TWN Info Service on Health Issues (Dec24/03)
19 December 2024
Third World Network

Health: Activists demand for expansion of access to Lenacapavir

Rio de Janeiro, 19 Dec (Rajnia de Vito) – On this year’s World AIDS Day (1 December), a global coalition of activists, public health advocates, and civil society organizations launched a regional and a global campaign for access to Lenacapavir.

They rejected the practices of  Gilead Sciences, Lenacapavir's originator, such as restrictive pricing and licensing. Activists called for urgent reforms to ensure equitable access to this game-changing medication, especially in regions most affected by the HIV epidemic.

Lenacapavir, a biannual injection, has shown near-100% efficacy in preventing HIV infections during clinical trials. Phase 3 clinical trials showed 100% efficacy in preventing new cases of HIV in cisgender women and 99.9% efficacy in cisgender men, transgender men, transgender women and non-binary people over 16 years of age, outperforming daily oral treatments.

Despite its revolutionary potential, Gilead’s product is priced at $42,250 per year per patient. Asia Russel, director of Health Gap, said it is a paradox. “1.3 million new HIV infections are occurring every year, as well as an AIDS death every minute… while this new revolutionary long-acting HIV prevention technology at the staggering price of $42,250 by Gilead, has proven to be virtually 100% efficacious in clinical trial settings in stopping new HIV acquisitions”.

Apart from the efficacy of Lenacapavir in HIV, it fills an unmet need in HIV/AIDS response i.e. the use in prevention of HIV infection.  According to Professor François Venter, while HIV/AIDS treatment has been deployed and developed through the years with some success, prevention from infections is a key aspect that has been lagging. The world now has Lenacapavir as an effective prevention tool but it requires access at scale. “We need huge amounts of this drug now to be pumped into the system so that we can finally end HIV. And that we can finally say on World AIDS Day that we are making decent progress", said Venter.

However, scaling up does not seem to be in Gilead's plans. To address the public condemnation of its pricing policy and Lenacapavir's patents being disputed in some countries, Gilead announced voluntary licenses to facilitate generic production. However, these licenses are very restrictive, with strict conditions for licensees and a narrow scope, with only six generic manufacturers in India, the United States, Pakistan and Egypt covering 120 low- and lower-middle-income countries.

(Upper middle income countries are habitually excluded from voluntary licenses even though they often have among the highest disease burden with their larger populations as a total of world population.)

Latin America, a region excluded from the voluntary license despite hosting Lenacapavir’s clinical trials, exemplifies the inequity. The region has a rising trend in new HIV infections and hosted clinical trials for Lenacapavir. Veriano Terto Jr, vice-president of the Brazilian AIDS Interdisciplinary Association, was adamant: “It infringes the law on the use of the medication. It violates some very basic ethical issues to keep out people from the benefits of studies, especially when they are carried out in their communities, in their countries.”

Terto also highlighted the need for Lenacapavir in a country like Brazil, where the rollout of pre-exposure prophylaxis (PrEP) has not been picked up, and where about 40% of people enrolled in the program end up dropping out.

However, Gilead's patents in several countries in the region will last until 2037 and therefore the generic version can be introduced only after more 13 years, unless there is a compulsory license.

In response, a group of Latin American organizations led by People's Medicine Alliance, Public Citizen and the International Treatment Preparedness Coalition called on Gilead to expand its voluntary license to cover all of the region. Javier Llamoza, representing the People's Medicine Alliance, underscored Peru's vulnerable position in accessing essential medicines. "Peru is consistently excluded from voluntary licensing agreements. This issue is particularly concerning given that the country allocates only about 3.5% of its GDP to healthcare—well below the PAHO's recommended average. This low investment underscores the critical need for the efficient use of Peru's limited public resources," he emphasized.

(PAHO is the Pan American Health Organization, a specialized international health agency for the Americas and serves as the Regional Office for the Americas of the World Health Organization.)

Issues with Gilead's license

Sangeeta Shashikant, intellectual property programme coordinator at the Third World Network, is critical of the license. “Every aspect of production and supply is actually controlled by Gilead. There are even draconian anti-diversion clauses. We should not expect access through this voluntary license".

She said it is a strategy to delay the entry of generic versions into the market, an exemplary case of patent evergreening, particularly because it involves key countries with generic manufacturing capacity like Indonesia, India, South Africa and Thailand. "Gilead has filed many different frivolous patent claims on pharmaceutical forms such as salt forms, which are generally considered to be known and non-inventive ... This is an abuse of the patent system”.

(Evergreening patents are patents given in addition to a compound or molecule patent, for changes that are trivial or non-inventive, often with no additional therapeutic value. These extend patent monopolies beyond the first 20 years for compounds, and each additional or secondary patent is for another 20 years.) 

Further, a voluntary license puts various restrictions on supply to countries excluded from the voluntary license. These restrictions would undermine supply of  Lenacapavir to countries using compulsory licenses, compassionate use and parallel importation through the anti-diversion clause. It also imposes stringent control over the production, sourcing, and distribution of raw materials and final products.

Fatima Hassan, director of Health Justice Initiative (South Africa), called attention to another strategy Gilead is known to use. Gilead has been spreading news that this license was designed in consultation with civil society and activists groups. “We’d like to know who Gilead has consulted, because we don’t believe that civil society has actually supported this. I think it’s a self-serving narrative being created by Gilead to try and deflect (protests)".

In response, a global coalition led by Health Justice Initiative, Health GAP, the Brazilian Interdisciplinary AIDS Association and Just Treatment is also urging governments in high-burden countries such as South Africa, Brazil, and India, to take proactive measures. They recommend measures including compulsory licensing and local production to circumvent Gilead’s restrictive agreements and accelerate access. “Compulsory licensing is a legal and ethical right. Advocating for it is not radicalism; it is just justice", concluded Veriano Terto.

(Compulsory licensing is one of several flexibilities in the Trade-related Aspects of Intellectual Property Rights Agreement administered by the World Trade Organization, within the legal right of countries to use.)

The coalition published a communication to Gilead outlining the following demands: expand licensing to all high-burden countries, remove restrictions on generic manufacturing, and ensure affordable pricing. They call for a single, affordable global price for Lenacapavir, rejecting tiered pricing models that perpetuate inequality.

If Gilead fails to act, the coalition is prepared to escalate its campaign, including potential legal action at the national and international level.