Philip Kenol

Editor’s update, June 17, 2021: At the G7 summit, member countries committed to sharing at least 870 million COVID-19 vaccine doses over the next year. While this pledge is welcome, it falls short of the 1 billion target touted in the lead-up to the summit and only a small fraction of the 11 billion doses still needed to vaccinate 70 percent of the global population. Additionally, no new financial commitments were made to the Access to COVID-19 Tools Accelerator, which is facing a US$18.1 billion funding gap. In a positive directional step, leaders promised to “explore options for building consensus this year, around sustainable global health and health security financing,” and affirmed that they “support efforts to accelerate manufacturing capacities of COVID-19 tools on all continents…and in particular will strive to support African efforts to establish regional manufacturing hubs.” However, there was no clear guidance on how the G7 will transform these high-level pledges into concrete action. Overall, member states affirmed the sustained importance of research and development for COVID-19, promising “to continue our investment in cutting edge research and innovation,” expand genomic sequencing and sharing, and build upon existing innovation and collaboration.This weekend, leaders from the G7 will come together in Cornwall, England, for the first in-person summit of this group in two years, after last year’s meeting was cancelled and high-profile geopolitical rows caused much acrimony at previous convenings. Leaders are seeking to revive multilateralism and highlight that this forum can still play a significant role in shaping and responding to major world events. Their most urgent task will be to tackle the global pandemic and particularly address the unequal distribution of COVID-19 tools, as well as start to build additional long-term infrastructure and capacities both regionally and globally to prevent future health outbreaks. Greater coordination around innovation and greater investment in research and development (R&D) capacities as part of health system strengthening and pandemic preparedness should play a crucial role in these discussions, and G7 leaders must seize the moment to take bold action and reimagine the future of global health security.G7 leaders take first steps to create improvements to the global health security architectureLast week, health ministers already took several steps toward scientific collaboration to address current and future health threats by making concrete pledges in their G7 Health Ministers’ Declaration. This included adopting a new therapeutics and vaccines clinical trials charter, which sets out shared principles to accelerate the speed with which clinical trials generate robust evidence and lead to quicker adoption of new tools in this and future pandemics. This charter will strengthen collaboration in large-scale international trials and enable greater diversity of participants, including pregnant people and children.Health ministers also agreed to develop a shared set of principles that could incentivize the development of and access to both novel and existing antimicrobial products and ensure a sustainable antimicrobial R&D ecosystem, including resilient and diverse supply chains and greater manufacturing capacity. They also underscored the important contributions of several initiatives and organizations, including the Global Antibiotic Research and Development Partnership as well as Global AMR R&D Hub, which push for accelerating the development of novel technologies to fight antimicrobial resistance.Scientific capabilities, including pathogen genomics, also have a vital part to play in surveillance and development of new tools, and leaders also sought to create platforms to enable greater collaboration through the United Kingdom’s New Variant Assessment Platform, as part of a focused global effort to strengthen surveillance of potential COVID-19 variants of concern and potential future priority pathogens.While these decisions represent progress and are welcome steps in the right direction, with the pandemic still raging in much of the world, both immediate COVID-19 needs and larger reform efforts will have to be addressed simultaneously during the Leaders’ Summit.The time for bold action is nowGlobal leaders must take immediate decisive action to fully fund the Access to COVID-19 Tools Accelerator (ACT-A) and fill urgent gaps for all aspects of the current global framework, including the diagnostics and therapeutics pillars. This means G7 leaders should pledge 60 percent of the US$19 billion required for ACT-A in 2021 during this weekend’s summit. This would ensure that organizations like the Coalition for Epidemic Preparedness Innovations are properly resourced to advance R&D, ensuring that vaccines are keeping up with variants and that diagnostics and other medical countermeasures are not neglected as part of the global response efforts.Testing, oxygen therapies, and therapeutics are central to combatting the pandemic and must be recognized through continued investment. This is especially relevant given that fewer than one in five health facilities across Africa had access to COVID-19 tests in 2020. To address these imbalances, further innovation is needed to ensure appropriate, high-quality rapid tests and other health tools are affordable and available everywhere. Donor countries must scale up the production of tests, treatments, and health commodities, including oxygen, and accelerate low- and middle-income country (LMIC)-led R&D to ensure greater equitable access globally.Many advocates are also expecting G7 leaders to finally deliver on vaccine sharing, release more vaccine doses to COVAX, and commit to a clear strategy for global vaccination. While the politics of prioritizing their own domestic populations represents a continuing factor for global leaders, especially with G7 countries not having reached herd immunity at home, there are clear epidemiological and ethical imperatives to accelerate the pace of vaccine shipments abroad. The Biden administration did take a major first step with the announcement that the US government will purchase 500 million doses for LMICs, with 200 million doses being shared by the end of this year. Now other donor nations must follow suit and raise their ambition at this forum and scale up their own dose sharing pledges and allocation strategies. G7 leaders should pledge 2 billion doses at the Leaders’ Summit, delivering 1 billion by the end of August and the second billion by the end of 2021, and as part of this delivery, ensure that 250 million additional people in LMICs have actually received their doses by the end of August in parallel with national vaccine rollout plans.Laying the groundwork for future pandemic response frameworksWe have seen during this pandemic how essential scientific collaboration has been, and how investment in R&D spurred unprecedented innovation of new vaccines and other health technologies in record time. These successes continue to be hampered by a lack of equitable access, unpredictable and insufficient funding, and a lack of clear coordination frameworks. G7 leaders have an opportunity this weekend to also start to outline a road map for the future and make concrete commitments to reform efforts for the pandemic preparedness ecosystem. This includes leveraging existing multilateral institution resources in new ways, unlocking sustainable financing for global health innovation by making R&D investments eligible for financing from the World Bank and other international financial institutions, and creating new financial mechanisms for pandemic preparedness. This new capital would support LMICs in securing new resources to strengthen their research, laboratory, surveillance, and manufacturing capabilities, and ensure that all countries have pathways to gain access to the innovations and health technologies they need to respond to health outbreaks.The pandemic has elevated and highlighted the importance of science, the power of partnerships, and the necessity of investing in R&D to ensure that countries are equipped with the vital tools to respond to major health outbreaks. G7 leaders must now ensure that the pressing challenge of global equity is addressed and use the political momentum to create the kind of game-changing reforms that enshrine greater scientific coordination and clear preparedness structures that allow for a more equitable and comprehensive global response to future health threats. This summit is a test for G7 leaders, especially for the United Kingdom as host, as the group must come together to ensure that any new commitments to strengthening the health security architecture do not come at the expense of decades of investments in other health R&D areas.

On Monday, the 74th World Health Assembly (WHA) will kick off and take place virtually for the second year in a row, exhibiting the largest agenda ever with more than 72 items. While the COVID-19 pandemic will once again feature quite heavily, there will also be plenty of time spent discussing necessary broader reforms to the global health architecture, as well as more traditional agenda items. As global health experts gather online and weigh in on the plethora of topics being discussed, here are the top five things the Global Health Technologies Coalition is watching over the course of this year’s forum:1. Ongoing COVID-19 pandemicUnsurprisingly, COVID-19 will remain front and center during the Assembly this year. This year’s forum will come on the heels of the G20 Global Health Summit, which will focus on immediate global response needs, including funding for the Access to COVID-19 Tools Accelerator (ACT-A) and closing gaps in equitable access to health technologies in low- and middle-income countries (LMICs), as well as longer-term reform efforts to bolster the global health security architecture, from strengthening the World Health Organization’s (WHO) mandate and ensuring sustainable funding, to advancing new mechanisms to deal with supply chain and manufacturing bottlenecks.It will be interesting to see how the debate around WHO’s coordinating role as part of ACT-A is discussed, whether member states take the opportunity to provide further financial commitments to COVAX and other multilateral entities, and what additional steps WHO will outline for providing technical support to member states as part the broader discussion on this topic.2. WHO reform and changes to the global pandemic preparedness architectureHeading into the Assembly, a number of review processes, including the International Health Regulations (IHR) review committee as well as the Independent Panel for Pandemic Preparedness and Response (IPPPR), provided their assessment of how WHO and member states responded to the pandemic, how current systems are falling short, and what key systemic changes need to be made to ensure the world is never again caught unprepared.In particular, the IPPPR call for advancing a Pandemic Framework Convention (more commonly referred to as pandemic treaty) within the next six months that would be complementary to the IHR, using the powers under Article 19 of the WHO Constitution, will be something to watch. First floated by European Council President Charles Michel in November, the idea has so far been backed by 25 countries as well as WHO. While current efforts are still a bit disjointed and lack detail, the Assembly could serve as the forum to help set the parameters and start the deliberations on the mechanisms that need to be integrated. This includes a new research and development (R&D) coordinating mechanism, as was suggested in the recent IHR review panel report recommendations. It is notable that the United States, while open to considering the treaty proposal principle, is looking to slow the process and ensure that there is broad consensus around some of the key principles being discussed. There is likely also going to be a discussion about the future of ACT-A, especially whether the model can be carried forward beyond COVID-19 and what lessons can be learned from the past year on how the process was developed and operated. The IPPPR highlighted the need for a pre-established platform that helps coordinate and accelerate the development, delivery, and uptake of vaccines, therapeutics, diagnostics, and essential supplies for emerging infectious diseases, looking at end-to-end product development and ensuring equitable access for all populations. The IPPPR did not specify what the model should be however, leaving some flexibility on whether it is simply an evolution of ACT-A or a new platform entirely. Either way, this debate should be an important one as the global health community looks for ways to pivot beyond the current crisis and also ensure that systems being constructed and reformed could have a reverberating impact beyond pandemic preparedness including through strengthening research capacity to fight a broad range of poverty-related and neglected diseases.3. Intellectual property, access, and strengthening local manufacturing capacityIssues around access and intellectual property (IP) have been hot-button topics for years, with discussion of IP rights, transparency of R&D costs, and technology transfer being contested by member states and civil society. This year though, the dialogue is shifting around the need for global common goods for COVID-19, and the recent surprising announcement by the Biden administration in support of India and South Africa’s proposal to waive IP rights for COVID-19 vaccines under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) highlights the seismic shift in the dynamics on this issue. While it is unclear whether this will lead to concrete commitments, the dialogue around what is possible is evolving, and we will tune into any decisions or resolution that could come out of WHA.  There is also likely going to be a resolution focused on strengthening local production of medicines and other health technologies to improve access. The resolution brings to the fore a key issue that emerged in the first months of the pandemic when the globalized and highly concentrated global supply chains for critical medicines were interrupted—from antimalarials in some parts of Africa to certain common antibiotics in Europe. The resolution is likely to reaffirm and complement other key initiatives that are in the works around strengthening manufacturing capacity in LMICs, including the recent partnership announcement between the Coalition for Epidemic Preparedness Innovations and the African Union.4. Refocusing on health areas disrupted by the pandemicThere will be a strong push to discuss topics that have taken a back seat to the immediate pandemic and have a return to (or close to) business as usual at this year’s Assembly. From an R&D perspective, agenda items focused on Immunization Agenda 2030 (IA2030) and antimicrobial resistance will also be front and center. This is significant as we have seen routine immunization campaigns and clinical trials being stalled during the pandemic, and disrupted immunization services and supply chains have left millions at risk and widened inequities. Member states will discuss the implementation of the newly adopted IA2030 and outline operationalizing the strategy. Member states and advocates are likely to highlight the need for additional technical support for countries as well as clear accountability metrics to be considered as part of the initiative.There will also be updates and revisions to existing strategies, including WHO’s Global Technical Strategy for Malaria. The United States and Zambia are working on a draft that would highlight the need to reinvest to counter the backsliding on the progress made and strengthen service delivery, particularly for marginalized communities.5. Civil society engagement 2.0 Over the past year, civil society has lamented the diminished role and engagement it has had in major WHO meetings, especially at the Executive Board meeting and WHA. WHO decided to try to recalibrate the way non-state actors (NSAs) participate in these fora, by creating a three-day consultation summit held with NSAs a few weeks ago and changing some of the processes for engagement at the Assembly itself. While the consultation forum provided a new platform for some organizations to engage more in depth with the WHO Secretariat, member state participation was low, and it remains unclear how the feedback shared on various agenda items will be considered in the deliberations of resolutions and draft decisions being crafted by officials in the weeks leading up to the Assembly. Civil society organizations are also displeased and concerned with the continued efforts to push NSAs to make statements as constituencies and to group agenda items together, leading to less targeted and technical interventions from civil society groups. WHO is nevertheless plowing ahead with this concept, piloting this new process this year. Coming out of the forum, many organizations will likely try to provide very blunt feedback on the direction that WHO has taken and push for more meaningful mechanisms for NSAs to contribute to important discussions.

2020 was a devastating year for global health. A previously unknown virus raced around the world, rapidly emerging as one of its top killers, laying bare the inadequacies of health systems, and setting back decades of hard-won progress in fighting infectious diseases and improving maternal and child health.Yet as the first major multilateral convening of 2021, the World Health Organization (WHO) Executive Board (EB) meeting, came to a close last week, there was a sense that with the turn of the calendar also comes a fresh sense of palpable optimism that the stage is set for meaningful reforms to build a smarter, more responsive international system for public health and emergency preparedness. This includes opportunities to strengthen the research and development (R&D) ecosystem both for dealing with the ongoing and future pandemics, as well as enduring global health challenges.Leaders push for global effort to “Build Back Better”Member states spent a vast portion of their time during the EB reviewing WHO and global preparedness systems, including the International Health Regulations (IHR)—which govern countries’ obligations for health preparedness—highlighting areas of reform and proposed changes that would make them fit for purpose. Some member states even raised the idea of a pandemic “treaty” that would strengthen the legal requirements attached to the IHR. Encouragingly, while integrating R&D was not a core theme of that dialogue, the notion of ensuring that R&D is a central pillar of the global health security architecture is becoming more mainstream. The Independent Panel for Pandemic Preparedness and Response, which was established by the World Health Assembly (WHA) to assess and recommend actions to strengthen WHO and other global institutions, even highlighted in its progress report that was presented at the EB that “the effective flow and access of new diagnostics, therapeutics, and vaccines to the populations most in need, based on equitable public health criteria, must be the central plank of international co-operative efforts.”As these proposals gain steam, the importance of the Biden-Harris administration’s move to reverse US withdrawal from WHO and recommitment to the institution cannot be overstated. US participation not only strengthens WHO, through funding, technical expertise, and support for research capacity, but also allows global leaders to finally move past some of the political impediments to progress that hampered the overall reform dialogues. Stakeholders can now develop a road map for change that ensures that global response mechanisms are in place to prevent the next pandemic and address the need for stronger governance of research coordination.US reengagement in multilateralism could boost R&D in other multilateral initiatives and foraIn addition to reengaging with WHO, the Biden-Harris administration also announced that the United States will participate in the COVAX Facility, an international effort to develop and equitably distribute vaccines, and donate any surplus vaccines to the cause. Taken together with its announcements of new deals for Pfizer/BioNTech and AstraZeneca/Oxford vaccines, the global effort received a crucial shot in the arm just as stakeholders across the world expressed criticism for slow rollouts and a lack of access to doses for low-income countries. While equity and access will remain major challenges in the short term, this is a step in the right direction and is renewing hope for COVAX to fulfill its mission.The change in US leadership may also benefit other multilateral fora, including the G20 and G7, where concrete action and global health dialogues were often stalled the past four years as countries struggled to find a compromise with the US government’s erratic approach to multilateral engagement. A central focus this year will be a new push for sustainable and innovative financing for pandemic preparedness, and GHTC hopes that this scope will be expanded to address research capacity-building for other health areas. In particular, international financial institutions (IFIs) could play a larger role in providing more stable sources of investment for expanding regional research, late-stage clinical trial, and manufacturing capabilities. Last year, the World Bank already took steps toward implementing new mechanisms to help countries finance the purchase and distribution of COVID-19 vaccines and other health technologies, and there should be continued dialogue around what the Bank and other IFIs can do to advance capacity-building not just for emerging infectious diseases but other key health R&D priorities in low- and middle-income countries.Recommitting to the fight against other global health challenges, not just COVID-19 The WHO EB meeting also signaled a desire by member states to reassert the importance of other global health priorities, including antimicrobial resistance, the Immunization Agenda 2030, neglected tropical diseases (NTDs), and continued discussions around intellectual property. For much of 2020, these WHA workstreams were delayed and stalled as the global community focused almost exclusively on COVID-19. It was therefore encouraging to see global leaders push ahead once more, knowing the dangers of falling further behind.Much of the discussion at the EB centered around accountability and implementation, creating concrete pathways for driving impact in these key areas. Many member states also framed the discussion in a holistic way, highlighting the need for strengthening health systems. Throughout 2020, advocates including GHTC have highlighted how the pandemic underscores both the need and opportunity to make sweeping changes to how global, regional, and country mechanisms support R&D not just for the current and next pandemic, but also for long-standing challenges like malaria, tuberculosis, HIV/AIDS, and NTDs, and for R&D capacity-strengthening to be seen as a key facet of health systems strengthening efforts.Make no mistake, the battle against COVID-19 will continue to dominate the international agenda in the months ahead. But global leaders are starting to recognize that we must concurrently move to build a better, more resilient global health architecture and ensure that we continue the investment in systems and institutions that accelerate the development of new tools and technologies to tackle the global health challenges of the 21st century. 

“We might be tired of COVID-19, but it is not tired of us.” With those words punctuating his opening remarks, World Health Organization (WHO) Director-General Dr. Tedros Adhanom Ghebreyesus reminded World Health Assembly (WHA) participants that the ongoing pandemic continues to dominate both our lives and the agenda in multilateral fora. This year’s virtual assembly tried to continue to galvanize the global community around a coordinated response to the pandemic and reassert the importance of other key global health priorities. While this virtual assembly did not provide the same opportunities as years past to engage with stakeholders, GHTC tracked the proceedings and worked with partners to weigh in on key agenda items. Here are our top takeaways from this year’s forum:WHO and member states remain focused on pandemic response, health emergencies governanceWith the ongoing pandemic continuing to dominate the attention of the world, global coordination to address COVID-19 was a clear priority for WHO during the assembly. Delegates debated the challenges and gaps in the ongoing response efforts, as well as preparedness and response mechanisms for future health emergencies. The assembly also approved a resolution to bolster WHO’s work and strengthen countries’ preparedness capacities; while the resolution primarily focuses on health system strengthening, the International Health Regulations, and governance, it does include a provision that calls on member states “to facilitate investment in strong national research agendas and adequate infrastructures for research and development in support of new measures to counteract the impact of health emergencies, including non-pharmaceutical interventions.” The debate between member states over the resolution felt like a precursor for the more far-reaching reform proposals that may be in the offing next year, following the completion of multiple reviews over pandemic response that are now underway. Those reviews are looking at countries’ and WHO’s pandemic performance, WHO’s health emergencies program, and the International Health Regulations system itself. There appeared to be a slowly emerging political consensus shaping up around initiatives being advanced by both Germany and France to significantly strengthen the hand of WHO in terms of its emergencies powers to obtain data from member states and take action. Unfortunately, the proposals currently don’t formally integrate research and development (R&D) into their frameworks. WHO develops Immunization Agenda 2030  Member states expressed broad support during the assembly for the Immunization Agenda 2030, which outlines research and innovation as one of its seven strategic priorities, highlighting the need for “continued research into new and improved vaccines, technologies and vaccine manufacturing platforms, as well as innovations in immunization service delivery and program management.”Germany noted that the current strategy does not factor in the impact of COVID-19 on current immunization priorities and programs and that an additional evaluation to integrate pandemic response efforts will be necessary to adequately reflect the shifting landscape.WHO TB research and innovation strategy moves forwardThis year, WHO unveiled their new Global Strategy for Tuberculosis Research and Innovation, drawing on consultation with scientists, national tuberculosis (TB) program managers, and other officials from within and beyond ministries of health, including ministries of science and technology, representatives of civil society and affected communities, research funding institutions, and other TB research and innovation stakeholders. A resolution on this new strategy was passed by member states via silence procedure in the summer and formally adopted during the assembly.The strategy outlines four major areas for action: 1) creating an enabling environment for TB research and innovation; 2) increasing financial investments in TB research and innovation; 3) promoting and improving approaches to data sharing; and 4) promoting equitable access to the benefits of research and innovation. “This global strategy will guide member states and other relevant stakeholders in translating political commitments on TB research and innovation into concrete action backed by investment, as an integral part of efforts to end TB,” said Dr. Tereza Kasaeva, director of WHO’s Global TB Program. The WHO strategy also promotes the sharing of data arising from publicly funded research, with the ultimate goal of ensuring that the public benefits from public investments in science. The resolution also calls for WHO to provide technical and strategic assistance to member states, urges countries to strengthen efforts for TB research and innovation as a complement to broader cooperation to tackle antimicrobial resistance at all levels, and pushes for increased coordination across United Nations agencies and greater collaboration with the private sector.While the strategy is a welcome development, further investment for TB research must follow from member states. Global leaders must close the US$1.3 billion funding gap for TB R&D annually if the 2030 targets are to be achieved. WHA adopts new road map for neglected tropical diseasesWhile member states did not spend much time debating the topic, they did adopt a new road map on tackling neglected tropical diseases (NTDs) at the assembly. The NTD road map sets global targets and milestones to prevent, control, eliminate, and eradicate 20 NTD groups.One of the key components of the road map is a shift away from single-disease vertical programs to integrated approaches, which promote improved coordination and collaboration. Another distinct feature is to drive greater ownership by national and local governments, including communities. The overarching 2030 global targets include a 90 percent reduction in the number of people requiring treatment for NTDs and a call to eradicate dracunculiasis—also known as Guinea-worm disease—and the chronic skin disease yaws, which affects mainly children under 15 years old.Research and innovation will be a critical component to ensure that these targets are met, and several member states called for greater investment for new tools to combat these diseases.Civil society engagement with WHO remains limited Civil society engagement with WHO continues to be a challenging process, and after several disappointing meetings this year, this month’s assembly was no different. The often hectic and oblique communication, or lack thereof, on how civil society organizations (CSOs) could meaningfully participate in these meetings heading into the assembly was yet another sign that the trend line on productive collaboration between WHO and CSOs is heading in the wrong direction.CSOs were also prohibited from delivering statements on certain agenda items, and like member states, they were forced to consolidate a number of agenda items into a single statement as WHO pulled together several topics into one session, creating a disjointed dialogue in which not all issues received adequate airtime.Moving forward, WHO needs to provide new avenues for CSO input around these fora, whether through separate listening sessions, online consultations, or other mechanisms that allow civil society to bring its expertise to bear and provide technical feedback to various processes.This year’s assembly felt largely more ceremonial than substantive at times, given the lack of debate on many agenda items and WHO speeding through the list of topics. The pandemic will continue to be a major focus in 2021 for WHO and member states, but other health areas that have been neglected through underinvestment on the WHA73 agenda must also re-emerge as key priorities.

The COVID-19 pandemic has revealed a collective failure to take pandemic prevention, preparedness, and response seriously and prioritize it appropriately, according to a report released this week by the Global Preparedness Monitoring Board (GPMB)—an independent panel co-convened by the World Bank and World Health Organization (WHO) to offer policy recommendations on pandemic preparedness. As a result, the world is paying a hefty price in economic and health losses, the report stresses. Vaccination campaigns around the world have been suspended, threatening polio eradication and potentially leading to new outbreaks of preventable diseases. Interrupted access to HIV/AIDS, tuberculosis, and malaria care threatens to cause more than 1 million additional deaths in 2020-2021 alone. Meanwhile, the costs of this pandemic have already been measured in the trillions of dollars, while the costs of preparedness are billions. GPMB representatives have noted it would take 500 years to spend as much on investing in preparedness as the world is losing due to COVID-19. In their inaugural report last year, GPMB stressed the inadequacy of systems and financing required to detect and respond to health emergencies. As COVID-19 has proven, these systems remain dangerously deficient and under-resourced. This year’s report, “A World in Disorder,” highlights five calls for urgent action: 1) responsible leadership; 2) engaged citizenship; 3) strong and agile national and global systems for global health security; 4) sustained investment in prevention and preparedness, commensurate with the scale of a pandemic threat; and 5) robust global governance of preparedness for health emergencies. Three of the five recommendations connect to strengthening the global health research and development (R&D) ecosystem.  A call for strong and agile national and global systems for global health security In its 2019 report, GPMB called on heads of government to “appoint a high-level coordinator and invest in research and development for countermeasures and non-pharmaceutical interventions, along with mechanisms for sharing genome sequences of new pathogens, and for equitable allocation of scarce medical countermeasures.” The need for this has been apparent throughout the COVID-19 pandemic, as uneven and uncoordinated responses have hampered efforts to flatten the curve.  This year’s report doubles down on the need for greater coordination and highlights the need for formal global mechanisms to facilitate the development, assessment, and distribution of diagnostics and medical countermeasures. The following recommendation and the supporting points underscore this priority: “Urgent action: Researchers, research institutions, research funders, the private sector, governments, the World Health Organization and international organizations improve coordination and support for research and development in health emergencies and establish a sustainable mechanism to ensure rapid development, early availability, effective and equitable access to novel vaccines, therapeutics, diagnostics and non-pharmaceutical interventions for health emergencies, including capacity for testing, scaled manufacturing and distribution.” Progress has been made on a coordinated R&D response but remains fragile. Scientists and researchers around the globe have raced with record speed to develop and assess countermeasures. This progress is based on past investments and existing infrastructure for basic research, as well as new frameworks and initiatives, including the Access to COVID-19 Tools (ACT) Accelerator, which highlights the need to work more collaboratively not just across different geographies, but with the end-to-end process in mind. Yet GPMB highlights that it remains to be seen whether these initiatives can deliver on their promise, or whether they will expand their scope beyond the current pandemic. What is certain is that if these endeavors are to be successful, they will need serious investment. ACT Accelerator partners estimate they will need US$35 billion to fund this initiative, of which $15 billion is needed by the end of this year. GHTC has been working diligently behind the scenes with government, private sector, and civil society stakeholders to push for greater collaboration, ensure world leaders leverage these mechanisms in the future, and use the current focus on the pandemic to establish more sustainable financing mechanisms for R&D to confront future health threats. Global preparedness is not simply the sum of national preparedness. The GPMB report highlights the need for global agreements or mechanisms to share information and allocate limited supplies of countermeasures. The expert panel notes that while “national preparedness is key, global and regional mechanisms for tracking potential pathogens, early alert, information sharing, research and development, regulatory capacity-building and harmonization, allocation of countermeasures, stockpiles and supply chains must also be strengthened and developed, sustained and financed. Preparedness to conduct rapid research and countermeasure development requires sustained commitment to capacity-building and funding for basic science research.” Past pandemics have shown that without clear frameworks and procedures to facilitate the equitable sharing of limited medical countermeasures, low and middle-income countries (LMICs) may be unable to secure access to the innovative medical products they need. GHTC believes that as instruments such as the COVID-19 Global Vaccine Access (COVAX) Facility are stood up, it is important to ensure that the world leaders look beyond the current pandemic and establish sustainable mechanisms that will outlast COVID-19 to support the range and scope of R&D necessary to confront health emergencies in the future. Manufacturing capacity, stockpiling, and supply chains have become major bottlenecks. When COVID-19 struck, most countries did not have sufficient stockpiles of medical countermeasures or the pre-existing capacity and resources to suddenly scale up manufacturing to respond to a pandemic. This created a major surge in global demand and exposed the fragility of global supply chains for medical goods. In LMICs that cannot afford bidding wars, it has been extremely challenging to source personal protective equipment, testing materials, treatments, and medical equipment. Over the past decade, the manufacturing of vaccines, therapeutics, and diagnostics has become increasingly concentrated in a few countries, which has exacerbated the risk of ruptures and has proven detrimental to the equitable distribution of health products. This shortage of manufacturing capacity for medical countermeasures has threatened countries’ capacities to fight COVID-19.  A global coordination mechanism can support regional capacity building in LMICs. GHTC is urging world leaders to create a global institution or broaden the mission of an existing mechanism like the Coalition for Epidemic Preparedness Innovations (CEPI) that can coordinate and galvanize biomedical research expertise and advance health products to respond to emerging health threats. This institution should also work closely with countries to improve regional capacity, provide technical assistance, and highlight where there may be a need for additional strategic investments to support preparedness capabilities.  A need for sustained investment in prevention and preparedness, commensurate with the scale of a pandemic threat As seen previously with Ebola, and now with COVID-19, the cost of response is far greater than preparedness due to massive economic disruption caused by pandemics. It also demonstrates the urgent need for global financing mechanisms to accelerate national health preparedness and prevention capacity, including for biomedical research, development, and manufacturing. The GMPB report follows the calls of many experts, articulating the need for new health security financing incentives and investment accountability. The following recommendation from the report highlights the need for international financing for R&D: “Urgent action: The World Bank and other International Financial Institutions (IFI) make research and development (R&D) investments eligible for IFI financing and develop mechanisms to provide financing for global R&D for health emergencies.” Extraordinary events require extraordinary financing. The world urgently needs a robust, dedicated global health security funding mechanism to catalyze and accelerate the necessary investments that will help prevent the next pandemic. The GPMB expert panel argues in its report that rapid financing of emergency R&D and capacity-building is hampered by the lack of mechanisms in IFIs to provide such financing at the global level. Many experts believe that new mechanisms are needed, and some— including GHTC—believe that the World Bank’s Health Emergencies Preparedness and Response Fund (HEPRF) can fill that role by financing some short-term R&D capacity-building programs. This includes rapidly increasing regional diagnostics manufacturing and laboratory capacity, expanding clinical trial capabilities in LMICs for COVID-19 health products, and supporting regional regulatory processes to speed the uptake and use of these new technologies. Advocates have also pushed for innovative financing models such as a Global Health Security Challenge Fund to close the massive global gaps in pandemic preparedness.  Robust global governance of preparedness for health emergencies is vital for global security COVID-19 has highlighted significant gaps in the governance of preparedness. Key issues have arisen around the functioning and implementation of the International Health Regulations (IHRs), which countries have committed to meet, and our current mechanisms are inadequate to fully respond to the crisis or help catalyze and coordinate R&D for medical countermeasures. The GPMB recommendation below highlights the need to galvanize world leaders to develop a new governance framework for global preparedness through a United Nations (UN)–led forum: “Urgent action: The Secretary-General of the United Nations, the Director-General of the World Health Organization, and the heads of International Financing Institutions convene a UN summit on Global Health Security, with the aim of agreeing on an international framework for health emergency preparedness and response, incorporating the IHR, and including mechanisms for sustainable financing, research and development, social protection, equitable access to countermeasures for all, and mutual accountability.” Current measures of preparedness are not predictive. The GPMB expert panel asserts that our understanding of preparedness is based on a narrow set of public health capacities that does not fully capture the range of national and international capacities necessary to ensure preparedness, including R&D, measures to mitigate the socioeconomic impacts of epidemics and ensure continuity of essential services, international cooperation, and the preparedness of international organizations. This underscores a problem GHTC has raised for several years, namely that while it has never been more apparent that R&D for health technologies and medical countermeasures is vital to enhance our capacity to prevent and combat threats as they emerge, capacity-building of R&D for medical countermeasures including diagnostics is noticeably absent from IHRs and the Global Health Security Agenda. In order to address current and future pandemics, it will be essential to ensure that R&D is integrated formally into both. While not every country needs a full suite of R&D capabilities for vaccines, diagnostics, therapeutics, and other technologies like personal protective equipment and oxygen therapies, GHTC believes every country should have a plan and pathway to gain access to these tools at an affordable price when needed. Final thoughts: GPMB highlights that the pandemic is a stress test for global solidarity and multilateralism One of the greatest challenges of the COVID-19 pandemic is faltering multilateral cooperation. While a plethora of new initiatives have emerged to combat the coronavirus, nationalistic attitudes and political tensions have hampered the global response. We have seen this year that disagreements over the adequacy of WHO’s response to the pandemic, as well as continued diplomatic strife between the United States and China have complicated the implementation of a collective response and stalled progress in the G7 and G20, with both fora failing to develop or publish strong consensus resolutions or roadmaps. The report makes it quite clear that we are at a fork in the road when it comes to this crisis. We can either choose to take bold collective action and strengthen the multilateral system, with a strengthened focus on gaps like R&D capacity, or retreat into nationalism. COVID-19 will remain a protracted crisis without global collaboration, and now is the time to strengthen the global health security R&D architecture of the future to ensure that we are prepared for the next pandemic.

The COVID-19 pandemic is a wake-up call for multilateralism. As leaders from around the globe convened for the first-ever virtual World Health Assembly (WHA), it has never been clearer that every country has been touched by this horrible disease, as evidenced by delegates highlighting their countries’ actions and response efforts in their interventions. The COVID-19 crisis has demonstrated just how crucial multilateral conveners like the World Health Organization (WHO) are to our collective health, prosperity, and security and the need for enhanced international cooperation and worldwide solidarity. Innovation is our exit strategy for defeating COVID-19 and combating the pandemic calls for a robust, coordinated, large-scale, and science-based global response. Governments and foundations are pouring billions into scientific research efforts to develop new tools to detect, treat, and prevent COVID-19. Yet these new initiatives and efforts need to be aligned. The World Health Organization (WHO) has been called on to coordinate several of the R&D response efforts to accelerate the development of diagnostics, vaccines, therapeutics, and other health technologies to combat this novel coronavirus, and the organization’s ability to effectively help support these efforts will be vital to their success. Accelerating research to develop new tools The global response will have to be well coordinated. With so many new mechanisms being developed to fight COVID-19, it is essential to ensure that efforts are not counterproductive. It will also be important that there is a holistic approach to tackling this crisis because there will be no silver bullet.  We can start with WHO’s creation of COVID-19 Target Product Profiles (TPPS), which outlines the product gaps to be filled. Building on that, WHO launched a new program, called the Access to COVID-19 Tools Accelerator, or the ACT Accelerator. This collaboration between WHO and dozens of governments, nonprofit organizations, and industry leaders seeks to facilitate partnerships, provide technical guidance, and provide support to health systems and strengthen countries' capacities to enable the delivery of new COVID-19 tools. The global initiative will draw on the expertise and infrastructure already put in place by organizations that work across the globe, including Gavi, the Vaccine Alliance; CEPI, the Coalition of Epidemic Preparedness Innovations; FIND; the Global Fund; and Unitaid. Speed is a key factor to quelling the pandemic. As scientists around the world race for a cure for COVID-19, international cooperation is critical for accelerating research. One of the ways WHO has supported these efforts is by designing a large international randomized controlled clinical trial, called the Solidarity Trial, to enable the simultaneous evaluation of the benefits and risks of different vaccines at sites with sufficiently high rates of the disease. This will ensure a faster turnaround of results and ensure that sufficient data is being captured to make more robust assessments of the efficacy and safety of these treatments. While the trial is currently only being leveraged for the most severe cases, with few trials in resource-poor settings, this approach should be broadened and connected to initiatives like the COVID-19 Clinical Research Coalition in order to have a more complete assessment of how R&D treatments for COVID-19 are progressing. Assessing new technologies quickly will also be a major factor in how rapidly they can be deployed. In order to ensure quick access to high-quality, safe, and effective new health technologies for COVID-19, WHO has activated its Emergency Use Listing (EUL), a procedure that allows for rapid assessment of diagnostic and labrotary technology. This is crucial for countries that have weaker regulatory systems or  lack local infrastructure such as laboratory capacity to evaluate new tools. EUL helps accelerate access to these innovations, but this should only be the first step. Beyond emergency approvals, full technology assessments such as the WHO Prequalification process should also be leveraged as new products are realized. For example, we saw the new Ervebo Ebola vaccine go through WHO Prequalification within 48 hours of the European Medicines Agency’s recommendation, and GHTC would like to see that approach  mirrored for products developed to respond to COVID-19 as well as other health threats. Tackling supply challenges and access What happens once vaccines, treatments, diagnostics, and other technologies receive emergency use authorization or full regulatory approval? A global pandemic means these life-saving tools have unprecedented global demand with herculean scale-up requirements. Manufacturing could be slow, expensive, and vulnerable to export controls. We have already witnessed conflicts over raw materials and reagents for diagnostics, and meeting global demand for a COVID-19 vaccine would require an unprecedented effort to utilize the world’s current capacity to produce, package, and deliver these products. Countries like China and India control major stakes in supply chains for active pharmaceutical ingredients, glass vials, and adjuvants. These challenges represent a significant threat to lower-income countries as they may be unable to access scarce medical technologies or component parts if wealthy countries dominate the global bidding wars for essential equipment. Some countries will also be unable to administer and scale-up the response on their own and will need support in building the health systems and managing the supply chains required to provide access to these life-saving tools. WHO has already started working on ways to ensure that key technologies and equipment will be available to frontline health workers and the most vulnerable populations, helping marshal essential resources and equipment, and looking for ways to secure the supply chain for key medical products. Service delivery systems need to be strengthened with the support of international donors, and new commitments and resources should be made to existing global health mechanisms like Gavi, the Vaccine Alliance, and the Global Fund to Fight AIDS, Tuberculosis and Malaria. Access was also a central focus of the European Union led resolution on COVID-19 that was adopted at the virtual WHA. It included far-reaching provisions, including the creation of a voluntary pool of patents for COVID-19 treatments and language highlighting the rights of countries to legally override international patent rules during a health emergency. While some of the specific items remain hotly debated, it is clear that there is a growing consensus that more needs to be done to ensure equitable access for safe, quality, effective, and affordable COVID-19 diagnostics, therapeutics, and vaccines to ensure that in the fight against COVID-19, no one is left behind. Global response and scientific research hampered by politics While it is clear that a global approach is crucial to stemming the worldwide spread of the disease, global cooperation has been strikingly absent in many multilateral forums, including G7, G20, and WHA. The rift between China and the United States endures, and this tension was also on full display during WHA. While many countries reiterated their support for WHO, the US took a different approach, delivering a fiery rebuke of the organization and accusing WHO of failures in responding to the pandemic while also alleging that China was not open and transparent at the outset of the crisis. Coupled with President Trump’s continued threats to cut funding to the organization, key functions of WHO in responding to the pandemic are in jeopardy. It will be paramount in the coming weeks that leaders push to ensure that key initiatives being led by WHO are not derailed.  They must be able to continue their work supporting response efforts and coordinating disease incidence surveillance and COVID-19 R&D efforts around the world. The role WHO is uniquely qualified to play WHO is uniquely qualified to coordinate global research and development efforts, marshal equitable allocation of resources, and provide technical guidance to fight the pandemic. We know this pandemic will not be the last. The important question now is whether the battle against COVID-19 will strengthen or exhaust our ability to respond again in the future. While this crisis presents unique challenges, it also presents the world with an opportunity to reimagine the architecture of global health systems including new ways to advance and coordinate R&D to address future health threats in a more holistic and sustainable way. Now more than ever, leaders from around the world must look to our multilateral institutions like WHO to drive the global effort that is required to develop the health technologies we need to defeat the coronavirus and enhance our global health security capacity to respond to future outbreaks.