The Department of Health’s National Essential Medicines List Committee (NEMLC) has approved the addition of the recently registered injectable anti-HIV drug lenacapavir (LEN-LA) to the Essential Medicines List (EML), saying including treatments like this is vital for encouraging the production of generic medicines, and can enhance their availability and affordability.
The NEMLC is a non-statutory committee appointed by the Minister of Health, established under the National Drug Policy to develop and review an EML for public sector use, accompanied by standard treatment guidelines for three levels of care – primary, secondary, and tertiary.
The South African Health Products Regulatory Authority (SAHPRA) announced the registration of lenacapavir last month, making South Africa the first country on the continent to approve Gilead Sciences’ twice-yearly anti-HIV injection.
LEN-LA is expected to be launched here as early as March 2026 – but while the US Government, Gilead Sciences, and the Global Fund to Fight Aids, TB, and Malaria (Global Fund) announced the arrival of a donation of 500 doses of each for Zambia and eSwatini, a large group of activists has slammed this as a PR stunt.
‘Lenacapavir for all’
In a statement, they condemned what they called the greed and the politicking behind it.
Fatima Hassan, director of the Health Justice Initiative (HJI), said Africa and the global South were being offered “symbolic hand-outs, while Gilead and donors shape markets to serve corporate and geopolitical interests, not urgent public health needs”.
“By procuring a minuscule number of doses, Gilead can claim LEN-LA is ‘introduced’ in Africa, creating demand and laying the path for commercial bullying instead of introducing the product at actual cost and at scale,” she said.
Hassan described it as “a profit-seeking, corporate strategy dressed up as solidarity”.
At least 10m people need LEN-LA in Africa alone, to help achieve the global goal of a 90% reduction in new HIV infections by 2030 – but the US State Department Under Secretary Jeremy Lewin said they would provide LEN-LA doses for only 300 000 people in 2026 in total, globally.
“Protection for only 300 000 people is insulting, compared with the unmet need for HIV prevention, and the superiority of LEN-LA when compared with oral PrEP. Instead of crumbs, the US should be providing millions of doses, to alter the course of the HIV pandemic and repair the harms caused by their illegal and deadly cuts to HIV programmes since January,” said Bellinda Thibela, Health GAP’s International Policy and Advocacy Co-ordinator.
Beginning in January, the US decimated HIV testing, treatment, and prevention programmes when it issued stop-work and funding-freeze orders and then abruptly terminated the vast majority of USAID-funded Pepfar awards and unilaterally slashed Pepfar funding by almost 40%, refusing to spend money already budgeted for HIV, defying the will of US Congressional lawmakers.
While announcing a trickle of LEN-LA doses, Trump has also, in effect, been going behind the back of the US Congress and negotiating bilateral Memoranda of Understanding (MoUs) in 18 African countries. These MoUs are being used to continue illegal Pepfar funding cuts, restrict prevention (especially for key populations), and attempt to end programmes in as few as two-five years.
“HIV testing has fallen, infections have increased, and treatment has stalled, all causing deaths and illness far more than any impact the US’ small and stunt-driven, LEN-LA donations will have,” said Sibongile Tshabalala, chairperson of the Treatment Action Campaign (TAC).
Petty decisions affect millions
The US also announced it would exclude South Africa from its LEN-LA roll-out plan because, in effect, the Trump administration has made South Africa the target of harsh foreign policy decisions based on its racism, lies and conspiracy theories, the activists stated.
Nigeria is also being pushed out from LEN-LA support, coincidentally after being criticised by US Government officials, including for refusing to imprison US detainees extracted during US immigration raids.
By contrast, eSwatini has accepted the offer of not just the 500 LEN-LA doses before World Aids Day, but also $5.1m in funding from the US Government in exchange for imprisoning US detainees, their statement pointed out.
Amid these developments, China is announcing a new HIV prevention project in South Africa, focusing on young people and people who inject drugs in partnership with UNAIDS.
South Africa has been promised LEN-LA doses, but they will only be paid for from a reallocation of its Global Fund budget, and there will only be enough for 480 000 people from April 2026-2028.
“Gilead and the US Government are thwarting efforts to increase LEN-LA volumes and use cheaper generic versions sooner. Their profit-seeking and at times deeply exclusionary and racist 'market shaping' efforts will unnecessarily prolong the pandemic,” added the HJI’s Hassan.
LEN-LA costs only $25 per year to make generically, once sufficient volumes are achieved.
The group said Gilead’s global strategy to roll out LEN-LA is blatantly flawed: of the six voluntary licensees, no South African or Sub-Saharan African generic manufacturer has received a licence from Gilead yet, despite the continent’s capacity for manufacturing injectables.
The company, additionally, is also frustrating the speed at which generic entries are possible – and has not yet filed with India’s drug regulatory authority to enable faster generic entry. It has prioritised registration in only 22 LMICs, effectively delaying supply for millions, and demanded LEN-LA price secrecy in a move to increase its corporate power.
“These price secrecy demands are unacceptable, especially when Health ministries in low – and middle-income countries are already squeezed by the debt crisis, high or punitive US tariffs and massive US government funding cuts,” said Tian Johnson, strategist at the African Alliance.
As a result, countries excluded from the Global Fund’s supply agreement and Gilead’s voluntary licences will be left to negotiate directly with the company, facing the prospect of unaffordable “tiered” prices designed to maximise profit.
And despite the recent registration of LEN-LA with SAHPRA, Gilead is excluding the South African private sector, which will create a limitation on access and undermine the country’s ambition for HIV prevention.
This must be urgently remedied, they said.
“We urge the South African Government to take action,” added Johnson.
The group calls on the Department of Health, Department of Trade, Industry & Competition, and the Office of the Presidency to take the necessary steps to issue a compulsory license to guarantee supplies and protect the lives of millions of people.
“It is a public health emergency. Global North countries have previously taken similar measures, and South Africa should take these steps now,” added Thibela of Health GAP.
“Cheap politics and zero foresight will thwart global efforts for a proper rollout. South Africa was also one of the countries that contributed to the success of LEN-LA – and we should remember that HIV knows no borders, and that our fight for human rights is not for sale,” said Yvette Raphael, Co-founder of Advocacy for Prevention of HIV and Aids (APHA).
Global generic entry for local use is critical if Africa is to secure equitable access to lenacapavir.
“South Africa has domestic companies that can manufacture quality assured LEN-LA for domestic and regional use and to supply excluded countries. Gilead should either license such companies without territorial and other restrictions for LMICs and include full technology transfer, or the South African government should use its lawful powers to issue compulsory licenses,” said Tshabalala.
The country must step forward and show solidarity with countries excluded by the US government in its rollout announcement, and also by Gilead in its licensing arrangements, by supporting and including regions in Latin America and elsewhere, that like South Africa, participated in the very clinical trials that enabled Gilead to hold monopoly power, the group said.
The government must demand Gilead include additional African licensees with manufacturing capacity in its voluntary licensing arrangements, in the interests of fostering self-reliance.
“South Africa must also insist on and ensure that the Global Fund discloses the prices it will pay Gilead for the initial allocation, since public resources are implicated. Transparency is not negotiable, nor are our lives,” they added.
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