News: Announcement

The Global Health Technologies Coalition (GHTC) yesterday honored Senator Chris Van Hollen (D-MD) and Congressman Brian Fitzpatrick (R-PA) for their leadership in championing global health research and development (R&D) at its 2023 Innovating for Impact Awards, an annual initiative celebrating US policymakers and partnerships catalyzing global health innovation. GHTC also recognized the partners, led by ViiV Healthcare, that developed and are accelerating global access to cabotegravir long acting (CAB-LA) for HIV prevention—the first and only long-acting injectable option for pre-exposure prophylaxis (PrEP)—for their efforts to advance this groundbreaking new product that could transform global HIV prevention efforts. Senator Chris Van Hollen, who is a member of both the Senate Appropriations Subcommittee on State and Foreign Operations and the Foreign Relations Subcommittee on Africa and Global Health Policy, was honored with a Congressional Champion Award for his longstanding work to grow funding for US biomedical research and global health programs and to advance smart policies to further their impact. “I am pleased to be on the appropriations committee, and not only using that platform to try to fully fund, for example, our efforts at NIH and all of our health research here at home, but also, the research here at home that has a direct benefit to people around the world,” Senator Van Hollen said in accepting the award. GHTC also recognized Congressman Brian Fitzpatrick with a Congressional Champion Award for his leadership in introducing the Supporting Innovative Global Health Technologies (SIGHT) Act to establish a new disease-agnostic research and development (R&D) program at the US Agency for International Development (USAID), as well his support of numerous other bills to bolster product development for tuberculosis, maternal and child health, epidemic preparedness, and antimicrobial resistance. “The United States must remain a world leader in health technology innovation, both at home and abroad. And I personally will always oppose any dangerous cuts to critical agencies that allow our nation to remain a leader in global health,” Congressman Fitzpatrick stated in prerecorded acceptance remarks. GHTC also presented the Partnership Award to Dr. Kimberley Smith, head of research and development at ViiV Healthcare, who accepted the award on behalf of the many partners who have contributed to developing and advancing global access to CAB-LA for PrEP. As a discrete solution that reduces the frequency with which people must take HIV medicine from daily pills to as few as six injections per year, CAB-LA can help more people adhere to PrEP and reduce infections, particularly among at-risk women and girls.  Developed by ViiV, with support from the US National Institutes of Health (NIH) and the Bill & Melinda Gates Foundation, and first approved in the United States in late 2021, CAB-LA for PreP is beginning to be rolled out in low- and middle-income countries (LMICs) through a series of unique public-private partnerships. This includes projects funded by the US President’s Emergency Plan for AIDS Relief (PEPFAR) to support countries in implementing and scaling up CAB-LA, as well as an agreement with the Medicines Patent Pool (MPP) to enable generic manufacturing of the product for use in LMICs.  “It is literally humbling and a tremendous honor to be here to accept this partnership award on behalf of all of the partners,” said Dr. Smith. “This is a game changer, and I'm very much looking forward to the day when we can look back and say that this was the beginning of the end of the AIDS epidemic.Dr. Smith from ViiV was joined in accepting the award by Dr. Jeanne Marrazzo, director of the NIH National Institute of Allergy and Infectious Diseases (NIAID); Dr. Carl Dieffenbach, director of the Division of AIDS at NIH/NIAID; Dr. Emily Kainne Dokubo, deputy global AIDS coordinator for program quality at PEPFAR; Dianna Edgil, chief of the supply chain at USAID; Dr. Myron Cohen, principal investigator of the HIV Prevention Trials Network; and representatives from other organizations involved in advancing CAB-LA for PrEP. “GHTC is thrilled to honor Senator Van Hollen, Congressman Fitzpatrick, and the partners who advanced CAB-LA for PrEP with our Innovating for Impact Awards,” said Jamie Bay Nishi, executive director of GHTC. “History has shown us time and again just how important accessible health technologies, smart policymaking, and multisector partnerships are to confronting global health challenges. We’re delighted to be recognizing the outstanding work of our honorees who are driving innovation to advance global health progress.” During the awards reception, in recognition of 2023 being the year of the World Health Assembly resolution on strengthening diagnostic capacity, GHTC also featured a digital exhibit on diagnostic tools as an often underrecognized driver of global health progress. Now in its seventh year, the Innovating for Impact Awards celebrate US commitment to global health R&D and honor the multisector partnerships and policymakers helping to transform breakthrough scientific research into lifesaving technologies for unmet global health challenges.  View photos from the event on Flickr.Learn more about the initiative and past honorees.

Today, the Supporting Innovative Global Health Technologies (SIGHT) Act, a bill spearheaded and endorsed by GHTC, was introduced in the US House of Representatives. Below is a press release from the bill's sponsors, which quotes the executive director of GHTC.WASHINGTON, DC – Congressman Brian Fitzpatrick (PA-01), Congresswoman María Elvira Salazar (FL-27), and Congresswoman Chrissy Houlahan (PA-06) introduced the Supporting Innovative Global Health Technologies (SIGHT) Act of 2023. The bipartisan bill to empower the United States Agency for International Development (USAID) to boost its research and development capabilities for health care technologies in low and middle income countries abroad."The United States must remain a leader in health technology innovation at home and abroad," said Congressman Fitzpatrick. "Our bipartisan bill aims to address global health issues and provide further research and development in order to help save millions of lives on the world stage.”“We need stronger American investments to tackle the global health challenges of the 21st century,” said Congresswoman Salazar. “The SIGHT Act establishes a program dedicated to research at USAID, allowing us to better focus our energy on transformative tools that can save lives and drive down costs. I’m proud to co-lead this bipartisan bill to improve healthcare outcomes for the most vulnerable.”"COVID-19 laid bare that we must ensure populations at home and abroad have the resources to innovate rapidly, and that global health directly impacts economic stability and prosperity. As health emergencies continue to affect communities worldwide, it's important that we invest in organizations with a track record of successfully advancing global health. One great example is USAID," said Congresswoman Houlahan. "I am proud to introduce this bipartisan piece of legislation to support USAID, enabling them to advance cross-cutting research and development and respond quickly to emerging public health threats."“We applaud Reps. Fitzpatrick, Houlahan, and Salazar for recognizing both the need and the opportunity to elevate USAID’s role in global health R&D,” said Jamie Bay Nishi, executive director of the Global Health Technologies Coalition (GHTC), which represents 45 nonprofit organizations, academic institutions and aligned business committed to advancing innovations that save lives worldwide. “R&D partnerships led by USAID have been instrumental in saving millions of lives around the world—while also stimulating investments that create jobs here in the United States. It’s good to see Congressional leaders committed to intensifying the agency’s impact by encouraging USAID to go beyond a disease-specific approach and embrace a disease-agnostic approach—to pursue R&D partnerships that address the biggest priorities in global health, whatever and wherever they may be.”The SIGHT Act is also endorsed by:1. 3rd Stone Design2. Advancing Synergy3. American Academy of Pediatrics4. American Society of Tropical Medicine and Hygiene5. AVAC6. BEMPU Health7. BIO Ventures for Global Health8. Bugworks9. Catalysts for Change10.  Center for Global Health Innovation11.  CEPI U.S.12.  Coalition for Health Research and Development13.  CORE Group14.  Deutsche Stiftung Weltbevoelkerung15.  FIND16.  FREO2 Foundation17.  Global Health Council18.  Global Health Strategies19.  Global Health Technologies Coalition20.  Global Impact21.  Hemex Health22.  IAVI23.  Innovative Vector Control Consortium24.  International Union Against Tuberculosis and Lung Diseases25.  International Vaccine Institute26.  Makerere University School of Public Health27.  Management Sciences for Health28.  Mbarara University of Science and Technology29.  Medical IMPACT30.  Medicines for Malaria Venture31.  MRIGlobal32.  Pandemic Action Network33.  Panorama34.  PATH35.  Pathfinder International36.  Policy Cures Research37.  Population Council38.  Population Services International39.  Rice University Institute for Global Health Technologies Coalition40.  Sabin Vaccine Institute41.  Sightsavers42.  Sinapi Biomedical43.  Society for Children Orphaned by AIDS Inc.44.  South Africa Health Technologies Advocacy Coalition45.  Speak Up Africa46.  The BroadReach Group47.  The Task Force for Global Health48.  Treatment Action Group49.  Unlock Aid Coalition50.  White Ribbon AllianceRead the text of the bill here.

GHTC submitted the following intervention at a US Department of Health and Human Services (HHS) listening session held on June 28, 2023 on the zero draft of the Intergovernmental Negotiating Body's zero draft of a pandemic accord.The Global Health Technologies Coalition (GHTC) is a coalition of more than 45 nonprofit organizations, academic institutions, and aligned businesses advancing policies to accelerate the creation of new drugs, vaccines, diagnostics, and other tools that bring healthy lives within reach for all people.We appreciate the US government, particularly leadership from the Departments of Health & Human Services and State, for providing this consultative opportunity to comment on the ongoing Intergovernmental Negotiating Body process and highlight that our focus remains the innovation of and equitable access to health tools, thereby strengthening the world’s capacities for preventing, preparing for, responding to, and recovering from pandemics.We call on the United States to consider explicit language in the draft that highlights the need for interconnectedness between health system strengthening and pandemic preparedness and includes provisions that underscore the need to focus on sustainability and dual use when it comes to research and development. We note that Article 9 currently does not cover incentivizing continuous research to develop vaccines, diagnostics, therapeutics, and other health technologies for diseases that cause outbreaks primarily in lower- and middle-income countries but are not profitable for manufacturers to produce, such as those for cholera, Ebola/Marburg fever, and other neglected tropical diseases. Continuous research can accelerate the development of medical countermeasures for novel pathogens, as was the case when research on an mRNA vaccine for HIV helped to speed up the development of the COVID-19 vaccine. A provision should be added for supporting such research.Article 9 also outlines important principles of an effective and equitable system for developing the research base needed to accelerate the production of pandemic countermeasures; however, the latest draft does not currently include provisions for accountability of these principles. As an example, there should be an explicit reference to the inclusion of underserved populations in all their diversity in clinical trials, including children and people who are pregnant or of child-bearing age. GHTC would also appreciate more clarity on whether the newly proposed medical countermeasures platform could eventually fit into this space.We also urge the United States to support provisions strengthening the capacity of regional regulatory bodies, like the newly formed African Medicines Agency. Investing in the regulatory capacity, and not just harmonization, of these regional bodies will help fill gaps for countries with lower regulatory maturity levels. There is a need to include text that establishes national and regional policies or protocols for the regulation of products during health emergencies. Currently, the draft only highlights general regulatory harmonization and focuses on the licensing of pandemic products without taking into account broader elements of the regulatory ecosystem.

GHTC submitted the following intervention at a US Department of Health and Human Services (HHS) listening session held on June 20, 2023 on the amendment process for the International Health Regulations (IHR).The Global Health Technologies Coalition (GHTC) is a coalition of more than 45 nonprofit organizations, academic institutions, and aligned businesses advancing policies to accelerate the creation of new drugs, vaccines, diagnostics, and other tools that bring healthy lives within reach for all people.We appreciate the US government, particularly leadership from the Departments of Health & Human Services and State, for providing this consultative opportunity to comment on the ongoing International Health Regulations (IHR) amendment process. GHTC supports the ongoing negotiations of the Working Group on Amendments to the International Health Regulations (WGIHR) as it continues to advance discussions of the Member States Working Group on Strengthening WHO Preparedness and Response to Health Emergencies.  These negotiations must be inclusive and transparent and must find ways to meaningfully engage a broad spectrum of stakeholders to ensure a successful outcome. We would encourage the United States to use its voice as a member state to ensure that non-state actors can engage in these processes and have the opportunity to provide their technical expertise.We also wish to stress the importance of embedding research as a core pillar of health preparedness and that capacity-building assessments must reflect the essential role that research and development plays in responding to pandemics. While some progress was made in the latest version of the Joint External Evaluation (JEE), including adding a specific indicator to measure research and development with a particular focus on implementation research, the United States should push the World Health Organization (WHO) and other member states to also consider further revisions or expansion of the JEE to better reflect a range of health preparedness requirements, including the ability to develop and manufacture medical countermeasures, as well as regulatory indicators that assess capacity to rapidly approve new health technologies. Meaningful end-to-end development of medical countermeasures only happens when research, manufacturing, and regulatory capacities can come together.The United States must also underscore its commitment to the Global Health Security Agenda (GHSA) and work with partners to ensure that the framework can continue to play an important role in IHR implementation. GHSA has offered a unique and valued platform to drive country ownership, multisectoral cooperation, and innovation for health security, and a new framework that is built with the changing global health architecture in mind, including a stronger focus on research coordination, as well as clinical trial, regulatory, and manufacturing capacities in lower- and middle-income countries, should be a key focus for the working group.While not every country needs a full suite of capabilities for the end-to-end development of vaccines, diagnostics, therapeutics, and other technologies, like personal protective equipment and oxygen therapies, through manufacturing, every country should have a plan and pathway to gain access to these tools at an affordable price when needed.