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The 140th session of the World Health Organization (WHO) Executive Board (EB) is officially done and dusted. Despite one of the lengthiest agendas in the history of the EB, the meeting actually finished a day early on January 31. As GHTC noted before the meeting, there were several agenda items relevant to global health research and development (R&D), in addition to broader decisions about WHO’s overall future direction. Some resulted in substantive decisions, while others served as an opportunity for delegates to provide input to shape resolutions for the World Health Assembly (WHA) in May. Here are the highlights from the week: Director-General Elections – Decision Point The biggest news out of the EB was the narrowing of the pool of Director-General (DG) candidates from six to three in preparation for a vote at WHA. Contrary to expectations heading into the EB vote, Dr. Sania Nishtar (Pakistan), Dr. Tedros Ghebreyesus (Ethiopia), and Dr. David Nabarro (UK) made the shortlist, while Drs. Flavia Bustreo (Italy) and Philippe Douste-Blazy (France), both of whom many considered to be strong contenders going into the meeting, failed to make the cut. The three have all positioned themselves as reform candidates, committed to continuing many of the reform processes started under outgoing DG Margaret Chan. The campaign now kicks into high gear, and it will be interesting to see if and how the candidates evolve their platforms to respond to priorities from the full membership of WHO now that they have made the shortlist. Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property – Decision Point The EB approved a new terms of reference for the Global Strategy and Plan of Action on Public Health, Innovation, and Intellectual Property (GSPOA), recognizing the need for WHO to consult with private-sector companies and establishing rules for this engagement as set out by the Framework for Engagement with non-State Actors (FENSA). Adopted in 2008, the GSPOA guides WHO’s work on fostering innovation and improving access to medical technologies for people in low- and middle-income countries. It was designed to promote innovation, build capacity, and mobilize resources by positioning WHO in a central and strategic role managing the relationship between public health, innovation, and intellectual property. As it nears its decade anniversary, WHO is undertaking a review of progress, as well as identifying areas for reform moving forward. In line with WHO’s move to put in place more stringent conflict of interest protections, initial drafts of the terms of reference for the review would have limited the agency’s ability to engage with private-sector companies involved in health R&D. The final draft as approved, however, recognizes the need to consult with these groups. Follow up to the Consultative Expert Working Group on R&D: Financing and Coordination and the UN Secretary-General’s High-Level Panel on Access to Medicines – Input/Information Point The EB’s session to review progress on the establishment of an R&D observatory and pooled fund at WHO to finance R&D as recommended by the Consultative Expert Working Group on R&D: Financing and Coordination (CEWG) was largely sidelined by member state debate on how or whether to carry forward recommendations of the United Nations (UN) Secretary-General’s High-Level Panel on Access to Medicines (HLP), which has proved highly controversial among member state delegations. In the run-up to the meeting, the officers of the EB decided not to include a separate item for discussion of the HLP’s findings in the EB agenda. As a compromise, the president of the EB permitted discussion of the HLP findings to occur under the existing CEWG agenda point. A number of countries, including Brazil, India, Iran, and others had strenuously objected to the exclusion of a HLP agenda item, arguing that WHO is relinquishing its global leadership role on a topic fundamental to health in not taking the lead on implementation of the HLP recommendations. Others, including the United States and some European delegations including Switzerland, Germany, and the UK argued that there was no consensus on the panel’s findings, that the report unfairly targeted specific countries, and that the HLP process had been overly narrow from the start in focusing on intellectual property, as opposed to a broader set of factors that impact access. The EB also did review progress on implementation of the CEWG recommendations. The final plan to establish an R&D observatory will be up for approval at this year’s WHA, while the proposal for a pooled fund to compliment the observatory is significantly less advanced, and work is still underway to determine exactly how a fundraising mechanism can be constructed to support it. GHTC delivered a statement at the meeting welcoming progress by WHO on the CEWG process and encouraging full funding of the observatory and ongoing consultation with stakeholders as the process moves forward. Antimicrobial Resistance – Input/Information Point Following on the heels of last year’s political declaration of the high-level meeting of the UN General Assembly on antimicrobial resistance (AMR), the EB reviewed progress made by WHO and other UN technical agencies to establish a plan to operationalize the declaration’s key recommendations, including spurring R&D for new antibiotics and other tools to combat AMR. As GHTC noted in our statement delivered at the EB, the effectiveness of follow up mechanisms to hold stakeholders accountable for their commitments on AMR will be critical to the overall success of the fight. Many delegates’ interventions focused on this need to deliver on commitments, and the tone of the session seemed to indicate that we will see a robust plan approved at WHA, which will be a great win for global health. R&D for Potentially Epidemic Diseases – Input/Information Point The EB reviewed progress by WHO on establishing an R&D blueprint for potentially epidemic diseases to reduce the delay between the identification of an outbreak and the deployment of effective medical interventions, calling for the agency to accelerate its work, given that the next outbreak can happen at any time. GHTC highlighted in its statement the importance of the blueprint addressing platform technologies, frameworks for collaborative R&D, and investing in regulatory/procurement systems strengthening. These efforts by WHO are part of its self-examination following lessons learned in the response to the Ebola outbreak. Heading into WHA in May, the agenda will be very full. In addition to the items above, the Assembly will also consider WHO’s response in crisis situations, polio elimination, immunization, WHO’s overall budget, implementation of the International Health Regulations to enhance global health security, global shortages of medicines and vaccines, and dozens of other items. GHTC will continue monitoring and will provide updates before, during, and after WHA.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Scientists have identified a gene that stops tuberculosis (TB) from mutating and becoming resistant to antibiotics. Researchers at Centro Nacional de Biotecnología in Madrid and the University of Sussex in Brighton individually deactivated each of the 11,000 genes that make up the TB bacterium, and tested the modified strains against an antibiotic commonly used to treat the disease. The study revealed that the NucS gene, which produces an enzyme that repairs DNA, significantly reduces the frequency of genetic mutations, and consequently, the development of antibiotic resistance. As drug-resistant strains of TB have been reported in more than 100 countries, this discovery could pave the way for improved diagnosis and treatment, making it easier for clinicians and researchers to predict which cases of TB will develop resistance. The US Agency for International Development (USAID) is the largest donor of food aid worldwide, spending US$1.5 billion on wheat, sorghum, rice, and other edible commodities annually. As the food travels around the world, an estimated 1 percent is lost to spoilage, which amounts to 10,000 tons of food worth $15 million. Now, researchers at the Massachusetts Institute of Technology are exploring new ways to package the food to avert spoilage and are testing eight different bags of varying sizes and materials to determine their ability to protect against humidity, water damage, and pests. One model has a completely airtight liner that resists moisture, while another uses a biopesticide that stops insects from reproducing, rather than killing them. The research team is also investigating the use of an airtight liner for the shipping containers, rather than the bags themselves. The final results and recommendations will be available this summer. Gene drives, a promising technique for eliminating mosquitoes and eradicating mosquito-borne diseases, may be stymied by evolution. The novel method involves genetically modifying mosquitoes by introducing an unusually dominant genetic mutation that is passed on to the insects’ offspring, overtaking an entire population of mosquitoes within a few generations. To combat malaria, Zika, and other mosquito-borne diseases, scientists have engineered mosquitoes whose offspring are infertile, and initial trials suggest that gene drives could be a breakthrough in vector control. However, additional research indicates that as these manmade genetic mutations spread through a population, so too do natural mutations that counteract the effect. Furthermore, there is an immense amount of genetic variation among mosquitoes, which limits the potential targets for gene drives. To overcome this, some researchers are introducing multiple genetic mutations at once, however, it remains to be seen whether the manmade or natural mutations will be more powerful.

A researcher holds onchocerciasis (river blindness) diagnostic tests. Photo: PATH/Patrick McKernLast Thursday, the World Health Organization (WHO) took the first step toward establishing an essential diagnostics list (EDL), releasing a proposal outlining how it intends to develop and operationalize the list by early 2019. This move follows calls by GHTC and other partners for the agency to establish an EDL to provide guidance to countries on the vital diagnostics that should be made available through health systems to complement WHO’s existing Model List of Essential Medicines (EML).As GHTC has previously noted, the need for an EDL to complement the EML is clear and has been compellingly demonstrated. An essential diagnostics list would not only help health care providers, particularly in low- and middle-income countries, improve diagnostic capacity and access, and thus improve patient care, it also holds potential to catalyze research and development (R&D) for new diagnostics by exposing health areas where we today lack appropriate and effective tools. GHTC is pleased to see WHO heed this call from advocates and scientists and begin the process to establish an EDL.A researcher holds onchocerciasis (river blindness) diagnostic tests. Photo: PATH/Patrick McKernThe proposal released by WHO lays out the broad principles the agency will follow in standing up an initial version of the diagnostics list. This includes: Focusing on in vitro diagnostics (IVDs): Given the large number of diagnostic tools, WHO believes that it will be most feasible to focus the first version of the list on IVDs—which are tests on samples derived from the human body—before considering expanding the list at a later date to include other diagnostic methods like radiological tests or x-rays. Targeting the list to support and complement the existing EML: Even limiting the list to IVDs leaves a wide breadth of potential diagnostics to be considered. Therefore, WHO proposes to start with identifying the diagnostics needed to enable appropriate use of medicines on the EML. Making an allowance for IVDs to address outbreak identification and response: While the EDL would be designed initially to complement medicines on the EML, WHO acknowledges that there is a clear need to help countries identify diagnostics necessary to address disease outbreaks with pandemic potential. As such, the EDL could include initially or be expanded later to include these technologies as well. Including diagnostics for various levels of the health care system: Different levels of health care facilities have different capacities and diagnostic needs within clinical care. Therefore, WHO will ensure the EDL includes diagnostics to meet the needs of these different providers and contexts. Designing for ease of use: WHO will focus on presenting the EDL in a format that is easy-to-use and accessible for countries, to facilitate use of the information and uptake of the suggested technologies. WHO is considering a variety of methods to support this goal.  Moving forward, WHO’s essential medicines staff will consult with the Expert Committee on the Selection and Use of Essential Medicines at its meeting in March to gather technical input on how to best operationalize the principles outlined above. Based on this feedback, a pilot group of diagnostics will be evaluated based on existing evidence of programmatic impact, with the goal of completing the development of an initial version of the EDL by early 2019.GHTC will continue to follow this issue closely and work with our members to ensure that the first version of the EDL is solidly grounded in our decades of combined experience with diagnostics and that the process of establishing the list moves forward efficiently. Keep watching this space for updates.