Features of state regulation of the pharmaceutical industry in the context of a pandemic

   The purpose of the study is a comprehensive analysis of the development of the pharmaceutical industry in the context of a pandemic of a new coronavirus infection based on the identification of the high socio-economic significance of the industry and the specifics of its development over 2020–2022; identification and analysis of problems, characteristics of management decisions in the field of state regulation aimed at improving the drug supply of the population of Russia; assessment of existing experience in regulating the pharmaceutical industry and the market of medicines abroad in order to further assess the feasibility of its use in the activities of Russian regulatory authorities.

   Based on the analysis of foreign experience on the studied issues, the most effective measures of state regulation during the pandemic were identified: mandatory state control in the field of pricing for medicinal products; regular state monitoring and adjustment of prices for medicinal products in the direction of their reduction; priority of budget generic medicinal products over expensive LP. The article provides a critical analysis of the applied measures of state regulation of the industry since the beginning of the pandemic. The prospects for the development of the Russian pharmaceutical industry and the corresponding measures of state support and regulation of its development, the effectiveness of state levers of influence aimed at regulating pricing in the industry, financial support measures, tax regulation, combating access to the Russian market of counterfeit medicines, stimulating healthy competition and import substitution are determined.

1. O Strategii natsional’noi bezopasnosti Rossiiskoi Federatsii: Ukaz Prezidenta RF ot 2 iyulya 2021 g. № 400 // Spravochno-pravovaya sistema «Garant». – URL: http://base.garant.ru/401425792/. – Tekst : elektronnyi.

2. Strategiya lekarstvennogo obespecheniya naseleniya Rossiiskoi Federatsii na period do 2025 goda : Prilozhenie № 1 k Prikazu Ministerstva zdravookhraneniya RF ot 13 fevralya 2013 g. № 66 // Spravochno-pravovaya sistema «Garant». – URL: https://base.garant.ru/70317532/53f89421bbdaf741eb2d1ecc4ddb4c33/. – Tekst : elektronnyi.

3. Ob utverzhdenii gosudarstvennoi programmy Rossiiskoi Federatsii «Razvitie farmatsevticheskoi i meditsinskoi promyshlennosti»: Postanovlenie Pravitel’stva RF ot 15 aprelya 2014 g. № 305 (s izmeneniyami i dopolneniyami) // Spravochno-pravovaya sistema «Garant». – URL: http://base.garant.ru/70644070/. – Tekst: elektronnyi.

4. Myatlik, A. S. Metodicheskie podkhody k sovershenstvovaniyu gosudarstvennogo regulirovaniya farmatsevticheskoi promyshlennosti (Methodological approaches to improving state regulation of the pharmaceutical industry) : avtoreferat dissertacii na soiskanie uchenoj stepeni kandidana ekonomicheskih nauk. – Sankt-Peterburg, 2001. – 19 s. – Tekst : neposredstvennyi.

5. Analiticheskii otchet DSMGroup: Farmatsevticheskii rynok Rossii: Itogi 2020 goda. – URL: https://dsm.ru/docs/analytics/2020_Report_rus.pdf. – Tekst : elektronnyi.

6. Analiticheskii otchet DSMGroup: Farmatsevticheskii rynok Rossii: Itogi 2021 goda. – URL: https://dsm.ru/docs/presentations/%D0%A4%D0%B0%D1%80%D0%BC%D1%80%D1%8B%D0%BD%D0%BE%D0%BA_2021_%D0%98%D1%82%D0%BE%D0%B3%D0%B8_12%D0%BC%D0%B5%D1%81%D1%8F%D1%86%D0%B5%D0%B2.pdf . – Tekst : elektronnyi.

7. Farmatsevticheskii rynok Rossii 2021: vliyanie pandemii i strategii razvitiya : Ofitsial’nyi sait auditorsko-konsaltingovoi gruppy «Delovoi profil’». – URL: https://www2.deloitte.com/content/dam/Deloitte/ru/Documents. – Tekst : elektronnyi.

8. Opyt gosudarstv v bor’be s pandemiei COVID-19: Sbornik stranovykh keisov (The experience of States in the fight against the COVID-19 pandemic : A collection of country cases) // Ofitsial’nyi sait Schetnoi Palaty RF. – URL: https://ach.gov.ru/upload/pdf/casebook_COVID-19.pdf. – Tekst : elektronnyi.

9. Ulumbekova, G. E. Rol’ gosudarstva v razrabotke innovatsionnykh lekarstv (The role of the state in the development of innovative medicines) / G. E. Ulumbekova, I. Yu. Khudova // ORGZDRAV: novosti, mneniya, obuchenie. Vestnik VShOUZ. – 2020. – T. 6. – № 1. – S. 83–99. – Tekst : neposredstvennyi.

10. O roznichnoi torgovle lekarstvennymi preparatami dlya meditsinskogo primeneniya: Ukaz Prezidenta RF ot 17 marta 2020 goda № 187 // Spravochno-pravovaya sistema «Garant». – URL: https://base.garant.ru/73755186/. – Tekst : elektronnyi.

11. Ob utverzhdenii pravil vydachi razresheniya na osushchestvlenie roznichnoi torgovli lekarstvennymi preparatami dlya meditsinskogo primeneniya distantsionnym sposobom: Postanovlenie Pravitel’stva RF ot 16 maya 2020 g. № 697 // Spravochno-pravovaya sistema «Garant». – URL: https://base.garant.ru/74034756/. – Tekst: elektronnyi.

12. Ob obrashchenii lekarstvennykh sredstv : Federal’nyi zakon ot 12 aprelya 2020 goda №61 // Spravochno-pravovaya sistema «Garant». – URL: https://base.garant.ru/12174909/. – Tekst : elektronnyi.

13. Ob utverzhdenii Metodiki ustanovleniya organami ispolnitel’noi vlasti sub»ektov RF predel’nykh razmerov optovykh i roznichnykh nadbavok na LP: prikaz FAS Rossii ot 9 sentyabrya 2020 goda № 820/20 // Spravochno-pravovaya sistema «Garant». – URL: https://base.garant.ru/74641902/. – Tekst : elektronnyi.

14. Ets, A. V. Osnovnye mery sistemy gosudarstvennogo regulirovaniya farmatsevticheskoi promyshlennosti v Rossiiskoi Federatsii (The main measures of the system of state regulation of the pharmaceutical industry in the Russian Federation) / A. V. Ets // Nauchno-obrazovatel’nyi zhurnal dlya studentov i prepodavatelei «StudNet». – 2020. – № 9. – S. 1556–1560. – URL: http: file:///C:/Users/user/Downloads/osnovnye-mery-sistemy-gosudar-stvennogo-regulirovaniya-farmatsevticheskoy-promyshlennosti-v-rossiyskoy-federatsii.pdf. – Tekst : elektronnyi.

15. Normativno-pravovoe regulirovanie deyatel’nosti vnebol’nichnykh aptek shagovoi dostupnosti v Evropeiskom regione VOZ (Regulatory and legal regulation of the activities of community pharmacies within walking distance in the WHO European Region). – Kopengagen : Evropeiskoe regional’noe byuro VOZ, 2020. – URL: https://apps.who.int/iris/bitstream/handle/10665/331232/9789289054591-rus.pdf. – Tekst : elektronnyi.

16. Aityan, T. V. Primenenie opyta evropeiskikh stran v ramkakh reformirovaniya sistemy gosudarstvennogo regulirovaniya farmatsevticheskoi otrasli v Rossii (Application of the experience of European countries in the framework of reforming the system of state regulation of the pharmaceutical industry in Russia) / T. V. Aityan // Ekonomika i predprinimatel’stvo. – 2017. – № 3-2 (80). – S.55-61. – Tekst : neposredstvennyi.

17. Petrukhina, I. K. Postroenie strukturno-funktsional’noi modeli lekarstvennogo obespecheniya naseleniya (Building a structural and functional model of drug provision for the population) : avtoreferat dissertacii na soiskanie uchenoj stepeni kandidana ekonomicheskih nauk / I. K. Petrukhina. – Moskva, 2017. – 48 s. – Tekst : neposredstvennyi.