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GHTC, in partnership with other coalitions, sent the letter below to US National Institutes of Health (NIH) leaders and other government officials raising concern about the new NIH policy increasing scrutiny over foreign subgrantees.To the attention of:Lawrence Tabak D.D.S., Ph.D., Acting Director, NIHLyric Jorgenson Ph.D., Acting Associate Director and Director, Office of Science Policy, NIH  Tara A. Schwetz Ph.D., Acting Principal Deputy Director, NIHMichael Lauer M.D., Deputy Director, Office of Extramural Research, NIHPeter Kilmarx M.D., F.A.C.P., F.I.D.S.A., Acting Director, Fogarty International Center, NIH and Acting Associate Director, International Research, NIHChristi Grimm M.P.A, Inspector General, Office of the Inspector General, HHS   Loyce Pace M.P.H, Assistant Secretary for Global Affairs, HHSArati Prabhakar Ph.D., M.S., Director, Office of Science and Technology Policy, White HouseWe are writing today as a group of US-based coalitions — representing tens of thousands of global health researchers and advocates and hundreds of research institutions and organizations — to share feedback on the recent announcement of a new policy increasing scrutiny and reporting requirements over international recipients of National Institutes of Health (NIH) subawards. The successful stewardship of lifesaving research conducted by the NIH is of utmost importance to our organizations and US taxpayers, as it plays a critical role in advancing the global health research and development pipeline and the work of US-based research institutions. However, we are concerned about the potential ramifications of the updated policy guidelines, as announced in the request for information (RFI) regarding "NIH Grants Policy Statement (NIHGPS), Section 15.2, which outlines the requirements for consortium/subaward agreements on NIH-funded grants."  Before this policy takes effect, we request that NIH meet with the US research community and relevant global stakeholders in a consultation process to explore strategies that meet the Inspector General's call for enhanced research oversight without jeopardizing international collaboration and engendering other adverse consequences.  Among our concerns, the decision to apply this policy exclusively to foreign research partners jeopardizes a key facet of diversity, equity, inclusion, and accessibility (DEIA), even though DEIA has been a notable priority of the Administration. In the NIH-Wide Strategic Plan for DEIA Framework, the agency makes clear its "People-Centered" framework includes foreign partners in its mission to "embrace, strengthen, and integrate diversity, equity, inclusion, and accessibility (DEIA) across all NIH activities in service of the NIH mission." Imposing these requirements could chill the environment for international research collaborations, contravening that framework and threatening efforts to engage researchers and other research stakeholders from underrepresented communities. Rather than advance DEIA and international research partnerships, the new policy could disincentivize them, by deterring US-based grantees from collaborating with international research institutions-- especially if the primary grant recipient is in charge of managing the review process.   Furthermore, we are concerned that the operationalization of the new policy may contradict existing international research and data-sharing policies such as the Nagoya Protocol. Additionally, the data collection process may run into barriers concerning privacy and what data individual countries legally allow to be collected and distributed internationally. It is a matter of both national and global health security that the US can continue collaborating fully with international research partners. Obstacles to US engagement could compromise our access to vital information needed to respond to health threats and leave other world powers to fill the void that we have left behind. Beyond the concerns already highlighted, the policy would impose a significant new administrative burden on grantees, which could derail or stall research progress. The policy calls for international subawardees to turn over, at least every six months, "all lab notebooks, all data, and all documentation that supports the research outcomes as described in the progress report." For all labs, but particularly those that are not resourced to compile all data digitally or that do not operate in English as a primary language, these requirements could be cost-prohibitive.  Even in high-income countries, the administrative processes created by the planned policy would likely require additional resources to carry out. The timelines for releasing certain data may well leave primary grantees unable to meet the new requirements, undermining collaborations that promise significant gains in medical and public health progress. The new policy also favors tenured professors and larger institutions, who have a greater capacity to absorb this administrative burden, running counter to NIH's goal to better support early-stage researchers. We believe the increased administrative costs associated with this policy would be higher than necessary to meet the worthy transparency and oversight goals which we agree are critically important. Ultimately, we are concerned this policy and its known (and yet unknown) ramifications have not been sufficiently vetted by the research community. With these considerations, our ask of the NIH and the Administration is to extend the timeline for vetting and implementing the policy until the aforementioned issues are resolved so that the spirit of the new directive is not overshadowed. While we welcome the chance to comment via the RFI, we feel further interactive dialogue with the research community is warranted. We are cognizant of the need to take definitive action and know members of the research community stand ready to work with the Institutes to identify strategies that advance research oversight without compromising fruitful international research collaborations.  We see this policy as one that has been proffered in good faith to assuage the fears and doubts that closed-door science can inadvertently cause. However, as highly invested stakeholders of domestic and global research, we want to ensure the policy is not simply reactionary, but rather one that strengthens science and international collaborations and further solidifies scientific advancement as a cornerstone of the US's global influence.  Thank you for your attention to this matter, and we look forward to engaging in future dialogue to discuss our concerns in greater detail. Signed:American Society for MicrobiologyAmerican Society of Tropical Medicine and HygieneBay Area Global Health AllianceCenter for Global Health InnovationGlobal Health Technologies CoalitionFederal AIDS Policy Partnership Research Working GroupInfectious Disease Society of America North Carolina Global Health AllianceResearch!America

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.

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. Last week, the World Health Organization (WHO) published its first global research agenda outlining key priorities in the fight against antimicrobial resistance. The intent of the agenda is to provide researchers, policymakers, funders, and other stakeholders with priority research topics for which greater action and evidence is needed. It covers issues including preserving current antimicrobials, advancing point-of-care diagnostic tests, and developing novel drugs to treat drug-resistant infections. The 40 priorities that relate to prevention, diagnosis, treatment and care, and cross-cutting topics were developed after a review of more than 3,000 documents published over the past decade looking at antimicrobial resistance.A recent study found promising results for a new, point-of-care genomic test for human papillomavirus (HPV) that could be a cheaper and more accessible option for cervical cancer screening in low-resource areas like sub-Saharan Africa, which has the highest rate of deaths from cervical cancer globally. Unlike currently available screening options, the HPV DNA test can be performed by a health care professional with minimal training using a mini centrifuge in the lab, cutting out the need for robust laboratory infrastructure and highly skilled professionals. The research team behind the test is now trying to make the test even more effective and efficient in low-resource settings by making it faster, inclusive of more HPV genotypes, and more sensitive.Researchers from the University of Montreal recently published a study showing for the first time the crucial role of a protein, adyl hydrocarbon receptor, or AhR, in allowing HIV to remain latent in the body, thus requiring antiretroviral therapy to be maintained in order to keep the virus from replicating. The researchers used CRISPR technology and drugs to neutralize the activity of AhR and observed that viral growth occurred in people living with HIV and on antiretroviral therapy. The study proposes a “shock and kill” strategy that would use drugs to inhibit and then reactivate AhR in the presence of AhR inhibitors to expose the HIV-infected cells for the immune system to then target and kill. Investigators hope further research can validate this method of fighting HIV.

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.