Gilead’s announcement of their voluntary license for lenacapavir—a
groundbreaking, long-acting HIV prevention method—highlights why we
cannot rely on pharmaceutical companies to deliver genuine global access
strategies for the medicines, vaccines and diagnostics that the world needs.
Lenacapavir (LEN), a twice-yearly injection, has been highly effective in clinical
trials. It could prevent millions of new HIV infections – if it was affordable and
available everywhere. But Gilead has limited the countries that will be able to
access generic versions of LEN.
Selective Inclusion and Exclusion:
While the license includes several low- and middle-income countries, it strategically
excludes many others such as Algeria, Argentina, Brazil, Colombia, El Salvador,
Guatemala, Peru, Malaysia… In Brazil alone, 51.000 people were newly infected with
HIV in 2023.
Gilead’s voluntary license (VL) will prevent millions of people especially key
populations from accessing LEN. It will shift the burden of new HIV infections into
middle-income countries that are excluded from the VL, who must pay whatever
Gilead decides to charge for LEN. In the United States (where LEN is currently
approved as part of treatment for multidrug-resistant HIV), LEN is priced at US $
42,500 per person, per year (PPPY). 1 Yet experts estimate that generic versions of
LEN can be profitably mass-produced for less than $100 per person PPPY,
decreasing to $41 PPPY, once the volume reaches 10 million courses per year. 2
The agreement prevents supply of generics to countries where no patents have
been filed or granted like Algeria, Lebanon, Jordan… This further exposes this
license as a tool for Gilead to control new markets and impose its own monopolistic
agenda rather than address global health needs.
Reinforcing Inequities, Not Solving Them:
This license perpetuates inequities by prioritizing profit over people. Voluntary
licenses are controlled by the pharmaceutical industry and negotiated behind closed
doors. VLs offer access only to selected markets, where pharmaceutical corporations
collect royalties and good publicity, while retaining control and dictating supply terms
in these – and all other markets. This strategy restricts access and locks countries
into dependency to pharma companie’s supposed good will, ultimately preventing
them from taking more sustainable measures such as the use of TRIPS flexibilities to
address public health emergencies.
Pharma’s Strategy to Undermine Health Sovereignty:
By tying generic manufacturers to such licensing agreements that prevent supply to
countries where patent barriers have been successfully addressed through
compulsory licences or patent oppositions, Gilead and other pharmaceutical
companies effectively undermine the use of TRIPS flexibilities that were specifically
designed to address public health challenges. This approach prevents countries from
leveraging these tools to produce or import affordable medicines and build their own
manufacturing capacities.
Blocking Local Production Capacity:
By awarding licenses to a select group of manufacturers, Gilead is promoting
continued reliance on foreign production, especially in Africa and Eastern Europe
Central Asia regions. This approach stifles the growth of local manufacturing
capacity, undermines efforts to achieve regional self-sufficiency, and hinders long-
term sustainability. These countries should be empowered to produce their own
medicines, without being restricted by exclusive agreements that promote
dependency on selected generic manufacturers and limit local production capacity.
The Need for True Global Access Solutions:
Pharmaceutical companies, including Gilead, have repeatedly demonstrated that
they cannot be trusted to lead global access efforts. History has shown that voluntary
licensing is used as strategy to maintain favorable public perception, while prioritizing
commercial interests of pharmaceutical corporations. True global access cannot be
achieved through fragmented, company-led licensing schemes that continue to put
profit over people’s health.
A Call for Systemic Change:
This announcement underscores why we need systemic reform in global health
governance. Governments, civil society, and international bodies and donors must
push for policies that prioritize people’s health needs over corporate profits. We
cannot entrust pharmaceutical companies with the responsibility of ensuring
equitable access to medicines. It is time for countries to reclaim their sovereignty in
health policy and use every tool available, including TRIPS flexibilities and other
measures, to guarantee access for all.
Lenacapavir has the potential to transform HIV prevention – but only if it is
made truly accessible to everyone who needs it, without restrictions and
exclusions. We call on global health leaders and stakeholders to stand against
these monopolistic practices and advocate for robust, transparent, and
inclusive policies that place public health above profit.
1 https://www.npr.org/sections/goats-and-soda/2024/09/17/g-s1-23248/hiv-drug-aids-epidemic-lenacapavir#:~:text=Lenacapavir’s%20cost%20as%20HIV%20treatment,less%20than%20%244%20a%20month.
2 https://academic.oup.com/jac/advance-article-abstract/doi/10.1093/jac/dkae305/7748089