Historical overview of regulatory framework development on pricing and reimbursement of medicines in Bulgaria

References

• Regulating pharmaceuticals in Europe: striving for efficiency, equity, and quality. In: European observatory on health systems and policies. Edited by Mossialos E, Mrazek M, Walley T. Buckingham: open University Press; 2004. p. 3–5.
   Google Scholar
• Kingham R, Wheeler J. Government regulation of pricing and reimbursement of prescription medicines: results of a recent multi-country review. Food Drug Law J. 2009;64(1):101–114.
   PubMed Web of Science ®Google Scholar
• Vogler S. The impact of pharmaceutical pricing and reimbursement policies on generics uptake: implementation of policy options on generics in 29 European countries─an overview. GaBI J. 2012;1(2):93–100.
   Google Scholar
• Carone G, Schwierz C, Xavier A. Cost-containment policies in public pharmaceutical spending in the EU. European Commission (Directorate General for Economic and Financial Affairs). Economic paper 461. European Union; 2012. Doi:10.2765/27111
   Google Scholar
• von der Schulenburg JMG, Schöffski O. Unintended effects of cost-containment policy: results of a natural experiment in Germany. Soc Sci Med. 1997;45(10):1537–1539.
   PubMed Web of Science ®Google Scholar
• Kanavos P. Overview of pharmaceutical pricing and reimbursement regulation in Europe. Overview of pharmaceutical regulations in Europe. 2001. [cited 2018 Feb 02]. Available at: http://www.eco.uc3m.es/servicios/sesam/actividades/jornada_legislacion/DOC%209%20EMEARoadMap.pdf.
   Google Scholar
• Mrazek MF. Comparative approaches to pharmaceutical price regulation in the European Union. Croat Med J. 2002;43(4):453–461.
   PubMed Web of Science ®Google Scholar
• Towse A. Value based pricing, research and development, and patient access schemes. Will the United Kingdom get it right or wrong? Br J Clin Pharmacol. 2010;70(3):1365–2125.
   Web of Science ®Google Scholar
• Espin J, Rovira J. Analysis of differences and commonalities in pricing and reimbursement systems in Europe. Brussels. Final report June 2007; 29 Ref. Ares (2014) 3852948-19/11/2014. [cited 2018 Jan 31]. Available from: http://ec.europa.eu/.
   Google Scholar
• Danzon PM, Wang YR, Wang L. The impact of price regulation on the launch delay of new drugs-evidence from twenty-five major markets in the 1990s. Health Econ. 2005;14(3):269–292.
   PubMed Web of Science ®Google Scholar
• Vogler S, Martikainen JE. Pharmaceutical pricing in Europe. Book Chapter In: Pharmaceutical prices in the 21st century. Informs about current pricing policies in European countries. Available from: http://www.springer.com/us/book/9783319121680
   Google Scholar
• Bardey D, Bommier A, Julliend B. Retail price regulation and innovation: reference pricing in the pharmaceutical industry. J Health Econ. 2010;29(2):303–316.
   PubMed Web of Science ®Google Scholar
• Kajdiž R, Bojnec Š. Determinants of public expenditurs for medicinal products in non hospital consumption in Slovenia. E & M. 2014;17(3):27–33.
   Google Scholar
• Kajdiž R, Bojnec Š. Do the price regulation and reimbursement affect public expenditures for medicinal products? Slovenian Med J—Zdravniški vestnik. 2012;81(9):618–625.
   Google Scholar
• Kajdiž R, Bojnec Š. Price developments of the first level of anatomic-therapeutic-chemical classification of regulated medicines. Slovenian Med J—Zdravniški vestnik. 2013;82(9):564–572.
   Google Scholar
• Vogler S, Österle A, Mayer S. Inequalities in medicine use in Central Eastern Europe: an empirical investigation of socioeconomic determinants in eight countries. Int J Equity Health. 2015;14:124.
   PubMed Web of Science ®Google Scholar
• Lee I-H, Bloor K, Hewitt C, et al. International experience in controlling pharmaceutical expenditure: influencing patients and providers and regulating industry—a systematic review. J Health Serv Res Policy. 2015;20(1):52–59.
   PubMed Web of Science ®Google Scholar
• Adamski J, Godman B, Ofierska-Sujkowska G, et al. Risk sharing arrangements for pharmaceuticals: potential considerations and recommendations for European payers. BMC Health Serv Res. 2010;10:153.
   PubMed Web of Science ®Google Scholar
• Cameron A, Hill S, Whyte P. WHO Guideline on Country pharmaceutical pricing policies. Geneva: World health organization; 2015. Available from: http://www.who.int/medicines/publications/pharm_guide_country_price_policy/en/
   Google Scholar
• Gilley J. Towards rational prescribing. BMJ. 1994;308(6931):731–732.
   PubMedGoogle Scholar
• Granlund D, Rudholm N, Wikström M. Fixed budgets as a cost containment measure for pharmaceuticals. Eur J Health Econ. 2006;7(1):37–45.
   PubMedGoogle Scholar
• Håkonsen H, Horn AM, Toverud E-L. Price control as a strategy for pharmaceutical cost containment - what has been achieved in Norway in the period 1994-2004? Health Policy. 2009;90(2–3):277–285.
   PubMed Web of Science ®Google Scholar
• Pillans PI, Conry I, Gie BE. Drug cost containment at a large teaching hospital. Pharmacoeconomics. 1992;1:377.
   PubMedGoogle Scholar
• Leopold C, Mantel-Teeuwisse AK, de Joncheere K, et al. Differences in external price referencing in Europe—a descriptive overview. Health Policy. 2012;104(1):50–60.
   PubMed Web of Science ®Google Scholar
• Bloom N, Van Reenen J. Regulating drug prices: where do we go from here? J Appl Econ. 1998;19(3):321–342.
   Google Scholar
• Carone G, Schwierz C, Xavier A. Cost-containment policies in public pharmaceutical spending in the EU. Eur Econ Econ Papers. 2012;1(461):1–64.
   Google Scholar
• National Statistical Institute database. [cited 2019 Feb 22]. Available from: www.nsi.bg
   Google Scholar
• WHO. Global health expenditures database. [cited 2019 Feb 22]. Available from: http://www.who.int/health-accounts/ghed/en/
   Google Scholar
• National health Insurance Fund. Medicinal products. [cited 2019 Feb 22]. Available from: https://www.nhif.bg/page/45
   Google Scholar
• National Peoples’ Assembly. Law for medicines and pharmacies in human medicine. Gov. newspaper 36/18 April 1995. 1995.
   Google Scholar
• National Peoples’ Assembly. Law for health of the population. Governmental Newspaper 88/1973. 1973.
   Google Scholar
• DIRECTIVE 2001/83/EC of the European parliament and of the council of 6 November 2001 on the community code relating to medicinal products for human use. 2001L0083 — EN — 16.11.2012 — 011.001 — 1. [Access date 2019 Feb 22]. Available from: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_en.pdf
   Google Scholar
• National Peoples’ Assembly. Health insurance law, Gov. Nespaper 70 / 19 June 1998. 1998.
   Google Scholar
• National People’s Assembly. Health insurance law, amendments. Gov. Newspaper 70/1998. 1998.
   Google Scholar
• Ministry Council. Decree 81/2003 for the adoption of criteria, conditions and rules for introduction of medicinal products in the positive drug list. Gov. Newspaper 34/2003:2–34. 2003.
   Google Scholar
• Regulation 4/04.03.2009 for the rules for prescribing and dispensing of medicinal products in Bulgaria. [cited 2019 Feb 22]. Available from: http://www.bda.bg
   Google Scholar
• Ministry Council. Regulation for the way and order of medicines prices registering. Gov Newspaper 56 / 20 June 1995. 1995.
   Google Scholar
• Ministry Council. Decree on adoption of the regulation for ceiling prices of medicinal products during their retail sale. Gov. Newsp. 59 / 21 July 2000. 2000.
   Google Scholar
• Regulation on the criteria, conditions and rules for inclusion of medicnal products in the PDL of republic of Bulgaria. Gov. Newsp.34 / 15 April 2003. 2003.
   Google Scholar
• National Peoples’ Assembly. Law for medicinal products in human medicine amen. Gov. Mewspaper 102 / 21 December 2012. 2012.
   Google Scholar
• Ministry Council. Regulation on conditions and rules for regulating and registering the prices of medicinal products amend. Govern. Newspaper 40 / 30 April 2013. 2013.
   Google Scholar
• Ministry of Health. Regulation for the conditions and order for performing a health technology accessment. Gov. Newsp. 97/11 December 2015. 2015.
   Google Scholar
• Petrova G, Getov I. Methodological approach for economical and/or phamracoeconomical assessment of the drugs. Social Med. 2000;4.
   Google Scholar
• Tordrup D, Tzouma V, Kanavos P. Orphan drug considerations in health technology assessment in eight European countries. Rare Dis Orphan Drugs Int J Public Health. 2014;1(3):83–97.
   Google Scholar
• Klok RM, Brouwer W, Annemans L, et al. Towards a healthier discount procedure. Future Drug. 2005;5:59–63.
   Google Scholar
• Regulation (EC) No 726/2004 of the European parliament and of the council of 31 March 2004 laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European medicines agency. European Parliament and the Council. Off J. 2004 Apr 30; L 136:0001–0033.
   Google Scholar
• COUNCIL DIRECTIVE of 21 December 1988 relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems (89/105/EEC). Council of the EU. Off J Eur Communities. 1989 Feb 11;L 40/8. Available from: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31989L0105
   Google Scholar
• Vasileva M, Manova M, Marik V, et al. External and internal reference pricing as cost containment measures in Bulgaria. Value Health. 2015;187:A534. Available from: http://www.valueinhealthjournal.com/article/S1098-3015(15)03744-4/fulltext
   PubMed Web of Science ®Google Scholar
• Marcheva M, Tosheva-Konteva L, Petrova G. Pricing and reimbursement of medicines in Central and East European Countries. World J Pharm Pharm Sci. 2013;2(6):4311–4328.
   Google Scholar
• Health Policy and European Union Enlargement. McGraw-Hill Education (UK); 2004:205.
   Google Scholar
• Toumi M. Introduction to market access for pharmaceuticals. CRC Press.  Routledge; 1 edition (January 6, 2017). U.S. 2017. p. 74–76.
   Google Scholar
• Mitkova Z, Manova M, Savova A, et al. Generic competition and its impact on reference pricing system and medicnes utilization in the group of sartans. Value Health. 2017;20(9):A628.
   Web of Science ®Google Scholar
• Mitkova Z, Vasileva M, Savova A, et al. Analysis of cardiovascular medicines prices and reimbursement in Bulgaria and Romania. Farmacia. 2016;64(4):633–642.
   Web of Science ®Google Scholar
• Petrova G, Benisheva T, Ivanova A. Pharmacoeconomics and the new Bulgarian positive list. Regul Affairs J. 2005;175–178.
   Google Scholar
• Stoimenova A, Penkov S, Savova A, et al. Generic policy in Bulgaria: a policy of failure or success? Biotechnol Biotechnol Equip. 2016;30(5):1031–1037.
   Web of Science ®Google Scholar
• Kawalec P, Tesar T, Vostalova L, et al. pharmaceutical regulation in Central and Eastern European Countries: a current review. Front Pharmacol. 2017;8:892.
   PubMed Web of Science ®Google Scholar
• Seiter A. Pharmaceutical policy challenges in Central and Eastern Europe. Eurohealth. 2010;14(1):30–32.
   Google Scholar
• Tesar T, Hloska A, Wawruch M, et al. Introduction of health technology assessment for medicines in Slovakia. Int J Technol Assess Health Care. 2017;33:1.
   PubMedGoogle Scholar
• Zlatareva A. Analysis of the reimbursement policy in Central and Eastern European Countries - the policy of Poland, Romania, Hungary and the Czech Republic, PART II. World J Pharm Pharm Sci. 2015;4(9):64–76.
   Google Scholar