Activists React to Merck’s Voluntary License for Generic Production of Investigational Long-Acting Oral PrEP Product, Alimatravir 

Activists React to Merck’s Voluntary License for Generic Production of Investigational Long-Acting Oral PrEP Product, Alimatravir 
If Alimatravir is Approved, Merck’s Unethical Exclusion of Middle Income Countries will Prolong the Pandemic
Countries Must Issue Compulsory Licenses for Generic Alimatravir Now 

(Rio de Janeiro) Activists working for global universal access to long-acting pre-exposure prophylaxis (PrEP) reacted to Merck’s announcement today of a voluntary license with 7 generic companies to produce generic alimatravir, a monthly PrEP pill, should ongoing Phase III clinical trials of alimatravir prove the pill is efficacious. 

“This unethical license excludes many countries in Latin America, where we are facing an HIV prevention crisis,” said Susana van der Ploeg of Associação Brasileira Interdisciplinar de AIDS (the Brazilian Interdisciplinary AIDS Association, ABIA). “The Brazilian government and all excluded countries must issue compulsory licences, break Merck’s monopoly, and support development of generic alimatravir.” 

Brazil along with Peru, Argentina, and Colombia are participating in Merck’s ongoing Phase III clinical trials, but are among the excluded countries, violating basic ethical principles that participants in scientific research must benefit from that research.  Salud por Derecho’s comparison of LMICs excluded by the alimatravir and the Gilead license for generic production of long-acting lenacapavir (LEN-LA), a twice yearly injection that is virtually completely protective against HIV, is available here.  

Merck has refused to announce the price they will charge for alimatravir and the volumes they will make available for low- and middle-income countries. New data reveal alimatravir is extremely inexpensive to manufacture.   

“Merck must commit now to a public price of $4.50 per year, and a commitment to supply at least 6 million people while it is the sole source manufacturer, if and when alimatravir comes to market,” said Asia Russell, Health GAP Executive Director. 

Gilead has been widely criticized because they refused to supply LMICs at scale as soon as LEN-LA was approved, instead providing for only 2 million people spread out over several years. As a result, Gilead has slowed the pace of desperately needed long acting PrEP roll out.

“Merck must commit not to make the same mistake as GIlead, which is choosing unnecessary, artificial scarcity that will prolong the HIV pandemic,” said Fatima Hassan of Health Justice Initiative. “People at high risk of HIV infection, including key populations and young women are already being turned away.” Hassan will present findings at AIDS2026 from LEN-LA roll-out which show the consequences of Gilead’s harmful approach. 20 million people need PrEP worldwide, and oral PrEP programs have been slashed by 42% as a result of the Trump Administration’s decision to decimate PEPFAR’s HIV prevention programs, beginning in 2025.