Breakthroughs Blog: Diagnostics

GHTC Statement on the WHO Diagnostics ResolutionThe COVID-19 pandemic has highlighted the centrality of access to diagnostics as a key component of detecting and controlling emerging infectious diseases. Early issues in developing accurate tests hampered the understanding of, and response to, the initial stages of the COVID-19 outbreak. This is the case for a broader range of health areas, including poverty-related neglected diseases.Simply put, medicine cannot respond effectively without diagnostics. Yet despite diagnostics being an integral pillar to quality health care, a recent study from The Lancet highlighted that 47 percent of the global population has little to no access to diagnostics.This resolution on diagnostics is a good first step in acknowledging and addressing the gap in political prioritization, and we urge the World Health Organization (WHO) and member states to consider the following: Push for a special advisor to serve as a senior central point of contact at WHO for diagnostics to ensure internal alignment and push for greater strategic prioritization through a potential “International Diagnostics Alliance.” Likewise, the resolution should reaffirm the essential role played by civil society in defining, developing, and deploying better diagnostics. Include provisions in the resolution to build, strengthen, and enforce national and regional regulatory frameworks covering the market for diagnostics and the registration, accreditation, and oversight of laboratories. Coordinate national regulations concerning medical devices, and streamline and improve the WHO prequalification process to ensure greater access to diagnostics in lower- and middle-income countries. Mechanisms like collaborative registration should be strengthened to expedite the registration of new diagnostics in countries.Promote local and regional research and development, manufacturing, and distribution capacities for diagnostics. Prioritize investment in the procurement of diagnostics for all health areas, in particular recognizing that significant gaps remain for poverty-related and neglected diseases. Funding for diagnostic procurement remains significantly underfunded, and improved coordination across stakeholders—including donors and procurement mechanisms—is needed to fill gaps and ensure populations, particularly those in low- and middle-income countries, have access to critical diagnostics. 

Next week, the World Health Organization’s (WHO’s) 152nd Executive Board (EB) meetings kick off in Geneva, with delegates and civil society representatives participating in person for the first time in two years. Recent months have seen a shift away from COVID-19 and an increased focus on long-term reforms to the broader global health architecture. While the dialogue around designing global frameworks and new mechanisms to address future health threats is vital, many of the discussions on poverty-related and neglected diseases are seemingly absent from this year’s discourse.  Here are the four issues to watch at this year’s meetings: Continued focus on global health security  2022 was a fruitful year for advancing two processes that will significantly influence the future of pandemic response. First, the intergovernmental negotiating body tasked with shepherding the Pandemic Accord process developed its first conceptual draft for the new framework. This comes following multiple public hearings, member state negotiations, and consultations on specific elements including equity, access and intellectual property, and antimicrobial resistance. Encouragingly, the document includes some strong research and development (R&D) focused language and recognizes R&D as an integral pillar of health preparedness. However, the current draft emphasizes downstream response measures such as manufacturing and registration, with less of a focus on early-stage research, clinical development, and even post-registration access and delivery of health tools. Additional focus on early-stage discovery research, clinical development, regulatory processes, and access and delivery of medical countermeasures is needed to ensure the type of true end-to-end approach critical to global health security. The second major global health security focused process has been centered around targeted amendments to the International Health Regulations. This policy discussion primarily focused on changes to provisions on trade and travel health certificates, as well as data-sharing and reporting requirements. Though perhaps less prominently discussed, disputes over intellectual property, in particular those centered on genetic sequence and pathogen sharing, remain major barriers to consensus. Both of these processes will be debated during EB, and we can expect a concerted effort to clearly delineate these processes and advance dialogues around defining the terminology and scope of both endeavors.  Limited progress on the implementation of the clinical trials resolution Last year, member states passed a resolution on clinical trials with the intent to build on lessons learned from the COVID-19 pandemic. The crisis drove a surge in funding for clinical research on COVID-19 tools, but we also saw many trials that were not large enough or that failed to employ consistent protocols and outcome measurements across geographies, making it difficult to pool and compare data to turn conclusions into medical practice. Among other matters, the resolution urged countries to better coordinate research, standardize protocols, improve reporting on trial registration and results, and work to increase clinical trial capacity globally, particularly in low- and middle-income countries—though none of these actions are binding. It also requested that WHO develop a global action plan to strengthen clinical trial practices to be presented for consideration at this year's assembly.EB will provide a chance to level set the current status of the implementation of the clinical trials resolution and figure out which elements of the framework could be improved. Previous discussions suggest that the current progress in implementing the resolution has been limited. During consultations held last fall, member states highlighted gaps in data on specific population groups and disease targets, as well as gender biases in data, which may result in these groups being precluded from access to needed interventions, as a point of inequity that must be addressed. The public consultation also noted the crucial importance of strengthened national regulatory authorities and national ethics committees, as well as increased international collaboration and coordination for efficient funding of agreed-upon priorities for multinational and multiregional trials, where appropriate.  The EB now has a chance to build on the progress and push WHO to follow through on their global action plan and for member states to support mechanisms like the WHO International Clinical Trial Registry Platform to push this agenda forward.  A new resolution on diagnostics could be passed New on the docket this year is a resolution that focuses on the development of—and access to— diagnostics. A recent Lancet report sounded alarm bells, highlighting that almost half of the global population has little or no access to diagnostics. The COVID-19 pandemic has clearly shown that a country’s diagnostic capacity is directly linked to its ability to respond to pandemics with appropriate public health measures and effective monitoring of emerging variants. Given the depth of the challenge, sustained access to quality, affordable diagnostics will require multi-decade prioritization, commitment, and investment.  This resolution is a good first step in acknowledging the need for more political will in addressing the diagnostics gap. Notably, it urges member states to develop a National Essential Diagnostics List, adapting the WHO Model List of essential in vitro diagnostics and the WHO List of Priority Medical Devices. The resolution further urges countries to invest in R&D, expanding manufacturing capacity for diagnostic medical devices and surveillance and strengthening international collaboration and assistance during epidemics and pandemics.  The resolution also calls on WHO to support member states to strengthen national and regional regulatory systems for diagnostic medical devices, collect data on the affordability and availability of essential diagnostic medical devices, and consider and support mechanisms for procurement that will enable access to high-quality, affordable diagnostic technologies for all member states. Some hurdles to approving this resolution remain, including outstanding disagreements on whether to include provisions pertaining to intellectual property and access, but there appears to be broad support from member states to get this resolution across the finish line in Geneva.  UHC back in the spotlight Universal health coverage (UHC) is also back in focus for this year’s EB, especially with September 2023 marking the halfway point of the timeline to reach the Sustainable Development Goals (SDGs) and leaders preparing for a United Nations High-Level Meeting on them at this year’s General Assembly. While some progress toward the SDGs has been made, the COVID-19 pandemic caused major disruptions in both health services and the development of health system capacities globally.  From a research perspective, a report by WHO ahead of EB highlighted that research and innovation continues to play a crucial role in UHC. Inequitable access to medical products is among the main causes of financial hardship in many lower- and middle-income countries. The report also notes how the recent World AIDS Day 2022 campaign highlighted the dangers of these inequalities, calling on global leaders and citizens to equalize access to essential HIV services, particularly for children and key populations, in order to end AIDS as a public health threat.  EB is a chance to hit reset on the UHC dialogue and for countries to reaffirm their commitment to the SDGs. It is also an opportunity to reassert that health system strengthening supports all health areas, including pandemic preparedness and poverty-related and neglected diseases. It is vital that leaders break down silos and take a more holistic approach to ensure progress toward advancing the global development agenda and 2030 targets. As discussions on global health architecture reforms advance, and new investments in pandemic preparedness are made, it is vital that global decision-makers ensure the benefits of these resources are also leveraged to benefit the fights against tuberculosis, HIV, malaria, and neglected tropical diseases. 

Neglected tropical diseases (NTDs) are a group of infectious diseases that exert a crushing burden in vulnerable communities around the world. These diseases blind, disable, and disfigure people, robbing them of health and opportunity and trapping them in poverty. While breakthroughs in recent years have brought new resources to the fight against NTDs, significant gaps remain in the arsenal of tools needed to control and eliminate these diseases. In recognition of World NTD Day on January 30, GHTC is testing our readers’ knowledge with nine questions about NTD innovation. See if you can beat our quiz below and join the fight to #BeatNTDs and #EndTheNeglect.

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 World malaria report 2022, published last Thursday, found that progress in the fight against malaria has been steady, despite setbacks due to the COVID-19 pandemic. In order to strengthen the global response to malaria, investment is needed to close the funding gap and ensure money is available for the research and development (R&D) of new tools. There is a robust R&D pipeline of innovative technologies for malaria control including new long-lasting bednets, diagnostic tests, next-generation medicines, and other vaccines that will be essential to address the growing challenges of antimicrobial resistance and the spread of the Anopheles stephensi malaria vector in urban areas.Despite rising COVID-19 cases in the United States, no monoclonal antibodies treatments are available for use as the US Food and Drug Administration paused the emergency authorization for the last remaining antibody treatment developed by Eli Lilly because it is not as effective against newer variants. There are other medications aimed at preventing COVID-19 that are currently authorized, including Evusheld and Paxlovid, but these treatments may not be as effective against new variants and may not be available for everyone. New antiviral treatments are in development, including one drug developed by researchers at the Dana-Farber Cancer Institute and another by Shionogi, which has received emergency authorization in Japan.The spread of Sudan ebolavirus in Uganda has slowed dramatically, raising questions about whether the trial testing vaccine efficacy that was expected to begin shortly can go on due to reduced numbers of potential participants. A cancelled trial would be considered by many a loss given the incredible amount of effort that has gone into securing the vaccines, permissions, and funding for the trial, as well as the interest in testing new vaccines that could be effective against Sudan ebolavirus. Looking forward, stockpiling experimental vaccines and pre-agreed trial protocols could ensure readiness for any future Sudan outbreaks.