About this Journal Publication ethics Editorial Board Editorial Council Editorial Office For the Authors Contacts
English

News feeds

Journal in Databases

eLIBRARY.RU - ÍÀÓ×ÍÀß ÝËÅÊÒÐÎÍÍÀß ÁÈÁËÈÎÒÅÊÀ

Google Scholar

Google Scholar

Main arrow Archive of previous Issues arrow ¹6 2013 (34) arrow State policy on developing national pharmaceutical industry: analysis of strategic documents
State policy on developing national pharmaceutical industry: analysis of strategic documents Print
Friday, 27 December 2013

M.A. Flores
I.M. Sechenov First Moscow State Medical University, Moscow

Abstract. Background. Policymaking and implementation of national policy on pharmaceutical products supply is one of the State’s healthcare priorities and is closely related to renewal and development of the national pharmaceutical industry.

The aim of the study was to analyze strategic documents defining priority areas for developing pharmaceutical industry in the Russian Federation and to define the State’s role as a financing source for effective performance of this sector.

Methods and data. The author analyzed regulatory documents adopted by the Government of the Russian Federation and relevant ministries that determine policy, concept and strategy on developing national pharmaceutical industry until 2025.

Results. Strategy on pharmaceutical products supply until 2025 emphasizes access to high-quality pharmaceutical products and covers objectives to improve the system of cost control and introduce effective models of cost reimbursement of pharmaceutical products. Addressing those objectives the Strategy relies upon the two target programs: the State Program of the Russian Federation on “Healthcare development” and Federal Target Program on “Development of pharmaceutical and medical industry in the Russian Federation until 2020” that define volumes of budgetary and extra-budgetary resources to ensure complete production cycle of strategic pharmaceutical products in the Russian Federation, and development of target scientific programs and research centers for development of pharmaceutical products.

To attain the target indicators it is planned to increase the share of state expenditures on healthcare in gross domestic product from 3.6% to 5.2-5.5% during 2008-2020. The Federal Target Program envisages funding for program activities through federal budget up to 180,454.359 million rubles.

Conclusions. Strategic documents on socioeconomic development of the country and renewal of the national pharmaceutical industry frame main directions of the sector development and clearly define target indicators, sources and volumes of financing for key groups of activities aimed at developing innovative pharmaceutical products, import-substituting pharmaceuticals and finished dosage forms as well as effective financial frameworks for their development.

Keywords. Pharmaceutical industry; development concept and strategy; innovative pharmaceutical cluster; seed financing; venture capital funds; guidelines for good clinical practice.

References

  1. Bulletin of the Audit Chamber of the Russian Federation ¹ 10(154), 2010 [Internet]. [Cited 2013 Aug 20]. Available from: http://center-vibor.ru/publications/magazines/eeg/eeg19990402/eeg19990402_001.htm. (In Russia).
  2. Vyalkov AI, Polesskiy VA, Martynchik SA. Key WHO strategies for improving national healthcare systems. GlavVrach 2008;(5):10–25. (In Russia).
  3. Vyalkov AI, Kucherenko VZ, Rayzberg BA, Latfullin GR, Shilenko YuV, Vorob'ev PA, et al. Healthcare management and economics: Training Manual for higher education. 3-rd ed., revised. Moscow: GEOTAR-Media; 2009. 664 p. (In Russia).
  4. Health care development: the State Program of the RF. [Internet]. [Cited 2013 Sep 24]. Available from: https://www.rosminzdrav.ru/health/zdravo2020/72/gprzo.pdf (In Russia).
  5. GÌP news [Internet Journal]. [Cited 2013 Jul 25]. Available from: http://gmpnews.ru/istoriya-gmp/ (In Russia).
  6. Clinical Pharmacia. [Internet Journal]. [Cited 2013 Aug 20]. Available from: http://www.clinical-pharmacy.ru/digest/farmacevtrinok/ (In Russia).
  7. The conception of long-term social and economic development for the period up to 2020: the Regulation of the Government of the RF of November 17, 2008 ¹ 1662-ð [Internet]. [Cited 2013 Oct 10]. Available from: http://www.ifap.ru/ofdocs/rus/rus006.pdf (In Russia).
  8. Conception of national security of the Russian Federation: the Decree of the President of the RF of January 10, 2000 ¹ 24. [Internet]. [Cited 2013 Aug 23]. Available from: http://nvo.ng.ru/concepts/2000-01-14/6_concept.html (In Russia).
  9. Methodical recommendations on implementation of the cluster policy in the subjects of the Russian Federation. Approved by the Regulation of the Ministry of Economic Development of the RF of December 26, 2008 ¹ 20636-àk/d19 [Internet]. [Cited 2013 Oct 16]. Available from: http://www.economy.gov.ru/minec/activity/sections/innovations/development/doc1248781537747 (In Russia).
  10. Narkevich IA, Trofimova EO. Prospects for pharmaceutical industry provision with human resources of a new type. Remedium 2011;6:56–60.
  11. Provision for the program of training public health masters: Training manual. Moscow: Meditsina dlya vsekh; 2007. 386 p. (In Russia).
  12. On approving the rules for allocating subsidies from the federal budget to the budgets of the RF subjects to realize the activity provided by the programs for development of pilot innovation regional clusters: the Regulation of the Government of the RF of March 06, 2013 ¹ 188. [Internet]. [cited 2013 Oct 16]. Available from: http://base.consultant.ru/cons/cgi/online.cgi?req=doc;base=LAW;n=143138 (In Russia).
  13. Polesskiy VA, Martynchik SA, Zaporozhchenko VG, Martynchik EA. Federal target programs as a tool for state regulation in healthcare: general requirements for organization of target program management. Obshchestvennoe zdorov'e i profilaktika zabolevaniy. 2005;(5):3–10. (In Russia).
  14. Polesskiy VA, Martynchik SA, Zaporozhchenko VG, Martynchik EA. Social program in healthcare as a subject for technical control and regulation of organization activity. Obshchestvennoe zdorov'e i profilaktika zabolevaniy. 2005;(4):3–15. (In Russia).
  15. Polesskiy VA, Martynchik SA, Zaporozhchenko VG, Martynchik EA, Kucherenko VZ. Evolution of the models of a quality system: international practice. Ekonomika zdravookhraneniya. 2005;(8):25–36. (In Russia).
  16. Polesskiy VA, Martynchik SA, Zaporozhchenko VG, Martynchik EA. Program target planning and management as a tool of government regulation in health care. GlavVrach 2006; (6): 25–33. (In Russia).
  17. On approving the List of innovation regional clusters: the Order of the Prime Minister of the RF of August 28, 2012 ¹ DM-P8-5060 [Internet]. [Cited 2013 Aug 20]. Available from: http://www.economy.gov.ru/minec/activity/sections/innovations/politic/doc20120907_02 (In Russia).
  18. On the conditions for admission of goods originating from foreign countries for the purpose of placing orders for goods supply for the needs of customers: the Order of the Ministry of Economic Developed of the RF of April 17, 2013 ¹ 211 [Internet]. [Cited 2013 Oct 16]. Available from: http://www.consultant.ru/document/cons_doc_LAW_147071/ (In Russia).
  19. Strategy on pharmaceutical provision of the population of the Russian Federation for the period up to 2025: the Order of the Ministry of Health of the RF of February13, 2013 ¹66. [Internet]. [cited 2013 Sep 23]. Available from: http://www.garant.ru/products/ipo/prime/doc/70217532/ (In Russia).
  20. Strategy for development of the pharmaceutical industry of the Russian Federation for the period up to 2020: the Order of the Ministry of Industry and Trade of the RF of October 23, 2009 ¹ 965 [Internet]. [Cited 2013 Oct 13] Available from: http://do.gendocs.ru/docs/index-14493.html (In Russia).
  21. Trofimova YeO. Russian pharmaceutical market in the line with global trends. Remedium 2013; 7-8: 72. (In Russia).
  22. On improving the state policy in health care: the Decree of the President of the RF of May 7, 2010 ¹ 59. [Internet]. [Cited 2013 Oct 13] Available from: http://www.rg.ru/2012/05/09/zdorovje-dok.html (In Russia).
  23. On the contract system in purchasing goods, works, and services for state and municipal needs: the Federal Law FZ-44. [Internet]. [Cited 2013 Aug 23] Available from: http://www.rg.ru/2013/04/12/goszakupki-dok.html (In Russia).
  24. On circulation of pharmaceuticals: the Federal Law FZ-61. [Internet]. [Cited 2013 Aug 23]. Available from: http://www.rg.ru/2010/04/14/lekarstva-dok.html (In Russia).
  25. Research and scientific and educational personnel of innovational Russia for 2014-2020: Federal Target Program. Approved by the Regulation of the Government of the RF of May 21, 2013 ¹ 424. [Internet]. [Cited 2013 Oct 16] Available from: http://base.garant.ru/70384512/ (In Russia).
  26. Development of pharmaceutical and medical industry: Federal Target Program. Adopted by the Regulation of the Government of the RF of February 17, 2011 ¹ 91. [Internet]. [Cited 2013 Oct 16]. Available from: http://www.minpromtorg.gov.ru/ministry/fcp/employer/med (In Russia).
  27. Martynenko VF, Vyalkova GM, Polesskiy VA, Belyaev EN, Groysman VA, Seregina IF. Information technologies in the system of health care management in the Russian Federation: Training Manual. Ìoscow: GEOTAR-Media; 2006. 128 p. (In Russia).
  28. Martynenko VF, Vyalkova GM, Polesskiy VA, Belyaev EN, Groysman VA, Seregina IF. Information technologies in health care management in the Russian Federation: Training Manual. 2-nd ed., revised. Ìoscow: GEOTAR-Media; 2009. 248 p. (In Russia).

Views: 22758

Be first to comment this article

Write Comment
  • Please keep the topic of messages relevant to the subject of the article.
  • Personal verbal attacks will be deleted.
  • Please don't use comments to plug your web site. Such material will be removed.
  • Just ensure to *Refresh* your browser for a new security code to be displayed prior to clicking on the 'Send' button.
  • Keep in mind that the above process only applies if you simply entered the wrong security code.
Name:
E-mail
Comment:

Code:* Code

Last Updated ( Thursday, 16 January 2014 )
< Prev
home contact search contact search