Gilead’s Regulatory Delays Block Access to Lenacapavir for PrEP
Brook K. Baker, Professor Emeritus Northeastern University School of Law
Senior Policy Analyst Health GAP
July 25, 2025
Alongside ensuring adequate supplies, guaranteeing an affordable, transparent price at USD 25-40 per year, and breaking through Gilead’s monopoly in countries excluded from its voluntary license, addressing unnecessary delays and roadblocks in national registration of long-acting lenacapavir (LEN-LA) for PrEP is a critical step toward accelerating global access to LEN-LA.
Gilead will be the sole supplier of long-acting lenacapavir (LEN-LA) for many more months. On July 9, it announced a non-transparent agreement with the Global Fund for the procurement of doses for up to 2 million people over a three-year period to be supplied on a non-profit basis to Global Fund eligible countries (a subset of the 120 countries included in its voluntary license). However, Gilead has not disclosed the not-for-profit price or its plans for seeking regulatory approval (registration or marketing authorization), which is ordinarily a prerequisite for marketing and use of a medicine.
Gilead has been relatively non-transparent about its regulatory intentions from the beginning. In its initial Access Strategy, Gilead identified 18 focus low- and middle-income countries for registration: Botswana, Eswatini, Ethiopia, Kenya, Lesotho, Malawi, Mozambique, Namibia, Nigeria, Philippines, Rwanda, South Africa, Tanzania, Thailand, Uganda, Vietnam, Zambia and Zimbabwe. However, according to more recent announcements, it has only filed for regulatory approval in the US, EU, Australia, Canada, Switzerland, South Africa (March), and Brazil (April). South Africa is the sole not for profit price eligible country. Subsequent to US FDA approval on June 18, Gilead says it is preparing US FDA-reliance applications in Argentina, Mexico and Peru.
An infographic developed by Salud por Derecho tracking global LEN-LA registration is available here.
The European Medicines Agency EMA recommended approval of LEN-LA for PrEP on July 25 and said that “target country” regulators from Uganda, Zambia, Kenya, Nigeria, Zimbabwe, South Africa, Thailand and Vietnam participated in the assessment of the EU-Medicines for all application (EU-M4all). Gilead has not directly disclosed what LMICs are listed as targets for registration, but the EMA announcement suggests that it may only have identified the eight named countries. Additional countries that directly accept or rely on EU regulatory approval for medicinal products by the European Medicines Agency (EMA) (Argentina, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Mexico, Panama, Paraguay, Peru, Uruguay, and 15 Caribbean States using the Caribbean Regulatory System) will be able register LEN-LA promptly, but only if and when Gilead applies for national regulatory approval. Several countries that directly accept or rely on the EMA Conformité Européenne marking (Republic of Macedonia, Montenegro, Serbia, and Turkey) may also be able to quickly approve a Gilead application if and when it applies.
Regrettably, Gilead has not yet applied for WHO prequalification, which it could have done even while US FDA and EMA applications were pending. Instead, it is waiting on EU-M4all approval to trigger a reliance prequalification decision from the WHO; the WHO PQ decision will likely be delayed by up to 60 days for processing as a result.
Regrettably, Gilead has not published its intent to use WHO Collaborative Registration Procedures, though representatives of Gilead did give verbal assurances during a meeting July 14 at the 2025 International AIDS Conference in Kigali. Use of Collaborative Procedures would accelerate regulatory decisions by national regulatory authorities within 90 days–this decision causes unnecessary delays, contradicting Gilead’s claim to seek speedy market entry. At this point only 66 LMICs (not including India) are listed as participating in Collaborative Procedures, but if Gilead gave notice of its intent to register in non-participating countries and its consent to WHO sharing regulatory assessments, the WHO could seek and facilitate any additional countries’ participation. Moreover, Gilead would not be limited to the subset of countries it had listed in its EU-M4all application.
According to the analysis above, rapid regulatory approval of Gilead’s LEN-LA in the vast majority of LMICs is uncertain at best. Although some of those countries supported by LEN-LA procurement by entities like the Global Fund can benefit from temporary, humanitarian import waivers, that will not be a long-term solution for countries procuring LEN-LA directly.
Health GAP joins other advocates for accelerated equitable access to LEN-LA for PrEP to demand a low and transparent no-profit price, for additional quantities to meet global need (minimally estimated at 10-20 million people), and for expansion of the territories licensed under Gilead’s bilateral voluntary licenses to include 26 excluded LMICs and territories , and for amendments to licensing agreement to allow licensees to supply countries where patents would not be violated. We also have demands regarding Gilead’s grossly inadequate and non-transparent regulatory agenda that will negatively impact access during its two-year period as a sole supplier and further hobble efforts to register generic equivalents in the future. We demand that Gilead:
