Robert M. Davis
Chairman and Chief Executive Officer
Merck & Co., Inc.
126 East Lincoln Avenue
Rahway, NJ 07065
United States
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Re: Ensuring Equitable Global Access to MK-8527 for HIV Prevention
Dear Mr. Davis,
We, the undersigned, write to you as members of the HIV community, both people affected by and living with HIV, and HIV and health organisations, regarding Merck’s promising once-monthly oral PrEP candidate MK-8527, now in Phase III clinical trials.
MK-8527 represents a potentially transformative addition to the HIV prevention toolkit—a convenient monthly oral option that could address the adherence challenges that have limited the impact of daily oral PrEP, particularly in low-income and middle-income countries (LMICs) where the vast majority of the 1.3 million people who acquire HIV each year reside.
We are at a historic inflection point. For the first time, we are witnessing a new HIV prevention tool—long-acting injectable lenacapavir (LEN)—being introduced in high-income countries and a handful of LMICs nearly simultaneously. We can see the interest from HIV programmes with lenacapavir receiving ten African regulatory approvals within just six months of FDA approval. This stands in stark contrast to the painful history of HIV treatment, where life-saving antiretroviral therapy transformed HIV from a death sentence to a manageable illness in wealthy countries by the mid-1990s, yet did not reach African communities at any scale until the mid-2000s due to lack of availability, high prices and intellectual property barriers. Millions of people died while waiting.
The LEN acceleration demonstrates what is possible when HIV programmes, product developers, regulators, communities, activists, and global health stakeholders work together with intention and urgency. MK-8527 offers Merck the opportunity to build on this momentum and set a new standard for equitable access—one where people in LMICs can access a breakthrough prevention tool at the same time as people in high-income countries.
We urge Merck to commit now—during the clinical development phase, not after regulatory approval—to a comprehensive access strategy. Specifically, we call on Merck to take the following actions:
Pursue Multiple Regulatory Pathways
In addition to filing with the US FDA, we ask that Merck simultaneously utilize the EMA’s EU-M4all process (formerly Article 58), WHO Prequalification, and WHO’s Collaborative Registration Procedure to accelerate national regulatory reviews. We urge Merck to commit publicly to broad, accelerated registration of MK-8527 globally for all LMICs. In addition, we request Merck submit dossiers for regulatory approval in at least ten high-burden African countries within six months of any major regulatory approval, working proactively with national regulatory authorities to prepare dossiers in advance of efficacy results. In order to avoid regulatory barriers in India, specifically, we ask that Merck include people of Indian ethnicity in the ongoing clinical trials, so that the data becomes available at the time of registration in India, a major supplier of more affordable generics.
Commit to Fair, Transparent Pricing from the Outset
High launch prices for new prevention technologies create a chilling effect on programmatic ambition, leading to rationing, restrictive eligibility criteria, and perpetuating stigma around prevention tools. We have seen this pattern repeatedly: when products are priced beyond what programs can afford, they simply do not reach the people who need them.
We urge Merck to commit to pricing MK-8527 at or near parity with generic oral PrEP in LMICs from the point of introduction—not years later after generic competition forces price reductions. MK-8527’s price must be public. Achieving a launch price point of less than $40 per person per year would enable programs to plan for scale rather than resort to rationing. Merck should engage proactively with market-shaping mechanisms, including volume commitments and advance purchase agreements with the Global Fund, Unitaid, and other procurement partners, to bring the future price forward.
Establish Pro-Access, Non-Exclusive Licensing That Includes All LMICs
Generic production and supply are essential for ensuring affordable, equitable access at scale. Merck should commit to non-exclusive voluntary licensing agreements, such as with the Medicines Patent Pool, now, before regulatory approval, to ensure generic production of the active pharmaceutical ingredients and the finished product can begin as soon as possible. The licenses should allow manufacturers from Latin America, Africa, and countries in Asia with manufacturing capacity (Central Asia, Thailand, Malaysia, Bangladesh, India, China).
Critically, these licensing agreements must include all countries classified as LMICs—not just low-income countries and high-incidence nations, or a subset of middle-income countries, but upper-middle-income countries as well. The experience with lenacapavir’s licensing illustrates the problem: Gilead’s voluntary license covers 120 countries but excludes many middle-income countries facing continued and sometimes accelerating HIV incidence, including countries in Latin America, Eastern Europe, and the Middle East where an estimated 23% of global new infections occur. Countries where clinical trials were conducted were then excluded from the license. This exclusion is ethically untenable and counterproductive for public health efforts to reduce HIV infections.
We urge Merck to grant non-exclusive voluntary licenses that cover all LMICs without geographic restrictions and ensure that there are no clauses that would prevent licensees from supplying countries that are outside the scope of the license if there are no granted patents in place or in the event of a compulsory license being issued. These licenses should be finalized and announced before regulatory filing with the US FDA.
Refrain from Filing or Enforcing Secondary Patents That Could Delay Generic Entry
We urge Merck not to file patent applications for MK-8527 for PrEP across LMICs, and to refrain from seeking data exclusivity, and/or secondary patents designed to prolong exclusive rights beyond the primary patent expiration. Such “evergreening” tactics could obstruct production or importation of more affordable generics for years. Where patents have already been filed, Merck should commit not to assert them in ways that would block generic access in LMICs.
Support Technology Transfer and Manufacturing Capacity
Beyond licensing, Merck should actively share data with generic manufacturers and provide technology transfer when requested to enable generic production. This includes sharing manufacturing know-how, providing technical assistance to generic manufacturers, and providing data needed for regulatory submissions for generic products. Building manufacturing capacity in regions with high HIV incidence—particularly in Africa, Latin America, and Asia—will strengthen supply security and support long-term sustainability of HIV prevention programs.
Embed Access Planning Throughout the R&D Process
Rather than waiting for Phase III results or regulatory approval to begin planning for access, Merck should integrate access considerations into all stages of research and development. This includes conducting clinical trials in diverse geographic settings (as Merck is doing with sites in South Africa, Kenya, and Uganda) and across key populations, engaging with normative bodies like WHO early to facilitate rapid development of guidelines, and working with procurement agencies and country programs to forecast demand and prepare health systems.
Importantly, this approach aligns with emerging international norms. The WHO Pandemic Agreement includes provisions committing countries to implement policies ensuring pro-access terms in public research funding agreements. The NIH Intramural Research Program Access Planning Policy, implemented in January 2025, reflects growing recognition that access planning must be embedded from the earliest stages of development. Merck has the opportunity to lead by example.
The decisions Merck makes now, during the development phase of MK-8527, will shape the trajectory of this product for years to come. The patterns of slow adoption and inequitable access that characterized previous prevention innovations are not inevitable—they are the result of choices made by product developers, policymakers, and funders. Merck can choose a different path.
We stand ready to work with communities and engage governments to ensure MK-8527 reaches everyone who needs it, regardless of where they live. We would welcome the opportunity to discuss the requests above with you and your team.
Sincerely,
Academy of Integrative Health and Medicine
Access Care Treatment and Support Ghana, Ghana
Acción Internacional para la Salud, Perú
Action against AIDS Germany
Activists’ Coalition on TB Asia-Pacific (ACT! AP), Asia Pacific
Advocacy Network for Africa (AdNA), US
AIDS ACCESS Foundation, Thailand
AIDS and Rights Alliance for Southern Africa (ARASA)
AIDS Cell, Ibn Sina Academy, India
Alliance for Reproductive Health Rights, Ghana
Ama Cradle for Development, Uganda
APCOM, Asia Pacific
APCASO, Asia Pacific
Ashokta Punarbashan Sangstha (APOSH), Bangladesh
Asociación Acceso Justo al Medicamento (AAJM), Spain
Associação Brasileira Interdisciplinar de AIDS (Brazilian Interdisciplinary AIDS Association), Brazil
Associação de Gays e Amigos de Nova Iguaçu, Mesquita e Rio de Janeiro (AGANIM), Brazil
Association de Lutte Contre le Sida (ALCS), Morocco
Association for Promotion Sustainable Development, India
Association Lambda, Mozambique
Association of Concerned Africa Scholars (ACAS-USA), US
Astha Samuha, Nepal
Arms to Lean On, Kenya
Asia Pacific Network of People Living with HIV (APN+), Asia Pacific
Asia Pacific Network of Sex Workers, Asia Pacific
Asia Pacific Trans Network, Asia Pacific
ATLO, Kenya
AVAC, International
Batanai HIV and AIDS Service Organisations, Zimbabwe
Bidii Youth Group, Kenya
Blue Diamond Society, Nepal
Baylor College of Medicine Children’s Foundation, Uganda
Bungoma KPs CBO, Kenya
Caribbean Women’s Health Association, US
Centre for Girls and Interaction (CEGI), Malawi
Child Way Uganda, Uganda
Children’s Dignity Forum (CDF), Tanzania
Children Education Society (CHESO), Tanzania
Coalition for Health Promotion and Social Development (HEPS), Uganda
Coast Hostess Empowering Community, Kenya
Community Network for Empowerment (CoNE), India
Community Support Group, Nepal
Decisive Minds, Zambia
Delhi Network of Positive People (DNP+), India
Disability Advocacy and Services Kenya (DASK), Kenya
Divas of Changamwe Coast, Kenya
Decisive Minds, Zambia
Development Alternatives with Women for a New Era (DAWN), Global South
Drug Policy Reform Indonesia (DPR-INA), Indonesia
Dr. Uzo Adirieje Foundation (DUZAFOUND), Nigeria
eDaktaris, Kenya
Eurasian Coalition on Health, Rights, Gender and Sexual Diversity (ECOM), Estonia
European AIDS Treatment Advocacy Group (EATG), Europe
Faraja Women’s Initiative, Kenya
Foundation for Action on Inclusion Rights (FAIR), Thailand
Fondation Sante et Développement Durable, Guinea
Fundación IFARMA, Colombia
Foundation for Integrative AIDS Research (FIAR), US
Generation Alive, Zambia
Georgetown University Center for Global Health Policy & Politics, US
Global Forum For Development (GLOFORD), Uganda
Global Humanitarian Progress (GHP Corp), Colombia
Good Women Association (GWA), Nigeria
Health GAP (Global Access Project), International
Health and Diversity, Inc., US
Health Justice, US
Vietnam Network of People Who Use Drugs (VNPUD)
Health Justice Initiative, South Africa
HIV i-Base, UK
HODSAS, Democratic Republic of Congo
Hoymas, Kenya
Just Treatment, UK
ICHANGE, Côte d’Ivoire
Indian Drug Users Forum (IDUF), India
Indonesia AIDS Coalition (IAC), Indonesia
Institute of HIV Research and Innovation, Thailand
Institute of Research and Behavioural Studies (IRESCO), Cameroon
International Community of Women Living with HIV (ICW), Asia Pacific
International Community of a Living with HIV/AIDS Southern Africa (ICWSA), Southern Africa
International Network of Women Who Use Drugs (INWUD), International
International Planned Parenthood Federation (IPPF), International
International Treatment Preparedness Coalition Global (ITPC Global)
International Treatment Preparedness Coalition Middle East and North Africa (ITPC MENA)
Kenya Key Population Consortium (KKPC), Kenya
Kenya Network of People Who Use Drugs (KENPUD), Kenya
Kenya Sex Workers Alliance (KESWA), Kenya
Kisumu Sex Workers Alliance, Kenya
KNH VCT CENTER, Kenya
Kripa Foundation Nagaland, India
Laikipia Peer Educators, Kenya
Lighthouse Social Enterprise, Vietnam
Malaysian AIDS Council, Malaysia
Mambo Leo Peers Empowerment Group (MPEG), Kenya
Medicinas para la Gente Cap Latinoamérica, Latin America
Men for Positive Living Support Community Based Organization (MOPLS), Kenya
National Black Gay Men’s Advocacy Coalition, US
National Association of PLWHA in Nepal, Nepal
National Forum of People Living with HIV and AIDS Networks Uganda, Uganda
National Harm Reduction Network (NHRN), India
Network For Key Populations Affected by HIV (NEKEPA), Kenya
NETWORK Lobby for Catholic Social Justice, US
Network of Asian People who Use Drugs (NAPUD)
Nigerian Women Agro Allied Farmers Association, Nigeria
Nina Schwalbe, Candidate for Congress – NY 12, US
North East African Community Health Initiative, Uganda
Malawi Network of Religious Leaders Living with or Personally Affected by HIV and AIDS (MANERELA+), Malawi
Médecins Sans Frontières/Doctors Without Borders (MSF), International
MSWHARi CBO, Kenya
Muranga Stars, Kenya
Muslim Family Counselling Services, Ghana
Mwaka Nawila Foundation, Zambia
Organización Vida, Integración y Humanidad, Guatemala
Pan African Positive Women’s Coalition, Zimbabwe
Partners In Health, International
Persaudaraan Korban Napza Indonesia (PKNI)/Indonesian National Network for Drug Users, Indonesia
Pharmaceutical Accountability Foundation, International
Pleaders of Children and Elderly People at risk (PEPA/NGO), Democratic Republic of Congo
Picture Youth Group Organization, Kenya
Positive Women’s Network, International
Positive Women Network, India
Public Citizen, US
Public Health Initiative Liberia, Liberia
Raksthai Foundation, Thailand
Recovering Nepal, Nepal
Recovering Nepal Women, Nepal
Salud por Derecho, Spain
Salamander Trust, International
Salud y Farmacos, US
Sankalp Rehabilitation Trust, India
Service Workers in Group Foundation (SWING), Thailand
Silence Kills Support Group, Botswana
SISTERS Foundation, Thailand
Smartladies, Kenya
Society for Positive Atmosphere and Related Support to HIV and AIDS (SPARSHA) Nepal
Society for Mobilization Advocacy and Justice (SMAAJ), Pakistan
Sophia Forum, Unied Kingdom
Stop AIDS In Liberia (SAIL), Liberia
Star Ladies of Hope CBO (ESWA), Kenya
Strengthening Africa’s Health Technology Coalition (SAHTAC), South Africa
Survivors Organization, Kenya
Survivor Mentors Group, Kenya
Tamtang Foundation, Thailand
Teens Watch Centre, Kenya
Thai Network of People who Use Drugs, ThaiNPUD, Thailand
Thai NGO Coalition on AIDS, Thailand
The Health, Law and Human Rights Center-SA, South Africa
The Rainbow Sunrise Group, Thailand
Treatment Action Group (TAG), US
Treatment Action Campaign, South Africa
Treatment Optimization Campaign, South Africa
True Experience on Drugs Addiction (TEDA) Malindi, Kenya
True Vine Mentors, Kenya
Tunaweza CBO, Taita-Taveta County, Kenya
Uganda Network on Law, Ethics and HIV/AIDS, Uganda
UK Community Advisory Board (UK CAB), UK
Universities Allied for Essential Medicines, International
University of Miami Public Health Policy Lab, US
Vietnam Network of People Who Use Drugs (VNPUD), Vietnam
Vietnam Network of People living with HIV (VNP+), Vietnam
Vision Ladies, Kenya
Ward 86 HIV Clinic, UCSF, US
West Africa Youth Network for Peace Education and Economic Development (WAYNPEED), West Africa
WINS, India
Wokovu Way, Democratic Republic of the Congo
Women and Media Collective, Sri Lanka
Women in Response to HIV/AIDS and Drug Addiction (WRADA), East Africa
Wote Youth Development Projects CBO, Kenya
Yayasan Gerakan Mandiri Pita Merah (GEMPITA), Indonesia
Yayasan Peduli Hati Bangsa, Indonesia
Y-Fem, The Young Feminists Movement of Namibia
Youth and Adolescent Representatives of Health Uganda (YARHU), Uganda
Youth Health and Right Initiative for Advocacy and Empowerment, Nigeria
Youth LEAD, Asia Pacific
Young Generation for Social Support, Kenya
Young Pharmacists Group, Nigeria
Zimbabwe Civil Liberties and Drug Network, Zimbabwe
Zipcare Women Initiative, Kenya
cc: Dr. Dean Y. Li, President, Merck Research Laboratories Silas Holland, Executive Director, Global Public Policy
Lee Robson, Executive Director, Market Access and Policy
