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Third World Network (TWN), an independent non-profit international research and advocacy organisation, has asked Gilead Sciences to make its patented HIV prevention drug lenacapavir available at $40 a year to all patients across the world.
It said that the two latest deals by Gilead Sciences to supply generic formulations of its patented HIV prevention drug lenacapavir at $40 a year will expand access in licensed countries.
Considering the urgency of the HIV epidemic, the drug should be made available at this lower price to all patients across the world, TWN said.
On September 24, an announcement was made towards Gilead Sciences making injectable lenacapavir available at a cost of $40 a year in 120 low- and middle-income countries starting in 2027, under two partnerships, one between Dr. Reddy’s Laboratories, Unitaid, the Clinton Health Access Initiative (CHAI), and Wits RHI, and another between Gates Foundation and Hetero Drugs. Dr Reddy's and Hetero are already listed as two of the six generic manufacturers in Gilead's (the originator) lenacapavir voluntary license deal.
Although the decrease from the original list price of $28,218 is much welcomed, TWN along with 12 civil society organizations and coalitions in a statement alleged that Gilead’s restrictive licensing blocks access in many countries, despite generic production being feasible at low cost, as the latest announcements show and studies corroborate.
“While the $40 generic lencapavir price will expand access in licensed countries, Gilead has deliberately excluded numerous nations from its agreement—even those without patent protections. Most damaging of all, many excluded nations lack the manufacturing infrastructure to invoke compulsory licensing, leaving them trapped in Gilead's artificial scarcity system with no viable alternatives", said K M Gopakumar, senior researcher at TWN. “Gilead doesn't seem to understand the urgency of the HIV epidemic," he added.
Nearly one-quarter of all new HIV infections worldwide occur in countries that Gilead has deliberately excluded from its voluntary license for lenacapavir—among them Brazil, Malaysia, Mexico, Argentina, Peru, China and many others across Latin America, Asia, Eastern Europe and the Middle East, and which still cannot access lenacapavir under this price. This scenario will only worsen with US aid cuts, said the Network.
It also alleged that Gilead is using legal and regulatory tactics to block competition. In India alone, the company has filed 14 separate patent applications for lenacapavir. If granted, its monopoly could last 28 years. Meanwhile, Gilead has been slow to register lenacapavir in many countries, effectively preventing governments from taking steps to incorporate the medicine into national programmes and possibly allow generics, alleged TWN.
“Gilead is weaponising its patent portfolio in India to crush generic competition. Patent thickets, missing regulatory registrations and exclusion of countries from voluntary licenses reveal a systemic failure. Until access is universal, the revolutionary lenacapavir will remain in limbo, out of reach of many who need it the most”, said Chetali Rao, scientific researcher at TWN.
Urging India and other governments to reject evergreening patents for lenacapavir and use compulsory licenses to scale up access to lenacapavir, the activists demanded Gilead to expand voluntary license to all countries, ensuring price transparency, broadening licensed manufacturers to all regions, removing restrictive conditions from its license, and accelerating regulatory filings so lenacapavir can be rolled out quickly.
In October 2024, Gilead granted voluntary licenses to six generic manufacturers, including Dr. Reddy’s, to supply this product across 120 low- and middle-income countries.
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