For decades, the architecture of global generic drug manufacturing followed a predictable pattern. When a pharmaceutical company in the Global North decided to license a patented medicine for the developing world, it turned to Indian manufacturers. Indian firms had the scale, the regulatory expertise, and the supply chains. Sub-Saharan African manufacturers, if they entered the picture at all, did so years later as secondary sublicensees or after the patent expired.
A licensing announcement from Merck this week suggests that pattern may be breaking.
Merck signed seven royalty-free voluntary licensing agreements for alimatravir, its experimental once-monthly oral pill for HIV prevention. The drug, still enrolling patients in late-stage clinical trials, targets HIV-1 and provides protection within one hour of dosing that lasts roughly a month. Trial results are expected in the second half of 2027.
The deals themselves are not unprecedented. They follow a model Gilead established in 2024, when it licensed its HIV prevention drug lenacapavir to six generic manufacturers for 120 countries. What sets Merck’s announcement apart is not the number of countries covered or the royalty terms. It is who got invited to the table and when.
African Manufacturers at the Start
Of the seven licensees Merck selected, three are sub-Saharan African manufacturers: Aspen Pharmacare Holdings of South Africa, Quality Chemical Industries of Uganda, and Universal Corporation Limited of Kenya. The other four are Indian companies with long track records in generic production: Aurobindo, Cipla, Emcure, and Viatris.
Merck’s global vaccines and infectious diseases head described this as a deliberate departure from precedent. He stated that this is the first time sub-Saharan African manufacturers have been included in licenses from the very beginning of a voluntary licensing program.
The phrasing matters. Including African manufacturers at the outset rather than as an afterthought signals a recognition that local manufacturing capacity is not just a nice-to-have after generics reach the market. It is a strategic asset that needs to be built and exercised from day one.
A Drug Still in the Pipeline
Alimatravir is not yet approved. It is an investigational drug in late-stage development, and Merck is still enrolling patients in trials. The company’s global pharmaceutical public policy lead acknowledged that results are unlikely before the second half of 2027 but said the early licensing gives generic manufacturers time to begin scaling up their production processes.
This timeline is unusual. Typically, voluntary licensing deals are announced closer to or after a drug receives regulatory approval. Announcing them years in advance gives generic manufacturers a head start on the complex work of reverse-engineering the drug, establishing quality control protocols, and preparing manufacturing facilities for regulatory inspections. By the time alimatravir reaches the market, if approved, the generic supply chain could be ready to produce at scale almost immediately.
The economics of HIV prevention make this preparation critical. PrEP, or pre-exposure prophylaxis, works best when it is widely and cheaply available. A once-monthly oral pill represents a significant improvement over the daily pills that currently dominate the market, and the inclusion of African manufacturers from the start could help ensure that supply meets demand where the need is greatest.
Industrial Strategy Meets Pandemic Preparedness
The decision to license to African manufacturers is about more than drug access. It reflects a growing consensus within global health that relying on a small number of manufacturing hubs creates dangerous vulnerabilities. The COVID-19 pandemic exposed what happens when vaccine and treatment production is concentrated in a handful of countries. Export controls, supply shortages, and hoarding left much of the Global South waiting months or years for access to life-saving medicines.
Since then, initiatives to build local pharmaceutical manufacturing capacity in Africa have accelerated. The African Union’s Partnership for African Vaccine Manufacturing aims to produce 60 percent of the continent’s vaccine needs by 2040. The World Health Organization has pushed for technology transfer hubs. But these efforts take time, and they require companies like Merck to actively participate by bringing African manufacturers into the supply chain rather than treating them as competitors to the existing generic ecosystem.
The inclusion of Aspen, Quality Chemical Industries, and UCL from the beginning of this licensing program gives those companies hands-on experience manufacturing a complex antiretroviral drug years before it might reach patients. That experience is not easy to replicate through training programs or technology transfer agreements alone. It requires doing the actual work of pharmaceutical production at commercial scale.
The Limits of Voluntary Licensing
Not everyone sees Merck’s announcement as an unqualified step forward. A Northeastern University law professor and longtime advocate with Health GAP called the deals a step in the right direction but said they fall short of what is possible. He noted that Merck could have granted more expansive licenses covering a wider range of countries or including fewer restrictions on how the generics can be manufactured and distributed.
Voluntary licensing is, by its nature, a compromise. The patent holder retains control over who can make the drug, where it can be sold, and under what conditions. Countries not included in the list of 129 must negotiate separately or wait for the patent to expire. Critics argue that compulsory licensing or patent challenges would produce broader access, though these approaches carry their own risks and have historically been slow and litigious.
Gilead’s 2024 licensing of lenacapavir, while similar in structure, also faced criticism for the countries it excluded. Middle-income countries that bear a significant burden of HIV were left out of that deal, and advocates have warned that Merck’s list of 129 countries may have similar gaps.
Still, the inclusion of African manufacturers from the beginning addresses a structural weakness that earlier licensing deals did not. Even Gilead’s lenacapavir licenses, which were praised at the time for their scope, did not include sub-Saharan African manufacturers as direct licensees from the start. That asymmetry mattered. When emergency orders surged or supply chains faltered, African countries had to rely on Indian-produced generics and the logistics networks that delivered them.
What the Shift Means
If Merck’s approach becomes the new normal, it represents a meaningful change in how the pharmaceutical industry thinks about global manufacturing capacity. The decision to license to African manufacturers at the same time as Indian ones suggests that pandemic preparedness is no longer an abstraction discussed at WHO meetings but a factor that influences real commercial decisions.
The World Health Organization has urged governments to improve access to affordable HIV medicines through voluntary licensing, and Merck’s deal aligns with that guidance. But the more significant signal may be the industrial one. By investing in the production capability of sub-Saharan African manufacturers before the drug is even approved, Merck is conceding that local manufacturing matters not just for access but for resilience.
A once-monthly HIV prevention pill that can be manufactured in Africa, by African companies, alongside Indian generics, from the outset of its commercial life would be a first. If alimatravir succeeds in clinical trials and reaches the market, the infrastructure to produce it at scale will already exist on the continent. That is not just a story about drug access. It is a story about who gets to participate in the global pharmaceutical economy and when.
For the seven generic manufacturers named in these licenses, and for the 129 countries where their products will be sold, the answer to that question may finally be changing.
References
- Reuters. “Merck signs licensing deals with generic drugmakers for HIV prevention pill.” July 24, 2026.
- Silverman, Ed. “Merck licenses experimental HIV prevention pill to generic drugmakers.” STAT News Pharmalot. July 24, 2026.
- Medical Dialogues. “Merck signs royalty-free licensing agreements for once-monthly HIV prevention pill Alimatravir.” July 2026.
- Northeastern University School of Law. “Brook Baker Commentary on Merck Voluntary Licensing for HIV Prevention.” July 2026.
- World Health Organization. “Voluntary licensing and HIV medicine access.” WHO Technical Brief, 2025.
- Gilead Sciences. “Gilead Signs Royalty-Free Voluntary Licensing Agreements for Lenacapavir.” Press Release, October 2024.
- African Union. “Partnership for African Vaccine Manufacturing (PAVM): Framework for Action.” African Union Development Agency, 2024.