Statement on the Merck Voluntary License on Alimatravir and Unitaid’s Announced Support For African Licensees

The NGO and Communities delegations to the Unitaid Board welcome Unitaid’s announcement of investment in African manufacturing capacity whilst calling for stronger commitments to ensure equitable access to next-generation HIV prevention by Merck.

In addition, we welcome Unitaid’s investment in African manufacturing capacity to make alimatravir as an important step towards a more equitable, resilient and sustainable global health system. Strengthening regional manufacturing capacity is critical to ensuring that African countries are not dependent on a small number of suppliers and can access new HIV prevention technologies more quickly and sustainably.

Unitaid’s support for three African manufacturers to prepare for the production of alimatravir (MK-8527), a once-monthly HIV prevention pill currently in Phase 3 development, demonstrates the importance of investing early to ensure countries are ready to benefit from innovations once the products become available.

However, the impact of these investments will depend on whether the products can be produced affordably, supplied at sufficient scale, and made available to all countries and communities who need them. Affordability seems quite promising as new evidence shows that alimatravir can be sold profitably at under $3 for an annual supply once economies of scale are reached by generic producers.

Merck’s decision to establish a voluntary licence covering 129 countries for its investigational long-acting oral PrEP medicine, alimatravir, before regulatory approval is an important step that could help accelerate generic production. However, the current approach risks repeating longstanding inequities in global health access given the exclusion of many middle-income countries from the voluntary license.

Last week, as the global HIV community gathered in Brazil for the International AIDS Conference, the need for equitable access has never been more urgent. Brazil has long been at the forefront of the HIV response, contributing to research, innovation and implementation efforts, yet it is among the countries initially excluded from access to new HIV prevention technologies through current licensing arrangements from Merck. One positive development is that Merck and Brazil’s Fiocruz have signed a memorandum of understanding to explore Fiocruz manufacturing for the Latin American region.

It is unacceptable and unethical that any countries in Latin America and several other middle-income settings with significant HIV burdens may be excluded from accessing affordable generic versions of a medicine that some communities in these regions have helped to advance through participation in clinical trials.

Communities should not be asked to contribute to the research and development of new health technologies, only to be excluded from accessing those same innovations once they are available. Excluding middle-income countries from voluntary licensing arrangements risks leaving behind millions of people who need new prevention options and undermines the goal of ending AIDS as a public health threat.

Should Merck not expand geographic coverage of its voluntary licenses, countries outside the licensed territory can be supplied by Merck licensees if no patent is violated. Although existing data suggest patents have been granted or are pending in most or all of the excluded countries and territories, they can provide for government use measures or compulsory licenses thereby allowing generic supply.

Unitaid’s investment in African manufacturing is an important contribution towards a more equitable future for HIV prevention. However, for alimatravir to achieve its potential, Merck must expand licensing arrangements to include all countries with significant HIV need, commit to affordable pricing, guarantee sufficient supply and guarantee that communities and civil society have a meaningful role in shaping access strategies.

We are entering a critical window of opportunity for the global HIV response. With four years remaining to reach the 2030 goal of ending AIDS as a public health threat, new prevention tools such as long-acting lenacapavir and alimatravir offer the possibility of accelerating progress, expanding access and transforming prevention interventions. However, in the context of drastically reduced overseas development assistance and growing pressures on health systems, ensuring these innovations are affordable, that there are adequate supplies for 20 million people, and that they reach all the people who need them most is more important than ever.