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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.

“We cannot solve what we need to solve with existing interventions—we need science and technology,” said Gary Cohen, executive vice president at Becton, Dickinson and Company (BD), at an official side event at the 6th Session of the Opening Working Group on Sustainable Development Goals this week in New York City. The event—co-sponsored by GHTC, the International AIDS Vaccine Initiative (IAVI), and COHRED—aimed to ensure that a strong commitment to research and innovation for health is included in the post-2015 development framework. As the United Nations (UN) and Member States continue progress toward meeting the Millennium Development Goals, the goals’ 2015 expiration date is right around the corner, and the global community needs to come to consensus on what’s next. Earlier this year, a UN High Level Panel of Eminent Persons released a report outlining recommendations for the post-2015 development agenda, including twelve potential goal areas. The goal areas are a promising start, and a new GHTC position paper calls on the governments of the world to ensure that innovation is embedded as a key component of the post-2015 agenda. Ensuring that innovation is included in the post-2015 development agenda is necessary to maximize health impact for those most in need—namely populations in low- and middle-income countries. Products that are affordable, available, and accessible can contribute to more equitable health outcomes, ultimately ensuring that people are able to live healthy lives and reach their full potential. During the event this week, PATH President and CEO Steve Davis discussed the need for innovative ways to break the cycle of poor health and how PATH—a nonprofit product developer—is making a difference with some of its technologies. It is crucial that the patient is always the top priority in development of new tools. Davis noted that, “Innovation that doesn’t address the most vulnerable populations is not innovation.” From left to right: Steve Davis, PATH; Gary Cohen, BD; Kaitlin Christenson, GHTC; Margie McGlynn, IAVI; and Koki Muli, Kenyan Mission to the UN In order to fully address the need for new global health technologies, the post-2015 development framework must consider creating an enabling environment for health and development. Because of the lack of a commercial market for many products that address the health needs of low- and middle-income countries, for-profit pharmaceutical and biotechnology companies are sometime hesitant to take on the development of new tools on their own. Nonprofit product developers, including product development partnerships (PDPs), are able to address this gap by bringing together the public, philanthropic, and private sectors. Margie McGlynn, president and CEO of IAVI, noted at the event that partnerships like PDPs “are critical for delivering innovation and improving health in developing countries.” To achieve sustainable development, an increased number of good and decent jobs are essential. Science, technology, and innovation are key drivers in economic growth, the creation of new jobs—and ultimately—poverty reduction. Part of this economic growth comes from the private sector’s involvement in global health product development. Cohen of BD mentioned the many areas the private sector can contribute to the development of new technologies and economic growth, including: technology innovation, clinical testing, product development, manufacturing, regulatory processes, and global distribution. As the Open Working Group on Sustainable Development Goals and others continue to discuss what will be included in the post-2015 development agenda, the GHTC has four key recommendations for UN Member States that ensure the that the critical role of global health R&D is acknowledged. Specifically: Official development assistance, as well as domestic investments by low-and middle-income countries must prioritize support for the development of new global health technologies. All stakeholders involved in the development of new health tools must be accountable for ensuring timely and equitable access to new and effective technologies. Donors and national governments must prioritize scientific capacity building and strengthening local health innovation systems when investing in development programs. Donors and national governments must invest in building systems that promote and sustain innovation capacity in low- and middle-income countries to promote a truly enabling environment for achieving sustainable development goals. This includes investing in global R&D partnerships, improving health and regulatory systems, and creating national science, technology, and innovation policies. We’ve seen countless examples of how new technologies can make a difference in the health of vulnerable populations. “New technologies have contributed to saving millions of lives and billions of dollars,” Kaitlin Christenson, coalition director of the GHTC, said at the event. It now time to make sure that science, technology, and innovation have a clear place in what the final post-2015 development agenda looks like.

The US Agency for International Development (USAID) is the nation’s lead foreign assistance agency. Throughout its 50-year history, USAID has worked with other government agencies, the private sector, and nongovernmental organizations to support the development and introduction of affordable health products appropriate for addressing the diseases and health issues in developing countries. Today, the GHTC is launching a new blog series to highlight the impact of USAID’s commitment to global health research and development (R&D). The series will showcase stories from individuals who have benefited from the agency’s support and investment in R&D—as well as people whose lives would vastly improve if USAID were to expand its support for health R&D into new areas. Our first post is by Ted Prusik, senior vice president of Temptime. Temptime is a New Jersey-based company that has made a huge impact in global health with support from USAID. Ted Prusik is a senior vice president at Temptime, a New Jersey-based company that has made a huge impact in global health with support from USAID. Credit: Temptime. Q: Temptime has a long history of working with USAID to improve global health. How did this partnership begin, and what have been some of the global health research successes you’ve achieved with USAID support? Temptime’s history is a wonderful case study on the effectiveness of US investments in efforts to solve critical global health problems. In the early 1980s Temptime, then called Lifelines, developed a unique technology that gradually changes color when exposed to time and temperature. The original idea was to use this unique chemistry for food spoilage applications. At the same time, the World Health Organization (WHO), USAID and the global health nonprofit PATH identified a pressing need to improve the effectiveness of immunization programs in the developing world. Vaccines are heat sensitive. Exposure to excessive heat can result in the loss of efficacy, leaving children who are vaccinated with heat damaged vaccines vulnerable to disease. But vaccines are stable enough to withstand some exposure to heat. Immunization program managers faced the following issues: How to better protect children from receiving a heat-damaged vaccine that was no longer efficacious? How to prevent the wastage that is common in immunization programs when health care workers presume that the vaccine is heat damaged even when it is not? USAID, WHO, and PATH recognized that the answer was a time-temperature indicator, put on each unit of vaccine, that would clearly signal when the vaccine had been exposed to a pre-determined heat load. The technology that Temptime was working to develop for the food industry was a potential solution for this application: scientifically based, predictable, easy to read, and cost effective. The application of the Temptime technology to the need identified by USAID, WHO, and PATH resulted in the development of the vaccine vial monitor, or VVM, specifically designed for oral polio vaccine. The VVM is a small circular indicator that is applied on each vial of vaccine and clearly indicates whether or not that specific vial has been exposed to excessive heat. Q: Temptime also has a notable track record of working with other partners to improve global public health. How have your partnerships with nonprofit organizations like PATH helped you to maximize investments from government agencies like USAID? The VVM is an illustration of how public-private partnerships are one of the most effective ways to deploy new technologies to support global health and how successful partnerships work. In the case of the VVM, each party brought something unique to the development. PATH, WHO, and USAID were able to clearly define the health need because of their on-the-ground presence in developing countries. From this knowledge, they were able to specify key technology requirements needed to successfully develop and deploy the VVM. Industry as a private partner could then focus its resources and capabilities on what it does best: developing and manufacturing scientifically proven, time-temperature monitoring devices. Often, while a technology exists to address the basic market need, adaptation of that technology is required to truly solve the specific global health problem. Having the knowledge of the product specifications from public sector experts on the ground—as well as the commitment to deploy the technology once it is developed—takes much of the risk away from the private sector investment. Q: Temptime products created with USAID support—like the VVM—have proven tremendously successful at saving lives and improving health worldwide. What have been some of the most notable public health benefits of the VVM? PATH estimates that between 2002 and 2012, VVMs allowed health workers to recognize and replace more than 860 million doses of overexposed vaccine and to deliver 1.45 billion more doses in remote settings—helping to save more than 150,000 lives and reduce illness for countless others. The original intent and benefit of the VVM was to ensure that vaccines overexposed to heat not be administered to children. But the introduction of this technology through the USAID/PATH/WHO/Temptime partnership has had a multiplier effect in public health programs. For example, because the VVM contributes to the effectiveness of vaccination programs, it also plays an important role in improving health outcomes and reducing health care costs. In India, for example, there are 366 million children under age 14. If 5 percent of these children received temperature-damaged vaccines that were no longer efficacious, the ongoing medical costs to treat these children for the contracted disease would exceed $1 billion annually. By contributing to the effectiveness of immunization programs, the VVM improves outcomes and frees up dollars that can be spent on other key health initiatives. Q: New tools developed for global health needs often help improve health right here at home. What have been some of the domestic health benefits of the VVM? In the case of the PATH/USAID/WHO/Temptime partnership, there were also multiple benefits to US public health. The original investment by USAID enabled Temptime to develop a technology platform that could be leveraged for other important applications. The same technology that protects children in immunization programs is used on ready-to-eat meals and rapid skin decontamination lotion for US troops. Temptime over the years has also developed new technologies that are used to support patient protection in the US. These include freeze monitoring technology used on the H1N1 vaccine in 2009, currently used in each shipment of vaccine to participating providers in the US Vaccine for Children program, as well as numerous pharmaceuticals and medical devices. Q: Temptime’s experience also demonstrates that investments in global health research and development not only help save lives around the world—they’re also a smart economic investment. What impact has USAID funding had on Temptime’s ability to create jobs, expand your business and contribute to the domestic economy? Beyond the public health benefits worldwide, new health tools and the partnerships that develop them bring benefits to US industry. In the case of Temptime, we have built a small but growing company that continues to hire and develop people. We also manufacture all of our technologies in the US and export them globally, so in our own humble way we are contributing to the improvement of the US trade deficit.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. President Barack Obama on Wednesday signed legislation into law that averts the majority of the so-called "fiscal cliff.” The law defers decisions on sequestration by two months, meaning that lawmakers will debate sequestration at the same time as they tackle a debate on the overall federal budget plans for 2013 and 2014. The law also “keeps researchers on tenterhooks for at least another two months by delaying mandatory spending cuts that could threaten science funding.” A new article examines the international military sector's role in global health activities, which "has gained visibility in recent years." According to the article, the military provides support for a range of activities, including “medical research and development to peacekeeping operations while providing normative, technical assistance, and coordinating roles.” Devex examines possible policy changes that Sen. John Kerry (D-Mass.) will bring to the State Department if confirmed as the next Secretary of State. Approvals from the US Food and Drug Administration for new drugs hit 16-year high in 2012. The agency approved 39 new drugs in 2012, including a new treatment for multi-drug resistant tuberculosis. Researchers announced that they have developed a therapeutic vaccine that can temporarily halt the growth of HIV in patients. There is an alarming rise in resistance to artemisinin in Thailand, which is currently the front-line drug in the treatment of malaria. Doctors fear it could be the start of the global spread of malaria drug resistance, underscoring the need for research into new treatments for the disease.