Exclusive: WHO’s pandemic ‘countermeasures’ plan takes shape

The World Health Organization only declared the end of the global COVID-19 emergency a few weeks ago, but discussions of how to ensure equitable access to medical products during future pandemics have been happening for months. In February, WHO launched a design and consultation process for a platform to combat pandemics. The aim is to ensure that when a new health threat emerges, there will be a platform ready to coordinate access to lifesaving medical products, or what the global health community has dubbed “medical countermeasures.” The goal is for it to operate on day zero of a pandemic — but that can be adjusted to the outcomes of a pandemic agreement, which is still under negotiations and will be considered at the 2024 World Health Assembly. Outbreaks are occurring left and right, including the H5N1 avian flu, which has killed thousands of birds and mammals, and infected three humans so far this year in the Western Pacific region. The death of an 11-year-old girl in Cambodia in February raised concerns of what might happen if widespread human-to-human transmission were to occur, given that there are currently no systems in place to coordinate a global response. The goal of the WHO-led process on medical countermeasures is to have a prototype by April and an “interim working platform” by September, although those timelines can change. “My concern is that if something happens next month, you know, I'm not waiting till September. We know who would do what,” Dr. Bruce Aylward, WHO assistant director-general for the universal health coverage, life course division, told Devex. “Pandemics have sort of fallen aside from the emergency of the day, so to speak. So that's one big challenge — having enough political priority on this issue.” --— Victoria Fan, senior fellow in global health at the Center for Global Development But there remain questions on the governance, functions and focus of the platform. It also faces a legitimacy question — who gives it the mandate to function. Some are also concerned it may end up similar to the Access to COVID-19 Tools Accelerator, or ACT-A, the multilateral initiative launched during the COVID-19 pandemic that had big ambitions to ensure equitable access but struggled to meet them. The idea so far … In a draft working paper seen by Devex, dated May 18, the platform will consist of a steering group made up of 25 members, representing countries, international and regional organizations, civil society, and the private sector. The steering group will be constituency-based, although no details yet on who will be part of it and how that will be organized. WHO is proposed as the host of the secretariat, with staff seconded or loaned from other multilateral organizations. The platform consists of three main pillars, dubbed “vertical product axes” in the paper, focused on vaccines, diagnostics and therapeutics — although there’s currently a push from some of those involved in the discussions to include a fourth arm to cover any emerging need beyond that. There are areas of work that cut across all pillars and will require collaboration, such as research and development, manufacturing, and delivery support for “last mile” and priority populations. The platform aims to work during a pandemic and interpandemic period, with more limited engagement during the latter. The document doesn’t specify which particular pathogens it will focus on, only saying those with “pandemic potential.” It plans to focus on “new and/or scarce” vaccines, therapeutics and diagnostics, but is flexible to add on more products “if needed.” It will prioritize support to low-income and lower-middle-income countries and “others that face access barriers.” It identifies an initial set of global and regional entities as “anchor” partners — technical agencies that agree to convene and coordinate constituencies working in their areas of work. These include most organizations that make up ACT-A, including UNICEF and the World Bank, and three regional entities: Africa Centres for Disease Control and Prevention, the European Commission’s Health Emergency Preparedness and Response Authority, or HERA, and the Revolving Fund of the Pan American Health Organization. The set of anchor partners is expected to expand and include other regional bodies, as well as civil society and industry representatives. The discussions are informed by lessons from ACT-A, which received criticisms for its failure to integrate expertise from low- and middle-income countries, including regional entities such as Africa CDC. According to the draft proposal, regional entities like the Africa CDC and HERA play a “critical role” in pandemic preparedness and response. Several reviews, including an external evaluation of ACT-A, underscored the need to engage regional bodies more meaningfully in global coordination mechanisms. In the coming months leading up to September, the concept of the platform will be refined — and potential members of the steering group identified — through collaboration with organizations such as the World Health Assembly, the Group of Seven leaders, and Group of 20 major economies. Early concerns While nothing is final, some have already expressed concerns on how the initiative is shaping up. In the draft working paper, it says the platform “will take an end-to-end approach, covering the full medical countermeasures value chain, and will integrate with the wider emergency response ecosystem.” But some are worried the current draft doesn’t go far enough to address the injustices experienced by many communities during the COVID-19 emergency. Others said discussions on countermeasures shouldn’t lose sight of the importance of basic items such as masks — not mentioned in the current document — which were the first products to experience shortages during the COVID-19 emergency. “We think that a proposal that is based on diagnostics, therapeutics, vaccines without cross-cutting emphasis on key injustices that occurred in the COVID-19 pandemic is the same as the ACT-Accelerator. It's not going to work,” a source, who requested anonymity given the discussions are still ongoing, told Devex. A civil society proposal, seen by Devex, wants a rotating advisory board involving civil society and experts from low- and middle-income countries. In a pandemic situation, the group would work on six cross-cutting areas of work, including open science that includes voluntary licensing and technology transfer, which isn’t included in the draft working paper. “The platform must grapple with issues of licensing and technology transfer to be successful. While the [medical countermeasures] platform wouldn’t have the authority to make decisions in these areas, it can leverage its expertise to provide guidance and inform evidence-based actions,” Samantha Rick, an advocacy specialist who works for HIV prevention organization AVAC and is involved in the countermeasures discussions, told Devex. This can include a mapping of regional manufacturers that can replicate tools; coordinating and facilitating voluntary licensing and technology transfer; and making recommendations about which technologies would require compulsory licensing and use the Trade-Related Aspects of Intellectual Property Rights, better known as TRIPS, flexibilities to scale and expand access, she said. Tension points Prior to our review of the draft, Aylward acknowledged in an interview with Devex that there are varying proposals on the table. But he’s worried those handling the negotiations are losing sight of the goal — a “minimum viable product.” “Everybody has a perspective. I'd love to say they all go in the same direction. But many people will always come up with new ideas about, ‘this should be there, that should be there,’” he said. In identifying which pathogen to focus on, for example, they’re looking at viral families that have been causing spillover events in recent years, such as coronaviruses. But some have argued the attention shouldn’t just focus on global threats, but also regional ones, he said. The same goes for discussing what the platform should coordinate. In any pandemic, there are likely to be scarce resources from day one. The question is if the interim coordinating platform for countermeasures should both coordinate supply and manage demand for all health products, or focus on the development of new countermeasures likely to be needed for the response. The same questions could be asked about delivery: Should the platform create its own mechanisms to deliver the countermeasures to people, or leave that to the wider emergency response handled at regional, national, and global levels? In Aylward’s opinion, it should be the latter. “I think it would be a mistake, if you have a whole bunch of agencies working with countries to help them scale up their response. And then separately, you have an initiative that's trying to do end-to-end delivery of countermeasures,” he said. But WHO’s job is not to provide the answer, he said, but to get everyone in the same room to work out an answer: “Does the ACT-Accelerator of the future, whatever you call it, include all of that, or is it refocused on the new things? It's a design decision.” According to the draft, the platform “will need to seamlessly interface with wider emergency response systems … [and] connect and integrate with national delivery systems that will roll out and administer the vaccines, tests and treatments.” Wider issues While different groups hash out the details of an “interim” platform, bigger questions exist, such as what gives the platform legitimacy and where the money for pandemic response will come from. “We're looking at this as a matter of consideration, where [we would] actually ensure that this platform gets legitimacy to do the coordination work that we're proposing that it should do,” said a source privy to the discussions, who requested anonymity because they are not authorized to speak on the matter. What they’re working on, according to Aylward, is to find consensus to ensure that the final product can work for the various countries and organizations that are going to be part of it. “The reality is we're in a world where no single person makes that decision, and no single group makes that decision. You need to get a collective consensus that this is a good workable solution, and then be able to adjust that to whatever comes out of the [Intergovernmental Negotiating Body] process next year,” he said. There’s also the funding question. A huge barrier to ACT-A playing an effective role in COVID-19 response was money. While high-income countries were hoarding the limited vaccine doses available, ACT-A could not secure supplies because it didn’t have enough funding to do so. By the end of its transition period in March, ACT-A had raised a total of $24 billion — but it took almost two years to do so. In “peace time,” running a coordination platform for medical countermeasures isn’t likely to cost much — Aylward estimated $20 million to $25 million per year. But during a pandemic, resource requirements exponentially rise, and much of that will be needed immediately, both to coordinate a response and to help countries roll out necessary interventions and secure supplies. Aylward said a lot of the work they’re doing now is figuring out who would need the money, how much, how fast they might need it, where it will come from — and how all those details can be agreed in advance. But funding is currently a constraint globally, and countries are facing a host of challenges, such as debt crisis, inflation, food insecurity, and climate change. “Pandemics have sort of fallen aside from the emergency of the day, so to speak. So that's one big challenge — having enough political priority on this issue,” Victoria Fan, a senior fellow in global health at the Center for Global Development, told Devex. The G-20 and G-7 are currently looking at surge financing for pandemics, but getting much-needed resources, including for national responses, may mean looking at different financing options, such as debt relief and debt suspension, and callable capital, aka money that has been promised to multilateral banks but not yet delivered. According to the Independent Panel for Pandemic Preparedness and Response, $50 billion to $100 billion will be needed to support low- and middle-income countries when a health threat emerges to ensure the purchase of pandemic supplies, and avert “catastrophic economic, fiscal, and social crises.” Some are worried about the current focus on surge financing. “If the surge is too heavy and the piping is too narrow, it's likely to burst. You're not likely going to have free flow [of goods],” said the second anonymous source, who said funding should also be made available to prepare the systems for when a pandemic hits. Last year, the G-20 supported the launch of the Pandemic Fund, housed at the World Bank, to support pandemic prevention, preparedness and response. It’s raised over $1.6 billion in financial commitments, which is far less than the demand so far for pandemic preparedness financing. “It's a conversation that we cannot wash away. Otherwise, you're getting back into a situation where a pandemic is here with us, the systems are not ready to actually absorb the vaccines, or therapeutics or diagnostics … or even resources itself,” the source went on. “We saw countries actually pumped with money that were unable to spend simply because the systems were not ready for it.”