US pharma giant Gilead’s partnership with domestic generic manufacturers, aimed at enhancing access to affordable lenacapavir—a groundbreaking therapy for HIV prevention—may fall short in addressing the needs of high-incidence developing countries, and those grappling with rising HIV infections, patent and public health experts say.
While the introduction of generics is expected to significantly reduce prices from the exorbitant $40,000 per patient per year, they argue that the voluntary license (VL) granted by Gilead is “restrictive,” limiting the ability of generics to make a meaningful contribution to ending the decades-long HIV pandemic.
On Oct 2, Gilead announced it would allow generic manufacturers including Dr Reddy’s, Emcure, Hetero and Mylan — to produce a generic version of the twice-yearly HIV injection in 120 low- and lower-middle-income countries.
“Given the transformative potential of lenacapavir for prevention, our focus is on making it available as quickly and broadly as possible where the need is greatest,” said Daniel O’Day, chairman and CEO of Gilead.
The pathbreaking AIDS therapy which costs around $44,000 for twice-yearly injections in the US, has garnered attention for its potential in HIV prevention globally.
“The VL appears good on paper. However, it seeks to control the production of the active pharmaceutical ingredient (API)—key to the production of affordable versions—while failing to fully utilize the capabilities of large API manufacturers like Natco, Lupin, Aurobindo and Laurus Labs. And for finished formulations–Lupin, Cipla, Strides and Aurobindo. If the overall supply of API from generic companies is restricted, a reduction in the prices could take longer”, Leena Menghaney, India Head of Médecins Sans Frontières Access Campaign told TOI.
Additionally, it excludes key countries such as Argentina, Brazil, and regions in Central Asia, which are experiencing rising rates of new HIV infections.
Further, the entry of generics could take a few years after the requisite regulatory approvals, and prices could drop around $100 with substantial supply over the next few years.
A study by Liverpool University estimated that prices of generic lenacapavir could be reduced to a fraction, initially at $100 per person per year, and then at $40 per person per year.
Meanwhile, Gilead has filed patents widely on the drug, and the VL meant to overcome patent barriers will not make lenacapavir accessible in many key countries, KM Gopa Kumar a senior researcher with Third World Network noted.
The US firm is facing widespread opposition from patient groups and public health groups across India, Argentina, Indonesia, Thailand, and Vietnam.
In India, Sankalp Rehabilitation Trust, a patient group, has opposed the patent applications in 2021 on grounds of lack of novelty and inventive step, according to India’s Patent Act. The case is expected to be heard here on Oct 18.
The VL can also be seen as a strategic move by Gilead to preserve its monopoly on lenacapavir, especially in light of the weak and questionable nature of its patent claims that are being challenged globally, Third World Network (TWN) said in a statement.
Under the license, Gilead retains full control over the licensees’ sourcing of the active ingredients, ensuring that its supply requirements are prioritized.
“The terms of the VL underscore the company’s primary objective of safeguarding its monopoly and, by extension, its profits. In this context, challenging Gilead’s patents becomes even more crucial. If these patents are rejected, it will encourage real market competition, increase production diversity, and ultimately drive down prices, ensuring wider access to lenacapavir for those who need it’’, TWN statement added.
The VL announced by Gilead is a strategic move to counter global opposition against its frivolous patent claims. The license excludes supply to many developing countries categorised as Upper middle-income countries, which account for 41% of new HIV infections and 37% of the global population living with HIV, according to UNAIDS.