Objectives: The current study aims to analyze, from a historical perspective, the regulatory framework of prices and reimbursement in Bulgaria with emphasis on the introduction of economic evaluation.Methods: The study explores all regulatory changes during the period 1995-2016 combining the macroeconomic and regulatory analysis on medicines pricing and reimbursement. A roadmap summarizing the current regulatory requirements for the medicinal product entrance on national market and access to public funding was elaborated.Results: Demographic processes in the country have been negative for the past decade. On the other hand, health care and pharmaceutical expenditures experienced a growth up to 8.6% and 3% of total GDP, respectively. The total pharmaceutical market permanently grew from 309 to 1409 million of Euro. During the last 20 years, the pricing and reimbursement legislation of medicines in Bulgaria was changed extensively.Conclusion: Pricing policy remains oriented toward the lowest European prices and reimbursement policy impose cost containment measures. Appraisal of the obligatory Health Technology Assessment Dossiers and pharmacoeconomic analysis is in accordance with world recommendations. Main regulatory issues that still remain to be tackled are the slower entrance of medicines on the national market and lower national prices that often lead to parallel import.

中文翻译：

---

保加利亚关于药品定价和报销的监管框架发展的历史概述。

目标：本研究旨在从历史的角度分析保加利亚的价格和报销监管框架，重点是引入经济评估方法：本研究探讨了1995年至2016年期间宏观经济和社会发展的所有监管变化药品定价和报销的监管分析。拟定了一份路线图，概述了目前在国家市场上进口药品和获得公共资金的法规要求。结果：在过去十年中，该国的人口统计过程一直是不利的。另一方面，医疗保健和医药支出分别增长了GDP的8.6％和3％。整个药品市场永久从309亿欧元增长到14.09亿欧元。在过去的20年中，结论：定价政策仍然以欧洲最低价格为导向，而补偿政策则采取了成本控制措施。强制性“健康技术评估档案”的评估和药物经济学分析符合世界的建议。尚待解决的主要监管问题是药品在国内市场上的进口速度较慢，以及较低的国家价格（通常导致平行进口）。强制性“健康技术评估档案”的评估和药物经济学分析符合世界的建议。尚待解决的主要监管问题是药品在国内市场上的进口速度较慢，以及较低的国家价格（通常导致平行进口）。强制性“健康技术评估档案”的评估和药物经济学分析符合世界的建议。尚待解决的主要监管问题是药品在国内市场上的进口速度较慢，以及较低的国家价格（通常导致平行进口）。