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RESTRICTIVE LISTS OF DRUGS: REGULATIONS, FUNCTIONS, SOURCES OF FINANCE, AND GUIDELINES FOR CREATION

https://doi.org/10.17749/2070-4909.2017.10.1.046-056

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Abstract

The present report reviews various aspects of legal regulation, function, guidelines for creation and sources of finance pertaining to the restrictive lists of drugs, which play a substantial role in the drug supply policy in theRussian Federation. The following restrictive lists (currently in effect) are carefully analyzed: the list of VED, the list of medications supplied to certain population groups, the list of “7 medical conditions”, the minimum assortment, the lists of regional benefits, the lists of medicines to treat rare diseases, in accordance with the list of rare (orphan) diseases, the list of strategically important medications, the list of drugs allowed for tax deduction. 

About the Author

M. V. Sura
Center of examination and quality control of medical care Ministry of health of Russia; The Russian Presidential Academy of National Economy and Public Administration
Russian Federation

Sura Mariya Vladimirovna – PhD, a leading researcher at the Center for Health Technology Assessment of the Institute for Applied Economic Research at the Russian Presidential Academy of National Economy and Public Administration (RANEPA).

Address: Nastasyinsky per., 3-2, Moscow, Russia, 127006



References

1. Sura M.V. Optimizing the selection of medical technologies in the quality management system of medical care PhD. diss. [Optimizatsiya vybora meditsinskikh tekhnologii v sisteme upravleniya kachestvom meditsinskoi pomoshchi. Avtoref. diss. …kand. med. nauk (in Russian)]. Moscow. 2004; s. 26.

2. The decree of the RF Government from 28.12.2016 No. 2885-R “On approval of the list of vital and essential medicinal products for medical use in 2017” [Rasporyazhenie Pravitel’stva RF ot 28.12.2016 № 2885-r «Ob utverzhdenii perechnya zhiznenno neobkhodimykh i vazhneishikh lekarstvennykh preparatov dlya meditsinskogo primeneniya na 2017 god» (in Russian)].

3. Federal law of 12.04.2010 № 61-FZ (as amended on 03.07.2016) “On circulation of medicines” [Federal’nyi zakon ot 12.04.2010 № 61FZ (red. ot 03.07.2016) «Ob obrashchenii lekarstvennykh sredstv» (s izm. i dop., vstup. v silu s 01.01.2017) (in Russian)].

4. Federal law of 21.11.2011 № 323-FZ (ed. from 03.07.2016) “About bases of health protection of citizens in the Russian Federation” [Federal’nyi zakon ot 21.11.2011 № 323-FZ (red. ot 03.07.2016) «Ob osnovakh okhrany zdorov’ya grazhdan v Rossiiskoi Federatsii» (s izm. i dop., vstup. v silu s 01.01.2017 g.) (in Russian)].

5. The decree of the RF Government dated 28.08.2014 No. 871 “On approval of Rules of forming of lists of medicinal preparations for medical application and the minimum assortment of medicinal preparations necessary for rendering of medical care” [Postanovlenie Pravitel’stva RF ot 28.08.2014 № 871 «Ob utverzhdenii Pravil formirovaniya perechnei lekarstvennykh preparatov dlya meditsinskogo primeneniya i minimal’nogo assortimenta lekarstvennykh preparatov, neobkhodimykh dlya okazaniya meditsinskoi pomoshchi» (in Russian)].

6. Resolution of the Government of the Russian Federation from 19.12.2016, No. 1403 “On the Programme of state guarantees of free rendering to citizens of medical aid in 2017 and the planning period of 2018 and 2019” [Postanovlenie Pravitel’stva RF ot 19.12.2016 g. № 1403 «O Programme gosudarstvennykh garantii besplatnogo okazaniya grazhdanam meditsinskoi pomoshchi na 2017 god i na planovyi period 2018 i 2019 godov» (in Russian)].

7. The Federal law from 17.07.1999 No. 178-FZ (ed. from 19.12.2016) “On state social assistance” [Federal’nyi zakon ot 17.07.1999 № 178-FZ (red. ot 19.12.2016) «O gosudarstvennoi sotsial’noi pomoshchi» (s izm. i dop., vstup. v silu s 01.01.2017) (in Russian)].

8. Federal law of 19.12.2016 No. 422-FZ “On the specification of financial expenses in the month on one citizen receiving state social assistance in the form of social services medications, medical products, and also specialized products of medical nutrition for children with disabilities, for 2017” [Federal’nyi zakon ot 19.12.2016 № 422-FZ «O normative finansovykh zatrat v mesyats na odnogo grazhdanina, poluchayushchego gosudarstvennuyu sotsial’nuyu pomoshch’ v vide sotsial’noi uslugi po obespecheniyu lekarstvennymi preparatami, meditsinskimi izdeliyami, a takzhe spetsializirovannymi produktami lechebnogo pitaniya dlya detei-invalidov, na 2017 god» (in Russian)].

9. Aleksandrova O.Yu., Nagibin O.A., Kremenkov A.R. Meditsina. 2013; 4: 32-52.

10. A report on the implementation of the Programme of state guarantees of free rendering to citizens of medical aid in 2015 [Doklad o realizatsii Programmy gosudarstvennykh garantii besplatnogo okazaniya grazhdanam meditsinskoi pomoshchi v 2015 godu (in Russian)]. 2016; s. 34.

11. The order of MH of the Russian Federation from February 13, 2013 № 66 “On approval of the strategy for medications supply to the population of the Russian Federation for the period up to 2025 and its implementation plan” [Prikaz MZ RF ot 13 fevralya 2013 g. № 66 «Ob utverzhdenii strategii lekarstvennogo obespecheniya naseleniya rossiiskoi federatsii na period do 2025 goda i plana ee realizatsii» (in Russian)].

12. The decree of the RF Government from 26.12.2015 No. 2724-R “On approval of the list of vital and essential medicinal products by 2016, as well as lists of medicinal preparations for medical application and the minimum assortment of medicinal preparations necessary for rendering of medical care” [Rasporyazhenie Pravitel’stva RF ot 26.12.2015 № 2724-r «Ob utverzhdenii perechnya zhiznenno neobkhodimykh i vazhneishikh lekarstvennykh preparatov na 2016 god, a takzhe perechnei lekarstvennykh preparatov dlya meditsinskogo primeneniya i minimal’nogo assortimenta lekarstvennykh preparatov, neobkhodimykh dlya okazaniya meditsinskoi pomoshchi» (in Russian)].

13. Resolution of the Government of the Russian Federation of 26.12.2011 № 1155 (ed. from 11.08.2016) “On procurement of medicines is designed to provide individuals with hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, malignant neoplasms of lymphoid, hematopoietic and related tissue, multiple sclerosis, and persons after transplantation of bodies and (or) tissues” (together with “Regulation on procurement of medicines is designed to provide individuals with hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, malignant neoplasms of lymphoid, hematopoietic and related tissue, multiple sclerosis, patients after transplantation of bodies and (or) tissues”) [Postanovlenie Pravitel’stva RF ot 26.12.2011 № 1155 (red. ot 11.08.2016) «O zakupkakh lekarstvennykh preparatov, prednaznachennykh dlya obespecheniya lits, bol’nykh gemofiliei, mukovistsidozom, gipofizarnym nanizmom, bolezn’yu Goshe, zlokachestvennymi novoobrazovaniyami limfoidnoi, krovetvornoi i rodstvennykh im tkanei, rasseyannym sklerozom, lits posle transplantatsii organov i (ili) tkanei» (vmeste s «Polozheniem o zakupkakh lekarstvennykh preparatov, prednaznachennykh dlya obespecheniya lits, bol’nykh gemofiliei, mukovistsidozom, gipofizarnym nanizmom, bolezn’yu Goshe, zlokachestvennymi novoobrazovaniyami limfoidnoi, krovetvornoi i rodstvennykh im tkanei, rasseyannym sklerozom, lits posle transplantatsii organov i (ili) tkanei») (in Russian)].

14. Sdvizhkova M. Farmatsevticheskii vestnik. 2016 ; 12 (841): 11.

15. Resolution of the government of RF of 30.07.1994 n 890 (ed. by 14.02.2002) “On state support of medical industry development and the improvement of providing the population and healthcare institutions with medicines and medical products” [Postanovlenie Pravitel’stva RF ot 30.07.1994 № 890 (red. ot 14.02.2002) «O gosudarstvennoi podderzhke razvitiya meditsinskoi promyshlennosti i uluchshenii obespecheniya naseleniya i uchrezhdenii zdravookhraneniya lekarstvennymi sredstvami i izdeliyami meditsinskogo naznacheniya» (in Russian)].

16. Federal law of 22 August 2004 № 122-FZ “On amendments to legislative acts of the Russian Federation and the annulment of certain legislative acts of the Russian Federation in connection with adoption of Federal laws “About modification and additions in the Federal law “On General principles of organization of legislative (representative) and Executive state authorities of constituent entities of the Russian Federation” and “About General principles of organization of local selfgovernment in the Russian Federation” [Federal’nyi zakon ot 22 avgusta 2004 g. № 122-FZ «O vnesenii izmenenii v zakonodatel’nye akty Rossiiskoi Federatsii i priznanii utrativshimi silu nekotorykh zakonodatel’nykh aktov Rossiiskoi Federatsii v svyazi s prinyatiem Federal’nykh zakonov «O vnesenii izmenenii i dopolnenii v Federal’nyi zakon “Ob obshchikh printsipakh organizatsii zakonodatel’nykh (predstavitel’nykh) i ispolnitel’nykh organov gosudarstvennoi vlasti sub”ektov Rossiiskoi Federatsii» i «Ob obshchikh printsipakh organizatsii mestnogo samoupravleniya v Rossiiskoi Federatsii» (in Russian)].

17. The decree of the RF Government dated 26.04.2012 No. 403 (edited on 04.09.2012) “the order of conducting the Federal register of persons suffering from life-threatening and chronic progressive rare (orphan) diseases, leading to reduced life expectancy of citizens or their disability, and its sub-segment” (together with “Rules of maintaining the Federal register of persons suffering from life-threatening and chronic progressive rare (orphan) diseases, leading to reduced life expectancy of citizens or their disability, and its regional segment”) [Postanovlenie Pravitel’stva RF ot 26.04.2012 № 403 (red. ot 04.09.2012) «O poryadke vedeniya Federal’nogo registra lits, stradayushchikh zhizneugrozhayushchimi i khronicheskimi progressiruyushchimi redkimi (orfannymi) zabolevaniyami, privodyashchimi k sokrashcheniyu prodolzhitel’nosti zhizni grazhdan ili ikh invalidnosti, i ego regional’nogo segmenta» (vmeste s “Pravilami vedeniya Federal’nogo registra lits, stradayushchikh zhizneugrozhayushchimi i khronicheskimi progressiruyushchimi redkimi (orfannymi) zabolevaniyami, privodyashchimi k sokrashcheniyu prodolzhitel’nosti zhizni grazhdan ili ikh invalidnosti, i ego regional’nogo segmenta») (in Russian)].

18. Sura M.V., Omel’yanovskii V.V., Avksent’eva M.V., Tatarinov A.P., Gerasimova K.V. Meditsinskie tekhnologii. Otsenka i vybor. 2014; 3: 43-50.

19. Sura M.V., Gerasimova K.V., Omel’yanovskii V.V., Avksent’eva M.V. FARMAKOEKONOMIKA. Sovremennaya farmakoekonomika i farmakoepidemiologiya / Pharmacoeconomics. Modern pharmacoeconomics and pharmacoepidemiology. 2014; 3: 36-43.

20. Sura M., Gerasimova K., Omelyanovsky V., Avxentyeva M., Tatarinov A., Fedyaev D. Estimating the costs of drug supply for rare diseases patients in Russia. Value in Health. 2014; 17 (7): A525.

21. Omel’yanovskii V.V., Sura M.V., Gerasimova K.V., Avksent’eva M.V., Tatarinov A.P. Newsletter. Assessment of the necessary financial costs of drug coverage of patients with rare diseases in Russia [Informatsionnyi byulleten’. Otsenka neobkhodimykh finansovykh zatrat na lekarstvennoe obespechenie bol’nykh s redkimi zabolevaniyami v RF. (in Russian)]. Moscow. 2014; 44.

22. The availability of medical care and drug supply patients with rare diseases in the Russian Federation: challenges and ways of solving problems” (results of medico-economic studies for the period 2013-2015. The center for the study and analysis of population, demography and health Institute of the EEU [Dostupnost’ meditsinskoi pomoshchi i lekarstvennogo obespecheniya bol’nykh s redkimi zabolevaniyami v Rossiiskoi Federatsii: realii i puti resheniya problem» (rezul’taty mediko-ekonomicheskogo issledovaniya za period 2013-2015. Tsentr izucheniya i analiza problem narodonaseleniya, demografii i zdravookhraneniya Instituta EAES (in Russian)]. Moscow. 2016; 146.

23. http:izvestia.ru›news/621879. Accessed: 01.02.2017.

24. The decree of the RF Government dated 06.07.2010 No. 1141-R “On approval of the list of strategically important drugs” [Rasporyazhenie Pravitel’stva RF ot 06.07.2010 № 1141-r «Ob utverzhdenii perechnya strategicheski znachimykh lekarstvennykh sredstv» (in Russian)].

25. Resolution of the Government of the Russian Federation of 17.02.2011 n 91 (ed. by 09.06.2016) “About the Federal target program “Development of pharmaceutical and medical industry of the Russian Federation for the period till 2020 and further prospect” [Postanovlenie Pravitel’stva RF ot 17.02.2011 № 91 (red. ot 09.06.2016) “O federal’noi tselevoi programme “Razvitie farmatsevticheskoi i meditsinskoi promyshlennosti Rossiiskoi Federatsii na period do 2020 goda i dal’neishuyu perspektivu” (in Russian)].

26. Resolution of the Government of the Russian Federation of 19.03.2001 No. 201 (as amended on 26.06.2007) “On approval of Lists of medical services and expensive types of treatment in medical institutions of the Russian Federation, medicines, amounts which is payment for the expense of own funds of the taxpayer are taken into account when determining the amount of a social tax deduction” [Postanovlenie Pravitel’stva RF ot 19.03.2001 № 201 (red. ot 26.06.2007) «Ob utverzhdenii Perechnei meditsinskikh uslug i dorogostoyashchikh vidov lecheniya v meditsinskikh uchrezhdeniyakh Rossiiskoi Federatsii, lekarstvennykh sredstv, summy oplaty kotorykh za schet sobstvennykh sredstv nalogoplatel’shchika uchityvayutsya pri opredelenii summy sotsial’nogo nalogovogo vycheta» (in Russian)].

27. “The tax code of the Russian Federation (part second)” from 05.08.2000 № 117-FZ (as amended on 28.12.2016) [«Nalogovyi kodeks Rossiiskoi Federatsii (chast’ vtoraya)» ot 05.08.2000 № 117-FZ (red. ot 28.12.2016) (in Russian)].


For citation:


Sura M.V. RESTRICTIVE LISTS OF DRUGS: REGULATIONS, FUNCTIONS, SOURCES OF FINANCE, AND GUIDELINES FOR CREATION. FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology. 2017;10(1):46-56. (In Russ.) https://doi.org/10.17749/2070-4909.2017.10.1.046-056

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