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On Tuesday, the Trump Administration released its full fiscal year 2018 (FY18) budget proposal, “A New Foundation for American Greatness.” As foretold by the “skinny budget” proposal released in March, this budget proposes dramatic increases in defense spending and border security, offset by cuts to discretionary spending—including significant cuts to programs that support global health and medical research at the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and the US Agency for International Development (USAID). Dramatic cuts to global health programs at the State Department & USAID At a high-level, President Trump proposed roughly a 25 percent cut to global health programs at the State Department and USAID, when compared to final fiscal year 2017 (FY17) funding levels. Looking just at USAID global health programs, funding levels were reduced over 50 percent from FY17 levels, from US$3.05 billion to $1.5 billion. The Administration also used the budget proposal to advance goals of streamlining USAID and State Department operations to find cost savings and efficiencies. Despite strong bipartisan support for the United States’ flagship global HIV and AIDS program, the President’s Emergency Plan for AIDS Relief (PEPFAR), HIV and AIDS programs across State and USAID were targeted for cuts and consolidation. Direct funding for PEPFAR through the State Department received a $477 million cut, dropping to $3.85 billion from $4.32 billion, and USAID funding for complementary HIV and AIDS programs was zeroed—reflecting a funding cut of $330 million. The zeroing of HIV and AIDS programs at USAID also means associated research and development (R&D) funding for HIV vaccines and microbicides was eliminated. Man and woman standing in front of a sign that reads "USAID." (PATH/Felix Masi)Other funding cuts include a $62 million cut to global tuberculosis (TB) programs—including cuts to the TB drug facility and multidrug-resistant TB financing—a $65 million cut to maternal and child health programs, a $47 million cut to nutrition programs, and a $25 million cut to programs for neglected tropical diseases. USAID malaria programs (the President’s Malaria Initiative) received an $81 million cut, after factoring in a proposed $250 million transfer of remaining Ebola funds. USAID family planning programs were eliminated.Slashed funding for medical research at NIH and public health protection at CDC Biomedical research also saw significant cuts, with a proposed $7 billion or 21 percent cut to NIH. Of particular importance to global health R&D, the Administration proposed a $1.1 billion cut to the National Institute for Allergy and Infectious Diseases—which leads research in infectious diseases like HIV and AIDS, Ebola, and Zika—and elimination of the $70 million Fogarty International Center, which builds partnerships and trains researchers around the world. Instead, the Administration allocated $25 million to the Office of the NIH Director to coordinate global health research. At the CDC—our lead agency for preventing, detecting, and responding to public health threats at home and abroad—overall budgets were cut by $1.3 billion, over 15 percent. This included a $70 million cut to CDC’s National Center for Emerging and Zoonotic Infectious Diseases and an $85 million cut to the Center for Global Health.What happens next for global health R&D?These broad and wide-ranging cuts proposed for global health and medical research programs are deeply concerning, and threaten to reverse gains achieved through our landmark global health programs, stall progress in promising research, and ultimately jeopardize lives at home and abroad. They also are in stark contrast to stated goals of the Trump Administration to honor our commitments to global health, bolster global health security, and support high-priority biomedical science.Fortunately, Congress has ultimate control over government spending, and leadership on both sides of the aisle has asserted that dramatic cuts to foreign aid, global health, and medical research will not pass muster. As FY18 negotiations continue in Congress, GHTC will continue to stress the importance of global health R&D programs across the US government and highlight the critical role US-supported research plays in saving lives at home and around the world.

Photo: CDC/ Dr. Scott SmithHealth ministers from G20 nations, meeting for the first time last Thursday and Friday, pledged to work together to combat antimicrobial resistance (AMR) and improve pandemic preparedness, emphasizing the critical role research and development (R&D) plays in confronting these global challenges. “By putting global health on the agenda of the G20, we affirm our role in strengthening the political support for existing initiatives and working to address the economic aspects of global health issues,” stated the declaration released Saturday. “Global health risks, such as infectious disease outbreaks and antimicrobial resistance (AMR), have a severe impact on the lives and well-being of millions of people as well as on the global economy. Since these global challenges cannot be addressed by one country, region or sector alone, they call for a coordinated global response.” In the declaration, G20 health ministers noted the role of new and improved medicines, vaccines, diagnostics, and other health tools in containing infectious disease outbreaks and pledged support for new models for R&D preparedness: “Research and Development (R&D) are necessary for the timely availability and development of new and improved quality medicines, vaccines, diagnostics and medical equipment for containing emergencies. This requires mobilization of national and international research efforts and facilities, and norms and commitments to share data and samples, in accordance with national legislation, and public health benefits in an inclusive, timely and transparent manner. In addition, sustainable funding and effective international R&D coordination is needed.  We welcome and support new models for R&D preparedness including the “WHO R&D Blueprint”, the Global Research Collaboration for Infectious Disease Preparedness (GLOPID-R) and the “Coalition for Epidemic Preparedness Innovations (CEPI)”, which is developing new vaccines for epidemics. We underscore the importance that products emerging from such R&D efforts become accessible to all people in need. In regard to sample and data sharing, we recognize the importance of the WHO global influenza surveillance and response system and Pandemic Influenza Preparedness (PIP) framework, as well as the global initiative on sharing all influenza data.” The declaration also noted concern about the insufficient R&D pipeline of antimicrobial therapies and highlighted the importance of fostering R&D for new antimicrobials and other vital health tools, citing support for incentive mechanisms and global partnerships to spur technology development: “We note with concern that the research and development (R&D) pipeline for developing new antimicrobial therapies against life-threatening and highly resistant organisms has been drying up and does not correspond to the global needs in light of growing antimicrobial resistance during past decades. We highlight the importance of fostering R&D for new antimicrobials, alternative therapies, vaccines and rapid-point-of care diagnostics, in particular for priority pathogens as identified by WHO and for tuberculosis. We recognize the importance of reactivating the R&D pipeline through incentive mechanisms that avoid the reliance on high price/volume combinations. We also recognize the need to promote prudent and responsible use of antimicrobials. In the Hangzhou G20 Leaders’ Communiqué, G20 leaders called on the WHO, FAO, OIE and OECD to collectively report back in 2017. Their report ‘Tackling Antimicrobial Resistance, Ensuring Sustainable R&D’ will be considered by leaders when they meet on 7-8 July. In this context we support ongoing initiatives, examining push and pull mechanisms that take into account needs of all countries and stress the need for a better coordination of existing initiatives. Furthermore, we note the importance of affordable access to new and existing antimicrobial drugs, diagnostic tools, alternative therapies and vaccines of quality to all patients in need. We will preserve the widest possible therapeutic treatment options through avoiding removal of old antibiotics from the market and work for a sustainable solution to address this issue. To reinvigorate research and development in science and industry for antimicrobials, we welcome and build on the work of existing global and regional product development partnerships and funding initiatives such as the Global Antibiotic Research and Development Partnership (GARDP), launched in May 2016 by the WHO and the Drugs for Neglected Diseases initiative (DNDi), UNITAID, the Joint Programming Initiative on AMR (JPIAMR), Combating Antibiotic Resistance Bacteria Biopharmaceutical Accelerator (CARB-X), Innovative Medicines Initiative (IMI), the TB Alliance for new anti-tuberculosis medicines. We commit to broaden the voluntary financial support for these initiatives. We call on other countries, philanthropic organizations, academia and the private sector to support these initiatives. We recognize the necessity of tools such as Target Product Profiles to describe high need products and the importance of prioritization of pathogens, to steer R&D efforts to the most pressing public health needs. Therefore, we welcome the WHO priority pathogen list, which, in addition to existing recommendations for HIV, TB, Malaria and NTDs, should guide R&D for antimicrobials. We recognise drug-resistant tuberculosis as an important threat and therefore commit to address tuberculosis within interventions for AMR. We acknowledge the need to develop and promote access to new drugs, diagnostics and vaccines to tackle drug-resistant tuberculosis consistent with the WHO End TB Strategy. We recognize the importance of other relevant initiatives and plans, such as the STOP TB Partnership. We welcome the decision by Member States to hold a United Nations High-Level Meeting on Tuberculosis in 2018 and the WHO Ministerial Conference on Ending TB in the Sustainable Development Era to be held in Moscow in November 2017.” The inclusion of supportive language for R&D in the health ministers’ declaration follows calls by GHTC and partners for G20 leaders to commit investment in research, innovation, and development of innovative health technologies to counter threats posed by AMR, poverty-related and neglected diseases, and pandemics. The health ministers’ declaration will feed into and inform outcomes of the G20 leaders’ summit in Hamburg, Germany, in July, where G20 leaders will release a final joint communique. While GHTC is very pleased with the health ministers’ clear acknowledgment of the importance of R&D, we also caution that this is not the end of our advocacy efforts for the G20. While the health ministers are clearly on board, the advocacy community must keep pushing to ensure that global health R&D does not get lost in the much larger debate that happens for the full, formal G20 communique. We look forward to working with all of our partners to do so.

Researchers at the University of Cape Town discovered a compound that blocks the cycle of malaria within the human body, regardless of its drug-resistant status. The compound acts a preventative tool as well as a treatment for those infected with malaria, as it can block transmission and prevent infection. The compound, MMV390048, began phase I clinical trials in 2014, but subsequent data has not yet been published. The drug will enter phase II clinical trials this year in Ethiopia, and it is hoped this drug will be on the market within the next ten. With the world circling in on polio eradication, global public health professionals have run into a major obstacle that makes ridding the disease incredibly complicated: A vaccine shortage. There currently isn’t enough injectable polio vaccine for the world to use, as demand is so high. There isn’t enough of the vaccine in production for each child to receive two shots, which is what researchers suggest to protect against contracting polio. An alternative is the oral polio vaccine, but due to its heightened risk of complications, professionals believe this vaccine will soon be phased out. While polio vaccine manufacturing may be ramped up to treat children in the next few years, it is essential that health care professionals continue to vaccinate children ten years post-eradication to ensure there is no resurgence of the disease. Funders, including the Gates Foundation, are now putting efforts toward the next surge in vaccine demand, and hope to overcome this obstacle to reach global eradication of polio once and for all. An outbreak of Ebola has been confirmed in the Democratic Republic of the Congo (DRC), and health researchers around the globe are working to distribute an experimental vaccine. While the outbreak is contained due to the geographic isolation of the cases, the WHO and Gavi are still working quickly toward an effective and globally approved vaccine that can be used in future outbreaks. The DRC has not requested a vaccine at this point in time, but these organizations are prepping for when the country requests it, or for if the outbreak spreads past the DRC. The vaccine is experimental, and requires special modes of transportation, yet proved incredibly successful during the Ebola outbreak of 2014.

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.