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The annual cycle of World Health Organization (WHO) governance meetings continues, with many WHO member states and advocates convening in Geneva this week for the 140th WHO Executive Board (EB) meeting where they will shape the agenda and resolutions for May’s World Health Assembly (WHA). The agenda is extensive, and covers everything from narrowing the field of WHO Director-General (DG) candidates to a short list in preparation for a vote at WHA, to addressing routine administrative matters. In discussions with other stakeholders and member states, the agenda items receiving the most attention are those on WHO reform and the DG election. But there are also two key resolutions that will directly impact global health research and development (R&D): Follow-up to the Consultative Expert Working Group on R&D: Financing and Coordination (CEWG) The long-running CEWG process continues soldiering forward from its inception in a movement to create a treaty to fund R&D for neglected diseases and conditions in the early 2000s. After many years of negotiations, in 2015, WHA approved five “demonstration projects” designed to test the feasibility of establishing a multilateral pooled fund to finance R&D, as well as the establishment of an R&D observatory to identify areas of unmet R&D need and inform the priorities of such a fund. In 2016, a sixth demonstration project was added, though these projects have yet to be fully funded and face a shortfall of roughly US$73 million to complete their programs. The policies currently on the table this governance cycle are approval of a plan to operationalize the global health R&D observatory, as well as solicitation of member state guidance into developing the principles that will guide a pooled fund for R&D. The observatory plan has been thoroughly vetted and would consist of a database documenting worldwide global health R&D projects and initiatives, with an expert committee responsible for ensuring that insights are gleaned from the database through data mining. There appears to be broad consensus among member states and advocates that this repository of data would be helpful in coordinating and organizing R&D, but it has yet to receive full funding from member states. The pooled fund proposal is much less developed. At this point, member states are only being asked to weigh in on broad principles and terms of reference. Overall the fund is proposed to disperse $100 million per year over 10 years, supporting 35 to 40 R&D projects of varying complexity (from simple repurposing of existing drugs to possibly developing new chemical entities). One key advantage many advocates see to the proposal is that access requirements could be baked into the mechanism from the very beginning so there is a strategy in place to ensure the availability and affordability of resulting products. What is much less clear is how the pooled fund would be sustainably financed in the long term. The paper outlines a number of options, including a cyclical replenishment and voluntary contributions, though these are all untested at this point. R&D for potentially epidemic diseases The WHO Secretariat will present a progress report and request for input on its efforts to develop and execute an R&D blueprint to combat potentially epidemic diseases in response to lessons learned and challenges faced during the Ebola outbreak. The goal of the blueprint overall is to reduce delays between the identification of an outbreak and the deployment of effective medical interventions. To support this goal, the WHO Secretariat has developed roadmaps or blueprints to support R&D projects for both Middle East respiratory syndrome coronavirus (MERS-CoV) and Zika. The Secretariat will also outline their future plans in supporting platform technologies, building regulatory capacity, and encouraging coordination among global health stakeholders in epidemic scenarios. These future activities are much more malleable, and stakeholders will have the chance to help shape them as work continues. Given the uncertainties around how a pooled fund and R&D observatory will be fully operationalized and sustainability funded and the necessity of enhancing global preparedness to address future disease outbreaks, it will be important to see what comes out of these EB discussions since they will set the stage for what will be voted on and address at WHA in May. GHTC will continue tracking these processes closely to ensure that the concerns of the global health R&D community remain front and center. For more information about the policy issues that will be addresses at the 140th WHO EB meeting, check out an archived video of webinar briefing on the topic organized by the Global Health Council.

Donald Trump. Photo: Flickr/Gage SkidmoreAs eyes turn to the inauguration of President-elect Donald Trump this Friday, we still have only limited insight into the incoming administration’s vision for global health and medical research. At GHTC we have long championed a strong role for the US government in developing new vaccines, drugs, and diagnostics to address the world’s most pressing diseases and health conditions and have celebrated America’s historic leadership in global health research and development (R&D). We urge the Trump administration and the 115th Congress to continue to prioritize global health and medical research and will be watching the following issues in 2017:Budgets and fundingOne of the first ways the Trump administration can demonstrate commitment to global health, international development, and medical research is through the president’s fiscal year 2018 budget request. Traditionally, the Executive Office of the President uses the first budget of a new administration to articulate priorities and set the stage for the following years. We expect President-elect Trump to release a preliminary budget request in February, with a more detailed budget proposal released by May. These two policy proposals will provide the most comprehensive picture to-date of the Trump administration’s views on global health, development, and medical research, and whether the new president will continue to prioritize these areas of American leadership.As Congress ultimately sets the budget and appropriates funds, it will also be critical to watch this body. As a check on executive power, Congress has the power to accept, reject, or find middle ground with the president’s proposal. Importantly, while there have been shifts in the makeup of Congress, strong global health and medical research champions remain—and we can look to these members to support continued and robust investments in these areas.GHTC will be closely following the budget and appropriations process to ensure US leadership in global health and medical research continues to be prioritized. The United States leads the world in investment in global health R&D, so any changes to US funding—positive or negative—can have a significant effect on global health research projects worldwide.Key nomineesWhile President-elect Trump has nominated cabinet-level officials, many of those who will assume leadership posts with a more direct role in global health, international development, and medical research have yet to be named. Who Trump picks to lead the US Agency for International Development (USAID), USAID’s Bureau of Global Health, the National Institutes of Health (NIH), and the Centers for Disease Control and Prevention (CDC) will provide insight into the administration’s plans for global health R&D.Key questions for these future nominees will include how a Trump Administration USAID will advance innovation to further development efforts, how new leadership of NIH will prioritize research that benefits the health of Americans and the global community—including research for both emerging and long-standing disease threats—and how the CDC will continue leadership in critical work to prevent, detect, and respond to emerging health threats around the world, including investments in new technologies.Commitment to US leadership in global health and international developmentPresident-elect Trump has not yet articulated a policy direction on global health and international development. On the campaign trail, Mr. Trump promisingly expressed support for signature US global health programs like President Bush’s President’s Emergency Plan for AIDS Relief (PEPFAR), and his nominee to lead the State Department, Rex Tillerson, stated in his nomination hearing that PEPFAR is a “remarkable success” and model we should look to in the future. However, recent reports cite potential skepticism toward health, development, and aid programs. Members of the Trump transmission team have asked “Is PEPFAR worth the massive investment when there are so many security concerns in Africa?” and “Is PEPFAR becoming a massive, international entitlement program?” The team is also cited as questioning US engagement in Africa more broadly, including whether corruption in African governments means US aid to certain countries is “stolen.”Photo: CDC/James GathanyWhile worrisome, our hope is that this line of questioning leads to a better understanding of the value of US investments in regions such as Africa. GHTC will continue to champion the United States’ history of leadership in global health and development, as well as highlight the dramatic number of lives saved and other returns to economic growth and national security from US investment in global health and development. Prioritization of global health securityRecent outbreaks of Ebola and Zika have demonstrated that America is not immune to diseases and health conditions that have traditionally only threatened other geographies. Global health is American health, and recent efforts to strengthen health security and infrastructure around the world through initiatives such as the Global Health Security Agenda, are beginning to show impact.Given the increasing threat of diseases with potential to impact American health, it is likely that global health security could rise to the top of the Trump Administration’s global health agenda. In order to address this urgent need, Mr. Trump will need to support robust and expanded activities to prevent, detect, and respond to emerging diseases that threaten American and global health. This must include establishing dedicated funding for both emergency response to threats as they occur and ongoing investments to strengthen health systems and bolster capacity to prevent, detect, and respond to emerging diseases, including investments in the development of new technologies.Engagement with key multilateral bodiesMultilateral partnerships are essential to global health policy that works for the United States. In an interconnected world, we can’t stop the spread of new, emerging diseases or eradicate long-standing heath challenges like polio without countries working together in partnership. Strong participation in bodies like the United Nations (UN), the World Health Organization (WHO), and the Global Fund to Fight AIDS, Tuberculosis and Malaria is key to advancing American leadership, as well as to ensuring that those organizations function as effectively as possible. While the Trump administration has offered general statements implying more inward-facing policy, several of his nominees to defense and diplomatic positions have stressed the value of strong international and multilateral engagement as a “force multiplier” for the United States GHTC will also be monitoring efforts in Congress to restrict funds to the UN. Political tensions around passage of a UN Security Council Resolution on Israeli settlements have prompted several US legislators to introduce bills and resolutions to defund the UN, with some proposing a fifty percent reduction in funding to all UN agencies—including WHO, the UN Development Programme, and other specialized agencies. While these measures do not currently have bipartisan support, any cuts to the UN and UN agencies would have significant effects on global health programming and achieving global goals for health and development.GHTC is committed to maintaining a strong, coordinated voice to champion policy that advances US leadership in global health R&D in 2017 and beyond. Global health, development, and medical research are historic areas of bipartisan agreement, and we look forward to maintaining this legacy and driving progress in the years ahead.

Surgical masks are a popular accessory worn in public spaces during outbreaks of airborne diseases, however, in reality, they provide limited protection against pathogens; they may trap viruses, but they can’t kill them. Consequently, even just the act of removing the mask can expose the wearer to a virus. A team of scientists at University of Alberta are hoping to change that. They have adapted the standard surgical mask so that it can both trap and deactivate viruses. The inspiration for the mask came from a challenge faced by lead researcher Dr. Hyo-Jick Choi in his work adapting vaccines for oral administration: when liquids (i.e., vaccines) turn into solids (i.e., pills), they crystallize, damaging the viral components that make the vaccine effective. Dr. Choi realized he could turn this challenge into an advantage to target viruses that come in contact with surgical mask. He and his team developed and applied a safe, salt-based solution to the masks. As predicted, when a virus—in this case, influenza—came in contact with the mask, it was destroyed, as the droplet carrying it crystallized. Dr. Choi has received a provisional patent and plans to further advance the innovation. Advocates are calling for greater inclusion of pregnant women in clinical trials, a necessary step to address critical knowledge gaps and improve health care for pregnant women and their fetuses. In the United States, nearly two-thirds of women receive at least one prescription during pregnancy, yet more than 90 percent of drugs approved by the US Food and Drug Administration over the past three decades have not been proven safe for use in pregnancy. The hesitancy to include pregnant women in clinical trials is well-founded: drugs and vaccines can cross the placental barrier, resulting in complications or birth defects. However, pregnant women need safe, effective medicines, and clinical trials ensure that negative side effects are caught early, limiting the number of patients impacted. Further, pregnant women are more susceptible to certain pathogens, and as illustrated by the ongoing Zika outbreak, pathogens can cross the placental barrier too, making treatment during pregnancy all the more imperative. Additionally, women may process drugs at higher rates during pregnancy, consequently requiring higher doses. Advocates argue that while testing experimental drugs in pregnant women is risky, it is much safer than allowing a medicine to enter the market, leaving the decision to physicians and patients. The Defense Advanced Research Projects Agency (DARPA), an entity within the US Department of Defense, invests in high-risk, high-reward research, developing innovative technologies to advance US national security, with its health portfolio spanning research from neural and psychiatric health to infectious diseases. Through its Biological Technologies Office, DARPA scientists are taking an innovative approach to drug development. Rather than relying on chemicals to generate novel drug compounds, researchers are genetically modifying yeast, bacteria, and other microbes to do the job. Already, BARDA’s work with yeast has resulted in nearly 100 new molecules, and officials hope to reach 1,000 over the next three years. DARPA is also devising new platform technologies to expedite the development and improve the efficacy of vaccines against emerging infections. One method uses nucleic acids (i.e., RNA and DNA) to signal to the immune system how to respond to a pathogen, rather than introducing a pathogen and allowing the immune system to learn how to respond on its own. If successful, this technology could be adapted for different diseases and would provide instantaneous protection—a significant advantage as most vaccines take at least two weeks to provide protection.

Secretary of State–designee Rex Tillerson. Photo: Center for Strategic and International StudiesWednesday’s nomination hearing for Secretary of State–designee Rex Tillerson provided an opportunity for the global health community to learn more about his views on the United States’ role in international development and global health.While the majority of the hearing highlighted policy toward Russia, human rights, global terrorism, and how Tillerson’s professional experience in the oil industry will impact his role as chief foreign policy advisor to the President, Tillerson was also questioned on women’s empowerment, family planning, development aid, and the President’s Emergency Plan for AIDS Relief (PEPFAR).Here’s what he said:Gender equity and women’s empowermentIn response to Senator Shaheen’s (D-NH) question on whether he would support programming to increase women’s empowerment, Tillerson described how these types of programs had been a priority for the Exxon Foundation and cited a program Exxon supported in Papua New Guinea. He committed to continuing these programs, noting “I think it’s an important part of our foreign aid assistance efforts, whether it’s through the USAID [US Agency for International Development] or whether it’s through other opportunities we have in more structured ways.”Family planning and reproductive health Senator Shaheen also pushed Tillerson on family planning and reproductive health, asking if he would pledge to “continue to prioritize quality family planning and reproductive health services for women worldwide, and ensure that resources and access to these programs are not conflated with support for abortion.” Tillerson responded that he was aware that the United States spends roughly a half a billion dollars per year on family planning aid, and he thinks this level of funding is “an important level of support.” Asked whether his answer represented a pledge to continue this commitment, Tillerson deferred, and said he would examine these programs further, if confirmed.Development aid and disaster assistanceSenator Flake (R-AZ) discussed the role of soft diplomacy with Africa and USAID programs, questioning what works and what doesn’t. Tillerson replied that it is important that US assistance be used to nudge countries toward diplomacy, punish countries when required, and encourage cooperation. He noted that USAID has two important streams of assistance: disaster relief, to address immediate suffering, and development assistance, which is important for achieving lasting change. He said that recently the proportion of disaster assistance relative to development assistance has been growing, which constrains the government’s ability to use aid as a tool for change. He suggested when possible, the United States should tie assistance to behavior change and then follow up. He also said that assistance should be targeted, designed to support American values, and help countries continue their own development. He noted that tying aid to governments meeting obligations is hard to do with disaster relief, and that he understands and appreciates this difference.PEPFARWhen questioned about PEPFAR by Senator Flake, Tillerson called it “one of the most extraordinarily successful programs in Africa.” He described how he saw the success of global health programs up close through Exxon’s work to eradicate malaria in central Africa. He noted that PEPFAR broadly has generated much goodwill from Africa and “recognition of the goodwill and compassionate nature of American people,” calling PEPFAR one of the best projections of America to the African people.Questioned by Senator Markey (D-MA) on his views of PEPFAR and the Global Fund to Fight AIDS, Tuberculosis and Malaria, and his commitment to strengthening these programs in the years ahead, Tillerson replied: “PEPFAR is one of the remarkable successes of the past decade or more…I think what’s notable about PEPFAR is that there are measurable results…I think it serves as a model for us to look to as we’re thinking about other ways in which to project America’s values, project our compassion to want to solve these threats that are in other parts of the world that by and large we’re not threatened by a lot of this here in this country. Malaria was eradicated decades ago, TB well under control, AIDS—great treatment programs are available to people. Projecting that into other parts of the world is a marvelous way to send a message of the compassion of the American people that we care about people’s lives all over the world. So PEPFAR is a terrific model to look at in the future as we look at other areas that may be useful for us to put additional programs in place.”At GHTC, we will continue to monitor Tillerson’s views on US support for global health and development aid and urge strong support for programs that further the development and rollout of urgently needed global health technologies.