Pharmaceutical Governance Challenges in The Gambia: A Systematic Analysis of Legal and Policy Frameworks

Pharmaceutical governance is fundamental to an effective health system because it influences the availability, affordability, quality, safety, and rational use of medicines. Effective governance requires coherent legislation, capable institutions, adequate financing, transparent procurement, reliable supply chains, and strong accountability. This study examined pharmaceutical governance challenges in The Gambia through systematic analysis of national legal and policy frameworks. A qualitative document analysis design was employed using an instrumental case study approach. Eleven key legal, policy, regulatory, planning, procurement, and financial documents were purposively selected and analysed. The analysis was guided by the World Health Organisation Good Governance for Medicines Framework, the Pharmaceutical Public Value Governance Framework, and the Health System Governance Framework. Thematic and gap analyses were used to identify weaknesses between policy provisions and implementation requirements. The findings revealed systemic governance challenges across regulatory, procurement, financing, supply chain, human resource, information management, and accountability dimensions. Major gaps included weak regulatory independence, limited post-market surveillance, absence of a national medicines quality control laboratory, inadequate pharmaceutical expertise in procurement, weak medicine price transparency, poor storage and inventory systems, limited digitalisation, insufficient pharmaceutical personnel, and weak pharmacovigilance. Also, low government health expenditure, high out-of-pocket expenditure and substantial donor dependence remained serious financial challenges. The National Essential Medicines lists require regular updates to enhance effective stratification of the level of care, procurement linkages and quality assurance processes. Public access to pharmaceutical information was limited by weak whistleblower protection, while inadequate parliamentary and civil society involvement was severely constrained by accountability. In order to strengthen regulatory independence, financial information, pharmaceutical capacity and accountability mechanisms are essential to enhance pharmaceutical governance and medicine security in The Gambia.