The role of innovative financing to bridge the gap between implementation and commercialisation

The deployment of novel medical products requires more than one party willing and able to shoulder the risk of failure. While GSK's RTS,S/AS01_E malaria vaccine received a positive scientific opinion from the European Medicines Agency, further evidence was needed for the World Health Organization (WHO) to be willing to recommend the vaccine for broad use. This increased uncertainty around whether WHO would ultimately issue a recommendation and when and who might buy vaccines to enable the wider scale-up to occur. With no large-scale demand outside of Gavi-financed markets, GSK was faced with a decision whether to continue production of the RTS,S antigen. Creative risk-sharing solutions can ensure and accelerate access to medical products, particularly where risks are intolerably high for key actors. Innovative finance providers deploy financial products to share risk and address these breaks in the product development and deployment pathway. To support continued manufacturing of the RTS,S antigen while waiting for a WHO policy recommendation and Gavi funding decision, MedAccess, Gavi, and GSK structured a risk-sharing arrangement. Sustained vaccine manufacturing due to the MedAccess-Gavi-GSK innovative financing agreement, was projected to result in 8.7M malaria cases averted and 36.3k deaths averted in children. Available capital can be deployed in creative ways, tailored to the individual needs of the market and perceived risks to achieve health benefits in the populations with the greatest need. Gaps in risk coverage created by changing timelines or market failures can be identified in advance so that innovative financing can be secured sooner rather than later. The partnership between WHO, MedAccess, Gavi, and GSK to support RTS,S/AS01_E demonstrates the ability of the global health community to develop creative risk-sharing solutions that can help to support timely access to new innovations for populations in need.