An exploratory study of the mandate and functions of national pharmaceutical services units: global trends and the cases of Côte d'Ivoire, Kenya, and Nepal.

Background: National pharmaceutical services units (NPSUs) - organisational units within the central government usually responsible for pharmaceutical services and management - have an increasingly narrow mandate. Anecdotal evidence points to an increasing focus, almost exclusively, on logistics management, while pharmaceutical care and policy oversight have become fragmented. This study examined NPSUs' current functions and mandates, and proposed what should be the critical functions and roles of these units going forward. Methods: Using case studies of Côte d'Ivoire, Kenya and Nepal, the study relied on a literature review and in-depth interviews. We triangulated and synthesised the findings to identify NPSUs by level in the health ministry's hierarchy and reporting line, mandate, and function. Results: We identified medicine regulation, procurement and supply chain management, selection and rational use of medicines, and pharmacy practice regulation as four broad sets of functions that NPSUs commonly have as their mandate. A clear position in the Ministry of Health's hierarchical structure, the legal or administrative framework that mandates an NPSU's functions, and national pharmaceutical policies and regulations to guide the pharmaceutical sector are three critical factors for effective functioning. It is essential to have a legislative framework that at a minimum identifies one NPSU as responsible for pharmaceutical policy and governance, serving as the steward for the pharmaceutical system. This role encompasses pharmaceutical system coordination and administrative functions, formulating and implementing policies for organising, managing, financing, regulating, monitoring, and evaluating the pharmaceutical system. As such, we recommend that NPSUs should at a minimum have four broad sets of functions: pharmaceutical policy and governance, medicine regulation, pharmacy practice regulation and procurement and supply chain management. Conclusion: The study substantiates the need for a pharmaceutical policy and governance unit that stewards the pharmaceutical system and is empowered to monitor and evaluate system performance and coordinate efforts for system strengthening.