ITPC Global and Make Medicines Affordable (MMA) campaign condemn the exclusion of dozens of countries from today’s announcement of $40-per-year generic lenacapavir.
Lenacapavir – a twice-yearly HIV prevention injection – could transform the fight against HIV. But Gilead’s restrictive voluntary license excludes regions of the world with fast-growing epidemics – including Latin America, Eastern Europe, North Africa, and Asia – deliberately locked out.
“Once again, people’s lives are being divided according to a company’s profit strategies,” said Solange Baptiste, ITPC Global’s Executive Director. “This is the same abusive playbook we saw with HIV treatment, hepatitis C cures, and COVID-19 tools. Communities in so-called ‘middle-income’ countries are treated as if they can afford monopoly prices – but the reality is health systems are collapsing, programs are being cut, and millions will be denied prevention that could end AIDS.”
The $40 price point was not a gift from industry. It was established in research sponsored by the MMA campaign – which demonstrated that lenacapavir could be manufactured sustainably for around $40 per person per year. Prices could even go down to $25 with growing volumes. Today’s deal proves what communities have said all along: affordable pricing is possible when monopolies are challenged.
According to UNAIDS, more than one in four new HIV acquisitions occur in countries and territories that are excluded by Gilead from its license, including Argentina, Brazil, Mexico, and Peru, countries where communities participated in clinical trials that generated the data that proved lenacapavir’s effectiveness.
As part of our long-standing strategy, ITPC Global and our MMA campaign partners are already taking action to prevent monopolies on lenacapavir. To date, we have filed 11 patent oppositions in 9 countries, and key primary applications have already been rejected by one of the patent offices. We will intensify this work in the months ahead, especially in countries excluded from the pricing agreement and in those with strong local manufacturing capacity, to open the door for alternative sources of supply. In parallel, we will continue engaging governments to issue compulsory licenses wherever appropriate, ensuring that abusive and unmerited patents do not stand in the way of saving lives.
MMA Demands Immediate Action:
- Expansion of the $40 price to all low- and middle-income countries, not only those handpicked by Gilead.
- Governments in excluded countries to use TRIPS flexibilities to override monopolies, including by strict application of patentability criteria to examine patent applications, and by compulsory licensing.
- Local manufacturers outside the license to step forward and produce affordable generic versions of lenacapavir, supported by donors, governments and civil society, to build a diversified and sustainable supply.
- Rapid registration of generics in producer countries to unblock global supply chains.
- Donors, the Global Fund and PEPFAR, make public pricing deals and stop legitimizing restrictive licensing deals and instead fund scale-up strategies that guarantee universal access, not selective access. Donors must condition their support on inclusion of all countries in need, not on Gilead’s monopoly terms.
“Lenacapavir could be a game-changer – or it could become yet another scandal of exclusion and profiteering,” said Othoman Mellouk, Access to Diagnostics & Medicines Lead at ITPC Global. “We will not allow communities in middle-income countries to be left behind. Our message to governments is clear: you have the legal tools to act – use them now. To local manufacturers: the world needs you to break monopolies and deliver. And to donors: stop endorsing exclusion and start funding access for all.”