Breakthroughs Blog: WHO

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The University of Southampton studied malaria funding in Sub-Saharan Africa with the intent to map funding amounts in regions where the malaria is endemic. While global deaths due to malaria have fallen by 60 percent over the last 20 years, the parasite still kills over 400,000 individuals every year. Further, the University found that about 25 percent of Sub-Saharan African countries do not receive the funding for malaria research they need to successfully mitigate the impact of the disease. While all countries received funding for non-research purposes—such as for resources like bed nets and anti-malarial drugs—this funding is not sufficient for the regions where mosquitos carrying the parasite are becoming increasingly resistant to current drugs, vector controls, and preventative methods. A number of factors contribute to this gap in funding. Among the most critical is the lack of adequate research infrastructure in many Sub-Saharan African countries. The European Commission, in partnership with the European Union (EU), have devised and launched a new-age action plan to combat antimicrobial resistance (AMR). The foundation of the plan posits that AMR impacts not only human health, but also in environmental and animal health. The goal of these efforts is to make the EU a “best practice” region for combatting AMR; to boost research, development, and innovation; and to shape the global agenda. The new plan was launched to improve upon the efforts of the previous action plan, as AMR-related deaths are estimated to kill 25,000 Europeans every year. The new plan aims to address a wide range of issues related to AMR in the EU, including the varying levels of resistance around the Union, controlling agricultural practices, and controlling antimicrobial use. Quality-assured malaria drugs undergo substantial testing and verification from international organizations such as the World Health Organization (WHO). A recent study published in Malaria Today found that the private sector has made many non-quality-assured medicines available in several malaria-endemic countries. For instance, over 40 percent of private sector organizations in Kenya stock non-quality-assured drugs. These drugs have not been patient tested, have not gone through adequate clinical trials, or may have even been denied approval by regulating bodies such as WHO. Thus, not only is patient health and safety is compromised, but also these drugs have the potential to exacerbate vector- or malaria-resistance, making combating this disease more difficult.  

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. A study recently published in Science Immunology found that mice infected with malaria had shorter thigh bones than their control counterparts by ten percent, suggesting if the same effect takes place in human, children could suffer stunted growth due to malaria infection. Researchers found the malaria parasite left behind waste which killed the mice’s bones, resulting in the disruption of cells responsible for breaking down and rebuilding bones. The researchers found a possible solution, however. By giving the mice a derivative of vitamin D, they were able to stimulate more bone regrowth and suppress the breakdown of bone. Fifteen children have died in a rural South Sudanese village after one needle was used over the course of multiple days with a vaccine that was not stored properly. Almost 50 individuals fell ill after being inoculated on the same day, resulting in 15 deaths due to either sepsis or a related toxicity. According to the World Health Organization (WHO), the series of events were a result of a lack of training and qualification from the individual administering the vaccines, who failed to adhere to WHO immunization safety standards. South Sudan has been affected by a years-long civil war which has reduced the ability to carry out health care services. Immunization coverage has fallen from 77 percent before the conflict down to 44 percent.  The National Institute of Allergy and Infectious Diseases and the National Institutes of Health have sponsored a phase 1-2 Chikungunya vaccine trial at three different sites around the United States, including Emory University, Baylor College of Medicine, and the University of Iowa in Iowa City. The study will focus on three groups, one receiving a high-dose vaccine, one receiving a low-dose vaccine, and a control group. The results will help establish the best dosage and timing for the vaccine. If this trial is successful, the vaccine could become an important tool to combat the Chikungunya endemic in Eastern Africa and prevent the spread of cases within the United States.  

As the 70th session of the World Health Assembly (WHA) winds to a close, memberstate delegates and civil society advocates are collectively taking a moment to catch their breath and reflect on an extremely eventful WHA. In a single week, the World Health Organization (WHO) gained a new Director-General—Dr. Tedros Gehbreyesus of Ethiopia—increased mandatory contributions from member states, and passed a landmark cancer resolution, just to name a few key decisions. In addition to these seismic shifts in the landscape of WHO, health research and development (R&D) was also featured prominently across a number of WHA agenda items, some of which saw highly consequential developments. Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) The long-running CEWG process finally appears to have reached its end. After more than a decade of exploring approaches to support R&D for neglected diseases and actions to stand up a voluntary R&D-pooled fund at WHO, Assistant Director-General (ADG) Marie-Paule Kieny notified the Assembly that no further work would be done on either the pooled fund or the initial round of demonstration projects associated with it. Her comments came at the close of a lengthy session in which both member states and civil society organizations universally echoed the call for more resources to enable the fund and demonstration projects to operate effectively, as well as bemoaning the lack of contributions to date. In justifying the decision to cease work on these projects, ADG Kieny noted that no additional funding has been raised for the fund beyond the US$11 million pledged over three years ago. With that level of funding, the programs were simply not sustainable, she explained. On a positive note, the WHO Global Observatory on Health R&D—which was created to facilitate R&D coordination and guide prioritization—was spared the ax. While resources are not available to expand its database of R&D projects and data immediately, it is now operational and can be expanded at any time, as additional data and funding become available. Access to medicines As expected, the debate around access to medicines continued to rage at this year’s WHA. Although there was not a dedicated agenda item on follow-up to the United Nations Secretary General’s High-Level Panel on Access to Medicines (HLP) report, a number of countries, including Brazil, India, and Argentina, took every opportunity to raise the report in their remarks on other agenda items. In particular, agenda item 13.3 Addressing the Global Shortage of, and Access to, Medicines and Vaccines—which has historically focused more on supply chain issues—saw particularly heated debate, as well as intricate parliamentary maneuvering. India and Brazil led a concerted push, supported by South Africa, for the WHO Secretariat to initiate a consultation process that could result in WHA adopting “consensus language” on access to medicines. A number of European countries pushed back, noting that the WHA agenda item simply contained a report from the Secretariat for the Assembly to note, thus there was no need for consensus language. Implicit in this objection was a concern on the part of countries opposed to recommendations within the HLP report that any opening created to develop new language on access to medicines would invariably result in references to the HLP report. After extensive debate, including the intervention of WHO’s legal counsel, member states reached a compromise whereby the issue of access to medicines would be included on the agenda for January’s WHO Executive Board (EB) meeting, although that item would not specify discussion of the HLP report. South Africa further proposed a standing EB and WHA agenda item on access, which was vetoed by the United States. Beyond parliamentary maneuvering, the debate around access centered on many of the arguments that have become familiar to those following this issue over the years. On one end, civil society activists and some member states called for a wholesale rethink of the ways in which countries provide incentives for innovation, typically through some form of “delinkage,” wherein R&D costs are no longer related to the costs of the final product. At the opposite end of the spectrum, industry representatives and countries with significant pharmaceutical industries argued that intellectual property is not the primary barrier to access and that attention is better focused on supply chains and countries’ lack of domestic financing for health. Concluding thoughts Overall, this WHA featured one of the most packed agendas I have seen since I started tracking WHO. It is promising that, despite all of the competing agenda items, R&D remained a central focus of vigorous discussion and received significant attention. Even beyond the specific policy developments, it is clear that R&D and innovation remains a priority for the global health community.

As it does every year, the global health community is preparing for our collective trek to Geneva for the World Health Assembly (WHA) where the World Health Organization’s (WHO) 194 member states and various civil society or multilateral observers will come together to review WHO’s programming over the prior year, sets policy and program priorities for the upcoming one, and approve the budget with which to carry them out. As with most WHAs, there are a number of items related or relevant to research and development (R&D) at this year’s assembly: Director-General elections The highest profile issue on the agenda this year is the selection of the next WHO Director-General (DG) to succeed Margaret Chan. The three candidates still in the running are Dr. Tedros Ghebreyesus (Ethiopia), Dr. David Nabarro (United Kingdom), and Dr. Sania Nishtar (Pakistan). Dr. Ghebreyesus has previously served as Minister of Health and Foreign Affairs for Ethiopia, Dr. Nabarro boasts an extensive track record in the United Nations (UN) and other multilateral organizations, and Dr. Nishtar served as Minister of Health for Pakistan, in addition to founding and leading a successful nonprofit. From an R&D perspective, none of the candidates have direct experience in technology development, but all have indicated in general terms that they would be supportive of R&D. As the chief executive of WHO, the DG sets operational policies and priorities across a variety of programs important to R&D, from the pooled fund and observatory, to ongoing discussions around intellectual property and access to medicines. The influence of the DG is hard to overstate. The race remains very open, and member state delegation contacts have indicated that it is anyone’s race, though this was before news reports emerged containing allegations about Dr. Ghebreyesus’ tenure as Ethiopian Minister of Health. It is unclear to what extent these reports have shifted the race, but GHTC will be on the ground in Geneva providing daily updates as the final days of the campaign unfold and the election occurs on May 23. R&D for potentially epidemic diseases In examining the response to the West Africa Ebola outbreak; ongoing yellow fever and dengue outbreaks; and Zika, WHO recognizes the need for R&D to be a central component of the agency’s strategy to combat potentially epidemic diseases. To that end, WHO has undertaken a number of activities and will be presenting progress to date at WHA. One of the most impactful of these activities is the creation of an R&D blueprint for action to prevent epidemics. The blueprint lays out a number of areas that require global attention to prepare for outbreaks, including product development, as well as social science and epidemiology studies. GHTC is very pleased to see R&D getting its fair share of attention in the context of epidemic preparedness. Without the ability to rapidly develop new tools to address emerging diseases, we will not have the necessary tools in place to prevent or curb an epidemic. Although the blueprint is a step in the right direction, GHTC believes that WHO should also address regulatory guidance and health systems strengthening; new technologies won’t help stop outbreaks if they are held up in regulatory review, nor will it be possible to develop the right tools if health systems are too weak to collect the vital data and samples needed when an outbreak occurs. Antimicrobial resistance Another hot topic over the past year has been the global focus on antimicrobial resistance (AMR) coming out of last year’s UN General Assembly High-Level Meeting on AMR. WHO has been at the forefront of this movement to combat AMR and has committed to supporting countries in developing national action plans to fight AMR, setting up global surveillance systems to track AMR, and helping coordinate across the UN system to ensure a unified UN response. Support for R&D has been a central component in these discussions. GHTC welcomes all of these actions, but notes that WHO and member states have been slow to agree on an AMR stewardship and development framework, which is a vital next step. We will not make progress against AMR without the Framework helping guide investments in R&D, and ensuring that the products developed through that R&D remain effective in use. GHTC will continue pushing for the Framework and for WHO and countries to be held accountable to the promises they made at the UN General Assembly. Consultative Expert Working Group on Research and Development: Financing and Coordination The long-running Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) process continues for this year’s WHA, and the progress update report shows some progress, some treading water, and some disappointment. On a positive note, the WHO R&D Observatory—which will serve as a coordination clearinghouse for information on global health R&D—is moving toward implementation. Once active, the Observatory will be a key tool in helping ensure efficient R&D by facilitating coordination, exposing gaps, and helping researchers prioritize according to need. The second piece of the CEWG’s mandate is standing up a pooled fund to support neglected disease R&D. To be housed at the Special Programme for Research and Training in Tropical Diseases (TDR), the pooled fund would operate in a similar fashion to the Global Fund to Fight AIDS, TB and Malaria, accepting contributions from member states and making grants to research institutions pursuing R&D for neglected diseases that are not commercially viable. While TDR has developed a solid set of terms-of-reference for an expert advisory group to prioritize areas for the fund to focus on, it still has not come to grips with the elephant in the room for any funding mechanism—how they are going to raise the money to support it. Unfortunately, even the current set of demonstration projects to pilot the approach remain underfunded, and it does not appear that most member states or other donors are willing to reach into their pockets for this project. GHTC will continue advocating for them to do so, and for more resources to be made available for R&D in general, but it will be interesting to see the dynamics at this year’s WHA. Closing thoughts Overall, this year’s assembly is likely to be dominated by the DG election, with other topics only attracting attention once this heated content is wrapped up. It is not clear how the three DG candidates will approach R&D should they be elected, so it is very hard to predict what impact the decisions at this year’s WHA will have. Will they chart a direction for the new DG or will WHO’s new leader want to make his or her mark and change course entirely? GHTC will be on the ground providing updates as they happen, as well as the analysis of what they could mean for R&D. Follow us on Twitter at @GHTCoalition for live updates over the course of the week and check back here for a wrap-up blog on outcomes from the 70th WHA later this month.