Philip Kenol

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.

With the global health emergency of the novel coronavirus looming large, last week the global health community gathered in Geneva to kick off the World Health Organization (WHO) Executive Board (EB) meeting. In his opening remarks, WHO Director-General Dr. Tedros Adhanom Ghebreyesus highlighted the agency’s new Science Division and underscored WHO’s commitment to “being at the forefront of science,” signaling the importance of research and development (R&D) to achieve the agency’s goals. GHTC was on the scene following the official agenda and delivering statements. Here are our top three takeaways from this year’s EB:1. Coronavirus and public health emergency preparedness take center stageWith the coronavirus [COVID-19] crisis dominating the attention of the world, the global response to this health emergency was a clear priority for WHO during the EB. Throughout the week, WHO held daily briefings to update member states on the evolving situation and ongoing response efforts. While plenty of the discussions were mired in the ongoing political controversies around travel and trade restrictions, a good portion also encouragingly centered around the need to fast-track the R&D response. Delegates highlighted the development and evaluation of effective diagnostic tests, vaccines, and medicines, as part of the R&D priorities and called for establishing mechanisms that ensure access to these new treatments and technologies for the most vulnerable populations. Data sharing, public-private partnerships, and collaboration were also highlighted as key elements to be strengthened as part of emergency preparedness activities.A global research and innovation forum specifically on the coronavirus was convened by WHO in the days following the EB in line with the WHO R&D Blueprint strategy and preparedness plan to rapidly activate R&D activities during epidemics. Its aim is to fast-track the availability of effective tests, vaccines, and medicines that can be used to save lives and avert large-scale crises.The theme of rapid response capabilities also dovetailed into the dialogue at the EB around the Nagoya Protocol, a legal framework that regulates the sharing of genetic resources across borders to ensure any benefits derived are fairly and equitably shared. China was continuously praised at the EB for its rapid sharing of genetic sequence data on the virus, which has helped accelerate the R&D response. However, this action was not in line with the Protocol, which calls for this type of genetic data sharing to be negotiated individually with each country. In a session on the public health implications of the Nagoya  Protocol, member states called on WHO to continue to gather intelligence and provide a review of the current impact of the Protocol. Several members also highlighted the need for a new international framework to specifically govern pathogen sharing, modeled on the Pandemic Influenza Preparedness (PIP) framework, a non-binding mechanism that seeks to strengthen global influenza surveillance and response systems. WHO Chief Scientist Dr. Soumya Swaminathan promised that her team would continue its efforts to study the issue and hold additional consultations to provide more clarity to all stakeholders.2. R&D features prominently in Global Vaccine Action Plan and Ending TB agendaWith sessions on the Global Vaccine Action Plan, intellectual property, ending tuberculosis (TB), and neglected tropical diseases, it is not surprising that this year’s EB featured an agenda with significant implications for R&D.In particular, the session on ending TB generated critical momentum for R&D, as member states called for increased investment in developing new technologies, including shorter, high-quality treatment regimens and diagnostic tools. The need to enhance data sharing and strengthen enabling environments for R&D was also discussed by country delegates.Member states also unanimously approved two decisions that set the stage for global vaccine policy in the next decade—a draft resolution on “strengthening global immunization efforts to leave no one behind” and the first-ever draft resolution on “eliminating meningitis by 2030”—after reviewing a report prepared by the Director-General on lessons learned from the Global Vaccine Action Plan 2011–2020. Member states were urged to continue working with R&D stakeholders to support immunization supply chain innovations and vaccine administration technologies to increase the efficiency of vaccine delivery. Countries were also encouraged to improve and increase vaccine production capacity and develop new products, services, and practices, including those addressing emerging infectious diseases.3. Civil society engagement at WHO remains strainedCivil society engagement with WHO continues to be a challenging process and this year’s EB strained relations between stakeholders even further. In a surprising move, the EB Chairman, took fairly drastic actions to further curtail civil society participation during the official proceedings. Non-state actors’ (NSAs) statements were reduced to one minute, which has occurred at EB meetings in the past, often as a way to protect time allocated for other agenda items. However, this time, some organizations were also prohibited from delivering statements if they had already made previous interventions during the EB, and the Chair aggressively admonished those who wished to speak on multiple topics.This came amidst the backdrop of a proposal that member states were set to consider that could considerably hamper civil society’s ability to provide input to important fora like the EB and the World Health Assembly (WHA). The proposal called for streamlining the statement process by compelling NSAs to deliver joint interventions, limiting the overall size of civil society delegations, and possibly introducing an altogether new process for dialogue between member states and NSAs at a separate forum. Member states supported the idea of joint statements and a constituency approach, while civil society pushed back against these measures that they believe would restrict meaningful contributions and silence important voices. All stakeholders agreed that the idea of a forum for NSAs required additional dialogue and was too premature for this year’s process. WHO is looking to pilot some of the new procedures, at least in part, during the next WHA, though details are not yet available. With many items still up in the air and further discussion needed to implement and advance programs, the WHA in May promises to be quite the roller-coaster. GHTC will be present and look forward to advancing these conversations with our partners as well as continuing to strategically drive the innovation agenda heading into the Assembly. 

The World Health Organization (WHO) recently announced that at its upcoming Executive Board meeting in February, member states will discuss challenges and issues in implementing the Nagoya Protocol—a legal framework that governs the access to and benefits gained through the sharing of genetic resources, including human and animal DNA, plants, and pathogens. As these discussions heat up, GHTC is taking a brief look at what the Nagoya Protocol is, how it impacts global health research and development (R&D), and what’s next for the future of this framework.WHAT IS THE NAGOYA PROTOCOL?The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization‒or Nagoya Protocol for short‒is a legal framework that went into effect in 2014. It regulates the sharing of genetic resources, including human and animal DNA, cultures and specimens, plants, and pathogens that are used in the course of R&D.Origin and goalThis protocol supplements a United Nations treaty, endorsed over a decade earlier in 1992, called the Convention on Biological Diversity (CBD), which established a basic principle: That every country has sovereignty over the genetic resources found within its borders. Its broader goals were to support the conversation of biological diversity, ensure its sustainable use, and ensure the “fair and equitable sharing” of the benefits derived from the use of genetic resources.The Nagoya Protocol was established to advance that third and final goal by creating greater legal certainty and transparency for both the providers and users of genetic resources. The protocol establishes more predictable paths for gaining access to genetic resources and creates frameworks for tangible agreements that outline the benefits that a donor country will receive in exchange for providing access. It also requires that users comply with any national legislation or regulatory requirements in the provider country governing the collection, use, or storage of these resources.  How does it work in practice?When a researcher, company, or institution wants to access the genetic resources in a foreign country that is party to the protocol, it should start by obtaining a prior informed consent from the country where the materials are located and outline the goal of the planned research and use. Second, the party seeking access and the provider country should also negotiate and reach “mutually agreed terms” that set conditions for the use of the genetic material and define the benefits arising from their use, such as when commercial products results from such research. These benefits could be monetary, such as a lump-sum payment or a share of the profit, or non-monetary, such as transfer of knowledge, technology, or training. A healthy debate over the Nagoya ProtocolThe aim of the protocol is to stop piracy of genetic materials across borders. Sovereignty is at the heart of the matter. Health authorities in low- and middle-income countries are often concerned that providing genetic resources will not yield a tangible benefit to their country or that the genetic materials will be shared without their consent and result in health innovations that may ultimately be unaffordable to their population. Ensuring that there are access provisions in place is critical.On the other hand, the provisions of the Nagoya Protocol can have a negative impact on international research collaborations. From basic research through clinical trials, medical research is highly collaborative and routinely involves the sharing of organisms, cultures, and research findings across borders. Adhering to the protocol can place a heavy bureaucratic burden on researchers and their institutions or companies who must comply with its requirements, as well as the procedures or laws of individual countries, which can vary greatly. The process of obtaining prior-informed consent and reaching mutually agreed terms between users and countries can take several weeks or months, putting research temporarily on hold.CONSEQUENCES AND POTENTIAL IMPLICATIONS ON HEALTH R&DThese delays can have serious consequences to public health. For example, in late 2018, implementation of the Nagoya Protocol in several countries caused significant delays in sharing seasonal influenza strains. Given selecting the strains for each year’s seasonal flu vaccine is a time sensitive process and researchers need genetic material to make this determination, this resulted in a delayed seasonal vaccine rollout and lack of public health preparedness to address influenza.Many fear that the protocol could cause similar challenges in detecting and responding to emerging infectious diseases, including advancing medical products, given pathogens spread regardless of national borders and creating control measures requires partnerships and sample and data sharing between countries and research institutions. Long negotiations to obtain specimens for research potentially increase the risk of disease spreading in populations that have no immunity and can harm the global interest of protecting against emerging infectious diseases.WHAT’S NEXT FOR NAGOYA?Given the potential impacts that the Nagoya Protocol could have on the development of vaccines and other medical products, many stakeholders are calling for exemptions to the protocol and for alternative approaches for the sharing of genetic materials to be considered. In the aftermath of the of the swine and avian flu a decade ago, WHO developed an agreement called the Pandemic Influenza Preparedness Framework, which outlines a potential path forward to mitigate unforeseen health consequences related to the protocol. The agreement provides for global sharing of pandemic influenza viruses within a network of public health laboratories. Organizations and companies outside of this network can also access this pool of viruses after making a partnership contribution to and signing a material transfer agreement with WHO, in which they agree to share benefits. While the agreement only covers flu, some see it as a model that could resolve the disputes over the Protocol and genetic materials and sequence sharing, and create a timelier pathway for researchers looking to combat emerging infectious and other global diseases.

On Monday, the United Nations (UN) members unanimously adopted a high-level political declaration on universal health coverage (UHC), which World Health Organization (WHO) Director-General Dr. Tedros Adhanom Ghebreyesus called a “landmark for global health and development.” While the adoption of the declaration is welcome news, in many ways it represents a starting point for the next phase of UHC, in which the thornier issues of financing, follow through, and accountability will rise to the forefront. UHC declaration adopted unanimously at United Nations High-Level Meeting It was a bit of a bumpy journey to Monday’s political declaration. After months of tense negotiations among member states, the UHC debate had stalled over two hot-button issues—sexual and reproductive health and the rights of migrants and refugees—which weren’t resolved until a few days before the High-Level Meeting. Thankfully, countries were able to push the UHC declaration across the finish line, with a several countries, including the United States, disassociating themselves from the provisions linked to those thornier issues. It was encouraging to see that the final declaration was inclusive of GHTC-supported language on research and development (R&D), focused in particular on innovative financing for new products and technologies, emphasizing the role of the private sector and new models for sustainable investment.  “This declaration represents a landmark for global health and development,” Dr Tedros Adhanom Ghebreyesus The UHC process now moves into a new phase: countries are tasked with developing their own strategies or national action plans to fulfill these commitments and advance UHC within their own borders. The agreement is intended to be country-led, and as member states adopt the commitments to their own geographic contexts, they must outline a clear path for how they will mobilize their governments and increase investment in UHC.  Assessing gaps in the tools to mitigate each countries’ priority health challenges also needs to be considered as part of this new phase.  It’s all about the money Now that countries have committed to UHC, how will they pay for it? That question seemed to be on everyone’s mind as numerous events throughout the week of the UN General Assembly focused on the financing side of UHC. The message was clear: not enough is being done, particularly on domestic resource mobilization. Most countries don’t have a UHC investment strategy to achieve the lofty goals set forth in the UHC declaration and the Sustainable Development Goals. As countries start to develop their health investment plans, it is crucial that investment in R&D remain an integral pillar. UHC cannot be achieved without stepping up the fight against the world’s endemic and emerging infectious diseases. This will require new tools and technologies, as was echoed by stakeholders throughout the week, including Global Fund Executive Director Peter Sands and Dr. Tedros. We also need to invest more in the uptake and scaling of innovations and technologies and ensure that we are thinking of end-to-end solutions.  "Existing tools won't be enough"@PeterASands highlights that innovation hasn't been fast enough. We need to push more aggressively to scale up innovation and integration of new tools. @GlobalFund #TBinnovation #HealthForAll pic.twitter.com/7tSluSlIL5— GHTC (@GHTCoalition) September 22, 2019 There were several side events this week on financing reforms, tax redistribution into UHC—from the tobacco industry, for example—and the need for innovative financing approaches. Outcomes-based finance such as social impact bonds and blended finance models, in particular, attracted some attention. All countries did commit to spending one percent or more of their GDP on public health as part of the declaration. That is likely insufficient to achieve UHC, but money isn’t the only factor for success. Some countries, such as the United States, already spend more on health care but still lack access to coverage for all citizens.  Accountability emerges as central focus after the political declaration Now the real work begins. Many speakers this week devoted time to discussing the challenge of accountability and follow through, drawing on past experiences from other high-level meetings.  Stakeholders recognized that the declaration is just a starting framework and that the lofty language needs to be translated into tangible actions and investment. While this declaration symbolizes a major shift for the global health agenda, fears persist that the momentum will dissipate and that countries won’t be able to follow through on their commitments by 2030—just over a decade from now.  Those fears are warranted. Just last week, WHO published a report stating that while advances have been made on UHC, as many as five billion people will be left without full access to healthcare in 2030 at the current rate of progress. Countries must set clear targets for moving their populations on the journey towards UHC and create specific metrics through which progress can be monitored. Mechanisms and incentive structures must be put in place to allow for follow-up and accountability, underscoring the political will expressed in New York this week. In adopting the declaration, member states have committed to investing in policies which would allow everyone, everywhere to have access to quality health care products and services without financial hardship. Leaders must now pivot to move from commitment to concrete action.

Last week, the Australian government and the Indo-Pacific Centre for Health Security convened practitioners, researchers, educators, and decision-makers across the fields of public health, medicine, veterinary science, agriculture, government, defense, and anthropology for the first Global Health Security Conference in Sydney to examine the progress made to date in strengthening health systems and to identify gaps and opportunities for enhancing the international community’s ability to respond more efficiently and effectively to future health crises.GHTC was on the ground, following the official agenda, participating in side events, and speaking on a panel on innovative game changers to advance prioritization of research and development (R&D) in the Global Health Security Agenda. Here are our three key takeaways from the conversations:1. Innovation recognized as vital to advancing health security.The role of innovation in strengthening health security was highlighted throughout the week, with official sessions and side events showcasing innovative products, partnerships, and research central to advancing global health security.GHTC had a speaking role on a Global Health Security Agenda Consortium panel focused on game changers in global health security and used the opportunity to highlight key innovations that are being used on the front lines in the fight against Ebola in the Democratic Republic of the Congo. The panel hit on key themes that were echoed in other sessions, including the need to build local capacity for deployment of new tools and medicines, enhancing laboratory infrastructure, and strengthening health systems and community response capabilities. Much of the dialogue also centered around the need to engage local stakeholders in the development of innovations, ensuring that tools and technologies are designed and adapted for the local context, and that the deployment of treatment measures for emerging health threats is executed with firm community support to increase the chance of successful implementation.Other speakers throughout the week also highlighted the regulatory and implementation challenges that organizations and countries face when seeking to develop and deploy new tools and innovations and recommended strenghtening global governing structures that could facilitate addressing hurdles around approval timelines and streamline the processes.2. We need a strong focus on financing and sustainability. One core message that was consistent throughout the week was the need for a stronger focus on sustainability. Delegates agreed that states and organizations are too reactive in their mindsets, only responding to the latest outbreak and not taking the necessary preemptive steps, including through R&D, to develop the local, regional, and global capacities that are necessary to effectively combat emerging infectious diseases and other health threats. Ensuring that local infrastructure, laboratory systems, clinical capacity, and overall primary health care services are continually enhanced will allow for a more effective response.  Ebbs and flows in funding for epidemic diseases create additional challenges. The recent Ebola outbreak is a perfect example of how additional public resources can be mobilized to respond to global threats. However, absent a crisis, emergency preparedness and capacity building are often de-prioritized, and the necessary funding needed for additional innovation and product development is often lacking. Delegates called for a more durable approach of creating policies and incentives that catalyze investment for specific diseases, infrastructure, and health workers. Some also suggested looking to multilateral institutions for greater financial support for programmatic activities and creating stronger partnerships with the private sector. As one speaker put it best: “We must marry political capital with money.”3. Multisectoral approach critical to path forward.Are we asking too much of the health sector and not enough of everyone else? In the closing plenary, this question served as a call to action to engage non-traditional stakeholders and relevant decision-makers in other sectors to develop a truly multisectoral approach to strengthen health systems overall and develop the tools and capabilities in-country to detect, diagnose, and treat those threatened by global health threats.Ministers of Health have a difficult case to make when asking for more resources, financial or otherwise. The value of preventive measures is often invisible, since doing it right means there is no outcome. As global health practitioners, advocates, researchers, and decision-makers look for new ways to engage partners in different fora, such as the G20, building linkages to other sectors and government priorities will be key to creating the political buy-in necessary to advance the agenda around global health security.