Analysis of Legislative and Regulatory Frameworks Governing Community Pharmacy in Bulgaria and North Macedonia.

Abstract

The common border between Bulgaria and North Macedonia, alongside the regulatory requirements stemming from Bulgaria's membership in the European Union, provide grounds for comparing the legislative environment in both countries. This article presents a comparative case study of the regulatory frameworks governing community pharmacies in Bulgaria and North Macedonia. The aim of this study is to examine the specific features of current legislation related to the operation of community pharmacies, and to identify similarities, differences, and gaps in the organizational structure of pharmacy services, the population's access to pharmaceutical care, and the qualification requirements for personnel working in community pharmacies. Bulgaria has been a member of the European Union since 2007, while the Republic of North Macedonia has had official EU candidate status since 2005. This provides a basis for comparing the regulatory frameworks of an EU and a non-EU system within the same regional context. In both countries, the overall pharmacy-to-population ratio exceeds the European average (3.3 pharmacies per 10,000 inhabitants), indicating sufficient availability. However, pharmacies are predominantly concentrated in major urban areas. In Bulgaria, challenges remain in ensuring access to pharmaceutical services in smaller and rural settlements, while in North Macedonia, the provision of such services is better ensured. The findings of this case study may be particularly relevant for countries undergoing health system reforms or EU harmonization processes.