Looking to US Leadership in Support of the Global Pandemic Response

When President-elect Biden takes office on January 20, 2021, quick action is expected from the new administration on global health issues. This action should take into account the following three ways that the global health arena has changed in response to the COVID-19 pandemic:

  1. Supporting the new multilateral frameworks that are being enabled by and often inspired by a multitude of different kinds of stakeholders, especially non-state actors;
  2. Expanding the global approach for an equitable distribution of COVID-19 vaccines and other tools as they become available; and
  3. Engaging in a broadened dialogue on how collaboration and innovation need to be adapted to changed circumstances in the related areas of intellectual property and trade.

This commentary starts with a brief summary of these three points, followed by an in-depth analysis of each point.

Looking to US Leadership in Support of the Global Pandemic Response:  SUMMARY
ONE: SUPPORTING THE NEW MULTILATERAL FRAMEWORKS IN GLOBAL HEALTH

The coronavirus pandemic has mobilized some incredibly unique and truly multi-stakeholder initiatives. The ACT-Accelerator initiative, launched at the WHO in April, has been the most striking of these multi-stakeholder initiatives. And the COVAX Facility, a vaccine effort established at GAVI, the Vaccine Alliance in cooperation with the Coalition for Epidemic Preparedness Innovation, is especially illustrative of how multi-stakeholder collaboration can work. The US should broaden its own leadership to encompass support and participation in these multi-stakeholder efforts.

RECOMMENDATION ONE:

The ACT-Accelerator and the COVAX Facility are examples of the new model for multi-stakeholder engagement that should be embraced and expanded through a revitalized American presence in these and other global collaborations. The opportunities for strengthening the participation of multiple American stakeholders in these kinds of efforts should become an important part of what a revitalized American presence can bring.

TWO: APPRECIATING THE NEED FOR GLOBAL DISTRIBUTION OF COVID-19 VACCINES

The COVAX Facility is not only a multi-stakeholder initiative; it is also the vehicle for a truly global distribution of COVID-19 vaccines. Media attention has focused primarily on its role for vaccine distribution to low and middle income countries, but GAVI has also proposed that the COVAX Facility could serve as a risk-sharing mechanism for all countries. Although enthusiasm for this comprehensive pooling strategy has attracted well over 90 governments of middle and high income countries, critics have been skeptical of the capacity of the COVAX Facility to compete with the resources that governments have been directing to national purchases. “Vaccine nationalism” may be the order of the day for this pandemic, but the pooling effort should continue to supplement national efforts and could operate as a prototype for a broader all-inclusive global mechanism for future pandemics.  This is in line with a recent proposal from the head of the European Council for a global pandemic treaty.

RECOMMENDATION TWO:

The US should be playing a leadership role in ensuring that whatever vaccines do end up working should be made available as rapidly as possible to everyone who needs it – and especially in the low and middle income countries whose only access to COVID-19 vaccines is through GAVI. But the COVAX Facility should also be a first step toward a global pooling of pandemic vaccines for everyone.

THREE: NAVIGATING THE INTELLECTUAL PROPERTY AND TRADE ISSUES

The third area where multi-stakeholder and global coordination on the pandemic has altered the multilateral environment is in the interplay between health, trade and intellectual property.  The Agreement on the Trade-related Aspects of Intellectual Property (the TRIPS Agreement) at the World Trade Organization is playing a central role in the debate about possible waivers to intellectual property protections during this pandemic. The urgency of the debate means that it will be among the first issues facing the Biden administration in January. At the WTO, furthermore, it will be part of a lengthy reform agenda for which the membership will need to agree on a new director-general.

RECOMMENDATION:

The US should work collaboratively with other concerned governments and stakeholders at the WTO to resolve the leadership issue and set out a reform agenda that includes the interplay between health, IP and trade.

GOING FORWARD

This commentary provides in-depth analysis of these three areas in the hope that the US return to leadership on global health will incorporate more opportunities for multi-stakeholder collaboration; an enhanced appreciation for and serious movement toward developing global mechanisms to control global pandemics in the future; and attention to the adaptation of policies in health, intellectual property and trade to accommodate this changed global environment.  The unfolding drama will be exciting to monitor and comment on.  Let us all hope that the new US administration will be able and willing to play a dynamic and engaged role in opening the world to these new ways of joining together, new ways of stimulating equitable access and new ways of sharing the impetus for innovation.

In-Depth Commentary on the Three Recommendations:
ONE: SUPPORTING THE NEW MULTILATERAL FRAMEWORKS IN GLOBAL HEALTH

First, the US needs to re-engage with the World Health Organization, but this also needs to be supplemented with engagement and support for a variety of new and multilaterally diverse international frameworks. The WHO remains the center of global health coordination, but the coronavirus pandemic has mobilized some incredibly unique and truly multi-stakeholder initiatives. The US should broaden its own leadership to encompass support and participation in these multi-stakeholder efforts.

When the World Health Organization launched the ACT-Accelerator in April, it was the beginning of a new outreach. It confirmed that the global pandemic was a major crisis calling for resources and actions above and beyond the regular operations of the WHO or the UN or any other international organization. Thus, the ACT-Accelerator initiative was established to facilitate the rapid acceleration of the development and global access to COVID-19 tools – the whole range of them, including testing and protective equipment, therapeutics, and vaccines, as well as the strengthening of health systems generally to respond to this new crisis. And it is inspirational that both President Emmanuel Macron of France and European Commission President Ursula van der Leyen took the lead in hosting a series of pledging summits for the Act-Accelerator initiative in May and June.

What was especially striking, though, was that the Bill & Melinda Gates Foundation was also a co-host of the pledging summits and has continued to expand its support. Beyond that, furthermore, other philanthropies (e.g. the Wellcome Trust), global business associations (the World Economic Forum and the International Federation of Pharmaceutical Manufacturers) and civil society actors (Global Citizen) have also been associated with the effort – all non-state actors, thereby making it a diverse multi-stakeholder initiative. This collaborative effort elicited close to $16 billion in pledges – all done without any contribution or pledge from government of the United States!

Although the key sponsors have insisted that the fund-raising mission of the ACT-Accelerator initiative would not lead to any new institutions but would only work through existing ones, it was important to support the multi-stakeholder nature of its participants.  Thus, an ACT-Accelerator’s “Facilitation Council” was convened in early September to reaffirm a willingness to collaborate and pool resources on the main tasks of the ACT-Accelerator initiative – vaccines, treatments, testing and health system oversight. This might only be a temporary arrangement and technically speaking might not be a new institution, but it does suggest that a very new kind of truly multi-stakeholder framework is emerging out of this initiative.

With co-chairs from Norway and South Africa, 25 governments are on the Council, many of whom represent regional groupings, while others are designated as either “founding donors” or “market shapers”.  In this respect, this is still an intergovernmental council. But, along with the European Commission and the WHO, the Council has included those early non-state supporters – the Bill & Melinda Gates Foundation, the Wellcome Trust, the World Economic Forum, plus the International Chamber of Commerce from the business side.  And more significantly, it has been noted that “numerous other civil society and industry representatives” have been supporting the effort and were in attendance at the Council’s inaugural meeting in September, too. See the terms of reference for the Facilitation Council here.

The multi-stakeholder nature of pandemic collaboration is further illustrated by what has been happening with the vaccine pillar of this ACT-Accelerator initiative. The two organizations that are coordinating this pillar with the WHO are two well-regarded (and already existing) multi-stakeholder partnerships – GAVI, the Vaccine Alliance and the Coalition for Epidemic Preparedness Innovations (CEPI). GAVI is the older of the two, having been established in 2000 for the purpose of purchasing and distributing vaccines for vaccine-preventable diseases to low and middle income countries. CEPI is a more recent partnership (established in 2016) oriented to mobilizing collaborative efforts to focus on epidemic preparedness, including research and development of vaccines. Both are excellent examples of multi-stakeholder initiatives, where representatives of civil society and industry participate with governments in their governance structure. Both organizations are headed, furthermore, by prominent American scientists, Dr. Seth Berkley and Dr. Richard Hatchett.

Even as these two partnerships were already operating on related health challenges, there needed to be a focused way to channel resources to a COVID-specific acceleration. Thus, in carrying out its coordinating function with CEPI (and the WHO) on the vaccine pillar of the ACT-Accelerator initiative, GAVI announced the establishment in June of a separate COVAX Facility. The Facility was envisioned to include a specific advance marketing commitment (AMC) fund to purchase COVID-19 vaccines for distribution to developing countries. The primary goal here has been to raise $2 billion by the end of 2020 (which was realized by late November) and $5 billion by the end of 2021 to facilitate the acquisition of 2 billion doses of a successful COVID-19 vaccine for distribution to the 92 participating developing countries that have been part of GAVI’s existing services.

The multi-stakeholder nature of GAVI has been extended to this initiative through a COVAX Coordination Meeting that coordinates the different participant groups, including recipient governments and funding governments. But both industry and civil society representatives are also part of this coordinating body, and the way they are identified is illustrative of the multi-stakeholder schematic.  For industry, the representation is channeled through two associations – the IFPMA and the Developing Countries Vaccine Manufacturers Network. For civil society, nine different NGOs have been assigned a variety of participatory and oversight functions. They include the International Red Cross and the International Federation of Red Cross and Red Crescent Societies but also Médecins sans Frontières, World Vision, Save the Children and the Aga Khan Federation, all of whom are widely known in the developing world. Village Reach, Safari Doctors and the International Federation of Aging are the others with stellar records and added value potential.  See more information on governance of the COVAX Facility here.

These examples (the ACT-Accelerator’s Facilitation Council and the COVAX Facility’s Coordination Meeting) are included here to show how effectively one can put together a global multi-stakeholder partnership. The United States would add a significant governmental presence to this effort, both through the COVAX Facility and the ACT-Accelerator generally. It could also make a difference in mobilizing both resources and other American stakeholders to meet the full needs of the initiative as outlined in its strategy and investment case.

Financially, one can appreciate that the €15.9 billion that was pledged in May and June without any support from the US government, is still far from the targeted goal of $35 billion that the WHO has estimated is needed to implement all four of its action areas. American government resources will be important to reach this goal, but there is also the advantage of being able to formalize the involvement of other American stakeholders, besides those that are already there. The cross-border collaboration among vaccine developers (e.g. US-based Pfizer with the German BioNTech) may be working through the IFPMA and the World Economic Forum, but other collaborations are including some of America’s major academic institutions (Vanderbilt University with British-based Astra Zeneca), while numerous American NGOs like the Global Health Council or the various health and health professional associations are all showing the strength of American activism at the global level in this pandemic. These should all benefit from a Biden administration’s actions to reinforce the significance of global and multi-stakeholder collaboration.

RECOMMENDATION ONE:

The ACT-Accelerator and the COVAX Facility are examples of the new model for multi-stakeholder engagement that should be embraced and expanded through a revitalized American presence in these and other global collaborations. The opportunities for strengthening the participation of multiple American stakeholders in these kinds of efforts should become an important part of what a revitalized American presence can bring.

TWO: APPRECIATING THE NEED FOR GLOBAL DISTRIBUTION OF COVID-19 VACCINES

Even more significant for the longer term handling of the pandemic (and future pandemics) was the proposal by GAVI that the new COVAX Facility might also serve as a risk-sharing mechanism for higher income countries to pool their bargaining power for the procurement and equitable distribution of COVID-19 vaccines. This is the second recommendation in this commentary. That is, the US should adapt its return to global leadership by embracing the effort to enable a fully global and equitable sharing and distribution of these COVID-19 vaccines.

The COVAX Facility launched by GAVI is understandably a vehicle for helping poorer countries with cost-effective access to these vaccines, but the COVAX Facility now has two parts. One is for the 92 regular low and middle income countries of GAVI, while the other is intended to serve as a global coordinating mechanism for vaccine distribution in higher income countries. It has the potential to be truly remarkable new territory for a global approach to shared acquisition and distribution.

Through a process of soliciting expressions of interest, pledges and advance payment commitments, GAVI’s proposal to expand its services has attracted an impressive number (94 as of the end of November and 4 more as of mid-December) of higher income countries or what GAVI is describing as “self-financing participants” (SFPs).  They include our neighbors Canada and Mexico, our Asian allies Japan and South Korea, the UK, the European Union and others from all regions – Europe, Africa, Asia, the Middle East and South America!  It has the potential to be truly remarkable new territory for a global approach to shared vaccine acquisition and distribution.

Thus, the COVAX Facility now has two parts, one for the 92 regular low-income countries in GAVI and the other for the 98 self-financing participants. The SFPs in this latter group of developed countries have been able to choose between either fully committing to purchase a fixed number of doses or to reserving an opt-out provision with a slightly higher down payment. The initial offering suggested that that the SFPs might pool their resources to acquire up to 20% of vaccine needs for each country, to be distributed according to an allocation model being developed by the WHO. The point here was that health care workers and people at risk should first be protected in all countries, estimated at 20 % of a country’s population) rather than just all people in some countries. However, this proved to be overly ambitious, and the current aim seems to be to ensure equitable distribution for up to 5 % of each country’s needs.

Critics have been skeptical of this effort, regardless of whether its aim is to reach just 5% or up to 20% of the population in each participating country. They point out that global manufacturing capacity is limited, with a substantial portion of it that is already committed in agreements negotiated by national governments for their own use. A recent report (available here) suggested that full coverage of the global population would require 12 to 15 billion doses for what is expected to be a two-dose vaccine.  Meanwhile, the tracking of advance purchase commitments is being done by the Duke University’s Global Health Innovation Center (available here). It has identified 7.3 billion doses already purchased and another 2.5 billion in negotiations. The top three purchasers are the USA, the EU and India, but the UK, Canada, Japan and Australia are all up there. And only 700 million of this number has been reserved by the COVAX Facility, clearly set aside for the traditional low-income countries of GAVI. This is the kind of “vaccine nationalism” that the COVAX Facility was trying to avoid.

The COVAX Facility, nonetheless, has already negotiated advance purchase commitments or statements of intent with several manufacturers (Astra-Zeneca, the Serum Institute, Novovax, Johnson & Johnson, Sanofi-GSK) and is negotiating with several others, with a target of linking up 10 to 15 manufacturers by the end of the year.  GAVI’s partner organization CEPI is also working on increasing both vaccine development and manufacturing capacity.  So it’s not out of the realm of possibility that the COVAX Facility could be a viable option for acquiring sufficient vaccine manufacturing capacity, especially with the benefit of an American presence that could set aside substantially more capacity for the Facility.

On the other hand, it is unrealistic to expect any government to defer to a global distribution mechanism, even for a 5% pooling approach with other countries, if it hasn’t yet covered its own population satisfactorily.  Obviously, we all know that this is a global pandemic and that incomplete vaccine coverage anywhere has ramifications everywhere. But how can one justify a trade-off, especially when, as President-elect Joe Biden has been promising, the first priority is a free COVID-19 vaccine for every American? And with similar commitments for immediate distributions in the UK, France and other EU countries? The pending or already granted approval for emergency distribution of two vaccines (Pfizer/BioNTech) and Moderna) in these countries would suggest that vaccine nationalism is the priority. Expectations are just too high for national distribution.

The answer for now seems to be that the 5% allocation commitment through the COVAX Facility could still serve as an insurance policy for a minimum amount, especially if all vaccine commitments at the national level are for vaccines that turn out not to work or don’t work well enough. Given the uncertainty of success in the accelerated research and development program, this modest approach of relying on the COVAX Facility as a back-up mechanism could at least set the stage for negotiating a broader all-inclusive global mechanism for future pandemics. That is in line with a recent proposal from the President of the European Council, Charles Michel, to start the process for negotiating a global pandemic treaty. And the COVAX Facility should at least be supported for distribution to the 92 low and middle income countries that have been relying on vaccine distribution through GAVI.

The current US administration has declined to participate in the COVAX Facility because of its direct links with the WHO, but this should be quickly reversed by the Biden administration. The US should also quickly commit to joining the COVAX Facility.  In the longer term it would be a good idea for all pandemic vaccine distribution to be done through a global mechanism like the COVAX Facility, but a modest back-up approach of at least supporting a 5% global distribution should easily be integrated into the Biden strategy. And the US should then agree to explore initiating a global pandemic treaty.

RECOMMENDATION TWO:

The US should be playing a leadership role in ensuring that whatever vaccines do end up working should be made available as rapidly as possible to everyone who needs it – and especially in the low and middle income countries whose only access to COVID-19 vaccines would be through GAVI. The COVAX Facility can at least be a first step for that to happen. But steps should also be taken to move toward negotiating something more inclusive and in advance – such as a global treaty for whatever other pandemics there may be in our future.

THREE: NAVIGATING THE INTELLECTUAL PROPERTY AND PRICING ISSUES

The third area where multi-stakeholder and global coordination of vaccine distribution (and other aspects of the ACT-Accelerator) has altered the global multilateral environment is in the interplay between health, trade and intellectual property. There are multiple perspectives involving the mandates of several international organizations that will need to be recalibrated in the changed environment of a global pandemic.

One of these certainly is the mandate (and structure) of the World Health Organization, and a re-engagement by the US in the WHO will require consideration of how the multi-stakeholder features of the ACT-Accelerator initiative and globally inclusive approach to vaccine distribution can be folded into the deliberations on the possibilities of WHO reform. Several review panels are already active, and one can hope that they will be incorporating these multi-stakeholder and globally inclusive perspectives. But there is another place where institutional reform needs to address the impact of the COVID-19 pandemic, and that is at the World Trade Organization.

The WTO is where the Agreement on the Trade-related Aspects of Intellectual Property (the TRIPS Agreement) has brought the three policy areas of health, IP and trade together.  Efforts to coordinate the health, IP and trade policies among the three Geneva-based international organizations (WHO. WTO and the World Intellectual Property Organization or WIPO) have had their ups and downs, but the COVID-19 pandemic has brought in some new circumstances for the coordination effort.

As an example of this new environment, it was particularly striking to see how relevant the IP issue was becoming in the most recent declaration coming out of the G20 Riyadh Summit just a month ago.   The G20 Declaration for the Riyadh Summit (available here) stands out for having been adopted unanimously by all G20 members including the US (that is, under the current US head of state). It is interesting that the Declaration even included the phrase “we fully support all collaborative efforts, especially the Access to COVID-19 Tools Accelerator (ACT-A) initiative and its COVAX facility”.

What is worthy of note, however, is that this phrase on collaborative efforts continued with an important additional provision – of full support for “the voluntary licensing of intellectual property”. Indeed, the paragraph also includes a related provision that ensuring affordable and equitable access of COVID-19 diagnostics, therapeutics and vaccines has to be “consistent with members’ commitments to incentivize innovation”.  These references to voluntary licensing of intellectual property and incentivizing innovation are warning signals that the IP and innovation debate will be front and center in the global response to the COVID-19 pandemic, especially at the World Trade Organization (WTO).

True, it is a debate that is regularly featured at the World Health Organization, and one can expect it to continue there in the context of the WHO’s official position that health (including a pandemic-free world) is a global public good. The World Health Assembly has even approved the formation of a COVID-19 Technology Access Pool to stimulate voluntary pooling of COVID-19-related knowledge. One can also expect the various WHO panels established to evaluate the global response to the pandemic and to revise the International Health Regulations to be drawn into the fray as well. And several NGOs, including Oxfam, Amnesty International, Global Justice Now and the online advocacy group known as AVAAZ, are actively urging a patent-free distribution of COVID-19 vaccines.

Both GAVI and CEPI, meanwhile, are negotiating directly with manufacturers for increasing capacity and for developing and acquiring vaccines. Both have taken the position that blocking intellectual property rights would inhibit innovation. Even so, there are concerns brewing about profit-gouging by some manufacturers even where others are adopting voluntary initiatives to deliver vaccines at cost or even giving away some of it, at least until the pandemic is declared over.  Some products, however, are not patent protected but still require negotiating a reasonable price on the market, while other products, especially the new biologics, depend on enabling a transfer of knowhow and not patents. No matter what one does about IP and patents, therefore, there are multiple challenges to ensuring enough manufacturing capacity and flow of supply chains that will bring the WTO into the global debate.

Without delving into all these issues, however, one can appreciate that the pharmaceutical and biotech industries are crucial partners in the research and development of a COVID-19 vaccine – and central defenders of the IP system.  The TRIPS Agreement is the part of the WTO policy framework that cannot be ignored. At the TRIPS Council recently, there was a proposal put forward by South Africa and India to waive certain provisions of the TRIPS Agreement (copyright and related rights, industrial designs, patents and the protection of undisclosed information) during the prevention, containment or treatment of COVID-19.

The US and others with significant pharmaceutical industries were opposed to this proposal and expressed the view that intellectual property rights were not operating as a barrier to prevention, containment or treatment of COVID-related products. Instead, they asserted, the immediate barriers were inefficient and underfunded health care and procurement systems, a spiking in demand and a lack of manufacturing capacity. (See the TRIPS Council meeting summary here and an update of informal deliberations among TRIPS Council members here.)  However, Pakistan, Kenya, Mozambique, Eswatini and Bolivia have joined South Africa and India on the waiver proposal; while Australia, Canada, Chile and Mexico are conducting a survey to determine if IP protection is a hindrance to scaling up COVID-19 vaccine production.  The proposal and survey results are due to be brought back to a special session of the TRIPS Council in early 2021.

The WTO is facing a lengthy reform agenda, to say the least. The IP issue is only one among many. But the disarray on issues like dispute settlement rules or which countries are classified as needing special and differential treatment or how to handle digital trade or trade in environmental goods and services has made the WTO especially ripe for a comprehensive reform debate. And this has been aggravated by the trade disruptions affecting the pandemic. There is even a special page on the WTO website listing all of the pandemic-related proposals (available here) that have been put forward by its members. The WTO Secretariat has also prepared a checklist and an “infographic” on the trade-related issues for the development and distribution of COVID-19 vaccines (available here).

All of these disruptions are also operating in a leadership vacuum.  Director-General Roberto Azevedo chose to end his term early and left the WTO in September. The carefully orchestrated selection process for a new Director-General rested on a step-by-step building of a consensus that was recently blocked by the US. That is to say, the WTO’s members had reached a consensus by late October in support of one out of an initial group of eight candidates, the candidate nominated by Nigeria, Ngozi Okonjo-Iweala – an “almost” consensus, that is, with the notable exception of the United States.  The US reasoning was that the other remaining candidate, Yoo Myung-hee, who had been nominated by South Korea, was the more directly qualified trade expert.  But Ms. Okonjo-Iweala has broad expertise in development, finance, health and, most importantly, coalition-building.

The leadership challenge at the WTO, furthermore, calls for a more proactive and independent secretariat. Consistent with the message on multi-stakeholder engagement in this commentary, there also needs to be a more receptive leadership for the participation of civil society and industry at the WTO. Thus, the selection of a dynamic coalition-building director-general is especially important for the WTO at this stage of its institutional crisis, and Ngozi Okonjo-Iweala is clearly the best and most widely supported candidate to play this crucial role.

In conclusion on this third point, the implications for a return to US leadership in global health collaboration extend from the WHO to the WTO and WIPO because of the importance of intellectual property and trade for the handling of the COVID-19 pandemic. This is especially relevant to US leadership at the WTO, where a massive reform agenda and new leadership are on the table. The US should support the consensus candidate for director-general and should evaluate the IP and trade issues that have been affected by the pandemic with an appreciation both for multi-stakeholder engagement and globally equitable distribution of relevant pandemic tools.

RECOMMENDATION:

The US should work collaboratively with other concerned governments and stakeholders at the WTO to resolve the leadership issue and set out a reform agenda that includes the interplay between health, IP and trade.  Regardless of whatever approach is taken by the Biden administration on the IP and trade issues, they should incorporate commitments to embrace the new models of multi-stakeholder engagement and to ensure the equitable distribution globally of the vaccines and other tools that are needed – at a reasonable cost – to bring an end to the COVID-19 pandemic.

GOING FORWARD

This commentary has focused on three important areas of the global health environment that have changed because of the pandemic. These changes may have already been in the works, but the pandemic has been a catalyst to bring them to the forefront. The collaboration around the ACT-Accelerator is encouragingly multi-stakeholder, and new frameworks are falling into place to accommodate this variety of concerned actors. The global ramifications of this pandemic have also stimulated the pooling of resources through the COVAX Facility for a global focus on equitable access and distribution.  Might we see an entirely different global market in the making?

The new US administration should build on these changes to incorporate more opportunities for multi-stakeholder collaboration, an enhanced appreciation and serious movement toward developing global mechanisms to control global pandemics in the future; and attention to the adaptation of policies in health, intellectual property and trade to accommodate this changed global environment.  The unfolding drama will be exciting to monitor and comment on.  Let us all hope that the new US administration will be able and willing to play a dynamic and engaged role in opening the world to these new ways of joining together, new ways of stimulating equitable access and new ways of sharing the impetus for innovation.

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