Global health advocates have intensified pressure on Gilead Sciences to extend access to its long-acting injectable HIV prevention medicine, lenacapavir, at a generic price of $40 per person per year.
They have also warned that the current licensing framework entrenches inequities in prevention programmes.
The drug, administered twice annually, has been endorsed by the World Health Organisation for all populations at risk of HIV infection after clinical trials that demonstrated superior efficacy compared to daily oral pre-exposure prophylaxis.
Gilead has entered into voluntary licensing agreements with Indian manufacturers Dr Reddy’s and Hetero to supply the product at $40 a year from 2027 — but the licence applies only to 115 low and middle-income countries.
Twenty-six countries, including Argentina, Brazil, Mexico and Peru, are excluded despite their participation in pivotal trials.
Civil society organisations argue that this selective licensing undermined the principle of equitable access to essential medicines, a principle recognised in the Doha Declaration on the Trips Agreement and Public Health, and reflected in section 27 of the SA constitution, which guarantees the right of access to healthcare services.
The pricing disparity is stark. While generic manufacturers have indicated that production costs could be as low as $25 per year, Gilead’s “access price” has been set at $100 per year, with the US market price exceeding $28,000 annually.
Activist groups including Health GAP, the International Treatment Preparedness Coalition and Public Citizen have initiated patent oppositions and compulsory licence requests in several jurisdictions.
Leveraging WTO Trips
These actions are grounded in provisions of the WTO Trips Agreement, which allow member states to issue compulsory licences in the interest of public health, and mirror earlier legal strategies that enabled the scale-up of affordable antiretroviral therapy in the early 2000s.
The political dimension is equally significant. The US Congress appropriated $2.3bn under the President’s Emergency Plan for Aids Relief (Pepfar) in the 2026 fiscal year to support the procurement of long-acting PrEP.
However, the Trump administration has withheld disbursement, citing a review of programme priorities. This decision has delayed procurement and limited the ability of donor-funded initiatives to expand access.
Current donor plans envisage reaching 2-million people in nine to 12 countries over three years, far short of the estimated 20-million people in need of PrEP globally.
Parliamentary oversight bodies in several jurisdictions have begun to scrutinise the implications of these delays.
The portfolio committee on health has noted that the exclusion of middle-income countries from licensing arrangements may worsen regional disparities in HIV prevention, particularly in Southern Africa where incidence remains high.
Members have raised questions regarding the alignment of Gilead’s licensing practices with the objectives of the national strategic plan on HIV, TB and STIs, and the state’s constitutional obligation to take reasonable measures to progressively realise the right to health.
The Health Justice Initiative has cautioned that “science alone does not end epidemics — access does”, underscoring the need for co-ordinated legal, financial and administrative measures.
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