Calls on Governments in the Global South to Break Trade and Intellectual Property Barriers and Take on Gilead’s Power
Countdown to access campaign launched on World AIDS Day
Today, a coalition of leading global health organizations launched an advocacy campaign to secure rapid, affordable access to groundbreaking long-acting HIV prevention technologies, with a focus on the Global South. This urgent call to action, supported by the Health Justice Initiative, Health GAP, Just Treatment, the Brazilian Interdisciplinary AIDS Association (ABIA), PLWHA, and civil society experts on access to medicines in India and beyond, arrives at a critical juncture in the fight against HIV. Each year, 1.3 million people are newly infected with HIV, and an AIDS-related death occurs every minute.
Long-acting injectable PrEP medicines, particularly lenacapavir (LEN-LA), have shown unprecedented effectiveness in preventing HIV infection. Recent clinical trials demonstrated that LEN-LA, administered twice yearly, is 100% effective in preventing HIV transmission among cisgender women and reduced the risk of HIV infection by 96% among gender diverse people and other populations at high risk of HIV infection. This revolutionary technology could transform HIV prevention, especially for marginalised communities who are not adequately served by current PrEP options that need to be taken daily. Despite the promise of this breakthrough for HIV prevention, the drug is priced at over $42,000 per year in the U.S., whereas generic versions could be produced for under or between $40-100.
“This is not just another prevention tool – it’s a game-changer that could protect millions of people for whom current prevention options simply don’t work,” says Fatima Hassan, Director of the Health Justice Initiative (HJI) in South Africa, “But corporate greed, monopoly control and restrictive licenses are creating unnecessary barriers to local production and access to more affordable versions of lenacapavir, particularly in middle-income countries where HIV rates are rising. This is why we are calling on the South African government to take compulsory measures so that the drug can be widely manufactured in Africa, and everyone in the Global South has access.”
Forty-one per cent of new infections are in upper-middle-income countries. Yet, Gilead excluded many upper-middle-income countries with patent barriers from their voluntary licensing deal, blocking the potential for price-lowering generic competition creating a chilling effect on the scaling up of lenacapavir for HIV prevention and treatment.
“People across Latin America (Brazil, Argentina, Mexico, Peru) participated in Gilead’s clinical trials of lenacapavir, yet the corporation’s licensing scheme excludes our people at risk of HIV infection from accessing affordable generic versions for prevention. People have the human right to enjoy the benefits of scientific progress, but Gilead has undermined this right with its monopoly control,” said Veriano Terto Jr., Director of ABIA. “Brazil and other governments excluded by Gilead must take compulsory measures to overcome patent barriers to ensure local production and affordable access – it is morally and legally required now.”
The campaign aims to challenge pharmaceutical corporations’ restrictive pricing and licensing practices while advocating for measures to accelerate generic competition. It calls on governments in the Global South facing exclusion and high prices to urgently consider opening up supply through compulsory licensing to access affordable sources of lenacapavir. Gilead Sciences’ pricing strategy (approx. US$ 42k per patient, per year, for treatment) would make LEN-LA prohibitively expensive despite expert analysis several months ago showing it could be produced for as little as $40-100 per year. Recent indications are that it could be produced for even less than $40. Gilead’s earlier commitment to ‘non-profit’ pricing, has not, as yet, been followed through with a public declaration of the price it will charge. When that price is announced or shared, it will require heightened global scrutiny and transparency.
“Everyone, everywhere who needs lenacapavir must get it as quickly as possible,” said Asia Russell, Executive Director of Health GAP. “Instead, Gilead’s greed is obstructing global access and will prolong this pandemic. Twenty-five years ago, we built a global movement that reduced HIV treatment costs by 99% and saved over 25 million lives. Now we must do it again with prevention technologies that could help end the HIV epidemic.”
The timing of the campaign is particularly significant as South Africa prepares to take over the G20 Presidency from Brazil and will hand it over to the USA in 2026. This leadership position provides a key platform to try to advance more ambitious policy priorities around access to medicines and global health equity, while the South African Presidency also calls on G20 Members to discuss systemic reforms of the World Trade Organisation (WTO).
Sibongile Tshabalala, Chairperson of the Treatment Action Campaign (TAC) emphasised the campaign’s grassroots focus: “This isn’t just about Gilead deciding which markets it will control – it’s about empowering communities most affected by HIV to demand their right to access these revolutionary prevention and treatment tools across developing countries. We refuse to accept a system where we cannot produce the medicines, we need in our health systems and people are excluded from life-saving scientific breakthroughs based on income classifications, and where people live. We demand an equitable system where all low and middle-income countries are able to take steps to provide the drug free of cost to people. Who gave Gilead the power to exclude Latin American and Asian countries, where the trials were done, from benefiting from generic competition now? As people living with HIV we have taken on Big Pharma before, we are ready to do it again.’’
The campaign launches against the backdrop of concerning global HIV statistics, with 1.3 million new HIV infections occurring annually. Notably, 55% of these infections affect key marginalised populations and their partners, with 80% now occurring outside sub-Saharan Africa.
“Our efforts to provide technical support to patent oppositions in India and elsewhere are part of a global effort to challenge Gilead’s monopoly on lenacapavir and open up generic supply from developing countries with manufacturing capacity, as well as where required for developing countries to issue compulsory licenses to overcome patent monopolies for the production or supply of generic lenacapavir, said Sangeeta Shashikant, Legal and Policy Advisor at Third World Network (TWN).
The campaign calls on all people living with HIV, HIV researchers, clinicians, health groups, activists, faith leaders, UN officials, and governments to demand Gilead immediately remove the chokehold of restrictions from its voluntary licenses, and instead issue multiple, non-exclusive and non-restrictive licenses across different regions to benefit all LMICs which include opening up generic manufacturing regionally and locally; and commit to one access price for all non-High Income Countries that is at least comparable to the cost of oral PrEP. The coalition also demands that Global South leaders including the governments of Brazil, South Africa and India renew the political will to act against pharmaceutical monopolies that are dictating the pace and scale of the global HIV response.
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