By Marcus Moloko
South Africa’s registration of Lenacapavir (LEN) marks a significant milestone in the country’s fight against HIV and AIDS.
The South African Health Products Regulatory Authority (SAHPRA) recently announced the registration of Lenacapavir, making South Africa the first country on the continent to approve the twice-a-year anti-HIV injection.
Gilead Sciences, the drug manufacturer, has excluded South Africa from the licensing agreement, citing technical specifications as justification. The exclusion means the country must rely on imported versions of LEN, which are often priced above public health budgets.
This also prevents South Africa from developing domestic capacity to produce and distribute the drug at scale, thereby hindering the creation of a resilient healthcare system.
Two weeks ago, Health Minister Dr Aaron Motsoaledi, speaking at the national roundtable, announced that South Africa planned to launch Lenacapavir in March 2026.
While Motsoaledi highlighted the drug’s potential to address critical gaps in current HIV prevention methods, the Economic Freedom Fighters (EFF) have said that South Africa has been excluded from licensing agreements that would allow local generic manufacturers to produce the drug.
This raises urgent questions about pharmaceutical equity and long-term sustainability, the party said in a statement.
The EFF condemned the exclusion and called it “a modern form of pharmaceutical exploitation and a continuation of the colonial logic that uses African bodies for research while denying African’s the right to manufacture and benefit from outcomes of that research”.
While the registration of LEN is a step forward, the EFF warns against celebrating short-term access without addressing long-term sustainability.
The party argues that relying on imported medication creates dependency and leaves the country vulnerable to supply chain disruptions and other geopolitical pressures.
It called for government action to ensure local production of LEN, even if it requires upgrading manufacturing systems.
The approach would not only reduce costs while improving access, but would also strengthen the country’s position in the global pharmaceutical landscape.
Meanwhile, SAHPRA stated that the review process was done in collaboration with the European Medicines for all (EU-M4all) procedure.
“This procedure enables the European Medicines Agency, together with the participating regulatory authorities, to provide scientific opinions on high-priority medicines, such as Lenacapavir, intended for markets outside the European Union.
“The benefits of this pathway are to strengthen regulatory systems and accelerate access to essential medicines,” the watchdog explained.
Motsoaledi has confirmed plans to integrate Lenacapavir into domestic financing mechanisms, aiming for routine funding after two years.
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