Daniel Kiesa

Voluntary licensing (VL) has long been central to expanding access to medicines in low- and middle-income countries (LMICs), particularly for HIV and other infectious diseases. By enabling generic manufacturers to produce affordable medicines at scale, VL agreements have brought life-saving therapies to millions. But as the pace of innovation accelerates and global health stakeholders aim for quicker access to new products, the limitations of the business arrangement surrounding current VL models – especially during the “bridging period” of originator-only supply – are becoming more apparent.

Historically, supply of new products to LMICs has lagged behind initial product approvals. For example, dolutegravir (DTG) was approved by the U.S. FDA in 2013, but large-scale introduction of the medicine in LMICs didn’t happen until 2018 with the rollout of the TLD (tenofovir/lamivudine/dolutegravir) regimen. That five-year gap to LMIC access has been reduced in recent years. Lenacapavir (LEN) for HIV prevention is expected to be delivered to sub-Saharan Africa within 12 months of U.S. FDA approval, a significant improvement.

Originator supply enables earlier access in LMICs while generics pursue regulatory approval under voluntary licenses. But this bridging period often comes with limited supply, high costs, and restrictive delivery models – challenges that can slow rollout and shape a product’s early reputation, particularly in high-burden settings.

Generic Supply Is Sustainable Supply

Generic manufacturers have consistently demonstrated they can deliver products at scale, at lower cost, and with sustained commitment. Their cost structures, supply capacity, and global customer support infrastructure are optimized for LMIC needs. In contrast, originators have limited incentives to innovate for cost-efficiency, and their supply investments tend to focus on long-term, high-income markets which are often lower in scale than LMIC markets. This limits their capacity and flexibility when serving LMICs, particularly in the bridging phase before generics arrive. Yet this phase is the first, and potentially lasting, impression a new product makes on users and providers.

Market-shaping interventions by global health funders and partners, such as price guarantees or volume commitments, are typically designed to accelerate the future benefits of supply, often leading to expanded capacities or lower prices. These interventions are difficult to apply effectively in a temporary originator-only market, where the supplier may have no role in the long-term market and therefore lack incentive to engage.

The Case for Reimagining the Relationship

If generic supply is the ultimate pathway to access, affordability, and sustainability, why not involve generics sooner? What if VL agreements were expanded to allow generic manufacturers to distribute originator-produced stock during the bridging period?

This model would allow generics, who are experienced in price competition, local engagement, and long-term market development, to play a role even before they can manufacture the product themselves. They could work with funders to set prices, manage distribution, and build early demand – all while maintaining a long-term view of the market.

Focusing originator engagement to generic companies streamlines the burdensome, and often secretive, sales relationship. The number of buyers served could increase to the steady state normal during generic supply. Prices could be set by the generic companies free to take the long view, keeping originator-demanded confidentiality. Originator companies wouldn’t need to flex their organizations to supply many LMIC importation processes for a short period of time.

Addressing Challenges: Quality, Control, and Regulation

Originator companies are understandably risk-averse when it comes to quality control and regulatory oversight. Handing over distribution to third parties could raise concerns about product integrity, liability, and compliance. However, structured partnerships, clear regulatory frameworks, and shared risk models could help mitigate these concerns. The key is collaboration – between originators, generics, and global health stakeholders – to rethink the role each actor plays in bridging access.

Toward Smarter Bridging Models

The global health community has made real progress in reducing the time lag between innovation and access. But if we are serious about maximizing early access without sacrificing sustainability or efficiency, we need to evolve the relationship surrounding the VL model. That means finding ways to engage generic manufacturers earlier, even while originators remain the sole producers.

VL has served us well but the next generation of voluntary licenses should be more ambitious, more inclusive, and more attuned to the realities of LMIC markets. The goal is clear: faster, cheaper, and more sustainable access to innovation. Now it’s time to rethink the tools we use to get there.