South Africa is seeking to produce Gilead Sciences’ long-acting HIV prevention drug, lenacapavir, locally after criticism that no South African pharmaceutical companies were included when the US drugmaker first licensed manufacturers to produce the breakthrough treatment.

Pretoria is now asking domestic drugmakers to begin a process that could allow the twice-yearly HIV prevention injection to be manufactured in the country, in a push to bring production closer to the region most affected by the epidemic.

The government is working with international partners to identify a local company capable of producing the drug safely, effectively, and affordably. The selected company would then be recommended to Gilead for a potential voluntary licence.

Gilead, a US pharmaceutical company, granted six voluntary licences in 2024 to generic manufacturers across India, Egypt, and Pakistan to produce and supply the drug to 120 low- and middle-income countries, including South Africa. There was criticism that no South African drugmakers were included.

Increased access

A licence for a South African company would be the seventh such deal, potentially boosting access to a drug many HIV/AIDS experts have said could help bring an end to the 44-year-old pandemic by slashing the number of new infections.

Gilead said it has been open to adding an additional voluntary license for local manufacturing in Sub-Saharan Africa. "Gilead will review the proposals and assess whether required quality standards can be met before any voluntary license is granted," the company said in an email.

Paul Mashatile, chair of the South African National AIDS Council and deputy president, said making the drug in South Africa would benefit the whole region.

Kenyan President William Ruto also says, “Africa can no longer rely on medicines produced elsewhere for diseases that affect us most.”