Letter to Gilead Demanding Ambitious, Transparent Plan for Regulatory Approval of Lenacapavir
Letter PDF (English) Letter PDF (Espanol)
UPDATE: On August 28, 2025, Gilead responded to our letter. Given that Gilead’s response did not address many issues raised in the letter, we urged Gilead to provide a more concrete response regarding their plans for regulatory approval of lenacapavir. Gilead’s response is here.
Daniel O’Day, Chief Executive Officer
Gilead Sciences
333 Lakeside Drive
Foster City, CA 94404
Dear Mr. O’Day,
We are writing as HIV, access-to-medicines and human rights advocates to call on Gilead to announce and expand its commitment to register long-acting lenacapavir (LEN-LA) for broad use in low- and middle-income countries (LMICs).
Delays in registration are delays in access, with potentially deadly consequences.
This is especially so since Gilead will be the sole supplier of LEN-LA until 2027, when generic product and export/import will start. Long-acting PrEP is poised to make a transformative difference in the fight against HIV, but only if access is massively accelerated and scaled-up.
Gilead has not disclosed under its agreement with the Global Fund its price or 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:
- In its initial Access Strategy, Gilead identified 18 focus low- and middle-income countries for registration. 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).
- Gilead has not disclosed what low- and middle-income countries are listed as targets for registration in its EU-Medicines-for-all application but the EMA recommendation for marketing approval lists only Uganda, Zambia, Kenya, Nigeria, Zimbabwe, South Africa, Thailand and Vietnam as “target countries”.
- Gilead has not yet applied for WHO prequalification, which it could have done even while US FDA and EMA applications were pending.
- Regrettably, Gilead has not publicized any intent to use WHO Collaborative Registration Procedures, which would accelerate regulatory decisions by national regulatory authorities within 90 days, though it has said it would do so verbally.
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 import waivers, that will not be a long-term solution for countries procuring LEN-LA directly.
We call on Gilead to urgently address this inadequate regulatory agenda that will harm access during its two-year period as a sole supplier and further hobble efforts to register generic equivalents in the future.
We call on Gilead to:
- 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 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.
We request your response by August 28, 2025.
Sincerely,
Organizations
Health GAP
Public Citizen
Salud por Derecho
Acción Internacional para la Salud
50 Fathers Movement Credible Messenger USA
Action against AIDS Germany
Advocacy for the Voiceless Sierra Leoneans (AVSL)
AFE One Health Initiative
Africa Freedom of Information Centre (AFIC)
Africa Substance Use Disorder Management Clinic
Africa Youth Transformation
African Alliance
AIDS Action Baltimore
AIDS and Rights Alliance for Southern Africa (ARASA)
AIDS-Fondet (The Danish AIDS Foundation)
Amaruss Guendanavanii Ixtepec AC
Amoru AIDS Support Community Initiative (ASCI)
APCASO
Ashdown Community Development
Ashowed Charitable Organization limited Uganda
ASOCIACION CADENAS POSITIVAS PERÚ
Asociación CCEFIRO Construyendo Caminos de Esperanza frente a la Injusticia el Rechazo y Olvido
Asociación INPACVIH
Asociación Programa de Soporte a la Autoayuda de Personas Seropositivas – PROSA
Asociación Santa Micaela
Associação Comité para a Saúde de Moçambique (CSM)
Association des jeunes pour les développements de la région du Nord
Association For Promotion Sustainable Development
AVAC
Bontate Ba Kopane Forever
Brazilian Interdisciplinary AIDS Association – ABIA – Brazil
Cantsa Home Based Care
CARAM Asia
Chicago Women’s AIDS Project
Christ Soldiers Foundation NGO
CISE Malawi
Coalition for Health Promotion and Social Development (HEPS) Uganda
Coalition of Civil Society and Human Rights Activists – Sierra Leone (CCSHRA-SL)
Coalition of Women Living with HIV and AIDS (COWLHA) Malawi
Community Development Network of the Americas
Congregation of Our Lady of Charity of the Good Shepherd, U.S. Provinces
Dandora Community AIDS Support Association
DECISIVE MINDS
ECOM – Eurasian Coalition on Health, Rights, Gender and Sexual Diversity
European AIDS Treatment Group (EATG)
FIAR
Foro de la Sociedad Civil en Salud para la región del Callao
Foro Regional por los Derechos Sexuales y Reproductivos FORDES Arequipa
Fundación Acción Positiva por la Vida
Fundación Sida Región Táchira
GIVAR
Global Coalition of TB Advocates (GCTA)
Global Communities
Global Fund Advocates Network
Global Health Advocates
Global Health Italian Network
Global Humanitarian Progress (GHP) Corp, Colombia
Global Network of Black People working in HIV
Global Sentinels Movement
Grupo de Ayuda Mutua Hermanos de Sangre de Pucallpa
Grupo de Trabalho sobre Propriedade Intelectual – GTPI/Rebrip
Guardian Angels Care And Support Centre Organisation
Health Access Network – Ghana
Health Equity Matters
Health Justice Initiative SA
HIV i-Base
Housing Works
Indonesia AIDS Coalition (IAC)
INNOVARTE ONG
Interfaith Center on Corporate Responsibility (ICCR)
International Community of Women Living with HIV- Eastern Africa
International Planned Parenthood Federation (IPPF)
IRESCO
ITPC Global
ITPC LATCA
Kenya Key Population Consortium
Kenya NGO Alliance Against Malaria
LHL International Tuberculosis Foundation
Malaria and NTDs Youth Corps Cameroon
Médecins Sans Frontières
medmissio – Institute for Global Health
MENA H Coalition
Misión Salud
Mothers First
Movement for Community-led Development
Movimiento Mexicano de Ciudadanía Positiva, A.C.
MPICSO
National Advocacy Center of the Sisters of the Good Shepherd
National Association for Young People Living with HIV (Y+ Malawi)
NETWORK Lobby for Catholic Social Justice
NGO “Positive Initiative”
ONG LES BATISSEURS (DR Congo)
Pacientes Alto Costo
Pan-African Treatment Access Movement
Partners In Health
People’s Health Movement
Pharmaceutical Accountability Foundation
Positive Action Campaign
PrEP4All
Public Health Initiative Liberia -PHIL
PWUD Sub-sector
Red de Medicamentos de Guatemala
Red de Personas Viviendo con VIH
Red Mexicana de Personas que Viven con VIH/SIDA, AC
Red Nacional de Personas Viviendo con VIH/SIDA en Bolivia REDBOL
Red Peruana por una Globalización con Equidad (RedGE)
Réseau Burundais pour la Prévention et Contrôle des Infections
RESULTS
Ringa Women Fighting AIDS Group
Salud y Farmacos
Samkeni Development Foundation
SANAC FAITH BASED SECTOR
Sankalp Rehabilitation Trust
Show Me Your Number HIV Prevention Project NPC
Sí, da Vida
Society Health And Morals Association-NPC
Sophia Forum
South African Coalition of Civil Society Organizations
South African Men’s Health Conference (SAMAHC)
STOPAIDS
The Health Law and Human Rights Centre-SA
TIP Global Health
Treatment Action Campaign
Treatment Action Group
Treatment Optimization Campaign
Tsohang Youth Project
UK CAB
Union Congolaise des Organisations des PvVIH (UCOP+)
Universities Allied for Essential Medicines
Vidas Diversas AC
Vietnam Network of People living with HIV (VNP+)
Wemos
West Africa Youth Network for Peace Education and Economic Development Sierra Leone WAYNPEED-SL
West African Institute of Public Health (WAIPH)
Women’s Probono Initiative (WPI) – Uganda
Wote Youth Development Projects CBO
КАР
Individuals
Abou Mere, Director, Kripa Foundation Nagaland
Adrienne K. Chan, MD MPH FRCPC, Associate Professor, Infectious Diseases, University of Toronto, Canada; Board Chair, Partners in Health, Canada
AJ Cho, public health advocate
Ajok Beatrice counsellor sign language interpreter, an advocate for HIV Aids Gender Based Violence
Akoth Mariane, Registered Nurse
Alex de la torre
Analyst Dare E. Jimoh -PHC Chief Cracker
Andrea Caputo Svensson, Global Health Advisor, Uppsala University
Anna Ramasamy
Bellinda Thibela, Activist
Beth Linas
Bienfait KISAMBA, Deputy program manager SANRU
Brook K. Baker, Professor Emeritus, Northeastern U. School of Law
Bruce Tushabe-ARASA
Catherine Banobi, HANC
Cederick Taylor
Cedrick Harrell, Community Health Worker
Christine McNab, Global Health Consultant
Cindra Feuer
Dan Meltzer, MPH, MA
Deana Jordan Sullivan, Global Public Health advocate
Djibril Wade, Researcher
Dr. Darren Whitfield, Associate Professor
Dr. Frankline WIRSIY, Community Mobilization Coordinator at the Cameroon Baptist Convention Health Board
Dr. Hermes Manrique
Dr. Lindsey Shultz
Dr. Mengistu Tafesse
Dr. Mohga Kamal-Yanni, Global Health and Access to Medicines Consultant
Dr. Sherin Susan Paul N, Independent Monitoring and Evaluation Consultant, Geneva
Dr. Tonia Poteat
Ebunoluwa Akinola
Enrique Adrián Gómez Rincón
Eric Friedman, Global Health Justice Scholar, O’Neill Institute for National and Global Health Law, Georgetown University Law Center
Erica Bersin President ERO Health Communications
Erika Beatriz Garcia, MD
Ethan Guillen, Global Health Consultant
Ezekiel Peter, Executive Director, Eagle Lead Development Initiative (ELDI)
Fasika Mekete, Senior Technical Expert, Africa CDC
Goitsemang Ntoatsabone, TAC
Héctor Castelan Vargas
Hendy Kristyanto
Ida Savadogo, Programme Officer, Réseau Accès aux Médicaments Essentiels (RAME)
IRIEBI Gboh, Activist, Côte d’Ivoire
Ivan Gonzales Govea
Jacqueline Goldenberg, Defend Public Health
Jahaira Pimentel
Janis K. LAZDINS HELDS, MD, PhD. Retired WHO / TDR, Coordinator R&D NTDsHO/TDR
Jim Ferguson
Jim Pickett
JL Angell
Joel Lexchin MD, retired emergency physician
John Tanko Bawa, Director, Vaccine Implementation-PATH
Jorge Perez Jimenez
José Luis Gonzales Maiqui / José Luis Gonzales
Julia Campos
Julio Rondinel Cano. Psicólogo
Katherine Footracer, MS, PA-C
Kathleen Fagan, MD, MPH
Kristin Giordano, MPH
Kristina Tang, Private Citizen
Kristine Yakhama
Laia R. Mingote
Lashawn Hardy, community health worker
Leslye Heilig, M.D.
Luciana Kamel, Community advocate
Manju Chatani, Global Health Advocate
Marco Ninahuanca, Comunidad Ulcumayo Perú
Maria Mercedes Trujillo Cubillas, Licenciada en enfermería
Marilena Bertini, AMREF Health Africa
Mark Hubbard, Independent advocate
Martha Tholanah, Health and Human Rights Advocate
Marwin Meier, RGN, MSc Health Promotion
Mary-Frances O’Connor, PhD
Matthew Kavanagh, Georgetown University
Md. Sanwar Hossain, Program Manager, Ashar Alo Society
Meena Saraswathi Seshu
Mfundo Edmond Msusa, Eastern Cape Provincial Leader of People Who Use Drugs
Michael Zamudio
Michelle Lopez, HIV Advocate
Michelle Orengo-McFarlane MD
Midori de Habich, Directora Tecnica
Miguel Granados Vergara
Miss Delisile Sindane
Miss Mponang
Miss Natalie Jacobs from the South African Network of People Who Use Drugs (SANPUD) South Africa
Mmatsie Tsotetsi, Civil Society
Monica Nana Mkhize
Morgan Garcia, MPH
Mr. Ariel Molefi Mabalane, a member of Motsamai Clinic Committee in Ekurhuleni
Mr. Hope Kubeka
Mr. Klaas Mtshweni
Mr. Lebowa Malaka
Mr. Vhangani Ndou
Mrs. Zandile Mokoena
Ms. Akona Ntsaluba
Ms. Sarah Karanja
Ms. Simphiwe Xaba
Mthuthuzeli Isaac Skosana
N.M. Nkosi
Nebiat Teshager
Neetha Morar, Advocate for access to drugs
Ngwoke Ifeanyi/Monitoring, Evaluation and Research Officer/YouthRISE Nigeria
Nicholas, Outcast Activism Forum Uganda
Nina Schwalbe, MPH, PhD
Nolitha Mazwayi, TAC
Nomsa Zulu
Omar Alba, LCSW
Omar Jara
Paloma Fernández
Patrick Mdletshe, TAC Deputy General Secretary
Paul Davis, Policy and Partnerships, Health In Harmony
Percy Romero López
Peter Staley, AIDS Activist
Puneet Upreti
Reena Agarwal, MD
Refilwe Rasiile, Confidence Rasiile Social Worker
Ricardo Chuquimia Vidal
Rob Camp EUPATI Spain
Robert Kessler, Program Communications Manager
Roberto Chávez
Roberto Miranda
Rocio Millán Meza
Rubén vargas Martínez
Ryan Maves, Infectious Diseases Physician, Winston-Salem, North Carolina, USA
Samantha Schild, MS, MPHc
Sandra Vallenas/Pontificia Universidad Católica del Perú (docente jubilada)
Sarah M Kalufyanya, ReAct Africa, Community Engagement Officer
Satya Sivaraman, Journalist
Sharonann Lynch, Co-director, Center for Global Health Policy & Politics, Georgetown University
Shaun Palmer, PhD Candidate, Vrije Universiteit Amsterdam
Simon Makgoale
Sr. Javier Anamaria – Representante Alterno ITPC LATCA en Perú
Stephanie Rosenberg, J.D.
Susana T Fried, Co-director, Just Futures Collaborative
Thabo Majuja
Thulisile Mgiba, Treatment Action Campaign
Veronika Wirtz, PhD, Pharmacist and Public Health Researcher
Wendy Leonard, MD AAHIVS
Wim Vandevelde, Treatment Activist, South Africa
Yolaan Andrews, Key Populations Programme Manager, NACOSA
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