While Sub-Saharan Africa bears the highest HIV burden globally and is home to almost 65% of all people living with HIV, for decades, access to HIV treatment across the African region depended almost entirely on imports of lifesaving drugs and diagnostic tests manufactured thousands of miles away.
To boost supply chain resilience and regional self-reliance, WHO's Global HIV, Hepatitis and Sexually Transmitted Infections Programmes Department, in collaboration with the Regulation and Prequalification Department, has been actively advocating for locally manufactured quality-assured medicines and diagnostics. This work is carried out in close partnership with countries, manufacturers in Africa and partners such as the Global Fund and Unitaid.
In 2023, Universal Corporation Ltd (UCL), a Kenya-based pharmaceutical company led by Mr Palu Dhanani, became the first African manufacturer to receive WHO prequalification to produce tenofovir disoproxil fumarate, lamivudine and dolutegravir (TLD), a WHO-recommended first-line antiretroviral therapy for HIV infection.
"Local production of quality-assured health products is an urgent priority. With every African manufacturer that meets WHO prequalification standards, we move closer to a more self-reliant, resilient, and equitable health system. Regulation and prequalification are not just technical processes; they are catalysts for health sovereignty and timely access to lifesaving medicines and diagnostics," said Dr Rogerio Gaspar, WHO Director for Regulation and Prequalification.
A first for the continent
As recently announced, the Global Fund now procures UCL's TLD for Mozambique, marking the first time TLD is manufactured on African soil. This milestone reflects ongoing collaboration between WHO and the Global Fund to support essential HIV services, through the NextGen market shaping approach.
"The procurement of the African-manufactured first-line HIV treatment by the Global Fund for Mozambique is a great milestone towards strengthening supply chain systems in Africa. This will contribute to better health outcomes for people living with HIV who need uninterrupted medicine supplies," said Dr Meg Doherty, Director of WHO's Global HIV, Hepatitis and STIs Programmes.
However, production alone isn't enough. To ensure sustainable and resilient supply chains, critical enablers are needed, such as advanced market commitments, fair procurement policies and continued technical support.
WHO shares the vision of a world where every region has the capacity to secure its own health. Locally manufactured TLD is a major step towards that goal, but more action is needed. African manufacturers should be prioritized in global supply chains, and guaranteed equitable access to health technologies that meet quality, safety and efficacy/performance standards.
HIV testing: another critical frontline
HIV testing is a critical health service and a vital gateway to both prevention and treatment. With current shifts in donor funding, many countries are facing financial strain, putting testing programmes at risk. Keeping people living with HIV on treatment is important and requires affordable and reliable access to HIV rapid tests.
WHO is urging governments to shift towards low-cost, quality-assured HIV rapid tests , especially the first test in their national testing algorithms, for significant cost savings.
Codix Bio, a Nigerian in-vitro diagnostics company, has received a sublicense to manufacture rapid diagnostic tests (RDTs) , with an initial focus on RDTs for HIV, using technology transferred from the global in-vitro diagnostics company SD Biosensor. Thanks to the collaborative efforts of WHO's Health Technology Access Programme and the Medicines Patent Pool, this new local manufacture of HIV RDTs will improve access to affordable diagnostic tests and help mitigate disruptions of HIV testing services.
"Having locally produced HIV RDTs will help increase affordability, and more broadly address supply chain vulnerabilities and delays in access to diagnostics," said Dr Meg Doherty, Director of WHO's Global HIV, Hepatitis and STIs Programmes.
In addition to switching to low-cost quality-assured HIV tests, WHO encourages countries to use HIV self-tests to mitigate gaps in human resources for health as well as stockouts for the first RDT in national algorithms.
