On October 2nd, Gilead announced that it has signed voluntary licensing agreements with six companies for the production and supply of generic lenacapavir. These agreements come after pressure from civil society, following data from the PURPOSE 2 trial, which showed the potential of lenacapavir to prevent HIV cases.
Long-acting lenacapavir has proven to be a groundbreaking tool for pre-exposure prophylaxis (PrEP). Administered through an injection every six months, phase 3 clinical trials showed 100% efficacy in preventing new HIV cases in cisgender women and 99.9% efficacy in cisgender men, transgender men, transgender women, and non-binary people over 16 years old, outperforming daily oral treatments.
The licensing agreement covers the commercialization of the treatment in 120 low- and middle-income countries and includes a commitment to supply at cost price to these countries until the generic companies part of the agreement can start providing the medication. However, the details of these licenses reveal several negative points, such as the lack of transparency in the criteria for country inclusion and exclusion, excessive control over supply, and a lack of information on pricing.
Insufficient Country Coverage, Millions Left Behind
The limited territorial coverage of the license excludes numerous middle-income countries, especially in Latin America, which is largely left out of the agreement. Access to effective health technologies against HIV remains a challenge in the region, as demonstrated by the recent case of Colombia, which issued a compulsory license for dolutegravir, another essential treatment to combat HIV. Faced with a price of USD 1,224 per patient per year for this medication, Colombia had to resort to this tool, recognized under international law, to access generic versions after being excluded from the licensing agreement between the company holding the monopoly and the Medicines Patent Pool. Meanwhile, generic versions of the drug are sold in other parts of the region for as little as USD 44.
Leaving patients from middle-income countries behind hinders the achievement of global goals for 2030, which require tripling the current rate of reduction in HIV incidence. Pre-exposure prophylaxis (PrEP) with the new lenacapavir formulation could be key to achieving these goals, but no region of the world can be left out. The 12 excluded countries in Latin America represent more than two million people living with HIV. By excluding Brazil, Colombia, Mexico, and Venezuela alone, populations representing 7% of global HIV infections are left out.
It is also important to analyze the trend of HIV in these excluded areas: while globally, new infections have decreased by 39%, in Latin America, the trend has been the opposite, with a 9% increase. Additionally, 66% of these new infections occur in key populations that would greatly benefit from the use of lenacapavir as PrEP. Although the goal is to reach 2.3 million PrEP users in the region, only an estimated 204,000 people used PrEP at least once in 2023. These data show that Latin America is a priority region for accelerating the introduction of innovative PrEP to meet the targets set in the UNAIDS roadmap.
The Inclusion or Exclusion of Countries in the License Does Not Seem to Be Based on Public Health Criteria
Let’s take two upper-middle-income countries (UMIC) as examples: Vietnam, included in the license, and Peru, excluded. Peru has seen an 81% increase in infections since 2010, with 6,300 new infections in 2023, while Vietnam reported 6,100 new infections in 2023, with a 58% reduction since 2010. However, Vietnam has an opposition to Gilead’s lenacapavir patent that is still under review. The same goes for Thailand, India, and South Africa, countries included in the license, all with ongoing pre-grant patent opposition processes. The inclusion of these countries by Gilead has been pointed out by civil society as a strategy to disincentivize these necessary processes while presenting itself as a player concerned with global health.
Furthermore, several countries that participated in the PURPOSE2 clinical trial, such as Argentina, Brazil, Mexico, and Peru, have been excluded from the license. Excluding these countries is not only a public health issue but also an injustice: populations that contributed to the product's development through clinical trials should be able to access the benefits of the research, as recognized by the Declaration of Helsinki.
The License Text Increases Barriers to Global Access
In the details of the license clauses, we can see that Gilead maintains strict control over the supply of materials, especially the active ingredient, and over relationships with suppliers, prioritizing its own supply chain. This limits licensees' ability to choose suppliers or negotiate terms independently, something unusual in other agreements, such as those with the Medicines Patent Pool.
Additionally, Gilead imposes restrictions that make it difficult for generic companies to sell the medication to countries excluded from the license that issue a compulsory license to access the treatment. This complicates the implementation of compulsory licenses, recognized under international trade law, as generic licensees would be the best option to respond quickly to demand. As Dr. Melissa Barber, an expert in access to medicines, argues, these clauses represent a step backward, even compared to Gilead's stance in 2017, when it acknowledged the use of compulsory licenses in its agreement for sofosbuvir under the auspices of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement.
1. Compulsory license | 2. Voluntary license |
A compulsory license allows a government to authorize the production of a medication, even if it is patented, without the permission of the company holding the patent. This is done in emergency situations or when the medication is too expensive and necessary for public health. One example is when some countries produced HIV medications at lower prices without the companies' permission, in order to save lives. | A voluntary license, on the other hand, is when the company that owns the patent for a medication grants permission to another company (called the "licensee") to manufacture or sell it, under mutually agreed conditions. This is done to make medications more accessible to a wider population at affordable prices, as seen with medications for HIV or COVID-19 in resource-limited countries. |
No News on the Price or Conditions Under Which Generics Will Be Sold
The licensing agreement also does not specify clauses regarding the affordability of the medicines. Gilead’s only apparent interest is in knowing the net sales per country from the generic companies. Transparency cannot be solely a condition to protect private interests; it is essential to safeguard the public interest and ensure access to medicines as a right. This lack of approach to affordability contrasts with other agreements, such as the one signed between CSIC and the MPP, which included the following clause:
8.2. Licences and sublicences: “MPP and CSIC will discuss and agree upon the identities of interested and suitable Third Parties to whom MPP shall grant sublicences for the purposes of developing, fabricating and/or commercializing the Product. MPP will require in the sublicences that sublicensee(s) use commercially reasonable efforts to ensure that the Product(s) be made available in LMICs at affordable pricing.” |
According to Gilead’s press release, one of the priorities is to ensure that "prices allow for broad availability." However, no prices have been revealed for countries outside the license, nor how much the medication will cost in included countries until generics arrive. A recent study showed that it can be manufactured for as little as USD 40, while in Spain, Sunleca (the commercial name for lenacapavir) has a notified price of 40,443 euros.
Therefore, the license seems more aimed at maintaining Gilead’s position in the global market than genuinely caring about public health. Implementing a voluntary licensing policy risks becoming a mere public relations strategy if it does not ensure the affordability of treatments, includes more middle-income countries based on public health criteria, or restricts the exercise of rights established under the TRIPS Agreement.