WHO Leads Effort To Build R&D Roadmap For Future Epidemics

The World Health Organization is working to learn from the fast response on research and development for Ebola that led to effective treatments in a short time. It hopes that this changes the way emergency R&D is done forever.

A Summit on Ebola Research and Development was held at WHO on 11-12 May.

Actions taken by the international community in response to the Ebola virus demonstrated that R&D can be accelerated, WHO Assistant Director General Marie-Paule Kieny said at a 12 May press briefing.

The WHO is trying to develop a roadmap for R&D for diseases with epidemic potential and other health threats. A preparedness plan could provide clear rules, platforms for information sharing, and established processes to expedite development and clinical trials, she said.

“Ebola is not the only epidemic-prone disease for which there are no medicines, vaccines or diagnostics,” said Kieny. “Nor is this the first time the world has been caught unprepared in the face of an epidemic.”

What made the rapid progress possible was the coming together of many partners, including private and public funders, nongovernmental organisations, defence ministries, research institutions, regional government bodies and multinational pharmaceutical companies, she said.

What normally would have taken 5 to 10 years – the development of at least two possibly effective vaccines – took less than 10 months. As the Ebola crisis diminishes, they will try to capture some standards and best practices from this case.

WHO Director General Margaret Chan spoke at the opening of this week’s meeting, and said in remarks (available here): “What we see emerging, over a very short time, is a new model for the accelerated development, testing, and approval of new medical products during emergencies caused by any emerging or re-emerging infectious disease.”

“Your collaborative efforts prove that the traditional R&D model can be adapted, timeframes can be compressed, and partnerships that are otherwise unlikely can be formed,” said Chan. “The implications are huge. Many other serious diseases have no vaccines or therapeutic options, and some of these diseases have epidemic potential.”

“The job now is to harness the lessons from Ebola to create a new R&D framework that can be used for any epidemic-prone disease, in any infectious disease emergency,” she said.

Possible elements for fast-tracking emergency R&D could be: putting certain research activities under one coordinating entity, such as VEBCON phase I vaccine trials consortium that was convened by WHO. The emergency use assessment and listing procedure could become standard in all public health emergencies. There could be joint ethics and regulatory reviews, which Kieny said cut bureaucratic corners and accelerated data sharing. And the WHO could play a role of overall convenor and facilitator, providing a common point of reference and collaboration.

The independent expert panel this week urged member states to invest in WHO, saying, “at present, WHO does not have operational capacity or culture to deliver a full emergency public health response. The panel will present its final report after visiting and consulting with the affected countries, planned for June, WHO said.

This was emphasised by panel chair Barbara Stocking, president of Murray Edwards College at the University of Cambridge and former chief executive of Oxfam Great Britain.

There are several reports related to Ebola for consideration of the annual World Health Assembly, to be held 18-26 May (IPW, WHO, 14 May 2015).

IP, Vaccines and ‘Biobanks’

In response to an Intellectual Property Watch question, Kieny said the concern with Ebola was not about intellectual property protection, but that the treatments were not available. There is not likely a viable market for such products, so authorities need to make sure they are available, she said. Research will continue in order to make sure these products are being developed further for future outbreaks. The research agenda must be owned at the country level, and national decision-makers must be much more integrated into the process than before. There has been emphasis on global coordination.

On the sharing of virus strains, Kieny said it is another area that needs focus. Samples, even if exported, belong to the countries, so going forward it is needed to see what solutions they can have to establish “biobanks” of samples with ownership at country level, with samples being made available for research. This is part of the roadmap, she said.

WHO listed the panel members in addition to Stocking. They are: Professor Jean-Jacques Muyembe-Tamfun, director-general of the National Institute for Biomedical Research, Democratic Republic of the Congo; Dr Faisal Shuaib, head of the National Ebola Emergency Operations Center, Nigeria; Dr Carmencita Alberto-Banatin, independent consultant and advisor on health emergencies and disasters, Philippines; Professor Julio Frenk, dean of the faculty, Harvard T. H. Chan School of Public Health, Boston, Massachusetts; and Professor Ilona Kickbusch, director of the Global Health Programme at the Graduate Institute of International and Development Studies, Geneva.