GHTC submits comments to Senate HELP Committee on PAHPA Discussion Draft

July 11, 2023 The Honorable Kay Granger Chairwoman House Appropriations Committee 1026 Longworth House Office Building Washington, DC 20515 The Honorable Rosa DeLauro Ranking Member House Appropriations Committee 2413 Rayburn House Office Building Washington, DC 20515 The Honorable Mario Diaz-Balart Chairman House Appropriations Subcommittee on State, Foreign Operations, and Related Programs 374 Cannon House Office Building Washington, DC 20515 The Honorable Barbara Lee Ranking Member House Appropriations Subcommittee on State, Foreign Operations, and Related Programs 2470 Rayburn House Office Building Washington, DC 20515 Dear Chairwoman Granger, Ranking Member DeLauro, Chairman Diaz-Balart, and Ranking Member Lee: Global Health Council (GHC) is the leading member organization with more than 120 members devoted to advancing global health priorities by uniting advocates, implementers, policymakers, and other stakeholders. As a community of global health and development advocates, we are deeply concerned with the steep cuts being proposed to the House State and Foreign Operations and Related Programs (SFOPS) budget at a time when the world is facing concurrent destabilizing events, such as the recovery from the COVID-19 pandemic, further instability and food insecurity caused by the war in Ukraine, and the continuous threat of emerging infectious diseases. The Fiscal Year (FY) 2024 budget being proposed by the House Appropriations SFOPS Subcommittee falls woefully short of the resources needed to address these converging crises and severely undercuts critical global health and humanitarian assistance programs, which are a key component of how the U.S. engages with the world. According to the U.S. Agency for International Development, these cuts would reverse gains made to combat infectious diseases, including through the President’s Emergency Plan for AIDS Relief (PEPFAR), programs to prevent maternal and childhood deaths, and funds to support health workers and global health security. This bill is a dangerous signal to the rest of the world that the U.S. is ceding leadership on the global stage. Therefore, as FY24 appropriations negotiations progress, GHC, and the undersigned organizations, strongly encourage robust funding for global health and humanitarian assistance programs within the International Affairs (150) account and, at a minimum, support investments for these programs in line with the FY23 enacted levels. Additional funds should come as an increase to the overall topline and not at the expense of any other accounts. If you have any questions about our recommendations, please feel free to contact the Global Health Council at advocacy@globalhealth.org. WWW.GLOBALHEALTH.ORG Sincerely, Abt Associates Action Against Hunger Advancing Synergy AHF Global Public Health Institute Aidsfonds American Academy of Pediatrics Amref Health Africa American Heart Association American Jewish World Service American Leprosy Missions American Society of Tropical Medicine and Hygiene AVAC Better World Campaign CARE Center for Biological Diversity ChildFund International Children's HeartLink Christian Connections for International Health CORE Group Drugs for Neglected Disease initiative (DNDi) Elizabeth Glaser Pediatric AIDS Foundation Fast-Track Cities Institute Global Health Council Global Health Technologies Coalition Global Justice Center Global Network of Black People working in HIV Heartland Alliance International Health GAP (Global Access Program) Helen Keller Intl HIV Medicine Association IADR - International Association for Dental, Oral, and Craniofacial Research International Association of Providers of AIDS Care International Center for Research on Women International Medical Corps IntraHealth International Ipas JSI Management Sciences for Health Marked By Covid Medical Impact MPact Global Action m2m WWW.GLOBALHEALTH.ORG NCD Alliance Operation Smile PAI Pandemic Action Network PATH Pathfinder International Planned Parenthood Federation of America Policy Cures Research Population Connection Action Fund Population Institute Preventing Pandemics At The Source (PPATS) Secretariat Project HOPE Public Citizen RESULTS RH Impact RTI International Save the Children Shot@Life Spark Street Advisors Stop TB USA Task Force for Global Health TB Alliance The END Fund Treatment Action Group (TAG) United to Beat Malaria University of Miami Health Policy Lab VillageReach WaterAid America WI-HER Women's Refugee Commission World Vision WWW.GLOBALHEALTH.ORG

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