News: Announcement

Next week’s World Health Assembly will be setting priorities that could have enormous implications for billions of people around the world. As World Health Organization (WHO) member states considers this year’s agenda items, GHTC urges them to prioritize the following actions to bolster research and development (R&D) to combat long-standing and emerging threats.:Global strategy for tuberculosis research and innovation: Substantially increase investment in tuberculosis R&D in line with fair share targets, improve coordination through global platforms and protocols, and streamline regulatory pathways and guidance processes to accelerate products to patients.Road map for neglected tropical diseases 2021–2030: Expand investment in R&D for urgently needed treatment and prevention tools for neglected tropical diseases, including therapies designed for children and simplified regimens, and advance regulatory and manufacturing pathways for diagnostic products to close the diagnostic gap.Immunization Agenda 2030: Strengthen implementation of recommendations from WHO’s expert body on immunization, accelerate the R&D agenda to advance next-generation COVID-19 vaccines, and support research on the full spectrum of needed immunization innovations, including vaccine administration, storage, and delivery tools.Draft resolution “Strengthening Clinical Trials to Improve Public Health”: Support the draft resolution, including its provisions calling upon countries to link grant funding with requirements to use standard data protocols, improve data sharing and harmonization, and increase investments in strengthening clinical trial capacity globally.Read GHTC’s full position statements on each agenda item below.14.3 Global strategy for tuberculosis research and innovationProgress toward tuberculosis milestones and targets has been hit hard by the COVID-19 pandemic. In 2020 alone, annual deaths from tuberculosis increased from 1.4 million to 1.5 million globally, far fewer people were diagnosed and treated for tuberculosis, and spending on essential tuberculosis services and research failed to increase in line with existing and new needs. This poses a risk to the achievement of the targets set in the political declaration of treating 40 million people diagnosed with tuberculosis and providing tuberculosis preventive treatment to 30 million people by 2022.To reverse the impact of the pandemic, avert preventable deaths, and put the world on track to end tuberculosis, essential tuberculosis services must be restored as a matter of urgency, and more domestic and international resources need to be mobilized. It is also critical that the development and uptake of new technologies is part of that investment. The Treatment Action Group reported tuberculosis research and development investment of US$915 million in 2020, far below the 2018 UN high-level meeting target of at least US$2 billion per year. Annual funding for tuberculosis research needs to more than double to reach the global target.Therefore, GHTC calls on the World Health Organization (WHO) and member states to:Substantially increase investments in tuberculosis research to drive technological breakthroughs and the rapid uptake of innovations, ensuring they are adapted to the needs of all populations, including children. Member states must mobilize domestic resources, foster public–private partnerships, and incentivize the responsible and well-regulated engagement of pharmaceutical companies, biotechnology firms, and other health product developers to expand the pipeline of new and equitably accessible tuberculosis tools, especially true point-of-care molecular diagnostics, new antibiotic regimens, and vaccines. While the specific call for member states to meet their tuberculosis research funding fair share targets is most welcome, much work remains to make these targets a reality.Address the unmet needs in translational research for tuberculosis. The pandemic has demonstrated that rapid sharing of data helps accelerate research and discovery. Some countries have already made strides by using common protocols coordinated through the Regional Prospective Observational Research for Tuberculosis (RePORT) network and contributed data and biospecimens to the platform. Member states should double down and push for additional coordination and collaboration through these platforms.Address the drug-resistant tuberculosis crisis and close persistent gaps in diagnosis and treatment access and care. WHO and member states should work to ensure that the process for including new technologies to fight drug-resistant tuberculosis on the essential medicines and diagnostic lists and other guidelines is streamlined, and that national regulatory agencies simplify local processes and collaborate regionally to ensure greater harmonization to facilitate the uptake of these technologies.WHO must continue to support the implementation of the global strategy for tuberculosis, including through the Special Programme for Research and Training in Tropical Diseases to provide crucial capacity-building and implementation research support to countries.14.4 Road map for neglected tropical diseases 2021–2030Neglected tropical diseases (NTDs) are inextricably linked to poverty and inequality. These diseases exact a heavy toll, causing chronic illness, severe disfigurement, blindness, and death. More than 1.5 billion people are estimated to require interventions against NTDs each year with many existing tools inadequate to effectively screen and treat populations in low-income and low-resource settings. Increased attention in recent years has brought new resources to the fight against NTDs and fueled research breakthroughs. Yet, very significant gaps remain in the arsenal of tools needed to control and eliminate these diseases, underscoring the need for research and development (R&D) of new tools. COVID-19 has also significantly disrupted interventions and activities across the entire spectrum of research and essential health services for NTDs. Leaders must demonstrate greater urgency to ensure that the progress made over the past decade is not reversed due to challenges caused by the pandemic.Therefore, GHTC calls on the World Health Organization (WHO) and member states to:Address the current diagnostic gaps for NTDs. The Diagnostic Technical Advisory Group for Neglected Tropical Diseases recently published a number of target product profiles, and more guidance and support from WHO will be necessary to spur the development of new diagnostic tools. We urge WHO and member states to work together to explore regulatory and manufacturing pathways to facilitate prequalification and regulatory approval of in-vitro diagnostics.Support programs that help catalyze innovation and build capacity to develop new diagnostics, drugs, vaccines, and other health technologies, and urge WHO to facilitate greater coordination across the full scope of diseases. Accelerated programmatic action could advance scientific understanding for developing new tools, improving strategies, and strengthening service delivery. We urge member states to fill key gaps by investing in R&D for new and improved treatments and prevention tools, including therapies designed for children and shorter, simplified regimens with fewer side effects.14.5 Immunization Agenda 2030Many recent scientific and multilateral agency reports and publications suggest that overall, immunization took a step backward in the past two years. Despite the tireless efforts of countless immunization program staff and health workers to ensure the availability of vaccination services, vaccination coverage globally fell for the first time in a decade. The COVID-19 pandemic has overwhelmed immunization infrastructure and workforce, impacted the global supply chain, increased the incidence of antimicrobial resistance (AMR), and derailed gains made in immunization campaigns around the world. Immunization is a pillar of people-centered primary health care, and we urge the World Health Organization (WHO) and member states to strengthen vaccine-related research and innovation with the most vulnerable populations in mind.GHTC calls on WHO and member states to:Accelerate and expand the COVAX facility research and development agenda to advance next-generation COVID-19 vaccines, including “variant-proof” COVID-19 vaccines and shots that could provide wide protection against coronaviruses, vaccines with optimized dosing, and vaccines more suitable for delivery in low-resource settings. World leaders must also do everything in their power to correct the shameful lack of equitable access to these lifesaving tools.Focus on the full spectrum of innovations that support immunization programs. The near term will inevitably be dominated by a continuing focus on COVID-19 vaccine rollouts. Nevertheless, it is vital that these activities are also leveraged to strengthen vaccine manufacturing capacities, storage, administration, and co-administration with other health interventions as well as novel service delivery, including focused “test & vaccinate” strategies as recently recommended by the Gavi board.Support implementation research and the development of formal feedback loops to monitor follow-up of recommendations made by groups such as the Strategic Advisory Group of Experts on Immunization and regional immunization technical advisory groups.Strengthen manufacturing capacities in low- and middle-income countries. This support must be paired with parallel investment and coordination to ensure sustainable markets exist to procure locally manufactured vaccines. This also includes supporting strengthening regional and national regulatory bodies, ensuring locally manufactured vaccines are safe, effective, consistent, and of high quality.Mandate WHO to immediately lead a comprehensive assessment of the resources and policies needed to meet IA2030’s targets.Draft resolution “Strengthening Clinical Trials to Improve Public Health”While the pandemic has disrupted and delayed many research activities, it has also highlighted the importance of quality clinical trials in responding to public health threats nationally, regionally, and globally. Leaders recognize the need for additional investment, new capacities, and reform of existing systems to create a stronger enabling environment for research and development in low- and middle-income countries.As countries seek to develop a more responsive and resilient global health architecture, it is vital to bolster regionally distributed clinical trial capacity. This resolution on strengthening clinical trials to improve public health is a strong first step, taking concrete action to facilitate investment in high-quality clinical trials, adopt robust clinical trial standards in routine practice to expedite the development of effective health care interventions, and develop the governance infrastructure to support enhanced collaboration and coordination between nations.We urge the member states to support the resolution and to:Endorse the provision in the resolution calling for grant funding for clinical trials to be linking to requiring using standard data protocols where available and to mandate registration on a clinical trial registry within the World Health Organization’s International Clinical Trials Registry Platform.Work with the World Health Organization and other member states to support the provision highlighting the need for data sharing between regulatory authorities to speed up and harmonize clinical trial approvals in other countries.Support greater clinical trial capacity globally through investment and technical support, enabling a greater number of clinical trial sites in lower- and middle-income countries and more readily coordinating activity between existing and new clinical trial networks.

Ahead of the 2nd Global COVID-19 Summit tomorrow, GHTC Executive Director Jamie Bay Nishi shared the coalition’s commitments to unlocking funding to advance research to expand the pipeline of affordable, easier-to-deploy COVID-19 technologies for low-resource settings and strengthen regionally distributed research and development (R&D) capacity.Her video remarks are below, followed by GHTC’s full commitments across the three summit thematic pillars: Full commitmentsVACCINATE THE WORLD: The Global Health Technologies Coalition will amplify evidence of gaps in the upstream vaccine research and development (R&D) aspects of the COVID-19 response and work to ensure political support and additional resources to support R&D of next-generation vaccines designed to better reach the last mile and address emerging variants and for strengthening regional research and manufacturing capacities. This includes expanding multisector support for research and clinical trials to accelerate vaccine development, strengthening vaccine prequalification and regulatory authorities to facilitate market entry while ensuring quality and safety, and mobilizing sustainable financing for regional vaccine manufacturing hubs that can be deployed for the COVID-19 response but also effectively leveraged and optimized for a broader range of health areas.SAVE LIVES NOW: The Global Health Technologies Coalition (GHTC) will hold public- and private-sector stakeholders accountable to unlocking funding and advancing research to expand the pipeline of affordable, easy-to-deploy diagnostics and therapeutics, particularly for use in low-resource settings. GHTC will galvanize its partners to push for more efficient prequalification and regulatory reviews of novel COVID-19 technologies and work to remove policy barriers to support bolstered testing, surveillance, genomic sequencing, and data sharing to better detect and monitor emerging variants. GHTC will also amplify the calls by its global partners for strengthened regional capacities to manufacture all types of medical countermeasure products.BUILD BETTER HEALTH SECURITY: The Global Health Technologies Coalition (GHTC) supports the creation of a new pandemic preparedness fund and will leverage its platform and network of partners to highlight how the fund should be utilized to bolster country and regional pandemic research and development (R&D) capacities including surveillance, laboratory infrastructure, clinical trial, manufacturing, regulatory capabilities, pharmacovigilance, and supply chain management. The Global Health Security Agenda (GHSA) is a ready-made platform for countries to identify and articulate their capacity gaps and financing needs. GHTC, through the Global Health Security Agenda Consortium, is engaging the GHSA R&D Task Force to develop a tool that enables countries to assess their R&D pandemic preparedness capabilities. The Task Force also serves as a platform to elevate perspectives of national and regional stakeholders, especially those from low- and middle-income countries, to ensure global investments and new sustainable financing for pandemic preparedness are allocated to filling key national and regional R&D capacity gaps.

A coalition of more than 100 leading global health and research organizations is calling on Congress to provide $250 million in new funding to the US Agency for International Development (USAID) to establish a fund to supercharge global health innovation.In an open letter to congressional appropriators, these organizations urged policymakers to appropriate this dedicated innovation funding to USAID in the fiscal year 2023 State, Foreign Operations, and Related Programs spending bill. This new influx of resources, which advocates are calling the Supporting Innovative Global Health Technologies Fund, or SIGHT Fund, would enable USAID to expand its support of research and development (R&D) of products for a range of global health challenges.The letter highlights how USAID has for decades excelled in facilitating R&D of new vaccines, drugs, and other tools as part of its broader global health mission. But it also notes how stagnant budgets and growing needs have squeezed the agency, resulting in a worrisome trend of USAID investment in R&D declining as a proportion of overall global health spending. The signatories make the case that this new dedicated source of R&D funding would reverse this decline and better enable the agency to make bold, forward-looking innovation investments to stock the global health toolbox of tomorrow.The request for an initial appropriation of $250 million for the SIGHT Fund is an amount representing less than 3 percent of current US spending on global health, yet this modest investment could catalyze the development of game-changing tools that could accelerate progress against both emerging and enduring global health challenges—saving US taxpayer dollars, maximizing the impact of programs, and ultimately improving and saving lives around the world. The full text of the open letter can be viewed here and the full list of signatories is below:1,000 Days3rd Stone DesignAdvancing SynergyAmerican Academy of PediatricsAmerican Society of Tropical Medicine and HygieneAVACBay Area Global Health AllianceBEMPU HealthBetter World CampaignBilimetrix s.r.l.BIO Ventures for Global HealthBoston University Social Innovation on Drug Resistance ProgramBridges to DevelopmentBugworksBurnet InstituteCatalysts for ChangeCenter for Global Health InnovationCenter for Innovation in Global Health, Georgetown UniversityChristian Connections for International HealthCoalition for Epidemic Preparedness InnovationsCoalition for Health Research and DevelopmentCONRADConsortium of Universities for Global HealthCORE GroupDeutsche Stiftung WeltbevoelkerungDr Marri Channa Reddy FoundationDrugs for Neglected Diseases initiativeElizabeth Glaser Pediatric AIDS FoundationEmory UniversityEpiPointeEqualize HealthFINDFREO2 FoundationFriends of the Global Fight Against AIDS, Tuberculosis and MalariaGlobal Antibiotic Research and Development PartnershipGlobal Health CouncilGlobal Health Innovative Technology FundGlobal Health StrategiesGlobal Health Technologies CoalitionGlobal ImpactHarvestPlusHemex HealthIAVIInfectious Diseases Society of AmericaInnovative Vector Control ConsortiumInternational Business & Technical Consultants, Inc.International Partnership for MicrobicidesInternational Union Against Tuberculosis and Lung DiseaseInternational Vaccine InstituteJohns Hopkins Center for Health SecurityKNCV Tuberculosis FoundationLinux Foundation Public HealthLittle Sparrow Technologies, Inc.Lucky Iron FishMakerere University School of Public HealthManagement Sciences for HealthMbarara University of Science and TechnologyMedical IMPACTMedicines for Malaria VentureModula S Inc.MRIGlobalMustERONE CampaignPAIPanAfricarePandemic Action NetworkPanorama GlobalPartners In HealthPATHPathfinder InternationalPolicy Cures ResearchPopulation CouncilPopulation Services International Research!AmericaRESULTSRice University Institute for Global Health TechnologiesSabin Vaccine InstituteSanaria Inc.Seed Global HealthShot@LifeSightsaversSinapi BiomedicalSmile TrainSociety for Children Orphaned By AIDS Inc.South Africa Health Technologies Advocacy CoalitionSpeak Up AfricaTB AllianceTexas Children's HospitalThe BroadReach GroupThe END FundThe Task Force for Global HealthTreatment Action GroupUCSF Institute for Global Health SciencesUnited to Beat MalariaUnlock AidVanderbilt Institute for Global HealthWashington Global Health AllianceWCG CaresWhat To Expect ProjectWhite Ribbon AllianceWomen in Global HealthZenysis

The fiscal year 2023 (FY23) budget request released yesterday by the White House includes some much needed and welcome increases to several global health and research and development (R&D) priority accounts but does not meet the moment in terms of putting forth a comprehensive commitment to growing resources across all these essential programs. The Global Health Technologies Coalition (GHTC) is disappointed to see FY23 requests for some critical accounts fall below FY22 enacted levels. The administration has proposed incredibly ambitious multi-year, multi-agency mandatory—or automatic—funding to bolster pandemic preparedness but must lay out a path forward marrying these new visionary commitments with increases to discretionary—or annually determined—global health and R&D spending.Unprecedented global challenges demand unprecedented American leadership—including unprecedented investments in global health and R&D programs, both those newly proposed to respond to emerging challenges and those with decades of proven impact. These investments are not just numbers on a page: they directly translate into lives saved from the enduring epidemics of HIV/AIDS, tuberculosis, and malaria; ground gained against the COVID-19 pandemic still smoldering as 40 percent of the world’s population awaits a first vaccine dose and we live under constant threat of new variants; strengthened health systems worldwide to detect, prevent, and respond to the next health threat; and new and improved health tools designed for impact everywhere in the world they are needed. The International Affairs Division of the FY23 budget request released today includes some hopeful steps in that direction, including a significantly increased US contribution to the Global Fund for AIDS, Tuberculosis and Malaria; new global health security commitments, including the establishment of a financial intermediary fund for pandemic preparedness; and increases to malaria, neglected tropical diseases, and international family planning programming at the US Agency for International Development (USAID) and State Department. Other critical global health accounts, however, are flat funded or even cut relative to FY22 enacted levels in the request. GHTC is disappointed that the budget request does not include comprehensive funding increases across the entire State Department and USAID Global Health Programs account. This sends a mixed message from the White House and does not reflect the administration’s stated commitment to global leadership on a broad range of health challenges. Flat funding or cutting global health programs under more budgetary strain than ever due to the continued impact of COVID-19 does not meet the moment. The $6.5 billion in five-year funding requested for the State Department and USAID through a new mandatory funding pathway, which includes a strong US commitment to the Coalition for Epidemic Preparedness Innovations, is an exciting proposal. The White House must now work with congressional appropriators to ensure this and other mandatory spending for pandemic preparedness proposed in the budget request is realized alongside increases to discretionary spending accounts. Reaching our global health goals in the months and years to come requires robust investments in R&D today, and GHTC welcomes the increases proposed in the budget framework for the Biomedical Advanced Research and Development Authority, the Centers for Disease Control and Prevention’s Center for Global Health and National Center for Emerging and Zoonotic Infectious Diseases, and the transformative level of new mandatory spending proposed for pandemic preparedness through these and other agencies within the Department of Health and Human Services. However, of the $4.3 billion increase requested for the National Institutes of Health (NIH), $4 billion would be used to boost the new Advanced Research Projects Agency for Health, leaving very little room for increases to other NIH institutes and centers. GHTC welcomes the increase proposed for the Fogarty International Center but is disappointed that the FY23 request for other NIH institutes and centers vital to global health R&D, including the National Institute of Allergy and Infectious Diseases, National Center for Advancing Translational Sciences, and National Institute of Child Health and Human Development, fall below FY22 enacted levels. There are some bright spots and visionary proposals included in the White House’s FY23 budget request, and the proposed mandatory spending for pandemic preparedness across the US government would be transformative—if enacted by Congress. However, the administration missed a crucial opportunity to lay out a comprehensive approach to boosting our global health and R&D capabilities through increases to discretionary spending in this request. At this moment of intersecting global health crises—layered on top of so many other pressing international challenges—maintaining hard-won gains against enduring global health threats and preparing for new threats to come will require even bolder investments. GHTC looks forward to working with champions in Congress to ensure that the final FY23 budget rejects any cuts relative to FY22 and sustains a pathway toward funding commensurate with unprecedented global needs.