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Pricing and reimbursement in the European Union (EU) are unified by Directive 89/105/EEC/21.12.1988. The directive has a framework nature; it defines deadlines for decision-making, legal protection, publicity of information, tacit consent, etc. The specific mechanisms are subject to national measures, leading to differences in Member States. The aim of the study is a comparative analysis of the regulatory measures for pricing and reimbursement of medicinal products in Bulgaria and Italy. We looked at four main pricing and reimbursement measures: positive drug lists, reference pricing, health technology assessment, and innovative schemes. We used documentary analysis and synthesis, comparative, and statistical methods. The two countries’ pricing and reimbursement systems are fundamentally different. Italy’s system has long traditions and guarantees stability in the availability and affordability of medicinal products for the population. Since 2000, the regulations concerning the pricing and reimbursement system in Bulgaria have been amended more than 42 times, which characterizes the Bulgarian pricing and reimbursement policy as regulatoryly unstable.
Cannavale et al. (Mon,) studied this question.