MSF Urges SA to Pursue Fair or Compulsory Licensing for Access to Breakthrough HIV Prevention Drug Lenacapavir

"Doctors Without Borders (MSF) notes South Africa’s interest in exploring local production of lenacapavir (a long-acting injectable HIV prevention drug) and welcomes its ambition to diversify and expand global manufacturing. However, for local production 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.

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 to issue a compulsory licence that would free local manufacturers from patent restrictions.

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."

On 5 March 2026, the South African government announced 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. The government has issued a call for expressions of interest to identify South African pharmaceutical companies with the capacity to produce lenacapavir.

HIV remains a key global public health challenge, with 1.3 million people becoming newly infected with HIV in 2023, with one 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. ​

Lenacapavir, a long-acting injectable, has been proven to be highly effective in preventing HIV in cisgendered women (100% effective -PURPOSE 1 study) and in gender-diverse people (96% effective - 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 (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). ​ ​

Currently, Gilead Sciences is the sole supplier of lenacapavir.

Gilead 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 (e.g., 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. ​

Gilead’-s voluntary licensing agreements also contain provisions that may limit the ability of generic manufacturers to expand supply beyond the designated territory. These include:

These restrictions may constrain the potential for broader regional manufacturing and supply, even in countries where patent barriers may not exist or where governments use public-health safeguards to address them.

MSF protests at the International AIDS Conference, asking for a price reduction for CAB-LA and LEN-LA. Photographer: MSF | Date: 23/07/2024 | Location: Germany

A pharmacy on site means clients can get everything they need at the time of their clinic visit. Photographer: Joanne Lillie | Date: 04/03/2025 | Location: Eswatini

A dose of CAB-LA - a long-acting injectable HIV pre-exposure prophylaxis - prepared for a client. Photographer: Joanne Lillie | Date: 04/03/2025 | Location: Eswatini

Jane Rabothata

Communications Specialist, Doctors Without Borders

• jane.rabothata@joburg.msf.org
• 0712873613

About Doctors Without Borders (MSF)

Doctors Without Borders (MSF) is a global network of principled medical and other professionals who specialise in medical humanitarian work, driven by our common humanity and guided by medical ethics. We strive to bring emergency medical care to people caught in conflicts, crises, and disasters in more than 70 countries worldwide.

In South Africa, we currently run a non-communicable diseases (NCDs) project in Butterworth, Eastern Cape province, where we support the Department of Health (DoH) in improving care for patients with diabetes and hypertension. The project focuses on improving screening, diagnosis, management, and prevention of NCDs through advocacy, research, health promotion, training, and mentorship of Community Healthcare Workers.

MSF is also recognised as one of the pioneers in providing antiretroviral treatment (ART) in the public sector. It started the first HIV programme in South Africa in 1999. The organisation's earlier interventions in the country have primarily been on developing new testing and treatment strategies for HIV/AIDS and Tuberculosis (TB) in Eshowe (Kwa-Zulu Natal) and Khayelitsha (Western Cape). The Eshowe project was handed over to DoH in 2023 after 12 years of operations. The Khayelitsha project was closed in 2020 after 22 years of activities and campaigning for improved HIV and TB treatment.

Other projects we have been involved in include our Migrant Project in the country's capital, Tshwane, which was handed over to authorities and a local Community-Based Organisation after building the capacity to work with undocumented populations. We also previously offered free, high-quality, and confidential medical care to survivors of sexual and gender-based violence in Rustenburg, North West province.

To learn more about our work in South Africa, please visit this page on our website (www.msf.org.za). To support MSF’s work: