Commentary: MPP and Roche move to expand access to influenza treatment in LMICs

Who could benefit: The agreement covers 129 low- and middle-income countries (LMICs) and includes adult and paediatric formulations (see Figure). 

Why does it matter: Access to baloxavir marboxil (Xofluza_^®) increases treatment options for populations in LMICs at high risk of severe disease. The risk of influenza-related ICU admission is sevenfold higher in LMICs than in high-income countries. Moreover, an estimated 99% of deaths from influenza-related lower respiratory tract infections in children under five occur in LMICs. 

Well ahead of patent expiry: With secondary patents in some LMICs not expiring before 2039, the voluntary licence comes years ahead of patent expiry, enabling earlier generic entry and broader access. It builds on earlier milestones – baloxavir marboxil (Xofluza_^®) received its first EU approval in 2021 and was added to the MPP priority list in 2024, where it was identified as a candidate for a voluntary licence to expand access through earlier generic market entry and deliver significant health benefits. 

Improving preparedness: Influenza’s pandemic potential makes early access to effective antivirals a matter of global health security, not just seasonal response. The agreement strengthens preparedness across both - enabling more proactive responses to seasonal outbreaks and highly virulent strains alike. This comes amid growing global focus on pandemic preparedness, including at the United Nations General Assembly and World Health Assembly. 

Progress on an Access to Medicine Index opportunity: The 2024 Access to Medicine Index highlighted expanding access to baloxavir marboxil (Xofluza_^®) as an opportunity for Roche, including through a NEVL. This agreement is a promising development to improve access to the antiviral treatment – though uptake by generic medicine manufacturers will be the key determinant of how quickly and how broadly supply can materialise and reach those who need it. 

Looking ahead: MPP is now launching an Expression of Interest to identify qualified generic medicine manufacturers. The Foundation will monitor developments in three areas: 

• Generic medicine manufacturer uptake: The licence is a necessary first step, not a guarantee of supply. Broad participation by qualified manufacturers will be crucial to driving market competition and ensuring affordability and availability across all 129 countries.  

• Transparency on implementation: MPP and Roche are encouraged to report openly on expected timelines and patient reach projections. 

• The broader Roche portfolio: Trastuzumab/hyaluronidase (Herceptin_^®SC) is also listed as a priority candidate for voluntary licensing. In oncology, where access gaps persist across LMICs and NEVLs remain rare, doing so would represent a significant step forward.