Abstract
National legislative frameworks governing prescribing, pricing, reimbursement, and dispensing play a decisive role in shaping access to medicines. This study examines the financial availability of medicines in Bulgaria and North Macedonia through a comparative review of national pharmaceutical legislation, pricing mechanisms, reimbursement models, and digitalisation policies, assessed in relation to European Union standards. The findings indicate that access to medicines in both countries is shaped by the combined effects of multiple regulatory and financial instruments rather than by individual policy measures. Both systems apply strict control of prescribing and dispensing, external reference pricing, and positive reimbursement lists, reflecting alignment with international recommendations. However, significant differences in policy design lead to divergent access outcomes. Bulgaria's more advanced digitalisation of prescribing and reimbursement, including mandatory electronic prescribing for selected therapeutic groups, enhances regulatory oversight and expenditure control but is associated with higher patient out-of-pocket expenditure, partly due to the application of the standard value-added tax on medicines. In contrast, North Macedonia combines lower taxation with capped patient co-payments, higher regulated pharmacy margins, and fixed pharmacy remuneration per prescription, contributing to improved financial affordability for patients while supporting pharmacy sustainability. Additional instruments, such as the Generics without Co-Payment List, further strengthen patient financial protection. The study provides comparative evidence relevant to pharmaceutical policy reforms and highlights the importance of balanced regulatory approaches that promote affordability, system sustainability, and equitable access to medicines.