World Health Organization

WTO’s April 14th virtual meeting to review COVID-19 vaccine availability

WTO’s Director-General Ngozi Okonjo-Iweala had indicated when she took office that she would be gathering industry, multilateral groups, and some governments to look at how vaccine production could be expanded and the role the WTO could play in that effort. At the same time, with the proposal from India and South Africa for waiver from most TRIPS obligations on medical products relevant to addressing the COVID-19 pandemic still under consideration in the TRIPS Council, with opposition from a number of important Members, DG Okonjo-Iweala has been seeking an approach that in fact expands production in developing and least developed countries and greater distribution to low- and middle-income countries. without needing an all or nothing resolution to the proposed waiver.

I have previously reviewed the issue of vaccine availability and prior DG Okonjo-Iweala statements in a number of posts. See, e.g., April 13, 2021, April 15, 2021 — U.S and Gavi co-host event for additional funding for COVAX amid concerns about two workhorse vaccines for COVAX, ttps://currentthoughtsontrade.com/2021/04/13/april-15-2021-u-s-and-gavi-co-host-event-for-additional-funding-for-covax-amid-concerns-about-two-workhorse-vaccines-for-covax/; April 8, 2021, COVAX delivers COVID-19 vaccines to 100th country; India surge in infections likely to reduce product availability for COVAX through May and likely longer, https://currentthoughtsontrade.com/2021/04/08/covax-delivers-covid-19-vaccines-to-100th-country-india-surge-in-infections-likely-to-reduce-product-availability-for-covax-through-may-and-likely-longer/; April 2, 2021, Global vaccinations against COVID-19; developments and challenges in the roll-out for many countries, https://currentthoughtsontrade.com/2021/04/02/global-vaccinations-against-covid-19-developments-and-challenges-in-the-roll-out-for-many-countries/; March 25, 2021, Global vaccinations for COVID-19 — continued supply chain and production issues and a new wave of infections in many countries delay greater ramp up for some until late in the second quarter of 2021, https://currentthoughtsontrade.com/2021/03/25/global-vaccinations-for-covid-19-continued-supply-chain-and-production-issues-and-a-new-wave-of-infections-in-many-countries-delay-greater-ramp-up-for-some-until-late-in-the-second-quarter-of-2021/; March 12, 2021, COVID-19 vaccines – U.S., Japan, India and Australia agree to one billion doses for Indo-Pacific countries, https://currentthoughtsontrade.com/2021/03/12/covid-19-vaccines-u-s-japan-india-and-australia-agree-to-one-billion-doses-for-indo-pacific-countries/; March 12, 2021, The 8-9 March  “Global C19 Vaccine Supply Chain and Manufacturing Summit” – efforts to ramp-up production, https://currentthoughtsontrade.com/2021/03/12/the-8-9-march-global-c19-vaccine-supply-chain-and-manufacturing-summit-efforts-to-ramp-up-production/; March 5, 2021, COVID-19 vaccines — France supports Italy’s blockage of a shipment to Australia; while Australia has asked the EU to permit the shipment, Australia will have its own production of AstraZeneca product by the end of March, https://currentthoughtsontrade.com/2021/03/05/covid-19-vaccines-france-supports-italys-blockage-of-a-shipment-to-australia-while-australia-has-asked-the-eu-to-permit-the-shipment-australia-will-have-its-own-production-of-astrazeneca-produc/; March 4, 2021, Italy blocks exports of COVID-19 vaccines to Australia, first blockage of export authorization by the EU or its member states, https://currentthoughtsontrade.com/2021/03/04/italy-blocks-exports-of-covid-19-vaccines-to-australia-first-blockage-of-export-authorization-by-the-eu-or-its-member-states/; March 4, 2021, The EU’s response to challenges to its actions on COVID-19 vaccine exports, https://currentthoughtsontrade.com/2021/03/04/the-eus-response-to-challenges-to-its-actions-on-covid-19-vaccine-exports/; March 3, 2021, WTO Director-General opinion piece in the Financial Times and recent actions by the U.S., https://currentthoughtsontrade.com/2021/03/03/wto-director-general-opinion-piece-in-the-financial-times-and-recent-actions-by-the-u-s/; March 1, 2021, WTO Director-General Ngozi Okonjo-Iweala’s opening statement at the March 1 General Council meeting, https://currentthoughtsontrade.com/2021/03/01/wto-director-general-ngozi-okonjo-iwealas-opening-statement-at-the-march-1-general-council-meeting/.

“COVID-19 and Vaccine Equity: What Can the WTO Contribute?”

While the virtual meeting convened by DG Okonjo-Iweala was conducted under Chatham House rules, a number of participants made their prepared comments public and there was some press coverage.

DG Okonjo-Iweala provided a wrap-up at the end of the session which was posted on the WTO website. See WTO news, DG Okonjo-Iweala calls for follow-up action after WTO vaccine equity event, April 14, 2021, https://www.wto.org/english/news_e/news21_e/dgno_14apr21_e.htm (“Director-General Ngozi Okonjo-Iweala today (14 April) called on WTO members, vaccine manufacturers and international organizations to act to address trade-related obstacles to the scale-up of COVID-19 vaccine production to save lives, hasten the end of the pandemic and accelerate the global economic recovery.”). DG Okonjo-Iweala’s summary comments are copied below. See WTO speeches, Chair Summary following “COVID-19 and Vaccine Equity: What Can the WTO Contribute?”, April 14, 2021, https://www.wto.org/english/news_e/spno_e/spno7_e.htm.

“One thing that came out of today’s discussions is that it was only through working together across borders that scientists developed safe and effective vaccines in record time. And it is only by working together, across borders, that we’ll be able to solve the problems [of vaccine scarcity and equitable access] discussed today. This is a problem of the global commons, and we have to solve it together.

“Our purpose today was to contribute to efforts to increase vaccine production and broaden access, starting with the immediate term.

“Specifically we had three goals:

“The first was to pinpoint the obstacles, particularly the trade-related obstacles, to ramping up production, and to equitably distributing and administering vaccines — and we looked at how the WTO could contribute to these solutions.

“The second was to bring together people who are able to increase and to scale up manufacturing, people in a position to share technology and knowhow, and people willing to finance additional manufacturing capacity.

“And third, to think about the road ahead, including on the TRIPS waiver and incentives for research and development, so that we get the medical technologies we need, and no country is left at the back of the line waiting. If there is one refrain we heard continuously from everyone today it is that no one is safe until everyone is safe.

“We heard first-hand from governments and vaccine manufacturers from developed, developing, and least developed countries, as well as a wide range of other stakeholders from international organizations, civil society and development finance institutions.

“And we heard good news: that supplies are ramping up and companies are learning by doing, that there have been major gains in productivity, and that there is still capacity. We also heard that there is a willingness to finance investment in vaccine manufacturing both in the short- and long-term, and there are ideas and energy to do things differently.

“However, we heard from many that we need to do more. It hasn’t really been business as usual, so we may need to move on to ‘business unusual’ to solve the problems before us.

“In the discussions today we heard a great deal of agreement. We agree that it’s not acceptable for people and countries to have to wait indefinitely for vaccines. We do not want to repeat experiences of the past.

“We heard a consensus on the urgent need to scale up production and vaccinate everyone, because every day the shortage continues, scope for dangerous new variants will increase, and the number of prevent preventable deaths will grow. The economic impact of these delays can and has been quantified by many institutions, including the IMF, the World Bank, and the WTO.

“It was agreed that production capacity needs to be expanded, particularly in developing and least developed countries and emerging markets. And that vaccine distribution needs to be more effective and more equitable.

“We heard that open cross-border trade in raw materials, and other inputs, was essential for maintaining and scaling up production, and that supply chains in these inputs must be maintained.

“Also widely shared was the view that innovation, research and development will be vital for dealing with COVID-19 variants and in other health crises.

“We had useful exchanges on issues where some perspectives were different, such as on the future shape of vaccine supply chains, on the appropriate role for intellectual property protections, on issues of vaccine contract transparency — which was pointed to by many as an important factor in appropriate pricing and distribution and a critical part of access and equity.

“Concerns expressed by some about cross-border supply chain operations, including export restrictions and shortages of skilled personnel reinforced my view, and hopefully that of members, that the WTO must and can play a central part in the response to this crisis.

“Various perspectives about the TRIPS Agreement, and whether the existing flexibilities are enough to address developing country needs were put on the table. These echoed the discussions on the waiver proposal going on in the TRIPS Council, and I want to reiterate that today is a way of contributing to that discussion.

“I agree with the view that the WTO is a logical forum for finding a way forward on these issues, and I hope that the ideas raised here will contribute to convergence in the TRIPS Council on meaningful results that can contribute to the goals that we have.

“I hope that the discussion today, listening to each other, seeing that we all share a common goal, and that we may not be so far apart, will lead to the willingness to come to the middle,  and work out something that will be acceptable to all.

“Participants were generally of the view that ramping up vaccine manufacturing capacity is a complex process. It requires large, long-term investment and sustainable business models. It relies on open international supply lines for ingredients and equipment. We heard how shortages of even a single piece of equipment, filters, can halt operations at a production facility. Vaccine manufacturing necessitates collaboration, and the movement of skilled labour, to facilitate transfer of technology and knowhow.

“Safety is a paramount consideration, and quality is the other part of safety. This demands effective regulatory capacity and stringent compliance, down to the factory floor. Indeed we heard this is a big risk companies factor in when making decisions as to where to produce, and how to produce. I hope that they’ve heard sufficient encouragement today, to enable us to move towards leveraging the existing capacities in emerging markets and developing countries mentioned repeatedly today, which could actually help to take care of the shortages talked about.

“Turning capacity around to produce COVID-19 vaccines is not only about the physical space alone. We heard repeatedly that it requires transfer of technology and knowhow, together with investment and support for quality assurance.

“We also learned about how existing licensing arrangements have operated — including an example of how skills transfer was carried out in a few as six months. We also heard calls for support to build human capital, and to help build regulatory cooperation.

“Some participants suggested more active matchmaking to connect companies that have the investment capacity with those that have potential for expanding production capacity, even in the short term.

“We also heard about ongoing efforts to build new manufacturing capacity, and the lessons that can be learned from that.

“We also began to see the aspects of the collaboration we need to make things happen. We had many international organizations show they are willing to work together to bring to fruition things like putting in place technical expertise, helping with capacity building and quality control, and investing directly in production.

“I believe that today’s exchanges have advanced our understanding of the challenges we face for scaling up vaccine production, and that working together is the only way ahead.

“In the coming weeks and months, we expect concrete follow-up action. These issues are not easy, but the political will and engagement from the private sector displayed today, suggests it is possible.

“As we move forward, I expect:

“- From WTO members:

“- Action to further reduce export restrictions and supply chain barriers, and to work with other organizations to facilitate logistics and customs procedures.  We are monitoring this as part of our regular work, and we’ll continue doing so to increase supplies and maintain robust supply chains. Trade has been underlined as a critical factor in production; it is incumbent upon WTO members to act.

‘- Advance negotiations in the TRIPS Council on the waiver proposal and incentives for research and innovation. I hope that the ideas and the open dialogue heard will move us closer to agreement. 

‘- For vaccine manufacturers:

‘- Concrete moves to scale up vaccine manufacturing, both short-term turnaround of existing capacities, milking whatever productivity gains we can from current facilities, and taking steps to invest.

“- Increased technology and knowhow transfer, which many participants stressed would be necessary to make additional production work.

“- We need transparency in contract agreements and product pricing. We hope to continue this dialogue and to help monitoring steps in that direction.

“- For international organisations and financial institutions:

“- We noted your willingness to finance, both existing and new capacity, your willingness to work on capacity building for regulatory issues, not just for vaccines, but also for therapeutics and diagnostics, which are equally important.

“I trust that we have found a good basis to deliver concrete action, and to continue this discussion that we’ve had today.

“This should not be a one-off, we should continue to talk to each other, and make sure that we can deliver.

“I hope that besides concrete action to increase capacity, this discussion has given us elements of a framework on trade and health that we can put together at the WTO, and that can be put before ministers at the 12th Ministerial Conference in mid-December. Such a framework should provide for trade-related preparedness to handle this pandemic, and the next one.”

Press accounts indicate that the United States, European Union, India and South Africa participated. Statements from USTR Katherine Tai and Executive Vice President Dombrovskis are available from government websites. See USTR press release, Ambassador Katherine Tai’s remarks at a WTO virtual conference on Covid-19 vaccine equity, April 14, 2021, https://ustr.gov/about-us/policy-offices/press-office/press-releases/2021/april/ambassador-katherine-tais-remarks-wto-virtual-conference-covid-19-vaccine-equity; European Commission press release, Speech by Executive Vice-President Valdis Dombrovskis at the WTO Webinar “Covid and Vaccine Equity,” 14 April 2021, https://ec.europa.eu/commission/commissioners/2019-2024/dombrovskis/announcements/speech-executive-vice-president-valdis-dombrovskis-wto-webinar-covid-and-vaccine-equity_en.

The Biden Administration has been meeting with various interest groups on the TRIPS wavier proposal (both pro and con) and is receiving pressure from some Members of Congress and prior government officials to agree to a waiver. Ambassador Tai’s statement stresses the need for equity in vaccine availability. “These losses have been disproportionately borne by vulnerable and economically disadvantaged communities within our countries. And the significant inequities we are seeing in access to vaccines between developed and developing countries are completely unacceptable. Extraordinary times require extraordinary leadership, communication, and creativity. Extraordinary crises challenge all of us to break out of our comfortable molds, our in-the-box thinking, our instinctive habits. This is not just a challenge for governments. This challenge applies equally to the industry responsible for developing and manufacturing the vaccines. The desperate needs that our people face in the current pandemic provide these companies with an opportunity to be the heroes they claim to be – and can be. As governments and leaders of international institutions, the highest standards of courage and sacrifice are demanded of us in times of crisis. The same needs to be demanded of industry.”

The EU statement is consistent with their views that equity is necessary and that the EU has been working to contribute to that result through production ramp up and large exports in fact, including to the COVAX facility. The EU summed up what the WTO should be doing. “To sum up, the WTO can support vaccine equity through five sets of actions:
Promoting best practices in terms of trade facilitation and regulatory cooperation to maintain open supply chains; Facilitating cooperation with the private sector, both to ramp up production in the short term, and to enhance manufacturing in global regions with under-capacity, focusing in particular on Africa; Supporting Members’ use of the available TRIPs flexibilities; Continuing to seek joint approaches with the World Health Organisation and the World
Intellectual Property Organisation; and Ensuring transparency and effective monitoring of any temporary export restriction, as proposed by the Ottawa Group.”

I have not found statements from either India or South Africa but at least one publication indicated they stressed the need for a TRIPS waiver for all Members. See Washington Trade Daily, WTO’s Role in Vaccine Equity, April 15, 2021, https://files.constantcontact.com/ef5f8ffe501/63ac7508-8034-44b3-8c3c-045c1bedec43.pdf.

The World Health Organization also participated and the Director-General’s statement is available from the WHO website. See WHO press release, COVID-19 and vaccine equity panel: what can the World Trade Organization contribute?, 14 April 2021, https://www.who.int/director-general/speeches/detail/covid-19-and-vaccine-equity-panel-what-can-the-world-trade-organization-contribute (“COVAX was created, as you know, almost a year ago to avoid the same thing happening again. And although COVAX has distributed almost 40 million doses of vaccine to 110 countries and economies, vaccine nationalism, vaccine diplomacy and severe supply constraints have so far prevented COVAX from realizing its full potential. Global manufacturing capacity and supply chains have not been sufficient to deliver vaccines quickly and equitably where they are needed most.  More funding is needed, but that’s only part of the solution. Money doesn’t help if there are no vaccines to buy. We need to dramatically scale up the number of vaccines being produced. To address this challenge, WHO and our partners have established a COVAX manufacturing task force, to increase supply in the short term, but also to build a platform for sustainable vaccine manufacturing to support regional health security. We need to go beyond the traditional modus operandi to provide sustainable and effective solutions to address this extraordinary crisis. Some manufacturers have begun sharing the know-how and technologies to produce more vaccines, but only under restrictive conditions, on a very limited basis. The current company-controlled production sharing agreements are not coming close to meeting the overwhelming public health and socio-economic needs for effective, affordable and equitable access to vaccines, as well as therapeutics and other critical health technologies.  This is an unprecedented emergency that demands unprecedented measures.”).

One of the private sector participants, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) included its statement on the IFPMA website. See IFPMA, IFPMA statement at WTO event “COVID-19 and Vaccine Equity: What can the WTO Contribute”, 14 April 2021, https://www.ifpma.org/resource-centre/ifpma-statement-at-wto-event-covid-19-and-vaccine-equity-what-can-the-wto-contribute/. The IFPMA statement is embedded below but highlights the extraordinary effort of the private sector in ramping up production which is expected to be 10 billion doses by the end of 2021 with some 272 partnerships entered into and 200 technology transfer agreements.

IFPMA_WTO_Event_COVID-19_and_Vaccine_Equity_Statement_15April2021

Rising Infections; dramatically ramped up production

Last Thursday’s summary from the European Centre for Disease Prevention and Control (ECDC) shows the world going through a massive ramp up of new infections such that week 14 of 2021 is the second highest week during the pandemic of new infections with the vast majority of the cases and increase in Asia, the Americas and Europe. See ECDC, COVID-19 situation update worldwide, as of week 14, updated 15April 2021, https://www.ecdc.europa.eu/en/geographical-distribution-2019-ncov-cases.

Distribution of COVID-19 cases worldwide, as of week 14 2021

Distribution of COVID-19 cases worldwide, as of week 14 2021
“Distribution of cases of COVID-19 by continent (according to the applied case definition and testing strategies in the affected countries)

“Cases reported in accordance with the applied case definition and testing strategies in the affected countries.”

The ECDC data show Africa as accounting for 3.18% of total infections during the pandemic, Asia accounting for 19.50% (India is 9.91%; China is 0.07%), the Americas for 43.18% (United States 22.91% and Brazil 9.90%), Europe 34.08% (the Eu is 20.79%, the UK is 3.20%, Russia is 3.4%), and Oceania 0.05%.

At the same time as new infections are ramping up, vaccinations are also increasing sharply. Bloomberg data through April 17, 2021 shows a global total of 884 million vaccinations having been given globally. See Bloomberg, More Than 884 Million Shots Given: Covid-19 Tracker, updated April 17, 2021, https://www.bloomberg.com/graphics/covid-vaccine-tracker-global-distribution/.

While there are countries who have fewer or more vaccinations as a percent of the global total than their share of infections, considering distribution equity from that vantage point has some surprising results.

Country Percent of infections Percent of vaccinations

United States 22.91% 23.16%

European Union 20.79% 12.36%

United Kingdom 3.20% 4.76%

Japan 0.37% 0.21%

Republic of Korea 0.08% 0.17%

India 9.91% 13.85%

China 0.07% 21.18%

South Africa 1.14% 0.33%

Brazil 9.90% 3.92%

The pharmaceutical industry is projecting that 10 billion doses of COVID-19 vaccine will ship in 2021. That means that in the next eight and a half months, some nine billion doses will ship. If 10 billion doses are shipped in 2021, that is sufficient to fully vaccinate 5-6 billion people in 2021 (depending on number of doses that are for single shot vaccines). That is sufficient doses to vaccinate 63.3-75.9% of the current estimate of the global population (7.9 billion). See Worldometer, Current World Population, https://www.worldometers.info/world-population/#:~:text=The%20current%20world%20population%20is,currently%20living)%20of%20the%20world./ With the continued efforts to expand production and approve additional vaccines, 10 billion doses may be exceeded in fact by the end of the year.

This suggests, just as the COVAX and UNICEF distribution plans indicate, that low- and middle-income countries will see a large increase in supplies in the second half of 2021, just as will be true for the rest of the world.

The U.S.-Gavi event on April 15 talked about increasing funding for COVAX to go from 20% to 30% of populations the COVAX facility is serving. See U.S. Department of State, Video Remarks of Secretary of State Antony Blinken, Launch of GAVI’s COVAX Commitment, April 15, 2021, https://www.state.gov/launch-of-gavis-covax-commitment/. Moreover, the World Bank is committing billions to increases purchases of vaccines for low- and middle-income countries. And many countries are executing their own contracts with vaccine producers.

If there are issues besides assistance in resolving bottlenecks that would appear to be important to speeding up distribution and ensuring access by all, it would be to ensure that all countries with vaccine supplies greater than their internal needs, work to get those vaccines distributed to other countries later this year as their internal needs clarify.

Moreover, there are very exciting developments on the vaccine front with the start up of trials in a number of developing countries of a new vaccine where the potential exists for low costs with a vaccine that can be produced locally by many countries based on technology similar to what is already used for other vaccines. See New York Times, Researchers Are Hatching a Low-Cost Coronavirus Vaccine, A new formulation entering clinical trials in Brazil, Mexico, Thailand and Vietnam could change how the world fights the pandemic, April 5, 2021, updated April 17, 2021, https://www.nytimes.com/2021/04/05/health/hexapro-mclellan-vaccine.html.

All to say, there is considerable reason for optimism with the current efforts and progress. Efforts by governments, multilateral institutions, industry and others are helping identify challenges both to production and distribution but also to the needs for a speedy recovery once the pandemic is brought under control. While everyone needs to continue to focus on resolving bottlenecks, securing cooperation to ensure all are reached, and addressing developments as they arise, 2021 is not a repeat of the HIV situation.

The WTO has an important role in monitoring trade restrictions and looking forward to what actions Members are willing to take to advance trade and health needs and help ensure a next pandemic is handled more quickly than the COVID-19 has been. The effort to obtain a waiver from TRIPS obligations is, in this writer’s view, missing where the challenges are and seeking an outcome that will not advance improved vaccinations in 2021. While it is common for countries to continue to fight yesterday’s problems instead of addressing the current challenges, such an approach will not secure equitable and affordable access to vaccines in 2021-2022.

April 15, 2021 — U.S and Gavi co-host event for additional funding for COVAX amid concerns about two workhorse vaccines for COVAX

An important part of global efforts to vaccinate the world has been the work of the World Health Organization, Gavi, CEPI and UNICEF to provide an array of vaccines through early support of research and procurement of large quantities of doses for distribution to countries participating in the program including 92 low- and middle-income economies through COVAX. The COVAX objective for 2021 has been distribution of around two billion doses. While a large amount of money has been raised for vaccine purchases, additional needs in 2021 for COVAX are around $2 billion.

This Thursday, the United States and Gavi will co-host an event seeking additional funding for COVAX. The U.S. State Department press release from April 12 is copied below. See U.S. Department of State, United States to Host Event to Launch the 2021 COVAX Investment Opportunity, April 12, 2021, https://www.state.gov/united-states-to-host-event-to-launch-the-2021-covax-investment-opportunity/.

“On Thursday, April 15, 2021 at 8:00 a.m. EDT the United States will co-host the launch of the Investment Opportunity for the Gavi COVAX Advance Market Commitment (COVAX AMC), a virtual convening to galvanize additional resources and commitments to support global COVID-19 vaccination.

“Secretary of State Antony Blinken, USAID Acting Administrator Gloria Steele, and Gavi Board Chair José Manuel Barroso will bring together world leaders, the private sector, civil society, and technical experts to advance and accelerate global access to COVID-19 vaccines. Secretary Antony Blinken will offer opening remarks.

“Equitable access to safe and effective COVID-19 vaccines across the globe is critical for reducing the tragic loss of life, ending the pandemic, bolstering the U.S. and global economy, and keeping Americans safe at home and abroad. By pooling donor resources, the COVAX AMC provides access to safe and effective COVID-19 vaccines for 92 low-and middle-income economies, supporting the delivery of quality, lifesaving vaccines to those most in need and helping to contain the spread of COVID-19 and emerging variants.

“Thanks to Congress and the generosity of the American people, the U.S. government has already contributed $2 billion to support the COVAX AMC, out of a total planned $4 billion through 2022. The United States is currently the largest donor to COVAX, making up nearly forty percent of the COVAX AMC funding commitments announced to date.

“This event will be live-streamed on Gavi’s website, gavi.org and open to the public.  For more information email OES_PA_DG@State.gov.”

Gavi’s press release of 29 March 2021 announcing the event is copied below and provides the needs that hopefully will be met by Thurday’s event. See Gavi, United States to host launch event for Gavi COVAX AMC 2021 investment opportunity, 29 March 2021, https://www.gavi.org/news/media-room/united-states-host-launch-event-gavi-covax-amc-2021-investment-opportunity.

Geneva, 29 March 2021 – The United States government announced today that it will host the launch of the Investment Opportunity for the Gavi COVAX Advance Market Commitment (AMC). The virtual event, which will take place in April, will be co-hosted by José Manuel Barroso, Chair of the Gavi Board, and the Secretary of State and USAID Administrator on behalf of the United States. It will bring together world leaders, the private sector, civil society and key technical partners to present the case for additional resources for the Gavi COVAX AMC. 

“Country demand for COVID-19 vaccines has increased significantly in light of new COVID-19 variants, and the need for additional financing has become more urgent. In addition to committing US$ 4 billion to support Gavi’s COVID-19 related work, the United States is a long-standing supporter of the Alliance. It was one of Gavi’s original six donors and has contributed more than US$ 2.7 billion to Gavi’s core work since 2000. 

“’We welcome U.S. leadership in hosting the launch of the Gavi COVAX AMC Investment Opportunity,’ said José Manuel Barroso, Gavi Board Chair. ‘The United States has been a key Gavi partner for more than two decades, playing a critical role in helping the Alliance expand access to lifesaving immunisations for the most vulnerable around the world. Its recent contribution of $4 billion for procurement and delivery of COVID-19 vaccines for lower-income countries has made the United States Gavi’s top donor and a leader in the global pandemic response. With U.S. financial and diplomatic support, Gavi is very well positioned to mobilize the funds and the doses we need to end the acute phase of the pandemic.’

“The Gavi COVAX AMC is an innovative mechanism that seeks to provide access to up to 1.8 billion donor-funded doses of COVID-19 vaccines for 92 lower-income economies. In order to achieve that goal and build on the contributions made by donors so far, Gavi will be seeking at least US$ 2 billion in additional funding for the AMC in 2021. The Investment Opportunity will outline how Gavi will use this funding to support equitable access around the world, thus helping end the acute stage of this pandemic. The Investment Opportunity also looks ahead to the future, describing how to address the pandemic as it continues to evolve. 

“’As the United States has made clear through its Gavi partnership and commitments to global health security, no one is safe until everyone is safe,’ said Dr Seth Berkley, CEO of Gavi. ‘Gavi is thrilled to co-host the launch of the Investment Opportunity with the United States. With new donor funding, we will be able to procure up to 1.8 billion COVID-19 vaccine doses for lower-income countries. Strong U.S. support for the AMC is a reminder that COVAX offers the fastest, most comprehensive way out of the acute phase of the global pandemic.’

“’The emergence of new, more transmissible COVID-19 variants makes fair global access to vaccines more important than ever to protect the most vulnerable, reduce the prevalence of disease and slow down viral mutation.’ said Dr Richard Hatchett, Chief Executive Officer of the Coalition for Epidemic Preparedness Innovations (CEPI), which manages COVAX vaccine research and development. ‘Equitable access to COVID-19 vaccines will benefit the entire world, so I’m delighted that the U.S. will help COVAX to secure additional donor funding for lower-income countries.’

“Hon. Kwaku Agyeman-Manu, Minister of Health of Ghana, which took one the first deliveries of COVAX-supported vaccine doses, remarked that ‘this is about fairness, about justice, and about bringing a swift end to the pandemic. COVID-19 has affected all of us, and we must protect at risk populations everywhere if we are ever going to see a return to normal. We will only recover fully if we recover together and with its support for COVAX, the United States is helping set the course for a safer, more resilient world.’

“The Gavi COVAX AMC is a central part of the COVAX Facility, the global pooled procurement mechanism designed and administered by Gavi. Thanks to the support of COVAX AMC donors, coupled with the demand and resources of 191 participating economies, the Facility has already begun to deliver doses – the majority to lower-income countries – as part of the largest and most rapid global vaccine rollout in history.

“COVAX, the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator, is co-convened by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI), and the World Health Organization (WHO) – working in partnership with UNICEF as a key delivery partner, developed and developing country vaccine manufacturers, the World Bank, and others. It is the only global initiative that is working with governments and manufacturers to ensure COVID-19 vaccines are available worldwide to both higher-income and lower-income countries.”

Challenges to COVID vaccines through COVAX from concerns over AstraZeneca and Johnson & Johnson

A large portion of total vaccine doses expected in 2021 through COVAX is from AstraZeneca/Serum Institute of India and from Johnson & Johnson. AstraZeneca has had early production issues and the Serum Institute of India (which licenses the AstraZeneca vaccine for production) has curtailed exports in March and April (and possibly longer) because of the large increases in new COVID-19 infections in India and a redirection of production of vaccine doses for use in India. The AstraZeneca vaccine (from AstraZeneca and from the Serum Institute) constitute the bulk of doses expected in the first half of 2021 by COVAX and the Johnson & Johnson vaccine is expected to be a major supply source in the second half of 2021 as well as Novavax (either produced by Novavax or by license from the Serum Institute. However, both the AstraZeneca vaccine and the Johnson & Johnson vaccine have seen temporary stoppage of use by one or more countries flowing from a number of serious blood cot situations for patients who have taken the vaccine (causation under investigation). The AstraZeneca vaccine, which has been available for longer and under more scrutiny, has been limited in terms of age eligibility in a number of countries at this point. The AstraZeneca vaccine is the lowest priced vaccine (Novavax has an identical price to COVAX of $3.00/dose but is not yet approved). See UNICEF, COVID-19 vaccine market dashboard, https://www.unicef.org/supply/covid-19-vaccine-market-dashboard (prices). COVAX has a $3.00/dose ceiling price, so it is assumed that the Johnson & Johnson vaccine is similarly priced because of the pricing cap used by COVAX. With options, purchase agreements with COVAX have AstraZeneca/Serum Institute supplying some 700 million doses, Johnson & Johnson 500 million doses and Novavax (if approved) 1.1 billion doses. Id (COVID-19 vaccine supply agreements).

The challenge for COVAX and the low- and middle-income countries dependent on supplies from COVAX is the cost and availability of supplies if delays in shipments from the Serum Institute of India are prolonged or if there develops hesitancy in using vaccines which, while approved by many countries, carry some additional risk of serious blood clots. The prices recorded by the UNICEF data base show all other vaccines as significantly higher cost than the three supplying large quantities to COVAX. This suggests much larger financial needs to acquire the doses needed to address the “acute stage” of vaccination — 20% of populations representing health care and those at high risk — if COVAX must change sourcing for the major part of its vaccine doses. It also raises questions about the ability of other vaccines to fill the gap volume-wise in 2021 if major vaccines from AstraZeneca, Johnson & Johnson are not widely accepted or if exports are delayed for months out of India for each of AstraZeneca, Johnson & Johnson and Novavax (if approved).

While the event on Thursday will be focused on raising funds to meet the perceived needs of COVAX at the present time, those needs may be significantly larger in the coming months depending on developments.

Other funding and supply options

While the COVAX effort has been developed to handle the acute phase through contributions, the vaccination needs to get the world fully vaccinated are a multiple of the doses that COVAX is focused on procuring in 2021-2022.

The World Bank has earmarked $12 billion for vaccines and infrastructure for vaccinations for the world’s needy. Many low- and middle-income countries are working with suppliers directly or with Individual countries to obtain doses outside of the volumes expected from COVAX. Suppliers alone or in conjunction with governments have been working to license other producers and to ramp up production so that, depending on approvals of various vaccines, global production by the end of 2021 could be 10-15 billion doses. For example, the Quad countries (United States, Japan, India and Australia) have announced a plan to expand production in India to supply around one billion doses (2021-2022) to countries in the Indo-Pacific region paid for by Quad members and distributed by Australia. The UNICEF vaccine dashboard shows 6.9 billion doses of capacity of all vaccines under development or approved in the first half of 2021 increasing to 14.2 billion doses of capacity in the second half of 2021. See UNICEF, COVID-19 vaccine market dashboard, https://www.unicef.org/supply/covid-19-vaccine-market-dashboard (capacity). Thus, there should be significant additional capacity available later in 2021 for vaccine doses needed for low- and middle-income countries.

Similarly, it is likely that as major countries like the United States, Canada, the European Union, the United Kingdom and others get their populations vaccinated, there will be significant volumes of vaccines that have been bought by these countries that can be distributed to other countries in the last months of 2021 and in 2022.

Some of these efforts may be undertaken in consultation or conjunction with COVAX.

Conclusion

COVAX is an important effort at facilitating vaccinating large parts of the world against the COVID-19 pandemic, including many low- and middle-income countries. Many countries and the EU have led efforts in 2020 to increase funding for the effort. With the Biden Administration rejoining the World Health Organization and reengaging with multilateral organizations, and with the support of the U.S. Congress in funding U.S. contributions to COVAX, this Thursday’s event co-hosted by the United States and Gavi is an important chance to help COVAX receive the additional funding needed for its 2021 objectives.

Because the pandemic continues to be problematic around the world, there are many moving parts to a successful global vaccination effort including availability of vaccines, efficacy of vaccines including against new variants, ability to overcome vaccine hesitancy among portions of the population in many countries and the evolving understanding of human reactions to some of the vaccines available.

Greater cooperation among health administrators and the WHO would seem important to ensure that safe vaccines are not derailed because of discovered risks where the balance of benefits to risks strongly supports continued availability and use of the vaccines (with appropriate warnings). Where restrictions are appropriate, greater cooperation would permit a common approach versus differing restrictions which can only serve to cause confusion to the public and encourage vaccine hesitancy. COVID-19 reported cases globally are presently 137 million with deaths approaching 3 million. Vaccination doses administered globally are 806 million with serious adverse reactions and deaths quite limited (likely in the thousands globally). Serious adverse reactions and deaths if tied to vaccines are obviously a concern that should be addressed appropriately. However, eliminating vaccine availability to large portions of populations where there are not other options available risk far greater damage.

Global vaccinations against COVID-19; developments and challenges in the roll-out for many countries

Globally there have been extraordinary developments of vaccines to help against the COVID-19 vaccine. UNICEF has set up a COVID-19 Vaccine Market Dashboard which notes that at present 14 vaccines have been approved by one or more countries, that the companies in production or testing vaccines report existing or intended capacity in 2021 of 21 billion doses (depends on other vaccines being approved and companies overcoming any bottlenecks in supply), indicates that there are 10.4 billion “secured vaccine doses”, that there are 3.56 billion doses “secured and optioned for the COVAX facility” and that prices in the market range from $2.06/dose to $44.00/dose. See UNICEF, COVID-19 Vaccine Market Dashboard, https://www.unicef.org/supply/covid-19-vaccine-market-dashboard (visited April 2, 2021). The dashboard contains a great deal of information looking at information on products, capacity, agreements, price and delivery.

The COVAX facility, administered by Gavi, put out in early March the first round of allocation of vaccine doses procured for low- and middle-income countries and others choosing to participate in acquiring through COVAX to improve equitable and affordable access for all. 142 of the countries participating in the COVAX facility were identified as allocated delivery of specific quantities of vaccine from a total of 237 million doses that were expected to be available to COVAX during the February – May timeline. See The COVAX Facility, First Round of Allocation: Astra Zeneca/Oxford Vaccine (manufactured by Astra Zeneca & licensed and manufactured by Serum Institute of India), https://www.gavi.org/sites/default/files/covid/covax/COVAX-First-round-allocation-of-AZ-and-SII.pdf . 87 of the 92 countries who will receive doses at no cost or reduced cost are included in the first round allocation (“AMC” countries). The March 2, 2021 document is embedded below.

COVAX-First-round-allocation-of-AZ-and-SII

In an April 1, 2021 update, Gavi notes that to date COVAX has shipped more than 33 million doses to 74 country. See GAVI, COVAX vaccine roll-out, https://www.gavi.org/covax-facility (visited April 2, 2021). While the ramp-up of deliveries to COVAX is scheduled to occur over time, COVAX received notice in late March of delays for shipments from India (Serum Institute of India) in both March and April, which COVAX has estimated could be a delay for as much as 90 million doses and indicated the delays were due to internal needs in India for more doses to support their own vaccination program. See UNICEF, COVAX updates participants on delivery delays for vaccines from Serum Institute of India (SII) and AstraZeneca, 25 March 2021,https://www.unicef.org/press-releases/covax-updates-participants-delivery-delays-vaccines-serum-institute-india-sii-and. The bulk of the press release is copied below.

GENEVA/NEW YORK/OSLO, 25 March 2021 – Deliveries of COVID-19 vaccines produced by the Serum Institute of India (SII) to lower-income economies participating in the COVAX Facility will face delays during March and April as the Government of India battles a new wave of COVID-19 infections. COVAX and the Government of India remain in discussions to ensure some supplies are completed during March and April.

“According to the agreement between Gavi and the Serum Institute of India (SII), which included funding to support an increase in manufacturing capacity, SII is contracted to provide COVAX with the SII-licensed and manufactured AstraZeneca (AZ)-Oxford vaccine (known as COVISHIELD) to 64 lower-income economies participating in the Gavi COVAX AMC (including India), alongside its commitments to the Government of India.

“To date, COVAX has been supplied with 28 million COVISHIELD doses and was expecting an additional 40 million doses to be available in March, and up to 50 million doses in April.

“COVAX has notified all affected economies of potential delays. SII has pledged that, alongside supplying India, it will prioritize the COVAX multilateral solution for equitable distribution.

“Participating economies have also received WHO guidance on optimizing the national deployment doses of the AstraZeneca-Oxford vaccine in a constrained supply environment.

“Separately, the COVAX Facility has informed participants allocated AstraZeneca-manufactured doses of the AstraZeneca-Oxford vaccine that some of the first deliveries due in March are now set to take place in April.

“In this early phase of COVID-19 vaccine roll-out, vaccine manufacturers require time to scale and optimize their production processes. AstraZeneca, which uses a novel supply chain network with sites across multiple continents, is working to enable initial supply to 82 countries through COVAX in the coming weeks.

“COVAX retains its objective of supplying initial doses of vaccines to all participating economies in the first half of the year before ramping up significantly in the second half of 2021. To date, COVAX has shipped vaccines to over 50 countries and economies.”

While there have been various manufacturing challenges in the early months of vaccine roll-outs, the decision by India to slow distribution of vaccine doses purchased by COVAX will clearly slow distribution to many least developed and developing countries dependent on COVAX for their vaccine doses. Since as much as a third of vaccine doses that COVAX has distributed have gone to India, the Indian government has what is at least a public relations challenge at the present time. See India Today, India received one-third of vaccines made for poor countries by India under COVAX programme: Report, 30 March 2021, https://www.indiatoday.in/coronavirus-outbreak/vaccine-updates/story/india-received-one-third-of-vaccines-made-for-poor-countries-by-india-under-covax-programme-report-1785242-2021-03-30. However, with a number of variants of the virus circulating widely and with infections increasing in many countries around the world, the delays are of concern to many governments with anxious populations looking for a path past the pandemic.

In a paper from Airfinity and the St. Gallen Endowment for Prosperity through Trade on March 31, 2021, an effort is made to look at the likely damage to low income countries from the announced delays in shipments to COVAX. See Simon J. Evenett and Matt Linley, Halting India’s Vaccine Exports: The Fallout, 31 March 2021. The paper estimates that the delays in shipments will push back achieving even minimum vaccinations by 60-90 days for many of the COVAX recipient countries. The paper is embedded below.

AF-SGEPT-TL1-31-March-2021-finalised

While there is a lot of positive news being reported (e.g., expansion of capacities and expected shipments in 2021, effectiveness of some of the existing vaccines against some of the new variants, agreement between the United States, Japan, India and Australia to generate one billion doses of a vaccine in India for distribution in the Indo-Pacific area in 2021 and 2022, and the United States hosting a funding effort for COVAX later in April to help close the funding needs for 2021 (after the U.S.’s $4 billion contribution)), delays for up to 90 million doses ( 37.97% of the total doses expected in the February – May 2021 time period by COVAX) to those dependent on COVAX is a significant challenge. See, e.g., Gavi, United States to host launch event for Gavi COVAX AMC 2021 investment opportunity, 29 March 2021, https://www.gavi.org/news/media-room/united-states-host-launch-event-gavi-covax-amc-2021-investment-opportunity; March 25, 2021, Global vaccinations for COVID-19 — continued supply chain and production issues and a new wave of infections in many countries delay greater ramp up for some until late in the second quarter of 2021, https://currentthoughtsontrade.com/2021/03/25/global-vaccinations-for-covid-19-continued-supply-chain-and-production-issues-and-a-new-wave-of-infections-in-many-countries-delay-greater-ramp-up-for-some-until-late-in-the-second-quarter-of-2021/; March 12, 2021, COVID-19 vaccines – U.S., Japan, India and Australia agree to one billion doses for Indo-Pacific countries, https://currentthoughtsontrade.com/2021/03/12/covid-19-vaccines-u-s-japan-india-and-australia-agree-to-one-billion-doses-for-indo-pacific-countries/; March 12, 2021, The 8-9 March  “Global C19 Vaccine Supply Chain and Manufacturing Summit” – efforts to ramp-up production, https://currentthoughtsontrade.com/2021/03/12/the-8-9-march-global-c19-vaccine-supply-chain-and-manufacturing-summit-efforts-to-ramp-up-production/.

The WTO Director-General Ngozi Okonjo-Iweala is planning a meeting on vaccines later in April that was described in a WTO press release as follows.

“DG Okonjo-Iweala also said that she plans to convene an event in mid-April to discuss ramping up COVID-19 vaccine production and how the WTO can contribute to a more rapid and equitable distribution of vaccines. 

“The event, to be held under Chatham House rules, will include all regional member groups, representatives from vaccine manufacturers from developing and developed countries, civil society groups working on access to medicine, and other relevant stakeholders.

“’The idea is to move us along on our quest to solve this unacceptable inequitable access of poor countries to vaccines,’ she said. ‘At the bottom of this is a very serious scarcity in supply. And how to solve it is to look at how we expand manufacturing in all its ways.’ 

“She stressed that the event would help advance global discussions on access to vaccines. She expressed hope both for increased vaccine manufacturing in the short- to medium-term, and a longer-term framework agreement that would provide for automatic access to vaccines and other medical products for developing countries in future health crises, including a way forward on the TRIPS waiver proposal many of them support.

“’We also need to look to the future and agree a framework where countries do not need to stand in the queue in order to get access to life-saving vaccines, therapeutics, and diagnostics,’ she said, emphasizing that this can be done while still incentivizing research and development.”

WTO, Director-General urges WTO members to deliver concrete results this year, 30 March 2021, https://www.wto.org/english/news_e/news21_e/dgno_30mar21_e.htm.

Conclusion

Governments are understandably focused on trying to end the pandemic at home as a first priority. The efforts of the WHO, Gavi, CEPI and UNICEF through the COVAX facility in recent years has provided a welcome source of hope for many nations for greater equity in distribution and in affordability of vaccines, including in the last year addressing the enormous challenge presented by the COVID-19 pandemic. Many countries and private groups have stepped up with major funding contributions to make vaccine available. Individual governments are also working to increase supplies globally. Many bottlenecks have arisen with the large number of inputs and the enormous increase in demand that has arisen over the last year. There is a need for continued efforts by governments and businesses to address the challenges and to see that the needs of the low- and middle-income countries can be met in a timely manner as well. While there will be a lot more production in the second half of 2021, there are and will continue to be challenges in the second quarter. Focus on identifying challenges and global cooperation to solve bottlenecks will do a lot to ensure greater global success in the remainder of 2021.

The 8-9 March “Global C19 Vaccine Supply Chain and Manufacturing Summit” — Efforts to Ramp-Up Production

On Monday and Tuesday of this week, the Chatham House hosted an event that was”sponsored by COVAX (the COVID-19 vaccine initiative led by the World Health Organization, the Coalition for Epidemic Preparedness Innovations and Gavi, the Vaccine Alliance), together with the Developing Countries Vaccine Manufacturers Network (DCVMN), the Biotechnology Innovation Organization (BIO), and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).” WTO, DG calls on COVID-19 vaccine manufacturers to increase production in developing countries, March 9, 2021, https://www.wto.org/english/news_e/news21_e/dgno_09mar21_e.htm. Because the event was conducted under Chatham House rules, the information available is from the participants’ releases.

The participants had a document and apendix to provide some factual background to help the discussion. “Towards Vaccinating the World: Landscape of Current COVID-19 Supply Chain and Manufacturing Capacity, Potential Challenges. Initial Responses, and Possible “Solution Space” — a Discussion Document” is the 28 page background document. It is accompanied by a 12 page Appendix. The introduction provides a useful overview of efforts to address the COVID-19 pandemic and the areas for discussion at the meeting. The introduction is copied below and is followed by both the background document and appendix being embedded.

Introduction

“I feel like I didn’t just get a vaccine, I got a shot of hope. It’s hope that this is the beginning of the end of this terrible pandemic.” – Dr Hagan, Frontline Worker1

“With over 2.6 million deaths as of 3rd March 2021,2 and economic cost estimated at 5-14 trillion USD per year3 due to COVID-19, mitigating the pandemic is a paramount global priority and vaccines are a critical part of the solution.

“Since the start of the COVID-19 pandemic, the world has seen unprecedented progress in vaccine development, manufacturing ramp-up, and deployment. Within a record time of less than a year, 11 vaccines are already in clinical use in the countries where they obtained approval (often with emergency/limited authorisation), more than 80 additional candidates are in clinical trials, and hundreds of candidates are in the pre-clinical phase. At the same time, vaccine manufacturers and suppliers of vaccine components are scaling up for COVID-19 vaccine production from zero to billions of doses, with an announced cumulative supply target of up to 14 billion doses by the end of 2021. This represents three to four times the pre-COVID-19 annual global demand for all vaccines of 3.5-5.5 billion.4 The impact of these efforts is starting to be seen, with over 270 million people globally vaccinated as of 3rd March 2021.5

“The increase in capacity is remarkable because of the complexity of vaccine manufacturing processes that require specific know-how and equipment. It usually takes more than five years to build manufacturing capacity and 18-30 months to transfer production to other sites or manufacturers.6 The use of new technologies such as mRNA in response to COVID-19 poses additional challenges because no large-scale manufacturing capacity nor specific raw materials existed at the outset of the pandemic. COVID-19 vaccine manufacturers ramped up their own manufacturing in parallel to clinical development (“scale-up”) in response to this challenge. They also formed more than 150 partnerships7 with contract development and manufacturing organisations (CDMOs) and other multinational biopharmaceutical companies to transfer their technology and increase their overall production (“scale-out”). Notwithstanding these efforts, the strain on manufacturing capacities and capabilities is very high, in light of the immediacy and scale of the demand, which may be exacerbated further if a broader coverage of the population is needed and if boosters are needed due to waning efficacy and need to protect from new variants.

“However, it has become apparent that many COVID-19 vaccine input supplies of raw and packaging materials, consumables and equipment are in short supply which may result in several COVID-19 vaccine manufactures not being able to meet their current vaccine manufacturing commitments. Such shortages will also impact the ability to manufacture other lifesaving vaccines and biologics. Mechanisms to ensure input supplies for current and increased manufacturing capacity intent need to be put in place with short, medium and long-term solutions.

“Supply of COVID-19 vaccines will more than double the annual volume of vaccines procured via UNICEF. These additional COVID-19 vaccine needs from manufacturers of routine vaccines and other essential supplies is of concern to UNICEF. There is a need for expanded manufacturing capacity while building on existing mechanisms to sustain and scale current investments that the Vaccine Alliance has achieved thus far.

“The summit will evaluate all potential bottlenecks of supply chain for input supplies, from manufacturing, through procurement, export, delivery and use of the materials for COVID-19 vaccine manufacture. It is of paramount importance to anticipate, understand, and establish an open dialogue with all stakeholders to find and implement additional short-term and sustainable solutions to the inevitable supply chain challenges.

“For this reason, Chatham House – with co-sponsorship from COVAX (CEPI, Gavi, WHO, UNICEF), IFPMA, BIO, and DCVMN – has convened the COVID-19 Vaccine Manufacturing and Supply Chain Summit with key public, private, and other vaccine stakeholders on 8th and 9th March 2021, to explore the emerging input supply challenges in depth and to start to work towards strategies to avoid or mitigate them. The main goals of the Summit are:

“▪ Help to identify and define the most critical bottlenecks across the supply network for a diverse array of COVID-19 vaccines with an emphasis on input supply

“▪ Provide a platform to explore a range of solutions to address bottlenecks.

“▪ Lead to a series of recommendations, and ideally commitments, on the priority areas for monitoring and/or action.

“Today, the only element that can be predicted about the future is its high degree of uncertainty. The objective of this document is to provide a structured fact base to serve as background for participants, not to attempt to predict any aspect of the future course of this pandemic. This fact base builds on perspectives and information developed and provided by Summit conveners and participants. Given the rapid pace of events in this space, it should be considered as a ‘best effort’ guide towards a high-level analysis and assessment of the state of play today but it is unlikely to be complete and may have omissions. Any estimates should be validated before being used for decision-making. The discussion document should be viewed as a discussion guide for participants and is structured into the following sections:

“1. Introduction to Vaccine Manufacturing and Supply Chain

“2. COVID-19 Vaccine Supply and Demand Overview

“3. Input Supply Challenges

“4. Manufacturing Capacity and Interdependencies beyond COVID-19 Vaccine

“5. Overview of Potential Solutions for Discussion

“6. Moving to Action

In parallel to the Chatham House Summit, many discussions are ongoing on how further to increase available manufacturing capacity of vaccine drug substance/drug product and accelerate technology transfer.

The purpose of this Summit, and this discussion document, is not aimed to identify or assign responsibility. COVID-19 is an exceptional crisis with unforeseen and shifting challenges. The aim is to bring stakeholders together to understand and align on how to move forward together leveraging their combined capabilities to optimise access to vaccines against COVID-19 for good of the world.

“1 New York Times, ‘A Shot of Hope’: What the Vaccine Is Like for Frontline Doctors and Nurses. 2020. https://www.nytimes.com/2020/12/14/us/coronavirus-vaccine-doctors-nurses.html

“2 WHO; Economist

“3 Airfinity; IMF

“4 WHO Global Vaccine Market Report 2019, 2020. http://who.int/immunization/programmes_systems/procurement/mi4a/platform/module2/2019_ Global_Vaccine_Market_Report.pdf?ua=1#:~:text=Global%20market%20volumes%20increased%20approximately,large-scale%20campaigns%20in%20India.

“5 WHO, WHO Coronavirus Disease (COVID-19) Dashboard. https://covid19.who.int/; Bloomberg, COVID-19 Vaccine tracker. https://www.bloomberg.com/graphics/covid-vaccine-tracker-global-distribution/

“6 McKinsey & Company, Why tech transfer may be critical to beating COVID-19. 2020. https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/why-tech-transfer-may-be-critical-to-beating-covid-19

“7 Airfinity”

Summit_Landscape_Discussion_Document

Summit_Landscape_Discussion_Document_Appendix

The background paper is useful by pulling together information on demand, likely production, a review of the challenges in supply chains, and the fact that globally only 3% of likely 2021 vaccines had been manufactured by March 3, 2021, meaning there are huge production increases coming in the remaining ten months driven by more vaccines being approved for use by countries and the WTO. Several exhibits from the report are copied below (Exhibit 2, page 7; Exhibit 5, page 12; Exhibit 6, page 14; Exhibit 7, page 16) and show the distribution of manufacturers with approved vaccines or vaccines in third stage trials, projected supply under three scenarios, input supply bottleneck issues, and a “summary of major supply challenges and drivers”.

There was a joint press release which is embedded below. See Global C19 Vaccine Supply Chain and Manufacturing Summit Press Release, March 9, 2021, https://www.dcvmn.org/IMG/pdf/global_covid-19_vaccine_supply_chain_manufacturing_summit_press_release_1_.pdf.

global_covid-19_vaccine_supply_chain_manufacturing_summit_press_release_1_

Several paragraphs on the first page review the supply chain issues and then review areas for potential additional work. Because of their importance, they are copied below (emphasis added).

“Vaccine manufacturers and upstream suppliers are increasingly reporting shortages of raw and packaging materials, critical consumables, and equipment. Over time such shortages, if left unaddressed, will lead to shortages of vaccines and impact delivery commitments. Such shortages will also impact the ability to manufacture other lifesaving vaccines and biologics. Preventing bottlenecks in the system requires among others: addressing export restrictions, immediate easing and facilitation of access to raw materials and upstream supplies; regulatory prioritization of validation of supply, batch release and achieving greater visibility on vaccines demand forecasts to enable upstream suppliers to do better supply planning.

“All stakeholders agreed there is a need to expand capacity and in a way that promotes equitable access and leaves no one behind. Other approaches were discussed including:

“1. Free flow of goods and workforce;

“2. Continue technology transfer and manufacturing partnerships between innovators and manufacturers to scale up and scale out COVID19 vaccine capacity;

“3. Better demand forecasting and inventory management of raw materials and critical consumables;

“4. Support from the highest political level is needed;

“5. Value of regulatory harmonization and streamlining to accelerate manufacturing capacity and supply;

“6. Better production, demand and supply, forecast and visibility;

“7. Give consideration to the potential impacts of COVID-19 production on non-COVID products

The quotes from the six organizations participating fell along predictable lines — CEPI’s CEO focused on the need to address bottlenecks to ensure delivery of supplies; IFPMA’s DG reviewed the huge build up of capabilities and need to address bottlenecks while recognizing the need to continue to expand capacity; the CEO of GAVI viewed the event as “an important step in building the global consensus needed to solve the bottlenecks and supply constraints”; the WHO’s chief scientist focused on equitable distribution and in the “longer term more sustainable approach will be to enable technology transfer to manufacturing sites in LMICs that have the capacity”; the President and CEO of BIO noted that “We must invest across all of the ecosystem to ensure that there is not only manufacturing capacity but also increasing amounts of the vital production supplies needed for that capacity”; the President of the DCVMN focused on expanding production in developing countries, “Global products, local manufacturing, and leave no one behind.”

The WTO’s Director-General Ngozi Okonjo-Iweala who is a former Chair of GAVI, spoke to the participants on March 9 urging licensing and partnerships with vaccine manufacturers in developing countries and repeating her themes of recent days of focusing on ending or phasing out export restrictions. See WTO, DG calls on COVID-19 vaccine manufacturers to increase production in developing countries, March 9, 2021, https://www.wto.org/english/news_e/news21_e/dgno_09mar21_e.htm. The press release is copied below.

“Director-General Ngozi Okonjo-Iweala on 9 March called on COVID-19 vaccine manufacturers to do more to ramp up production in developing countries to combat the vaccine supply shortage that is excluding many lower-income nations from access. In remarks to an event hosted by the UK think tank Chatham House, she said cooperation on trade, and action at the WTO, would help accelerate vaccine scale-up.

The scarcity of COVID-19 vaccine supplies had led to a situation in which around 75 countries are able to move ahead with vaccination while 115 countries wait as people die, DG Okonjo-Iweala told the Global C19 Vaccine Supply Chain and Manufacturing Summit.

Not only was this morally “unconscionable,” she said, it would prolong the pandemic and cause economic harm to all countries. Instead of restricting exports and bidding up prices, she argued, “it is in all of our self-interest to cooperate in dealing with this problem of the global commons.”

The Director-General saw cause for hope in the first vaccine deliveries to developing countries by the COVAX facility, the global mechanism for procuring and equitably distributing COVID-19 vaccines. Nevertheless, production and delivery volumes remained too low.

“We have to scale up and scale out COVID-19 vaccine production, particularly in emerging markets and developing countries,” she said. Given the years required to build new manufacturing facilities from scratch, increasing production in the short-term means “making the most of existing manufacturing capacity — finding existing sites and turning them around.” Recent experience suggests that repurposing facilities and vetting them for safety and quality can happen in six or seven months, less than half as long as previously thought.

“By bringing more production online around the world, she said, vaccine manufacturers would send a signal that they are taking action, and ‘that people and governments in low- and middle-income countries can expect to get access to affordable vaccines within a reasonable timeframe.’

“DG Okonjo-Iweala observed that companies in India and elsewhere were already manufacturing COVID-19 vaccines under licence but said that more such arrangements are necessary.

“Discussions during the conference had highlighted three constraints to ramping up production, the Director-General noted: scarcity of raw materials, shortages of qualified and experienced personnel, and supply chain problems linked to export restrictions and prohibitions as well as excessive bureaucracy. The WTO’s mandate on trade facilitation, quantitative trade restrictions, and trade policy monitoring were relevant to the latter challenges in particular.

“Because vaccine production relies on sourcing components and ingredients from multiple countries, she said, trade restrictions would slow down production, and make it more expensive.

“Nevertheless, DG Okonjo-Iweala noted, WTO rules do allow for export restrictions or prohibitions to be ‘temporarily applied to prevent or relieve critical shortages’ of essential products. That said, such restrictions must be notified to all members. Restrictions should be transparent, proportionate to the problem at hand, and members should provide timelines for when they will be phased out, she said.

“She reported that WTO monitoring indicates that 59 members and 7 observers still had some pandemic-related export restrictions or licensing requirements in place at the end of February, primarily for personal protective equipment. It was welcome that these figures were lower than the 91 countries that had brought in such measures over the past year. However, ‘not all pandemic-related export restrictions have been notified,’ she said. ‘Not all of them appear to be temporary. Not all of them are proportionate.’

“’We must strengthen our monitoring and reporting function,’ DG Okonjo-Iweala said, explaining that her objective would be to encourage members to drop or reduce export restrictions, or set timelines for phaseout, to help minimize problems in the vaccine supply chain.

“With regard to trade-related bureaucracy, she invited manufacturers to tell the WTO about the problems they are encountering in real time, ‘so we can put them before our membership and find ways they can be minimized and if possible solved.’ She said a little-appreciated fact about trade policy during the pandemic is that members’ trade-facilitating measures, such as electronic customs procedures and simplified paperwork requirements, have far outnumbered trade-restricting policies, and covered a higher value of merchandise.

“On both export restrictions and trade facilitation, DG Okonjo-Iweala noted, prospects for action at the WTO would improve as businesses are seen to step up efforts on vaccine production.

“The Director-General referred to the ongoing debate at the WTO on a proposal to waive standard WTO intellectual property rules for COVID-related vaccines, therapeutics, and diagnostics.

“’Many of the proposal’s supporters are developing and least developed countries, deeply marked by the memory of unaffordable HIV/AIDS drugs,’ she told conference participants. ‘Many, many people died who should not have. More recently, they remember being left at the back of the queue for H1N1 vaccines as richer countries bought up available supplies, which in the end were not used.’ Critics of the proposed waiver, she noted, say it could threaten investment and innovation, and other members have asked for more evidence that intellectual property protections are an inhibiting factor in vaccine scale-up.

“While these ‘vitally important discussions are intensifying here in Geneva,’ she said, ‘the fact is that each additional day the vaccine shortage continues, people will pay with their lives.’ She argued that it was possible to ‘walk and chew gum at the same time,’ continuing the search for solutions in the TRIPS debate, while simultaneously taking action to increase production, ‘especially in emerging markets and developing countries where such possibilities exist.’

“She expressed hope that it would be possible for manufacturers from developed and developing countries to come together with civil society groups, organizations such as the World Health Organization, Gavi, and the Coalition for Epidemic Preparedness (which together run the COVAX facility), and business associations including the International Chamber of Commerce to find ways to increase vaccine production.

“’We must make sure that in the end we deliver so that the millions of people who are waiting for us with bated breath know that we are working on concrete solutions,’ she said.

“The 8-9 March ‘Global C19 Vaccine Supply Chain and Manufacturing Summit’ was convened by Chatham House and sponsored by COVAX (the COVID-19 vaccine initiative led by the World Health Organization, the Coalition for Epidemic Preparedness Innovations and Gavi, the Vaccine Alliance), together with the Developing Countries Vaccine Manufacturers Network (DCVMN), the Biotechnology Innovation Organization (BIO), and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). The meeting was held under the Chatham House rule, so the above report on the Director-General’s speech does not reflect views attributed to other participants.”

Conclusion

Countries around the world are starting the process of vaccinating their populations. The COVAX vaccine roll-out, which includes efforts to get doses to low- and middle-income countries, appears to be on target for its goal of two billion shots in 2021. While vaccine doses from COVAX started at the very end of February, by March 11, COVAX was reporting 28.5 million doses had been shipped to 37 countries. See Gavi, COVAX has so far shipped over 28.5 million COVID-19 vaccines to 37 countries, March 11, 2021, https://www.gavi.org/covax-vaccine-roll-out.

All countries working with vaccine producers have encountered some delays as manufacturers are having both start-up challenges at their own facilities and supply chain issues as reviewed in the background paper used by participants at this week’s Chatham House event. There are clearly supply chain issues that pose risks to current manufacturing efforts and already scheduled ramp ups of capacity. The major pharmaceutical groups have worked hard to develop capacity and upgrade supply chains. They all appreciate that more can and will be done.

There are a host of issues on COVID vaccines that need to be addressed that fall within the WTO’s wheelhouse — control of export restraints, easing and access to raw materials and upstream supplies to name two. As DG Okonjo-Iweala noted, the WTO TRIPS Council is considering whether to recommend a waiver of TRIPS obligations for medical products for COVID-19 use during the pandemic. Indeed another meeting of the TRIPS Council was held on March 10-11. See WTO, Members discuss TRIPS waiver, LDC transition period and green tech role for small business, March 11, 2021, https://www.wto.org/english/news_e/news21_e/trip_11mar21_e.htm. However, not only is the requested waiver opposed by major developed countries and at least one developing country (and hence unlikely to obtain consensus to forward to the General Council), but also a review of the background document shows the complexity of technology transfer in the best of situations. Pharmaceutical and biotech companies are opposed to the waiver and view such action as almost certain to slow the ramp up of production. See, e.g., IFPMA, Pharma delivers COVID-19 solutions, but calls for the dilution of intellectual property rights are counterproductive, 20 December 2020, https://www.ifpma.org/resource-centre/pharma-innovation-delivers-covid-19-solutions-beyond-expectations-but-calls-for-the-dilution-of-intellectual-property-rights-are-counteproductive/; Bio, Letter to President Biden, March 5, 2021, https://www.bio.org/letters-testimony-comments/bio-sends-letter-president-biden-discussing-collaboration-ensure-patient; PhRMA, letter to President Biden, March 5, 2021, https://phrma.org/Public-Communication/Letter-to-President-Biden-from-31-PhRMA-Board-Members.

The Chatham House event was a timely and practical effort to have the major participants review challenges currently being faced and to exchange ideas on how to move forward. Efforts such as we have seen under the Biden Administration to help address bottlenecks through the use of the Defense Production Act should be undertaken by other governments to help streamline the ramp up process for both vaccines and the key inputs and other materials needed for expanded production. The seven “other approaches” identified in the joint press release are sound and ambitious but will require not only government involvement (regulatory harmonization; support at the highest level of government) but also improved data gathering and dissemination (supply and demand forecasts). The size of the planned ramp up of production (assuming vaccines that are in stage three end up being approved and supply chain issues can be handled) as shown in Exhibit 5 of the background document is truly impressive. The addition of more capacity through additional licensing or partnership arrangements will further improve the outlook for 2021 for the world.

While COVAX was set up with the ambitious objective of 2 billion doses to the 192 countries (including 92 low- and middle-income countries were vaccines will be provided without charge) COVAX is serving in 2021, most scenarios in the background paper show the likelihood of additional billions of doses available by the end of the year. This suggests that the challenge may not be production but rather securing funding for the additional doses that will be available and/or movement of additional unneeded supplies from developed countries in the latter part of 2021. The G20 and others should be able to help with the financing. It is likely that doses may be available for transfer from at least some developed countries by the fourth quarter.

So there is a lot that is happening and lots that needs to be done to see that the COVID-19 pandemic is fully addressed. Waiving TRIPS obligations is not one of them.

WTO Director-General Ngozi Okonjo-Iweala’s first week on the job starts with a two day General Council meeting

While the WTO’s General Council, in special session, appointed Dr. Ngozi Okonjo-Iweala to be the next Director-General on February 15, 2021, her term starts on Monday, March 1. The challenges facing the WTO membership and the incoming Director-General are many and complex. At the same time, there is a lot of useful work that is done within the WTO including efforts of non-members to join the WTO (accessions).

In speaking to an informal Trade Negotiations Committee and Heads of Delegation meeting on February 25, Deputy Director-General Alan Wolff spoke in part on “The Ngozi Okonjo-Iweala Era”. See WTO, DDG Wolff calls on members to work with new Director-General to reform WTO, 25 February 2021, https://www.wto.org/english/news_e/news21_e/ddgaw_25feb21_e.htm. Part of the section of his statement on the new DG’s era is copied below.

“The Ngozi Okonjo-Iweala Era

“The landmark event of the last six months was the appointment of the new Director-General ten days ago after what turned out to be a lengthy process.  91 member delegations spoke last week to congratulate the new Director-General. The DDGs and the Secretariat join you in welcoming Dr Okonjo-Iweala’s appointment with great enthusiasm.

“Of course, member enthusiasm, optimism and hope need to be translated into concrete action.  

“There is much that needs to be done at this critical juncture for the WTO. World trade must contribute to a more effective pandemic response as well as a strong and sustainable economic recovery. Climate issues are demanding more urgent attention. WTO reform is overdue, having been called for repeatedly by you, by your ministers and by many heads of government. 

“The challenges are many but so are the opportunities. Dr Ngozi’s remarks at the Special General Council meeting last Monday, subsequently circulated to delegations in document JOB/GC/250, presented a worthy and ambitious agenda for the members of this organization.

“What did she say?

“To act with a sense of urgency to assist in controlling the COVID-19 pandemic through the nexus of trade and public health:

“First, by playing a more forceful role in exercising the WTO’s monitoring function. Part of this would involve encouraging members to minimise or remove export restrictions that hinder supply chains for medical goods and equipment. WTO monitoring suggests that as of yesterday, 59 members and 7 observers still had pandemic-related export restrictions or licensing requirements in place, mostly for personal protective equipment, disinfectants and to a lesser extent, for medicines and food. This represents a significant level of rollback compared to the 81 members and 10 observers that had implemented such measures over the past year. A welcome development — but there is much room to improve this record.  

“And second, by broadening access to new vaccines, therapeutics, and diagnostics by facilitating technology transfer within the framework of multilateral rules.

“Beyond these immediate responses to the pandemic, Dr Ngozi set out a number of other, also vitally important, challenges:

“To swiftly conclude the fisheries subsidies negotiations, and thus pass a key test of the WTO’s multilateral credibility while contributing to the sustainability of the world’s oceans.

“To build on the new energy in the multilateral trading system from the joint statement initiatives attracting greater support and interest, including from developing countries.

“To address more broadly the nexus between trade and climate change, using trade to create a green and circular economy, to reactivate and broaden negotiations on environmental goods and services, to take the initiative to address the issue of carbon border adjustments as they may affect trade.

“To level the playing field in agricultural trade though improving market access and dealing with trade distorting domestic support, exempting from export restrictions World Food Programme humanitarian purchases.

“To strengthen disciplines on industrial subsidies, including support for state-owned enterprises. 

“To defuse the divisions over Special and Differential Treatment (SDT).

“And to develop a work programme for restoring two-tier dispute resolution, to be agreed no later than MC12.

“I sense from my discussions with members that you chose this leader, Ngozi Okonjo-Iweala, because she has shown herself during her career to be fearless in the face of daunting challenges — and is experienced in knowing how to work with others to make progress toward solutions. 

“Each of the challenges the WTO faces, I am sure, can be met and overcome.  Echoing Dr Ngozi’s words, the trading system that we inherited, now only three-quarters of a century old, is about people.  This is inscribed in the opening section of the Marrakech agreement: ‘to raise living standards, ensure full employment, increase incomes, expand the production of and trade in goods and services, and seek the optimal use of the world’s resources in accordance with the objective of sustainable development.”’

DDG Wolff’s summation correctly lays out many of the issues needing to be addressed by the WTO membership. The vast majority of the issues are highly controversial among at least some Members.

The first major order of business is a two day General Council meeting on March 1-2 which has several agenda items that lay out controversies on important potential deliverables by the WTO in 2021. The agenda for the two day meeting contains sixteen items. See WT/GC/W/820 (26 February 2021) embedded below.

W820

General Council meetings deal with updates on ongoing work at the WTO and address issues teed up by particular Members for consideration at the meeting. This post does not take up all agenda items but highlights a few of possible interest. Because DDG Wolff’s statement on February 25 reviews many of the activities of the WTO in the last six months which shows some of the positive developments, the full statement is embedded below.

WTO-_-2021-News-items-Speech-DDG-Alan-Wolff-DDG-Wolff-calls-on-members-to-work-with-new-Director-General-to-reform-WTO

The 12th WTO Ministerial Conference

Agenda item 4 deals with the 12th WTO Ministerial Conference. It is expected that there will be a decision on the timing and location of the twelfth Ministerial Conference at the General Council session on Monday-Tuesday. The 12th MC was postponed from June 2020 because of the COVID-19 pandemic. With the continued challenges from the pandemic the likely date will be the end of 2021. Kazakhstan which had offered to host the conference in 2020 and again in the summer of 2021 has recently indicated a willingness to host in December of this year as well. The ministerial had originally been scheduled for June because of challenging weather conditions in Kazakhstan in December. See TWELFTH SESSION OF THE MINISTERIAL CONFERENCE, COMMUNICATION FROM KAZAKHSTAN, 8 February 2021, WT/GC/229 (24 February 2021)(embedded below).

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Report on WTO Accessions

Deputy Director-General Wolff will provide a statement on the annual report on WTO accessions. The report is WTO ACCESSIONS, 2020 ANNUAL REPORT BY THE DIRECTOR-GENERAL, WT/ACC/38, WT/GC/228 (18 February 2021). Activity on accessions was challenged by the pandemic and inability to travel/hold in person meetings. More technical assistance and virtual meetings were held. Accessions are important for acceding governments in terms of promoting reforms at home and obtaining increased certainty in their international trade relations. Accessions are also an important benefit of membership for existing Members as acceding Members reduce tariffs and various non-tariff barriers to gain accession. The first eight paragraphs of the report provide an overview of activities in 2020 and are copied below.

Overview of activities in 2020

“1. 2020 was an unprecedented year in recent history due the COVID-19 pandemic outbreak and its consequences which have touched upon every single aspect of our lives in every corner of the world. It was a challenging year for the WTO, not least because the pandemic disrupted its core activities, especially during the first half of the year, and it also disrupted the international trade of Members, except for supplies of essential goods critical to combatting the health crisis as trade in these goods expanded dramatically. The difficulties and challenges arising from the pandemic were particularly pronounced in acceding governments due to the uncertainties of being outside of the multilateral trading system. In fact, the desire and urgency to be part of the WTO was never felt stronger than in the pandemic year. This was reflected in the level of accession activities in 2020, which was sustained vis-à-vis previous years, with a significant increase in technical assistance and outreach activities.

“2. The year for accessions started with the establishment of a new Working Party for the accession of Curaçao, a constituent country within the Kingdom of the Netherlands (WTO Member), following its application for an independent membership as a separate customs territory pursuant to Article XII of the Marrakesh Agreement. This constituted the 59th request by a state or separate customs territory for membership since the establishment of the Organization in 1995. In July, Turkmenistan was granted observer status in the WTO, with the understanding that it would apply for accession no later than in five years. This brought the total number of observer governments with the intention to accede to the WTO to 24, an increase by five since 2016 when Afghanistan and Liberia became the Organization’s most recent Members. The continuing interest to become part of the multilateral trading system is a testament to the attraction and relevance of its values and principles for all economies, regardless of their size or level of development.

“3. The COVID-19 pandemic undoubtedly hampered or delayed the technical work by acceding governments, Members and the Secretariat to prepare for, engage in and follow up on Working Party meetings. However, thanks to the firm commitment of the acceding governments to advance their work, four Working Parties met, including through the use of virtual platforms that connected the acceding governments which were unable to travel to Geneva. One acceding government had to cancel its already scheduled meeting due to the suspension of all WTO meetings in March. Out of the four accession Working Party meetings held in 2020, three were on LDC accessions (Ethiopia, Comoros and Timor-Leste). In two cases – the Working Parties of Ethiopia and Uzbekistan – this also represented the formal resumption of accession processes after several years of inactivity (8 and 15 years, respectively), signalling their desire to use WTO membership negotiations to drive domestic economic reforms, which have broader implications in the regions where they are located.

“4. When the pandemic halted planned missions, technical assistance, and outreach activities which required air travel, the Secretariat rapidly shifted the mode of operation to virtual format and took advantage of the opportunities provided thereby. In addition to the formal accession Working Party meetings which took place via Interprefy, the Accessions Division organised virtual technical meetings and briefing sessions with acceding governments, Working Party Chairpersons and partners in support of accessions. Moreover, the Division delivered a number of technical assistance, training and outreach activities in response to articulated needs of acceding governments, using various virtual platforms, such as MS Teams, Zoom and WebEx. In fact, the number of activities delivered by the Division and of participants who attended or were trained in 2020 exceeded considerably the numbers in previous years.

“5. One of the novel outreach programs developed in 2020 was two week-long activities which consisted of a series of webinars combining lectures, training and panel discussions. The first Accessions Week was organised from 29 June to 3 July, and the first edition of the Trade for Peace Week took place from 30 November to 4 December. These virtual events brought together a large number of resource persons and panellists from around the world and reached out to a larger number of participants, in a highly cost-effective manner, in comparison with traditional in-person activities. While the full values and benefits of in-person interaction cannot be replaced or replicated, the Accessions Week enabled the Secretariat to remain engaged with acceding governments and Members, experts and partners, beyond Geneva and around the world. The Trade for Peace Week provided an effective networking platform to expand the WTO’s partnership with the peace and humanitarian communities in support of fragile and conflict affected (FCA) countries in accession.

“6. The importance of collaboration and cooperation with partners was never felt more strongly than in 2020. The Secretariat made concerted efforts to enhance and expand the “Trade for Peace through WTO Accession” Initiative to support FCA countries in accession and those recently acceded to the WTO. In 2020, nine acceding governments were identified as being in a FCA situation according to the World Bank’s classification1, while conflicts emerged or resurged in some others. The pandemic hit hardest countries which had already been suffering from years of conflict, political crises, drought and other natural disasters, compounded by declines of the price of oil and other commodities. Nonetheless, some FCA acceding LDCs showed remarkable resilience in sustaining their engagement in accession. The Working Party on the Accession of the Union of Comoros resumed its work with determination to finalise the process as soon as possible. The Working Party on the Accession of Timor-Leste activated the Working Party by holding its first meeting nearly four years after its establishment, despite various challenges faced on the domestic front. Moreover, Somalia submitted its Memorandum on the Foreign Trade Regime, the base document to start its accession engagement with Members. Furthermore, the Secretariat continued to provide support to the g7+ WTO Accessions Group, which was coordinated by Afghanistan.

“7. The year 2020 marked the 25th anniversary of the WTO. The Secretariat used its annual flagship event, the China Round Table on WTO Accessions, to review the contributions made by accessions to the multilateral trading system since 1995. The event also provided an opportunity for an exchange of ideas to explore the future expansion of WTO membership towards universality, including through possible improvements in the accession process. The year also marked a significant anniversary milestone for five Article XII Members2 – Albania, Croatia, Georgia, Jordan and Oman which joined the WTO in 2000, the year with the largest number of new members to date. Other anniversary milestones included the fifth anniversaries of Membership of Kazakhstan and Seychelles and the fifteenth anniversary for the Kingdom of Saudi Arabia. In recent years, membership anniversaries have become an important occasion to reflect on the benefits and values of being part of the Organization.

“8. Finally, the thematic focus of the 2020 Annual Report was on the complementarities and synergies in negotiating WTO membership and regional trade agreements. Almost all acceding governments are involved in regional integration initiatives in parallel with their efforts to achieve WTO membership. The highlight of the year was the implementation of the African Continental Free Trade Area (AfCFTA) to which all African WTO applicants are signatories. The Report’s thematic section builds on the rich discussions held on the topic during the 2020 Regional Dialogues on WTO Accessions for Africa and for the Arab Region, as well as other meetings on Central Asia and Eurasia. It aims to explore key opportunities and challenges that may arise in a simultaneous pursuit of regional and global integration efforts and to provide a checklist of issues for trade negotiators to consider in maximising the benefits from the participation in multiple trade arrangements.”

The full report is embedded below.

WTACC38

Waiver of TRIPS Obligations During COVID-19 Pandemic

The sixth agenda item involves the effort from India and South Africa with a number of other developing or least developed countries to obtain a waiver from most TRIPS obligations on medical goods needed for the COVID-19 pandemic. This has been a very controversial issue with developed countries with pharmaceutical companies involved in the production of vaccines and other items opposing the waiver on the basis of existing flexibilities within the TRIPS Agreement and on the global efforts through the WHO, GAVI and CEPI to provide vaccines to low- and middle-income countries through COVAX with financial contributions from many countries, NGOs and others. See, e.g., February 19, 2021, COVAX’s efforts to distribute COVID-19 vaccines  to low- and middle income countries — additional momentum received from G-7 virtual meeting, https://currentthoughtsontrade.com/2021/02/19/covaxs-efforts-to-distribute-covid-19-vaccines-to-low-and-middle-income-countries-additional-momentum-from-g-7-virtual-meeting/

The TRIPS Council received the proposal back in October but has been unable to provide a recommendation to the General Council. A meeting of the TRIPS Council earlier this month continued the lack of agreement. Thus, the agenda item will simply result in the item being continued on the General Council’s future agendas until resolved or dropped. See WTO, Members discuss TRIPS waiver request, exchange views on IP role amid a pandemic, 23 February 2021, https://www.wto.org/english/news_e/news21_e/trip_23feb21_e.htm (” In this context and given the lack of consensus on the waiver request, members agreed to adopt an oral status report to be presented to the General Council at its next meeting on 1-2 March. The report indicates that the TRIPS Council has not yet completed its consideration of the waiver request and therefore will continue discussions and report back to the General Council.”); December 11, 2020, Council for Trade-Related Aspects of Intellectual Property Rights meeting of December 10, 2020 – no resolution on proposed waiver of TRIPS obligations to address the pandemic, https://currentthoughtsontrade.com/2020/12/11/council-for-trade-related-aspects-of-intellectual-property-rights-meeting-of-december-10-2020-no-resolution-on-proposed-waiver-of-trips-obligations-to-address-the-pandemic/; December 6, 2020, Upcoming December 11th Council for Trade-Related Aspects of Intellectual Property Rights meeting – reaction to proposed waiver from TRIPS obligations to address COVID-19, https://currentthoughtsontrade.com/2020/12/06/upcoming-december-11th-wto-council-for-trade-related-aspects-of-intellectual-property-rights-meeting-reaction-to-proposed-waiver-from-trips-obligations-to-address-covid-19/; November 2, 2020, India and South Africa seek waiver from WTO intellectual property obligations to add COVID-19 – issues presented, https://currentthoughtsontrade.com/2020/11/02/india-and-south-africa-seek-waiver-from-wto-intellectual-property-obligations-to-address-covid-19-issues-presented/.

Fisheries Subsidies negotiations — Draft Ministerial Decision

The WTO has been pursuing negotiations on fisheries subsidies to address sustainable fishing concerns since the end of 2001. Conclusion of the negotiations were supposed to take place in 2020 but WTO Members were unable to get the job completed in part because of disruptions from the COVID-19 pandemic. While completing the negotiations remains a key objective of Members and the incoming Director-General and such completion is needed to fulfill the UN Sustainable Development Goal 14.6, WTO Members continue to face a large number of challenging issues. See, e.g., WTO press release, WTO members hold February cluster of meetings for fisheries subsidies negotiations, 24 February 2021, https://www.wto.org/english/news_e/news21_e/fish_24feb21_e.htm; February 22, 2021, An early test for the incoming WTO Director-General — helping Members get the Fisheries Subsidies negotiations to a conclusion, https://currentthoughtsontrade.com/2021/02/22/an-early-test-for-the-incoming-wto-director-general-helping-members-get-the-fisheries-subsidies-negotiations-to-a-conclusion/.

Agenda item 7 is entitled “Supporting the Conclusion of Fisheries Subsidies Negotiations for the Sustainability of the Ocean and Fishing Communities — Draft Ministerial Decision — Communication from Brazil (WT/GC/W/815. The draft Ministerial Decision is an effort by Brazil to highlight the critical aspect of the negotiations which is to address environmental sustainability and presumably reflects Brazil’s concerns with the efforts of so many Members to protect their subsidies versus ensuring sustainable fishing. The document is embedded below.

WTGCW815

An attack on Joint Statement Initiatives

As reviewed in the incoming Director-General’s statement on February 15 and the summary of her statement by DDG Wolff on February 25, an important aspect of ongoing work at the WTO is a number of Joint Statement Initiatives that were started at the end of the 11th Ministerial Conference in Buenos Aires, including on e-commerce/digital trade.

Agenda item 10 is a frontal attack on such initiatives by India and South Africa through their paper, “Legal Status of Joint Statement Initiatives and Their Negotiated Outcomes”, WT/GC/819. I had reviewed the submission in an earlier post. See February 20, 2021, Will India and South Africa (and others) prevent future relevance of the WTO?, https://currentthoughtsontrade.com/2021/02/20/will-india-and-south-africa-and-others-prevent-future-relevance-of-the-wto/. The agenda item will like see many delegations take the floor to support the use of joint statement initiatives within the WTO or to oppose them. While there won’t be a resolution of the issue, the challenge to the process could significantly handicap some of the efforts envisioned by the incoming Director-General to help developing and least developed countries take advantage of the e-commerce/digital trade world and eventually participate in talks and/or in an agreement. WT/GC/W/819 is embedded below.

WTGCW819-1

Agenda item 8 is viewed as related to agenda item 10. India has been seeking to limit WTO consideration of e-commerce issues to the multilateral efforts over many years within the existing Councils and Committees of the WTO (but where limited progress has been made).

COVID-19 and possible future pandemics — addressing existing trade restrictions and improving the functioning of the WTO to better handle in the future

The incoming Director-General has as a high priority to work with Members to improve monitoring of export restraints on medical goods and agricultural goods during the pandemic and working with Members to see that the WTO helps Members recover and better handle any future pandemics. The Ottawa Group had put forward a trade and health initiative in November 2020. See COVID-19 AND BEYOND: TRADE AND HEALTH, WT/GC/223 (24 November 2020). The communication was made by Australia, Brazil, Canada, Chile, the European Union, Japan, Kenya, Republic of Korea, Mexico, New Zealand, Norway, Singapore and Switzerland. The document contains an annex reviewing the types of actions Members could take to improve the response to the pandemic and improve conditions going forward. Included in the annex to the communication are sections on export restrictions; customs, services and technical regulations; tariffs; transparency and review; cooperation of the WTO with other organizations. Several paragraphs in the communication review the issue of possible export restrictions on vaccines and are copied below.

“9. We realize that the challenges related to the scarcity of essential medical goods, now alleviated to some extent by the response on the supply side, may be repeated at the moment of the development of a vaccine or new medical treatments. In this context, we welcome the COVID-19 Vaccine Global Access Facility (COVAX), a global pooled procurement mechanism for COVID-19 vaccines, managed by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI) and WHO. This mechanism is critical in securing an equitable share of vaccines for all Members of the international community. As we strongly support the objective of this facility, we call on WTO Members to ensure that any export-restricting measures do not pose a barrier to the delivery of necessary supplies under the COVAX facility.

“10. We recognize the collaborative efforts of private and public stakeholders in the research and development of COVID-19 diagnostics, vaccines and treatments. We encourage the industry to take actions to ensure access at affordable prices to COVID-19 diagnostics, vaccines and treatments for vulnerable populations and support voluntary pooling and licensing of IP rights to accelerate the development of such diagnostics, treatments and vaccines and scaling up their production. We recognize the importance of the IP system in promoting R&D and innovation for access to effective treatments. We note that the flexibilities provided by the TRIPS Agreement and reaffirmed in the Doha Declaration on the TRIPS Agreement and Public Health remain available to protect public health and to promote access to medicines for all.”

The full document is embedded below.

WTGC223

Canada will be providing an update on the initiative at the General Council meeting and will likely see many Members provide comments on the agenda item.

Agenda item 9 was added by Colombia, Costa Rica, Ecuador, Panama and Paraguay reflecting concerns by them (and presumably many other trading partners) about actions taken by the European Union to exert control over exports of vaccines from the EU in light of EU concerns about its own access to vaccines from manufacturers. See CALL TO PREVENT EXPORT RESTRICTIONS ON COVID-19 VACCINES, WT/GC/818 (18 February 2021). The document is embedded below.

WTGCW818

Since the EU is one of the Members who has pushed the trade and health initiative, there is concern by some WTO Members that its actions on vaccines run counter to the initiative it is supporting. Presumably the EU will argue that its actions are consistent with its rights under the WTO and is consistent with the language laid out in paragraphs 9 and 10 above.

The two agenda items are likely to show the concerns of many Members on equitable access to medical goods during the pandemic and the reluctance of at least some Members to reduce their flexibilities under the existing WTO rights and obligations.

Conclusion

DDG Wolff indicated that Members selected the incoming Director-General because she is “fearless in the face of daunting challenges”. There is no shortage of daunting challenges facing the WTO and its new Director-General. A few have been reviewed above.

Some good news is that the EU and the United States are supportive of many of the priorities laid out by DG Ngozi Okonjo-Iweala in her February 15 statement to the Special Session of the General Council as seen in the recent EU revised trade policy and the opening statement of USTR nominee Katherine Tai at yesterday’s Senate Finance Committee confirmation hearing See February 18, 2021, The European Commission’s 18 February 2021 Trade Policy Review paper and Annex — WTO reform and much more proposed, https://currentthoughtsontrade.com/2021/02/18/the-european-commissions-18-february-2021-trade-policy-review-paper-wto-reform-and-much-more-proposed/; February 25, 2021, U.S. Trade Representative nominee Katherine Tai confirmation hearing before the U.S. Senate Finance Committee, https://currentthoughtsontrade.com/2021/02/25/u-s-trade-representative-nominee-katherine-tai-confirmation-hearing-before-the-u-s-senate-finance-committee/.

The challenges the new Director-General and the WTO Members face will be made harder by the lack among Members of a common vision and agreed purpose of the WTO, by the current inability of the WTO system to address fundamentally different economic systems, by the structure of decision making, by the failure of obligations to be updated to match level of economic development and role in global trade and by the related issue of how special and differential treatment is used. These challenges have resulted in a negotiating function that is broken, in a dispute settlement system that has no checks on the reviewers for errors or failures to operate within the bounds of authority granted in the Dispute Settlement Understanding and in the underperformance of the monitoring and implementation function.

Hopefully, DG Okonjo-Iweala will develop a strong personal staff and group of DDGs to help her attempt the seemingly impossible — getting meaningful progress and reform from the 164 current WTO Members. See February 13, 2021, Leadership change at the WTO — with Dr. Ngozi Okonjo-Iweala’s arrival next week, what support team and early changes in the role of the Secretariat could help WTO Members move forward?, https://currentthoughtsontrade.com/2021/02/13/leadership-change-at-the-wto-with-dr-ngozi-okonjo-iwealas-arrival-next-week-what-support-team-and-early-changes-in-the-role-of-the-secretariat-could-help-wto-members-move-forward/

Director-General Ngozi Okonjo-Iweala will get her first reality check at the General Council meeting on March 1-2.


The Biden Administration’s efforts to rein in the COVID-19 pandemic start as global new cases tops ten million over the last two weeks for the first time

January 20, 2021 saw the inauguration of Joseph R. Biden, Jr. as the 46th President of the United States and Kamala D. Harris as the new Vice President. The top priority for the new Administration is addressing the COVID-19 pandemic with a focus on ramping up vaccinations across the country with a goal of 100 million additional vaccination shots in the first 100 days of the new Administration. The new Administration comes into office as the global pandemic records its worst two weeks and records more than ten million confirmed new cases in the last fourteen days (through January 16). See European Centre for Disease Prevention and Control, COVID-19 situation update worldwide, as of week 2 2021, https://www.ecdc.europa.eu/en/geographical-distribution-2019-ncov-cases (total global cases 94.6 million, total deaths 2.037 million, new cases last 14 days 10.052 million). Deaths in the U.S. by January 21st have topped 416,000 and total new cases in the U.S. are over 25 million. https://www.worldometers.info/coronavirus/country/us/. The number of doses of vaccines distributed in the U.S. was 35.99 million on January 20 with 16.524 million vaccinations provided. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/index.html

In a busy first half day as President, President Biden signed seventeen Executive Orders, memoranda and other documents including rejoining the Paris Climate Agreement and notified UN Secretary-General Antonio Gutterres that the United States would remain a member of the World Health Organization. The January 20 letter to Secretary-General Gutteres is copied below and can be found here: https://www.whitehouse.gov/briefing-room/statements-releases/2021/01/20/letter-his-excellency-antonio-guterres/.

The Executive Order signed by President Biden is titled “Executive Order on Organizing and Mobilizing the United States Government to Provide a Unified and Effective Response to Combat COVID-19 and to Provide United States Leadership on Global Health and Security” and can be found here: https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/executive-order-organizing-and-mobilizing-united-states-government-to-provide-unified-and-effective-response-to-combat-covid-19-and-to-provide-united-states-leadership-on-global-health-and-security/. The purpose of the order is laid out in Section 1.

Section 1.  Purpose.  The Federal Government must act swiftly and aggressively to combat coronavirus disease 2019 (COVID-19).  To that end, this order creates the position of Coordinator of the COVID-19 Response and Counselor to the President and takes other steps to organize the White House and activities of the Federal Government to combat COVID-19 and prepare for future biological and pandemic threats. “

The other four sections of the Executive Order deal with “Organizing the White House to Combat COVID-19” (Section 2), “United States Leadership on Global Health and Security and the Global Health and Security and the Global COVID-19 Response” (Section 3), “Prompt Resolution of Issues Related to the United States COVID-19 Response” (Section 4) and general provisions (Section 5). Section 2 includes efforts by the Federal Government to beef up production and distribution of “personal protective equipment, vaccines, tests and other supplies” including through use of the Defense Production Act. Section 3 includes efforts to engage with and strengthen the World Health Organization.

The text of the Executive Order is reproduced below (quotation marks are not added).

Executive Order on Organizing and Mobilizing the United States Government to Provide a Unified and Effective Response to Combat COVID-19 and to Provide United States Leadership on Global Health and Security

January 20, 2021

By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:  

Section 1.  Purpose.  The Federal Government must act swiftly and aggressively to combat coronavirus disease 2019 (COVID-19).  To that end, this order creates the position of Coordinator of the COVID-19 Response and Counselor to the President and takes other steps to organize the White House and activities of the Federal Government to combat COVID-19 and prepare for future biological and pandemic threats. 

Sec. 2.  Organizing the White House to Combat COVID-19.  (a)  In order to effectively, fully, and immediately respond to COVID-19, there is established within the Executive Office of the President the position of Coordinator of the COVID-19 Response and Counselor to the President (COVID-19 Response Coordinator) and the position of Deputy Coordinator of the COVID-19 Response.  The COVID-19 Response Coordinator shall report directly to the President; advise and assist the President and executive departments and agencies (agencies) in responding to the COVID-19 pandemic; coordinate all elements of the COVID-19 response; and perform such duties as the President may otherwise direct.  These duties shall include:  

(i)    coordinating a Government-wide effort to reduce disparities in the response, care, and treatment of COVID-19, including racial and ethnic disparities;

(ii)   coordinating the Federal Government’s efforts to produce, supply, and distribute personal protective equipment, vaccines, tests, and other supplies for the Nation’s COVID-19 response, including through the use of the Defense Production Act, as amended (50 U.S.C. 4501 et seq.);

(iii)  coordinating the Federal Government’s efforts to expand COVID-19 testing and the use of testing as an effective public health response;

(iv)   coordinating the Federal Government’s efforts to support the timely, safe, and effective delivery of COVID-19 vaccines to the United States population;

(v)    coordinating the Federal Government’s efforts to support the safe reopening and operation of schools, child care providers, and Head Start programs, and to help ensure the continuity of educational and other services for young children and elementary and secondary students during the COVID-19 pandemic; and

(vi)   coordinating, as appropriate, with State, local, Tribal, and territorial authorities.

(b)  The COVID-19 Response Coordinator shall have the authority to convene principals from relevant agencies, in consultation with the Assistant to the President for Domestic Policy (APDP) on matters involving the domestic COVID-19 response, and in consultation with the Assistant to the President for National Security Affairs (APNSA) on matters involving the global COVID-19 response.  The COVID-19 Response Coordinator shall also coordinate any corresponding deputies and interagency processes.

(c)  The COVID-19 Response Coordinator may act through designees in performing these or any other duties.

Sec. 3.  United States Leadership on Global Health and Security and the Global COVID-19 Response. (a)  Preparing to Respond to Biological Threats and Pandemics.  To identify, monitor, prepare for, and, if necessary, respond to emerging biological and pandemic threats: 

(i)   The APNSA shall convene the National Security Council (NSC) Principals Committee as necessary to coordinate the Federal Government’s efforts to address such threats and to advise the President on the global response to and recovery from COVID-19, including matters regarding:  the intersection of the COVID-19 response and other national security equities; global health security; engaging with and strengthening the World Health Organization; public health, access to healthcare, and the secondary impacts of COVID-19; and emerging biological risks and threats, whether naturally occurring, deliberate, or accidental. 

(ii)  Within 180 days of the date of this order, the APNSA shall, in coordination with relevant agencies, the COVID-19 Response Coordinator, and the APDP, complete a review of and recommend actions to the President concerning emerging domestic and global biological risks and national biopreparedness policies.  The review and recommended actions shall incorporate lessons from the COVID-19 pandemic and, among other things, address:  the readiness of the pandemic supply chain, healthcare workforce, and hospitals; the development of a framework of pandemic readiness with specific triggers for when agencies should take action in response to large-scale biological events; pandemic border readiness; the development and distribution of medical countermeasures; epidemic forecasting and modeling; public health data modernization; bio-related intelligence; bioeconomic investments; biotechnology risks; the development of a framework for coordinating with and distributing responsibilities as between the Federal Government and State, local, Tribal, and territorial authorities; and State, local, Tribal, and territorial preparedness for biological events. 

(b)  NSC Directorate on Global Health Security and Biodefense.  There shall be an NSC Directorate on Global Health Security and Biodefense, which shall be headed by a Senior Director for Global Health Security and Biodefense.  The Senior Director shall be responsible for monitoring current and emerging biological threats, and shall report concurrently to the APNSA and to the COVID-19 Response Coordinator on matters relating to COVID-19.  The Senior Director shall oversee the Global Health Security Agenda Interagency Review Council, which was established pursuant to Executive Order 13747 of November 4, 2016 (Advancing the Global Health Security Agenda To Achieve a World Safe and Secure From Infectious Disease Threats), and is hereby reconvened as described in that order.

(c)  Responsibility for National Biodefense Preparedness.  Notwithstanding any statements in the National Security Presidential Memorandum-14 of September 18, 2018 (Support for National Biodefense), the APNSA shall be responsible for coordinating the Nation’s biodefense preparedness efforts, and, as stated in sections 1 and 2 of this order, the COVID-19 Response Coordinator shall be responsible for coordinating the Federal Government’s response to the COVID‑19 pandemic.

Sec. 4.  Prompt Resolution of Issues Related to the United States COVID-19 Response.  The heads of agencies shall, as soon as practicable, bring any procedural, departmental, legal, or funding obstacle to the COVID-19 response to the attention of the COVID-19 Response Coordinator.  The COVID-19 Response Coordinator shall, in coordination with relevant agencies, the APDP, and the APNSA, as appropriate, immediately bring to the President’s attention any issues that require Presidential guidance or decision-making.

Sec. 5.  General Provisions.  (a)  Nothing in this order shall be construed to impair or otherwise affect: 

(i)   the authority granted by law to an executive department or agency, or the head thereof; or

(ii)  the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.

(b)  This order shall be implemented consistent with applicable law and subject to availability of appropriations.

(c)  This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

JOSEPH R. BIDEN JR. 

On the White House webpage, there is a section on the Biden Administration’s priorities. The section on COVID-19 provides explanation of the actions perceived to be needed, including increased production of personal protective equipment and additional funding to help with vaccinations, keeping schools open and help state and local governments cope with the revenue shortfalls from the pandemic. See White House Priorities,COVID-19, The Biden-Harris plan to beat COVID-19, https://www.whitehouse.gov/priorities/covid-19//. The COVID-19 priority description is copied below.

“The American people deserve an urgent, robust, and professional response to the growing public health and economic crisis caused by the coronavirus (COVID-19) outbreak. President Biden believes that the federal government must act swiftly and aggressively to help protect and support our families, small businesses, first responders, and caregivers essential to help us face this challenge, those who are most vulnerable to health and economic impacts, and our broader communities – not to blame others or bail out corporations.

“The Biden-Harris administration will always:

Listen to science

Ensure public health decisions are informed by public health professionals

Promote trust, transparency, common purpose, and accountability in our government

“President Biden and Vice President Harris have a seven-point plan to beat COVID-19.

Ensure all Americans have access to regular, reliable, and free testing.

“Double the number of drive-through testing sites.

“Invest in next-generation testing, including at home tests and instant tests, so we can scale up our testing capacity by orders of magnitude.

“Stand up a Pandemic Testing Board like Roosevelt’s War Production Board. It’s how we produced tanks, planes, uniforms, and supplies in record time, and it’s how we will produce and distribute tens of millions of tests.

“Establish a U.S. Public Health Jobs Corps to mobilize at least 100,000 Americans across the country with support from trusted local organizations in communities most at risk to perform culturally competent approaches to contact tracing and protecting at-risk populations.

Fix personal protective equipment (PPE) problems for good.

“President Biden is taking responsibility and giving states, cities, tribes, and territories the critical supplies they need.

“Fully use the Defense Production Act to ramp up production of masks, face shields, and other PPE so that the national supply of personal protective equipment exceeds demand and our stores and stockpiles — especially in hard-hit areas that serve disproportionately vulnerable populations — are fully replenished.

“Build immediately toward a future, flexible American-sourced and manufactured capability to ensure we are not dependent on other countries in a crisis.

“Provide clear, consistent, evidence-based guidance for how communities should navigate the pandemic – and the resources for schools, small businesses, and families to make it through.

“Social distancing is not a light switch. It is a dial. President Biden will direct the CDC to provide specific evidence-based guidance for how to turn the dial up or down relative to the level of risk and degree of viral spread in a community, including when to open or close certain businesses, bars, restaurants, and other spaces; when to open or close schools, and what steps they need to take to make classrooms and facilities safe; appropriate restrictions on size of gatherings; when to issue stay-at-home restrictions.

“Establish a renewable fund for state and local governments to help prevent budget shortfalls, which may cause states to face steep cuts to teachers and first responders.

“Call on Congress to pass an emergency package to ensure schools have the additional resources they need to adapt effectively to COVID-19.

“Provide a ‘restart package’ that helps small businesses cover the costs of operating safely, including things like plexiglass and PPE.

“’THIS ISN’T ABOUT POLITICS. IT’S ABOUT SAVING LIVES.’

“PRESIDENT BIDEN, SEPTEMBER 16, 2020

Plan for the effective, equitable distribution of treatments and vaccines — because development isn’t enough if they aren’t effectively distributed.

“Invest $25 billion in a vaccine manufacturing and distribution plan that will guarantee it gets to every American, cost-free.

“Ensure that politics plays no role in determining the safety and efficacy of any vaccine. The following 3 principles will guide the Biden-Harris administration: Put scientists in charge of all decisions on safety and efficacy; publicly release clinical data for any vaccine the FDA approves; and authorize career staff to write a written report for public review and permit them to appear before Congress and speak publicly uncensored.

“Ensure everyone — not just the wealthy and well-connected — in America receives the protection and care they deserve, and consumers are not price gouged as new drugs and therapies come to market.

Protect older Americans and others at high risk.

“President Biden understands that older Americans and others at high-risk are most vulnerable to COVID-19.

“Establish a COVID-19 Racial and Ethnic Disparities Task Force, as proposed by Vice President Harris, to provide recommendations and oversight on disparities in the public health and economic response. At the end of this health crisis, it will transition to a permanent Infectious Disease Racial Disparities Task Force.

“Create the Nationwide Pandemic Dashboard that Americans can check in real-time to help them gauge whether local transmission is actively occurring in their zip codes. This information is critical to helping all individuals, but especially older Americans and others at high risk, understand what level of precaution to take.

Rebuild and expand defenses to predict, prevent, and mitigate pandemic threats, including those coming from China.

“Immediately restore the White House National Security Council Directorate for Global Health Security and Biodefense, originally established by the Obama-Biden administration.

“Immediately restore our relationship with the World Health Organization, which — while not perfect — is essential to coordinating a global response during a pandemic.

“Re-launch and strengthen U.S. Agency for International Development’s pathogen-tracking program called PREDICT.

“Expand the number of CDC’s deployed disease detectives so we have eyes and ears on the ground, including rebuilding the office in Beijing.

“Implement mask mandates nationwide by working with governors and mayors and by asking the American people to do what they do best: step up in a time of crisis.

“Experts agree that tens of thousands of lives can be saved if Americans wear masks. President Biden will continue to call on:

“Every American to wear a mask when they are around people outside their household.

“Every Governor to make that mandatory in their state.

“Local authorities to also make it mandatory to buttress their state orders.

“Once we succeed in getting beyond this pandemic, we must ensure that the millions of Americans who suffer long-term side effects from COVID don’t face higher premiums or denial of health insurance because of this new pre-existing condition. The Biden-Harris Administration will work to ensure that the protections for those with pre-existing conditions that were won with Obamacare are protected. And, they will work to lower health care costs and expand access to quality, affordable health care through a Medicare-like public option.”

Comments

While significant parts of the full-throated Biden plan to address the COVID-19 pandemic will require Congressional action on a stimulus package ($1.9 trillion is what is being sought by the Biden team), there are clear areas of action that will take place including increased use of the Defense Production Act to ensure adequate supplies of PPEs to address the needs of all communities in the United States. The U.S. will now have a national plan for both reducing the spread of the virus and for expanding the ability to achieve the desired level of vaccinations. The U.S. will work with the WHO and other members to make the WHO more effective and will participate in COVAX to help ensure vaccine availability for all peoples. The U.S. will also reinstate the efforts to improve detecting and tracking viruses around the world and developing a better prevention and response effort.

Without Congressional action on a significant stimulus package in the coming weeks, the U.S. economy will likely suffer significant contraction as employment levels, already at levels depressed from those when President Trump took office in 2017, will continue to worsen, millions of Americans will be forced from homes and apartments, and tens of thousands of additional business will fold. The Biden plan offers hope that a national plan with cooperation from the states will lead to a curbing of the pandemic and hopefully by the third or fourth quarter of 2021, a return to a more normal state of life for Americans. With the tremendous contraction in some sectors of the U.S. and global economies (e.g., tourism), the Biden plan offers hope of revival as the year progresses.

U.S. engagement with the WHO and participation in COVAX will help improve the global ability to respond to the pandemic in particular by improving the likelihood that vaccines will be available to peoples in all countries as the year progresses.

While economists generally don’t support the concept of onshoring production of particular products, the use of the Defense Production Act to expand production of PPEs that are or are likely to be in short supply will expand global supplies which should be of assistance to other countries as well as the U.S. as the global surge of cases continues.

Nothing in the first day’s activities by the Biden Administration was directly aimed at the World Trade Organization or trade relations. However, the intent of the Biden Administration to work with allies and within multilateral organizations and treaties — as seen in the rejoining of the Paris Climate Agreements and retraction of the notice of withdrawal from the WHO — suggest that the Biden team will be looking for ways to strengthen the WTO while addressing core U.S. concerns.

COVID-19 Trade and Economic Fallout — Are current projections too optimistic?

The COVID-19 pandemic is not simply a global health crisis but also a global economic crisis of unprecedented proportions.

The WTO has projected that global trade will decline between 13 and 32 percent in 2020 before rebounding in 2021.  https://www.wto.org/english/news_e/pres20_e/pr855_e.htm.

The IMF in its April 2020 update of the global economy modified its projection to show global GDP contraction of 3.0% for 2020 with a 6.1% contraction by advanced economies (U.S., -5.9%; Euro Area, -7.9%; Japan, -5.2) and a 1.0% contraction for emerging markets and developing economies.  https://www.imf.org/en/Publications/WEO/Issues/2020/04/14/weo-april-2020.

Developments in global trade and the national economy for the United States and the rising severity of the pandemic in some of the emerging and developing countries will likely cause future downward revisions to the global trade and economic fallout occurring in 2020 and reemphasize the importance of global cooperation both in responding to the pandemic but also in posturing the world for an economic recovery in the second half of 2020 and beyond.

United States data through April as an example

Gross domestic product in the United States declined 5.0% in the first quarter of 2020 based on a May 28, 2020 second estimate provided U.S. Department of Commerce’s Bureau of Economic Analysis.  https://www.bea.gov/sites/default/files/2020-05/gdp1q20_2nd_0.pdf.

With more than 40 million people filing for unemployment benefits between mid-March and the end of May, the projection for second quarter GDP from at least one source on June 1, 2020 is an extraordinary contraction of 52.8%.  See https://www.frbatlanta.org/cqer/research/gdpnow.  This compares to the Congressional Budget Office’s projection of a 39.6% decline in the second quarter.  https://www.cbo.gov/publication/56335.  The CBO estimate uses a 3.5% decline in GDP for the first quarter and an annual projected decline of 5.6% for 2020.

With the current first quarter data GDP contraction in the U.S. at 5.0% and the most recent data from a model similar to that used by the Bureau of Economic Analysis projecting a 52.8% contraction in the second quarter, it is highly likely that the U.S. contraction in 2020 will exceed the 5.9% projected in the April IMF data.

Indeed, with the number of bankruptcies being reported in the U.S. and the large number of small and medium sized companies that may not be able to return to operation as reopening occurs, the economic rebound may not be as strong as current projections estimate either.  The continued large number of new cases in the United States may be a contributing cause as some states either delay the speed of reopening or face larger resurgence of cases once reopening occurs because of the continued high level of COVID-19 in the population.

While the number of cases in the United States has at least stabilized and has been  trending down, the rate of decline is far lower than that experienced in western Europe.  For example, the United States continues to have the largest number of new confirmed cases of any country in the world, many weeks after the U.S. peak.  Indeed in today’s European Centre for Disease Prevention and Control report on the COVID-19 situation update worldwide, as of 2 June 2020, the U.S. has 302,679 cases reported in the last fourteen days of the continuing to grow global total of 1,477,362 new cases in the last fourteen days.  European countries have relatively few (7,973 for Spain; 7,311 for Italy, 9,188 for France and 6,818 for Germany).  https://www.ecdc.europa.eu/en/geographical-distribution-2019-ncov-cases.  In a prior post, data were shown for various countries over the period December 31, 2019 – May 24, 2020.  Most European countries show reductions from their peak two week period of 80-90% while the United States has shown declines of only 23.5% through May 24 (slightly more through June 2, 26.0%).  See COVID-19 – new hot spots amidst continued growing number of confirmed cases,  https://currentthoughtsontrade.com/2020/05/25/covid-19-new-hotspots-amidst-continued-growing-number-of-confirmed-cases/.  To the extent that IMF projections are based on infection rates that decline more rapidly than the actual U.S. experience with COVID-19, that would be another reason to believe the IMF projected contractions for the U.S. are too low. 

On the trade front, the United States was doing well until mid-March.  But the COVID-19 challenges that resulted in government actions led to 1st quarter 2020 exports from the U.S. of goods being down 1.2%, services exports down 21.5% for a total contraction of U.S. exports of 6.7%.  U.S. imports of goods were down 11.5%, led by contraction of imports from China due to various additional duties imposed on Chinese goods.  U.S. imports of services were down 29.9% for total imports being down 15.5%.  See Bureau of Economic Analysis, News Release BEA 20-23, May 28, 2020 at 7, https://www.bea.gov/news/2020/gross-domestic-product-1st-quarter-2020-second-estimate-corporate-profits-1st-quarter.

The U.S. Department of Commerce, U.S. Census Bureau puts out a “Monthly Advance Economic Indicators Report”.  The April 2020 report was released on May 29th and showed estimated data for imports and exports of goods (seasonally adjusted).  April exports for the U.S. were down 29.9% with individual sectors being down 5.3% (food, feeds and beverages) to 70.8% (automotive vehicles).  Similarly, U.S. imports were down 20.6% for April with sectors varying from being down 5.6% (foods, feeds and beverages) to 57.0% (automotive vehicles).  https://www.census.gov/econ/indicators/advance_report.pdf.

Thus, U.S. trade contractions in April suggest that the range put forward by the WTO (13-32% for the year) is probably the correct range. 

Rising Number of COVID-19 cases in South America and in India

The IMF revised 2020 projections from April likely understate the negative effects that emerging and developing countries are experiencing.  Specifically, Latin America and the Caribbean are seeing major outbreaks of COVID-19 cases with the peak not yet reached in a number of important countries like Brazil, Peru, Chile and Colombia and also in Mexico.  Depending on developments in these major countries and the spread in others, the likely economic contraction in the region could be significantly higher than the 5.2% contained in the April 2020 projections by the IMF.  Brazil was estimated to experience a GDP contraction of 5.3% by the IMF, but recent estimates show a steadily growing projected contraction, latest figures showing 6.25%.  See https://www.statista.com/statistics/1105065/impact-coronavirus-gdp-brazil/.  With the COVID-19 cases still growing in Brazil, the contraction in GDP for 2020 will likely continue to worsen.

Similarly, India was projected to have GDP growth of 1.9% in 2020.  The country’s challenges with COVID-19 cases are just starting with the current total number of confirmed cases at just under 200,000 but with nearly half of the cases reported in the last fourteen days (97,567 of 198,706).   Indeed, some recent projections by Oxford Economics now have India’s GDP contracting in 2020.  See https://www.icis.com/explore/resources/news/2020/06/01/10513907/india-gdp-growth-slows-to-4-2-lockdown-stays-at-manufacturing-hubs.

Other countries are also seeing increasing case numbers and the global totals of new cases have not peaked as yet which likely mean greater numbers of cases than most models have anticipated.  If so global contraction could be significantly worse than the April estimates of the IMF.

High national debt levels are growing higher   

The collapse of economic activity even for a few months is reducing tax revenues, increasing government spending in many jurisdictions and worsening national debt levels.  For example, in the United States the Congressional Budget Office blog from April 24 estimated that the U.S. budget deficit in 2020 and 2021 will be $2.7 billion and $1.1 billion higher than earlier estimates and that federal debt held by the public is likely to grow from 79% of GDP in 2019 to 101% of GDP in 2020 and 108% of GDP in 2021.  https://www.cbo.gov/publication/56335.  The actual deficits and federal debt are likely to be significantly higher as the CBO estimates are based on forecasts for GDP contraction that already understates the severity experienced through the first quarter and assumes no further federal assistance will be required to pull the economy out of the steep contraction being experienced in the second quarter.  As governors across the country have made clear, the serious budget shortfalls being experienced by the states because of closed businesses, reduced revenues and increased expenditures are not sustainable.  If these 2020 shortfalls are not addressed through federal legislation, the outcome will be large reductions in state and local services and massive layoffs of state and municipal employees including police, fire, health care and teachers.  So either the budget shortfall of the federal government is understated because of additional stimulus funding needs or the expected recovery of the economy (and hence government revenues) is overstated because of the challenges for many states.

Virtually every country is facing budget challenges as they attempt to address the COVID-19 pandemic and its economic fallout.  See, e.g., articles on growing budget deficits for France, Italy, Brazil and India; https://www.reuters.com/article/us-health-coronavirus-France-budget/france-more-than-doubles-crisis-package-cost-to-100-billion-euros-idUSKCN21R2J2; https://www.nytimes.com/reuters/2020/05/22/world/americas/22reuters-brazil-economy.html; https://www.reuters.com/article/us-health-coronavirus-italy-budget-exclu/exclusive-italy-sees-2020-budget-deficit-near-10-of-gdp-source-idUSKBN21Y2U9; https://economictimes.indiatimes.com/news/economy/indicators/indias-fiscal-deficit-may-shoot-to-6-2-of-gdp-in-fy21-fitch-olutions/articleshow/74928660.cms?from=mdr#:~:text=NEW%20DELHI%3A%20India’s%20fiscal%20deficit,Fitch%20Solutions%20said%20on%20Wednesday.  

Budget shortfalls, the need to borrow more money and the pressure to reduce national, regional and local services all affect the ability of nations to contribute to international institutions, to provide financial assistance to the poorest countries and to facilitate short-, medium- and longer-term growth.

Conclusion

The global COVID-19 pandemic is creating economic havoc in addition to the heavy health toll on countries around the world.  A global challenge of this magnitude hasn’t been faced since World War II.  The projections that have been made by multilateral and national organizations have been for huge contractions in world trade and in global economic growth.  Unfortunately, the estimates at least on global GDP contraction are likely too optimistic both in terms of the severity of the second quarter 2020 contraction and the anticipated level of  second half 2020 recovery.  Moreover, there is likely to be significantly more national stimulus programs needed to help economies recover increasing already huge national debts for many countries and the likely greater need for trade financing and debt support for many developing and least developed countries because of the severity of the global trade and GDP contraction. 

The challenges being faced affect the health and livelihood of billions of people but are occurring at a time of reduced trust in multilateral institutions, increased trade frictions between major nations and groups of nations and a lack of strong leadership within and among nations.  

How severe the damage to the world turns out to be from the pandemic will depend on –

(1) whether countries come together to ensure open markets;

(2) whether countries both coordinate information about and promote expanded production of essential medical goods to ensure adequate and equitable availability to all at affordable prices,

(3) whether countries support efforts of both public and private players on the development of effective vaccines and therapeutics and facilitate the sharing of information while ensuring equitable availability to all at affordable prices where breakthroughs occur,

(4) whether countries support multilateral organizations’ efforts and individually support the bolstering of health care infrastructure of least developed countries and some developing countries where COVID-19 cases could easily overwhelm internal capabilities;

(5) whether countries cooperate for a strong global recovery by pursuing stimulus programs that don’t distort markets and create other challenges to global participation, and by providing multilateral organizations with the resources to address debt and trade financing needs of the poorest among us.

There are some efforts to address each of the five items above although the U.S. announced withdrawal from the World Health Organization handicaps efforts reviewed in (3). 

More needs to be done and could be done with greater cooperation among the top 50 countries in the world.  However, we may be at the maximum of what is the art of the possible at the moment.  For the 7.8 billion people living on earth in 2020, let us hope that more is possible quickly. 

 

 

 

 

 

 

U.S. Withdrawal from the World Health Organization and Decision to Revoke Preferential Treatment for Hong Kong — Reduced Cooperation as COVID-19 Pandemic Rages on

On May 29, 2020, President Trump indicated that the United States was withdrawing from the World Health Organization (“WHO”) because of the WHO’s failure to adopt reforms the U.S. had demanded and the belief of a bias within the WHO towards China and China’s failure to provide timely information on the start of the virus and the likely nature of the problem. https://www.nytimes.com/2020/05/29/us/politics/trump-hong-kong-china-WHO.html. This followed the U.S.’s earlier temporary withholding of funds from the WHO while awaiting developments on reforms.

President Trump also indicated that in light of actions by China to assert security controls over Hong Kong, the U.S. viewed China as violating its commitment to maintain “one China, two systems” and would accordingly be taking actions to remove special treatment provided Hong Kong in a wide range of areas (extradition, export controls, etc.) and would be treating Hong Kong as part of China for tariffs, export controls, etc. https://www.wsj.com/articles/u-s-to-cancel-visas-for-some-chinese-graduate-students-11590744602.

Not surprisingly, China has reacted negatively to the statements of President Trump on Hong Kong and has threatened to take retaliatory actions if the U.S. takes actions contrary to China’s interests and indicated that any U.S. action was doomed to fail. https://www.bloomberg.com/news/articles/2020-05-30/china-says-us-action-on-hong-kong-doomed-to-fail; https://www.cnbc.com/2020/05/30/china-says-us-action-on-hong-kong-doomed-to-fail.html.

Concerns have also been raised that U.S. action would be a double-edged sword in light of the large trade surplus the U.S. has with Hong Kong and the enormous presence of U.S. businesses in Hong Kong. For example, based on U.S. Census data as compiled by the U.S. International Trade Commission, the United States had a trade surplus with Hong Kong (total exports – general imports) of $26.086 billion in 2019 [the trade surplus based on domestic exports – imports of consumption being lower at $11.845 billion]. While China has not identified actions it is considering, harming U.S. interests in Hong Kong would obviously be one avenue China might take.

The trade implications, in terms of U.S. imports from Hong Kong, are relatively minor. If imports from Hong Kong are treated as imports from China, imports of items subject to additional duties from the 301 investigation would be relatively minor. That is because U.S. imports for consumption from Hong Kong in 2019 were just $4.646 billion, with half of that being under HS 9810 for articles that have been imported after exportation, after repair, etc. If China were to impose additional duties on U.S. exports to Hong Kong, the effect would be larger. U.S. domestic exports to Hong Kong in 2019 were $16.491 billion.

Increased tensions; reduced cooperation

Whatever the merits of the actions being taken by the United States (and the reactions anticipated from China), the results are predictable — we are entering a period of reduced cooperation and coordination of actions to address the pandemic as well as increasing bilateral tensions between the U.S. and China at a time of global economic contraction. This despite the fact that cooperation has been less than robust even before the current increased tensions.

In the trade arena, the pandemic continues to grow in severity as confirmed cases continue to climb globally with the hot spots shifting. Cooperation at the WTO and G20 is critical in terms of keeping markets open, minimizing export restraints, addressing logistics needs in a manner that preserves the health needs of importing countries, avoiding inventory builds of agricultural products, the introduction of export restraints where there is no underlying agriculture production problem globally, taking actions to expand production of medical goods to meet the demand surge flowing from the pandemic, ensuring transparency, and promoting best practices. The world is struggling already to achieve the trade needs identified above. Reduced cooperation will make the challenges that much harder.

Similarly, the search for vaccines, therapeutics and diagnostics to effectively prevent, treat and identify medical needs requires global cooperation, information sharing and the work of a multilateral institution like the WHO and various NGOs to ensure all peoples who need these products have equitable and affordable access to them when developed. Trials on potential vaccines are at various stages in China, in the United States and in Europe and possibly other areas. Often the research is amongst companies working jointly from multiple jurisdictions. Which research project or projects will prove effective, if any, is obviously not known. Implications of a lack of cooperation between countries should effective vaccines, therapeutics and diagnostics be developed are for the possible hording of products, refusal to sell to other countries or delays in sharing and other actions that would make global escape from the pandemic harder, longer and more deadly.

And for many developing and least developed countries, the pandemic, whether significantly affecting individual countries directly, threatens most countries through contraction in global trade (estimated to be between 13 and 32% by the WTO in 2020), limited financial capabilities to address budget shortfalls and increased unemployment and challenges to existing health care infrastructure from the pandemic. Multilateral institutions like the World Bank and the IMF and others are critical here but are dependent on the cooperation of key members like the U.S., China, and others. While these organizations have been working effectively to date, the size of the challenge posed by the pandemic which is unprecedented will likely result in additional funding needs in the coming months or years which will require cooperation to meet.

Conclusion

The United States and China have very different economic and political systems. In the trade sphere, the United States has reached the conclusion that coexistence of such disparate systems doesn’t make sense under the World Trade Organization’s rules which are premised on market-based economic policies. The U.S. actions vis-a-vis China on trade have been an effort to achieve reciprocity with China, a situation not possible under the existing WTO rules. That the U.S. effort to obtain reciprocity in fact is proving contentious is hardly surprising and will not likely lessen in bilateral tensions in the near future.

In the political sphere, our two systems have resulted and will continue to result in periodic tensions, such as we are currently witnessing over the actions of China on security measures in Hong Kong.

Historically, major nations who view each other as adversaries have been able to cooperate effectively on issues of mutual interest. That was true during the cold war between the U.S. and the Soviet Union on certain issues. Whether the U.S. and China view each other as adversaries as well as competitors at the present time, the same ability to cooperate between them should be true when looking at issues such as addressing the pandemic effectively and efficiently.

Let us hope that regardless of the bilateral tensions and of the U.S. departure from the WHO, all WTO Members can step up their efforts to keep markets open and transparent and that governments will cooperate to ensure that medical developments are available to all on an equitable and affordable basis and that the financial resources are available to help those least able to weather the pandemic’s effects alone to survive and move forward.