Breakthroughs Blog: Diagnostics

The US Agency for International Development (USAID) released a new report on its global health research and development (R&D) programs for fiscal year 2022 that includes unprecedented insight into the product development programs the agency supported—and highlights the need for additional, dedicated resources for global health research.Why it matters: The report gives insight into an agency that is a key sponsor of global health product development.Due to a lack of commercial incentive for industry investment, most global health research is supported by public funders, most notably the US government.Several US agencies support global health research, but USAID is the only agency with a mandate to improve global health and development. The agency excels at pushing products through the end of the research pipeline and advancing tools to suit the needs of people in low-resource settings.What’s new: This report includes an unprecedented 13-page appendix detailing USAID’s individual product-level investments. By our count, USAID supported at least 59 products in 2021 covering multiple health areas and product types.By the numbers: In 2021, USAID spent US$165 million in baseline funding and $50 million in COVID-19 supplemental funding on health product development and research to assess the best way to implement new products and practices.Research spending from baseline funds increased slightly over the prior year (+$4 million) — but continued to decline as a proportion of total global health spending. In 2021, proportionate spending on research dropped slightly to 5.1 percent, continuing a years-long pattern. If the trend continues, GHTC estimates that proportionate spending on R&D will drop to 4.2 percent by 2026 unless Congress passes a policy like the Supporting Innovative Global Health Technologies (SIGHT) Fund to direct more dedicated funding to R&D.Our take: GHTC applauds the release of the report and the additional detail provided by USAID. We call policymakers’ attention to the continued need for additional, dedicated resources for global health research at USAID that this report exposes.

As is tradition, the World Health Organization (WHO) Executive Board (EB) kicked off what promises to be another packed multilateral calendar. While much has remained the same, this year’s forum also ushered in noteworthy shifts in deliberations, dynamics, and dialogue that advocates should be aware of. Here are GHTC’s top takeaways from the week: 1. EB shrinks space for civil society engagement. As civil society delegates entered the halls of WHO for the EB for the first time since 2020, they were confronted with a harsh reality: The ability for non-state actors to meaningfully participate in these meetings is at an all-time low. New protocols had been introduced limiting delegation size and physical and structural changes put in place that left civil society literally on the outside looking in. Gone are the days when civil society could be physically present in the assembly room to follow the proceedings. Instead, advocates were relegated to a small, hot, and stuffy overflow room, more akin to a small press room, located far away from the official proceedings, hampering their ability to connect with officials and country delegates, which is often the most valuable part of the week. As EB participation and the number of agenda items have ballooned, WHO has also imposed new constraints on civil society statements, which have hit non-state actors particularly hard. WHO has tried to force civil society organizations to come together and develop single constituency statements for certain agenda items, a challenge that often further dilutes specific technical feedback from a diverse set of voices as various WHO-accredited institutions try to reconcile diverging views into a single, cohesive communication. Individual interventions are now reduced to just one minute, and they must be uploaded to a WHO database prior to the start of that agenda item. Apart from the challenge of distilling feedback and technical input down to around 100 words, the requirement to upload in advance prohibits advocates from rebutting issues that arise during debate or meaningfully influencing the decision making in real time. Other United Nations (UN) agencies, such as the World Trade Organization and the World Intellectual Property Organization have far more robust and meaningful civil society engagement processes that could serve as better models for WHO to emulate. 2. Debate on WHO’s work in health emergencies goes into the next round. Global politics tend to spill over into the parliamentary debates at EB, and this year was no different with the war in Ukraine creating serious tension between western allies and Russia. Much of the debate surrounding WHO’s role in health emergencies was derailed by several testy back-and-forths between delegations, leading to disruptions and little progress on key agenda items. A new ten-point proposal from WHO Director-General Dr. Tedros Adhanom Ghebreyesus to improve preparedness and response to health emergencies also received mixed reviews from WHO member states, with many warning the WHO secretariat not to move ahead of member states and the already ongoing processes to amend the International Health Regulations and negotiate a pandemic accord.  The latter did make waves at this EB, as the WHO Intergovernmental Negotiating Body (INB) published a “zero-draft,” that included a few surprises. The draft features some strong, equity-focused language, as well as calls for building and strengthening country regulatory, manufacturing, and innovative research and development (R&D) capacities for pandemic-related products. Surprisingly, it also features numerous callouts and provisions focused on intellectual property, including incentivizing relevant transfers of technology and know-how, forcing manufacturers that receive public funding to disclose prices for pandemic-related products, and time-bound waivers on medical countermeasures that can accelerate or scale up manufacturing, signaling the key battlegrounds for upcoming negotiations.  The biggest stunner, though, is a brand-new section focused on creating a new WHO Pathogen Access and Benefit-Sharing System (the “PABS System”) that would collect and equitably distribute a portion of all globally produced vaccines and other medical products during pandemics. According to the draft, 10 percent of total global production of pandemic products would be allocated to WHO, with half donated and half bought at an “accessible” price. Now, deliberations on the specific provisions will begin in earnest ahead of the World Health Assembly (WHA) in May, with the INB hosting two meetings in the next few months to debate individual chapters of the draft.  3. Implementation of the clinical trials resolution enters its next phase as member states argue about scope. Member states also debated the implementation of last year’s clinical trials resolution during the session on global health emergencies. Delegates noted the progress WHO had made over the past year in leading consultations and mapping the current clinical trial networks landscape. A few countries underscored the importance of inclusiveness and equity and called for greater technical support from WHO. On the contrary, in response to a WHO proposal to develop a complementary self-assessment tool to measure the maturity of the clinical trial ecosystem at national and international levels, the United States and United Kingdom instead urged the WHO secretariat to keep its focus limited to the scope of the actual resolution until more progress is achieved. The WHO is now set to move forward with a process to develop draft guidelines for clinical trials, with the help of experts and member states, that is expected to be in place by WHA. 4. Universal health coverage (UHC) reemerges as a priority from COVID-19 slumber. In 2019, UHC was the “it” topic of global health. It featured prominently on the agenda of WHO meetings and the UN held a high-level meeting on the subject to advance a new framework to achieve the Sustainable Development Goals. Then came the pandemic, and focus and attention on the topic slipped. This year, UHC is back on the map, having featured heavily at this year's EB.  During the broader discussion on UHC, WHO member states highlighted the importance of primary health care and health system strengthening, as well as considered and ultimately passed a resolution on strengthening diagnostics capacity. The resolution urges member states to address a range of diagnostic issues, including increasing local production, streamlining regulatory approaches, and addressing access barriers. It also calls for greater investment in diagnostic R&D and more systemic funding of capacity-building infrastructure for diagnostics, as well as urges WHO to enact specific technical changes to facilitate and catalyze diagnostic development.  The next couple of months will continue to deliver multilateral developments at a breakneck pace, and given the interlinkages between the many multilateral processes underway, it will be vital for advocates to understand the full landscape of possible changes to the global health architecture. While the dynamics may be shifting, it is encouraging to see that the research agenda is present throughout these different dialogues, both in Geneva and beyond. 

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.