News: Announcement

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.  

The prospect of deep cuts in the federal budget threatens to reverse the dramatic progress of a bipartisan US commitment to defeat neglected diseases in developing countries, according to a new report released today by the Global Health Technologies Coalition (GHTC). Federal investments in global health research and development (R&D) programs that span multiple agencies have helped nurture an array of new vaccines, medicines, diagnostics, and other health products needed to combat diseases like HIV/AIDS, malaria, tuberculosis (TB), and childhood killers like pneumonia and diarrheal diseases. Despite these advances, President Obama's budget request for 2013 calls for several decreases for global health when compared with last year's levels. Several global health R&D programs at US agencies also saw drastic funding cuts. There are widespread concerns that cuts to global health R&D programs, which support critical efforts to develop the next generation of lifesaving health products, could grow even larger, given the pressure to reduce the US budget deficit. "[T]he budget climate in the United States continues to be severe, and US policymakers are beginning to implement austerity measures that could impact funding for global health R&D," the GHTC report stated. "Indeed, the continuing fiscal situation undoubtedly puts these programs at risk in the future, when global health R&D programs could see even more severe funding cuts than have already occurred." According to the GHTC report, global health R&D projects are among the best investments US policymakers can make, which would make funding cuts even more devastating. Last year alone produced multiple research breakthroughs, including results from a trial showing that early antiretroviral treatment can prevent HIV transmission to uninfected partners and results from a Phase III malaria vaccine trial showing that the vaccine candidate known as RTS,S can provide young African children with significant protection against clinical and severe malaria. "It would be ironic if widespread and unprecedented cuts in global health R&D were to take place just as past investments begin to bear fruit," said Kaitlin Christenson, MPH, GHTC's director. "US commitment was instrumental in eradicating smallpox and conquering polio and is now helping achieve unprecedented reductions in deaths from malaria and diarrheal diseases. Equally dramatic breakthroughs can be expected for a variety of other diseases if we continue to invest in research for new lifesaving health products." GHTC, which represents 40 nonprofit organizations focused on developing new vaccines, drugs, and other disease-fighting tools for the developing world, warns that the future could look far different from the progress being made today. Its report, Sustaining Progress: Creating US policies to spur global health innovation, found that while the US commitment to global health R&D has bridged deep political divides in Congress and garnered particularly strong support from the last two presidential administrations, it is now confronting a major test. The report notes that in the 2012 budget process, some individual global health R&D programs experienced reductions, alongside cuts to what are known as product development partnerships (PDPs)--relatively new and innovative types of public-private partnerships focused on developing drugs, vaccines, diagnostics, and other products specifically for patients in low-income countries. In addition, the report found that overall investments in global health R&D remained far short of what is actually needed. Global health R&D is spread throughout the US government and includes research and product development efforts supported through a variety of programs at the US Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the Department of Defense (DoD), and the US Agency for International Development (USAID). The GHTC report points out that the US is not alone in trying to balance the need to address fiscal constraints with maintaining a commitment to reducing global health disparities. The report cites the recent "Global Funding of Innovation for Neglected Diseases" survey, which found that in 2010, investments in R&D from all sources worldwide, public and private, fell by 3.5 percent. Public sector investments declined the most, dropping by 6 percent. According to the GHTC report, "The rest of the world is struggling with the same global financial crisis that is challenging the United States." Further, "other major donors could be inclined to maintain their commitments if the United States persists." GHTC also recommends an increased emphasis on health-related R&D in major international development programs, such as the President's Emergency Plan for AIDS Relief (PEPFAR). According to the report, "US investments in global health research can produce real results, and the nation must persist in our efforts to develop the next generation of lifesaving health products. US leaders have the opportunity to seize on this bipartisan legacy and recent scientific advancements and stay focused on the end goal--saving lives around the world. The United States cannot give up now."