Would homegrown LEN cost more? Why SA should still make the HIV prevention jab

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South Africa wants to make the six-monthly HIV prevention injection, lenacapavir (LEN), on home soil. The question is whether we can do it quickly enough — and cheaply enough — for local manufacturing to help get the jab to more people.

LEN is near-perfect at preventing HIV for six months at a time.

That makes lenacapavir more than a test of HIV prevention. It is a test of South Africa’s ambition to manufacture more of the medicines Africa needs, while ensuring that access comes first.

South African researchers and trial participants helped generate the evidence showing that LEN can prevent HIV. The health department started rolling out the injection in June. Potential local manufacturers are also being assessed for a voluntary licence to produce generic versions in the country.

But wanting to manufacture a medicine locally and being able to make enough of it, at the right quality and price, are very different things.

If South Africa wants local production of LEN to improve access, we need to answer difficult questions now. Who will buy the locally made product? At what price? How much will manufacturers need to produce to make it viable? What technology and licensing will they need? And how quickly can this happen when lower-cost generics made elsewhere are expected from 2027?

The process has started. In July, the Deputy Health Minister Joe Phaahla announced that a committee convened by the South African National Aids Council (Sanac) and health department selected three South African manufacturers as potential candidates to make LEN and submitted the list to the injection’s developer, Gilead Sciences, for assessment and possible voluntary licensing. Sanac says that process will take between three and six months.

Any local arrangement will require technology transfer — giving manufacturers the knowledge and skills needed to make the product — as well as investment by the manufacturer and regulatory approval before locally made LEN can leave a production line.

A South African licence is also likely to differ from the six generic licences Gilead has already granted to manufacturers in Egypt, India and Pakistan. Those licences were designed to supply 120 low- and middle-income countries, including South Africa, from established generic manufacturing bases.

They require manufacturers to make LEN from start to finish, including its main ingredient, known as the active pharmaceutical ingredient, or API.

A South African licence would be more developmental: companies would not necessarily have to make the API themselves and could instead import it.

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.

But we need to be clear about what “local manufacturing” means, rather than confusing it with complete independence from global supply chains.

A shortlist of manufacturers is only the beginning.

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. It also needs to meet the production and registration requirements of the country’s medicines regulator, the South African Health Products Regulatory Authority, Sahpra.

Then come the practical steps: adapting a production line, testing and validating the manufacturing process, proving that the product remains safe and stable, training staff, passing inspections, registering the product and monitoring its safety once it is being used widely.

South Africa has regulatory experience, clinical trial expertise and a pharmaceutical manufacturing base. But none of this happens simply because local manufacturing is desirable.

An explainer on the LEN jab. The biggest risk is easy to predict: 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. If South African manufacturers can supply a regional market, particularly if countries combine their orders and buy together, the economics look very different.

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; we have around 134 000 new infections per year.

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. African countries could also join forces to place larger orders, which could help bring down the price.

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

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 (around R650) per person per year, South Africa will have to ask where a locally made product fits.

The answer should not be defensive. The fastest route to access may be to import affordable generics while local production is being developed.

Access and manufacturing are related goals, but they are not the same goal. People at risk of HIV should not have to wait for local production if safe, affordable products are available sooner.

At the same time, relying only on imports leaves South Africa and the region vulnerable to the next supply shock, pricing dispute or new medicine that takes too long to reach us.

Local manufacturing is worth pursuing because learning to make LEN could help South Africa make other important medicines locally in future, including for HIV, TB, STIs and future pandemics.

South Africa shouldn’t have to choose between getting LEN to people quickly and making it locally. We need to do both — without allowing local manufacturing to slow down access.

First, government should publish a realistic plan for how much LEN it expects to need and buy. Manufacturers need to know likely volumes, timelines and price expectations.

Communities need to know that LEN will be introduced as part of a broader package of HIV prevention options, rather than replacing existing choices.

Second, Gilead and its licensing partners should be clear about what South Africa will gain from a licence, including the knowledge and technology that will be shared with local manufacturers. A licence that initially allows only some parts of LEN production to happen locally could still be valuable. But over time, South African companies should be allowed to learn to do more of the work themselves.

An explainer on the LEN jab. Third, donors and organisations that buy medicines for African countries should help make local manufacturing work. If LEN made in Africa is safe, works well and is affordable, they should be willing to buy it. If it costs more at first, donors and governments will have to decide whether it is worth paying a little extra for a limited time to help build a reliable supply of medicines made in Africa.

Finally, Sahpra must have the resources it needs to move quickly without lowering its standards. Speed matters, but public trust depends on quality.

LEN gives South Africa a rare HIV prevention opportunity. A twice-yearly injection could help people who struggle with daily pills because of stigma, privacy concerns, transport costs, relationship dynamics or simply the difficulty of taking a pill every day.

But having the product will not, by itself, reduce HIV infections. Access will depend on price, procurement, trained health workers, community trust and services that reach the people who need LEN most.

South Africa helped prove that LEN works. The next question is whether we can make it affordable and widely available, while also strengthening our ability to make medicines in Africa.

Local manufacturing should not be used as a reason to delay access. Nor should getting affordable LEN in the short term become a reason to give up on local manufacturing.

The task is to do both: import affordable LEN when that is the fastest way to protect people now, while building the licensing, demand, financing and regulatory conditions that will allow South Africa to manufacture it for the region in the future.

That is the real LEN test. Not whether South Africa can announce an ambition, but whether it can turn that ambition into injections in clinics, a reliable supply for the region and a stronger medicines manufacturing base for the next breakthrough.

Prof Vinodh Aroon Edward is group chief operating officer at The Aurum Institute, where he helps to advance clinical research and health innovation across Africa. He has more than 20 years of experience in biotechnology and clinical research and has provided leadership in major international trials.

This story was produced by the Bhekisisa Centre for Health Journalism. Sign up for the newsletter.