Abstract
Introduction: European Union member states are free to develop their national and regional pharmaceutical pricing and reimbursement policies, as long as they comply with the Transparency Directive. External reference pricing (ERP), also called `External price referencing` has become one of the most common cost-containment tools to reduce prices for medicines. The objective of the study is to provide an overview of the ERP system in Bulgaria and to analyze the potential issues related to criticism of the entire process. Materials and Methods: A systematic structured legislation review as well as a consultation with representatives from the competent national authority were conducted to identify and characterize the use of ERP in Bulgaria. All the collected data were processed in figures and tables. A PEST analyses was also performed to evaluate the impact political, economic, social, and technological factors might have on the ERP system. Results: In Bulgaria, the use of ERP for setting the price of pharmaceuticals is based on legislated special pricing rules. The National Council on Prices and Reimbursement of Medicinal Products is the state body under the Minister of Health, which endorses and registers the prices for medicinal products. The number of reference countries included in the basket is 17. Twelve of them are primary and five are complementary. The lowest price among all reference countries is used in Bulgaria. Prices are re-evaluated on a monthly basis after the initial price has been set. We describe also the ERP impacts on the prices of pharmaceuticals and discuss some possible cross-country coordination issues in EU and Member States. Conclusions: ERP is actively used in Bulgaria to achieve cost-containment of prescription medicines included in the positive drug list. Its application and potential impacts remain highly debated, but are still considered to be the most effective action for keeping the prices of pharmaceuticals low.
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