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In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Rep. Leonard Lance (R-NJ) this week reintroduced a bill—called the Modernizing Our Drug & Diagnostics Evaluation and Regulatory Network Cures Act—that aims to stimulate the development of diagnostics and potential therapies that have no patent protection. The World Health Organization has announced it will start charging a fee to manufacturers seeking prequalification of their medicines and pharmaceutical components. Some public health advocates are expressing concern that fees might have a negative effect for procurement and access to medicines. Nature News examines the effects of sequestration and budget cuts on US researchers who receive funding from the National Institutes of Health (NIH). In related news, a new opinion piece in Nature argues that the effects of federal budget cuts provide an opportunity to revisit the NIH’s funding structure. The Centers for Disease Control and Prevention is supporting efforts to develop an all-natural insecticide to prevent malaria and other insect-borne diseases. The Pharmaceutical Research and Manufacturers of America released a report this week showing that 271 vaccines are under development, all in clinical trials or under review by the US Food and Drug Administration. This includes 137 vaccines for infectious diseases.

In this guest post, Claire Wingfield—product development policy officer at PATH—writes about a new paper she developed for the GHTC that outlines key funding challenges and opportunities for global health research and development (R&D). The funding landscape for global health R&D is evolving. Significant investments from governments and philanthropic organizations before the financial crisis helped create robust and promising product portfolios for poverty-related and neglected diseases and conditions. However, in the current financial climate, budget constraints are threatening this progress. Today, the GHTC is releasing a new paper that examines the implications of this changing environment—in particular, the financing challenges and opportunities facing organizations that advance the development of new vaccines, drugs, diagnostics, microbicides, and other health products for low- and middle-income countries (LMICs). Traditionally, the majority of funding supporting nonprofit product development organizations (NPPDs) to develop technologies for LMICs has been grants from government development agencies—predominately in the United States and Europe—and philanthropies. However, the funding landscape for NPPDs has changed significantly in recent years, and many organizations are reconsidering their business models and funding structures. In particular, traditional governmental and philanthropic donors have scaled back their overall investments in NPPDs, and some donors have become more restrictive in how their money is spent. A new paper from the GHTC outlines key funding challenges and opportunities for global health research and development . Credit: PATH. As a result, NPPDs are pursuing innovative financing models to sustain progress in developing new products and to attract new investment, both to fill the funding gap and to increase the flexibility of their funding. Across the diverse group of NPPDs we surveyed for the paper, we found common funding challenges that each is grappling with in this new environment. Donor shifts away from core funding to more narrowly restricted funding. Donors are increasingly awarding project-specific funding, which can only be used for a designated activity, as opposed to core funding that gives NPPDs the ability to support multiple projects at different stages of development. Because of this shift, NPPDs noted that funding can significantly influence scientific decision making. Each of the NPPDs interviewed said that this shift away from more flexible core funding toward project-specific funding is their most significant challenge. The small number of major funders. Shrinking resources means that NPPDs cannot keep pace with the increased costs of progressing new health products through large-scale studies. As a result, funding available to NPPDs is shrinking just as promising products are advancing through the research pipeline into large-scale studies needed to demonstrate safety and efficacy in diverse populations. Discordant funder priorities and requirements. As some funders scale back on their support, NPPDs are increasingly seeking out multiple donors and funding sources. While funding diversification can help provide independence, it can result in the misalignment of funder requirements. NPPDs with varied funding sources can experience challenges in managing multiple funder requirements, which creates the need for more administration and staff resources. Limited capacity to identify, cultivate, and sustain funding. As NPPDs seek out new funding opportunities, they must invest in a new configuration of skills—including managing, identifying, and cultivating new sources of support. This involves dedicating additional staff time, sometimes from researchers, and establishing new systems to cultivate new donor relationships. NPPDs noted that while the funding environment presents many challenges, there are also new investment and partnership opportunities. To ensure that the goal of creating cost-effective, culturally relevant, affordable, and accessible products is driving their work, NPPD outlined criteria that can be used to design and evaluate financing. Specifically, funding mechanisms and donor support should: Support a portfolio of products at different stages of development. This ensures that only the most promising products advance through the research pipeline and allows NPPDs to shift funds to more promising projects. It also ensures that the entire product development lifecycle—from preclinical through introduction and wide-scale adoption—is funded. Provide sustainable funding commitments. Additionally, the duration of funding commitments should be guided by the scientific need. This will require multi-year funding commitments that align with the timelines of the product development process. Support core activities. These activities—such as administrative and facility costs, support activities for advocacy and public awareness, and the cultivation of new funding sources—are critical to the success of any organization. All funding should include a proportionate level of support for the overall costs of running the organization or specific program. Incentivize new investment. Funding is most effective when it can be used to attract new financial support and other investments. The more flexible the funding, the better able the recipient is to create opportunities to complement existing investment. All of the NPPDs noted that exploring new financing models is not new to them but that they must continue to adapt their financing models and explore new opportunities to respond to an evolving funding environment. Finally, better collaboration among stakeholders—including NPPDs, governments, academia, foundations, and the private sector—is critical to maximizing R&D funding to improve health and well-being in LMICs.

The Global Health Technologies Coalition (GHTC) today released a new paper that provides unique insight into the funding landscape for global health research and development (R&D). The paper examines key financing challenges and opportunities facing organizations that advance the development of new vaccines, drugs, diagnostics, microbicides, and other health products 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 GHTC paper finds that the funding landscape for NPPDs has shifted in recent years, with donors from the public and private sectors reducing their overall investments in product development for LMICs. For instance, funding for NPPDs has seen a decrease of $50 million per year since 2009. The paper identifies four main funding challenges facing NPPDs in this changing funding environment: The small number of major funders means that NPPDs cannot keep pace with the increased costs of progressing new health products through large-scale studies. As a result, funding available to NPPDs is shrinking just as promising products are advancing through the research pipeline. Donors are increasingly awarding project-specific funding, which can only be used for a designated activity, as opposed to core funding that gives NPPDs the ability to support multiple projects at different stages of development. Because of this shift, NPPDs noted that funding can significantly influence scientific decision making. As some funders scale back on their support, NPPDs are increasingly seeking out multiple donors and funding sources. While funding diversification can help provide independence, it can result in discordant funder priorities and requirements. NPPDs with varied funding sources can experience challenges in managing multiple funder requirements and gaps in funding. As NPPDs seek out new funding opportunities, they must invest in developing new skill sets—including managing, identifying, and cultivating new sources of support. This involves dedicating additional staff time, sometimes from researchers, and establishing new systems to cultivate new donor relationships. Fortunately, the paper also finds that NPPDs are adapting in this new funding environment. For instance, many NPPDs are developing approaches to address these financing challenges, such as forming new partnerships and exploring innovative financing to sustain progress. The paper also provides a set of criteria that donors, NPPDs, and others can use to evaluate and better coordinate global health R&D funding opportunities. According to the paper, funding mechanisms and donor support must: Support a portfolio of products at different stages of development. This ensures that only the most promising products advance through the research pipeline and allows NPPDs to shift funds to more promising projects. Provide sustainable funding commitments. Additionally, the duration of funding commitments should be guided by the scientific need. This will require multi-year funding commitments that align with the timelines of the product development process. Support core activities. These activities are critical to the success of any organization. All funding should include a proportionate level of support for the overall costs of running the organization or specific program. Incentivize new investment. Funding is most effective when it can be used to attract new financial support and other investments. This paper—Financing and Coordination of Health Research: Perspectives from Nonprofits on Accelerating Product Development and Improving Access for Low- and Middle-Income Countries, Volume 2—is the second 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.

Now that Labor Day has passed and Washington, DC, is starting to cool down, members of Congress are filtering back into town from their August recess travels. Some were conducting district work, others were on vacation, and still others traveled to some of the hotspots for global health programming and research. With just nine working days left in the congressional calendar before the beginning of fiscal year 2014, the only thing most in Washington can agree on is that there won’t be a long-term budget deal by October 1. This means that we’re looking at another continuing resolution to keep the government open for the rest of the calendar year. Even beyond October, there are not very many days that Congress—particularly the House of Representatives—will be in session between now and the end of the year. What should Congress do with the limited working time it does have? Here are a few priorities. With the limited time Congress has between now and the end of the year, lawmakers should focus on avoiding a government shutdown, passing a budget agreement, and supporting global health R&D programs. 1. Avoid a government shutdown. First and foremost, Congress needs to pass legislation to keep the government open past September 30. Preferably, this legislation would support programs at least at their current levels. It should also include an expiration date far enough away to avoid yet more political battles related to the debt ceiling. 2. Pass a smart budget agreement that dodges sequestration while protecting key programs. Francis Collins, director of the National Institutes of Health (NIH), must be exhausted from explaining over and over the dire consequences of budget sequestration at his agency. NIH’s purchasing power has been reduced by 25 percent compared with fiscal year 2003. At least 700 NIH grants that would have been funded in the absence of sequestration have been denied support. Collins has stated that key vaccine research programs that are near fruition are at risk because of sequestration funding cuts. The case is similar at other US agencies that fund global health research and development (R&D). Congress must get past its political arguments and pass a budget that supports programs focused on saving lives and producing efficiencies and cost savings—thereby helping to avoid another round of sequestration cuts. Which leads us to… 3. Move legislation forward that creates efficiencies in global health and international development. One priority that the Obama Administration and Congress agree on is using efficiencies gained by technology and innovation to create cost-savings and promote US interests. The 21st Century Global Health Technology Act and the Foreign Aid Transparency and Accountability Act both achieve those goals. Congress should move to see them through committee approval and toward full House and Senate consideration. 4. Sustain global health programs, including global health R&D. Global health programs are recognized as effective and necessary by political champions of all stripes—particularly R&D for new global health technologies. Not only do these programs save lives at home and abroad, they also have a positive impact on local and global economic prosperity and save money in the long run. However, none of these positive effects is felt if budgets are indiscriminately slashed or if research is relegated to the back burner in order to save a few dollars upfront. Government shutdowns and sequestration cuts that slow R&D here in the United States impact populations far beyond our national borders—effects that reverberate back to the US. In addition to economic and political consequences, there is a growing burden of neglected diseases in the United States. For instance, 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. Supporting research to develop new health tools will help fight these diseases both at home and abroad. No one expects large budget increases this year, but Congress can halve the negative effects that even small decreases have by sustaining funding for global health and health research programs. 5. Act on the good stuff. Let’s end on a positive note. Recently at the US Agency for International Development’s Saving Lives at Birth Development XChange, author Dan Heath gave a TED-talk-like presentation on a model of thinking that does not get nearly enough emphasis: Instead of focusing on the problems, find the successes. As Heath put it, "Find a bright spot, and clone it." Congress appears to be at a standstill due to disagreements over budget levels, immigration programs, national security, and a host of other issues. However, members of Congress have the opportunity and the means to shake their obstructionist reputation and make progress on items they agree on—including supporting innovative global health research. There are lots of areas that Congress by and large agrees on, but which rarely make headlines. Members need to start acting on such unifying issues such as global health R&D and advance legislation that can have a positive impact on people’s health around the world.