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Review of calculation methods, procedures for registration and re-registration of producer prices of medicines in the countries of the Eurasian Economic Union

https://doi.org/10.17749/2070-4909/farmakoekonomika.2020.039

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Abstract

Aim. To analyze the methods of the state regulation of prices for the manufacturers of pharmaceutical drugs in the Eurasian Economic Community counties (EAEC).

Materials and Methods. The comparison of the aspects of the price regulation was presented as short characteristics of the regulating impact of the key normative legal acts (NLA) in the sphere of price formation on pharmaceutical drugs in the EAEC. The study included the following stages: the analysis of NLA in the Russian Federation, Republic of Belarus, Republic of Kazakhstan, Republic of Moldova, Republic of Armenia, and the Kyrgyz Republic, the comparison of the list of reference countries, and decreasing coefficients.

Results. The authors revealed the differences in the procedure of the registration, re-registration, referencing of prices, and decreasing coefficients for the generics. The authors highlighted the drawbacks of the existing procedure of the registration of prices in Russia in terms of the formation of the list of the referent countries, the re-registration of drugs with an increase in price, and limited economic efficiency.

Conclusion. The performed analysis showed that the differences in the methods of the state regulation of prices on pharmaceutical drugs in the EAEC countries do not allow for the formation of a unified approach. However, the creation of supranational method of price formation is an essential condition for the functioning of the united market of pharmaceutical drugs.

About the Authors

A. A. Leshkevich
Saint Petersburg State Chemical Pharmaceutical University
Russian Federation

Candidate of Pharmaceutical Sciences, Junior Researcher at Laboratory of regulatory relations and good practices

14, lit. А Professor Popov str., Saint-Petersburg 197022, Russia



D. S. Yurochkin
Saint Petersburg State Chemical Pharmaceutical University
Russian Federation

Candidate of Pharmaceutical Sciences, Junior Researcher at Laboratory of regulatory relations and good practices

14, lit. А Professor Popov str., Saint-Petersburg 197022, Russia



Z. M. Golant
Saint Petersburg State Chemical Pharmaceutical University
Russian Federation

PhD (Economics), Head of Laboratory of regulatory relations and good practices

14, lit. А Professor Popov str., Saint-Petersburg 197022, Russia



I. A. Narkevich
Saint Petersburg State Chemical Pharmaceutical University
Russian Federation

Doctor of Pharmaceutical Sciences, Professor, University rector

14, lit. А Professor Popov str., Saint-Petersburg 197022, Russia



References

1. Acts in the field of drug circulation. Eurasian Economic Commission [Electronic resource] URL: http://www.eurasiancommission.org/ru/act/texnreg/deptexreg/LS1/Pages/drug_products.aspx. Accessed: 03.06.2020. (in Russ)

2. Decree of the Government of the Russian Federation dated October 29, 2010 № 865 (as amended by the resolution of the Government of the Russian Federation dated December 16, 2019 № 1683) «Rules for state registration and re-registration of maximum selling prices for pharmaceuticals established by manufacturers of medicinal products included in the list of vital and essential drugs» (in Russ).

3. Decree of the Government of the Russian Federation dated September 15, 2015 № 979 (as amended by the resolution of the Government of the Russian Federation dated 16, 2019 № 1683) «The methodology for calculating the maximum manufacturer’s selling prices of drugs included in the list of vital and essential drugs, with their state registration and re-registration» (in Russ).

4. The Federal law dated April 12, 2010 №61-FZ (as amended by the Federal Law dated December 27, 2019 №475-FZ) «On the circulation of medicines» (in Russ).

5. Decree of the Government of the Russian Federation dated October 29, 2010 № 865 (as amended by the resolution of the Government of the Russian Federation of December dated 16, 2019 № 1683) «The rules of compulsory re-registration in 2019-2020, of the registered maximum selling prices of manufacturers of drugs included in the list of vital and essential drugs» (in Russ).

6. Decree of the President of the Republic of Belarus dated August 22, 2018 № 345 «About registration of prices for medicines». (in Russ).

7. Resolution of the Ministry of Antimonopoly Regulation and Trade of the Republic of Belarus dated October 19, 2018 №83 «On approval of the Instructions on the methodology for calculating the maximum selling prices of manufacturers of medicines» (in Russ).

8. Order of the acting of the Minister of Health and Social Development of the Republic of Kazakhstan dated July 30, 2015 № 639 «Rules for the formation of marginal prices and margins for medicines and medical devices purchased within the guaranteed volume of free medical care and in the system of compulsory social health insurance» (as amended as of February 08, 2018) (in Russ).

9. Law of the Republic of Moldova dated May 25, 1993 No. 1456- XII «On pharmaceutical practice» (in Russ).

10. Decree of the Government of the Republic of Moldova dated July 2, 1997 №603 «On approval of the Regulation on the pricing of medicines and other pharmaceutical and parapharmaceutical products» (in Russ).

11. Law of the Republic of Armenia dated June 13, 2016 №ЗР-86 «About medicines» (in Russ).

12. Decree of the Government of the Kyrgyz Republic November 29, 2019 №579 «On approval of the rules for regulating the prices of medicines in the Kyrgyz Republic» (in Russ).

13. Database of the marketing agency DSM Group [Electronic resource] URL: https://dsmviewer.ru/. Accessed: 15.03.2020 (in Russ).

14. OECD/EU (2018). Health at a Glance: Europe 2018: State of Health in the EU Cycle, OECD Publishing, Paris, page. 63. [Electronic resource] URL: https://doi.org/10.1787/health_glance_eur-2018-en. Accessed: 15.03.2020 (in Russ).


For citation:


Leshkevich A.A., Yurochkin D.S., Golant Z.M., Narkevich I.A. Review of calculation methods, procedures for registration and re-registration of producer prices of medicines in the countries of the Eurasian Economic Union. FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology. 2020;13(2):193-204. (In Russ.) https://doi.org/10.17749/2070-4909/farmakoekonomika.2020.039

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ISSN 2070-4909 (Print)
ISSN 2070-4933 (Online)