South Africa is exploring the possibility of locally producing lenacapavir, a highly effective HIV prevention injection, to increase access to the medication. The injection, which provides six months of protection against HIV, has shown near-perfect efficacy in preventing the virus. The South African health department began rolling out the injection in June, and potential local manufacturers are being assessed for a voluntary license to produce generic versions.
A committee convened by the South African National Aids Council and the health department has shortlisted three local manufacturers to produce lenacapavir, which will be submitted to the injection's developer, Gilead Sciences, for assessment and possible voluntary licensing. The process is expected to take between three to six months. Any local arrangement will require technology transfer, investment by the manufacturer, and regulatory approval before locally made lenacapavir can be produced.
Local production of lenacapavir would likely start with parts of the process that can be established quickly, such as making the finished product, producing the sterile injectable, packaging, or quality control. However, a local license would differ from the six generic licenses Gilead has already granted to manufacturers in Egypt, India, and Pakistan, which require manufacturers to produce the active pharmaceutical ingredient. A South African license would be more developmental, allowing companies to import the ingredient.
To make lenacapavir locally, a manufacturer needs a license with clear terms, access to technical knowledge, reliable supplies of ingredients and materials, and strict quality systems. They must also meet production and registration requirements of the South African Health Products Regulatory Authority. The practical steps involved in local production include adapting a production line, testing and validating the manufacturing process, and training staff.
One of the biggest risks associated with local production is that a manufacturer invests in capacity, but the market is too small or uncertain to produce the medication affordably. If locally made lenacapavir is produced in small volumes only for South Africa, it may struggle to compete on price with large generic manufacturers supplying many countries. However, if South African manufacturers can supply a regional market, the economics look more favorable.
Demand for lenacapavir is a crucial factor in determining the viability of local production. South Africa has a significant HIV prevention need, with around 134,000 new infections per year. However, government budgets are under pressure, and prevention programs have to allocate resources to various initiatives. Guaranteed demand, such as through national roll-out plans and commitments to buy the product, can help manufacturers.
Timing is also a critical factor, as existing generic license holders are expected to start supplying lower-cost lenacapavir from 2027. If those products arrive quickly and are affordable, South Africa will need to assess the role of locally made lenacapavir. The goal should be to ensure access to the medication while developing local manufacturing capacity, rather than relying solely on imports or local production.
Key points
- Local production of lenacapavir could help South Africa make other important medicines locally in the future.
- Guaranteed demand is crucial to making local production of lenacapavir viable.
- South Africa should aim to balance access to lenacapavir with developing local manufacturing capacity.
