Enhancing Access to Quality Health Products in Africa: The Global Fund’s Quality Assurance Policy Revisions and the Potential for Local Manufacturing
In a groundbreaking move towards ensuring equitable access to quality health products, the Global Fund has proposed revisions to its Quality Assurance (QA) Policies. Last updated in 2010 and 2017, they are due for a revamp as they no longer capture the dynamic regulatory environment, the Global Fund’s broader procurement scope, or the organization’s strategic goals. The recent COVID-19 pandemic magnified the urgency for swift access to quality health products during emergencies, emphasizing the need to formalize procurement pathways in future QA Policies. The initiative to revise the Global Fund’s QA Policies has been warmly received by the East and Southern Africa (ESA) and West and Central Africa (WCA) constituencies represented at the Global Fund as it reflects the organization’s commitment to adapt to a changing global health landscape.
In their statements for the Global Fund’s 50th Board, the ESA and WCA constituencies also lauded the potential benefits of transitioning to the World Health Organization’s (WHO) Listed Authority (WLA) approach. Envisioned as a game-changer, the shift to WLA is expected not only to ease and enhance access to quality health products, meeting international quality standards, but also broaden the recognition of global regulatory authorities and nurture collaboration with a diverse range of regulatory authorities and stakeholders. The ESA and WCA constituencies express their support, foreseeing the anticipated ripple effects, which include enhanced collaboration, greater innovation, improved regulatory systems and heightened supply security.
A noteworthy aspect of these transformative developments is the potential boost to local production within Africa. As regulatory recognition expands, there’s an exciting possibility of increased procurement of health products manufactured on the continent. This shift could catalyze growth in Africa’s pharmaceutical and medical device industries.
The existing QA Policies focus primarily on pharmaceutical and diagnostic products, leaving a gap in oversight for other critical medical devices. The ESA and WCA constituencies stress the importance of extending the same level of quality assurance oversight to a broader spectrum of health products, including equipment, personal protective gear, and oxygen plants.
In advocating for a harmonized approach, the ESA and WCA constituencies acknowledge inconsistencies in definitions and eligibility periods arising from separate updates for Pharmaceutical Products and Diagnostics Products. Clarity and coherence in the QA framework are essential for effective implementation.
In conclusion, the Global Fund’s revisions of its QA Policies, coupled with the potential of the WLA approach, paint a promising future for healthcare in Africa. The Global Fund, alongside other global health institutions, is actively supporting Africa and continental bodies such as the AUDA-NEPAD (African Union Development Agency – New Partnership for Africa’s Development) in their efforts to foster self-reliance and enhance accessibility to quality healthcare. By championing local manufacturing and expanding access to quality health products, this collaborative effort is empowering Africa to take charge of its health destiny.
Fassika Alemayehu
