A Case Study in Pharmaceutical Governance: A Critical Review of Somalia's Medicine Policy,

Somalia’s healthcare system has experienced prolonged instability, with pharmaceutical sector governance presenting a significant challenge. The national medicine policy is a foundational instrument for ensuring access to safe, effective, and quality-assured medical products, yet its application within the East African context is complex. This case study critically reviews Somalia’s medicine policy. It analyses the policy’s development, core provisions, and governance framework to identify its key strengths, implementation challenges, and role within the broader health system. A qualitative, document-based case study methodology was employed. This involved a critical analysis of official policy documents, legislative texts, and grey literature from governmental and non-governmental sources. The analysis focused on thematic content concerning policy formulation, regulatory structures, and supply chain governance. The review identified significant gaps between policy intent and practical implementation. A central finding was weak regulatory enforcement, which contributes to a substantial circulation of substandard or falsified medicines. Coordination between federal and state-level authorities was inconsistent, undermining a unified pharmaceutical sector. Somalia’s medicine policy provides a necessary framework but is hindered by systemic governance challenges. Effective implementation depends on strengthening regulatory capacity and improving multi-level governance coordination to protect public health. Prioritise capacity building for the national medicine regulatory authority. Foster clearer delineation of roles and improve collaboration between federal and state health ministries. Integrate medicine policy objectives more robustly into broader health sector strategic plans and financing mechanisms. Pharmaceutical policy, health governance, regulation, essential medicines, health systems, Somalia, East Africa This case study provides a focused, critical analysis of Somalia’s medicine policy, contributing to the sparse literature on pharmaceutical sector governance in fragile and conflict-affected settings.