Research Roundup: Underestimating Zika & Chagas and hopes for the Ebola vaccine in the DRC

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.

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.