R&D Blueprint

Message from Marie-Paule Kieny

Marie-Paule Kieny

The Ebola outbreak in West Africa showed us in no uncertain terms that research and development (R&D) for medical products needs to be an integral part of any response to epidemics and public health emergencies. During Ebola, WHO worked alongside numerous governments, public and private entities and scientists. That effort resulted in the first ever fully effective vaccine against Ebola, developed and tested in 12 months as opposed to the 5-10 years such a process would normally take. For that reason, the team who worked on Ebola R&D with me welcomed the opportunity to explore ways we could put our Ebola experience at the service of R&D for all public health emergencies. That is how the R&D Blueprint was born and was fully established in 2016 at the request of the 194 WHO Member States.

The WHO R&D Blueprint defined a priority list of diseases likely to cause epidemics in the future. For each of these, WHO is preparing R&D roadmaps and developing the profile for the kinds of vaccines, medicines and diagnostics we would need to address them. So far, four target product profiles have been developed for vaccines and diagnostics to address Zika, Nipah virus and Lassa fever. These ‘standards’ will guide the research of our partners and will ensure that everyone works according to the same parameters for quality, safety and efficacy.

WHO has also established an emergency procedure under its Prequalification Programme for rapid assessment of innovative health products during public health emergencies, making it easier for UN and other procurement agencies to purchase and distribute quality-assured products. So far, the procedure has listed several tests for Ebola and two Zika diagnostics. We have also called on companies to develop platform technologies to expedite the development and production of needed medical products during an epidemic, receiving several dozens of valid proposals. And we are developing a capacity building tool for biological sample sharing.

Given the physical presence of WHO in 160 of the world’s countries, we are supporting expansion of capacity to implement adequate study designs, developing tools to frame collaborations and exchanges, and generating evidence to inform regulatory review and policy development.

While the West Africa Ebola epidemic showed a tremendous upsurge of efforts and good will to find cures and save lives, it also showed sometimes unhealthy competition, where ‘getting there first’ is not just a matter of professional pride but also carries financial risks and the potential for large profits. This is the fundamental reason why only a global organisation such as WHO, which has no vested interests, is equipped to coordinate global R&D efforts during epidemics, and ensure that those efforts will truly serve populations at risk and safeguard public health. This is why we have also established a Global Coordination Mechanism to foster enhanced collaboration and stakeholders’ alignment for R&D preparedness and response.

I would like to thank the WHO Blueprint team, our Scientific Advisory Group and our many partners around the world for contributing to the WHO R&D Blueprint, often working well beyond normal hours and giving of their free time. The conviction and determination shown by all of these people will help the world face future epidemics more efficiently and with better medical countermeasures.

I will leave WHO very shortly but I look forward to continuing this amazing adventure and supporting you all in expanding the Blueprint and making it the vital tool it is promising to be.