Civil society organizations across the Global South are blasting the U.S.-based pharmaceutical company Gilead Sciences for its lenacapavir (LEN) voluntary license (VL), which allows six pharmaceutical manufacturers to make and sell generic LEN in 120 countries. All other countries must purchase LEN from Gilead, at whatever price the company chooses to set, because the generics manufacturers that signed the VL can only sell LEN to the 120 countries included in the VL.
LEN is a groundbreaking, long-acting method of HIV prevention, given as twice-yearly injections. It has prevented nearly all HIV infections in two phase III clinical trials, and it could prevent millions of new HIV infections, if it was affordable and available everywhere. However, public health experts from the Global South have stated the VL will make the drug inaccessible to some people who need it the most, despite claims from Gilead that its VL would “enable broad, sustainable access to lenacapavir … and align(s) with Gilead’s vision of ending the HIV epidemic for everyone, everywhere.”
Gilead’s VL will prevent millions of people, including those most vulnerable to HIV, from accessing LEN in low- and middle-income countries (LMIC) such as Algeria, Argentina, Brazil, Colombia, El Salvador, Guatemala, Peru, and Malaysia, among others. UNAIDS called this exclusion “deeply worrying,” since these and other countries which Gilead has excluded from the VL must pay whatever Gilead demands for LEN. The price is likely to be far too high, making it inaccessible from those who could benefit from the drug. In the US, where LEN is approved as part of treatment for multidrug-resistant HIV, Gilead charges over USD $40,000 per person per year for the drug.
Notably, Brazil was excluded from the VL, despite the country’s contributions to clinical trials. Although the World Bank classifies Brazil as an upper-middle-income country, the Brazilian Interdisciplinary AIDS Association (ABIA) states that this ignores Brazil’s deep socio-economic inequalities.
Brazil contributed to the clinical development of LEN by hosting the PURPOSE-2 trial. According to the Declaration of Helsinki, companies that conduct clinical trials should have a plan to ensure they benefit the communities where they are conducted. But drug companies often limit the benefits to the people who participate in trials for a limited amount of time. “I think it’s perverse that Brazil contributed to clinical trials and we are not even considered in the VL,” commented Veriano Terto Jr., Vice President of ABIA. “Our bodies served in these clinical trials and we are not even being [included]. Gilead should reconsider this in an act of solidarity.”
As Timothy Wafula, Programme Manager with the Kenya Legal & Ethical Issues Network on HIV and AIDS (KELIN) explained, excluding nearly half of all countries from the VL “directly undermines the progress aimed to make equitable healthcare access.” He added that excluding key LMICs from the LEN VL “worsens existing health disparities by denying people access to a powerful HIV prevention and treatment tool, particularly where healthcare access gaps are widest.”
Global health experts and civil society organizations agree that access to effective, long-acting HIV prevention is already limited, and that equitable access to LEN would be a gamechanger.
Over 30 million people worldwide take HIV treatment every day. By limiting access in excluded countries to a prevention method that could change lives, the VL goes against the principle of fair and equal access.
Othmane Marrakchi, Advocacy Officer at ITPC-MENA, Morocco, stated that people in Algeria, Lebanon, Jordan, Iran and Iraq will not have access to LEN, since these countries are excluded from Gilead’s VL. “These restrictions hinder progress in HIV prevention throughout the region,” he shared.
“We are talking about a twice-yearly dosing,” said Marrakchi. “This is revolutionary and could end many struggles people face with HIV. If lenacapavir were easily accessible … it could truly change lives. With just two doses a year, it would be much easier for people to prevent HIV, especially those with limited access to regular healthcare. This could lower new HIV cases and improve the lives of people at risk,” he said.
Instead, the VL will create a gap in technology, excluding middle-income countries from accessing groundbreaking long-lasting treatments, said Othoman Mellouk, who is the Access to Diagnostics & Medicines Lead at the International Treatment Preparedness Coalition. “We will have rich and poor countries who will access them [technology] and in the middle, we will have people who will never have access until the patent expires in 20 years. If we don’t pay attention we will create this gap.”
Poor choice of manufacturers
Civil society organizations have been united in calls for Gilead to expand the geographic scope of the VL and the number of manufacturers who are included in it. Gilead granted licenses to only six manufacturers to make and sell generic LEN – none of which are in Sub-Saharan Africa, which bears the world’s highest burden of HIV. Public health advocates say they are troubled by Gilead’s decision not to grant a license to manufacturers in Sub-Saharan Africa.
“By relying entirely on manufacturers outside of Sub-Saharan Africa, the VL risks slowing access to LEN in Africa, and perpetuates over-dependence on external suppliers with limited understanding of local needs. Local production could drastically reduce costs, improve supply chain resilience and ensure that the treatment reaches those who need it with minimal delays,” said Wafula.
UNAIDS has stated that manufacturing LEN in African countries with the highest HIV rates is crucial for sustainability, and urged Gilead to include manufacturers in countries with strong production capacity, such as South Africa. “If we really want to boost [medication] production in Africa, we should see two or three manufacturers in Africa,” said Mellouk.
Global solidarity against the VL
Although Thailand is included in the LEN VL, the Thai Network of People Living with HIV/AIDS (TNP+) still expressed opposition to it. “TNP+ decided to join the global movement on patent oppositions, because the [Gilead’s] patent applications are unmerited and do not meet patentability criteria,” said Chalermsak Kittitrakul, TNP+’s Project Manager for Access to Medicines.
Marrakchi explained that countries in the Global South oppose Gilead’s LEN VL, due to the inequity perpetuated by the license, which “exploits communities in one part of the world to justify restrictions in others. Gilead’s ‘access strategy’ claims to support access by including nearly all of Africa in the license, but we, as African advocates, say ‘not in our name.’ We don’t support being used as proof of Gilead’s goodwill when people in Latin America, Asia and MENA are left without access to LEN,” he said. “HIV knows no borders, so why should life-saving products have them?”
Advocates maintain that creating equitable health solutions and increasing accessibility of promising long-lasting HIV drugs such as LEN can support the UN goal of ending AIDS by 2030.
For more information on this issue, please refer to statements by the following organizations regarding Gilead’s voluntary license of lenacapavir: