Market access to COVID-19 oral therapeutics in low- and middle-income (LMIC) countries was delayed. It took nearly fifteen months from the US FDA emergency use listing for nirmatrelvir/ritonavir to be delivered to the first LMIC countries by global buyers, long after the major COVID-19 waves had passed. Vaccines played a major role in managing the pandemic; next time the first line of defense may be therapeutics, reinforcing the need to identify key insights and develop recommendations that will hasten the process in future global emergencies.
The QuickStart Consortium undertook a rapid policy analysis to understand global and national level factors that delayed market access to oral antivirals. The analysis established that significant but solvable challenges slowed down the time taken to get the oral antivirals to people when they needed them the most. Specifically, the analysis identified:
- Global stakeholders failed to effectively prioritize, coordinate and accelerate end-to-end treatment research and development, product access, and delivery as part of the global COVID-19 response.
- Multiple addressable bottlenecks slowed access to innovator product and quality-assured generic oral antivirals, including approach and slow pace of generic licensing, procurement challenges, limited market shaping interventions and lack of robust demand signaling and demand generation.
- Implementation timelines were highly variable from country to country, highlighting the critical importance of leadership at the national and subnational levels, community engagement, and “always on” emergency response capabilities for expediting both new product entry and delivery implementation.
The consortium hosted a virtual roundtable on May 21, 2024, to disseminate these findings and key recommendations that would fast track access. Twenty-seven organizations were represented in the meeting. The deliberations identified opportunities for future engagement and influence including the ongoing global dialogue on the Pandemic Fund and the Pandemic Accord.
The greater impact of this roundtable discussion was the awareness of QuickStart activities and insights by global agencies. This discussion also cumulated to an invitation to participate in the IPPS Therapeutics Coalition workshop to deliberate on a pathway to establish a CEPI-like consortium to coordinate the end- to- end development of the therapeutics during an emergency.