Recent market intelligence led by community health advocates in Kenya, Malawi, and Uganda reveal systemic challenges – procurement inefficiencies, donor dependency, and limited political will – that continue to undermine equitable, long-term access to life-saving medicines.
The reports, published by the Kenya Legal and Ethical Issues Network on HIV and AIDS (KELIN – Kenya), Community Health Rights Advocacy (CHeRA- Malawi), and the Centre for Health, Human Rights and Development (CEHURD-Uganda) with technical and financial support from the International Treatment Preparedness Coalition (ITPC) call for transformative actions, including modernizing and centralizing of data systems, investing in local manufacturing, and revising countries’ essential drug lists to align with emerging needs.
Conducted through comprehensive data review and regional and national analysis at both the national and regional levels, the market intelligence studies examine how medicines for HIV, TB, and Hepatitis C are procured – identifying notably where inefficiencies lead to delays and stockouts, where a disproportionate share of resources is spent on a few products, and where countries remain overly dependent on donor funding or importation. In doing so, the findings help identify situations – such as extreme price disparities or reliance on single suppliers – that may require further investigation into affordability or access barriers, and inform national and regional strategies.
Reports’ recommendations are meant to support policymakers and stakeholders to identify high-impact commodities that should be prioritized based on cost-effectiveness and alignment with national health strategies, health systems strengthening, in addition to helping stakeholders negotiate better pricing, ensuring that critical health commodities are available, accessible, and affordable.
Over-Reliance on International Donors
The studies underscore the critical role of international donors in health financing across all three countries, noting a “heavy reliance on international donors like the Global Fund, PEPFAR, and the World Bank, with minimal government funding.” This highlights the need for sustainable financing strategies and domestic health financing in relation to TB, HIV treatments and diagnostics.
In Kenya, the report found that “the lives of PLHIV [People Living with HIV] are largely dependent on the existing ARV supply value chain currently pegged on a 90% imported and donor-supported private sector mechanism, with minimal contribution from the government” which it stated is not sustainable in the event of global changes in the current supply paradigm.
The report suggests that Kenya adopt a pro-local pharmaceutical framework, similar to Nigeria’s Presidential PVAC Initiative, to support and sustain local pharma manufacturing, supply, and availability of quality essential ARVs and TB medicines. In Nigeria, the PVAC Initiative works to transform the ecosystem of health product manufacturing, among other aims in driving healthcare and economic development.
Trade Agreements Hindering Access to Generics
“This over-reliance on donor funding is unsustainable, and what makes it worse is our governments are negotiating trade deals that risk undermining our governments’ ability to safeguard public health and make medicines affordable. TRIPS-plus rules[1] are now being introduced into Free Trade Agreements which could hinder both the importation and local production of generics. In a time of fiscal strain and global health uncertainty, we can’t afford to sign agreements that will further limit access to affordable health products,” said Pesa Okania, Programme Officer HIV/TB and KAPS at KELIN Kenya. “Without access to affordable medicines and strong local production, we are vulnerable.”
For example, the Kenya–UAE Comprehensive Economic Partnership Agreement (CEPA), which is Kenya’s proposed Free Trade Agreement (FTA) with the United Arab Emirates could severely restrict access to affordable generic medicines. The proposed agreement introduces provisions which would require Kenya to introduce market exclusivity, meaning that even after a patent has expired (or if no patent exists), a generic version of a medicine cannot be approved for sale without the consent of the originator.
“This is disastrous for local production of generic medicines in Kenya. It will disincentive any generic company from trying to market a generic version, even if the production of the generic medicine does not violate the patent,” said Okania.
Calling on Procurement Transparency and Expanded New Drug Access
The Malawi study reviewed the procurement processes, quantities, and costs of health products to offer a critical analysis of the key commodities that should be prioritized for advocacy and resource allocation. It highlighted the need for regional integration between the regional blocs like SADC and AU Agencies like Africa CDC to support regional pooled procurement and production schemes, potentially through the African Medicine Agency while stating that procurement processes must be strengthened in order to increase equitable access to affordable and appropriately formulated medicines, biologics, vaccines, and diagnostics for people in low- and middle-income countries (LMICs).
“Continued advocacy for cost reduction, improved supply chains, and robust data systems will be pivotal in achieving equitable access to these life-saving health products,” the study states.
In Uganda, the study stated that “procurement mechanisms in government often lack transparency for external stakeholders” such as advocacy groups, regarding pharmaceutical expenditures within the health sector budget, which is critical for effective resource allocation.
Further compounding the challenge, the national treatment guidelines (NTG) for HCV have not been updated since 2019, and direct-acting antivirals (DAAs) for HCV are not included in the 2023 National Essential Medicines and Health Supplies List (EMHSLU), making government procurement nearly impossible. Only four HCV-related drugs were registered with Uganda’s National Drug Authority as of June 2024, compared to 133 for TB and 74 for HIV.
Moreover, patients are referred to private sector distributors, where treatment remains prohibitively expensive — a branded DAA regimen costing UGX 1.4 million (~USD 376), compared to a USD 58 generic through pooled procurement. This 549% price difference underscores how affordability remains a major barrier.
The report’s recommendations include calling on the government in Uganda to increase its contribution to the health commodity budget, particularly for HIV, TB, and HCV treatments, which would reduce dependency on international donors. It further suggests there is a need to fast track WHO recommendations and prequalification of new treatment options, such as long-acting injectable Cabotegravir/Rilpivirine (LA CAB/ RPV). Given the current high prices of these newer drugs, the report recommends multiple strategic interventions to ensure cost-effectiveness, such as generic competition, negotiating with manufacturers, policy and regulatory interventions, and innovative financing mechanisms.
The market intelligence reports from Kenya, Malawi, and Uganda show that current procurement systems often fail to deliver timely, affordable, and equitable access to essential medicines. Tackling these inefficiencies – alongside increasing domestic funding and strengthening regional production – will be key to ensuring long-term access to treatment. Governments and partners must now act on these insights to secure more resilient, fair, and sustainable health systems
Investigating Barriers to Local Production
In Kenya, the landscape for sustainable, resilient local production is not promising, despite the lessons learned from recent pandemic-related supply challenges and local availability of know-how and skills. The study identifies several key barriers and obstacles to achieving local production and recommends a critical review of the health policy, regulatory, and legislative frameworks which could help address the government’s “lack of political will and the inadequate infrastructure that impedes local manufacturers from participating in a level playing field with foreign manufacturers and importers.”
In Uganda, local production was encouraged in response to the introduction of new regimens like Lenacapavir, Cabotegravir (LA-CAB), and Dapivirine, as a way to manage costs effectively. The report’s cost-prevention strategies include local production, stating that this should be encouraged and supported, particularly for ARVs and PrEP drugs, with the benefits of local manufacturing including reduced dependency on international suppliers, lower transportation costs, and stabilized prices.
Strengthening Diagnostic Testing to Reduce New Infections and Improve Health Equity
In Kenya, the study highlighted that the HIV access challenge stems less from supply security issues and more from limited access to optimal diagnostic testing services. To address this, the study recommends a bold push to catalyze a surge of testing services, ensure that clients and patients remain on optimal regimens, and prioritize tackling the biggest opportunistic killers like TB and cryptococcal meningitis. Furthermore, “scaling up PrEP and PEP is essential to stem new infections and ensuring patients on treatment achieve viral suppression”. The study is calling for focused efforts to introduce and expand generic manufacturing of both medicines and diagnostics for TB and hepatitis, helping secure sustainable access to these critical health tools.
Additional market intelligence analysis reports are ongoing in Senegal and Tunisia, with technical and financial support from ITPC Global.
[1] The TRIPS Agreement (Trade-Related Aspects of Intellectual Property Rights) sets minimum standards for intellectual property protection globally. However, TRIPS-plus rules go beyond these requirements and are increasingly being introduced into Free Trade Agreements, potentially restricting countries’ ability to produce or import affordable generic medicines.