News: Announcement

The Global Health Technologies Coalition (GHTC) today released a paper that provides new and comprehensive insights into the challenges facing organizations that advance research and development (R&D) for neglected diseases. The paper—titled Financing and Coordination of Health Research: Perspectives from Nonprofits on Accelerating Product Development and Improving Access for Low- and Middle-Income Countries—also offers concrete solutions to these obstacles. The paper focuses on how nonprofit product development organizations (NPPDs) work to advance R&D for diseases in low- and middle-income countries (LMICs), such as HIV/AIDS, tuberculosis, malaria, neglected tropical diseases, and maternal and reproductive health conditions. NPPDs are nongovernmental organizations that partner with the public, philanthropic, and private sectors to develop health products—including diagnostics, drugs, devices, vaccines, and microbicides—specifically targeted for health needs in LMICs. NPPDs play a vital role in bringing together the fragmented resources and expertise of the various sectors involved in neglected disease R&D—not only by developing and delivering health products that would not be available otherwise, but also by improving scientific understanding for many of these conditions. For example, the NPPDs included in the paper reported contributing to the development of more than 450 health technologies across neglected and infectious diseases, as well as maternal, newborn, child, reproductive, and sexual health. Despite this progress, NPPDs reported significant gaps in current R&D efforts. These obstacles include: Funding: Numerous NPPDs said that there are too few funders investing too few resources in R&D for neglected and poverty-related diseases. In 2010 and 2011, 12 funders accounted for almost 90 percent of these R&D efforts. This lack of funding threatens to stall or halt progress. Regulatory systems: Navigating weak and disjointed regulatory systems can be a major obstacle for NPPDs. Many cited a lack of consistent regulatory requirements, as well as limited capacity of national regulatory authorities, as the cause of major delays and increased costs. Local capacity: NPPDs also reported that limitations on local research and manufacturing capacity hinder their ability to keep the R&D pipeline filled and successfully deliver new health tools. Fortunately, the paper offers the following solutions, which were identified by NPPDs as necessary to enabling the successful development and delivery of new health tools for LMICs: Sustainable and consistent funding. More predictable, stable, and long-term funding across all phases of product development is needed, as well as diversified funding sources and improved coordination across funders. Better coordination could be achieved through a centralized mechanism tasked with identifying R&D needs, gaps, and priorities. Capacity building for local partners. NPPDs and their partners need sufficient resources to invest in strengthening their local partners’ research and manufacturing capacities. Improving regulatory pathways and capacities. NPPDs noted that policy changes and adequate, sustainable funding are needed to support capacity building and alignment of regulatory requirements. This paper is the first in a series from the GHTC that will examine financing, accessibility, regulatory, and capacity issues facing NPPDs. The series aims to inform global policy and financing discussions about R&D for neglected and poverty-related diseases affecting LMICs. This first paper provides a high-level overview of the greatest gaps and challenges faced by NPPDs, and further papers will explore these issues in greater detail.

The Global Health Technologies Coalition (GHTC) recently released the Global Health Regulatory Requirements Database. The database is a unique resource designed to help researchers and regulatory professionals access necessary information to develop effective strategies for gaining approval to conduct clinical trials and market products.The database includes high-level regulatory information on a variety of countries in Africa, Asia, and Latin America, as well as links to key guidance documents and other resources where users can find more detailed information. Information included in the database includes: contact information for national regulatory authority regulators; information on the country’s institutional review board structure; an overview of clinical trial and product registration data requirements, costs, and timelines; and post-registration pharmacovigilance requirements. The Global Health Regulatory Requirements Database offers users easy navigation from country to country, and separates technology specific information into three categories—drugs, vaccines, and diagnostics. Information will be reviewed and updated regularly to ensure its accuracy, as well as to expand the country and data information included. To access the database, please click here.

Across-the-board cuts to US R&D programs could have a devastating impact on efforts to develop new drugs for tuberculosis (TB) and HIV/AIDS, the world's first malaria vaccine, and other vital global health products in development, according to a new report from a coalition of nonprofit groups focused on advancing innovation to save lives. "We know that policymakers are currently facing difficult budget decisions. But any reductions in funds could eliminate essential support for the development of global health tools and slow or halt the progress made against addressing a number of deadly diseases," said Kaitlin Christenson, MPH, director of the Global Health Technologies Coalition (GHTC). The report from the GHTC, Renewing US leadership: Policies to advance global health research, comes as Washington is bracing for a "budget sequestration" process that, according to some estimates, could cut 5.2 percent from programs across government, including initiatives that have put hundreds of new drugs, vaccines, diagnostics and other disease-fighting tools into the product pipeline and established the US as the world's leader in developing life-saving global health technology. The analysis finds the cuts to global health R&D "would barely make a dent in reducing the US federal deficit but would have a crippling impact on people's health and lives around the world." "There is much to lose by pulling back now," the report states. Some estimates predict that under sequestration, global health initiatives at the State Department and US Agency for International Development (USAID) could lose $482 million, money that supports, among other things, the development of new drugs to quell an alarming resurgence in deadly TB and new tools to escalate the fight against HIV/AIDS. Meanwhile, the National Institutes of Health (NIH), which is supporting a new dengue vaccine candidate, new HIV prevention methods, and potential new treatments for TB, could lose nearly $2 billion. In addition, the sequestration process would result in steep losses for R&D programs funded by the US Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the Department of Defense (DoD). Taken together, the cuts throughout the government could jeopardize any number of the 200 global health products that have advanced in the research pipeline thanks to US support. Conversely, the GHTC finds that "continued and consistent US investment in R&D...will provide the momentum needed to push promising new tools over the finish line." These tools include: a new microbicide that could give women the power to protect themselves from contracting HIV with or without their partners' cooperation; new insecticides that could help control insects that spread deadly diseases like dengue fever, Chagas, filariasis, and leishmaniasis; new drugs and vaccines to help fight back against the alarming spread worldwide of drug resistant TB; modern reproductive technology that could greatly lower maternal mortality rates by giving women worldwide the ability to plan for the birth of their next child; and a new oral drug for African sleeping sickness, which is fatal without treatment. "Today, all across the US government we see solutions emerging to global health problems we've been fighting for decades, or, in some cases, centuries," said Steve Davis, President and CEO of PATH. "The DoD is helping advance a promising AIDS vaccine candidate. The FDA is spurring the development of new drugs and vaccines for TB. NIH is helping to put us ever closer to a malaria vaccine. The CDC is coming up with a new test for detecting dengue virus, which is critical to monitoring its rapid spread. And USAID is providing essential support for new reproductive health technologies." "US taxpayers are rightly demanding results from federal expenditures," Davis added, "and the wise investments our government has made in global health R&D are clearly providing excellent returns." The GHTC report notes that US investments in global health R&D have helped deliver "some of the greatest advances" the field has ever experienced. Recent achievements include a new, highly effective Africa-specific vaccine for meningitis A; a new rapid test for detecting TB; and the world's first malaria drug for children. The GHTC also finds that global health expenditures, which include support for product development partnerships (PDPs) with the private sector, are helping boost the nation's economic performance. The report cites evidence that "64 cents of every dollar spent by the US government on global health R&D goes directly to US-based researchers and product developers." Moreover, the drugs, vaccines and diagnostics so crucial to saving lives in countries with high burdens of infectious diseases are increasingly needed to protect public health on the home front. For example, just this past summer, Florida experienced its largest TB outbreak in 20 years. Dengue fever has now persisted on the US mainland long enough that it may have developed its own unique US strain. And Chagas, a disease carried by so-called "kissing bugs" that can cause serious heart and digestive problems, is now migrating northward from Latin America. Up to one million cases have been found in the US, with the disease burden believed to be particularly high along the Gulf Coast. The GHTC report observes that "there are an estimated five million impoverished Americans who live with neglected tropical diseases--including a previously hidden burden of neglected diseases among the poor in the southern United States." The GHTC asserts that, ultimately, if "the damaging effects of sequestration do take place, agencies must do their best to protect product development priorities within their budgets." "Even in these difficult fiscal times, US policymakers must persist in their support for global health research," the report states. US Legacy and Leadership at Risk The GHTC report finds that the threat of cuts via sequestration is part of a broader and troubling trend that has seen US support for global health decline over the past few years. For example, the latest Global Funding of Innovation for Neglected Diseases (G-FINDER) survey documented a $30 million drop in 2011 in US support for global health-related research and product development. GHTC worries that the US is drifting in a way that could "put the nation's legacy as a scientific and humanitarian leader at risk." The report points out that the sequestration debate is occurring at the same time lawmakers are debating funding levels for the rest of this year and for 2014--a separate discussion, but one that also has significant implications for global health research. GHTC views the 2013 and 2014 appropriations process as an opportunity for the US decision makers to step back and re-examine budget priorities and "reverse the trend of decreased global health and R&D funding seen in recent years." According to the GHTC, "There could not be a better time for the United States to renew its global health R&D legacy." Also, given that budget pressures will demand better performance from government-funded endeavors, the GHTC is calling for a new "five-year strategy" that coordinates global health research and product development across the federal government. The GHTC envisions a strategy that, among other things, clarifies priorities and provides "metrics to measure success." The GHTC believes work should begin now with the goal of completing the strategy by December 2014.

The Global Health Technologies Coalition (GHTC) and Policy Cures recently called on the US Government to fund all stages of research—from early, basic research stages to later stage clinical trials—to create global health tools such as vaccines, drugs, diagnostics, microbicides, and devices. In a letter-to-the-editor in BMJ, the two nonprofits stress that all stages of research are critical for global health product development. GHTC and Policy Cures also emphasize that while the US Government currently provides most of its support to basic, discovery, and preclinical research, the US should also increase its funding for the final stages of product development, which are often the most expensive and in need of support. “This current system is unsustainable as more and more products move into these expensive, later-stage clinical trials. Given that there is now the largest pipeline of new global health products in history, with a total of 365 products under development, this scenario is very likely in the near future,” the letter reads. Many important global health products have been produced thanks to US Government support—and a very critical part of the development cycle is basic research, which has helped produce successful candidates that now need support in clinical trials. The US government can help push the next generation of lifesaving products into completion by supporting all stages of global health product development. To read the entire BMJ letter, click here. To read the GHTC and Policy Cures report, click here.