Philip Kenol

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.

Against a backdrop of mounting global health challenges, the 72nd World Health Assembly (WHA) convened last week, with politicians, philanthropists, business executives, and civil society leaders all descending upon Geneva. GHTC was on the scene—attending side events, technical briefings, and following the official agenda. Here are our top four takeaways from this year’s assembly:1. Universal Health Coverage (UHC) dominates WHA.Considered the theme of this year’s WHA and a core component of the platform of the World Health Organization (WHO) Director-General, UHC was a ubiquitous topic in Geneva as stakeholders prepare for the United Nations (UN) High-Level Meeting on UHC in September. Multiple side events and briefings focused on the topic with discussions yielding numerous calls to action from bolstering the inclusion of low- and middle-income country (LMIC) voices, to investing in community health workers, to making primary health care the central pillar of UHC. During the official WHA sessions, there was also strong consensus around the importance of leaving no one behind, equity in health, and a people-centric approach to UHC. The hotly anticipated zero draft of the Political Declaration of the High-level Meeting on UHC was also released last week. The draft is meant to serve as a baseline for members states who will ultimately endorse a political declaration at the high-level meeting this fall and reflects some of the feedback that civil society provided during the consultative process. The document features some encouraging language on health research and development (R&D): calling for improved availability, access, and affordability of quality medicines, vaccines, diagnostics, and other health technologies, and it encourages incentives for R&D, including stronger public-private partnerships. The draft also underlines the importance of investment in new health technologies.While the R&D community can be heartened by these inclusions, there are notable omissions. There was no direct mention of specific diseases affecting vulnerable populations in LMICs and no specific request or direct call for increased investment in R&D for new health tools.2. Contentious access debate at WHA ends with compromise resolution on drug and health product price transparency.Advocates anticipated that the access to medicines issue would be the one of the most contentious topics at this year’s WHA. They were right.After long and arduous negotiations which delayed the access to medicines session by several days, member states adopted a compromise resolution at WHA urging greater transparency on drug prices. The resolution calls on members to “take appropriate measures to publicly share information on the net prices of health products.” The most contentious element of the initial draft, which urged disclosure of R&D costs, particularly for clinical trials, was ultimately amended to feature language emphasizing the purely voluntary nature of those disclosures. While the resolution was celebrated as a landmark by the WHO Director-General, many member states were unhappy with the process, with Germany, the United Kingdom, and the United States expressing their discontent with the approach and timing.3. Ebola crisis keeps emergency preparedness at the top of the agenda.The worsening Ebola crisis in the Democratic Republic of the Congo loomed large at WHA, as tributes to health workers were featured throughout the proceedings. There was a common refrain during the week about the need for improved coordination in emergency preparedness between global actors and local communities, with many delegates from the global south, including WHO Director-General Dr. Tedros himself, emphasizing the importance of building trust and integrating community health workers in the process. From an R&D perspective, many stakeholders called for strengthening in-country capacity, including laboratory and clinical trial capacity, as an integral pillar of developing effective countermeasures.To better support member states in improving preparedness, WHO set up a new division specifically for emergency preparedness, as part of its reform process earlier this year, which will work in tandem with its existing workstreams on emergency response. WHO also welcomed the appointment of a UN emergency Ebola response coordinator to facilitate interagency activities. 4. Follow-up meeting to the UN High-Level meeting on Tuberculosis (TB) shows promise with accountability as key.Several sessions at WHA focused on the follow-up to previous political commitments, including the declaration from the UN High-Level Meeting on TB. It was encouraging to hear the United States, several members of the European Union, and a few other member states call for additional R&D to combat TB and underscore the need to develop new drugs and vaccines, scale up diagnostic capabilities, and invest in innovative technologies.WHO also released a multisectoral accountability framework to accelerate progress to end the TB epidemic, which was previously requested in 2018 by the WHA and the UN General Assembly. Several countries, including the United States, endorsed the framework during the official session, and WHO is looking to facilitate its adaptation and use by member states and their partners at country, regional, and global levels throughout 2019. This year’s WHA cemented the need for new approaches, partnerships, and models in order to deliver on many of the promises that were made as part of the 2030 agenda. The next few months will see a continuation of advances on the UHC agenda, movement on WHO reform, and implementation of newly adopted resolution and political commitments.

Universal health coverage (UHC)—the idea that everyone, everywhere, should be able to access quality health services—will take center stage at the World Health Assembly (WHA) later this month. World Health Organization (WHO) Director-General Dr. Tedros Adhanom Ghebreyesus has made UHC a top priority, as his institution estimates that at least half of the world’s population still does not have full coverage of essential health services.While there are many building blocks to achieve UHC—from galvanizing political will and investment to strengthening health systems and training health personnel—one integral pillar that is too often overlooked is innovation—the creation of new and improved drugs, vaccines, and diagnostic tools. Global health research and development (R&D) is indispensable in delivering on the vision of quality health for all. R&D a vital component to achieve UHCHealth systems cannot meet the fundamental needs of their populations without high-quality and accessible drugs, vaccines, and diagnostics with which to treat, prevent, and detect disease. Today, we still lack many of the tools needed to combat diseases and conditions that exact a tremendous health burden in the world’s poorest places. No preventative vaccines exist for many neglected diseases, including Chagas, leishmaniasis, and chikungunya, and treatments available are often inadequate or toxic. Tuberculosis (TB) sufferers today face six to twenty months of treatment, involving thousands of pills and painful injections. We still don’t have the right tests to diagnose many infectious diseases at point of care, leaving patients wondering and waiting for care. The goal of ending AIDS will remain out of reach without a vaccine or cure. Meanwhile, growing antimicrobial resistance (AMR) against malaria, TB, and other infectious diseases threatens to roll back progress and is adding even greater urgency to the need to develop new innovations to prevent emerging resistance. Neglected diseases affect hundreds of millions of people worldwide and jeopardize achieving UHC for the most vulnerable among us.As the global community invests in policies and programs that support UHC, it must also prioritize R&D for new health technologies, especially where markets don’t catalyze these investments on their own. It will be impossible to truly deliver quality care for all without new innovations. Delivering the next generation of lifesaving health technologies will require strong political commitment and increased investment from all nations. To make that happen, it’s critical that the world explicitly acknowledge the importance of global health R&D to attaining UHC.WHO’s role WHO has a crucial role to play in strengthening R&D and access to achieve UHC. Through its global convening power, WHO sets the agenda and is often the institution policymakers rely upon to frame their countries’ health priorities and lead the implementation of important programs vital to improving access to quality treatment and services. For example, WHO’s essential medicines and diagnostic lists are highly vetted, evidence-based recommendations that provide member states with a robust framework to determine key investment, health service, and policy priorities. WHO also provides technical expertise and capacity-building programs to build regulatory frameworks that accelerate access to medicines and create stronger enabling environments for global health R&D. This includes supporting the development of laboratory systems and infrastructure, as well as clinical trial capacity. For everything ranging from establishing safety standards, to producing treatment guidelines for infectious diseases, to designating good clinical research practices, WHO sets the normative technical standards and provides clear targets for low- and middle-income countries for health system strengthening. WHO must continue to use its global convening power to facilitate coordination and alignment of priorities in order to advance the UHC agenda. This is why the 72nd WHA meeting presents the global health community with an opportunity to ensure that WHO continues to play a significant role in supporting R&D by stepping up its efforts to catalyze additional investment, build capacity, and provide resources to stakeholders to facilitate the development and effective deployment of tools to patients globally. While governments can, and should, play a leading role in the global UHC movement, WHO will also play an important part in making the vision of quality health for all a reality. As the world gets ready to descend on Geneva for WHA week, global health advocates should remember that there is no UHC without R&D.