How South Africa can help secure immediate, global access to HIV prevention drug lenacapavir

One injection of lenacapavir every six months stopped 100% of new HIV infections among straight women and girls and cut the infection risk of gender diverse people older than 16 by 96%. This is according to data presented at the 5th HIV Research for Prevention Conference (HIVR4P) in Peru this month. 

This HIV prevention jab is a game-changer. It works much better than daily oral pre-exposure prophylaxis (PrEP) pills and holds enormous potential to change the course of the epidemic. Unfortunately, a deeply flawed licensing deal means only 120 governments will be able to buy cheaper versions of the injections from six generic manufacturers, and only in three years. 

South Africa is on this list of 120 and on a second list of 18 countries for whom Gilead will prioritise registration of the drug once it’s ready for the market. 

Even though South Africa got the sweet end of a bitter, colonial-era deal, we believe the country should issue a compulsory licence for the generic manufacture of lenacapavir and encourage other middle-income countries to do the same. A compulsory licence allows governments to override a company’s patent protections with a royalty payment during a health crisis.   

The best time to lead such a multicountry push is right now, in the lead-up to the G20 Summit, which will be hosted by Brazil on 18 and 19 November. Politico reports that medicines access, technology transfer and local manufacturing are already on Brazil’s to-do list for the event. 

South Africa and Brazil have both challenged pharmaceutical industry greed before. Brazil led the way in changing how the world responded to Aids at the height of the treatment access crisis of the late Nineties and early 2000s by making generic ARVs available. 

The world needs that bold moral courage now. These countries must work together to ensure access to lenacapavir, on behalf of all the nations that Gilead has excluded. 

It’s a move that will signal to other countries to step up, defy monopoly power and overturn the unjust prevention inequities that are driving the HIV epidemic. 

We need global action that is equal to the extraordinary promise of lenacapavir, and solidarity starts at home. 

Don’t be fooled by “the list” – 120 countries is not enough

The deals Gilead signed with generics companies are not as generous as they may appear. 

Until generics are available, South Africa will have to buy lenacapavir from the company at an “access price” that is yet to be disclosed. Other countries in Latin America and Asia excluded from the list seem to be ineligible for the access price.

The list of 120 countries also excludes many middle-income nations where new HIV infections are high and growing quickly. 

In India, many major HIV drugmakers (such as Cipla) that can already make the active ingredient in lenacapavir were not included in the Gilead deal, according to Médecins Sans Frontières (MSF).  

Gilead even shut the door on four countries (Mexico, Peru, Brazil and Argentina) where more than half of PURPOSE 2 trial participants live, according to a presentation about the trial at HIVR4P.   

Now Gilead will use the data generated by communities in these countries to rake in profit from high-income countries while pricing the medicine out of reach for them and the other excluded nations. 

This we know from a template deal shared by the pharmaceutical company, which includes an anti-diversion clause that blocks the six generic manufacturers from selling their cheaper injections to countries that have been excluded by Gilead.

Even if an excluded country like Peru were to issue a compulsory licence to override Gilead’s patent, the country could not import lenacapavir from the six companies who have the royalty-free deals. 

There are scores more generic manufacturers who aren’t bound by this and could contribute cheaper medicines, but only if their governments issued compulsory licences. 

Rather than rely on this unethical and fatally flawed voluntary licensing scheme, communities in India, Indonesia, Brazil and Thailand are opposing Gilead’s lenacapavir patents. 

South Africa, meanwhile, has been silent, despite its push for medicines access at the World Trade Organization during the Covid pandemic.

Patent oppositions are not an option under South Africa’s outdated, apartheid-era intellectual property system. But the government could spark a movement that determines whether we bend the global curve of new HIV infections or continue on the current path. 

Not a second to lose