News: Announcement

Reforms to a World Health Organization (WHO) program that focuses on certifying the safety and efficacy of health products have accelerated access to these innovations in low- and middle-income countries (LMICs), yet the program continues to struggle with challenging processes and practices that could lead to unnecessary delays.This is the central finding of a new report released today by the Global Health Technologies Coalition (GHTC) and the Duke Global Health Innovation Center (GHIC) that examines the WHO prequalification program. The program conducts comprehensive reviews of the safety, efficacy and quality of medical products, work that became even more important during the COVID-19 pandemic. Approvals clear the way for procurement of new drugs, vaccines, vector control products and diagnostics by aid agencies and LMICs.“We found that WHO has embraced reforms that can speed access to health technologies through expedited reviews of safety and efficacy,” said Jamie Bay Nishi, executive director of GHTC. “But we also identified issues that can be confusing for product developers and thus impede approvals. They included uncertainties regarding WHO review timelines, data needs and how prequalification is impacted by other WHO processes.”Experts at Duke GHIC and GHTC analyzed the review timelines for two dozen WHO prequalified products. They also conducted interviews with WHO staff, product developers and regulatory experts.  They found a WHO process for expediting reviews of products already approved through the stringent reviews of high-functioning national regulatory agencies substantially reduced the time it took to achieve prequalification — from an average 17 months to just six months. Also, they noted the benefits of a new collaborative registration procedure in which regulatory product reviews conducted by WHO prequalification staff occur jointly with assessments by regulatory officials in LMICs. Regulators in LMICs still conduct their own independent assessments of new medical products regardless of their approval by WHO. But doing this work jointly with WHO reviewers providing technical assistance and guidance allowed the first national product approval following WHO assessment of prequalification to occur within five months, on average, compared to a year lag when they were done separately. The report notes that the faster timelines achieved through the expedited and joint review processes are illustrative of tangible benefits emerging from WHO reforms. It also applauded WHO for piloting procedures to streamline reviews of innovations targeting COVID-19 and drug-resistant tuberculosis, noting the potential to apply these practices more broadly in the future. But the analysis of the prequalification program also revealed a number of pain points in the WHO review process that warrant immediate attention. For example, WHO does not provide estimated review timelines for all product types. This lack of visibility into the process makes it difficult for product developers to anticipate when WHO might reach a decision or request additional data. WHO also does not report performance indicators — data that could reveal whether reviewers are meeting internal expectations for completing product assessments. Furthermore, the report noted product developers were sometimes confused about how WHO was conducting reviews within the parameters of its own stated policies. For example, WHO PQ procedures state that before a product can be prequalified, it already must be included in WHO policy or treatment guidelines. However, there were instances when the processes for developing guidelines occurred either in parallel with prequalification reviews or after the product was prequalified. While this kind of flexibility by WHO could be beneficial for expediting reviews, product developers found the lack of clarity around the process was challenging to navigate. Finally, the report raises concerns that WHO staffing policies are putting a strain on the program’s ability to deliver on its mandate at a time when demands are increasing. The authors identify specific actions that can address inefficiencies and bottlenecks in the prequalification program: Improve reporting and communication to generate greater clarity for stakeholders. This includes publicly releasing performance indicators and launching a public database with complete timeline information on all prequalified products. It also recommends developing additional resources that help product developers navigate the prequalification process and clarifying how it interacts with other WHO treatment and technical guideline development processes.  Support the expanded use of interim or “living” guidelines for other novel products. The report notes that WHO recently relied on early or interim evidence to issue interim treatment guidelines for COVID-19 therapeutics and the treatment of drug-resistant tuberculosis. The report calls for expanding this practice. It’s a faster way to provide real-time information to health decisionmakers and reduces delays in the prequalification process.Provide greater opportunities for external stakeholder to inform prequalification processes and strategy. The report urges WHO to improve platforms and consultation processes for gathering ongoing feedback from product developers, regulators and product access ecosystem actors. It also recommends new efforts focused on expanding country and product developer participation in WHO’s collaborative registration procedure, given its success in speeding regulatory approvals.Adopt a new policy to enable the prequalification program to hire additional permanent staff and reduce reliance on consultants. The report explains that this would require WHO member states to approve changes to existing staffing policies, which currently limit the number of permanent staff that can be hired at WHO headquarters.“Our research unearths important advances the WHO prequalification program has made in enabling greater access to lifesaving health products in low-income countries, said Elina Urli Hodges, assistant director of programs at Duke GHIC. “But by adopting additional stepwise changes to the way it communicates and engages with developers and regulators, we believe the program can better deliver on its mission to make quality essential medical products available to all who urgently need them.”###The Global Health Technologies Coalition (www.ghtcoalition.org) works to save and improve lives by encouraging the research and development of essential health technologies. We bring together more than 40 nonprofit organizations, academic institutions, and aligned businesses to advance policies to accelerate the creation of new drugs, vaccines, diagnostics, and other tools that bring healthy lives within reach for all people.The Duke Global Health Innovation Center (www.dukeghic.org) supports the scaling of health care delivery and policy innovations through applied research and education to improve health worldwide. Duke GHIC links global health, health policy, and health innovation efforts across Duke University, and partners with Innovations in Healthcare, a Duke-hosted non-profit that aims to increase access to quality, affordable health care worldwide by scaling leading innovations.

The Global Health Technologies Coalition (GHTC) welcomes the decision this week by the Global Health Security Agenda (GHSA) Steering Committee to make permanent its pilot Research and Development (R&D) Task Force. This important decision gives the task force—which was launched in June 2021 as a one-year pilot effort focused on improving R&D readiness—a mandate to continue its work through the current GHSA strategic framework, which runs through 2024.In response to the decision, GHTC Executive Director Jamie Bay Nishi said, “GHTC and our members applaud the GHSA Steering Committee for making permanent the R&D Task Force—an action that not only enables it to continue its vital work, but also cements R&D capacity strengthening as a central part of GHSA’s broader mission to prevent, detect, and respond to health threats.”“The COVID-19 pandemic has made clear the importance of investing in R&D of medical countermeasures to combat health threats. But it has also exposed systemic gaps in the R&D capabilities of many nations—including limited surveillance, clinical research, manufacturing, and regulatory capacity—which have contributed to gross inequalities in access to health technologies between rich and poor nations. As a country-led collaborative effort, the GHSA R&D Task Force is uniquely positioned to play a leadership role in closing these gaps—and in just one year has already achieved important first steps toward that aim.”“Later this year, the task force will unveil a new tool designed to support countries in self-assessing their R&D capabilities, which aligns with and complements the International Health Regulations (IHR) and Joint External Evaluation (JEE) process. GHTC believes that at a local level, this tool can help GHSA nations identify country-specific R&D capacity gaps to address through their national preparedness plans, and at a global level, this evidence can inform the adoption of new indicators within the IHR or JEE to better address R&D readiness, as well as strategically guide the disbursement of funding from international mechanisms like the new World Bank prevention, preparedness, and response fund.”“Closing R&D capacity gaps is not a problem that will be solved overnight, but it is vital to bolstering the world’s pandemic defenses. We thank the GHSA Steering Committee for their vote of confidence to continue the task force’s work and their continued leadership and commitment to advancing a world better equipped with the R&D capabilities to prevent the next pandemic.”For more information on the GHSA R&D Task Force’s accomplishments and future vision, view its one-year progress report.

GHTC welcomes the recent addition of a specific indicator to measure research and development (R&D) capacity in the third edition of the Joint External Evaluation (JEE) tool—the instrument countries use to evaluate their health preparedness capabilities and compliance with the International Health Regulations (IHR), which govern countries’ obligations in handling public health threats. This is a significant addition, as it marks the first time R&D capacity has been explicitly factored into the JEE as a key measure of a country’s health preparedness.  As we saw with the COVID-19 pandemic, the lack of regionally distributed R&D and manufacturing capacities contributed to gross inequities in the global response, as regions with the strongest ability to develop medical countermeasures prioritized access for their populations while others were left scrambling to try to build their capabilities in real time. GHTC has for many years been calling for measures of R&D readiness to be formally integrated into the IHR and JEE, and we are pleased to see our advocacy efforts have contributed to this important update. We believe that the revised tool, and its inclusion of R&D, will ultimately improve the quality of assessment of countries’ capacities for timely detection, prevention, and effective response to public health emergencies.While the incorporation of an R&D-specific indicator is an important first step toward strengthening R&D capacity globally, GHTC is disappointed that the update has not gone further in comprehensively measuring the multitude of capabilities that are part of R&D readiness. The R&D indicator metrics have an insufficient focus on product development, and don’t measure important elements such as clinical trial, pharmacovigilance, and manufacturing capacity for various types of medical countermeasures, and we would have liked to see those incorporated into the new R&D indicator or elevated somewhere within the updated tool. While there are other separate indicators for surveillance and laboratory systems, they don’t interlink enough to provide countries with a comprehensive understanding of their national R&D capacity.As countries move to utilize this updated tool, GHTC will continue to work with partners and leverage platforms like the Global Health Security Agenda to push for an even more comprehensive R&D capacity assessment and strive to build a more equity-driven framework for prevention and response to future pandemic threats.

GHTC welcomes the G7 Health Ministers’ Communique, particularly the commitments leaders made to bolster the global health architecture and ensure that the world can respond to future pandemics in a more coordinated and equitable manner.The G7 expressed support for the proposal from the World Health Organization (WHO) Working Group on Sustainable Financing that would raise assessed contributions to WHO to 50 percent of its base budget by 2030–2031 to strengthen the organization’s global leadership role, something that GHTC and its partners have broadly supported.GHTC was encouraged to see that the communique also stresses the need to scale up local and regional research, development, and manufacturing capacities, along with more sustainable supply and distribution mechanisms to support faster, equitable global access to safe and effective medical countermeasures.Commitments were also made to tackle the silent pandemic of antimicrobial resistance (AMR)—including by exploring a range of market incentive options to encourage pharmaceutical companies and others to fund research and trials for new antibiotics. This included specific calls to support initiatives such as the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator, or CARB-X, and the Global Antibiotic Research and Development Partnership (GARDP). Furthermore, the G7 underlined the importance of closing GARDP’s funding gap to facilitate its “5 by 25” initiative for the delivery of five new treatments by 2025.Lastly, GHTC supports the new G7 framework, the Pact for Pandemic Readiness, which will see the United Kingdom, United States, Japan, Canada, France, Germany, and Italy coordinate more closely together—and with relevant multilateral organizations like WHO—by building upon the best of their COVID-19-inspired initiatives, including those on surveillance and rapid response.While it was encouraging to see such a strong consensus-driven agenda around global health security, it was disappointing to see that the communique makes no mention of several health priorities that have been neglected during the pandemic, including tuberculosis, malaria, HIV/AIDS, and neglected tropical diseases. It is vital that leaders continue to break down silos and ensure that investments to strengthen surveillance, laboratory, manufacturing, and clinical trial capacity for health security can be leveraged across disease areas. It was also disappointing to not see additional financial commitments made to support the launch of the financial intermediary fund or to bolster manufacturing hubs and laboratory infrastructure in low- and middle-income countries.Leaders must refocus their attention on a broader range of enduring and emerging health threats and make immediate long-term investments to put the world back on track to meet the sustainable development goals.