The Entry Lag of Innovative Drugs in Russia, 2010–2019

Alexander Chaplenko, Geliya Gildeeva and Vasiliy Vlassov
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Alexander Chaplenko: Department of Organization and Management in the Field of Drugs Circulation, I. M. Sechenov First Moscow State Medical University (Sechenov University), 119435 Moscow, Russia
Geliya Gildeeva: Department of Organization and Management in the Field of Drugs Circulation, I. M. Sechenov First Moscow State Medical University (Sechenov University), 119435 Moscow, Russia
Vasiliy Vlassov: Department of Health Care Administration and Economics, National Research University Higher School of Economics, 101000 Moscow, Russia

IJERPH, 2021, vol. 18, issue 10, 1-12

Abstract: Objective: Evaluation of the lag timelines for the launch of innovative drugs to the Russian market and pharmacoeconomic factors they can depend on. Methods: To complete the investigation, we used information about drug products, namely, dates of submission and approval, and pharmacological groups recovered from national registers and official databases. Results: Due to impacts of market factors and imperfection of the state regulation, original drugs developed abroad enter the Russian market a few years after their registration in the United States of America, the European Union, and Japan. The average time from the moment of initial approval of a drug in the aforementioned countries and jurisdictions to the moment of registration in Russia is 4 years and 8 months, with a median value of 2.5 years. It has been shown that half of this term is spent on the performance of the procedures of the expertise of the drug registration dossier in the Russian Federation. Conclusion: To attain the goal of adequate supplies to the population of the Russian Federation of the most up-to-date, high quality, safe, and efficacious medications, apart from the support of national originators of innovative drugs, we are required to upgrade the existing system of original drug registration. Improvement should be primary focused on the drugs already approved by the leading national regulatory authorities in order to ensure innovative medicine access for Russian patients.

Keywords: drug lag; drug regulation; health policy; access to innovative medicines (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2021
References: View complete reference list from CitEc
Citations: View citations in EconPapers (1)

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