South Africa Pushes for Local Production of HIV Prevention Drug Lenacapavir

South Africa plans to locally produce the HIV prevention drug Lenacapavir by Gilead Sciences after criticism that its companies were excluded from earlier production licences. The government is seeking a local manufacturer to recommend for a voluntary licence, a move aimed at improving access to the drug across Africa.

South Africa is taking steps to begin local production of the HIV prevention drug Lenacapavir, developed by Gilead Sciences, after criticism that no South African pharmaceutical companies were included when the US drugmaker initially granted licences to manufacturers to produce the breakthrough treatment.
The government in Pretoria is now encouraging local pharmaceutical manufacturers to start a process that could allow the drug to be produced within the country. Lenacapavir is a long-acting injectable medication used for HIV prevention and is administered only twice a year, making it one of the most promising new tools in the global fight against HIV/AIDS. Officials say producing the drug locally would help improve access across the African continent, which remains the region most heavily affected by the HIV epidemic.
To achieve this goal, the South African government is working with international partners and health organisations to identify a domestic pharmaceutical company capable of manufacturing the drug safely and effectively while keeping it affordable. The selected company would need to meet strict quality standards and demonstrate that it has the capacity to produce the medication at scale. Once a suitable company is identified, the government plans to recommend it to Gilead for consideration under a voluntary licensing agreement.
In 2024, Gilead granted six voluntary licences to generic drug manufacturers in India, Egypt, and Pakistan. These licences allow the companies to produce and distribute lenacapavir to 120 low- and middle-income countries, including South Africa. However, the decision generated criticism from public health experts and policymakers because none of the licences were awarded to South African pharmaceutical companies despite the country’s large HIV treatment and prevention programmes.
If a South African manufacturer receives approval, it would become the seventh voluntary licence granted by Gilead. Expanding the number of manufacturers could increase the global supply of the drug and help lower costs, making it easier for governments and health organisations to distribute it widely. Many HIV and AIDS specialists believe lenacapavir has the potential to significantly reduce the number of new infections and could help bring an end to the global HIV/AIDS pandemic, which has lasted for more than 40 years.
Gilead has said it is open to granting an additional voluntary licence for manufacturing in Sub-Saharan Africa. The company stated that it will review proposals from potential manufacturers and evaluate whether they can meet the required safety, quality, and production standards before granting any new licence.
Paul Mashatile, South Africa’s deputy president and chair of the South African National AIDS Council, said producing the drug locally would benefit not only South Africa but also other countries across the region. According to him, establishing local production would help strengthen the availability of HIV prevention medicines and reduce reliance on imported drugs.
William Ruto, president of Kenya, has also emphasized the importance of increasing Africa’s pharmaceutical manufacturing capacity. He said African countries can no longer depend entirely on medicines produced elsewhere for diseases that affect their populations the most.
The effort to produce lenacapavir locally is part of a broader push by African governments and health leaders to strengthen the continent’s pharmaceutical industry. Expanding local manufacturing capacity could improve access to life-saving medicines, reduce costs, and ensure that major medical breakthroughs reach African communities faster and more reliably.