Brazil Demands Equitable Access to Long-Acting HIV Prevention Drugs

Brazil's 830,000 people living with HIV face continued barriers to access life-saving prevention technologies due to pricing and licensing exclusions.
Innovation without access is injustice.
Brazil's health minister on why the country demands inclusion in affordable HIV drug deals.
Mark

Why does Brazil's income level matter so much here? Isn't the point just that people need the drug?

Mimi

It matters because it determines which deals a country qualifies for. Low-income countries get the cheapest generics through licensing agreements. High-income countries pay full price. Brazil falls in between—too wealthy to qualify for the lowest prices, but without the resources to absorb what Gilead charges the US.

Mark

So Gilead is charging Brazil ten times what Thailand pays. What's the justification?

Mimi

Gilead doesn't publicly justify it in those terms. They frame it as market-based pricing—different countries have different ability to pay. But from Brazil's perspective, that logic breaks down when the same company is making the drug in both places. The cost of production doesn't change tenfold.

Mark

The Merck deal sounds different. Why?

Mimi

Merck is negotiating access before the drug is even approved. They're building Brazil into the supply chain from the start, through Fiocruz, the government's own production agency. That means Brazil could manufacture the drug for the whole region, not just import it.

Mark

Is that actually going to happen?

Mimi

Only if alimatravir works in the phase 3 trial. But yes—if it does, Merck has already committed to the conversation. Gilead and ViiV didn't do that. They locked in their licensing deals, then Brazil had to fight for inclusion afterward.

Mark

What does Brazil actually want?

Mimi

Affordable access to long-acting HIV prevention for the people who need it most. But also recognition that a country with 830,000 people living with HIV, which participated in the clinical trials, shouldn't be treated as a secondary market. The minister called it injustice, and he meant it.

  • Brazil is paying ten times what Indonesia and Thailand pay for lenacapavir, a drug its own citizens helped test — a disparity that activists and officials alike are calling a moral failure.
  • Gilead and ViiV drew their licensing maps without Latin America, leaving a region of significant HIV burden outside the boundaries of affordable prevention, and protests at the conference are making that exclusion impossible to ignore.
  • Brazil has pivoted to cabotegravir as a stopgap, but even that compromise exposes the same structural problem: the region is treated as an afterthought in pharmaceutical access strategy.
  • Merck's early memorandum of understanding with Brazil's Oswaldo Cruz Foundation — negotiated before alimatravir is even approved — offers a contrasting model, one that builds access into the drug's development arc rather than bolting it on afterward.
  • The conference is crystallizing a broader question: whether Brazil's forceful advocacy will establish a new precedent for how upper-middle-income nations are treated in global pharmaceutical licensing, or remain an isolated moment of pressure.

At the International AIDS Conference in Rio de Janeiro, Brazil has placed a fundamental question before the global health community: can a nation that bore the burden of clinical trials be justly excluded from the medicines those trials produced? With 830,000 people living with HIV and transmission still rising among its most vulnerable populations, Brazil finds itself caught in a cruel paradox of development — too prosperous for the lowest-tier pricing, too constrained to afford what wealthier nations pay. The country's advocacy, amplified by Health Minister Padilha's declaration that 'innovation without access is injustice,' is pressing pharmaceutical companies to reckon with whether upper-middle-income nations belong in the architecture of global health equity.

Rio de Janeiro's International AIDS Conference became the stage this week for a confrontation Brazil has been building toward for years. The country arrived carrying both a grievance and a credential: nearly 830,000 Brazilians live with HIV, transmission continues rising among the most vulnerable, and Brazilian citizens participated in the clinical trials that proved lenacapavir — Gilead's twice-yearly injectable — could prevent nearly all HIV infections. Yet Gilead priced the drug at ten times what Southeast Asian countries pay, and its licensing agreements with generic manufacturers left Latin America largely excluded. Health Minister Alexandre Padilha distilled the frustration into a single sentence at the conference opening: "Innovation without access is injustice."

Brazil's middle-income classification has become a structural trap. The country earns too much to qualify for the lowest-tier generics and licensing deals designed for the poorest nations, but far too little to absorb the prices pharmaceutical companies charge wealthier markets. ViiV Healthcare's cabotegravir offered a partial escape — Brazil adopted it for its prevention program after ViiV offered acceptable pricing — but ViiV's broader licensing agreement with the Medicines Patent Pool covered 90 countries while excluding most of Latin America. The pattern was consistent enough to feel deliberate.

Activists from Brazil, Argentina, and Peru pressed the point at the conference: countries whose populations bore the risk of clinical trials should not be locked out when those trials succeed. Gilead's assurance that trial participants would retain access until their health systems could supply the drug rings hollow for nations priced out of that supply chain entirely.

The most consequential development came from an unexpected direction. Merck, testing a monthly HIV prevention pill called alimatravir, announced a memorandum of understanding with Brazil's Oswaldo Cruz Foundation — a commitment to negotiate access terms before the drug even completes phase 3 trials, expected in late 2027. Latin America had been absent from Merck's initial licensing geography, but the company moved to correct that gap rather than defend it. The contrast with Gilead and ViiV is pointed: Merck is building access pathways into the drug's development trajectory from the start, rather than drawing geographic boundaries after the fact.

Whether Brazil's pressure at this conference reshapes how pharmaceutical companies approach upper-middle-income nations — or whether Merck's early engagement remains an exception — is the question the sector will be watching as the week closes.

Rio de Janeiro hosted the International AIDS Conference this week, and Brazil arrived with a grievance that cuts to the heart of global health equity: the country is being priced out of the very HIV prevention drugs it helped test. Two years ago, when Gilead announced that lenacapavir—an injection given twice yearly—had prevented nearly all HIV infections in clinical trials, the news rippled through the sector as a potential turning point. But for Brazil, access has remained out of reach, blocked by pricing that Gilead set at ten times what Indonesia and Thailand pay.

The exclusion stings because Brazil carries real weight in this fight. Nearly 830,000 Brazilians live with HIV, and transmission continues to climb among the groups most vulnerable to the virus: men who have sex with men, transgender people, sex workers, people who inject drugs, and incarcerated individuals. Yet Brazil's classification as an upper-middle-income country has become a trap. It earns too much to qualify for the lowest-priced generics and licensing deals, but too little to absorb the prices pharmaceutical companies demand from wealthier markets. Health Minister Alexandre Padilha put it plainly at the conference opening: "Innovation without access is injustice."

Gilead's approach has left Latin America largely in the cold. The company signed voluntary licensing agreements with six generic manufacturers in October 2024, enabling production in select markets, but the geographic footprint excludes most of the region. Meanwhile, Gilead charges $28,000 annually for lenacapavir in the United States. The company says it is rolling out the drug in ten African countries and projects 600,000 users globally by year's end. Jared Baeten, speaking for Gilead at the conference, acknowledged that trial participants would retain access to lenacapavir, but only until they could obtain it through their own health systems—a condition that rings hollow for countries locked out of affordable supply.

Brazil has responded by turning to an alternative. ViiV Healthcare's cabotegravir, injected every two months, became the country's choice for expanding its pre-exposure prophylaxis program after ViiV offered what Padilha called "an acceptable price." Yet even this compromise reveals the problem. ViiV and the Medicines Patent Pool signed a licensing agreement covering 90 countries, but most Latin American nations were excluded from that deal as well. The message was clear: the region's needs ranked below other markets in pharmaceutical strategy.

Activists from Brazil, Argentina, and Peru staged protests at the conference, pointing out that their countries had participated in lenacapavir's clinical trials and deserved access to the results. The argument carries moral weight and practical logic: if a nation's citizens bore the risk of testing a drug, they should not be locked out when it works. Gilead's response—that trial participants would keep access—sidesteps the larger question of what happens to the broader population once trials end.

Merck has taken a different path, one that may signal a shift in how pharmaceutical companies approach these negotiations. The company is testing alimatravir, a monthly pill for HIV prevention, and last week announced voluntary licenses with seven generic manufacturers across sub-Saharan Africa and India, covering 129 low- and middle-income countries. Latin America was initially absent from that list. But on Tuesday morning, Merck announced a memorandum of understanding with Brazil's Oswaldo Cruz Foundation, the government's biomedical research and production agency. The agreement commits both parties to negotiate access terms should alimatravir prove effective in phase 3 trials, expected to conclude in the second half of 2027. Merck's Eliav Barr framed it as forward planning: "We are trying to reach agreements now to avoid limited supply at launch."

The difference is instructive. Merck is negotiating before the drug is approved, building supply chains and access pathways into the product's trajectory from the start. Gilead and ViiV, by contrast, locked in their licensing geography before Latin America could make its case. Brazil's push at this conference—backed by the weight of its HIV burden and the legitimacy of having hosted clinical trials—may be reshaping how pharmaceutical companies think about upper-middle-income countries. The question now is whether this moment becomes a precedent or an exception.

Innovation without access is injustice.
— Health Minister Alexandre Padilha, at the International AIDS Conference
We are trying to reach agreements now to avoid limited supply at launch.
— Merck's Dr. Eliav Barr, on the company's approach to access planning
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