Paper examines access to new tools for diseases of poverty

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 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.