Joint Response Statement
We welcome the announcement that Merck (MSD) has taken early steps to license generic production of Alimatravir, a once-monthly HIV prevention pill, for many low- and middle-income countries, including countries across Africa. This marks an important milestone for HIV prevention and demonstrates that equitable access planning can begin well before regulatory approval. We commend MSD for recognizing that access should be considered an integral part of innovation rather than an afterthought.
As organizations working across community leadership, implementation, market access, and accountability, we have valued the opportunity to engage throughout this process and remain committed to working alongside MSD, governments, regulators, procurement agencies, donors, generic manufacturers, and civil society to help ensure that, if Alimatravir is proven safe and effective, access planning starts now. The lessons from this process should establish a new benchmark for how future HIV prevention innovations are developed, introduced, and scaled globally.
For African women, adolescent girls and young women (AGYW), and key populations, innovation only matters when it is affordable, available, acceptable, and delivered with dignity. The HIV prevention field has repeatedly demonstrated that scientific breakthroughs alone do not end epidemics. Communities need meaningful prevention choice, including daily oral PrEP, the dapivirine vaginal ring, long-acting injectable options, and emerging products such as Alimatravir, supported by accurate information, respectful services, sustainable financing, and health systems capable of delivering prevention equitably.

We are encouraged that this licensing approach includes African generic manufacturers and supports regional production capacity. However, African manufacturing must be more than symbolic participation in global supply chains. It must include meaningful technology transfer, transparent licensing arrangements, investment in quality-assured production, support for active pharmaceutical ingredient supply, and predictable procurement that enables sustainable manufacturing at scale. African access cannot remain dependent on delayed markets. It is central to health security, equity, economic resilience, and the long-term sustainability of the HIV response.
At the same time, a licensing announcement is only the beginning. Access commitments must be transparent, time-bound, adequately financed, and accountable. Women, AGYW, key populations, people living with HIV, and community-led organisations should have meaningful influence over licensing transparency, pricing, regulatory planning, product introduction, demand creation, service delivery, implementation, and monitoring. Countries excluded from voluntary licensing arrangements, including middle-income countries and countries hosting clinical trials, should not be left behind. Prevention access should be driven by public health need, not income classification alone.
Experience has shown that access depends not only on licensing but also on implementation readiness. Regulatory preparedness, provider training, procurement planning, market shaping, community literacy, demand creation, differentiated service delivery, and sustainable financing should advance well before product approval so that countries are prepared to introduce new prevention options without unnecessary delay. The HIV prevention community should not repeat the years-long introduction gaps experienced with previous innovations.
Importantly, much of this foundation already exists. Through collaborative initiatives, partners have already developed global demand forecasts for next-generation HIV prevention products, including once-monthly oral PrEP, alongside country readiness assessments, market intelligence, and implementation planning tools. These resources provide governments, manufacturers, donors, and procurement agencies with an opportunity to accelerate equitable introduction rather than starting from scratch. They should be leveraged to guide investment, procurement planning, and product rollout from the earliest stages.
The introduction of Alimatravir also presents an opportunity to further democratize HIV prevention by expanding meaningful prevention choice. Every person should have access to the prevention option that best fits their lives, preferences, and circumstances. Achieving this will require moving beyond product availability toward person-centred delivery models supported by community engagement, differentiated services, prevention literacy, and sustainable financing.
We call on MSD, global health partners, donors, governments, regulators, regional procurement mechanisms, and implementing partners to continue working together to ensure that Alimatravir, if proven safe and effective, is introduced through people-centred, women-centred, and community-led programmes. This includes early regulatory submissions, fair and transparent pricing, sufficient generic supply, investment in community literacy and demand creation, sustainable market shaping, provider readiness, and differentiated delivery models integrated within sexual and reproductive health services, youth-friendly services, and programmes serving AGYW, sex workers, men who have sex with men, transgender people, people who use drugs, pregnant and breastfeeding women, and other key and vulnerable populations.
We further urge African governments, regional institutions, donors, procurement platforms, and global partners to begin preparing now for equitable introduction. This includes strengthening regulatory systems, investing domestic resources, supporting African manufacturing, protecting human rights, and embedding community accountability throughout planning, implementation, monitoring, and evaluation. Governments and partners should also invest in introduction readiness, procurement forecasting, provider preparedness, and implementation monitoring while leveraging existing demand forecasts and country readiness tools to accelerate access. Community-generated evidence and community-led monitoring should complement national reporting to identify implementation barriers early and support continuous improvement.
As coalition partners, we stand ready to contribute to this next phase of HIV prevention. Together, our organisations bring expertise in demand forecasting, market shaping, country readiness, prevention literacy, community accountability, implementation support, and monitoring. We are committed to working alongside manufacturers, governments, procurement agencies, donors, regulators, and communities to ensure that scientific innovation translates into equitable public health impact.
The message from African women and communities is clear: prevention choice saves lives. No single prevention product will meet every person’s needs, and no prevention strategy will succeed if it excludes those most affected by HIV. Alimatravir has the potential to become an important addition to the HIV prevention toolbox, but only if equitable access is built from the beginning through partnership, implementation readiness, accountability, and sustained investment.
Community Leader Quotes

Experiences Across Countries and Contexts: What Is Working and Not Working with LEN and PrEP Choice Delivery?
Experiences from early adopter countries and PrEP choice programmes show that prevention choice works best when it is built into existing, trusted services rather than delivered through parallel systems. Early LEN implementation and broader PrEP choice delivery demonstrate strong demand for long-acting options, especially where services are discreet, youth-friendly, community-linked, and integrated with sexual and reproductive health, antenatal care, family planning, key population services, pharmacies, mobile clinics, and community-based delivery. Countries preparing for or introducing LEN are learning from oral PrEP, CAB-LA, and the Dapivirine vaginal ring that choice is not simply about adding products; it requires trained providers, clear information, flexible switching, reliable supply, rapid HIV testing approaches, pharmacovigilance, and community-led demand creation and monitoring.
What is working is the move toward differentiated and person-centred delivery: offering prevention options in settings people already use and trust; allowing people to start, stop, restart, or switch methods as their lives change; engaging women’s networks, youth-led groups, and key population organisations early; and using simplified testing approaches so clinic burden does not become a barrier to long-acting PrEP. Experiences from countries such as Kenya, Zambia, South Africa, Nigeria, Thailand, Cambodia, India, and other early implementation settings point to the importance of political will, community pressure, strong partnerships, and delivery models that meet people where they are.
What is not working is the continued gap between product promise and delivery reality. Too many communities still face stock uncertainty, limited service points, high transport costs, stigma, provider bias, weak counselling on the full prevention basket, poor follow-up systems, and exclusion from decisions about procurement, targeting, eligibility, and rollout. Long-acting products can also become inequitable if they are rationed narrowly, introduced only through research-like settings, or made available without meaningful community literacy, human rights protections, and sustainable financing. Lessons from CAB-LA and the Dapivirine vaginal ring show that regulatory approval alone does not create access; countries need funded implementation plans, procurement certainty, trained health workers, differentiated delivery, and community accountability from the start.
For LEN, the lesson is urgent and practical: rollout must be faster, fairer, and more community-led than earlier prevention introductions. Countries should use existing PrEP platforms as the foundation, expand delivery beyond facilities, protect choice across oral PrEP, CAB-LA, the Dapivirine vaginal ring, condoms, harm reduction, and future products, and ensure that African women, AGYW, key populations, and people living with HIV are not treated as passive recipients but as designers, monitors, and decision-makers in prevention choice delivery.
Call to Action for Policymakers
Prepare now for equitable introduction
Begin regulatory, financing, procurement, and implementation planning before Alimatravir approval so countries can avoid delays seen with earlier HIV prevention tools.
Turn licensing into real access
Ensure licensing commitments are transparent, time-bound, adequately financed, and accountable, with clear plans for pricing, supply, rollout, and monitoring.
Invest in African manufacturing
Support African local and regional manufacturing through technology transfer, quality-assured production, API supply support, predictable procurement, and sustainable financing.
Increase domestic and regional financing
Allocate domestic resources and strengthen pooled procurement so HIV prevention choice is not dependent on uncertain donor funding.
Accelerate regulatory pathways
Strengthen regulatory systems and support early regulatory submissions, regional harmonisation, and faster review processes for new prevention options.
Protect prevention choice
Ensure Alimatravir is introduced as part of a broader prevention basket that includes oral PrEP, long-acting injectable options, the dapivirine vaginal ring, condoms, harm reduction, and future products.
Embed community accountability
Give women, AGYW, key populations, people living with HIV, and community-led organisations meaningful power in licensing transparency, pricing, demand creation, rollout, service delivery, monitoring, and evaluation.
Invest in implementation readiness
Fund provider training, procurement forecasting, market shaping, community literacy, demand creation, differentiated service delivery, and implementation monitoring.
Use existing readiness tools
Leverage existing global demand forecasts, country readiness assessments, market intelligence, and implementation planning tools to guide investment and rollout.
Remove legal and service barriers
Address stigma, criminalisation, user fees, weak supply chains, provider bias, and exclusionary policies that prevent AGYW, key populations, pregnant and breastfeeding women, women living with HIV, and other vulnerable groups from accessing prevention.
Ensure rights-based, people-centred delivery
Integrate prevention choice into trusted services, including sexual and reproductive health services, youth-friendly services, and programmes serving key and vulnerable populations.
Our call is clear: policymakers must turn licensing commitments into funded, rights-based, community-accountable access plans that deliver prevention choice equitably, urgently, and sustainably across Africa and beyond.