This background analysis is part of the blog series on the 8th Replenishment Conference of the Global Fund. Since 20 August 2025, civil-society organisations have been publishing weekly contributions on global health financing, health equity, and the role of the Global Fund.

Johanna Fipp, Aktionsbündnis gegen AIDS

In a clinic in eastern Africa, a young woman leaves the consultation room. She is not carrying a blister pack of pills in her bag, but only a small note in her medical record: next injection in six months. For her, this means fewer clinic visits, less fear of stigma, and protection against HIV.

What sounds like a dream, a medicine that protects against HIV and only needs to be injected twice a year, has been a reality since 18 June 2025. On that day, the U.S. Food and Drug Administration approved lenacapavir as the first biannual injectable option for HIV pre-exposure prophylaxis (PrEP).
UNAIDS Executive Director Winnie Byanyima has described the innovation as a “game changer” and stressed how crucial it is that it be introduced simultaneously in countries with both high and low incomes. For people who lack secure access to healthcare or who face stigma, a discreet, long-acting prevention option can make the difference between protection and infection.

Between laboratory and supply chain

Clinical trials have confirmed lenacapavir to be highly effective. In regions with high HIV incidence among young women and girls, such as southern Africa, it has the potential to save lives. The Global Fund has announced that it will make the first doses available in several African countries by 2025.

Yet behind this success story lies a complex web of price negotiations, licensing agreements and political decisions. Gilead Sciences, the manufacturer of lenacapavir, has reached an agreement with the Global Fund but refuses to disclose the price publicly. For activists such as Fatima Hassan from the Health Justice Initiative, this goes too far. Health as a human right for all cannot be realised under these conditions. Price transparency is essential – not only to prevent inequalities from being entrenched, but also to make it visible whether existing agreements actually ensure fair conditions for everyone.

Health equity: aspiration and reality

Health equity means more than securing market access. It is about ensuring that everyone, regardless of income, origin or identity, has the same opportunity to access prevention and treatment. Lenacapavir illustrates just how difficult this goal is to achieve in a commercially driven health system:

Demand exceeds plans: The Global Fund initially aims to provide lenacapavir to two million people, while estimated demand may reach up to 20 million.

Not everyone benefits at the same time: Brazil and Mexico – both countries with a high HIV burden and clinical trial sites for lenacapavir – are excluded from the licensing agreement and must negotiate separately, likely at higher prices.

Monopolies prevent price competition: According to a study by Andrew Hill, a generic version could be produced for USD 25–46 per year, while the U.S. market price exceeds USD 28,000.

Colonial continuities

That clinical trials are conducted in countries of the Global South whose populations later have limited or prohibitively expensive access to the resulting products is no coincidence. It is a pattern well known from the history of global health: research, risk and testing often take place in poorer countries, while the economic benefits accrue to wealthier nations in the Global North.

Exclusions from licensing agreements are therefore not merely logistical or contractual issues. They are part of a structural system in which medical innovations are distributed in profoundly unequal ways.

More than a single case

The dispute over lenacapavir is not just about one drug. It is another litmus test of whether the global health system is capable of distributing innovation fairly. We have seen similar debates in the history of HIV, during the COVID-19 vaccine rollout, and they continue today with treatments for hepatitis C and life-saving cancer medicines. Time and again, the same obstacles emerge: secret contracts, patents and monopolies stand in the way of rapid and equitable solutions for all.

What needs to happen?

If lenacapavir is not to become yet another example of “innovation without equity,” several steps are essential:

• full price transparency in all international procurement programmes;
• global licensing agreements that do not exclude countries with high HIV burden;
• investment in generic manufacturing capacity;
• and the political will to use compulsory licensing where negotiations fail.
• A test of the right to health

Lenacapavir is a technological breakthrough. But it will only become a breakthrough for everyone’s health if health equity is more than a buzzword. Whether the global community delivers on this promise will show whether lessons have been learned from past crises – or whether this opportunity, too, will disappear into the filing cabinets of secret price agreements.