CONTACT: Natalie Shure, natalie.shure@treatmentactiongroup.org
October 8, 2024 – TAG recognizes Gilead Science’s announcement that it has issued six voluntary licenses to produce generic lenacapavir for distribution within 120 high HIV burden countries as a first step toward broadening access to this potent preventive drug for millions of people at risk of HIV. Nevertheless, it still leaves far too many behind. Further action is urgently needed to ensure that everyone, everywhere is able to benefit from this intervention, and fulfill their universal human right to science.
Recent Phase III clinical trials have shown that twice-yearly injections of lenacapavir are highly effective in preventing HIV. Thanks to the drug’s dosing schedule and relative convenience compared to existing alternatives, it could represent an important new option for pre-exposure prophylaxis (PrEP). But this promise won’t be fulfilled if unaccompanied by sufficient proactive measures to guarantee access domestically and globally.
Flying in the face of the global need, Gilead’s voluntary licensing deal shuts out most middle- and high-income countries. In addition, countries in which lenacapavir has not been patented are included in the license and generic manufacturers granted voluntary licenses are also precluded from exporting lenacapavir to countries not included in the agreement. This is particularly egregious in the case of Argentina, Brazil, Mexico, and Peru, where Phase III trials for the drug took place.
Meanwhile in developed countries, Gilead’s pricing structure for lenacapavir is unworkable at its present level. In the United States, where lenacapavir is currently approved to treat multi-drug resistant HIV, the price is over $46,800 per year even without required companion drugs. “What is the point of scientifically promising high-tech new PrEP options if hardly anyone can access them?” asked Mark Harrington, Executive Director of Treatment Action Group. “Getting as many people at risk of HIV onto lenacapavir for PrEP will be impossible with the current pricing structure.”
The struggle to guarantee access to lenacapavir for people who need it everywhere illustrates the shortcomings of voluntary licensure as a mechanism for access to medicines, which leave too much power in the hands of monopoly-patent-holding companies like Gilead who themselves dictate the rules of resulting deals. We call upon duty bearers to use tools like TRIPS flexibilities and champion local manufacturing capacity to expand access to key drugs. Moreover, as TAG has long held, public funding — without which many key global health interventions wouldn’t be possible — must come with access conditions to guarantee end products reach the people who need them most. “The public funds research and development with public resources because pandemics are a collective burden – we share a collective responsibility to invest in effective public health, prevention, and treatment measures,” Harrington said. “The public is entitled to fully benefit from the investments in research and development it makes possible.”
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