Identifying barriers to access to innovative drug therapy

Abstract


This article addresses the issues of accessibility of innovative drugs in modern healthcare and identifies existing barriers. The share of such innovative drugs on the Russian pharmaceutical market (all channels) is approximately 20% (in value) and only 1% (in number of trade names/molecules) in recent years. From 2017 to 2021, 168 innovative molecules were registered in the EU, 35 of which were in Russia. The rate of introduction of innovative drugs into medical practice in Russia is high; however, access to them is limited to certain categories of patients, regions, and diseases. The main barriers to access to innovative therapy are: economic conditions caused by sanctions and logistical problems; insufficient coverage of reimbursement programs; imperfect pricing policy; the risk of compulsory licensing; insufficient technological and scientific development of the domestic pharmaceutical industry. The study showed that in the future, a further decline in the share of imported innovative drugs on the Russian market is likely, against the backdrop of the development of local innovations.

About the authors

Andrey A. Lebedev

N. A. Semashko National Research Institute of Public Health, Moscow, Russia

Email: aandrey.lebedev@gmail.com

Maria N. Denisova

K. M. Lakin Scientific and Educational Institute of Pharmacy, Russian University of Medicine, Moscow, Russia

Email: denisova@nriph.ru

Denis V. Kurkin

K. M. Lakin Scientific and Educational Institute of Pharmacy, Russian University of Medicine, Moscow, Russia

Email: kurkin-dv@rosunimed.ru

Olga V. Marincheva

K. M. Lakin Scientific and Educational Institute of Pharmacy, Russian University of Medicine, Moscow, Russia

Email: marincheva-ov@rosunimed.ru

Anastasia A. Sinitsyna

N. A. Semashko National Research Institute of Public Health, Moscow, Russia; K. M. Lakin Scientific and Educational Institute of Pharmacy, Russian University of Medicine, Moscow, Russia

Email: sinitsyna.anastasiia@gmail.com

References

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  2. Ravinetto R., De Weggheleire A., Dorlo T. P., et al. Predictable threats to public health through delaying universal access to innovative medicines for hepatitis C: a pharmaceutical standpoint. Trop Med Int Health. 2016;21(12):1490—1495. doi: 10.1111/tmi.12784
  3. Ravinetto R., Gaidano G. Regulatory agencies should engage in drug pricing. BMJ. 2016;354:i4524. doi: 10.1136/bmj.i4524
  4. Denisova M. N., Sinitsyna A. A. Availability of innovative drugs for the treatment of breast cancer in Russia. Medical Council. 2025;(10):70—75. (In Russ.)
  5. Kurolap M. S., Maleva A. B., Chupandina E. E., et al. Study of the role of charitable foundations in providing medicines to the population. Pharmacy. 2024;73(8):48—55. doi: 10.29296/25419218-2024-08-06 (In Russ.)

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