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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

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 Bill & Melinda Gates Foundation and Wellcome Trust announced that they will jointly invest more than $500 million in phase 3 trials for the GSK-developed M72/AS01E tuberculosis (TB) vaccine, which could become the first new tuberculosis vaccine in 100 years. 2018 phase 2b trials showed that the vaccine was 50 percent effective, but after GSK pulled out because they did not see a commercial market for the vaccine, the company passed the license to the Bill & Melinda Gates Medical Research Institute in 2020. The phase 3 trials will involve 26,000 people in Africa and Southeast Asia, hopefully confirming the vaccine’s viability as TB cases and deaths rise around the world.A new initiative led by Gavi, the World Health Organization, and the Coalition for Epidemic Preparedness Innovations will work to stockpile experimental vaccines for infectious diseases with epidemic potential to improve preparedness for future outbreaks. This global virtual pooled inventory will initially focus on Marburg and the Sudan strain of Ebola, for which there are no existing vaccines or proven treatments. Last year’s outbreaks in Africa of these two hemorrhagic fevers saw aborted attempts to move forward clinical trials for vaccines, losing crucial opportunities to gather essential data on potential tools and highlighting the need for this kind of stockpiling, preparation, and partnership.The Medicines Patent Pool recently announced sublicensing agreements with seven manufacturers to produce and distribute generic versions of Shionogi’s COVID-19 antiviral treatment in low- and middle-income countries, improving availability and equitable access in these countries, even after the end of the Public Health Emergency of International Concern. The oral antiviral, Ensitrelvir, is currently only approved in Japan, although it is being considered in the United States and all 117 countries in the agreements. Medicines Patent Pool previously signed sublicensing agreements with Pfizer in 2021 to manufacture and distribute its treatment, Paxlovid, in 95 low- and middle-income countries.

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.