A medicine injected just twice a year could fundamentally transform the global fight against HIV, offering a level of convenience and protection that researchers describe as the closest medical science has ever come to an effective vaccine. Developed by the United States pharmaceutical company Gilead Sciences, the long-acting injectable drug lenacapavir has emerged as a monumental scientific achievement in modern medicine. Yet, even as public health authorities celebrate its remarkable clinical efficacy, the arrival of the drug has sparked intense controversy over global healthcare equity, patent barriers, and the mechanisms governing who gets to survive.
The stakes of this unfolding access crisis were underscored by a landmark 2024 clinical trial involving more than 2,000 young women across South Africa and Uganda. The results were nothing short of extraordinary: not a single participant who received lenacapavir contracted HIV. This near-perfect protection profile has positioned the drug as a vital tool for pre-exposure prophylaxis, commonly known as PrEP, which encompasses various medications designed to significantly reduce the risk of acquiring the virus.
Reflecting the magnitude of these findings, the World Health Organization has officially recommended the long-acting injectable as an additional and crucial form of PrEP. For frontline medical humanitarian organizations, the clinical verdict is definitive. "It’s the most innovative tool that has reached the HIV arena for the last decade, because it’s the closest we have [to] a vaccine," said Carlota Baptista da Silva, the global HIV lead at Doctors Without Borders, widely known by its French initials, MSF.
However, the debut of lenacapavir arrives at a deeply challenging juncture for global health funding and infrastructure. According to the Joint United Nations Programme on HIV/AIDS, international funding for HIV experienced a sharp decline of 18 percent in 2025, dropping to $7.3 billion. This financial contraction represents the lowest funding level recorded in nearly two decades, and the squeeze has already severely damaged vital prevention programmes. Statistical data from UNAIDS reveals that the number of people receiving preventative medicine dropped from 1.4 million in 2024 to 1.1 million in 2025.
In this climate of fiscal austerity and rolled-back prevention efforts, the introduction of a highly effective, twice-yearly intervention carries immense weight. But this dynamic has made the fundamental question of drug accessibility infinitely more urgent. For organizations like MSF, the scientific debate has largely concluded because lenacapavir has proven it can prevent HIV with astonishing efficacy. The battleground has now shifted entirely to the political, legal, and economic rules governing manufacture, pricing, and global supply chains, determining whether this breakthrough will actually reach the vulnerable populations who need it most.
Why some countries are excluded
The stark economic divide surrounding lenacapavir is starkly visible in its geographic pricing disparities. In the United States, the annual cost of lenacapavir hovers around $28,000 per person. By contrast, projected generic versions—copies of the original drug manufactured by third-party companies after obtaining a licensed technology transfer—are expected to cost roughly $40 a year. These generic alternatives contain the exact same active pharmaceutical ingredients as the brand-name drug, but they can be produced and distributed at a fraction of the cost.
In June 2025, the US Food and Drug Administration approved lenacapavir for HIV prevention, establishing the twice-yearly injection as an accessible clinical option for domestic patients. But for millions of people residing in low- and middle-income countries, widespread access to affordable generic versions is not projected to materialize at scale until 2027.
In the interim, Gilead has committed to supplying its own brand-name version of lenacapavir on a no-profit basis for specialized programs supported by major international health initiatives, including the Global Fund and the US President’s Emergency Plan for AIDS Relief, known as PEPFAR. Initial rollouts under this corporate framework are currently under way in a select group of nations, including South Africa, Kenya, Zambia, Nigeria, and Eswatini.
Crucially, these non-profit corporate supplies are distinct from the cheaper generic alternatives that are slated to cost approximately $40 per person annually. Gilead has licensed six independent manufacturers to produce those low-cost generic variants, but full commercial rollout is not anticipated until 2027. Furthermore, public health advocates point out significant structural exclusions within these licensing agreements. According to MSF, at least 26 middle-income countries have been entirely excluded from Gilead’s generic licensing framework. This excluded cohort includes nations experiencing rising rates of new HIV infections, as well as countries that directly contributed to the clinical trials that established the drug’s safety and efficacy. Among the countries left out of the direct generic pipeline are regional economic powerhouses and high-burden areas such as Brazil, Mexico, Argentina, and Peru.
"People should not really help generate the evidence for breakthrough medicine and then find that their country is excluded from affordable generic access," da Silva noted, emphasizing the moral and ethical contradictions of the current distribution model.
Data compiled by MSF indicates that the nations excluded from Gilead’s primary licensing agreement accounted for close to 23 percent of all new HIV infections globally in 2023. In response to mounting criticism over these exclusions, Gilead subsequently announced a separate agreement with the Pan American Health Organization. This supplemental arrangement established an access pathway designed to cover 14 Latin American and Caribbean countries that fell outside the original generic licensing territory, explicitly incorporating nations like Brazil, Mexico, Argentina, and Peru.
However, medical humanitarian groups argue that this secondary framework falls short of true equity. MSF contends that the arrangement leaves these nations perpetually dependent on direct corporate negotiations with Gilead, rather than empowering them to automatically procure cheaper generic medications through open market competition.
Adding to these logistical frustrations, MSF reports that it has faced persistent barriers in attempting to secure the drug for its own humanitarian operations. For more than a year, the organization has formally sought permission to purchase lenacapavir directly from Gilead for its medical relief programs, explicitly stating that it was not demanding a discounted price.
"Despite those requests, Gilead has not allowed MSF to purchase this medicine directly," da Silva said.
This corporate restriction carries profound consequences in humanitarian emergencies and conflict zones. Populations forcibly displaced by warfare, civil unrest, or natural disasters frequently encounter immense obstacles in maintaining a daily pharmaceutical regimen, such as traditional oral PrEP pills. Moreover, systemic vulnerabilities, including the threat of sexual violence during crises, drastically elevate the risk of HIV transmission among displaced and marginalized groups.
While daily PrEP pills remain widely available as an alternative preventative measure, they demand unyielding daily adherence to provide reliable protection. In contrast, an advanced injectable intervention offering six months of continuous protection would represent an invaluable asset in unstable environments.
"People living through conflict [and] humanitarian crises cannot be the last in line for medical innovation," da Silva stressed.
When approached for comment, Gilead declined Al Jazeera’s interview request, citing scheduling constraints. In a formal emailed statement, the pharmaceutical enterprise defended its operational strategy, asserting that its global access framework successfully combines no-profit supplies, royalty-free licensing agreements, and regional partnerships. However, the company’s statement did not address specific inquiries regarding its refusal to sell the medication directly to MSF, nor did it clarify the precise criteria used to exclude certain nations from its generic licensing pacts.
Gilead has stated that it plans to manufacture and distribute enough lenacapavir supply to accommodate up to three million people globally through 2028, bridging the gap while third-party generic manufacturers gradually scale up their production capacities ahead of the anticipated 2027 rollout.
Medical advocacy organizations argue that these corporate projections are woefully inadequate given the sheer scale of the global epidemic. Public health projections indicate that close to 20 million people worldwide require proactive access to some form of PrEP to substantially drive down new HIV infections globally—a figure encompassing all preventative modalities, rather than lenacapavir alone. Given this immense treatment gap, governments left outside Gilead’s primary licensing architecture are actively exploring alternative administrative and legal avenues to secure the medication for their populations.
Can governments bypass the patent barriers?
For countries excluded from favorable corporate agreements, international trade frameworks offer potential legal remedies to overcome restrictive intellectual property laws. Under World Trade Organization rules, national governments possess explicit legal mechanisms to bypass pharmaceutical patents in specific circumstances. These provisions allow states to manufacture or import generic versions of essential medicines without requiring the permission of the patent-holding corporation, a process designed to safeguard public health during national crises.
Governments can authorize state use of patented technologies and legally challenge patents they deem excessively restrictive or legally unjustified. These protective measures were cemented into international law by the 2001 Doha Declaration, which formally reaffirmed the absolute right of WTO member states to utilize public health flexibilities to protect their citizens.
Precedents for utilizing these legal safeguards already exist within the developing world, particularly in Latin America. Brazil famously deployed these administrative tools during previous battles over HIV medication pricing. In 2007, following the breakdown of protracted price negotiations with pharmaceutical giant Merck over the cost of the antiretroviral drug efavirenz, the Brazilian government issued a compulsory license. This executive action successfully permitted the nation to bypass corporate patents and access affordable generic iterations of the life-saving medicine.
Nearly two decades after that landmark decision, public health activists and legal experts are increasingly urging nations like Brazil to seriously evaluate deploying these same statutory powers for lenacapavir if corporate patent barriers continue to block affordable generic access.
MSF is actively encouraging all governments excluded from Gilead’s commercial licenses to thoroughly examine these established legal safeguards. The organization’s recommendations include implementing compulsory licensing measures, authorizing domestic government use, and aggressively challenging questionable pharmaceutical patents in local courts. Furthermore, advocates are calling upon Gilead to explicitly ensure that its private contractual agreements with third-party generic manufacturers do not contain restrictive clauses that would legally bar those manufacturers from supplying nations that successfully remove patent barriers through state-authorized mechanisms.
For humanitarian organizations like MSF, the ongoing struggle over lenacapavir transcends the specifics of a single medication. The ultimate outcome of these access negotiations will likely establish a precedent for how future medical breakthroughs are distributed globally, determining whether life-saving innovations are allocated based strictly on urgent human need rather than geographic location or national wealth.
Reflecting on the protracted bureaucratic hurdles encountered by medical workers trying to secure the drug, da Silva underscored the profound systemic friction inherent in the current global health architecture.
"For a humanitarian medical organisation, we should not have to spend more than a year trying to find a way to buy a WHO-recommended medicine," she said.