Moving beyond a legacy paradigm: A vision for equitable access to quality medicines in Africa.

Ensuring the availability of quality medicines is fundamental to achieving health outcomes and safeguarding public health. However, in many low- and middle-income countries, especially across Africa, the current quality assurance paradigm-largely driven by historical donor preferences for WHO prequalification and stringent regulatory authority approval-can unintentionally limit access, equity, and sustainability. While these requirements have been effective in ensuring client safety, they can result in higher expenditures, reduced coverage, and deepening inequities. Moreover, such narrow focus risks undermining the authority of national regulatory authorities (NRAs), diminished economic development opportunities, erosion of trust in local health systems, and vulnerabilities to external shocks. This paper argues for a more inclusive approach to defining quality standards for procurement eligibility. It proposes qualifying for procurement products with marketing authorizations granted by NRAs that have achieved at least Maturity Level 3-a designation based on the WHO Global Benchmarking Tool that indicates a stable, well-functioning, integrated regulatory system; establishing financing mechanisms to minimize the budget impact of more costly quality medicines; promoting regulatory reliance through regional harmonization; and investing in system-wide regulatory strengthening. Such a model would not only enhance access to safe and effective medicines but also foster local regulatory capacity, support domestic pharmaceutical industries, reduce overdependence on donors and imported products, and promote self-reliance. By rethinking quality assurance strategies and aligning them with regional progress and aspirations, Africa can build more resilient, autonomous health systems and advance toward sustainable health equity.