Claire Wingfield

In this guest post, Claire Wingfield—product development policy officer at PATH—writes about a new paper exploring why research and development (R&D) of high-priority health tools for diseases and conditions affecting low- and middle-income countries (LMICs) should be a critical component of the post-2015 development agenda. The new paper make the case for the inclusion of research and innovation for health as a central component of the post-2015 agenda. Photo: PATH/Gabe Bienczycki A dearth of adequate health technologies and interventions targeting poverty-related diseases—like HIV and AIDS, malaria, tuberculosis, and neglected tropical diseases—means that millions of people in LMICs continue to die each year from preventable and treatable diseases and conditions. Progress on developing new interventions targeting the health priorities of LMICs has faltered because these diseases occur almost exclusively among the world’s poorest and most marginalized populations. Thus, there is little or no perceived commercial market encouraging companies to develop products targeting LMICs. Because the health burden imposed by poverty and social vulnerability remains far too high, achieving health for all is one major goal of the post-2015 development agenda. In a new paper—developed by the Council on Health Research for Development, the Global Health Technologies Coalition, the International AIDS Vaccine Initiative, and PATH—the authors make the case for the inclusion of research and innovation for health as a central component of the post-2015 development agenda. The paper describes the impact that increased investments in R&D and innovation for health—particularly for the world’s poorest—have had in contributing to progress toward achieving the Millennium Development Goals (MDGs)—particularly for MDGs 4 (reduce child mortality), 5 (improve maternal health), and 6 (combat HIV and AIDS, malaria, and other diseases). These investments have helped to create an enabling environment for research in and for the benefit of LMICs by increasing demand for new health technologies, expanding coverage of proven interventions, and strengthening the innovation infrastructure in these countries. Building on the work of The Lancet Commission on Investing in Health—a group of renowned economists and global health experts—the paper discusses the need for increased R&D investments by all countries to achieve the dramatic health gains envisioned in the post-2015 agenda. Adequate investment in R&D is important, but it alone does not guarantee more products or drive innovation toward the right type of products. PATH/Patrick McKern Adequate levels of investment, as suggested by The Lancet Commission, are critical for spurring the development of new health tools, provided they align with financing needs in R&D—notably predictability and flexibility. But even that sort of investment alone does not guarantee more products, and it does not drive innovation toward the right type of products—those that are suitable, acceptable, affordable, and accessible to populations most in need. It is essential, therefore, that indicators for R&D for health tools that primarily affect LMICs address a comprehensive set of outcomes including financing needs, infrastructure and human resources needs, enabling policies, necessary partnerships, capacity strengthening, and access requirements. Because poor health and disability contribute substantially to poverty, research and innovation for health is linked to improving economic prosperity and is critical to eradicating poverty. Therefore, it must be continuously prioritized within the post-2015 development agenda. Ultimately, the success or failure of the post-2015 agenda relies just as much on how the goals and targets are implemented as it does on how progress will be measured. Thus any research and innovation indicators measuring progress against the goals and targets outlined in the post-2015 agenda must also increase accountability of researchers, governments, and funders, and inform research processes. Inclusion of research and innovation for health must facilitate an enabling environment for research and innovation in LMICs and encourage endemic countries to set and pursue a domestically-driven health research agenda. The post-2015 development agenda is an opportunity for LMICs to set their own health agendas 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. Therefore, it is essential that there is broad agreement among all of the relevant stakeholders that research and innovation for health—which includes the scaling up of proven health interventions as well as the development of new and improved high-priority health technologies—is critical to meeting the ambitious goals of eradicating poverty and ensuring sustainable development for all within a generation. In support of the inclusion of research and innovation for health in the post-2015 agenda, over 150 organizations and individuals recently signed a petition to United Nations (UN) Secretary General Ban Ki-moon and Member States urging the UN to keep the research, development, and delivery of new and improved health tools for diseases and conditions impacting LMICs at the heart of the post-2015 development agenda. It is our hope that the Members States and other UN officials shaping the agenda will head this call.

In this guest post, Claire Wingfield—product development policy officer at PATH—writes about a series of papers she developed for the GHTC that outlines key challenges, lessons, and potential solutions in advancing research and development (R&D) to address poverty-related and neglected diseases and conditions. New drugs and vaccines and other health technologies developed over the last few decades have significantly increased life expectancy in most countries. But a wide gap still exists between the health outcomes of the richest and poorest countries. While high-income countries have been able to benefit from recent innovations in health R&D, many of the poorest populations are not able to access these new and improved technologies. For years there has been global debate about how to improve the coordination and increase resources being devoted to R&D targeting poverty-related and neglected diseases and conditions. In order to inform these discussions, the GHTC recently developed a series of briefing papers providing the perspectives of nonprofit product development organizations (NPPDs) on accelerating product development to meet the health needs in low- and middle-income countries (LMICs). Today, GHTC is launching a summary of the findings from the briefing papers which provides an overview of the key challenges, lessons, and potential solutions identified by NPPDs, as well as a final briefing paper describing capacity strengthening activities. New drugs and vaccines and other health technologies developed over the last few decades have significantly increased life expectancy in most countries. But a wide gap still exists between the health outcomes of the richest and poorest countries. Photo credit: PATH/Umit Kartoglu The first paper in this series set the stage by providing examples of how NPPDs approach product development and describing the key challenges that NPPDs and their partners face in developing and introducing technologies that address the health needs of LMICs. The second paper provided the perspectives of NPPDs on the most significant funding challenges and the types of financing mechanisms that support their work. The third paper described how NPPDs and their partners try to ensure access in LMICs to the knowledge and technologies they develop. The fourth paper outlined the most significant regulatory challenges faced by NPPDs and partners throughout the product development process and described how these challenges affect their work. The fifth paper in the series describes NPPDs’ efforts to strengthen the research and manufacturing capacity of academic, nongovernmental, and commercial partners in LMICs, and provides examples of the criteria that NPPDs consider when determining investment in capacity strengthening. NPPDs were created to speed the development and adoption of new technologies targeting the public health needs of the world’s poorest populations. Through partnerships with the public and private sectors, NPPDs bring together the resources and expertise of various groups to advance and increase access to health products that would not otherwise be available for commercial reasons in LMICs. Although many NPPDs have effectively advanced R&D for poverty-related and neglected diseases over the past two decades, progress has been hindered by a number of challenges. The summary paper provides a high-level overview of these challenges which include insufficient funding, lack of consistent regulatory requirements and limited capacities of national regulatory authorities, and limited local capacity for research and manufacturing. Each briefing paper provides a deeper analysis of NPPD perspectives on each of the challenges and how they have worked with partners to address these issues. NPPDs are working toward more predictable, stable, and long-term funding across all phases of product development, as well as diversified funding sources and improved coordination across funders. They are pursuing policy changes and sustainable funding to improve regulatory capacities and pathways for products targeting LMICs. And they are strengthening local partners’ research and manufacturing capacities in line with international standards. Implementing these solutions will further enhance R&D for poverty-related and neglected diseases and conditions and thereby increase access to needed drugs, diagnostics, vaccines, and devices in LMICs. This will not only help to save lives and improve health among vulnerable populations but also contribute to local economic development.

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 regulatory challenges encountered by nonprofit product developers. The regulatory landscape for health products targeting the needs of low- and middle-income countries encompasses many stakeholders, mechanisms, and levels of oversight on the global, regional, and national levels. And at every step of the product development process there are regulatory milestones to be met, no matter the type of health technology, the health condition being addressed, or the geography. Subsequently, developers often engage a number of regulatory stakeholders throughout a product’s lifecycle, and encounter any number of challenges along the way. Costs for product developers and manufacturers to comply with regulatory requirements are a large—and growing—component of research and development (R&D) expenditures, and regulatory challenges can delay timely access to technologies for patients. Despite this, until recently policymakers and donors have paid little attention to regulatory reform in discussions on improving financing and coordination of global health R&D. The GHTC has launched a paper outlining the most significant challenges that nonprofit product developers (NPPDs) and partners encounter throughout the R&D continuum to demonstrate how regulatory challenges impede their ability to accelerate R&D and increase the costs of product development. The GHTC has launched a paper outlining the most significant challenges that nonprofit product developers (NPPDs) and partners encounter throughout the R&D continuum to demonstrate how regulatory challenges impede their ability to accelerate R&D and increase the costs of product development. Photo credit: PATH/Umit Kartoglu Regulatory processes and obstacles can vary widely by product platform, as well as geography. However, representatives from all of the NPPDs contributing to the paper agreed on three thematic challenges that increase the costs of product development, cause delays in product introduction, complicate an already difficult process, and—ultimately—can result in fewer lives saved: Complex global regulatory environment. Weak regulatory capacity in low- and middle-income countries. The need for increased investment in regulatory capacity within NPPDs. Competing and misaligned requirements across regulatory authorities in high-, middle-, and low-income countries have created a confusing landscape for NPPDs. Because of the complexity of the regulatory environment, many NPPDs and partners face unclear signals about which regulatory body to approach first, what the requirements are for each review, and when these reviews can take place. Unfortunately, because many national regulatory authorities in low- and middle-income countries are often poorly funded, understaffed, and overburdened, they lack the resources to provide adequate guidance to developers, as well as proper oversight over many of the products being studied, introduced, and used in their countries. This lack of capacity and resources can be a significant hurdle and lead to considerable, costly delays in product development and introduction, and could mean reduced protection for patients. As their innovation pipelines grow, NPPDs are taking over more aspects of product development programs and recognizing the need to work more directly with regulators. Based on their experiences in navigating the regulatory pathways of health products to address poverty-related and neglected diseases, respondents had some 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. Increased development of health products targeting the health needs of low- and middle-income countries is highlighting the need for stronger regulatory systems and increased collaboration among stakeholders—including developers, manufacturers, regulators, and policymakers—to ensure that the innovation pipeline is filled with technologies that are being developed to maximize health impact.

In this guest post, Claire Wingfield—product development policy officer at PATH—writes about a series of dialogues PATH and other partners convened to discuss public-private partnerships for global health product development. PATH recently released a report outlining the key themes and recommendations identified during the three policy dialogues. Last year PATH hosted a series of dialogues in Washington, DC, London, and Brussels to highlight the role that public-private partnerships play in driving the development and introduction of new and innovative global health technologies. The aim of these discussions was to examine how the private, public, philanthropic, and nonprofit sectors are working together to address the health needs of low- and middle-income countries, and how these partnerships can evolve to sustain progress made during the past decade and better leverage limited resources in the future. Participants at the Brussels dialogue (from left to right): Gianpietro van de Goor, European Commission; Cecile Vernant, DSW Head of EU advocacy; Ole Olesen, EDCTP; MEP Maria da Graça Carvahlo; François Bompart, Sanofi; Claire Wingfield, PATH; Maite Suarez, IAVI. Photo credit: DSW Representatives from the US and European governments, nongovernmental organizations, philanthropies, and the private sector shared lessons learned, challenges, and why they see multi-sector partnerships as the most efficient means for accelerating research and development (R&D) targeting poverty-related and neglected diseases and conditions. At the event in DC—co-hosted by PATH and the Clinton Global Health Initiative in March—participants discussed ways to incentivize private-sector contributions to global health R&D, and leverage public-sector investment. The second dialogue took place in London in June and focused on the successes and challenges of public-private partnerships, and the important (and often unique) role that nonprofit product development organizations like PATH play in bridging the gap between partners and managing a complex portfolio. The third and final meeting, co-convened by PATH and Deutsch Stiftung Weltbevoelkerung (DSW)—a German NGO leading R&D advocacy efforts targeting the European Union—was held in Brussels in October, and participants reinforced the need for European governments to strengthen their investments in global health R&D. The key themes of the dialogues were: Innovative partnerships accelerate product development by bringing together the public and private sectors. Multi-sector partnerships can play an important role to address complex global health challenges. The business of health technology development changes quickly, and innovative, flexible models of collaboration for partnership are essential to ensure success. A comprehensive planning model that accounts for regulatory pathways, procurement, and distribution while products are still in development is necessary to speed product uptake. An important first step to a successful public-private partnership is ensuring the goals and strengths of each partner align. At the start of a project, partners must begin planning for both the product’s development and introduction. The markets of low- and middle-income countries represent tremendous growth opportunities and long-term sustainability for the private sector. By tapping into the burgeoning manufacturing capacity and knowledge economies of these and other low- and middle-income countries, public-private partnerships could better contain costs and support the efforts of government donors and funders that are prioritizing broader international development and economic growth over specific health outcomes. Product development for global health works best, fastest, and most efficiently when undertaken as part of a portfolio model in which partners coordinate R&D activities across a range of products at different stages of development. Because the perceived financial risks are often too high relative to the potential economic returns, and the scientific challenges are daunting for many of these diseases and conditions, it is impossible to rely solely on one organization or sector to meet the health needs of low- and middle-income countries. Therefore governments, academic institutions, nonprofit organizations, and private companies in high-, middle-, and low-income countries have—and must continue to) come together to share risk, leverage expertise, and maximize impact. These partnerships are an efficient and sustainable model for conducting global health R&D, and their impact can increase with flexible funding and business models, collaborations with nontraditional partners, and in close collaboration with governments and professionals in low- and middle-income countries.

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 issues surrounding access to global health products. In order to achieve impact, a health technology must be more than just safe and effective. It must also be affordable, available, and acceptable to ensure that it is accessible to those who need it most. The pipeline of products addressing public health needs in low- and middle-income countries (LMICs) has grown substantially over the past two decades. Much of that success can be traced back to the 1990s when a number of nonprofit product development organizations (NPPDs) were established to accelerate the development and accessibility of new health technologies targeting poverty-related diseases and conditions. Since that time, NPPDs and their partners have contributed to the development, evaluation, and/or introduction of 42 new health products. The GHTC has launched a new paper that outlines key issues surrounding access to global health products. Photo credit: PATH Because NPPDs were established to develop—not deliver—health technologies, they negotiate collaborations with partners from the public and private sectors that are designed to ensure access to the resulting products and knowledge. Today, the GHTC is launching a paper that explores how NPPDs approach access and how they manage partnerships and negotiate agreements to improve access – which they define as the affordability, availability, and acceptability of technologies targeting the health needs of LMICs. Although there is no “one size fits all” model for how NPPDs operate, they do employ some common strategies to ensure that the resulting products benefit those most in need: Spreading investment in research and development across a portfolio of technologies, thereby allowing NPPDs to select only the most promising products to advance through the pipeline. Prioritizing access to these technologies for poor populations. Planning for access from the beginning of the product development process. Working closely with manufacturing partners to guarantee that consistent supplies of high-quality, cost-effective 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 create a framework for access in LMICs. NPPDs also shared 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. Any delays in planning and implementing an access strategy can result in significant lag time from licensure to actual delivery in country. A product that needs to be retrofitted for affordability, availability, and acceptability will result in a costly and time-consuming development process. Therefore, as the GHTC’s new paper reveals, it is critical that NPPDs and partners address these principles from the beginning of the product development process.

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.