News: Announcement

As the world looks to American innovation to fight Ebola, malaria, tuberculosis, and a host of other health threats, a new report released today on Capitol Hill warns budget battles in Washington are eroding preparedness at home and abroad at a time when scientific advances are poised to deliver new lifesaving drugs, vaccines, and diagnostics. “Since 2009, we’ve seen declining, or at best stagnating, support for global health research and development, with politics trumping prudent investments that could protect the US and the world from an array of threats,” said Erin Will Morton, director of the Global Health Technologies Coalition (GHTC), an influential alliance of 25 nonprofit organizations seeking new tools to address existing challenges, including HIV/AIDS and tuberculosis; emerging problems, such as drug-resistant superbugs and dengue; and neglected diseases, like sleeping sickness and river blindness. The prospect of additional cuts is alarming disease experts, who warn that the next global health crisis could already be brewing in places like war-ravaged Syria and ISIS-occupied Iraq, where there has been an alarming rise in polio, measles, leishmaniasis, typhoid fever, hepatitis A, and meningitis. Meanwhile, Chagas, dengue, and chikungunya are gaining a foothold in the US. And the degraded health systems that abetted the spread of Ebola are not peculiar to West Africa: a recent report from Save the Children warns 28 countries are “highly vulnerable” to a deadly disease outbreak. Morton noted that while the Ebola crisis exposed the dangers of ignoring neglected diseases, one bright spot was the ability of US agencies to collaborate and quickly roll out desperately needed diagnostic tests and launch clinical trials for new drugs and vaccines. “But these innovations are the product of past investments that provided consistent, long-term support to researchers who steadily generated incremental advances,” she said. “So by failing to provide sufficient support today, we are systematically degrading our ability to respond to the next global health crisis.” The GHTC analysis notes that in the first decade of the 21st century, the United States doubled support for global health research and development (R&D). And it was rewarded with dozens of health innovations that have contributed significantly to major milestones in global health: since 1990, there has been a 50 percent drop in childhood deaths, a 45 percent decrease in maternal deaths, and a 25 percent reduction in deaths from infectious diseases. But since 2009, a succession of budget battles that culminated in the across-the-board “sequestration” cuts of 2013 reduced total US government spending for global health R&D by US$185 million, or 11 percent below 2009 levels. (Overall, global investments in neglected diseases fell by 6.2 percent in this period, placing more importance on the US—where economic conditions are improving faster than in other wealthy regions—to lead the fight.) The GHTC report acknowledges budget agreements in 2014 and 2015 have provided a respite from the sequester cuts. But it points out that, aside from the $5.4 billion in FY 2015 in emergency funding for Ebola, investments have remained largely stagnant for global health R&D activities across the government, which includes work at the US National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), the Department of State, the US Agency for International Development (USAID), the Food and Drug Administration (FDA), and the Department of Defense (DoD). And global health budgets could face another round of automatic spending cuts this fall if President Obama and Congress fail to strike a new budget agreement. “Governments were in many ways caught unaware by Ebola—despite decades of warnings from disease experts—yet instead of learning the lesson, we could end up heading in the opposite direction with investment decisions that would actually make the world even more vulnerable,” said Daniel G. Bausch, MD, MPH&TM, a consultant to the Office of Pandemic and Epidemic Diseases at the World Health Organization, who has worked on the front lines of the Ebola outbreak. “That’s unfortunate, because global health challenges present not only an opportunity for leaders in the field, such as the United States, to assert humanitarian leadership and do what’s right, but also an opportunity to ensure that those leaders remain global hubs for biomedical innovation." For example, the GHTC analysis notes that about “sixty-four cents of every dollar spent by the US government on global health R&D goes directly to US-based researchers and product developers, creating jobs, spurring business activity, and strengthening US competitiveness in research and technology.” And the report asserts these innovations directly contribute to economic progress in the global economy. The Lancet Commission on Investing in Health found that between 2000 and 2011, health improvements accounted for at least 11 percent of the economic growth in the world’s low- and middle-income countries. Dropping Our Guard at a Time of Peril and Promise The GHTC report reels off a long list of critically important innovations now under development that could be slowed or even derailed by anemic funding for global health R&D. They include new treatments to counter the disturbing rise of drug-resistant tuberculosis, malaria parasites, and bacterial superbugs; new diagnostic tools to help fight outbreaks like Ebola, where health professionals struggle to distinguish between conditions that have frustratingly similar symptoms; and new drugs and vaccines for neglected diseases like leishmaniasis, which threatens 350 million people around the world, and Chagas, which in Latin America kills more people than malaria. The GHTC is particularly concerned about how the budget cuts could affect work at the NIH, widely recognized as the powerhouse behind global health R&D and where a greater focus on translational research is placing more emphasis on product development. For example, in addition to its leadership in developing Ebola drugs and vaccines, NIH is supporting development of AIDS vaccines that could prevent infections, along with microbicides that could reduce sexual transmission of HIV. NIH also is supporting a new universal influenza vaccine candidate that could provide a major breakthrough for fighting both seasonal and pandemic flu and a new class of antibiotics that could be a potential game changer in the fight against drug-resistant superbugs. GHTC members noted that all of this work would be disrupted by across-the-board cuts. In addition, the GHTC warns that further cuts could hamstring the USAID’s new Global Development Lab, which includes a focus on innovations to advance maternal and child health, as well as the Grand Challenges competition for Ebola. Meanwhile, consistent funding is seen as crucial to CDC’s effort to develop better diagnostics and protective gear for fighting infectious diseases, the DoD’s role as a crucial player in the push for Ebola and AIDS vaccines, and the FDA’s initiatives to encourage product developers to coordinate early to tackle global health problems. In addition to providing strong and stable funding for global health R&D, the GHTC report also urges policymakers to make better use of existing investments and accelerate product development by taking concrete steps to better coordinate the global health work taking place across the government. Key activities include passage of legislation to support R&D efforts at USAID, incorporation of R&D into the Global Health Security Agenda, and creation of an overarching government-wide strategy for global health R&D. The GHTC also believes the US can leverage its leadership and influence in world affairs to ensure global health R&D assumes a prominent place in the United Nations’ new agenda for global development that will be finalized in September. “At a time when entrenched political divisions are causing many to search for areas of consensus, support for global health R&D stands out as important issue that can attract bipartisan support,” said Morton. “American-led innovation is also a great antidote to the fear that can surround threats like Ebola and AIDS and a way to encourage a more stable, prosperous and secure world.”

Today the Global Health Technologies Coalition (GHTC) welcomes Erin Will Morton as its Coalition Director. Morton joins the GHTC from her previous position as Senior Policy and Advocacy Advisor at the District Policy Group. While at the District Policy Group, Morton worked with a range of clients to develop and implement strategic government relations and advocacy programs. Morton has extensive experience in managing and convening coalitions and building support among coalition member organizations, and she has worked on a variety of policy areas, including grassroots advocacy, global health, medical simulation, Medicare reimbursement, and cancer care. Before joining the District Policy Group, Erin worked in the political department of NARAL, a national nonprofit women’s reproductive health organization in Washington, DC, where she participated in grassroots organizing during the 2006 Congressional elections. Erin received her bachelor’s degree from Dickinson College and a master’s degree from Johns Hopkins University. Morton is succeeding Kaitlin Christenson, who served as GHTC Coalition Director from May 2009 to October 2014.

The Global Health Technologies Coalition (GHTC) today released a new paper—co-authored with the Council on Health Research for Development (COHRED), the International AIDS Vaccine Initiative (IAVI), and PATH—which makes a case for why the research and development (R&D) of new and improved high-priority health technologies targeting the needs of low- and middle-income countries (LMICs) should be a critical component of the post-2015 development agenda. The paper—The Role of Research and Innovation in the Post-2015 Development Agenda—builds upon the findings of The Lancet Commission on Investing in Health and existing literature by: Highlighting the ways in which R&D for health has contributed significantly to progress made towards the Millennium Development Goals (MDGs) Discussing the rationale for continuous prioritization of R&D for health in the post-2015 development agenda Providing preliminary suggestions for areas to consider as potential indicators of progress in global health R&D and innovation While the paper details how past R&D investments have led to new health products which have driven significant progress toward achieving the health-related MDGs in the last decade, it also argues that current health technologies and levels of R&D investment are insufficient to overcome existing and emerging health threats and ultimately achieve the goals of the post-2015 agenda—poverty eradication and sustainable development. As the global community organizes around these ambitious goals, the paper calls on key players to recognize the value of health improvements in ending poverty and the role that research and innovation for new health technologies plays in not only improving health outcomes, but also driving economic growth and progress in LMICs. The paper notes the recommendations of The Lancet Commission on Investing in Health—which in its Global Health 2035 report—calls for a doubling of current R&D investments in health from all countries to bridge the health divide between the richest and the poorest in a generation. The Commission’s recommendation is based on data demonstrating that past investments in health innovation have driven not only significant progress in terms of increasing valuable life years in LMICs, but also in terms of economic growth. While adequate financing for health innovation is critical to spur the development of new health tools, it alone does not guarantee the development of more products and the right type of products for those populations most in need. Therefore, the paper recommends that any indicators used to measure progress against targets described in the post-2015 agenda also measure R&D outputs, as well as the enabling environment for innovation—including infrastructure, capacity, enabling policies, and partnerships. The paper concludes by noting that the post-2015 development agenda presents an opportunity for LMICs to set their own health and research priorities and to assert their leadership in strengthening the R&D landscape focused on the needs of the poorest and most marginalized populations. Finally, it calls for broad agreement among stakeholders that research and innovation for health—which includes both the scaling up of proven health interventions, as well as the development of new and improved technologies—is critical to meeting the ambitious goals of the post-2015 agenda. In addition to releasing this paper to inform discussion and debate, COHRED, GHTC, and IAVI released a petition last week—signed by over 150 organizations and individuals—calling for support in the post-2015 Sustainable Development Goals-Framework the research, development, and delivery of new and improved medicines, vaccines, and other health tools for the diseases and health conditions that predominantly affect LMICs as well as marginalized, vulnerable populations globally.

The Global Health Technologies Coalition (GHTC) today released the fifth and final paper and a summary of findings paper in its briefing series examining financing, accessibility, regulatory, and capacity issues facing nonprofits engaged in global health research and development (R&D). The five-part series aims to inform policymakers and other stakeholders with an interest in advancing R&D to meet health needs in low- and middle-income countries (LMICs). The series focuses on nonprofit product development organizations (NPPDs), or nongovernmental organizations that partner with the public, philanthropic, and private sectors to develop health products specifically targeting poverty-related and neglected diseases 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. The fifth and final paper examines efforts by NPPDs to strengthen the research and manufacturing capacity of academic, nongovernmental, and commercial partners in LMICs. The summary of findings paper provides an overview of the key challenges, lessons, and potential solutions identified by NPPDs in their efforts to advance the development of new vaccines, drugs, diagnostics, microbicides, and other health products for LMICs. The final paper on capacity-strengthening finds that while the mission of NPPDs is developing new health products, rather than capacity-building, many NPPDs have had to actively invest in improving the capacity and infrastructure of their local product development partners. This is because research and manufacturing infrastructure in LMICs remains weak, and many local partners have limited or no experience in conducting research and manufacturing in line with international safety and quality standards. NPPDs are engaged in capacity-strengthening work such as upgrading research and manufacturing facilitates, providing training across many skill sets, and transferring technological knowledge. In the capacity paper, NPPDs offer a set of key lessons that they and their partners have learned in trying to strengthen local research and manufacturing capacity to bring new health technologies to those most in need: There must be a shared commitment among partners to comply with international technical and ethical standards to ensure volunteers’ safety and rights as well as to facilitate access to high-quality products among those in need. Capacity-strengthening investments must weigh accelerating the near-term availability of much-needed products against the potential of lengthier timelines to increase capacity. At times, the need to accelerate access to a product may take precedence over local capacity strengthening. Capacity strengthening should enable home-grown solutions and local product development to be responsive to existing needs and emerging challenges. These efforts should enable local engagement and country ownership of health research, related product development, and manufacturing in endemic countries. Capacity-strengthening investment needs to be sustainable and enable LMICs to leverage the value of this increased capacity for their continued future growth. Because capacity strengthening can be a time-consuming and complex endeavor, donors and governments in endemic countries must commit to financing and enforcing international research and manufacturing standards to ensure an even playing field for the long-term sustainability of these efforts. The summary paper concludes that NPPDs face a number of challenges including insufficient funding, shortcomings in regulatory systems, and limited local research and manufacturing capacity which hinder progress on R&D for poverty-related and neglected diseases in LMICs. However, NPPDs have identified a number of solutions to address these challenges including working toward securing more predictable, stable, and long-term funding across all phases of product development, diversifying funding sources and improving coordination across funders. As well, NPPDs are seeking policy changes and sustainable funding to improve regulatory capacity and pathways and working to strengthen local partners’ research and manufacturing capacities to meet international standards. This fifth and final paper—Briefing Paper, Volume 5: Working with partners to strengthen local research and manufacturing capacity—and the summary of findings paper—Advancing research and development to address poverty-related and neglected diseases and conditions—are part of a series from the GHTC that examines 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.