
For additional information, please contact:
Elena Yankovskaya, Communications Lead, AIPM
+7 (495) 933 70 40, E.Yankovskaya@aipm.org