Legal and regulatory framework for procurement
The public procurement system has a key role in achieving the goals and programmatic objectives that are set by a government to meet its immunization programming needs.
In order to impact programme outcomes, procurement must align with other key functions, especially the programme responsible for resource mobilization and service delivery (MoH), as well as the regulatory function for health supplies (NRA) and the bodies responsible for financing activities in the health sector (MoF).
Each of these functions will operate under a framework that will determine (1) the principles followed, (2) the policy and regulation required, (3) guidance that is provided to institutions and individuals, (4) standard documents and SOPs that apply at the operational level, as well as (5) the human resource skills needed at all levels.
Regulation of medical products is covered by many assessment methodologies which focus on health supply chains or health procurement. The main principles assessed are related to accountability and integrity in market authorization and market control, which are considered key elements of a function where corruption has been highlighted as a risk. These functions are not well covered by the assessments that focus on general procurement (e.g. MAPS, WB APA).
The WHO GBT is designed to assess how regulatory systems perform against WHO standards for regulatory functions and covers the spectrum of activities and governance framework. The GBT assessment covers lightly the integration of regulatory functions in other sectoral activities (like procurement), making reference to alignment of pharmaceutical policy with health policy and reliance on regulatory decisions.