Orchestrating faster access to products of non-profit R&D: a case study of a novel regimen for drug-resistant tuberculosis.

INTRODUCTION

Non-profit product development partnerships (PDPs) have succeeded in bringing nearly 80 new drugs, vaccines and diagnostics for neglected diseases through regulatory approval, but arrangements to ensure they reach patients are unclear since the usual commercial incentives do not apply. We conducted a case study of how unusually fast access was achieved to a new treatment regimen for drug-resistant tuberculosis (DR-TB) developed by the TB Alliance (TBA). Over 100 countries procured the regimen in quantities to reach 67% of global demand by 2024, 5 years after first regulatory approval and 2 years after the WHO recommended it for routine use. What interventions contributed to this rapid rollout, and what role did the PDP play?

METHODS

We analysed the academic and grey literature, internal documents from TBA, and conducted interviews with 21 key informants from 16 organisations. We identified relevant interventions and actors, constructed a timeline and analysed the role TBA played.

RESULTS

We found TBA orchestrated a complex set of interventions implemented by dozens of actors over an 8-year time period across three categories: regulatory and normative guidance; market shaping for affordability and availability; and supporting country-level implementation through knowledge generation, knowledge sharing, stakeholder engagement and advocacy. Five attributes enabled TBA to do so: ability to generate and share knowledge about the product and regimen; non-profit status; ability to mobilise material resources for access interventions; pre-existing relationships and/or ability to develop new collaborative relationships; and intrinsic motivation to see the product reaching people with DR-TB.

CONCLUSION

An orchestrator able to steer many actors towards the shared goal of reaching patients is critical in a complex ecosystem where no single organisation can realise access alone. Non-profit product developers can play this role well, including managing actual or perceived conflicts of interest, but require clearer mandates and financial support to do so.