July 9, 2025

FOR IMMEDIATE RELEASE

Gilead Imposes Price Secrecy on Global Fund Over Breakthrough HIV Prevention Shot, Blocking Transparency and Accountability 

  

PRESS STATEMENT
FOR IMMEDIATE RELEASE: July 9 2025
Contact for more information: Asia Russell | +1 267 475 2645 asia@healthgap.org
Susana van der Ploeg | +55 32 9921-7496 susanaploeg@abiaids.org.br

Gilead Imposes Price Secrecy on Global Fund Over Breakthrough HIV Prevention Shot, Blocking Transparency and Accountability 

Today, Gilead Sciences announced a plan to sell long-acting injectable lenacapavir (LEN-LA) for HIV pre-exposure prophylaxis (PrEP) to the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) at a secret price. The Global Fund has signed an agreement with Gilead to keep the price secret indefinitely; South Africa, Eswatini, Lesotho, Mozambique, Kenya, Uganda, Zambia, Zimbabwe, and Nigeria have been invited by the Global Fund to participate.  

“The Global Fund is funded by public money. Its dealings, contracts, and the prices paid for life-saving tools have been made available for other medicines and should not now be kept secret because of Gilead’s bullying,” said Fatima Hassan, Director of Health Justice Initiative. “It is inexcusable for Gilead not to allow the Global Fund to disclose the prices it will pay.” In addition to undermining transparency, Gilead’s secrecy will obstruct civil society activism for lower drug prices and keep prices high in middle-income countries where Gilead will negotiate prices directly. Such secrecy undermines the power of buyers to negotiate affordable prices, and violates the human rights of all people to access information and life saving tools. 

During the COVID pandemic and since, non-disclosure agreements (NDAs) in vaccine and therapeutic purchase agreements were widely criticised for undermining transparency and accountability, particularly when public funds were used. Such secrecy limited governments’ ability to negotiate lower prices and enabled pharmaceutical corporations to charge higher prices in the Global South, including in countries like South Africa, where the Health Justice Initiative took legal action to force the contracts into the public domain. 

Regulatory approval for LEN-LA is also pending in South Africa, until then, the price Gilead will charge non-state patients in South Africa is also unknown.  

“Gilead wants to hold all the cards in medicine pricing negotiations and will try to set prices as high as it likes in Latin American countries and other countries excluded from their plans. Meanwhile people who need PrEP and the healthcare systems upon which they rely on will find the drug priced out of reach. Gilead is playing a dangerous game with the health and lives of millions of people who need LEN-LA,” said Veriano Terto of the Interdisciplinary AIDS Association of Brazil (ABIA). 

Asia Russell, Executive Director, Health GAP said: “Coming on top of Trump and Rubio’s  anti-science and anti-HIV funding cuts, Gilead’s greed has created an unprecedented, coordinated global regime of LEN-LA price secrecy that violates our basic rights and will undermine global access. We demand price transparency from Gilead and the Global Fund.” 

Gilead and the Global Fund must be required to disclose essential information such as medicine pricing in line with the WHO’s resolution on improving transparency in markets for medicines, vaccines, and other health products. Transparency is critical to saving lives and establishing strong global norms that address the unacceptable power imbalance between those who need and purchase medicines and those who produce and sell them.

Background:

The Gilead and Global Fund plan shared today follows its announcement in November 2024 that it intended to extend ‘access to LEN-LA in the Global South to 2 million people over 3 years. Global estimates indicate between 10-20 million people need LEN-LA to prevent HIV acquisition now. 

“Access for only 2 million people over three years is just a drop in the ocean,” said Professor Brook Baker of Health GAP. “Donald Trump and Marco Rubio’s despicable cuts to HIV prevention programs mean new HIV infections are surging. Price secrecy undermines the urgent need to reach all people, everywhere, who need LEN-LA.” Activists believe Gilead is demanding secrecy over their nonprofit LEN-LA price so that they can more readily attempt to rip off buyers in these middle income country markets where HIV incidence is rising. “This is greed in a time of crisis, and market monopoly manipulation,” added Baker. 

Gilead’s global lenacapavir access strategy has been widely criticized:

  1. Gilead has issued voluntary licenses to only six generic manufacturers and restricted countries eligible for that supply to 120 low- and middle-income countries (LMICs). 
  2. One in four new HIV acquisitions occur in the 26 countries excluded by Gilead in its license, including Argentina, Brazil, Mexico, and Peru, countries where Gilead carried out pivotal lenacapavir clinical trials. Gilead intends to maximize profit in excluded countries through opaque, unaffordable “tiered pricing” deals as well as a partnership agreement in Brazil, also announced today. 

Activists now call on Gilead, government, the Global Fund and other funders and global health agencies to:

  • Publicly share the so-called  ‘access price’ and the prices it negotiates directly with countries and demand full price and supply transparency from Gilead, the Global Fund and its procurement partners regarding the nonprofit price and Gilead’s planned tiered prices for other countries that fall outside of the limited license
  • Ensure a price comparable with oral PrEP in all LMICs at $25-40 per person per year. 
  • Regulatory: Ensure Gilead is fully transparent regarding its plans to secure (or not) regulatory approval outside of the US, Brazil and South Africa. 
  • Gilead has filed an application in the EU but has not stated how many countries it designated for regulatory filings, nor has it stated any intention to use WHO Collaborative Registration Procedures, which could accelerate regulatory approvals in many LMICs.  
  • Licensing: Expand Gilead’s “covered territories” so that all LMICs are included.
  • Support countries excluded from Gilead’s license to make use of all available legal tools, such as patent oppositions and compulsory licenses, to overcome patent and other intellectual property barriers to equitable and immediate access. 
  • Remove unnecessary and restrictive clauses from Gilead’s voluntary license, such as the ‘non-diversion’ clause, which would have the effect of preventing excluded countries that issue a compulsory license from purchasing lenacapavir made by one of a handful of Gilead’s  licensed generic companies.

Irrespective of Gilead’s plans, bullying and its pricing and market manipulation and tactics, we call on all governments and funders to increase domestic and international funding for the introduction and equitable rollout of LEN-LA. The world cannot wait for Gilead to do the right thing. We have a crisis on our hands. 

ENDS