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GHTC responded to a public request for comment on the pandemic accord negotiations that was released by the US Department of Health and Human Services' Office of Global Affairs. GHTC's comments focused on the need for the accord to feature provisions that incentivize continuous research and development, facilitate equitable access to medical countermeasures, and strengthen regulatory capacity.Global Health Technologies Coalition Recommendations for US Department of Health and Human Services on the Implications of Access and Benefit Sharing (ABS) Commitments/Regimes and Other Proposed Commitments Being Considered Under a WHO Convention, Agreement or Other International Instrument on Pandemic Prevention, Preparedness and ResponseThe 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, via the Departments of Health and Human Services and State, for providing this consultative opportunity to comment on the ongoing Intergovernmental Negotiating Body (INB) process, the Access and Benefit Sharing (ABS) commitments/regimes, and other research and development (R&D) provisions being considered.Many provisions in the draft agreement are positive, recognizing and affirming key points related to human rights and inclusive provisions that prioritize vulnerable and marginalized populations. The draft recognizes vaccine inequity as a vital concern and affirms key principles of equity and non-discrimination and the need to ensure adequate support for both health workers and the World Health Organization (WHO).However, we believe there are several areas in which the text could be strengthened, particularly when it comes to language around gender equity, a stronger focus of dual-use research and harmonizing pandemic preparedness investments with ongoing efforts to fight malaria, tuberculosis (TB), HIV/AIDS, neglected tropical diseases, and antimicrobial resistance (AMR). There are also ways the draft could be improved to include provisions that address the regulatory ecosystem and the distinct role of WHO.Please find our recommendations below.General CommentsElevate gender equity more broadly throughout the text.The agreement must meaningfully prioritize gender equity. The draft text promotes gender inclusion in areas such as workforce and clinical trials, but it misses other strategic opportunities to advance gender responsive policy essential to equitable pandemic prevention, preparedness and response (PPR). The draft should include specific language affirming the parties’ commitments to collect, report, and analyze data disaggregated by gender, ethnicity, race, and age, and uphold social protections and the full spectrum of essential health services for all during health emergencies.Broaden to all stages of R&D.The text focuses very heavily on later stages of R&D rather than all stages needed for preparation and response. Despite member state proposals to widen the focus to include early-stage collaboration, there are no provisions relating to early-stage R&D activities, including discovery research, where investments and collaboration are needed. Specific provisions should be added to Article 9 (Research and Development).Article 9: Research and DevelopmentLeveraging investments for PPR for health systems strengthening.While the agreement includes language that highlights the interconnectedness of health system strengthening and PPR, it lacks provisions that underscore the need to focus on sustainability and “dual-use” R&D capacity and infrastructure that can be leveraged for both pandemic response and longstanding challenges. Article 9 (Research and Development) should therefore add language that explicitly highlights that building clinical trial and laboratory capacity and networks to address ongoing epidemics like HIV/AIDS, TB, malaria, and polio; re-occurring outbreaks of Ebola, Marburg, and cholera; and AMR contributes to both pandemic preparedness and overall health system strengthening.Greater coordination between regulatory authorities and ethics committees for clinical trials.The role of regulatory authorities extends beyond regulatory approvals for market-ready health tools. Conduct of clinical trials requires approvals from regulatory authorities and ethics committees as well. Regulatory authorities and ethics committees, working in a coordinated way to grant approvals, especially during a public health emergency, will speed up the conduct of clinical trials. Article 9 should add a provision under its clinical trials section that promotes greater coordination between ethics committees and regulators. We urge the United States to push for new language encouraging and incentivizing joint reviews of regulatory dossiers, which will maximize opportunities for cooperation between countries and can help optimize review timelines by allowing regulatory authorities to share data, validate findings, and streamline communications with the applicant, thereby expediting market access to the health tools developed.The role of WHO.The pandemic agreement should ensure that WHO is sufficiently empowered to play a strong normative role in helping define a priority research agenda and in coordinating research, building on the R&D Blueprint, to speed innovation and avoid unnecessary duplication and fragmentation of data.Article 10: Sustainable ProductionGoing beyond rapid manufacturing scale-up.Pandemic prevention and response is too often marked by cycles of panic and neglect. While Article 10 (Sustainable Production) outlines provisions that seek to strengthen manufacturing capacity, as well as more diverse and regionally distributed production capabilities to respond during an emergency, the draft currently does not cover incentivizing continuous research to develop vaccines, diagnostics, therapeutics, and other health technologies for epidemic-prone diseases that disproportionately impact low- and middle-income countries. A greater focus needs to be placed at looking beyond just rapid scale-up of production capacity during an emergency, to instead supporting sustained research into disease threats during “times of peace”. Continuous research can yield discoveries that accelerate the development of medical countermeasures for novel pathogens, as was the case when prior research on an mRNA vaccine for HIV contributed to speeding up the development of mRNA COVID-19 vaccines. A provision should be added for supporting such research.Incentivize expanded registration of pandemic tools to accelerate equitable access.To ensure timely global access to health tools developed, manufacturers must seek regulatory approvals or authorizations beyond high-income countries, particularly in developing countries where transmission is high and clinical trials have been conducted, to ensure fair and equitable access to the fruits of research. Therefore, Article 10 (Sustainable Production) should include new text that calls on countries to provide incentives for manufacturers to facilitate this, with a view to achieving a more equitable geographical distribution of the global production of pandemic-related products.Article 11: Transfer of technology and know-howArticle 12: Access and benefit sharingEquitable access to medical countermeasures.The agreement must maintain language on global public health and equitable access at the center of policies, processes, and investments. This means ensuring low- and middle-income countries can create, manufacture, and buy countermeasures when needed and have the resources to respond quickly. Commitments to equitable access in Articles 11, 12, and 13 must be enshrined through robust language on distributed manufacturing capacity, technology transfer, and access and benefit sharing.Regulatory policy that enables innovation and access.The framework should include provisions strengthening the capacity of regional regulatory bodies, like the newly formed African Medicines Agency. Investing in bolstering the regulatory capacity of these regional bodies, and not just promoting harmonization, will help fill gaps for countries with lower regulatory maturity levels. Text should be included that standardizes policies or protocols for the regulation of products during health emergencies. Currently, the draft only highlights general regulatory harmonization and focuses on licensing of pandemic products, without taking into account broader elements of the regulatory ecosystem.

2024 will be a pivotal year for global health. With a record number of national elections, including one in the United States, many multiyear global health architecture reform processes are set to come to a close, and with several major replenishment and resource mobilization campaigns taking place, there is a palpable sense of “now or never” permeating global health discussions.  The World Health Organization (WHO) Executive Board (EB) meeting, which serves as the kickoff to the multilateral calendar, served as the first test on whether stakeholders could come together to ensure that progress continues. While the week offered welcome moments of political support for research and development (R&D), there is a sense that leaders have not yet met the moment to get the world back on track toward achieving the Sustainable Development Goals (SDGs).  Here are some key reflections from a busy week in Geneva:  Deadline looms over pandemic accord and International Health Regulations processes  As in previous years, the WHO’s role in global health emergencies was a central topic at the EB. Just weeks before the fourth anniversary of the COVID-19 pandemic, delegates received a new update from WHO on strengthening the global architecture for Health Emergency Prevention, Preparedness, Response and Resilience, which focused on the need for sustained political leadership and financing to drive the reform agenda forward. And while not on the official EB agenda, the work of amending the International Health Regulations (IHR) and finalizing a pandemic accord also loomed large. Little of the debate focused on specific proposals of these deliberations, though advancing access to medical countermeasures, vaccine equity, and regionally distributed manufacturing all got mentioned during these sessions. Instead, member states zeroed in on the process itself, with delegates seeking to inject a new sense of urgency to finalizing deliberations and adhering to the May deadline. Despite this, Poland became the first country to publicly question the feasibility of the current timeline, calling for a possible extension, signaling that there is also trepidation around how much progress can be achieved with limited negotiation days. The sessions on health emergencies also became the platform for geopolitical proxy battles, with the Russia and Ukraine and Israel and Palestine conflicts spilling over into the global health security debates. Several heated exchanges nearly derailed proceedings, and much airtime was spent addressing grievances.Tuberculosis, immunization, and neglected tropical disease reports highlight setbacksMultiple sessions during the week highlighted the continued disruption in healthcare caused by the pandemic. Despite reaching the midpoint in implementation of the SDGs, global progress remains off track in many key areas. This includes the fight against tuberculosis and neglected tropical diseases, which the WHO highlighted as requiring a renewed focus from member states.  The importance of investing in local production, strengthening laboratory capacity, and ensuring new tools are better adapted to the communities they are meant to serve were all key themes that came out of these sessions.Routine immunization levels are also still lagging behind pre-pandemic rates, with uneven progress regionally.  In its report to the EB, the WHO has documented that the current progress is not enough to meet targets set in the WHO’s Immunization Agenda for 2030. Low- and middle-income countries spoke of the cost of vaccinations as a major financial burden and challenge.  Yet there were notes of optimism too: 2024 is also expected to be a major year for immunization, with the rollout of two new malaria vaccines and two new polio vaccines, bringing the world closer to eradicating some of the planet’s deadliest diseases. Antimicrobial resistance shifts into bigger focus With the UN High Level Meeting on Antimicrobic Resistance (AMR) scheduled later this year and the WHO’s global action plan on AMR coming to an end in 2025, AMR was expected to be a prominent topic at this year’s meeting. While it made its way back on to the official agenda, it unfortunately did not receive as much attention as anticipated, with the agenda item being pushed late into the evening on Friday.  Member states ultimately advanced a resolution sponsored by Thailand which calls on member states to support R&D for new tools to combat AMR, to strengthen the capacities and standards of laboratories, and to participate in the WHO’s Global Antimicrobial Resistance and Use Surveillance System (GLASS), though several countries also wished to discuss the decision further ahead of the World Health Assembly (WHA) in May where it will be up for formal adoption. In his remarks on the topic, WHO Director-General Dr. Tedros Adhanom Ghebreyesus echoed the calls for stronger surveillance; the development of new vaccines, diagnostics, and antimicrobials; and measures to make these interventions accessible and affordable. New resource mobilization push for WHO  EB members supported the proposal for an investor round to raise funds for WHO, which would likely be held in November, with uncharacteristic enthusiasm last week. The WHO Working Group on Sustainable Financing’s report to the 2023 WHA highlighted that WHO’s budget is “up to 86% dependent on generous donors” and that only “roughly 14% of WHO’s finances are truly predictable”. The future effectiveness of WHO will depend on changing how the agency is funded. Progress has been made to increase the percentage of assessed contributions received in the form of member state dues, but far more flexibility and predictability in voluntary contributions will be needed to meet this moment. The idea of a WHO investment round, similar to those hosted by the Global Fund and Gavi, the Vaccine Alliance was accepted in principle by last year’s WHA. Dr. Tedros was charged by member states to provide a framework and justification at this year’s EB, and he delivered his investment case.  The investment framework is closely aligned with WHO’s 14th General Program of Work and the new strategic roadmap for the agency, but this WHO resource campaign will also have to compete with a number of replenishments set for this year, including for Gavi, as well as a resource push for the World Bank Pandemic Fund. This year feels like a make-or-break moment for the SDGs and the 2030 agenda. Yet the EB felt too much like business as usual, with ambition getting bogged down in a bloated agenda, geopolitical battles, and the minutia of internal processes. The urgency highlighted by several delegates on EB topics was not matched in the action or the commitments countries made in Geneva last week. While the EB did not jeopardize the potential of many processes moving forward, it did too little to contribute to the necessary forward momentum we will need to achieve the ambitious agenda set out by global leaders.  

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. The Genomic Surveillance Unit at the Wellcome Sanger Institute and the Centre for Epidemic Response and Innovation at Stellenbosch University are partnering to advance the practice of genomic surveillance, which has been around for decades but really came to the forefront during the COVID-19 pandemic and has the potential to improve global efforts against other infectious diseases, including malaria and cholera. During the COVID-19 pandemic, there was huge global investment in genomic surveillance infrastructure, with the Stellenbosch lab being the first to confirm the discovery of the Beta and Omicron variants. In the last year alone, the work of the two labs has contributed to doubling the number of sequences available for dengue, chikungunya, and malaria parasites. Genomic surveillance uses sequencing to get data about the genetic material of a pathogen, which is then used to track how the pathogen is changing or spreading.Researchers from the Health and Medical Research Institute at Japan’s National Institute of Advanced Industrial Science and Technology have developed a bioluminescent assay that could serve as a rapid, low-cost, and convenient test to complement laboratory testing for COVID-19. The test uses a bioluminescent molecule found in some small crustaceans that glows when it reacts with the virus that causes COVID-19 in a saliva sample and can be used with commercially available handheld luminometers at the point-of-care. The research team is planning for initial commercialization in the Japanese and US markets.ProteinLogic and Stellenbosch University will use a $1.35 million grant from the Bill & Melinda Gates Foundation to determine whether an immunoassay technology being developed by ProteinLogic can be used to monitor treatment response to tuberculosis (TB) antimicrobial chemotherapy in patients. ProteinLogic's ImmiPrint testing technology is a protein-based test based on predictive models developed through machine learning that aims to offer rapid, efficient, and cost-effective discovery of diagnostic biomarkers across multiple diseases. Its new partner, Stellenbosch University, has been leading clinical trials on TB diagnostic biomarkers. In the face of the growing threat of drug-resistant strains of Mycobacterium tuberculosis, there is an urgent need for new technologies to monitor the effectiveness of current treatments, in addition to the need for novel treatments and prevention methods for TB.

GHTC contributed to statements delivered by the Global Health Council at the 154th World Health Organization (WHO) Executive Board (EB) meeting on global health R&D agenda items: neglected tropical diseases (NTDs), tuberculosis (TB), and antimicrobial resistance (AMR). More of GHTC's recommendations to policymakers ahead of the EB are available here.