South Africa: Would Homegrown LEN Cost More? Why SA Should Still Make the HIV Prevention Jab

South Africa aims to produce the six-monthly HIV prevention injection, lenacapavir (LEN), domestically. However, cheaper generic alternatives are anticipated from 2027. The initial focus should be on ensuring the jab reaches people promptly while South Africa builds the expertise to manufacture it locally. LEN is highly effective at preventing HIV for six months at a time and represents South Africa's ambition to manufacture essential medicines while prioritizing access.

South African researchers contributed to the evidence supporting LEN's HIV prevention capabilities, and the health department commenced its distribution in June. Potential local manufacturers are being evaluated for a voluntary license to produce generic versions of the injection in the country.

However, transitioning from wanting to manufacture a medicine locally to successfully producing enough of it at the right quality and price presents significant challenges. Key questions need to be addressed before local production can improve access, such as identifying potential buyers, determining pricing, assessing the necessary manufacturing volume, determining required technology and licensing, and estimating the time frame.

The process involves technology transfer, investment, regulatory approval, and a possible difference between a South African license and existing generic licenses granted to manufacturers in Egypt, India, and Pakistan. Local production may initially focus on establishing parts of the process, such as producing the finished injectable, packaging, or quality control, before potentially expanding to other stages.

To successfully produce LEN locally, manufacturers require a license with clear terms, access to technical knowledge, reliable ingredient supplies, stringent quality systems, and compliance with the South African Health Products Regulatory Authority's requirements. Practical steps include adapting production lines, testing manufacturing processes, validating safety, training staff, passing inspections, registering the product, and monitoring its safety once widely used.

South Africa possesses regulatory experience, clinical trial expertise, and a pharmaceutical manufacturing base. Still, converting this potential into reality depends on overcoming substantial hurdles. The primary risk is investing in local production capacity without a sufficient market to justify affordability.

The question extends beyond whether South Africa can manufacture LEN to determining whether enough of it will be purchased at a price that allows local production to be sustainable. While South Africa has a significant HIV prevention need, annual new infections reach around 134,000. However, government budgets are strained, and prevention programs already allocate resources to daily oral prevention pills, condoms, HIV testing, STI treatment, community outreach, and treatment.

Therefore, ensuring guaranteed demand for LEN is crucial; commercial success should not come at the expense of essential prevention methods already in use. Unitaid has shown interest in supporting local production through guaranteed demand, and governments can provide manufacturers with more certainty through national roll-out plans and purchase commitments.

Additionally, donors and large buyers, including the Global Fund to Fight AIDS, TB, and Malaria, can contribute by purchasing locally made LEN. African countries may collaborate to place larger orders, potentially reducing costs. Without predictable demand, local licensing might become a symbolic achievement rather than a practical means to enhance access.

Existing generic license holders have demonstrated the feasibility of producing LEN, but the ultimate success of local manufacturing hinges on addressing these critical challenges and securing sufficient demand.