In an open letter sent today to Gilead CEO Daniel O’Day, activists, academics, policy experts, and civil society organizations from around the world called on O’Day to stop delaying applications for regulatory approval for long-acting injectable lenacapavir for HIV PrEP (pre-exposure prophylaxis) across all low- and middle-income countries (LMICs).
The letter, available here, is endorsed by Health GAP, Public Citizen, Salud por Derecho, Acción Internacional para la Salud (AIS Perú), Médecins Sans Frontières, Associação Brasileira Inerdisciplinar de AIDS (ABIA Brazil), Health Justice Initiative, Sankalp Rehabilitation Trust, Treatment Action Campaign, and others.
“After first refusing to disclose its so-called ‘access price,’ Gilead is now refusing to commit rapid to application for regulatory approval in LMICs,” said Bellinda Thibela, Health GAP’s International Policy and Advocacy Coordinator. “This is unconscionable. Lenacapavir for PrEP could help accelerate the end of this pandemic. Instead, Gilead is creating new barriers, apart from their existing exclusion of dozens of countries facing rising HIV incidence from their access strategy and untenable voluntary licensing restrictions.”
“Drugmaker delays and gaps in registration deny access, with potentially deadly consequences,” said Peter Maybarduk, director of Public Citizen Access to Medicines program. “Rapid global registration of lenacapavir would be a critical course change that should be relatively simple for Gilead to make. Everyone should be able to agree on timely and broad registration to support global access to HIV prevention.”
“A piecemeal approach, leaving many countries behind in securing regulatory approval, is unacceptable,” said Javier Llamosa, Project Coordinator, Acción Internacional para la Salud Perú (Action for Global Health).
Endorsers made the following demands of O’Day:
- Immediately commit to accelerating applications for regulatory approval of LEN-LA in all LMICs;
- Disclose the non-EU countries it has identified for registration in its EU-M4all application and amend its application to include all LMICs, if they are not already included;
- When its EU-M4all approval is finalized, promptly file for registration in all countries that can rely on EU approval;
- Expedite its application for WHO prequalification; and
- File its required expressions of interest and consent to the WHO Collaborative Registration system for all LMICs, not just the 66 participating countries.
For more information, read the original press release.
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