The WHO works closely with development actors to ensure that development programming supports health systems and thereby helps improve

universal and equitable access to quality health.

B.

Research and Development

183. The discovery and production of new vaccines, therapeutics and diagnostics is crucial in preventing and responding to communicable disease crises. Over the past century, discoveries in medical research have achieved significant reductions in morbidity and mortality from many diseases including rabies, polio, measles and rubella, and eradicated others, including smallpox. More recently, initiatives by the Gavi, the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund), the WHO and UNICEF, among others, have significantly expanded access to life-saving vaccines in developing countries.

184. However, too little R&D has been devoted to addressing the numerous communicable diseases that primarily affect developing countries and which could spark a health crisis. The WHO maintains a list of 18 neglected tropical diseases (NTDs) that are endemic in 149 countries and which affect more than 1.4 billion people. The 2014 Ebola outbreak in West Africa was another example of the consequences of the R&D spending gap. Ebola has been known for 40 years and there have been more than 20 outbreaks since its discovery. Yet in 2014, no Ebola vaccine was available for use in containing the epidemic.

185. The lack of R&D for diseases that largely affect the poor is the result of market mechanisms. Developing new pharmaceutical products requires high levels of investment and involves numerous unsuccessful trials. Guided largely by the need to recoup the costs of research and the opportunity for commercial gain, pharmaceutical companies focus their

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efforts on diseases that primarily afflict societies whose health care systems and citizens are willing and able to pay for new products. As a result, of the $214 billion invested in health R&D in 2010, less than 2 per cent was allocated to neglected diseases (NDs), and since that time the allocation has actually dropped further.

186. When the Ebola outbreak in West Africa gained international attention, significant funding was made available to research institutions to accelerate work on a vaccine.7 Had these vaccines been available prior to the outbreak, many more lives could have been saved.

187. Measures are urgently needed to expand the research, development and production of lifesaving medical products for NDs, with a particular focus on the communicable diseases that pose a high threat of causing health crises. Where possible, medical countermeasures (including vaccines, therapeutics and diagnostics) should be developed to the stage where they can be rapidly tested and produced in the event of an outbreak. In order to achieve this, the following issues must be addressed.

i. Establishing better incentives for R&D relating to neglected diseases

188. First, there is a need to better incentivize R&D on neglected communicable diseases and other dangerous pathogens. Since the market does not provide adequate incentives, public policy intervention is required to ensure greater resources are focused on these pathogens. A range of economic policy instruments can help achieve this, with varying levels of efficiency and effectiveness. These include direct public or private grants, tax breaks for organizations undertaking R&D, prizes for successful achievement of research goals, advance market commitments, or subsidization of basic research efforts.

189. There are also a number of regulatory incentive mechanisms that could be considered. For example, in December 2014, the US Congress passed the Ebola Treatments Bill, which added Ebola to the US Food and Drug Administration’s (USFDA) priority review voucher programme. This provides developers of a vaccine for a qualifying NTD with a voucher that grants FDA priority review status for any other product under development.

190. The best combination of different financial or regulatory incentive measures to be used will differ by pathogen, as well as a number of other factors. However, all will ultimately require public funding. The Panel therefore strongly supports the creation of a dedicated R&D Fund overseen by the WHO. (See Recommendation 22 in the Finance and Economic Measures section).

ii. Prioritizing research efforts on communicable pathogens

191. While there are a number of under-researched pathogens posing a threat to humanity, it is not clear which of them will lead to the next outbreak and should therefore be the subject of priority research. To date, different countries and agencies have created their own priority lists, but a unified risk-adjusted priority list does not yet exist. However, national lists focus on national priorities and potentially deprioritise the diseases most likely to present a significant international threat. Moreover, significant trade-offs are involved in vaccine research. The Panel heard from a representative of the pharmaceutical industry that in order to

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Because of these efforts, an experimental vaccine was reported to have shown positive results in clinical trials in Guinea on 31 July 2015. Several other vaccines were also tested in clinical trials.

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produce adequate amounts of an experimental Ebola vaccine for clinical trials, the company had to suspend its production of a vaccine against rotavirus, a pathogen that kills an average of 450,000 children every year. The lack of a priority list leads private sector actors to shift resources based on individually-determined criteria. Such trade-offs should be determined according to a set of priorities developed by a legitimate political body as opposed to the private sector.

192. The Panel feels there is a need to prioritize the communicable diseases that receive public R&D support. Furthermore, the Panel is of the view that the WHO is the appropriate institution to establish priorities among the under-researched pathogens that pose a risk of health crises. The WHO should also help identify which technology platforms are best suited to research medical countermeasures. The goal of this effort is to create diagnostics and to shepherd vaccines or therapeutics, as appropriate, through Phase I trials for the top 20 priority communicable pathogens posing a risk of a future health crisis.

Recommendation 13: The WHO coordinates the prioritization of global R&D efforts for