Brook K. Baker, Professor Emeritus Northeastern U. School of Law
David Deakin, MBA; BA(Hons), Independent Access Advocate
AIDS activists, researchers, and service providers are challenging Gilead’s decision to enter into narrow, bilateral voluntary licenses for its long-acting antiretroviral, lenacapavir (LEN-LA), instead of licensing much more broadly and openly with the Medicines Patent Pool (MPP). They also protest Gilead’s intention to delay seeking regulatory approval for LEN-LA’s pre-exposure prophylaxis (PrEP) use and to sell LEN-LA on an undisclosed tiered-pricing basis that will predictably prioritize commercial returns rather than access.
Lenacapavir, which is already authorized for salvage-therapy treatment, has shown 100% efficacy in Gilead’s Purpose-1 clinical trial as a twice-a-year PrEP injection in cis-gender young women, a high-risk group in Africa. Given efficacy in this highly vulnerable group of women, Gilead should seek regulatory approval for PrEP in this population instead of waiting, as planned, for results from its Purpose-2 trial focusing people who have receptive anal intercourse with men. Gilead’s price per person per year in the U.S. is over $40,000, even though new research shows that generic producers reaching economies-of-scale could make and sell LEN-LA with a 30% profit for only $40 per person per year or even less.
Gilead has stopped negotiating with the MPP and instead announced that it will license bilaterally with pre-selected generic companies to supply only high incidence, low-resource countries. Such licenses would limit the number of competitors and exclude most countries in Latin America, Eastern Europe and Central Asia, and the Middle East and North Africa; some Southeast Asian countries might be excluded as well. These exclusions will allow Gilead to pursue commercial returns that satisfy shareholders while thwarting access. These geographic limitations would be particularly devasting if LEN is PrEP-approved for key-populations, as expected. Fully 55% of new HIV infections in 2023 occurred in men-who-have-sex-with men, transgender women, sex workers, people who inject drugs, and their sex partners, many of whom live in excluded upper-middle-income countries (U-MICs) where nearly 41% of new global infections occurred 80% of which were in key populations. Far from covering the vast majority of adults at high risk of becoming infected, Gilead’s proposed bilateral licenses will foreseeably exclude millions of people who are most vulnerable to infection.
Instead of licensing restrictively and bilaterally, Gilead should commit to immediately entering into a comprehensive and broadest-possible license with the MPP, which can begin to work with generic licensees to expedite development, registration, and marketing of generic LEN-LA. Gilead must take further action do other things to speed up the path to equitable access. First, its MPP license should permit use of pending, current and future patents, trade secrets, and regulatory data and should permit licensees to supply any excluded country that issues a compulsory license or does not have granted patent in place (regardless of licensee receipt of trade-secret protected know-how). To support rapid entry of generic licensees, Gilead should make comparator LEN-LA available for bioequivalence studies on a cost-plus basis. In addition to rapidly filing with the US FDA and EMA for PrEP even before the conclusion of Purpose-2, Gilead should file quickly for WHO prequalification and authorize use of WHO Collaborative Registration procedures to accelerate approval by national regulatory authorities. Gilead should also register LEN-LA broadly in LMICs so the path to reference or reliance registration is free and clear. For the purpose of transparency and national planning, Gilead should publish and update its patent and regulatory landscapes. All licenses should be published in full.
During the interim, before generic supplies are available, Gilead should renounce profiteering and commit to cost-plus pricing in LMICs and equitable allocation based on need without prioritizing supplies to higher-priced and more profitable markets.
Community activists also continue to protest ViiV’s licenses with the MPP for its groundbreaking antiretroviral, dolutegravir (DTG). Despite those licenses covering 94% of the HIV-infected adults and 99% of infected children and DTG-based regimens now reaching 24 million people-living-with-HIV, the licenses can still be improved. Because ViiV initially failed to license dolutegravir (DTG) for use in all middle-income countries except those in sub-Saharan Africa in its 2014 adult and pediatric licenses, AIDS activists pressured it to do, including by mounting compulsory licensing campaigns. ViiV entered into a series of amended licensing agreements (2016, 2018, and 2020) when it expanded the licensed territory to include previously excluded and newly eligible lower-middle-income countries regardless of patent status (Algeria, Armenia, Moldova, Mongolia, Morocco, Tunisia, and Ukraine).
Fortunately, pursuant to a license provision allowing generic supply to countries where patents had not been filed, 34 U-MICs have been able to procure over 280 million packs of generic DTG regimens from MPP licensees (MPP letter, 20 July 2024), but other U-MICs where patents had been filed have largely been unable to do so. Under pressure, ViiV entered into a bilateral agreement with Brazil concerning local production of DTG; it also addressed a subset of excluded U-MICs in November 2020 when it entered into a license agreement covering the four non-sub-Saharan Africa U-MICs, Azerbaijan, Belarus, Kazakhstan, and Malaysia. This license was based on a new royalty scheme that had higher than normal royalty rates but which were reduced as governments procured higher volumes to treat more people. These royalty/quantity pricing terms were agreed to by government and civil society stakeholders when the license was negotiated as the countries preferred to be freed from ViiV’s ten-times-higher, tiered prices that had resulted in almost no coverage. With quantity discounts, prices are more than 90% cheaper than the unilateral tiered prices ViiV had previously charged but still estimated to be four-five times more expensive than the Global Fund generic price of $37 per person per year. Moreover, ViiV requires secrecy/non-disclosure of royalty terms.
After a slow start, scale-up in the four countries has accelerated. The governments have now procured sufficient quantities to support the following coverage rates by the end of 2024: 78% in Belarus, 86% in Kazakhstan, and 65% in Azerbaijan; but problems remain. ViiV still continues to enforce non-disclosure of royalty terms, even though its purported reason of wanting to see whether tiered and roll-out-dependent royalties could lead to government uptake and expanded access has been satisfied. Given the recent success in country uptake, there is no longer any justification for ViiV to enforce non-disclosure. It should immediately permit full publication of its licensing terms thereby allowing the MPP to return to its standard practice of publishing all details of its licenses.
Although tiered-royalties can be instrumental in expanding U-MIC access, the tiers must be modest and the rates must be disclosed. ViiV should drop its non-disclosure clause and moderate royalty terms to further reduce prices. ViiV must also amend its license to include all U-MICs unable to procure generic DTG, at this point: Bulgaria, China, Colombia, Hungary, Mexico, Romania, and Turkey.
In a related matter, activists are protesting ViiV and GSK’s unwarranted lawsuit seeking to enjoin operationalization compulsory license issued on DTG in Colombia, an U-MIC excluded from ViiV’s MPP license. ViiV’s MPP licenses clearly and directly permit generic licensees to supply excluded countries, like Colombia, that issue CLs. It is inconsistent and hypocritical for ViiV to agree to such a term and then to challenge the perfectly legal compulsory license issued by Colombia. ViiV and GSK should immediately drop this lawsuit.
MPP licenses are not perfect and companies like Gilead and ViiV still prioritize U-MIC profits instead of an all-out effort to end the HIV pandemic. Accordingly, as activists at the International AIDS Conference in Munich, called on countries excluded from MPP licenses to collaborate and issue compulsory licenses to expedite affordable and equitable access. Although the companies should bear the main opprobrium for country exclusions, governments must act, as Colombia has, on behalf of their own populations to prevent and treat HIV infections.
