South Africa Balances Local HIV Jab Production, Cost Challenges

South Africa has shortlisted three local manufacturers to potentially produce the six-monthly HIV prevention injection, lenacapavir (LEN). But making LEN locally will take time, and cheaper generic versions from other countries are expected by 2027.

The challenge is how South Africa can achieve both goals: ensure timely access to the injection while also building local manufacturing capacity to reduce reliance on imported medicines.

The Promise and Challenges of Local Manufacturing

LEN is highly effective at preventing HIV for six months at a time. The health department began rolling out the injection in June, and potential local manufacturers are being assessed for voluntary licenses to produce generic versions.

However, the ability to manufacture a medicine locally and produce it in sufficient quantities, at the right quality and price, are distinct challenges. Vinodh Aroon Edward from the Aurum Institute emphasizes that South Africa must address critical questions: Who will buy the locally made product? At what price? How much production is needed for viability? What technology and licensing are required? And how quickly can this be achieved before cheaper generics become available?

Local Manufacturers Shortlisted for LEN Production

The list was submitted to Gilead Sciences, the injection’s developer, for assessment and possible voluntary licensing.

Local manufacturing will require technology transfer, investment by manufacturers, and regulatory approval. The process is expected to take three to six months.

Local production would probably start with parts of the process that can be established fastest, such as making the finished product, producing the sterile injectable, packaging, or quality control.

To make LEN locally, a manufacturer needs a licence with clear terms, access to the technical knowledge needed to make the product, reliable supplies of ingredients and materials, and strict quality systems for producing a long-acting injection.

The biggest risk is that a manufacturer invests in the capacity to make LEN, but the market is too small or uncertain to produce it affordably. If locally made LEN is produced in small volumes only for South Africa, it may struggle to compete on price with large generic manufacturers supplying many countries.

Challenges in Local Manufacturing and Market Viability

The question, then, is not only whether South Africa can make LEN. It is whether enough of it will be bought, at a price that allows local production to survive.

South Africa’s HIV prevention needs are large. But government budgets are under pressure, and prevention programmes already have to pay for a daily HIV prevention pill, condoms, HIV testing, sexually transmitted infection (STI) services, community outreach and treatment.

LEN should expand people’s choices; it should not drain resources from prevention methods people already use. That is why guaranteed demand matters, which Unitaid has indicated it would be prepared to help with.

Governments can give manufacturers more certainty about demand through national roll-out plans and commitments to buy the product. Donors and large buyers, including the Global Fund to Fight Aids, TB and Malaria, can help by buying LEN made in Africa.

Without predictable demand, a local licence risks becoming a symbolic victory rather than a practical way to expand access.

Balancing Local Production with Imported Generics

Timing is the hardest question. Existing generic licence holders are expected to start supplying lower-cost LEN from 2027, subject to regulatory approval. If those products arrive quickly and cost around the projected $40 (R650) per person per year, South Africa will have to ask where a locally made product fits.

The answer should not just be about price. Relying only on imports leaves South Africa vulnerable to supply shocks, pricing disputes, or delays in accessing new medicines. Local manufacturing is valuable because it can help South Africa produce other essential medicines in the future, including those for HIV, TB, STIs, and future pandemics.

First, the government should publish a realistic plan for expected LEN needs and purchases. Manufacturers need clarity on volumes, timelines, and price expectations. Communities need assurance that LEN will complement, not replace, existing HIV prevention options.

Second, Gilead and its licensing partners should clarify what South Africa will gain from a license, including the knowledge and technology shared with local manufacturers.

If LEN made in Africa is safe, effective, and affordable, they should be willing to purchase it.

Finally, Sahpra must have the resources to act quickly without compromising standards. Speed is important, but public trust depends on quality.

Ensuring Access and Building Manufacturing Capacity

LEN offers South Africa a unique HIV prevention opportunity. A twice-yearly injection could benefit those who struggle with daily pills due to various reasons. However, having the product alone won’t reduce HIV infections. Access depends on price, procurement, trained health workers, community trust, and services reaching those most in need.

South Africa helped prove LEN’s effectiveness. The next challenge is making it affordable and widely available while strengthening Africa’s medicine manufacturing capacity.

The real test for LEN is not just announcing an ambition but turning it into injections in clinics, a reliable regional supply, and a stronger medicines manufacturing base for future breakthroughs.

Balancing Immediate Access and Long-Term Manufacturing Goals

South Africa faces a decision between importing affordable generics of the HIV prevention injection LEN and developing local production. While local manufacturing is a goal, it should not delay access to the medication. The fastest way to protect people now may be to import generics, ensuring the injection reaches those who need it without delay. This approach prioritizes immediate health needs while laying the groundwork for future local production.