News & Insights

GHTC submitted comments to the Senate Health, Education, Labor and Pensions (HELP) Committee in regard to the Senate's July 3 Pandemics and All-Hazards Preparedness Act (PAHPA) Discussion Draft, urging the committee to take the opportunity to reaffirm commitments to supporting innovative global health research and development.To the attention of: Bernard Sanders, Chair, Senate HELP Committee Bill Cassidy, M.D., Ranking Member, Senate HELP Committee Robert P. Casey, Jr., Member, Senate HELP Committee Mitt Romney, Member, Senate HELP Committee We, as the Global Health Technologies Coalition (GHTC), are writing today to submit comments on the discussion draft of the Senate’s 2023 Reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA). Like many other global health stakeholders, our coalition of nonprofits, industry leaders, and academic institutions see the reauthorization of PAHPA as a must-pass piece of legislation. PAHPA presents a critical opportunity to reaffirm our commitment to tackling emerging disease threats, as well as strengthen our current slate of medical countermeasures (MCMs) to meet the goals of the 21st century through innovative global health research and development (R&D). Below we list opportunities for improvement to the bill as it is written. We appreciate your attention to our suggestions. Authorize an Emerging Infectious Disease (EID) Division at the Biomedical Advanced Research and Development Authority (BARDA) with a dedicated funding line. We are pleased by the inclusion of more expansive language like “emerging infectious diseases” and “viral pathogens with a significant potential to cause a pandemic”—which recognizes the fuller spectrum of potential threats for which MCMs are needed. To further this aim, we urge policymakers to create a dedicated EID Division within BARDA to enable the agency to take a more proactive rather than reactive approach to MCM development for EIDs. While we understand the fiscal environment is difficult, if established, this division should receive around $775 million per year in dedicated funding.Direct BARDA to provide regular public reports on its product-level investments. We are supportive of the bill text directing the Assistant Secretary for Preparedness and Response to provide Congress with reports on a coordinated strategy for MCMs to address chemical, biological, radiological, and nuclear (CBRN) threats. In addition to this reporting requirement, we believe there should be additional language directing BARDA to regularly and publicly report on its product-level investments to the greatest extent possible without compromising national security, and as part of that reporting, to detail the funding amount, threat area, product type, and phase of development for each MCM. This policy would be a minimal burden to the agency since it already provides comprehensive reporting including funding on its website for COVID-19 and some level of information on CBRN threats. Prioritize deliverability in low-resource settings. We welcome the bill text expanding MCM research initiatives to include technologies to improve production and use of MCMs, like manufacturing, transport, storage, and administration technologies. For these initiatives to reach their full potential in expanding access to lifesaving tools, we believe there should also be language included that stipulates that all R&D efforts for new vaccines, drugs, diagnostics, and other tools prioritize applicability in low-resource settings. This objective could also be furthered by: requiring the Administration for Strategic Preparedness and Response to conduct a study on barriers to low resource deliverability, including the Administrator for the US Agency for International Development in the Public Health Emergency Medical Countermeasures Enterprise, and authorizing BARDA to support community engagement activities during MCM development. Further prioritize antimicrobial resistance (AMR) research by attaching the PASTEUR Act. We appreciate the specific language in the draft bill that reinforces a mandate to “conduct research to promote strategic initiatives, such as … broad-spectrum antimicrobials.” By attaching PASTEUR, it would create a program in the Department of Health and Human Services to incentivize the development of new AMR drugs through a subscription-based payment model. Eliminate the sunset for the medical countermeasure innovation partnership (MCIP). The 21st Century Cures Act authorized BARDA to enter a partnership with a nonprofit entity to accelerate MCMs through venture capital practices. BARDA has since entered a successful partnership that has leveraged matched external funding to sponsor at least eight promising innovations. Policymakers should extend this authority without a sunset in the reauthorization of PAHPA.Authorize loan authorities, like those available to the Department of Energy. This would give BARDA an additional mechanism to finance large-scale projects that could better prepare the United States and the world for future biological threats. Thank you for your work on this critical legislation and for providing an opportunity for input. Alex Long Policy and Advocacy Officer

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