Regulatory, patent barriers may hinder global access to new HIV prevention drug: activists

India faces a critical moment in its effort to end AIDS, healthcare activists said on Friday (November 28, 2025), warning that lenacapavir, a new long-acting HIV prevention medicine that confers virtually 100% protection against HIV infection, risks being undermined by regulatory delays and patent-related barriers.

If these barriers remain unaddressed, they will obstruct access to Lenacapavir for the marginalised communities most affected by the epidemic, said a group of healthcare activists, patients, and advocacy groups.

Global numbers of new HIV infections have remained virtually unchanged for three years, indicating the need for more effective HIV prevention tools, deployed at scale as an urgent global priority, the group said in a statement.

‘Clinical trial waiver needed’

Although Indian generic manufacturers can supply lenacapavir at affordable prices, regulatory delays and patent filings by American biopharmaceutical company Gilead Sciences threaten to delay access globally, it said.

Gilead Sciences developed lenacapavir as an innovative HIV medication and prevention option. The company sells it under the brand name Sunlenca for treatment, and more recently, under the name Yeztugo for prevention. Gilead has also licensed several generic manufacturers, including Dr. Reddy’s Laboratories, Hetero Labs, Emcure, and Mylan (Viatris), to produce and distribute generic versions of lenacapavir to lower-income countries. 

Under India’s New Drugs and Clinical Trials Rules (NDCTR) 2019, companies may seek a waiver of India’s requirement that drug companies conduct local clinical trials as a condition of regulatory approval, so long as a medicine has been approved by the drug regulatory authorities of the U.S. (USFDA), European Union (EMA), and other “specified countries”, and offers a “significant therapeutic advance.”

Lenacapavir’s use for HIV prevention has been widely recognised by UNAIDS, WHO, and other technical normative agencies as a significant advance that can bring new infections under control. Without the Indian regulatory waiver, however, the timely global introduction of Indian generics would be substantially hindered, the group said.

Patent filings

In addition to regulatory barriers, health groups — including the Third World Network, which works on healthcare accessibility — have raised serious concerns about Gilead’s patent filings on lenacapavir in India. They argue that the claims may lack sufficient novelty and, if granted, could restrict open competition among generic manufacturers producing active pharmaceutical ingredients (API) and finished formulations — directly undermining India’s capacity to manufacture and supply affordable generics.

While Gilead has granted royalty-free, non-exclusive licenses to six generic manufacturers — including four Indian companies — to supply lenacapavir to 120 low- and lower-middle-income countries and territories, regions with high HIV incidence among key populations, including parts of Latin America, are excluded, undermining equitable global access and unnecessarily restricting local production, the group said.

The patents granted in India will block other Indian generic companies that have not been granted a Gilead license from supplying locally or to countries excluded from Gilead’s list of 120 eligible countries, and thus, Gilead’s multiple patent claims must be expeditiously rejected, say activists.

“A decisive action is urgently needed. Regulatory authorities, patent offices, and global partners must work together to ensure that long-acting HIV prevention becomes accessible without delay, and that communities most at risk are not once again left behind,” said Eldred Tellis of the LEN-LA for All Coalition, which includes Health GAP (Global), the Health Justice Initiative (South Africa), Sankalp Rehabilitation Trust (India), Just Treatment (UK), and ABIA (Brazil).

Published – November 28, 2025 07:37 pm IST