SANAC ADVANCES REGIONAL ACCESS TO LONG-ACTING HIV PREVENTION THROUGH LENACAPAVIR LICENSING INITIATIVE
- Karabo Makgato
South Africa is advancing efforts to secure a seventh voluntary licence for lenacapavir, a long-acting injectable medicine for HIV prevention. The initiative aims to expand regional manufacturing capacity and support sustainable access across Southern African Development Community (SADC) Member States.
The initiative was highlighted at the third Southern African HIV Clinicians Society (SAHCS) Long-Acting HIV Treatment and Prevention Conference, held at The Maslow in Sandton on 15 September 2026. The specialised one-day event brought together stakeholders from across the HIV response to discuss emerging long-acting antiretroviral (ARV) options for treatment and prevention.
Speaking at the conference, former SANAC Chief Executive Officer Dr Thembisile Xulu stressed that equitable access must remain central to HIV innovation. South African communities, researchers and young women played a significant role in generating evidence that demonstrated lenacapavir’s effectiveness. However, the absence of a voluntary manufacturing licence covering the region raised important questions about equity, participation and access to life-changing health innovations.
Dr Xulu said this concern prompted SANAC to coordinate a national effort involving the National Department of Health, the Department of Trade, Industry and Competition, National Treasury, the private sector and civil society to pursue an additional voluntary licence.
“Local manufacturing is not an end in itself, but fundamentally an access agenda,” she said. Regional production could strengthen security of supply, improve affordability, develop local pharmaceutical capabilities and contribute to the long-term sustainability of HIV prevention programmes.
SANAC continues to coordinate the initiative nationally, while regional demand aggregation is being advanced through the existing SADC Pooled Procurement Services (SPPS) platform. By using established structures, the initiative seeks to avoid creating parallel mechanisms.
Through an open, competitive and transparent process, South African manufacturers were invited to express interest in producing components of lenacapavir, including the injectable formulation, tablets and active pharmaceutical ingredient (API). Once the process was completed, the selected manufacturers were formally recommended to Gilead for consideration, enabling licensing discussions to proceed.
Through SPPS, SADC Member States are also being asked to provide country-level volume estimates. Aggregating regional demand will help establish the market certainty needed to support manufacturing and supply planning.
The initiative comes as long-acting HIV prevention options gain momentum globally. In July 2025, the World Health Organization recommended twice-yearly injectable lenacapavir as an additional HIV pre-exposure prophylaxis (PrEP) option, recognising its potential to expand prevention choices.
Conference discussions emphasized that scientific progress must now translate into effective implementation at scale. Expanding choice and autonomy for people accessing HIV services must be matched by health systems capable of delivering new prevention options efficiently, sustainably and equitably.