A global coalition of health advocates is intensifying its campaign against pharmaceutical giant Gilead Sciences. They demand equitable access to its revolutionary long-acting injectable HIV prevention drug, lenacapavir.
Activists are calling for a universal generic price of $40 per person per year for all low and middle-income countries. They warn that Gilead's current policies entrench life-threatening inequities in the global fight against HIV.
The medicine, administered just twice a year, has been hailed as a potential game-changer. This follows clinical trials that have demonstrated its superior efficacy compared with existing daily oral pre-exposure prophylaxis (PrEP). The World Health Organisation has endorsed its use for all populations at high risk of HIV infection. However, the promise of this scientific breakthrough is being overshadowed. There is a fierce debate over pricing and access.
A High Price for Protection
Gilead has established voluntary licensing agreements with Indian generic manufacturers Dr Reddy’s and Hetero. These agreements would allow the production of lenacapavir for approximately $40 per year. However, with two significant caveats: the supply will only begin in 2027, and the licence is restricted to just 115 low and middle-income countries.
Crucially, this leaves 26 middle-income countries, including Brazil, Mexico, and Peru, without access to the affordable generic version. Pivotal clinical trials for the drug were conducted in these nations.
This exclusion has sparked outrage among civil society organisations. They argue it violates the principle of equitable access to essential medicines.
The price disparity is stark. While generic production costs are estimated to be as low as $25 annually, Gilead's proposed "access price" for excluded nations is $100. Meanwhile, the commercial price in the United States soars to over $28,000 per year.
Legal and Political Pressure Mounts
In response to these restrictive policies, activist groups, including Health GAP and the International Treatment Preparedness Coalition, have launched legal challenges.
Citing provisions in the World Trade Organisation's TRIPS Agreement, they have initiated patent oppositions in several countries. This strategy permits compulsory licensing in cases of public health crises.
This strategy mirrors the successful legal campaigns of the early 2000s. These campaigns dramatically lowered the cost of antiretroviral therapy and saved millions of lives.
Political hurdles further complicate the situation. In the US, the President’s Emergency Plan for Aids Relief (PEPFAR) has an allocation of $2.3 billion for the procurement of long-acting PrEP in the 2026 fiscal year.
However, the Trump administration has withheld the disbursement of these funds. This effectively stalls large-scale procurement and limits the reach of donor-funded programmes.
Current plans aim to reach just two million people over a three-year period. This is only a fraction of the estimated 20 million people globally who could benefit from PrEP.
A Call for Health Justice from the Front Lines
The impact of these delays and pricing barriers is felt most acutely in regions with high HIV incidence. In South Africa, the parliamentary Portfolio Committee on Health has expressed grave concerns about excluding middle-income countries. They believe it will worsen regional health disparities. The committee is scrutinising whether Gilead’s practices align with the nation’s constitutional guarantee of access to healthcare.
As the Health Justice Initiative starkly noted, "science alone does not end epidemics - access does". The global health community is now watching closely. They are urging Gilead to reconsider its position and ensure that this powerful new tool for HIV prevention is available to all who need it, not just those who can afford it.