News: Announcement

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.

While a ceasefire in Washington’s budget wars has restored funding for a range of programs targeting global health threats like AIDS and tuberculosis (TB), the simultaneous underfunding of the world’s biggest sponsor of global health research and development (R&D) puts future progress at risk, warns a new report from a coalition of nonprofit groups focused on advancing innovation to save lives. The Global Health Technologies Coalition (GHTC) released their annual policy report today at a Capitol Hill briefing. “The end of political gridlock in Washington put many global health programs on firmer footing with one notable exception: it continued to weaken the National Institutes of Health (NIH), which is the engine that drives innovation in the fight against infectious diseases,” said Kaitlin Christenson, MPH, director of the GHTC. The report, Innovation for a changing world: The role of US leadership in global health R&D, examines the state of global health R&D in the wake of a bipartisan agreement reached earlier this year to end an acrimonious budget battle. The GHTC report applauds efforts to halt draconian cuts that were crippling global health programs. And it calls for a long-term budget solution to sustain R&D efforts that are delivering a wealth of new tools to fight diseases that disproportionately affect poor countries.The report places a high priority on urging Congress to approve the 21st Century Global Health Technology Act and seeks a stronger role for the Food and Drug Administration (FDA) in delivering new products for neglected diseases. The big news for global health programs was the accord signed into law earlier this year that halted the so-called “sequestration” cuts that hit programs across the government in March of 2013 after negotiations over federal spending collapsed. The agreement revived appropriations for an array of global health initiatives. But when the dust settled, the NIH budget for 2014—while $1 billion above its 2013 post-sequester funding—was actually $950 million less than the agency received in 2012. In particular, two NIH institutes critical to sparking global health innovations—the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Child Health and Human Development—have less money, in actual dollars, in 2014 than they had in 2012. A report by the Congressional Research Service found that when adjusted for inflation, funding for NIH—which leads the world in support for global health R&D—has been steadily declining for years, with the agency’s real spending power down by 22 percent compared to 2003. “These cuts are short-sighted because our global leadership in the life sciences, a sector which contributes $69 billion annually to the US economy alone, rests on a foundation built with NIH-funded research,” said Steve Davis, president and CEO of PATH. “Just this past November, researchers from NIAID and Harvard announced they had developed a potentially transformative new treatment for HIV—and that’s precisely the kind of work we put at risk by failing to adequately support NIH.” The GHTC report asserts that the budget reductions triggered by the sequestration process were having a major impact on the global fight against infectious diseases. For example, clinical trial sites in the US and abroad involved in testing a new TB drug were forced to shut down. The GHTC report also asserts that reduced funding for programs that provide poor countries with HIV/AIDS treatments and tools to control malaria may have resulted in thousands of preventable deaths. The GHTC makes a case for stronger, more reliable funding for global health R&D by noting that US investments have consistently delivered valuable returns and that future breakthroughs are close at hand. It finds that between 2000 and 2010, the US government was involved in more than half of the vaccines, drugs, diagnostic tools, and devices that were developed to address global health problems. And US funding is now linked to 200 of the 365 global health products moving through the R&D pipeline. Some of the products in development with US government support—and which could fail if that support falters—include: New drugs to treat TB and malaria. A new microbicide that women could use to prevent HIV infections, which could avert 2.5 million HIV infections and save $2.7 billion in health care costs. New insecticides to help control insects that spread diseases such as dengue fever, Chagas disease, filariasis and leishmaniasis, which are a major cause of serious illness and death in developing countries. New tools that would make diagnosing malaria, HIV, and TB easier and faster, especially in low-resource settings. A vaccine for preventing HIV infections. The GHTC is urging Congress to make sure these and other tools become a reality by developing a long-term plan for retaining and expanding US leadership in global health product development. The GHTC notes that this work can begin with a 2015 budget agreement that provides strong support for global health programs government-wide. For the Centers for Disease Control and Prevention (CDC), the GHTC recommends providing $464 million for the Center for Global Health and $445 million for the National Center for Emerging and Zoonotic Infectious Diseases. The GHTC also is recommending a 2015 budget of $4.7 billion for the FDA, which plays an important role in ensuring the safety and efficacy of health products for neglected diseases; $32 billion for NIH; and $10.358 billion for global health programs at the US Department of State and US Agency for International Development. The GHTC also is seeking policy changes that would strengthen US-supported work in global health product development. And GHTC is calling for FDA to continue expanding its role in global health by allocating funding to match its global health commitments and ensuring it has the authority to review health products for all neglected diseases. Finally, the GHTC is urging US government officials to play a stronger role within the World Health Assembly as that body develops and funds a series of global health demonstration projects. And it wants to ensure that global health research is prominent in the Sustainable Development Goals now being drafted to replace the United Nations Millennium Development Goals.

The Global Health Technologies Coalition (GHTC) today released a new paper providing unique insight into the regulatory barriers incurred by nonprofits in global health research and development (R&D). The paper examines the most significant challenges organizations face in navigating the regulatory landscape to advance the development of new vaccines, drugs, diagnostics, microbicides, and devices for low- and middle-income countries (LMICs). The paper focuses on nonprofit product development organizations (NPPDs), or nongovernmental organizations that partner with the public, philanthropic, and private sectors to develop health products specifically targeted for HIV/AIDS, tuberculosis, malaria, neglected tropical diseases, maternal health, and other needs in LMICs. Previous research has found that NPPDs play a vital role in bringing together the fragmented resources and expertise of the various sectors involved in neglected disease R&D. The new paper finds that regulatory processes and obstacles can vary widely depending on product and geography. Each of these challenges has a significant impact on the ability for NPPDs and their partners to ensure new technologies are available for patients in LMICs. NPPDs identified three key regulatory challenges, including: Complex global regulatory environment: the regulatory landscape for products targeting the health needs of LMICs is difficult to navigate because of the different levels of regulatory oversight across a spectrum of experience and expertise. Weak regulatory capacity in LMICs: regulatory authorities in LMICs lack sufficient resources to reliably evaluate and monitor the safety, efficacy, and quality of all types of health products. The need for increased investment in regulatory capacity within NPPDs: the robust pipelines and increasing product responsibilities necessitate strengthening internal regulatory capacity of the NPPDs. While the regulatory landscape for the R&D of health products addressing poverty-related and neglected diseases and conditions is complex, NPPDs and their partners continue to grow their pipelines. Therefore, NPPDs contributing to this paper outlined a set of key recommendations to strengthen regulatory processes: Best practice is to develop a regulatory strategy at the beginning of the development cycle that outlines activities through product registration. All regulatory bodies should possess a foundational level of core competencies. Regulatory harmonization and capacity strengthening should encourage collaboration of poorly resourced regulatory bodies with better-resourced and more experienced regulatory authorities. It is critical to educate non-regulatory stakeholders on the impact of regulatory delays on increasing the cost and length of product development and introduction to make the case for increased investment. This paper—Briefing Paper, Volume 4: Addressing regulatory challenges throughout the product development process—is the fourth in 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.

The Global Health Technologies Coalition (GHTC) today released a new paper shedding new light on issues surrounding access to global health products. The paper examines how organizations that advance the development of new vaccines, drugs, diagnostics, microbicides, and other health products for low- and middle-income countries (LMICs) ensure access to the tools and technologies they develop. The paper focuses on nonprofit product development organizations (NPPDs), or nongovernmental organizations that partner with the public, philanthropic, and private sectors to develop health products specifically targeted for HIV/AIDS, tuberculosis, malaria, neglected tropical diseases, maternal health, and other needs in LMICs. Previous research has found that NPPDs play a vital role in bringing together the fragmented resources and expertise of the various sectors involved in neglected disease R&D. The new GHTC paper finds that NPPDs employ a range of strategies to ensure that the products they develop are accessible to those most in need in LMICs. The paper defines access as a set of activities needed to ensure that products are available, affordable, and acceptable to end-users, and adopted into developing country health systems. The strategies and activities employed by NPPDs include: Starting to plan for access at the beginning of the product development process. Establishing a product’s value, which must be defined by end users and the countries that will use the product. Working closely with manufacturing partners to guarantee that consistent supplies of high-quality products are available to target populations. Engaging end users and beneficiaries in the design and the development of the product. Negotiating collaborations with partners from the public and private sectors that are designed to ensure products are available, affordable, and acceptable. NPPDs also shared a set of key lessons that they and their partners have learned in trying to improve the affordability, availability, and acceptability of new health technologies for those most in need: Defining the value of a technology must be driven by the local communities and countries that will use the product. Product developers must understand and address the needs and wants of those who will ultimately be implementing and benefiting from the product. Achieving global access does not guarantee local access. NPPDs and partners may achieve global access targets (such as receiving World Health Organization prequalification), but this does not guarantee that the technology will be accessible at the national or subnational level. Relying on national average income status can undermine access for the poorest populations. In many middle-income countries, the burden of disease is among poorer populations who have not benefitted from strengthening economies. Therefore, the poorest populations, often the most at risk, are unable to access new technologies. Securing donor recognition that access activities need to be initiated early is critical. In order to ensure there is not a lag between licensing a product and making it available in the health system, NPPDs and partners must start planning for access from the beginning of the development process. Support from donors for these activities is critical. Demonstrating a niche in the market for manufacturers is essential to incentivize their investment. Manufacturing partners must understand the value that they bring to a market to enable them to invest time, effort, and expense to developing products for poverty-related and neglected diseases and conditions. This paper—Briefing Paper, Volume 3: Improving the affordability, availability, and acceptability of health technologies—is the third in 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 research and development for neglected and poverty-related diseases affecting LMICs.