Erin Will Morton

Erin Will Morton. Photo: GHTCChange is never easy, and today is no exception. On my last day with GHTC, I have so much to look back at and reflect on. It is a bittersweet transition to leave this great team of people. Together with our members we have built a strong coalition and can be proud of our impact in global health research and development (R&D). But today is not a day to look back. It is time to look forward. On to 2017 and the future of global health R&D. We have a lot of work ahead of us and much to look forward to. The coalition will continue to thrive and be the strong collective voice of the global health research community. In my new role as a member of the coalition, I look forward to working with all of you to hold policymakers accountable for the public sector’s role in research. We know our mission is strong. We know we fight for a good cause. But it is not always that easy to convince decision-makers that this is the right thing to do. To help build our case, GHTC is working on two reports to help build our advocacy capacity. The first is a comprehensive overview of the US government’s role in global health R&D. Examining both funding and policies, GHTC and the research team at Duke University’s Margolis Center for Health Policy and Global Health Institute are digging deep on what the government is doing, where there are gaps, what is working well, and what could be done better or different. Even when things seem to be working, we must continue to question process and look to find new solutions to advance the development of new tools to address our most pressing global health challenges. GHTC’s second report is an update to our 2012 Saving Lives and Creating Impact: Why investing in global health research works report with Policy Cures. Once again, GHTC and Policy Cures will look at the return on investment in global health R&D for the US government to help build a strong case for this continued role. I am looking forward to having both of these in hand for our advocacy work with a new Congress and new administration in 2017 and beyond. These reports and other evidence from members must continue to inform our advocacy work. In a challenging fiscal environment in which new money is hard to come by, we must make a strong case for our work. Global health R&D is a smart investment, it saves lives, and it can reduce health costs. These are the arguments we will continue to make. I am very proud of what we have accomplished over the last two years. Thank you to everyone who has supported me and GHTC’s mission. I look forward to continuing the fight and working to save and improve lives around the world!

This post is part of the #MarketsMatter expert blog series. Read the full series here. The size, strength, and stability of markets dictate how health product developers set priorities and fund research and development (R&D); a 1 percent increase in the potential market size for a drug category leads to a 6 percent increase in the number of medicines introduced in the US market.[i] However, relying on market forces alone to drive health R&D leads to staggering disparities in funding and real-world impact. Today, only 1 to 2 percent of all global investment in health R&D targets neglected diseases, which kill more than 6 million people each year and disproportionately affect low- and middle-income countries (LMICs).US Navy Lt. Kimberly Edgel, left, and Christian Baldeviano examine a positive malaria blood smear at Naval Medical Research Unit (NAMRU) 6 in Callao, Peru. When existing market forces alone fall short in ensuring availability of and access to lifesaving health tools, a range of interventions are needed to alter the market and ultimately change the behavior of its actors. Incentives and innovative financing mechanisms are interventions that have proven effective in accelerating R&D and delivering lifesaving vaccines, drugs, diagnostics, and other health tools to those who need them most. Incentives such as advance market commitments (AMCs), volume guarantees, milestone prizes, and priority review vouchers reward developers who conduct neglected disease R&D or guarantee a market for a health product, ensuring that developers are able to recoup the costs of R&D. Innovative financing mechanisms, including mix-method financing, cross-sector partnerships, pooled funding, and competitions directly subsidize and consequently catalyze R&D. These platforms and partnerships are already accelerating R&D and promoting access to new innovations. AMCs—agreements by procurers to purchase a specified quantity of a new product at a predetermined price, effectively securing a market for product developers—have moved from innovative idea to reality over the past decade. In 2007, Gavi, the Vaccine Alliance launched an AMC for pneumococcal vaccines, raising US$1.5 billion from six public and philanthropic donors to purchase a future vaccine. While there were already two late-stage candidates in the pipeline that met the AMC’s criteria, the commitment created competition and encouraged GlaxoSmithKline (GSK) and Pfizer to adapt the vaccine candidates for low-resource settings. The AMC also stimulated demand; the vaccine has been introduced in more than 50 LMICs, and both GSK and Pfizer scaled up manufacturing to meet the demand, reporting that these decisions were influenced by the existence of the AMC. Earlier this year, Gavi initiated a similar agreement, signing an advance purchase commitment with Merck, providing $5 million toward the development of an Ebola vaccine. Merck guaranteed that the product would be submitted for licensure by the end of 2017, and 300,000 doses would be made available by May 2016 for use in either a future outbreak or clinical trial. Not only has Ebola historically affected LMICs, but the disease typically emerges in short-term outbreaks, and thus, the market is limited and unstable. This agreement will ensure that a stockpile of vaccines are ready to be deployed during the next outbreak and signals to vaccine developers and manufacturers that cross-sector partnerships can offer a market for emerging and reemerging infectious diseases. While incentive mechanisms can expedite product development and access to new health tools by creating market demand and new financial incentives, innovative financing mechanisms that directly fund R&D remain critical and have played a tremendous role in bolstering the neglected disease pipeline. The pipeline has grown from 365 products in 2012 to 485 tools today, three-fourths of which are being developed by public-private partnerships, including product development partnerships, which facilitate collaboration across the public, private, and philanthropic sectors, bringing in new resources and diverse expertise. Other innovative financing mechanisms include pooled funds, such as the Global Health Innovative Technology (GHIT) Fund, which is financed by the Japanese government, seven Japanese pharmaceutical companies, and the Bill & Melinda Gates Foundation. The GHIT Fund has brought new investors and resources to the table and is currently supporting nearly 50 drug, vaccine, and diagnostic candidates. Alternately, Grand Challenge programs offer a platform for open innovation, identifying and financing promising ideas to address health and development challenges. Through its Grand Challenges series, the US Agency for International Development has elicited 7,400 ideas and has supported 224 of them, leveraging $125 million in new funding to match the agency’s investment of $76 million. Markets for neglected disease products are often perceived as insufficient to warrant investments in R&D, and thus, we can’t rely on existing market forces alone to determine R&D funding and priorities. An enabling policy environment, cross-sector partnerships, and innovative financing mechanisms have a critical role to play in galvanizing greater industry engagement and addressing the market failures that inhibit neglected diseases R&D.The Global Health Technologies Coalition (GHTC) works to save and improve lives by encouraging the research and development of essential health technologies. We are a coalition of more than 25 nonprofit organizations advancing policies to accelerate the creation of new drugs, vaccines, diagnostics, and other health tools that bring healthy lives within reach for all people. GHTC is housed at PATH and funded in part by the Bill & Melinda Gates Foundation. Learn more at www.ghtcoalition.org. [i] According to the authors of this study, the correlation between market size and new drugs entering the market likely applies beyond the US market, but this data is not readily available. However, the US market has a disproportionate impact on R&D funding and priorities, as it constitutes an estimated 40 percent of the global market. For more information, see the study, published in The Quarterly Journal of Economics, here.

New tools are needed to prevent HIV and AIDS, particularly among at-risk women. Photo: PATH/Gabe Bienczycki Sitting halfway around the world from my office in Washington, DC, looking out my Durban hotel window at the Indian Ocean, I am reminded just how small and interconnected our world really is. While home is a 24-hour journey from here, international travel is easy now. Like people, infectious diseases also move easily around the globe. As advocates gathered from across geographies, we are here in Durban to discuss research and development for new tools in the fight against HIV and AIDS. The excitement in our discussions is palpable as we think about where we have come in the HIV and AIDS epidemic to date, but also guarded as we look ahead to the daunting task of ending the epidemic forever. I traveled to Durban to participate in a partners meeting with the International Partnership for Microbicides (IPM). IPM, a GHTC member, is leading an exciting Phase III clinical trial program to determine if a new monthly vaginal ring it developed can prevent women from becoming infected with HIV and is safe for long-term use. The ring contains the antiretroviral (ARV) drug dapivirine, which is a new drug but part of the same class of ARVs currently in use for HIV and AIDS treatment. Initial efficacy results are expected as early next year. Dapivirine ring. Photo: IPM Throughout the meeting one thing became clear to me: we need new tools to combat the HIV and AIDS epidemic in South Africa, in Washington, DC, and everywhere in between. ARV treatment has helped save millions of lives. For the most part, people on treatment can live healthy and productive lives. That is, of course, if they have access to the medications they need, if they can take these medications daily, if they can keep regularly scheduled appointments with a health care provider, and perhaps most importantly, if they know they are infected in the first place. That’s a lot of ifs. What if we could prevent more infections in the first place? The new post-2015 development agenda about to be solidified by the United Nations later this month sets out to end the HIV and AIDS epidemic by 2030. This is a lofty goal that has policymakers and funders excited, but it should be regarded with caution as we look to the work that needs to be done. Truvada. Photo: CDC In the United States, the US Food and Drug Administration has approved the use of the ARV drug Truvada as a pre-exposure prophylaxis (known as PrEP) to prevent HIV infection among individuals who are determined to be at high risk for contracting HIV. PrEP is not yet approved for use in South Africa despite Truvada being an approved—and commonly used—drug for HIV and AIDS treatment. Why PrEP hasn’t been approved for use yet in South Africa is a complicated story, but unfortunately one that seems to haunt us in the global health advocacy community. All too often, we know what needs to be done to treat or prevent an infection, to save a mother’s life during childbirth, to keep a child alive during the most vulnerable early years of life, but politics keeps us from making progress. The stigma associated with HIV and AIDS is still real for women and men around the world. In the United States, it doesn’t help when we hear politicians talk about cutting funding for HIV and AIDS research because it doesn’t affect enough Americans anymore. Yes, we know how to treat people living with the disease, and yes, we know how to prevent mother-to-child HIV transmission, and yes, we even know how to prevent HIV infection in adults, but the reality is that politics are getting in the way. If we know how to save lives, it should not matter how policymakers personally feel about the way a disease is transmitted or the lifestyle of the populations most at risk for contracting a disease. Logic says that science should win this debate, but unfortunately, that is not the reality. To combat both the disease itself and a challenging global political environment, we need to keep our options open as we think about the tools we have and the tools that are needed to fight HIV and AIDS. We need to have an arsenal of tools that can be used safely and sometimes discretely by the people most at risk. IPM's monthly dapivirine ring has the potential to help women take more control over their health and reduce their risk. Too many women cannot negotiate the use of condoms (male or female) with their partners and therefore cannot be in control of their own HIV prevention. Developing and providing new options—like the dapivirine ring—that women could use as personal protection is essential. Further, we don’t just need to develop tools for the sake of new tools—we need to ensure that women and men have access to the most effective, affordable, and appropriate tools to address their health needs. I was fortunate to be able to accompany IPM and other partners on a visit to Qhakaza Mbokodo in Lady Smith, South Africa—one of the research clinics conducting IPM's Ring Study, which is one of two Phase III trials evaluating the ring. While there, I met an engaged and dedicated staff who have integrated themselves into a local community and really gotten to know the women who are participating in the trial. Women joined the trial voluntarily, many of them expressing an interest in helping to end a disease that is devastating their community or has killed a family member. They understand the potential risks associated with testing a new tool, and they know it might not be effective. But like me, as an advocate dedicated to preventing HIV, ending infectious disease epidemics, and empowering women to take control of their own health, they are all hopeful that the ring can be an effective tool to help us in the fight. We cannot end the HIV and AIDS epidemic with the current tools we have, and no one tool used alone—not PrEP, not the dapivirine ring, not condoms, not male circumcision—will get us to this goal. We need to have a comprehensive approach to the fight that involves both prevention and treatment. IPM's dapivirine ring program, regardless of the results, will teach us a lot about what works and what doesn’t. This is the way we must combat global health threats: with scientific rigor, with international partnership, and with robust investment in new tools. Erin Will Morton is GHTC’s Director

Health R&D is critically important to achieving the SDGs. Photo: PATH/Aaron Joel Santos Later this month global leaders are poised to approve the Sustainable Development Goals (SDGs), but a new report commissioned by a leading group of health nonprofits including GHTC warns that the SDG targets will not be achieved without the development and introduction of new and improved health technologies to address the health needs of the world’s poorest people. The report calls for the United Nations (UN) and its Member States to acknowledge the importance of global health research and development (R&D) in the SDGs and to include robust indicators in the monitoring framework to measure progress in advancing the development and accessibility of urgently needed new health technologies. The report includes a short list of recommended global health R&D indicators for inclusion in the global and national SDG monitoring frameworks. For the SDGs to be a success, it is vital they recognize the importance of R&D for global health There is no doubt the world has achieved enormous gains in health over the past few years—since 1990, we’ve halved child deaths, reduced maternal deaths by 45 percent, and achieved significant progress in fighting leading killers like HIV and AIDS, tuberculosis (TB), and malaria. The tools we have today are not sufficient to reach the SDG health targets. Photo credit: PATH/Evelyn Hockstein. Yet significant health challenges continue to weigh on the global economy and stand as barriers to poverty reduction and economic prosperity—particularly in low- and middle-income countries (LMICs) where their burden is most severe. Without addressing these challenges, we won’t achieve the ambitious goals of poverty reduction and economic prosperity envisioned in the SDGs. Recognizing the link between health and economic prosperity, global leaders included within the SDGs ambitious targets for reducing maternal and child mortality; ending the epidemics of HIV and AIDS, malaria, TB, and neglected tropical diseases; and addressing other health challenges. The problem? We can’t reach those targets using only the health tools we have today. The major disease-specific global strategies whose targets align with those in the SDGs clearly acknowledge this reality. For example, meeting the target of ending the epidemic of TB by 2030 will require new, effective drugs to treat the growing problem of multidrug-resistant TB. Likewise, without new tools to treat and prevent HIV transmission, the scale-up of existing tools will prove insufficient to achieve the end to HIV and AIDS by 2030 as envisioned in the SDGs. Despite its importance, global health R&D is largely missing from the SDG agenda Six essential elements of the SDGs. Credit: UN Despite the importance of global health R&D to achieving the SDGs, it’s largely missing from the current agenda. Only one of the 169 targets—target 3.b—is specifically aimed at advancing R&D to meet the health needs of LMICs, and, unfortunately, it excludes several important categories of health interventions including diagnostics, microbicides, devices, and other health tools, and it conflates two distinct problems—the need to support R&D to develop new tools and the need for those new tools to be affordable and accessible. Furthermore, none of the UN proposals for SDG indicators include any that can adequately measure progress on global health R&D. Delivering the next generation of lifesaving health technologies will require strong political commitment and the mobilization of resources from all nations to support health innovation. To make that happen, it’s critical that the SDGs explicitly acknowledge the importance of global health R&D and measure progress toward it. An opportunity to incorporate global health R&D in the SDG monitoring framework A new report recommends global health R&D indicators for inclusion in SDG monitoring framework. Photo: Policy Cures While the SDG goals and targets are now set, the indicators will not be finalized until later next year. Given the marginalization of R&D in the goals and targets, it will be vital that effective indicators to measure global health R&D are included in the SDG monitoring framework. Based on an extensive landscaping and consultative process to identify potential indicators and further analysis of their feasibility, data availability, level of community endorsement, appropriateness, and cross-cutting potential, the report recommends three indicators to measure health R&D for inclusion in the global monitoring framework: Public, private, and non-for-profit investment in R&D for the health needs that disproportionately affect people living in LMICs Number of new registered health technologies targeting the health needs that disproportionately affect people living in LMICs R&D expenditure as a percentage of gross domestic product The report also calls on Member States to voluntarily adopt national indicators to monitor progress on global health R&D if appropriate for their circumstances, recommending five additional indicators for this purpose: Number of new health technologies registered by the National Regulatory Authority and/or recommended by national guidelines National Regulatory Authorities participating in harmonized registration initiatives based on internationally recognized policies and standards; and sharing regulatory policies, legislation, guidelines, and information on registered products Number of formal coordination and collaboration initiatives aimed at increasing and facilitating transfer of health-related technology, including between public and private entities Number of registered clinical trials that meet international quality and safety standards Number of clinical trial sites that meet international quality and safety standards These indicators will help the global community monitor progress on advancing global health R&D, while creating very little additional burden on statistical offices. A win-win all around. With the right health tools, the world can achieve the SDGs. But to develop and deliver those tools, we need to mobilize greater resources and political commitment to support health R&D and put in place mechanisms–like indicators–to hold us accountable to make it happen. The SDGs present an opportunity to transform the future of global health through innovation. Will we grasp it? Learn more: Read the full report Read a fact sheet on the report’s findings and recommended indicators Read a press release about the report Express your support for the inclusion of global health R&D indicators in the SDG monitoring framework by adding your name or your organization's name to our call-to-action letter to the UN and its Member States