Breakthroughs Blog: WHO

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 US Food and Drug Administration (FDA) announced that it is slowing down Emergency Use Authorizations (EUAs) of new in vitro diagnostics for COVID-19 and Mpox. The agency will continue reviewing tests that have already been submitted for authorization and is expected to review only some additional tests from experienced developers that use innovative technological approaches, fill a gap in need, or demonstrate potential for wide public health benefits. Instead, the agency is encouraging most developers to submit their tests through different review processes. Despite the end of the national emergency declaration for the COVID-19 pandemic on May 11, the 440 EUAs already granted will remain in effect as long as a separate agency-level EUA declaration determined by FDA continues.The World Health Organization (WHO) convened an emergency meeting of the Marburg virus vaccine consortium following the confirmation of the first-ever Marburg outbreak in Equatorial Guinea. During the meeting, five vaccine developers shared updates on their vaccine candidates for the disease. WHO is taking steps toward pursuing a real-time clinical trial for some of the candidates in alignment with the already-approved WHO clinical trial protocol for Marburg vaccines (which needs to be adapted to the country context) and in consultation with country officials. Sabin Vaccine Institute and Janssen’s candidates are in phase 1 clinical trials, while IAVI, Public Health Vaccines, and Auro Vaccines’ candidates are still in the pre-clinical development stage.A new study published last week found that a drug tested in mice could potentially be used as a birth control option for men. If successful in further trials, the drug would work as an on-demand contraceptive compared to other male contraceptives in the pipeline, like daily pills and gels, that researchers say are more complicated, time-consuming, and long-lasting. The drug works by preventing a molecular action from turning sperm “on” and activating them to pursue an egg. The researchers have founded a new company to move forward development of the drug but note it will likely be years before it is ready for testing in men.

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 Clinical Trials ResolutionLast year’s clinical trial resolution was a major milestone for building greater clinical trial capacity in low- and middle-income countries. However, creating a framework for standardization and implementation is still slow and ongoing. There are numerous areas where the current framework could be improved. Member states have highlighted that there continues to be inadequate reporting of data disaggregated by sex and gender relating to the World Health Organization's (WHO’s) priority pathogens, such as those for neglected tropical diseases and in WHO’s R&D Blueprint, as well as for new antibiotics for highly-resistant pathogens. Actions are needed to fill these gaps in the global evidence base, as well as for strengthening inclusiveness. Greater coordination is also needed to ensure efficacy and alignment with other clinical trial capacity-strengthening mechanisms, including the Global Health Security Agenda, and investments driven through international financial institutions, including the new Pandemic Fund. There is also a need for domestic resource mobilization, and other sustainable financing mechanisms should also support capacity-building initiatives. We, therefore, urge members and WHO to consider the following recommendations to build upon the work started last year:Improve international collaboration and coordination among member states on key research priorities and multiregional clinical trials, where appropriate. At present, effective coordination mechanisms are lacking for clinical trials, and funding for clinical trials across all WHO regions and disease areas is insufficient. Furthermore, improved coordination around global research agendas could enable more timely capacity-building of clinical trial sites.Support new trial modalities such as decentralized and paperless clinical trials that incorporate patient perspectives, mobile technologies and telemedicine, and increased use of adaptive, multicountry platform trials.Invest in building regulatory capacity in low- and middle-income countries (LMICs), including further building off of progress to date across the African Medicines Regulatory Harmonization programme and supporting the launch of the African Medicines Agency. Continued investment in regulatory strengthening will be critical to expanding clinical trial capacity in LMICs. Increase investment in workforce capacity and research institute infrastructure in LMICs. Additional investment is critical to sustainably build the capacity of LMICs to execute their own research agendas.Address gaps in data on specific population groups and disease targets and gender biases in data. Biases may result in these groups being precluded from the development of, and access to, needed interventions. This includes, but is not restricted to, pediatric data and data from pregnant and breastfeeding people.Support the Global Accelerator for Paediatric Formulations and the WHO International Clinical Trial Registry Platform through data sharing and technical support, as these platforms will be crucial for providing and streamlining the clinical evidence base necessary for policymakers to understand the current clinical trial landscape and its current gaps. There is also an urgent need to overcome the challenges in clinical trials for children and support platforms such as the Global Accelerator for Paediatric Formulations to strengthen partnerships to overcome these barriers.

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.