Africa's Commitment to Diagnostic Access

Africa is taking a significant step towards enhancing access to diagnostics for epidemic-prone diseases across the continent. The Africa CDC has released a priority list of diseases, including mpox, dengue, cholera, bacterial meningitis, and measles, which will guide initiatives to improve diagnostics aimed at these critical health challenges.

Dr. Noah Fongwen, Senior Technical Officer for Diagnostics Access at Africa CDC, announced plans for specific tests related to these diseases to be evaluated in 2025. This evaluation will be part of a continental process led by the African Medicines Regulatory Harmonisation (AMRH) programme, designed to effectively tackle key health outbreaks. "This approach aims at streamlining the regulatory process for in-vitro diagnostics across Africa," Dr. Fongwen remarked during the launch of the priority diagnostics list at a conference held in Nairobi, Kenya, from November 26–29, 2024.

The Path to Equitable Access

Dr. Fongwen emphasized that enabling access to diagnostics is complex and requires concerted efforts to clear hurdles, enhance collaboration with key organizations like the African Medicines Agency (AMA), and address the lack of local production. Currently, diagnostic tests face a fragmented approval process, often taking years—or even decades—to be fully adopted. "Local manufacturing must be prioritized to provide the continent with the tests it desperately needs," he said.

Speaking at the conference, Mr. Alex Juma Ismail from AUDA-NEPAD elaborated on the need for a harmonized regulatory process to minimize duplication, accelerate product approvals, and ultimately improve public health outcomes across Africa.

Streamlining Regulatory Frameworks

The Africa CDC is closely collaborating with AUDA-NEPAD and the World Health Organization, ironing out the regulatory frameworks for medical devices, including diagnostics. Since 2009, AUDA-NEPAD has partnered with various regional bodies to align regulatory standards, which is pivotal for expediting access to essential health tools.

As part of this collaborative effort, a Diagnostics Advisory Committee (DAC) has been established to bridge the gaps in laboratory and regulatory operations, fostering a more efficient process for diagnostics approval. Professor Hicham Oumzil, DAC Chair, stressed the significance of identifying priority diseases in Africa while highlighting the importance of global cooperation through WHO's diagnostic initiatives.

Addressing Pressing Public Health Issues

Dr. Blaise Akenji, a DAC member, shed light on the challenges associated with prioritizing diagnostics for diseases like dengue and mpox, indicating that Western manufacturers often overlook these due to diminished market incentives. Meanwhile, Anafi Mataka, another DAC member, pointed out that cholera, bacterial meningitis, and measles are still significant public health problems, particularly in areas where access to clean water and sanitation is limited.

With alarming figures revealing nearly 500,000 cholera cases reported in 2024 alone, and fatalities surpassing 4,000, Mataka argued that limited diagnostics are exacerbating the problem. Vaccines for cholera exist but are short-lived, while measles outbreaks spiked during the COVID-19 pandemic due to reduced vaccination uptake.

Looking Ahead

As regulatory harmonization efforts continue, Ismail reminded stakeholders the focus will be on quality, safety, and performance standards. The evaluation process for diagnostics will adopt a comprehensive, three-step approach, ensuring that the products meet rigorous safety and effectiveness criteria before they can be utilized in health systems.

Moreover, Dr. Fongwen reiterated the importance of aligning health ministry initiatives with those of National Regulatory Authorities, ensuring cohesive regulation throughout the various levels of health systems.

Africa's commitment to enhancing diagnostics for critical diseases signals a pivotal movement towards stronger health security and outcomes on the continent, addressing both immediate public health needs and laying the groundwork for future health resilience.