OBJECTIVES: The aim of this study was to investigate the analysis, discussion, and challenges of the price and reimbursement process of medicinal products in Bulgaria in the period 2000-15 and health technology assessment (HTA) role in these processes. METHODS: The dynamics of the reform, with respect to the healthcare and pharmaceutical sectors, are tracked by documentary review of regulations, articles, and reports in the European Union (EU), as well as analytical and historical analysis. RESULTS: Pricing and reimbursement processes have passed through a variety of committees between 2003 and 2012. Separate units for pricing and reimbursement of medicinal products were established in Bulgaria for the first time, in 2013, when an independent body, the National Council at Prices and Reimbursement of Medicinal Products, was set up to approve medicinal products with new international nonproprietary names (INN) for reimbursement in Bulgaria. Over the course of 2 years (2013-14), thirty-three new INNs were approved for reimbursement. In December 2015, a new HTA body was introduced, and assigned to the National Centre for Public Health and Analyses. CONCLUSIONS: Although Bulgaria has current legislation on pricing and reimbursement which is in accordance with the EU rules, there is no mechanism for reporting and monitoring these processes or the financial resources annually, so as to provide an overall objective assessment and analysis by year. Therefore, this financial assessment should become a national policy objective for the future.
OBJECTIVES: The aim of this study was to investigate the analysis, discussion, and challenges of the price and reimbursement process of medicinal products in Bulgaria in the period 2000-15 and health technology assessment (HTA) role in these processes. METHODS: The dynamics of the reform, with respect to the healthcare and pharmaceutical sectors, are tracked by documentary review of regulations, articles, and reports in the European Union (EU), as well as analytical and historical analysis. RESULTS: Pricing and reimbursement processes have passed through a variety of committees between 2003 and 2012. Separate units for pricing and reimbursement of medicinal products were established in Bulgaria for the first time, in 2013, when an independent body, the National Council at Prices and Reimbursement of Medicinal Products, was set up to approve medicinal products with new international nonproprietary names (INN) for reimbursement in Bulgaria. Over the course of 2 years (2013-14), thirty-three new INNs were approved for reimbursement. In December 2015, a new HTA body was introduced, and assigned to the National Centre for Public Health and Analyses. CONCLUSIONS: Although Bulgaria has current legislation on pricing and reimbursement which is in accordance with the EU rules, there is no mechanism for reporting and monitoring these processes or the financial resources annually, so as to provide an overall objective assessment and analysis by year. Therefore, this financial assessment should become a national policy objective for the future.