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TWN
Info Service on Health Issues (Sep25/01) Price must decrease for ALL, activists react to $40 generic lenacapavir 24 September 2025––Two deals for the supply of generic Lenacapavir at $40 per patient per year in 120 low- and middle-income countries were announced today and hailed as a possible chance to end the HIV/AIDS epidemic. One between Unitaid, the Clinton Health Access Initiative (CHAI), Wits RHI and Dr Reddy’s Laboratories and another between the Gates Foundation and Hetero. Dr Reddy's and Hetero are both Indian generic manufacturers 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 joined 12 civil society organizations and coalitions in a statement arguing that Gilead’s restrictive licensing blocks access in many countries, despite generic production being feasible at low cost, as today's 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 Third World Network. “Gilead doesn't seem to understand the urgency of the HIV epidemic". 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. PEPFAR funding cuts have immediately disrupted services in Latin America, for example, some of the same ones that the license doesn't cover. A Lancet HIV modelling study projects 4.43 to 10.75 million additional infections and up to 2.93 million extra deaths worldwide by 2030, including in countries excluded from Gilead's voluntary license. Activists also warn 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, according to Third World Network. Meanwhile, Gilead has been slow to register lenacapavir in many countries, effectively preventing governments from taking steps to incorporate the medicine into national programs and possibly allow generics. “Gilead is weaponizing 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 Third World Network. Activists urge India and other governments to reject evergreening patents for lenacapavir and use compulsory licenses to scale up access to lenacapavir. They also continue to call on Gilead to end its harmful exclusions by expanding its 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.
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