Michael Gwarisa
Doctors Without Borders (MSF) has urged South Africa not to rush into local manufacturing of lenacapavir, an injectable HIV prevention drug, without first negotiating stronger, more equitable license terms or using a compulsory license to bypass patent restrictions.
Their call follows a recent announcement by the South African government that it is negotiating with Gilead Sciences to arrive at an agreement that would allow lenacapavir, a long acting HIV prevention injection, to be manufactured locally.
Though the move has been welcomed by global players such as UNAIDS, MSF warns that to genuinely expand access, any agreement with Gilead must include substantially improved terms compared to the company’s existing voluntary licensing agreements with generic manufacturers.
“Without such changes, local manufacturing risks deepening dependency by preserving Gilead’s tight control over supply, production, and geographic reach, and would simply lock South Africa, and many middle income countries that are currently excluded by Gilead’s licensing from accessing generics when they come onto the market, into the same patterns of exclusion we are fighting to dismantle,” said Candice Sehoma, MSF Access Regional Advisor for Africa.
The South African government has since issued a call for expressions of interest to identify South African pharmaceutical companies with the capacity to produce lenacapavir.
“If lenacapavir is to fulfil its promise as a breakthrough in HIV prevention, governments must ensure that intellectual property protections, restrictive licensing and other barriers do not stand in the way of affordable production and global access.”
HIV remains a key global public health challenge, with 1.3 million people becoming newly infected with HIV in 2023, with one infection occurring every 24 seconds. UNAIDS modelling suggests recent cuts in global funding could lead to an additional 6.6 million new HIV infections by 2029. South Africa has the largest population of people living with HIV in the world, at nearly 8 million people.
South Africa has a proud history of challenging barriers to HIV medicines to ensure equitable access for all. It must use this opportunity to negotiate equitable terms with Gilead, or even issue a compulsory licence that would free local manufacturers from patent restrictions.
Currently, Gilead Sciences is the sole supplier of lenacapavir even though it has signed a voluntary licensing agreement with six generic manufacturers, which will enable generic lenacapavir to be available in 120 countries and territories.
However, some countries are excluded from the voluntary licence and will therefore not have this access, despite representing 25% of all new HIV infections. Some of the excluded countries such as Brazil, Mexico, Argentina and Peru were participants in the clinical trials that enabled lenacapavir to be approved but are now denied access to affordable forms of the HIV prevention tool they helped to bring about.
Lenacapavir, a long acting injectable, has been proven to be highly effective in preventing HIV in cisgender women (100% effective in the PURPOSE 1 study) and in gender diverse people (96% effective in the PURPOSE 2 study). It is also available in twice yearly injections, which would provide longer protection and could make adherence easier than the current medical HIV prevention options including emtricitabine/tenofovir disoproxil fumarate and emtricitabine/tenofovir alafenamide, which require a daily pill or event based dosing, the dapivirine vaginal ring, which is replaced monthly, and cabotegravir, which requires an injection every two months.
