Looking to an American Future for a Global Response to COVID-19

As a long-term advocate of multilateralism, I am inspired by the amazing outreach from multiple American institutions and individuals to engage in global collaboration on fighting the COVID-19 pandemic. It has been an embarrassment to be an American in the past four years of a flawed Presidency, but the readiness of Americans to circumvent its barriers in order to participate with others in such initiatives as the Access to COVID—19 Tools Accelerator (ACT-Accelerator) and especially the new COVAX Facility for global vaccine distribution is truly phenomenal.

In order to build on that spontaneous outpouring of American expertise and compassion, the new administration in Washington should join in this effort. The US needs to return to its leadership role in global health matters, but this requires an appreciation for how the pandemic has transformed the issues and the actors. Thus, special attention should be directed to (1) supporting the new multilateral frameworks that are enabled by and often inspired by a multitude of different kinds of stakeholders, (2) expanding the global approach to the equitable distribution of COVID-19 vaccines and other tools as they become available, and (3) engaging in a constructive dialogue on the pricing and availability issues in this and future pandemics.

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 very 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. 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. It was exciting to witness how the summits featured some 30 heads of state who pledged their support and rallied around the four action areas of the initiative in diagnostics, therapeutics, vaccines and health systems. The initial goal was to raise €15 billion above and beyond any existing programs at the WHO, and the organizers and participants are to be commended for going beyond that target with pledges totaling €15.9 billion.

What was especially striking, though, was that the Bill & Melinda Gates Foundation was also a co-host of the pledging summits and that the Wellcome Trust, the World Economic Forum and the International Federation of Pharmaceutical Manufacturers and Associations were also associated with the effort. This was a truly multi-stakeholder initiative. It is too bad that the US was so noticeably absent from this effort, but then neither Russia nor India were there either. And China was only there in a token effort even though later on President Xi Jinping would pledge $2 billion for COVID-19 relief directly to the WHO.  I was inspired to write about the remarkable political leadership both from Europe and from key non-state actors  in spite of the absence of the US and these others. (See my commentaries on Prospects for a Transformative Global Coronavirus Response with Multiple Stakeholders” here and on “EU Leading a Global Response” here.)

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 put together and had its “inaugural” meeting in early September to reaffirm a willingness to collaborate and pool resources. This might only be a temporary arrangement and technically speaking perhaps not be a new institution, but it does suggest that a very new kind of truly multistakeholder framework is emerging out of this initiative.

Membership in this Facilitation Council was duly publicized in a WHO press release (available here) on the meeting. With co-chairs from Norway and South Africa, 25 governments are listed, 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, other stakeholders include the Wellcome Trust, the World Economic Forum and the Bill & Melinda Gates Foundation. And more significantly, the press release referred to the presence of “numerous other civil society and industry representatives” without specifically naming them.

The United States would add a significant governmental presence to this list and 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. But there is also the advantage of having the option to formalize the involvement of other American stakeholders, besides those that are already there. America’s major academic institutions are in the forefront of COVID-19 research, and numerous American NGOs like the Global Health Council or the various health and health professional associations are all showing the strength of American activism in this pandemic.

As the most immediate concern, the global focus now is on how the vaccine pillar of this new ACT-Accelerator initiative is being advanced. The two existing organizations that are coordinating this pillar with the WHO are two existing and well-regarded multi-stakeholder NGOs, the GAVI Vaccine Alliance and the Coalition for Epidemic Preparedness Innovations (CEPI). As I have noted previously (See my commentary on “Time for Vaccine Multilateralism” here), both organizations are headed by prominent American scientists, Dr. Seth Berkley and Dr. Richard Hatchett. While CEPI is channeling resources to develop the vaccines, the main vehicle for the acquisition and distribution of vaccines is GAVI.

GAVI has an excellent track record for purchasing and distributing vaccines for vaccine-preventable diseases like polio or yellow fever or hepatitis B to 92 participating developing countries. It is also an outstanding example of a global multi-stakeholder initiative, where representatives of civil society and industry participate with governments in its governance structure. This is in direct contrast to the WHO whose governance is exclusively made up of government members.

In carrying out its coordinating function with CEPI (and the WHO) on the vaccine pillar of the ACT-Accelerator initiative, GAVI first addressed the challenge of how to add access to a potential vaccine for COVID-19 to its existing program with developing countries. In June, it announced the establishment of a separate COVAX Facility with a specific advance marketing commitment (AMC) fund to purchase COVID-19 vaccines for distribution to developing countries. The goal here has been to raise $2 billion by the end of 2020 and $5 billion by the end of 2021 to acquire 2 billion doses of a successful vaccine for distribution to these 92 participating developing countries. The latest report is encouraging, with $700 million pledged so far and agreements announced with vaccine manufacturers to supply doses 850 million doses out of the 2 billion targeted for the AMC.

The multi-stakeholder nature of GAVI has been reinforced by the expansion of civil society participants in the implementation of the COVAX Facility. (See the GAVI announcement on these appointments here.) It is impressive that the GAVI Board received applications from a substantial number of global and regional NGOs to collaborate with the Facility and conducted a vetting process that resulted in nine different NGOs taking on 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.

RECOMMENDATION: It is this kind of model for multi-stakeholder engagement that should be embraced and expanded through a revitalized American presence in this 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.

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 developed economies to pool their bargaining power for the procurement and equitable distribution of COVID-19 vaccines. This brings me to my second point about how the US should adapt its return to global leadership through an enhanced appreciation for the ways that the pandemic has transformed the prospects for global coordination of resources. Through a process of soliciting expressions of interest, pledges and advance payment commitments, this proposal has attracted an impressive number (82 as of 31 October and counting) of high and middle 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 is truly remarkable new territory for vaccine acquisitions.

Thus, the COVAX Facility now has two parts, one for the regular low-income countries in GAVI and the other for the 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 already committed in agreements negotiated by national governments for their own use. A recent report (available here) suggested that maximum capacity globally is currently at 6.5 billion doses, whereas full coverage of the global population would require 12 to 15 billion doses for what is expected to be a two-dose vaccine.

That same recent report notes that domestic agreements have already been signed for 3.3 billion doses, including 1 billion for EU distribution to its member countries. A more recent report from Duke University’s Global Health Innovation Center identified the number at 3.8 billion, with options for 5 billion more. This is the kind of “vaccine nationalism” that the COVAX Facility was trying to avoid. But it would suggest that not all of the existing manufacturing capacity had been booked, at least as long as the countries with these additional options actually refrained from exercising them.  And GAVI had announced that it had already negotiated millions for developing countries through its AMC fund,

The COVAX Facility, furthermore, is negotiating with several different manufacturers, 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 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 for a 5% pooling approach with other countries if it hasn’t yet covered its own population satisfactorily.  This is the understandable impetus of that “vaccine nationalism” that I mentioned a couple of paragraphs ago (and wrote a critical commentary on a couple of months ago, available here). 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 former Vice President Biden has been promising, the first priority is a free COVID-19 vaccine for every American?

The answer for now seems to be that a 5% allocation commitment through the COVAX Facility is at least an insurance policy for a minimum amount if all vaccine commitments at the national level are for vaccines that turn out not to work or don’t work well enough. The modest approach, then, is to rely on the COVAX Facility as a back-up mechanism. Given the uncertainty of success in the accelerated research and development program that this pandemic has required, the COVAX Facility should be supported in addition to anything that is done at the national level.

RECOMMENDATION: 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 of course, the US should also 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. The COVAX Facility can be a first step for that to happen. And for whatever future pandemics there may be in our future, this first step should guide us to a path for global vaccine coordination across the board.

Navigating the intellectual property and pricing issues

My third point is that multi-stakeholder collaboration and global coordination of vaccine distribution are also taking us in the direction of new challenges for intellectual property rights and for global markets. I don’t have a solution to propose here, other than to encourage an openness to a dialogue on how the pandemic and the need for equitable and global access to a vaccine have become integral to the global debate on incentives and pricing. That is to say, there are multiple perspectives involving the mandates of several international organizations that need to be recalibrated in the changed environment of a global pandemic.

Over the years, I have worked with clients concerned about the access and pricing challenges of emerging health technologies in the three different approaches to intellectual property rights at the World Intellectual Property Organization, the World Trade Organization and the World Health Organization. The United States has generally been in the forefront of protecting the international property rights of the pharmaceutical industry (and IPR generally as defined by treaties administered by WIPO), but American NGOs have also been in the forefront of advocating for a different approach to innovation and access. And a former US President Bill Clinton was in the forefront of expanding the generic manufacturing worldwide of HIV/AIDS medicines and therapeutics at a time when the pharmaceutical industry had not yet appreciated the power of stakeholder activism.

The debate among the three Geneva-based international organizations is still waging, and the coronavirus pandemic has simply raised the stakes. This is especially the case at the WTO, where the new Director-General will be expected to navigate the shark-infested waters of the TRIPS Agreement (Agreement on the Trade-Related Aspects of Intellectual Property Rights) and other trade-related issues affected by the pandemic – such as export controls, transparency of trade information, and stockpiling for emergencies.

Without delving into all these issues, one can appreciate that the pharmaceutical and biotech industries are crucial partners in the research and development of a COVID-19 vaccine. 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.)  The proposal, however, is due to be brought back up when the TRIPS Council meets again in January.

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.

The WHO (and its member states), of course, takes the position that health is a global public good. That means equitable access for everyone around the world to all the tools whose developments have been accelerated for prevention, diagnosis and treatment for COVID-19. The WHO has even launched a separate COVID-19 Technology Access Pool (website page available here) that invites volunteers to pool their knowledge, intellectual property and data for collective efforts through a “Solidarity Call to Action”.  Costa Rica was the lead country for this initiative, and 40 mostly developing countries have joined the call. Europeans who have joined the call include Belgium, Luxembourg, the Netherlands, Norway and Portugal. Among the NGOs that have joined are American-based Knowledge Ecology International and Creative Commons through its Open COVID Pledge.

We are all interested in mobilizing whatever combination of public and private funds and initiatives it will take to bring this pandemic under control. The US government has launched “Operation Warp Speed” with huge sums of money to speed up the process, but even there almost all of the vaccines and other COVID-related products will be developed and manufactured by private sector entities. On top of these sums, the President-elect and his team intend to make a vaccine available for free to all Americans, the cost of which will necessarily have to come out of additional public funds. One can presume, of course, that the American government is in a good bargaining position to negotiate a reasonable cost plus a reasonable profit kind of price. And if all the COVID-19 vaccines in the US are distributed for free through the public sector, then one is likely to have the makings of a pooling by the buyer of the product rather than a pooling by the sellers or makers of the product.

RECOMMENDATION: The implications for a return to US leadership in global health collaboration extend from the WHO to the WTO and WIPO on these intellectual property and trade issues. Regardless of whatever approach is taken by the Biden administration on these issues, they should incorporate a commitment to ensuring 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 illustrated how the participants and programs in global health have changed as a result of the pandemic to encourage collaboration across national boundaries, even without the support of the political leadership of certain governments. 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.  Might we see an entirely different global market in the making? The unfolding drama will be exciting to monitor and comment on. I sincerely hope that the new US administration will play a dynamic and engaged role in opening up the world to these new ways of joining together and new ways of stimulating equitable access.

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