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WASHINGTON, DC—Next week’s World Health Assembly will be setting priorities that have enormous life-altering implications for billions of people around the world. The Global Health Technologies Coalition (GHTC) is calling on World Health Organization (WHO) member states to increase investments in research and development (R&D), as new tools and technologies are essential for meeting urgent challenges, from achieving universal health coverage (UHC) to fighting antimicrobial resistance (AMR), including drug-resistant tuberculosis (DR-TB), and emerging threats like Ebola.R&D is essential for delivering on the promise of UHC. We still lack many of the tools needed to combat major health challenges facing the world’s poorest and to achieve global goals to drastically reduce maternal, newborn and child mortality, end the epidemics of HIV/AIDS, TB and malaria, and eliminate neglected tropical diseases. Attaining all these goals will require new investments that deliver a range of innovations and insights, as well as efforts to strengthen the overall health system in multiple areas, including clinical trial capacity, laboratory systems and regulatory frameworks. That’s why it is critical to elevate R&D as a central pillar to achieving UHC.There is an urgent need to mobilize new R&D investments and enhance coordination to combat AMR, which could erase decades of medical progress. Growing drug-resistance is reinvigorating leading killers of children like tuberculosis, pneumonia, malaria, typhoid and diarrheal diseases, in addition to spurring deadly hospital-based infections. We currently lack tools needed to fight back, which is why R&D must be a central focus of the battle against AMR. We need new antimicrobials, as well as better diagnostics to detect drug-resistant infections and vaccines to prevent them. One of the biggest drivers of the global AMR challenge is DR-TB. The WHO and member states must support efforts to develop new TB drugs, diagnostics and vaccines, and deliver on the global commitments made at the United Nations High-Level Meeting on TB: to diagnose and treat 40 million people by 2022 and close the US$1.3 billion gap in annual funding for TB R&D. Finally, we need to intensify global efforts to develop new tools to prevent health emergencies. The recent re-emergence of Ebola in the Democratic Republic of Congo highlights the critical importance of developing drug and vaccine candidates, diagnostics and mobilizing additional tools, like mobile laboratories, well in advance of an outbreak. We will continue to struggle to contain Ebola, or an outbreak of a disease not yet on our radar, without sustained, coordinated investments that deliver the tools needed to ensure the next outbreak does not become a global crisis. WHO should also expand its Essential Diagnostic List to include platform technologies to help us better prepare to respond to the next “Disease X.” ###FOR IMMEDIATE RELEASECONTACT:   Katy Lenard, klenard@burness.com, +1 301-280-5719

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email. A report released by the Economist Intelligence Unit warns that the fight against drug-resistant tuberculosis (DR-TB) lags behind that of other diseases in terms of money and public attention. Deaths from DR-TB will cost the world economy nearly US$20 billion annually; however, international funding for TB is approximately one-eighth that of HIV and AIDS and about half that of malaria. The report calls for TB to be treated as a public health emergency and states that $9 billion is needed by 2020 to develop new drugs, diagnostics, and vaccines to address this disease—the world’s number one infectious disease killer. DR-TB can develop when patients fail to adhere to the notoriously grueling treatment regimen, which includes thousands of pills and painful injections, or because of poor-quality drugs. Last year, the United Nations held the first-ever High-Level Meeting on TB, determining that ending TB is a global priority after progress against the disease has stalled in recent years. The World Health Organization (WHO) announced plans last Tuesday to change its vaccination strategy in the Democratic Republic of Congo (DRC) in an attempt to better confront the country’s current Ebola outbreak, which has lasted nine months and claimed more than 1,000 lives. As part of the new vaccination strategy, WHO intends to launch “pop-up” vaccination campaigns in safe communities and shift to immunizing as many people in each target area as possible instead of relying solely on its current tactic of ring vaccinating health workers and the immediate contacts of each known case. To extend vaccine supplies, WHO also recommended offering smaller doses of the vaccine—developed by Merck—to those at high risk and low risk respectively, and eventually introducing a second vaccine made by Johnson and Johnson. A consortium, including the Coalition for Epidemic Preparedness Innovations and the London School of Hygiene and Tropical Medicine, is planning how to safely roll out the new vaccine. On Wednesday, the US Food and Drug Administration (FDA) released two new draft documents which provide guidance about how to study drug safety and efficacy in pregnant and lactating women. The draft documents provide insight to drug makers into the FDA’s thinking on when they should study a medicine in lactating women and how they can better monitor health outcomes in pregnant women who are taking medications that have already been FDA-approved. These documents follow 2018 recommendations made by a federal task force formed by Congress to study the lack of research involving pregnant and lactating women. Historically, the drug industry has excluded pregnant women from research out of concern that an experimental medication might harm a fetus. There is a similarly small amount of research on medications safety in lactating women. Once finalized, the documents will help companies collect more high-quality safety information about drugs used in pregnant and lactating women.

Universal health coverage (UHC)—the idea that everyone, everywhere, should be able to access quality health services—will take center stage at the World Health Assembly (WHA) later this month. World Health Organization (WHO) Director-General Dr. Tedros Adhanom Ghebreyesus has made UHC a top priority, as his institution estimates that at least half of the world’s population still does not have full coverage of essential health services.While there are many building blocks to achieve UHC—from galvanizing political will and investment to strengthening health systems and training health personnel—one integral pillar that is too often overlooked is innovation—the creation of new and improved drugs, vaccines, and diagnostic tools. Global health research and development (R&D) is indispensable in delivering on the vision of quality health for all. R&D a vital component to achieve UHCHealth systems cannot meet the fundamental needs of their populations without high-quality and accessible drugs, vaccines, and diagnostics with which to treat, prevent, and detect disease. Today, we still lack many of the tools needed to combat diseases and conditions that exact a tremendous health burden in the world’s poorest places. No preventative vaccines exist for many neglected diseases, including Chagas, leishmaniasis, and chikungunya, and treatments available are often inadequate or toxic. Tuberculosis (TB) sufferers today face six to twenty months of treatment, involving thousands of pills and painful injections. We still don’t have the right tests to diagnose many infectious diseases at point of care, leaving patients wondering and waiting for care. The goal of ending AIDS will remain out of reach without a vaccine or cure. Meanwhile, growing antimicrobial resistance (AMR) against malaria, TB, and other infectious diseases threatens to roll back progress and is adding even greater urgency to the need to develop new innovations to prevent emerging resistance. Neglected diseases affect hundreds of millions of people worldwide and jeopardize achieving UHC for the most vulnerable among us.As the global community invests in policies and programs that support UHC, it must also prioritize R&D for new health technologies, especially where markets don’t catalyze these investments on their own. It will be impossible to truly deliver quality care for all without new innovations. Delivering the next generation of lifesaving health technologies will require strong political commitment and increased investment from all nations. To make that happen, it’s critical that the world explicitly acknowledge the importance of global health R&D to attaining UHC.WHO’s role WHO has a crucial role to play in strengthening R&D and access to achieve UHC. Through its global convening power, WHO sets the agenda and is often the institution policymakers rely upon to frame their countries’ health priorities and lead the implementation of important programs vital to improving access to quality treatment and services. For example, WHO’s essential medicines and diagnostic lists are highly vetted, evidence-based recommendations that provide member states with a robust framework to determine key investment, health service, and policy priorities. WHO also provides technical expertise and capacity-building programs to build regulatory frameworks that accelerate access to medicines and create stronger enabling environments for global health R&D. This includes supporting the development of laboratory systems and infrastructure, as well as clinical trial capacity. For everything ranging from establishing safety standards, to producing treatment guidelines for infectious diseases, to designating good clinical research practices, WHO sets the normative technical standards and provides clear targets for low- and middle-income countries for health system strengthening. WHO must continue to use its global convening power to facilitate coordination and alignment of priorities in order to advance the UHC agenda. This is why the 72nd WHA meeting presents the global health community with an opportunity to ensure that WHO continues to play a significant role in supporting R&D by stepping up its efforts to catalyze additional investment, build capacity, and provide resources to stakeholders to facilitate the development and effective deployment of tools to patients globally. While governments can, and should, play a leading role in the global UHC movement, WHO will also play an important part in making the vision of quality health for all a reality. As the world gets ready to descend on Geneva for WHA week, global health advocates should remember that there is no UHC without R&D.