Breakthroughs Blog: SDGs

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. In response to a 2004 meningitis B epidemic in New Zealand, health clinics across the country offered free vaccinations over the course of two years for any individual under the age of 20. The vaccine, MeNZB, is used primarily to protect against meningitis B, but according to ecological data in Cuba, New Zealand, and Norway, the vaccine also appears to be associated with reduced rates of gonorrhea. To study this further, researchers took retrospective data from 11 health clinics across New Zealand, and compared rates of gonorrhea and chlamydia, analyzing the relationship between vaccination and infection rates. The researchers found that vaccinated individuals were significantly less likely to contract gonorrhea than their unvaccinated counterparts—but vaccine effectiveness rates fell for those co-infected with chlamydia. While this vaccine was only on the market from 2004–2006, these results suggest further study of the vaccine’s potential is warranted, especially as gonorrhea becomes increasingly resistant to first-line drugs. The path toward the elimination of measles, mumps, and rubella has been stymied by low vaccination rates in certain areas of the world, including in developed countries like Italy, Romania, Germany, and the United States. The surge in incidence and deaths from these diseases in developed areas of the world suggests there are pockets of low-immunized communities that are leaving thousands of neighboring children in danger of contracting these diseases. The debunked belief that vaccines cause autism has also contributed to this decline in immunization rates. The recent Ebola outbreak in the Democratic Republic of the Congo (DRC) helped the global health community understand the many complex, moving parts to contain an outbreak. While the DRC beat this particular outbreak in a short period of time, the global health community is still worried that this was merely an exception and the international community is still not equipped with the systems needed to deal with a complex, intercontinental pandemic. The outbreak happened in an incredibly remote area of the DRC, which limited the spread of the virus. While the response by the government and the World Health Organization was quick and effective, it is important to consider that outbreaks that occur in or closer to larger towns could pose a much greater threat and complicate the response. Another important factor in managing an outbreak like Ebola is the political health of a nation. Countries like Sierra Leone and Liberia, both heavily impacted by the 2014 outbreak, have been institutionally weakened by recent civil wars, leaving them more susceptible to large-scale and more deadly outbreaks.  

This coming week the “who’s who” of the global health community (as well as some much more modest global health advocates such as your humble author) will make the annual trek to Geneva, Switzerland, for the 69th World Health Assembly (WHA), where World Health Organization (WHO) member states will collectively decide WHO’s plans for the coming year. This year’s agenda is packed and includes many topics that could impact global health research and development (R&D). Below are the agenda items GHTC will be tracking in Geneva and topics we’ll dig into in more detail at a May 23 side event and webinar we are cohosting with the Geneva Centre for Security Policy, Global Health R&D: What’s at stake during the 69th WHA? Framework of engagement with non-State actors WHO routinely engages with a variety of non-State actors (NSAs)—any organization other than a member state. These collaborations support core components of WHO’s global health strategy. Some have argued, however, that WHO’s current ad-hoc approach to managing such engagements undermines its independence and impartiality. As I have written previously, the current draft framework runs the very real risk of excluding key WHO partners and actors in the global health R&D community. Given the significant member state pushback against the proposal, it will be fascinating to see how the tension is resolved.   Health in the 2030 Agenda for Sustainable Development With the approval of the Sustainable Development Goals (SDGs) in September 2015, the global development community has been trying to sort out how to implement and measure programming to achieve what are, by all admissions, extremely ambitious targets. WHO is no different, and has been hard at work laying out strategies to achieve the various components of goal 3, the “health SDG.” It is particularly heartening that target 3.b specifically commits member states to supporting health R&D. What shape this will take, and how WHO will engage are definitely hot topics to watch at this WHA.   Global Action Plan on Antimicrobial Resistance Following the 68th WHA’s adoption of the Global Action Plan on Antimicrobial Resistance (AMR), WHO has been working to develop strategic options to achieve the plan’s goals and will be presenting a progress update and an options paper to WHA this year for input. GHTC is closely monitoring plans for the R&D objective, which states: “… develop the economic case for sustainable investment that takes account of the needs of all countries, and increase investment in new medicines, diagnostic tools, vaccines and other interventions.” While the options paper is quite broad, in the R&D space the WHO Secretariat is specifically asking for input on methods to de-link R&D costs from sale price, how best to support access to innovative antimicrobials, and how to develop a prioritization mechanism to support appropriate R&D on AMR specifically. Given the danger that the global rise of AMR represents, the discussion is likely to be extensive and intense.   Follow-up to the report of the Consultative Expert Working Group (CEWG) on Research and Development: Financing and Coordination (Report of the open-ended meeting of Member States) GHTC has been following the CEWG process for some time as it winds its way forward after what has already been a decade-long process. The prototype R&D observatory is now online, and the demonstration projects are returning their progress reports. The WHO Special Program for Research and Training in Tropical Diseases (TDR) has prepared an analysis that outlines how a pooled fund and R&D observatory could work to identify unmet needs and channel funds to those R&D projects. While almost everyone agrees that additional funds and greater coordination are sorely needed, as we heard at GHTC’s webinar on CEWG, the jury is still split on the CEWG’s specific proposals. While it is unlikely that the CEWG process will come to an end at this WHA, the number of concerns that can be ironed out with all the decision-makers in the room will be telling in regards to future prospects.   For more analysis on these subjects, read GHTC’s fact sheet on Research and development at the 69th World Health Assembly.  

As 2015 draws to a close, the Global Health Technologies Coalition is reflecting on the past year in global health innovation. Below, in no particular order, are our picks for the top global health research and development (R&D) news and stories that shaped 2015. First ever vaccine against dengue virus approved The world’s first vaccine against dengue fever was approved by the national regulatory authority of Mexico, marking an important initial step in preventing this mosquito-borne infection, which is spreading worldwide. Nearly half the world’s population now lives in dengue-endemic countries, and an estimated 390 million infections occur each year. The vaccine’s developer Sanofi spent over 20 years and US$1.65 billion developing the vaccine and is now pursuing regulatory approval in 19 other countries. Sanofi has stated it will make the vaccine available for sale at a “fair, affordable, equitable, and sustainable price.” NIH finally receives funding boost Christmas came early for the US National Institutes of Health (NIH). After years of stagnated funding, NIH—the world’s leading public funder of neglected disease R&D—will finally receive a funding boost in 2016. In the fiscal year 2016 omnibus spending package, Congress approved a $2 billion—nearly 7 percent—increase in funding for NIH from $30 billion to $32 billion. NIH has lost 22 percent of its purchasing power since 2003 due to inflation, so this boost will provide critically-needed funding for the agency to continue to build upon its record of leadership in global health R&D. Photo: PATH/Satvir Malhotra Availability of the first child-friendly, appropriately-dosed TB medicines announced Health workers will soon have a critically-needed new tool to improve treatment for the one million children infected with tuberculosis (TB) each year. In November, TB Alliance and partners announced that the first-ever appropriate, child-friendly tuberculosis (TB) medicine in the correct dose will be available in early 2016. At the moment, TB medicines are not available in appropriate doses for children, so parents must crush or cut the pills to administer. This arduous process—combined with the bitter taste—leads to poor adherence. The new treatments are strawberry- and raspberry-flavored, appropriately-dosed versions of the three most commonly used TB medicines. These new treatments are expected to significantly improve TB treatment and adherence among children. Global Health Innovation Act passes House An important new piece of global health legislation championed by GHTC—the Global Health Innovation Act—passed the US House of Representatives earlier this month. This legislation would strengthen global health R&D programming at the US Agency for International Development (USAID) by directing USAID to incorporate R&D across its global health programming and requiring the agency to report annually to Congress on its R&D programs and activities. In 2016 the hard work will begin again to get the Senate to introduce and pass companion legislation so the bill can move another step closer to becoming US law. Ebola product development advanced at lightning speed After years of slow and stunted progress in the development of drugs, vaccines, and diagnostic tools to fight Ebola, product development jumped forward by leaps and bounds in 2015. Thanks to the collaboration of developers, regulatory agencies, and the World Health Organization, six Ebola diagnostics were developed and deployed in West Africa under emergency measures, early-stage clinical trials are underway for at least two Ebola drug candidates with others in development, and at least 15 vaccine candidates are in development with two candidates undergoing Phase II/III trials. The most advanced vaccine candidate VSV-EBOV was shown to offer near-total protection, according to preliminary data analysis from the trials. While these products arrived too late to have a major impact during the epidemic, the accelerated development approaches and mechanisms used may be able to be emulated to speed product development in the future. New pediatric malaria treatment receives positive scientific opinion paving path for regulatory approval A new pediatric malaria medicine— Pyramax® Granules—will soon be available for children worldwide. In November, Pyramax® Granules received a positive scientific opinion from the European Medicines Agency (EMA) under Article 58, a mechanism which facilitates regulatory approval of the product in malaria-endemic countries. The medicine, which was developed by Medicines for Malaria Venture (MMV) in partnership with Shin Poong Pharmaceutical Co. Ltd, is a combination of two antimalarials and is designed to be easy for children to consume. It is taken in liquid form and is flavored to mask the bitter taste. Next, MMV and Shin Poong will work to introduce Pyramax® Granules as well as Pyramax®, the tablet version which is suitable for adults, in malaria-endemic countries. Several promising global health products advancing through development The pipeline of global health technologies is growing and maturing with several exciting products moving through critical development stages. For example, a new medicine for drug-resistant TB became the first new TB drug to advance into clinical trials in six years when it entered Phase I trials in February, a vaginal microbicide containing a novel antiretroviral drug to prevent HIV entered Phase I trials in November, a drug candidate with the potential to become the first ever, oral-only, single-dose treatment for sleeping sickness completed Phase I trials in September, and a microbicide vaginal ring is completing Phase II trials with results expected in early 2016. Due to increased attention and investment over the last 15 years, there are now nearly 500 neglected disease product candidates in the pipeline. Global goals recognize importance of health R&D In September, global leaders ratified a new set of global goals, called the Sustainable Development Goals (SDGs), which will guide global development efforts for the next 15 years. GHTC was excited to see these goals recognize the importance of global health R&D with inclusion of a target supporting R&D of vaccines and medicines for diseases primarily affecting developing nations. It’s been broadly recognized that we cannot reach the ambitious SDG health targets—to reduce maternal and child mortality and end the epidemics of HIV/AIDS, TB, and neglected tropical diseases— by 2030 with the health technologies we have today. Now that the goals and targets are in place, accountability is key. We must ensure the SDGs translate into greater investment and political commitment from all nations to catalyze development of the next generation of health technologies needed to transform global health.

Moderator Lisa Cohen and panelist Tony Pipa. With the Sustainable Development Goals (SDGs) freshly adopted, the Global Health Technologies Coalition (GHTC) gathered representatives from the private, public, and nonprofit sectors on Capitol Hill this past Wednesday to discuss what it will take to achieve the global goals. One message rang loud and clear during the briefing: health innovation will be critical to achieving the SDGs, and it will take political commitment, funding, partnerships, and accountability mechanisms to deliver the next generation of health innovations needed to get us there. The panelists agreed that the SDGs—which set ambitious targets to end poverty, infectious disease epidemics, and preventable maternal and child deaths—are an important device for catalyzing political commitment and driving collective action to improve global health. Anthony Pipa, the US special coordinator for the Post-2015 Development Agenda, called the SDGs “a very optimistic global moment” and noted the power of the 193 United Nations member states coming together to agree on a set of goals, a point reinforced by moderator Lisa Cohen, executive director of the Washington Global Health Alliance. Pipa explained that the success of the Millennium Development Goals (MDGs) demonstrates the power of goal setting in advancing global health, and that the SDGs must build on that success. But he also clarified that “the SDGs are not just the MDGs 2.0,” as the SDGs are broader and more ambitious than the MDGs when it comes to health—they set goals to eliminate disease and preventable deaths, not just reduce them. He also described the inclusivity of the development process and the universality of the agenda, which promoted a sense of ownership among member states that are now starting to integrate the SDGs into their own national agendas. In the case of the US government, Pipa explained that the SDGs closely align with US priorities in global health and reflect the government’s longstanding commitment to health research and development (R&D). Panelists Dr. Dean Jamison and Kaitlin Christenson The need for strong and sustained investment in global health R&D to reach the SDGs was highlighted throughout the briefing. Dr. Dean Jamison, co-chair of the Lancet Commission on Investing in Health, explained that “we benefit today from investments in R&D of products made decades ago” and that health innovations have driven significant progress in global health over the past few decades. Jamison noted the Lancet Commission report’s conclusion that it is possible to achieve the ambitious SDG vision, but not without greater investment in R&D for new health technologies. He emphasized that, although health R&D can be a long and expensive process, it delivers huge returns on investment. The panelists all underscored that, because the SDGs are so ambitious, no one sector alone can ensure their success. Instead, it will take partnerships between the public, private, academic, philanthropic, and nonprofit spheres to reach the targets, particularly for health. Kaitlin Christenson, acting director of Advocacy and Public Policy at PATH, discussed the importance of product development partnerships (PDPs) in advancing the development of health technologies. Christenson remarked that PDPs leverage resources, expertise, and financing from across sectors and help “multiply” the impact of public sector investment. Gary Cohen Gary Cohen, senior vice president at BD, echoed this sentiment, noting that “so much of what we’ve achieved in health is due to collaboration, we couldn’t see doing it any other way.” Moving a promising idea through product development, regulatory approval, scale up of manufacturing, and market strengthening, in order to ultimately get the health innovation into the hands of patients who need it, is a daunting process. It’s not possible to do this, Cohen explained, without the involvement of the private sector. Cohen noted that throughout the process of developing the SDGs, it was widely acknowledged that the private sector would be critical to their successful implementation. Christenson pointed out that, while it is clear new health tools are needed to reach the global goals, it is not just about designing any technology, but the right technology. She explained that developers must stay focused on the needs of the end user and ensure that the product is affordable and contextually appropriate in order to achieve the desired health impact. She also noted that the community must be diligent in identifying health technologies with the greatest potential to drive dramatic improvements in health and rally the necessary investment and political support to bring them to scale. As an example, she highlighted PATH’s Innovation Countdown 2030 initiative, which identifies 30 innovations with the greatest promise to accelerate progress toward the SDGs. Attendees check out health technologies funded by US government investment. Pipa also emphasized that reaching the SDGs will require “doing business differently” and pointed to innovation within the US government to promote new thinking in global health, like USAID’s Saving Lives at Birth Grand Challenge. In the same vein, Christenson pointed out that “innovation comes from everywhere, not just white-coated scientists” and called for systems and policies that support a broad view of innovation. Cohen said that “innovation in business models will be just as important as innovation for technologies” and called for greater collaboration among key players to ensure that R&D investments are translated from the development of new tools and technologies to the ultimate delivery and use of lifesaving products. An audience member from PATH pointed out that, despite the importance of new health technologies to achieving the SDGs, the agenda does not currently include any indicator to measure progress in global health R&D, citing concern that “unless something is measured, it doesn’t necessarily happen.” Panelists agreed that data and measurement is a critical part of ensuring we are on the right track to reach the health targets. Pipa highlighted the expanded availability of data and the need to leverage data from different sectors, while Jamison cited the importance of data and monitoring in holding actors accountable to their SDG commitments. Though it will be a challenging road ahead to reach the SDG targets by 2030, the panelists were optimistic it could be done. Cohen emphasized that “these seemingly intractable problems are solvable.” Pipa agreed, saying, “the political consensus around ending extreme poverty is really powerful, and we shouldn’t underestimate that power.”