News: Announcement

GHTC welcomes the recent announcement by the World Health Organization (WHO) that it will apply parallel, rather than sequential, processes in developing guidelines recommending the use of novel health products and certifying their safety and efficacy via prequalification (PQ) and/or Emergency Use Listing (EUL). Many of our members and partners have highlighted how the prior procedure, which required guidelines to be in place as a prerequisite to EUL or PQ, was a major bottleneck for innovative products—adding significantly to approval timelines and delaying access to critical new health technologies in low- and middle-income countries.We believe that this new parallel process, which was first trialed during the pandemic for COVID-19 products, could significantly improve and accelerate access to vital innovative health technologies in countries that rely on WHO recommendations for the use of these products. We urge WHO to provide additional details on the implementation of this new process and encourage the PQ program to provide a platform for continued feedback and input from key stakeholders, including product developers, national regulators, procurers, and civil society.We believe that WHO’s PQ program continues to be an essential link in the regulatory ecosystem, and we hope this is just one of several steps WHO will take to reduce bottlenecks and improve the program’s efficiency and impact.  

Analysis reveals that over a 16-year period, $46 billion in U.S. public funding generated dozens of new tools for fighting HIV, TB and other global threats; boosted economic performance at home and abroad; and is likely to spur $102 billion in industry investments Over the last 16 years, U.S. government funding for research and development (R&D) targeting global health challenges supported dozens of breakthrough innovations while generating billions of dollars in economic benefits, both global and domestic, and spurring a surge of industry investments, according to a new analysis from the Global Health Technologies Coalition (GHTC) and Policy Cures Research (PCR). “Public funding for global health R&D is small, relative to the incredible returns it provides for fighting neglected and emerging diseases like malaria, HIV, tuberculosis, Ebola and COVID-19 — and for stocking the pipeline with many promising new technologies,” said Dr. Kristie Mikus, GHTC’s executive director. “The innovations emerging from this work are important for advancing health and opportunity globally and for addressing America’s increasing vulnerability to infectious diseases.” Dr. Nick Chapman, CEO of PCR, said, “Our analysis shows that the $46 billion invested by the U.S. government between 2007 and 2022 has not only delivered a steady stream of new drugs, vaccines and prevention tools, but has also supported basic research that is expected to attract an additional $102 billion investment from industry.” The report, Doing Well by Doing Good, looks at the return on investment from federal funding for global health R&D that flows through agencies such as the National Institutes of Health, Biomedical Advanced Research and Development Authority, the U.S. Agency for International Development, and the U.S. Centers for Disease Control and Prevention. This funding helps to support work targeting historically neglected diseases such as malaria, HIV and tuberculosis (TB); more recently emerging threats that include COVID-19, Ebola, chikungunya and mpox; and sexual and reproductive health issues. The report notes that new tools are urgently needed because these challenges cause a massive loss of life around the world, impede economic progress in low- and middle-income countries, and pose a growing threat to Americans — especially with climate change facilitating the spread of disease.  For example, in the fight against neglected and emerging infectious diseases (other than COVID-19), the report found the funding contributed to the development of 67 new health technologies that have been approved since 1999. This includes 12 new products for fighting Ebola, which continues to spark new outbreaks; 12 for TB, a resurgent disease fueled by an alarming spread of drug-resistant strains; and 11 for malaria, which is once again on the rise globally and recently caused a surprising spate of locally acquired cases in the U.S.The report found the investments also are supporting a product development pipeline for neglected and emerging diseases that now includes 261 promising innovations in late-stage development. Many carry the potential to deliver major benefits in reducing the human and economic toll of these threats.  New global health tools now available or close to fruition that benefited from recent U.S. government investments include: A new drug, pretomanid, whose addition to a treatment regimen for TB has dramatically improved outcomes and reduced costs for treating patients infected with drug-resistant strains of the disease. Switching all patients with drug-resistant TB to pretomanid-based regimens could generate global health care cost savings of $740 million annually.  Two new long-acting HIV prevention options have the potential to transform global HIV prevention efforts by offering an alternative to daily pills for at-risk groups. Long-acting cabotegravir, delivered via a single bi-monthly injection, could avert 45% of new infections in the U.S. and up to 28% of potential future HIV infections in low- and middle-income countries. The dapivirine vaginal ring, a monthly product offering discreet protection, is another breakthrough option for use by women at high risk of infection. The U.S. government’s multi-agency Operation Warp Speed supported development of four COVID-19 vaccines that have since been deployed around the world. These vaccines contributed to saving 14.4 million lives in the first year of the pandemic alone. Also, between December 2020 and March 2022, they played a prominent role in the estimated $895 billion in direct health care costs savings linked to vaccination.Powerful new monoclonal antibodies or mAbs have emerged for fighting Ebola and malaria. Two approved mAbs for treating Ebola were found to significantly decrease mortality, to 11% for one of the drugs and 6% for the other, compared to 54% in untreated patients. Meanwhile, three promising mAbs for preventing malaria are in clinical development. There is already evidence for one of these mAbs indicating a potential to reduce infections by 54%–75% in communities where malaria emerges as a seasonal threat. The report also notes that U.S. investments in global health R&D are delivering considerable economic benefits globally and domestically.  From 2007 to 2022, U.S. funding supported R&D capacity and product manufacturing capabilities in 43 low- and middle-income countries along with health innovations that can reduce the financial burden of neglected and emerging infectious diseases. For example, in countries where malaria is common, new drugs and vaccines can dramatically reduce the costs of managing the disease, which can consume up to 8% of a family’s budget and reduce national GDP by 1.3%. In the United States, the report estimates that from 2007 to 2022, the $46 billion in public spending on global health R&D created 600,000 new jobs, generated $104 billion in economic activity and supported basic research endeavors that are on track to catalyze $102 billion in additional industry investments. And it’s the gift that keeps on giving. By supporting basic research that will continue to inspire health innovations for years to come, the report finds that it’s likely the $46 billion in public funding ultimately will generate $255 billion for the American economy — a six-fold return on investment. (A companion analysis from GHTC available here explores the funding impact on a state-by-state level, which includes stimulating tens of thousands of jobs in top research states like Maryland, Massachusetts, California, Virginia, North Carolina, Washington state, New York, New Jersey, Pennsylvania and Georgia.)  The report points out that Americans also benefit because funding for global health R&D is delivering tools for threats that are increasingly viewed as potential domestic risks. For example, the report notes that climate change is facilitating the spread of insect-borne pathogens into the continental U.S., including Chagas disease, dengue, Zika, chikungunya and malaria.“The irony is that despite producing blockbuster returns, public funding for global health R&D is not keeping pace with growing needs and rising risks,” said Dr. Mikus. “R&D funding for emerging threats largely has been reactive — mainly focused on emergencies like Ebola, Zika and COVID-19 — and R&D budgets for neglected diseases actually dropped 11% in 2022. We encourage policymakers to look at global health R&D as one of the best investments a government can make, right up there with roads, schools and national defense.”  ### About the Global Health Technologies Coalition The Global Health Technologies Coalition (GHTC) works to save and improve lives by encouraging the research and development of essential health technologies. We bring together more than 45 nonprofit organizations, academic institutions, and aligned businesses to advance policies to accelerate the creation of new drugs, vaccines, diagnostics, and other tools that bring healthy lives within reach for all people. About Policy Cures Research Policy Cures Research is an independent, not-for-profit, research and policy organisation providing strategic analysis and decision-making tools for those involved in the creation of new health technologies for neglected diseases, emerging infectious diseases and sexual & reproductive health issues. Its focus is on providing governments, funders, researchers and civil society organisations with the insights they need to make optimal R&D policy and funding decisions for diseases affecting the world’s most vulnerable populations. For more information, please contact: Katy Lenard at klenard@burness.com or +1 301-280-5719 

WASHINGTON, DC (January 22, 2024)—Today, the Global Health Technologies Coalition (GHTC) announced the appointment of Dr. Kristie Mikus as the organization’s new executive director, effective February 26, 2024. Dr. Mikus will lead the coalition’s advocacy efforts to accelerate the creation of new technologies to drive global health progress. Dr. Mikus comes to GHTC from the U.S. Centers for Disease Control and Prevention (CDC), where she most recently served as senior policy advisor for the Global Health Center. She brings extensive experience in public policy, partnership building and program management in the global health sector from her two decades spent serving the U.S. government in various capacities, both in Washington, D.C., and abroad. Prior to her current role, Dr. Mikus served as the CDC deputy country director in Zambia and the Zambia country coordinator for the President’s Emergency Plan for AIDS Relief (PEPFAR). She has also held positions in the U.S. Department of State’s Bureau of Foreign Assistance, where she led foreign assistance reform efforts, and the Office of the U.S. Global AIDS Coordinator, first as a PEPFAR congressional liaison and later as PEPFAR country lead for South Africa, Tanzania, Haiti, Guyana, Mozambique and Zambia. Dr. Mikus first started her career in government at the U.S. Department of Commerce helping to negotiate free trade agreements for pharmaceuticals and biotechnology as a Presidential Management Fellow. “We are thrilled to welcome Kristie to GHTC. She’s a skilled and passionate leader with a comprehensive understanding of policy dynamics from her governmental roles, coupled with her firsthand experiences in countries that partner with the U.S. in global health initiatives,” stated Heather Ignatius, chief of external affairs at PATH, where the GHTC secretariat is based, and leader of the executive search team. “Kristie’s unique background, which includes actively working alongside these nations, positions her perfectly for cultivating collaborative relationships with diverse stakeholders, both within and outside of government. Her depth of experience and dedication to advancing innovation for global health makes her an outstanding choice to lead the coalition into its next chapter.” “I’ve had the opportunity get to know the GHTC community from my time within government, and I have seen firsthand how this coalition is a trusted source of expertise for U.S. and global policymakers and a powerful voice for the role of technology in advancing global health. I am honored and excited to take the helm of such a well-respected and dynamic organization and look forward to working with the coalition’s members and partners to continue to accelerate innovation to save lives worldwide,” said Dr. Mikus. Dr. Mikus will succeed former Executive Director Jamie Bay Nishi, who stepped down in December after leading the coalition through a period of significant growth and evolution over the past seven years. Under Dr. Mikus’ leadership, GHTC will continue to work to advance policies and funding to accelerate the development of vaccines, drugs and other technologies that improve global health. ### About GHTC The Global Health Technologies Coalition (GHTC) works to save and improve lives by encouraging the research and development of essential health technologies. We bring together more than 45 nonprofit organizations, academic institutions, and aligned businesses to advance policies to accelerate the creation of new drugs, vaccines, diagnostics, and other tools that bring healthy lives within reach for all people. 

As the governance body of the World Health Organization (WHO) meets next week for the 154th session of the Executive Board (EB)—which features agenda items on immunization, tuberculosis (TB), neglected tropical diseases (NTDs), and antimicrobial resistance (AMR)—GHTC urges policymakers to prioritize the following actions to strengthen research and development (R&D) to address these urgent health challenges:Develop a comprehensive global immunization research framework to support the goals of the Immunization Agenda 2030. The framework should outline priority research areas and foster global collaboration to address research gaps and accelerate vaccine development and introduction.Substantially increase investments in TB R&D and embrace global research coordinating platforms. To meet the goals of the Global Strategy on Tuberculosis Research and Innovation, member states must increase domestic investments in TB R&D in line with fair share targets and supercharge research efforts to develop novel vaccines, point-of-care diagnostics, and improved therapies, while ensuring tools are appropriate for all populations, including pregnant people and children. Member states should also embrace platforms that support improved TB research coordination, such as the new prioritized research agenda for drug-resistant TB and common research protocols.Expand investments in NTD R&D to address gaps in the availability of safe and affordable diagnostics and treatments. In implementing research efforts to support the NTD roadmap, member states and WHO should position impacted countries to lead in R&D priority setting, promote South-South collaboration models, consider the growing impact of climate change, and ensure interventions are tailored to the unique needs of different regions. They should also consider ways to better align the prequalification and regulatory approval processes to accelerate access to diagnostics.Bolster investments and incentives for R&D for new antimicrobials and other tools to fight AMR and improve global surveillance and laboratory capacity. Innovations should be developed with the goal of promoting broad accessibility, including for vulnerable populations and those in low-resource settings. Members states should actively participate in the global surveillance system for AMR and support the creation of a global AMR laboratory network to strengthen diagnostic capacity. In advance of this year’s United Nations (UN) High-Level Meeting on AMR, it is also vital that WHO and other relevant UN agencies hold an open, inclusive consultative process to define global AMR priorities.Read GHTC’s full position statements on each agenda item below.