Director-General Ngozi Okonjo-Iweala

COVID-19 vaccines — role of WTO and developments at May 5-6, 2021 General Council meeting on TRIPS Waiver

As the COVID-19 pandemic continues to create problems around the world, there has been increased activity in many countries and at multilateral organizations seeking to expand COVID-19 vaccine production and increase access to vaccines for low- and middle-income countries. While a number of vaccines have been approved by one or more countries (usually on an emergency use authorization basis) and a few have been approved the World Health Organization, a number of others are seeking approval or are in final stages of trials.

The European Centre for Disease Prevention and Control now issues a weekly update on the COVID-19 situation worldwide. Today’s release of data for week 17 of 2021 shows global cases since the beginning at 153,220,576 of which the Americas has the largest share with 41.16% (63,068,547 cases; U.S. being 32.4 million; Brazil being 14.8 million; Argentina being 3.0 million; Colombia being 2.9 million and Mexico being 2.3 million). Europe is second with 33.10% of the total cases (50,722,884; France with 5.7 million, Turkey with 4.9 million, Russia with 4.8 million, the U.K. with 4.4 million and Italy with 4.0 million). Asia represents 22.70% of cases (34,785,351 of which India is 19.9 million, Iran is 2.5 million, Indonesia is 1.7 million, Iraq is 1.1 million and the Philippines is 1.1 million). Africa accounts for 2.98% of cases (4,571,789 of which South Africa has reported 1.6 million and no other countries have more than 0.5 million). Oceania accounts for 0.05% of cases (71,300). See European Centre for Disease Prevention and Control, COVID-19 situation update worldwide, as of week 17, updated 6 May 2021, https://www.ecdc.europa.eu/en/geographical-distribution-2019-ncov-cases.

Deaths are similarly distributed globally with the Americas having 47.79% of global deaths (1,533,740 of 3,209,416); Europe having 33.47% (1,074,175), Asia having 14.89% (477,851), Africa having 3.81% (122,304) and Oceania having 0.04% (1,340). Id.

The world has seen increases in new cases for the last ten weeks in a row and has had the highest number of cases per week in the most recent weeks as the copied graphic from today’s ECDC publication shows.

Distribution of COVID-19 cases worldwide, as of week 17 2021

Distribution of COVID-19 cases worldwide, as of week 17 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.”

As the news accounts make clear, India is facing major challenges and has accounted for a very large part of new cases in recent weeks. For example, over the last 14 days, India reported 4.86 million new cases. This is the first time any country has amassed more than four million cases in a two week period. India has accounted for 42.61% of the world total of new cases in that two week period. Id.

Press accounts have shown a health care system in India struggling to keep up with shortages of everything from ICU units to PPE to medications to oxygen and with a small part of the population totally vaccinated or having received the first of two shots. BBC News, Coronavirus: How India descended into Covid-19 chaos, 5 May 2021, https://www.bbc.com/news/world-asia-india-56977653.

In response to its internal crisis, India has diverted production of COVID-19 vaccines to domestic use, essentially halting exports, complicating the efforts of the COVAX facility to get vaccines to the 91 low- and middle-income countries (other than India which also is supposed to receive vaccines from COVAX). While COVAX has shipped more than 53 million doses to 121 countries as of May 4, as much as 90 million additional vaccine doses were supposed to be supplied by Indian producers to COVAX during April and May that will not make it into the system. See, e.g., Gavi, COVAX vaccine rollout, https://www.gavi.org/covax-facility; Gavi, COVAX updates participants on delivery delays for vaccines from Serum Institute of India (SII) and AstraZeneca, 25 March 2021, https://www.gavi.org/news/media-room/covax-updates-participants-delivery-delays-vaccines-serum-institute-india-sii-az.

Considering the challenges that India is facing, many nations have been providing assistance in an effort to support India as it attempts to cope with the current surge of cases, hospitalizations and deaths. The U.S. assistance is summarized in a fact sheet from the White House which is embedded below.

FACT-SHEET_-Biden-Harris-Administration-Delivers-Emergency-COVID-19-Assistance-for-India-_-The-White-House

A number of countries in South America are also seeing major problems — e.g., Brazil, Argentina, Colombia, Peru — though receiving far less attention than India.

Vaccination development, production and distribution

Efforts have been made over the last decade to develop tools and organizations to develop, produce and distribute vaccines to achieve greater equity in access and affordability of vaccines. The WHO, Gavi, CEPI and UNICEF along with important private sector actors like the Bill and Melinda Gates Foundation have worked hard to both support research of potential vaccines to address the COVID-19 pandemic, worked with companies to arrange purchases of vaccines if approved for use, raised funds from governments and private sector participants to pay for the efforts on research and procurement, and organized distribution to the 92 low- and middle-income countries sufficient to address 20% of the populations as well as for any other countries choosing to work through the COVAX facility.

At the same time, a number of countries have negotiated contracts with companies developing vaccines. Because at the time of contracting, it was not known which vaccines would be effective or achieve approval from which governments, major advanced economies often contracted for quantities far in excess of likely needs (assuming all vaccines were eventually approved).

Because of the unprecedented government funding and industry cooperation, a number of vaccines were developed and approved on at least an emergency use basis and production efforts began in late 2020 and have been ramping up in 2021. This includes vaccines developed in the U.S., the European Union, the United Kingdom, China, India and Russia. While all have not yet been approved by the WHO, all have been approved by at least a number of governments. A number of others are either in the approval process or in final stage trials with vaccine approvals likely in the second half of 2021.

It is expected that capacity to produce more than 10 billion doses of vaccines to fight COVID-19 will be operational by the end of 2021. COVAX contracts and deliveries to economies outside of COVAX have anticipated relatively small volumes in the 1st quarter of 2021, with increases in each of the next three quarters. UNICEF has a “COVID-19 Vaccine Market Dashboard” which it describes as follows (https://www.unicef.org/supply/covid-19-vaccine-market-dashboard):

“The COVID-19 Vaccine Market Dashboard is the go-to public resource for the latest information on the world’s COVID-19 vaccine market and the COVAX Facility’s vaccine deliveries.

“From a global vaccine market perspective, the dashboard gives an overview of:  

“- COVID-19 vaccine development and progress towards vaccine approvals

“- Reported global vaccine production capacity

“- Manufacturing agreements  

“- Vaccines secured and optioned through bilateral and multilateral supply agreements  

“- Reported vaccine prices

“The ‘Delivery’ tab of the dashboard provides daily updates on total COVAX vaccine deliveries, doses allocated, and doses ordered. It also includes country- and economy level data on vaccine deliveries and planned shipments over a seven-day period. This information covers both UNICEF-procured doses and deliveries, as well as other national and institutional buyers participating in the COVAX Facility. It further tracks globally reported vaccine deliveries and vaccine donations outside of COVAX.”

For example, looking at the capacity figures from the dashboard by development stage shows 4 billion dose capacity approved for use in the first half of 2021, growing to 8 billion dose capacity approved for use in the second half of 2021, with 19 billion dose capacity projected for each of 2022 and 2023 as being approved for use.

There have been challenges in ramping up production, including manufacturing issues at individual companies, bottlenecks in supply chains for particular inputs, export restrictions in place for some, etc. In prior posts I have reviewed data pulled together by industry and others on the challenges as well as the enormous level of voluntary licensing, and other arrangements to grow capacity and production. Industry estimates have consistently been that capacity will be at 10-15 billion doses by the end of 2021 — an extraordinary accomplishment considering global capacity for vaccines previously (roughly 5 billion doses for all vaccines). See, e.g., April 18, 2021, WTO’s April 14th virtual meeting to review COVID-19 vaccine availability, https://currentthoughtsontrade.com/2021/04/18/wtos-april-14th-virtual-meeting-to-review-covid-19-vaccine-availability/ (” 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.” (emphasis added)); 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/.

As of May 5, 3032, Bloomberg reports that more than 1.21 billion COVID-19 doses have been administered. The top six areas for vaccinations are China (284.6 million doses administered), the United States (249.6 million), India (162.4 million), the EU (158.6 million), the U.K. (50.7 million) and Brazil (50.2 million). See Bloomberg, More Than 1.21 Billion Shots Given: Covid-19 Tracker, updated May 5, 2021 at 5:38 p.m. EDT, https://www.bloomberg.com/graphics/covid-vaccine-tracker-global-distribution/. Not surprisingly, with the exception of China which has one of the lowest rates of infection of any country in the world, vaccinations have been concentrated in countries with high rates of infection — both developed and developing.

Because of the disruption in supplies from India because of their current challenges, far fewer doses have been administered in low-income countries as COVAX is behind its schedule for deliveries. There are, of course, other challenges in a number of low-income countries, where poor health care infrastructure has resulted in many of the vaccine doses that have been received not being used. See NPR, They Desperately Need COVID Vaccines. So Why Are Some Countries Throwing Out Doses?, May 5, 2021, https://www.npr.org/sections/goatsandsoda/2021/05/05/991684096/they-desperately-need-covid-vaccines-so-why-are-some-countries-throwing-out-dose (“It seems incredible: At a time when low-income nations are clamoring for vaccines against COVID-19, at least three countries — Democratic Republic of Congo, Malawi and South Sudan — are either discarding doses or giving them to other countries. What’s going on?”).

The Proposal for a TRIPs Waiver from India and South Africa

Back in October 2020, India and South Africa filed a proposal for a waiver from many TRIPS Agreement obligations for all WTO Members for a period of years on vaccines, therapeutics and other medical goods relevant to handling the COVID-19 pandemic. There has not been agreement within the TRIPS Council on approving the proposed waiver with a number of advanced pharmaceutical producing countries (U.S., EU, U.K., Switzerland) opposing the proposal or disagreeing that a waiver would address the current availability challenges. The issue has been discussed on a number of occasions in the TRIPS Council. See, e.g., WTO press release, TRIPS Council to continue to discuss temporary IP waiver, revised proposal expected in May, 30 April 2021, https://www.wto.org/english/news_e/news21_e/trip_30apr21_e.htm. There have also been efforts to identify challenges to increasing capacity and production faster and addressing concerns over equitable access. Those issues have been addressed in prior posts, listed above.

There has been considerable pressure from NGOs and, in the U.S., from Democratic members of Congress to agree to the waiver despite concerns within the Biden Administration on whether agreeing to a waiver would actually improve production or access. The Biden Administration in late April announced its decision to make 60 million doses of AstraZeneca vaccines available for redistribution in the coming months (including 10 million doses in current inventory once FDA approves release). AstraZeneca has not yet applied for authorization for its vaccine in the United States, and the U.S. believes it has sufficient other supplies to permit sharing the 60 million doses expected to be available through June. See Financial Times, U.S. plans to share 60m doses of AstraZeneca’s Covid vaccine, 26 April 2021, https://www.ft.com/content/db461dd7-b132-4f08-a94e-b23a6764bdb3. And as part of the relief the U.S. is providing to India, the U.S. has directed inputs for 20 million doses of the AstraZeneca vaccine to be sent to India instead of to U.S. facilities.

Leading nations through groupings like the G-7, G-20 and others have been looking at the options for further increasing production in the coming months to give greater coverage, as well as looking at sending doses not needed to COVAX or particular countries in need. See, e.g., Gavi, France makes important vaccine dose donation to COVAX, 23 April 2021, https://www.gavi.org/news/media-room/france-makes-important-vaccine-dose-donation-covax.

On May 5, 2021, the G-7 Foreign Ministers completed a meeting in London and issued a communique which included language about access to vaccines. The G-7 consists of Canada, France, Germany, Italy, Japan, the United States and the United Kingdom with the European Union as an observed. The U.K. as host also invited Australia, South Korea, India, South Africa and Brunei (as Chair for the ASEAN group of countries). The communique from the G-7 and the EU can be found here and the section on access to vaccines is copied below. See G7 Foreign and Development Ministers’ Meeting Communiqué, London, May 5, 2021, https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/983631/G7-foreign-and-development-ministers-meeting-communique-london-5-may-2021.pdf.

“Enabling equitable global access to Covid-19 Vaccines, Therapeutics and Diagnostics (VTDs)

“62. We affirm our belief that commitment to an open, transparent and multilateral approach is essential in responding to the global health impacts of Covid-19. A global health emergency on this scale requires co-ordinated action and global solidarity. We reaffirm our support for all existing pillars of Access to Covid-19 Tools Accelerator
(ACT-A), including its COVAX facility. We recognise that equipping the ACTAccelerator with adequate funding is central. We support the strengthening of health systems, and affordable and equitable global access to vaccines, therapeutics and diagnostics, and we will further increase our efforts to support affordable and equitable access for people in need, taking approaches consistent with members’ commitments to incentivise innovation. We recall in this regard the Charter for Equitable Access to Covid-19 Tools. We recognise the importance of effective and well-functioning global
value chains for VTD supply and will work with industry to encourage and support on a voluntary basis and on mutually agreed terms, including licensing, technology and know-how transfers, contract manufacturing , transparency, and data sharing, public private costs and risk sharing.
We recognise the need to enable a sustainable environment for local, regional and global productions, beyond Covid-19 products for long-term impact. We welcome the collective G7 commitments of over $10.7 billion USD to date in funding to these initiatives and encourage all partners to increase their support as the next critical step in controlling the pandemic and strengthening health security. In this context, we look forward to the COVAX Advance Market Commitment (AMC) Summit to be co-hosted by Gavi and Japan following the COVAX AMC One World Protected Event co-hosted by Gavi and US. (Emphasis added)

“63. We commit to the G7 Foreign and Development Ministers’ Equitable Access and Collaboration Statement to help accelerate the end of the acute phase of the Covid19 pandemic. We commit to supporting COVAX financially, including by encouraging pledges to the Facility, including at the COVAX AMC Summit in June, disbursing as soon as possible, providing in-kind contributions, and coordinating with and using COVAX, which is the key mechanism for global sharing of vaccines to supplement its own direct procurement, to enable the rapid equitable deployment of vaccines.

“64. We support the work of G7 Health Ministers and continued G7 efforts to work with partners to improve pandemic preparedness and global health security, with WHO as the leading and co-ordinating authority, to strengthen health systems, develop solutions that embed a One Health approach, tackle antimicrobial resistance, and accelerate progress towards universal health coverage and the health-related Sustainable Development Goals. We welcome the establishment of the One Health High Level Experts Panel supported by WHO, FAO, OIE and UNEP. We are determined to ensure that lessons are learned and applied from the pandemic. We look forward to the forthcoming G20 Global Health Summit in Rome and to its Declaration, and to further close cooperation on strengthening the global health
architecture, including longer-term considerations such as exploring the potential value of a global health treaty, to strengthen global pandemic preparedness and response. We will deploy our foreign and development policies and programmes to build a more resilient world that is better protected against health threats, including encouraging new public health guidance in consultation with national and relevant international organisations on international travel by sea or air, including cruise ships, and supporting an expert-driven, transparent, and independent process for the next
phase of the WHO-convened Covid-19 origins study, and for expeditiously investigating future outbreaks of unknown origin. Together with G7 Health Ministers, we commit to work in partnership with low- and lower-middle income countries by improving coordination of G7 support for, and collaboration with, public health and health security capacities and their regional bodies in Africa, Asia and other regions, building on the G7 commitment to support implementation of and compliance with the International Health Regulations (IHR) in 76 countries, taking into account the recommendations from the IHR Review Committee. We will align with and support national and regional health priorities and leadership to improve public health. We look forward to the publication of the G7 Carbis Bay Progress Report on global health and what we can learn from its conclusions on G7 commitments to strengthening health systems to advance universal health coverage and global health security.

“65. We note the continuing need to support health systems and health security and secure sustainable financing, together with partner countries’ domestic resources, to help accelerate global vaccine development and deployment, recover and then sustain access to essential health and nutrition services and health commodities, including in
humanitarian settings and for sexual and reproductive health and rights, and to bolster the global health architecture for pandemic preparedness, including through stronger rapid response mechanisms. We look forward to working with G7 Finance Ministers to build consensus on practical actions to facilitate access to existing global financing
sources to meet demands for access to Covid-19 vaccines, therapeutics and diagnostics, as well as how best to tackle the ACT-A funding gaps, with the aim of shortening the lifespan of the pandemic and with particular focus on the needs of vulnerable countries. In this regard, we look forward to the outcomes of the Independent Panel for Pandemic Preparedness and Response (IPPPR) initiated by the WHO, and the High Level Independent Panel on financing the global commons for pandemic preparedness and response (HLIP) established by the G20.”

At the same time that G-7 foreign ministers were concluding their work in London, the WTO was holding the first of two days of a General Council meeting. The WTO’s Director-General Ngozi Okonjo-Iweala urged the resolution of addressing equitable access to vaccines. The U.S. Trade Representative issued a statement changing the U.S. position (and contradicting what they had agreed with other G-7 foreign ministers hours before) by indicating that the U.S. would support the waiver of TRIPS rights and obligations during the pandemic and would work on text in the TRIPS Council to see if a consensus could be achieved. The Director-General’s statement from May 5, the USTR statement and the Director-General’s comments on the USTR statement are embedded below.

WTO-_-News-Speech-DG-Ngozi-Okonjo-Iweala-General-Council

Statement-from-Ambassador-Katherine-Tai-on-the-Covid-19-Trips-Waiver-_-United-States-Trade-Representative

WTO-_-2021-News-items-Statement-of-Director-General-Ngozi-Okonjo-Iweala-on-USTR-Tais-statement-on-the-TRIPS-waiver

While the pharmaceutical industry in advanced countries is unquestionably shocked by the shift in U.S. position (and stocks of vaccine producers suffered stock market price declines on May 5), the EU President has indicated a willingness to look at the issue and the French President has indicated his support of the U.S. position. See Financial Times, Pharma industry fears Biden’s patent move sets dangerous precedent, 6 May 2021, https://www.ft.com/content/f54bf71b-87be-4290-9c95-4d110eec7a90; The Guardian, EU ‘ready to discuss’ waiver on Covidvaccine patents, 6 May 2021, https://www.theguardian.com/world/2021/may/06/eu-ready-to-discuss-waiver-on-covid-vaccine-patents (“The head of the European Commission, Ursula von der Leyen , has said the bloc is ‘ready to discuss’ a US-backed proposal for a waiver on the patents for Covid-19 vaccines and the French president, Emmanuel Macron, said he was ‘absolutely in favour’ of the plan as pressure built for a move that could boost their production and distribution around the world.”).

The concerns of industry have been identified in prior posts of mine and are summarized in yesterday’s Financial Times article on what if any benefit there will be should a waiver be agreed to. See Financial Times, Will a suspension of Covid vaccine patents lead to more jabs?, 6 May 2021, https://www.ft.com/content/b0f42409-6fdf-43eb-96c7-d166e090ab99 (“[T]he drug makers’ main argument is that waiving intellectual property is not the solution. Vaccine makers have already pulled out all the stops to supply billions of doses at an unprecedented speed, including signing unusual partnerships with rivals to expand production. Moderna put its patents online last summer but they are not useful alone.”).

The Road Forward

It is unclear where the process at the WTO goes from here. The WTO TRIPS Council is expecting a revised document from India and South Africa in May that arguably could become the basis for WTO Members, including the U.S. and EU and others who have been opposed to a waiver, to consider and negotiate from. If a consensus emerges around a text, then it would go to the General Council for a vote/approval. But while the formal process is understood, it is unclear what an agreement would actually look like. It is hard to imagine that the U.S., EU, Switzerland, Japan and possibly others would agree to waive the pharmaceutical companies rights within their own territories. So there is a question whether rights could be waived selectively? If so, what possible liability would exist for governments and/or companies exploiting the IP rights of others? It is unclear if there will be a requirement for some/all countries who engage in use of others intellectual property to provide compensation similar to a compulsory license fee. Will countries that have existing voluntary licensing agreements with producers be able to void those agreements or have the same IP rights used by other companies? Will there be limitations on where goods produced can be shipped (e.g., only to low- and middle-income countries)? What will the basis be for getting IP holders to transfer technology where there is no compensation? There are undoubtedly dozens of other issues that the industry and their lawyers have besides the above. If waiver is the direction the world goes, presumably there needs to be transparency and full opportunity for vetting proposals so that all issues are identified, understood and properly addressed.

In my prior posts, I have argued that to date vaccines have largely gone to the countries with large levels of infections and deaths. Those pushing for greater equity in access based on a simple percent of global population approach abandon those concerns when a large developing country runs into a surge and finds itself in serious difficulty, such as is happening with India. I support targeting relief to address fire situations like India. See April 29, 2021, COVID-19 — Efforts to help India during its current surge of cases, hospitalizations and deaths, https://currentthoughtsontrade.com/2021/04/29/covid-19-efforts-to-help-india-during-its-current-surge-of-cases-hospitalizations-and-deaths/. There are equally important fire situations in other countries that deserve the attention and concern of the world as well.

The WTO has been and should be encouraging Members to eliminate export restrictions as quickly as possible. The new Director-General has used the power of convening to probe what are the barriers to increased production and greater distribution to low- and middle-income countries. Many of the barriers are bottlenecks in supply chains, shortages of various inputs as the industry drastically ramps up production of vaccines, lack of trained personnel in some countries where there may be existing vaccine capacity for other vaccines. Governments can and should be working with industry to address bottlenecks on an expedited basis. Encouraging voluntary licensing is useful and there are some 272 agreements around the world already in place with others being worked on. However, as Johnson & Johnson’s experience (where it talked to 100 companies but only found 10 they could work with) shows, the presence of a facility in a country is not the same as a facility with trained personnel who can actually produce a safe vaccine of the types currently approved for use on COVID-19.

The biggest short term availability of more supplies for low- and middle-income countries is not from the waiver but rather from governments redirecting volumes that are not needed for their own populations. The U.S. and EU are each starting that, but more can and should be done. Such actions have real potential.

Similarly, pursuit of new vaccines, such as one being tested in a number of developing countries that is far lower cost than some currently being used to vaccinate against COVID-19 and which apparently can be easily used in many countries in existing vaccine facilities makes a lot of sense. 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.

While there are lots of groups and individuals arguing there is a moral imperative to wave the IP rights of pharmaceutical companies during the global pandemic, there is little practical evidence that such an approach will get the world to the place presumably everybody wants — the quickest curtailment of the pandemic for the benefit of all.

Time will tell whether an effort to negotiate a waiver is an aid or a hindrance to actually ending the pandemic.

WTO Director-General Ngozi Okonjo-Iweala announces selection of four Deputy Directors-General

A little over two months after assuming the position of Director-General (“DG”) of the World Trade Organization, DG Okonjo-Iweala announced her four Deputy Directors-General (“DDGs”). Two of the four DDGs are women, marking the first time that there is gender balance among the DDGs. The press release from the WTO is embedded below.

WTO-_-2021-News-items-DG-Okonjo-Iweala-announces-her-four-Deputy-Directors-General

DG Okonjo-Iweala’s selections follow past practice of picking DDGs from the four regions other than the region of the DG (Africa). The U.S. and the EU (France this time) continue to hold a DDG slot (Angela Ellard and Amb. Jean-Marie Paugam respectively). The Asian slot goes to China (Amb. Xiangchen Zhang) for the second time in a row (potentially indicating that three of the five slots will be going to the US, EU and China going forward). The Latin slot goes to Anabel Gonzalez of Costa Rica. Three of the four have extensive experience in Geneva with Amb. Xiangchen Zhang having recently concluded his role as China’s Permanent Representative to the WTO, with Amb. Jean-Marie Paugam having been France’s Permanent Representative to the WTO and with Ms. Anabel Gonzalez having had many roles both within the WTO Secretariat and with the Government of Costa Rica including Minister of Foreign Trade. All four have extensive experience with trade issues as the short bios included in the press release review. Ms. Angela Ellard from the U.S. has decades of experience in the interaction between the legislative and executive branches in the U.S. in the trade arena having served in a senior staff capacity for the House Ways and Means Republicans.

Today’s press release did not identify areas of responsibility for each of the four DDGs. That information will presumably be released in the coming days.

In prior posts I have urged the selection of strong individuals for the four DDG slots, people able to help DG Okonjo-Iweala with the myriad challenges facing the organization. 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/; March 31, 2021, When will WTO DG Okonjo-Iweala reveal choices for Deputy Directors-General?, https://currentthoughtsontrade.com/2021/03/31/when-will-wto-dg-okonjo-iweala-reveal-choices-for-deputy-directors-general/.  The four individuals who have been selected all appear to be strong individuals with the ability to help the DG in outreach to major Members. They bring a lot of talent and depth of understanding of current challenges to their jobs. Chemistry among the group and with the DG is something that will develop over time and hopefully will have them being a cohesive and highly supportive team for the DG.

With much to accomplish to restore credibility for the WTO and its ability to help move global trade forward in a more sustainable and equitable manner, I join all those wishing the new DDGs success in their new positions.

WTO and forced labor in cotton — Commentary by Amb. Dennis Shea, former Deputy U.S. Trade Representative

Ambassador Dennis Shea served as U.S. Permanent Representative to the World Trade Organization during the Trump Administration. He is now an Adjunct Fellow (Non-resident), Scholl Chair in International Business at the Center for Strategic & International Studies (CSIS). Today a commentary of Amb. Shea was posted by CSIS. See CSIS Commentary, Dennis Shea,The WTO Can Help Shine a Spotlight on Forced-Labor Practices in Xinjiang’s Cotton Industry, https://www.csis.org/analysis/wto-can-help-shine-spotlight-forced-labor-practices-xinjiangs-cotton-industry.

Amb. Shea notes that there is an upcoming “dedicated discussion” on trade developments on cotton at the WTO on May 28. His commentary states that

“For next month’s dedicated discussion to have credibility, it must examine the trade impact of the use of forced labor to pick cotton in China’s Xinjiang province. In light of what we have learned about forced-labor practices in Xinjiang, it is inconceivable that the WTO would convene a meeting on cotton and trade and not include these practices as a topic worthy of review. Simply put, ignoring what is happening in Xinjiang would be tantamount to the WTO holding a meeting on global public health and trade without mentioning the Covid-19 pandemic.”

I have in prior posts looked at the issue of forced labor and child labor both broadly and with special focus on cotton. See March 24, 2021, When human rights violations create trade distortions — the case of China’s treatment of the Uyghurs in Xinjiang, https://currentthoughtsontrade.com/2021/03/24/when-human-rights-violations-create-trade-distortions-the-case-of-chinas-treatment-of-the-uyghurs-in-xinjiang/; January 25, 2021, Child labor and forced labor in cotton production — is there a current WTO mandate to identify and quantify the distortive effects?, https://currentthoughtsontrade.com/2021/01/25/child-labor-and-forced-labor-in-cotton-production-is-there-a-current-wto-mandate-to-identify-and-quantify-the-distortive-effects/; January 24, 2021, Forced labor and child labor – a continued major distortion in international trade for some products, https://currentthoughtsontrade.com/2021/01/24/forced-labor-and-child-labor-a-continued-major-distortion-in-international-trade-for-some-products/.

As Amb. Shea points out, WTO Members should present information relevant to trade in cotton including potential subsidies (such as government provision of labor at little or no compensation (forced labor)). His commentary urges the U.S. to bring forward any information it may have on the cotton industry in Xinjiang. He notes that

“The United States should bring the issue of forced labor in Xinjiang directly to the WTO by placing it on the agenda of the upcoming dedicated discussion on cotton and trade. Whatever information the U.S. government has developed about forced labor in the cotton fields of Xinjiang and its impact on trade should be shared with other WTO members. Doing so would be consistent with President Biden’s trade agenda, which makes combating forced labor a priority. It is also consistent with the views of U.S. Trade Representative Katherine Tai, who said during her confirmation hearing that forced labor is ‘the crudest example of the race to the bottom in global trade.’”

While the Director-General of the WTO has been quoted as indicating that China does not respond well to being singled out, the cotton initiative at the WTO is looking at all trade practices that affect trade in cotton. Labor subsidies for a region that produces 85% of China’s cotton and 20% of the world’s is obviously fair game. See RT, Stop targeting China if you want it to support global trade reforms, WTO head tells world powers, April 26, 2021, https://www.rt.com/news/522151-wto-chief-stop-targeting-china-cooperation/ (“World Trade Organization (WTO) chief Ngozi Okonjo-Iweala has called on countries to stop targeting China if they want cooperation on global reforms, claiming that putting pressure on Beijing will only get ‘resistance.’ * * * Speaking to a conference held by the European Commission, Okonjo-Iweala suggested targeting China only alienates it further. He urged nations to just ‘put the facts on the table,’ claiming Beijing is ‘willing’ to consider proposals when they are presented without ‘negative spillovers.’”). While China challenges the claim that it uses forced labor for cotton or any other products, it makes sense for WTO Members to marshall the information available so that the matter can be considered as part of the semiannual dedicated session.

Amb. Shea’s commentary is a useful note on seeing to what extent the WTO’s existing process can address significant trade distortions of China or any other cotton producer. Hopefully, a robust process will occur next month in Geneva.

I

When will WTO DG Okonjo-Iweala reveal choices for Deputy Directors-General?

Today, March 31, 2021, marks the end of the tenure of the four existing Deputy Directors-General of the WTO. Normally, an incoming Director-General would have identified his/her choices for the four Deputy Director-General slots ahead of assuming office himself/herself. See, e.g., March 6, 2021, WTO’s four Deputy Directors-General tenure reportedly concludes at the end of March 2021 — thanks for an outstanding job, https://currentthoughtsontrade.com/2021/03/06/wtos-four-deputy-directors-general-tenure-reportedly-concludes-at-the-end-of-march-2021-thanks-for-an-outstanding-job/ ( “It is normal for existing Deputy Directors-Generals (DDGs) to depart shortly after the arrival of a new Director-General and to be selected before the new Director-General takes office. Indeed, typically DDGs have four year terms that start one month after the Director-General’s term. Pursuant to procedures adopted in late 2002, DDGs employment starts later and ends later than the DG’s. See PROCEDURES FOR THE APPOINTMENT OF DIRECTORS-GENERAL, Adopted by the General Council on 10 December 2002, WT/L/509 (20 January 2003) at para. 22 (‘In order to ensure continuity at the senior management level, the terms of office of the Director-General and of the Deputy Directors-General shall be staggered, such that the terms of the Deputies expire subsequent to the expiry of the Director-General’s term.’). Because of the short time from appointment (February 15, 2021) to start (March 1, 2021) as Director-General for Dr. Ngozi Okonjo-Iweala, presumably the DDG selection process was delayed until after she took up her position on March 1.”).

With less than eight months til the 12th Ministerial Conference at the end of November in Geneva, there is a great deal of work to be done if the Ministerial Conference is going to be successful. As reviewed in a WTO press release of March 30, DG Ngozi Okonjo-Iweala spoke at an informal General Council meeting on March 30. See 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. The press release reviews her comments and those of General Council Chair Ambassador Dacio Castillo (Honduras) and is copied below.

“The meeting was called by General Council Chair Ambassador Dacio Castillo (Honduras) to initiate a process of consultations on the nature of the prospective outcome document for the Twelfth Ministerial Conference (MC12), which will take place in Geneva the week of 29 November.

“He described the options in front of members, based on the documents that emerged from earlier Ministerial Conferences: a consensus Ministerial Declaration, a summary issued under the conference chair’s own responsibility, and a ‘hybrid’ document containing elements of the two.

“Members ‘may wish to start thinking about what type of outcome document we might realistically envisage for MC12, including its structure and elements,’ the General Council Chair added, announcing he would begin consultations on these issues with interested delegations. He cautioned that this process should not divert attention from ongoing substantive negotiations.

“With only seven working months until MC12, DG Okonjo-Iweala called on members to “create a recipe for success upfront,” starting with “two or three or four concrete deliverables” in areas such as fisheries and agreeing on work programmes for other items where differences remain.

“She noted that MC12 would come at the end of a series of international policy discussions aimed at ‘examining the lessons from this pandemic and trying to put the framework for tackling the next.’ If trade ministers emerge at the end of the year ‘with no agreement, no contributions to the meaningful issues that are being faced by the world today, nothing to add in terms of a framework for tackling the next pandemic, it will not look good.’

”’My wish is for all the Ambassadors, Ministers and Leaders on trade to come out of MC12 looking good. Looking good means being seen by the world as having delivered for today’s problems,’ she said.

“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.”

Obviously, having a full team, including the four Deputy Directors-General, on board to help facilitate work by Members on items of interest to the Members will be critical to permitting the Secretariat to support the WTO Members in their work in these coming months.

In a prior post, I had suggested the need for DG Okonjo-Iweala to pick a team that respects the historical geographical distribution of positions but also to pick individuals with sufficient trade and political gravitas to help the DG achieve the range of initiatives facing the WTO. 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/.

Press reports have indicated that there is, as there always is, a lot of lobbying by Members, on the composition of the Deputy Directors-General. Hopefully DG Ngozi Okonjo-Iweala will announce the new DDGs soon. The Director-General faces many issues with a deeply divided membership. A strong team including at the DDG level will improve the chances that the Secretariat can help the messy process of Member negotiations and moving to reform.

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 Okonjo-Iweala’s statement on International Women’s Day, a broader read on gender equality; U.S., EU and New Zealand actions and statements

In my post yesterday, I pulled some information from a short video put together by the WTO, UNCTAD and ITC that dealt with the issue of priorities for the three organizations in terms of recovering from the pandemic. I also reviewed some actions President Biden was taking in the United States. See March 8, 2011, March 8, 2021, International Women’s Day — statements of UN Women Executive Director,  heads of WTO, UNCTAD and International Trade Centre, and U.S. Executive Orders and Statement by President Biden, https://currentthoughtsontrade.com/2021/03/08/march-8-2021-international-womens-day-statements-of-un-women-executive-director-heads-of-wto-unctad-and-international-trade-centre-and-u-s-executive-orders-and-statement-by-president-biden/.

WTO Director-General Ngozi Okonjo-Iweala

Yesterday the WTO hosted a virtual event entitled “Women in leadership: Achieving an equal future in a COVID-19 world,” Director-General Okonjo-Iweala gave an opening statement which chronicles both the disproportionate harm women have encountered during the COVID-19 pandemic but also some of the actions some governments are taking to address the challenges facing women. See WTO, International Women’s Day: Focus on women for a stronger recovery, March 8, 2021, https://www.wto.org/english/news_e/news21_e/women_08mar21_e.htm. While the two priorities of the Director-General (DG) reviewed in yesterday’s post are also present in her statement at yesterday’s event (equitable and affordable access to vaccines, therapeutics and diagnostics; eliminating or phasing out export restraints), there is a lot more ground covered in the statement. The women and trade agenda at the WTO is relatively limited at the present time. Having a woman as Director-General can lead to changes in the organization and structure of the Secretariat — which is identified as a topic DG Okonjo-Iweala will be addressing — and can help ensure that women are at the table for all negotiations so that trade policy and negotiations include an understanding of the implications for gender equality and empowerment of women and girls. DG Okonjo-Iweala reviews the reasons women have been disproportionately affected — including being overrepresented in sectors heavily impacted by the pandemic (textile and apparel manufacturing, tourism), being heavily concentrated in the informal economy of countries with limited or no safety net if jobs are lost, for entrepreneurs, being in small businesses with limited financial resources making surviving a pandemic more challenging, shouldering heavy loads at home in terms of child care, and facing great health care risks because of the concentration in medical and essential services jobs, The text of DG Okonjo-Iweala’s statement, which ls linked to the press release is copied below. See Speeches — DG Ngozi Okonjo-Iweala, 2021 WTO International Women’s Day: “Women in Leadership: Achieving an Equal Future in a COVID-19 World”, March 8, 2021, https://www.wto.org/english/news_e/spno_e/spno2_e.htm.

“Ladies and gentlemen,

“Today is my first International Woman’s Day as the WTO Director-General. Given the particular challenges the pandemic has brought to women globally, I wish to focus my opening remarks today on what the WTO can do to help address these challenges. But I am keenly aware that achieving gender equality is also one of the top priorities for the Secretariat itself, and we will find an occasion soon to have a focused discussion on gender issues for the Secretariat.

“The COVID-19 pandemic has deepened inequalities of every kind. Between countries with money to spend on vaccines and economic relief, and those that cannot. Between workers who must risk their health every day, and those who can safely work from home. Between big firms and small businesses.

“But perhaps no divide has deepened more than that between men and women.

“In both paid and unpaid work, women bore the brunt of the pandemic’s social and economic impact.

“Globally, 5% of women lost jobs in 2020.  The employment loss of men was 3.8%. Women have also been much more likely than men to drop out of the labour market and become inactive.

“In low-income countries without the means to offer economic support during lockdowns, many women lost their only source of income. As family incomes fell, many girls stayed home when schools reopened, or went to work.

“Why has the recession caused by the pandemic had such a disproportionate impact on women?

“First, women are overrepresented in sectors that have been more negatively affected than others.

“This includes jobs requiring in-person contact, such as food service and retail — sectors that either shut down or became much riskier. Women also account for a large share of workers in services such as tourism — sectors directly affected by travel restrictions.

“Women also outnumber men in the manufacturing sectors hardest hit by the pandemic, such as textiles and apparel, where factories shut down early in the pandemic in response to plummeting export demand. In Bangladesh, for example, female employees represent 80 per cent of the workforce in ready-made garment production. Industry orders declined by 45.8 per cent over the first quarter of 2020 — by 81 per cent in April 2020 alone.

Second, more women work in informal sectors than men. Women make up 58% of employment in informal sectors, and the numbers are higher in developing and least-developed economies. In Africa, for example, almost 90% of employed women work in the informal sector.​ These women workers are hurt the most because they are likely to have lost their only source of income and been left with no social and legal protection. 

“Third, many women entrepreneurs own or manage small businesses that already struggle with limited financial resources and borrowing capacity. The pandemic worsened these pressures.

“And within families, women continue to shoulder a heavier burden than men. Temporary school closures made fathers step up a little, but mothers stepped up much more. Working mothers changed work schedules, reduced hours or took unpaid leave far more frequently than working fathers. In Germany, 6% of fathers but 62% of mothers indicate they have taken on the primary responsibility for their children during school closures.

“Finally, women face greater health risks as they work more in areas such as health and social care, sales of food and other necessary goods. In many countries, women comprise over 75% of the healthcare workforce. In certain countries (Italy, Spain, and the US), a higher proportion of women healthcare workers (69%, 75.5%, and 73% respectively) were found infected with COVID-19: although work is still ongoing to understand the reasons for this, one possible reason is that personal protection equipment has been designed to fit for men and even the smallest size is too big for some women.

“Even before COVID-19, progress towards gender parity had been too slow, too uneven. Now, unless we act quickly, the pandemic’s disproportionate impact on women could last for decades. This would be a moral failure — and an economic disaster.

“The biggest thing the WTO can do right now is to work with Members to keep trade open.

“As the economic data shows, trade has proven crucial in the global fight against the pandemic.

“While too many export restrictions remain in place, trade helped improve access to key medical products over the past year. In the first half of 2020, while global trade contracted by 14% compared to the year before, total imports of personal protective equipment and other COVID-related products rose by 29%. The value of trade in textile face masks grew six-fold. PPE trade grew by 50%. Trade thus enhanced supply resilience, particularly for those countries without manufacturing capacity.

“The pandemic has also highlighted how the temporary movement of healthcare workers, of whom many are women, has particularly helped the most affected countries to deal with the crisis. Open trade will continue to be key to building faster and more inclusive growth.

“Second, WTO Members must minimize or remove existing export restrictions that are impeding access to essential medical supplies and disrupting supply chains. Transparency on any export trade restrictions should also be improved through prompt notifications.

“In all these efforts, our priority should be to contribute to making vaccines, therapeutics and diagnostics available and affordable in all countries. Until we have successfully tackled health challenges for everyone, we cannot tackle economic ones.

“Third, trade can be a source of more and better jobs, and increased purchasing power for women. Overall, countries that are more open to trade, as measured by the ratio of trade to gross domestic product, have higher levels of gender equality.

“For one, women are more likely to be in formal jobs if they work in trade-integrated sectors with higher levels of exports, thereby giving them opportunities for benefits, training, and job security. A recent World Bank survey shows that, for women, the probability of being informal declines from 20% in sectors with low levels of exports to 13% in sectors with high levels of exports. 

“Digital technologies can also help women overcome gender-based barriers to trade, reach broader markets, and weather the impact of crises better. Women facemasks producers in Kenya, for example, found ways to develop and even expand their businesses during lockdowns using growing e-commerce opportunities. Rwandan women coffee producers were able to export their products directly to China. Let’s close the existing gender digital divide and help all women benefit from the opportunities created by digital technologies.

“Finally, all these efforts must be supported by targeted support measures for women.

“Women could be left behind in the recovery unless adequate measures are put in place to address the uneven impact of the pandemic on them. Let me give you one example of how targeted intervention can make a difference: in Zambia, the Enhanced Integrated Framework (EIF) and the International Trade Centre (ITC) helped women-owned businesses selling textiles, leather, and honey to attend trade fairs and other B2B activities. The result: they were able to break into 10 new international markets, and generate hundreds of thousands of dollars worth of new sales. They also expanded their supplier networks, and many of those new suppliers were also run by women.

“Governments need to prioritize women in the labour force and in the home through financial, legal, and educational measures. Fiscal support for women will be particularly crucial. Yet currently less than 40 per cent of all measures taken globally for the recovery are gender sensitive, with only 7 per cent containing measures supporting women’s economic security.

“This is a crude reminder for all of us that women must be at all decision-making tables equally as men. As Dame Graça Machel once said, “…socio-economic transformation will only be realized once we aggressively address gender-specific challenges, prioritize gender equality and women’s participation, and firmly entrench women in leadership positions at all levels in society.”

“The cost of gender inequality is enormous. A few years ago McKinsey estimated that if women played a fully equal role to men in the labour market, global economic output could increase by as much as $28 trillion per year. To put it in perspective, this pandemic reduced global output last year by between $3 and 4 trillion.

“The COVID-19 pandemic is setting women back in all domains of society.

“At the same time, it has reminded everyone of the enormous value of care and other kinds of work traditionally associated with women. And it has highlighted the power and effectiveness of women’s leadership. Although no analytical study has been conducted yet, anecdotal examples show that economies led by woman leaders (e.g. New Zealand, Denmark, Chinese Taipei, Iceland, Finland, and Norway) have outperformed their peers in terms of management of this pandemic.

“We cannot expect to make good policy for all members of society if half of the population is not properly and equally represented at the table.

“Gender equality is a fundamental human rights issue and also an economic empowerment issue. We should all work harder in our respective roles to achieve complete gender equality.

“I wish you all a happy International Women’s Day!”

Additional actions by President Biden

In yesterday’s post, I also reviewed actions President Biden was taking in the form of two Executive Orders (one Executive Order on Establishment of the White House Gender Policy Council, a second Executive Order on Guaranteeing an Educational Environment Free from Discrimination on the Basis of Sex, Including Sexual Orientation or Gender Identity). But President Biden on March 8th reviewed additional actions he has taken including nominating two women to hold command positions in the U.S. Military and putting forward to Congress the Violence Against Women Reauthorization Act of 2021. See Statement by President Biden on the Introduction of the Violence Against Women Reauthorization Act of 2021 and Remarks by President Biden on International Women’s Day (“On Friday, I submitted to the Senate for confirmation my first slate of nominations for four-star command positions in our Armed Forces — among them, two outstanding and eminently qualified warriors and patriots.  General Jacqueline Van Ovost in the United States Air Force is currently the only female four-star officer serving in our military.  I nominated her as Commander of the United States Transportation Command.  And when confirmed, the Lieutenant General Laura Richardson, of the United States Army, will be promoted in rank and join General Van Ovost as the only four-star — as another four-star general.  I nominated her as Commander in the United States Southern Command.  And, when confirmed, they will become the second and third women in the history of the United States Armed Forces to lead combatant commands.”). The Biden Administration also had a press briefing with the two co-chairs of the Gender Policy Council. See Press Briefing by Press Secretary Jen Psaki, Co-Chair of the Gender Policy Council and Chief of Staff to the First Lady Julissa Reynoso, and Co-Chair and Executive Director of the Gender Policy Council Jennifer Klein, March 8, 2021. And Vice President Kamala Harris reported participated in a discussion with an EU Parliamentary Committee. See eudebates.tv, We are all in this together! Jacinda Ardern on International Women’s Day, March 8, 2021, https://www.eudebates.tv/debates/world-debates/australia/we-are-all-in-this-together-jacinda-ardern-on-international-womens-day/ (“.During the plenary session of the European Parliament in Brussels, Jacinda Ardern, Prime Minister of New Zealand joined MEPs to celebrate the International Women’s Day during a debate. Prime Minister Jacinda was one of a number of high-profile guests, including US Vice President Kamala Harris, to address the European Union Parliament for International Women’s Day.”)..

So the Biden Administration has been taking actions to bring women into positions of power in a unprecedented manner in the United States and to embark on reviews to ensure problems to achieving gender equality are identified and addressed.

European Commission President Ursula von der Leyen

The EU has had relatively strong programs promoting gender equality over time. Like the United States, the EU is looking to do more. European Commission President Ursula von der Leyen made a statement yesterday at the EP FEMM Interparliamentary Committee meeting reviewing the important contributions of women to the development of COVID-19 vaccines and the actions the EU will be taking to improve gender equality. Like President Biden’s cabinet, EC President von der Leyen has much greater balance in the Commission composition in terms gender representation. See Opening speech by President von der Leyen at the EP FEMM Interparliamentary Committee meeting, on the occasion of the International Women’s Day 2021, March 8, 2021, https://ec.europa.eu/commission/presscorner/detail/en/SPEECH_21_1017. Her speech is copied below.

“Thank you very much Evelyn Regner,

“Presidents and Honourable Members,

“It is an honour to be with you today, in the company of so many amazing women. And allow me to begin by mentioning three women who are not with us today. Doctor Özlem Türeci. Professor Sarah Gilbert. Doctor Kizzmekia Corbett. Some of you may have never heard their names before. But we owe them a lot. They are three scientists from Germany, the UK and the U.S. And these three extraordinary women lead the teams that developed the first three vaccines against coronavirus. BioNTech, Moderna and AstraZeneca.

“And I am sure that they, like many of us, have fought against all sorts of stereotypes. But this is how women respond to stereotypes: By going their way, showing leadership and excelling in their field. And today the whole world can see that we are all better off when women get the opportunities they deserve. Of course, women are made for science. Of course, women are fit to lead. Of course, career and motherhood can go together. It is obvious, but unfortunately it still needs to be said.

“This year’s International Women’s Day is for women like these three scientists. This Women’s Day is for women on the front-line, and for women in the back-office. It is for the health workers, who have been our guardian angels, and it is for our sales assistants, who have kept our supermarkets open. And indeed, let us never forget that almost 80% of them are women.

“Women’s Day is also for all the mothers who have taken care of their children during the lockdowns, while also working from home. But this Women’s Day is also for the women who lost their job during the crisis. And Women’s Day is for those who no longer want to settle for discriminations, insecurity and unfairness. As a female leader, I would like 2021 to bring good news to all of them, to all European women. And this is what we are working on: Putting women at the centre of all our policies.

“And let me start with the basics. Later this year we will propose new legislation to fight violence against women. This has become even more urgent because of the lockdowns. Living free from fear and violence is a basic human right. And we must ensure adequate protection for all women, in all European countries, online and offline, and especially at home.

“Second, women must be at the centre of the recovery. This is a clear requirement for all national recovery plans. NextGenerationEU will finance good jobs for women and men alike. It will invest in quality education for girls and women, including scientific education. NextGenerationEU will be for all Europeans, women and men.

“Third, today indeed we are presenting our new Action Plan to implement the European Pillar of Social Rights. We have set ambitious targets on jobs, skills, and poverty reduction. These are clear and measurable goals to drive our work.

“And let me take one of them: By 2030, at least 78% of European adults should be employed. And this can only be achieved by having more women in the labour market. But to do this we need to make progress on work-life balance. Ensuring parental leave for mothers and fathers. Investing in childcare and good schools. And indeed creating a child guarantee, so that all parents, from all social backgrounds, can send their kids to childcare and school. And this is what empowerment means. Freedom to be a mother and to have a career, for all women.

“And this adds up to the fourth point, today we are also proposing a Directive for pay transparency. It builds on a very simple idea: Equal work deserves equal pay. And for equal pay, you need transparency. Women must know whether their employers treat them fairly. And when this is not the case, they must have the power to fight back and get what they deserve.

“And finally, women should always be able to reach for the top, including in private companies. I fought for this when I was a Minister in Germany. And I will not stop pushing for gender quotas on boards until we get a fair system for all European countries. We simply cannot exclude half of our talents from leadership positions.

“Having women in leadership position should become the norm, not the exception. And slowly but steadily, Europe is changing. Five EU governments are now led by women. For the first time, an EU country, Estonia, is led by two women, as President and Prime Minister. And you, President Sakellaropoulou, are the first woman to be elected as Greek President.

“For the first time in our history, not only the European Commission is led by a woman, but we have also achieved gender-balance in the College of Commissioners. As you know, this is something I promised on my nomination. I asked every European country to present a man and a woman as candidates for each post. It was not always easy. But we made it. And it shows that everything can change, with tireless perseverance.

“All of this matters. It matters to the quality of our decision-making. And it matters to our daughters. It tells them that they can reach for the top. It tells them that hard work pays off. That they will be judged on their ideas, their dedication and their talent, not for their chromosomes. A gender-balanced Europe is a better Europe. Not just for women, but for all of us.

“And in this spirit: Long live Europe, and happy Women’s Day!”

New Zealand Prime Minister Jacinda Arden

New Zealand’s Prime Minister Jacinda Arden also spoke to the European Parliament yesterday. Her speech can be found here. eudebates.tv, We are all in this together! Jacinda Ardern on International Women’s Day, March 8, 2021, https://www.eudebates.tv/debates/world-debates/australia/we-are-all-in-this-together-jacinda-ardern-on-international-womens-day/. New Zealand has done a lot to promote gender equality and has leadership in government that is roughly in number equal between women and men. But challenges remain as the Prime Minister notes in her speech including women being “overrepresented in job loss and low paid work and domestic violence statistics.” The Prime Minister’s speech is copied below (headers are from the webpage).

“Jacinda Ardern European Parliament speech on International Women’s Day 

“I’m honoured to see this kind invitation to speak with you and I bring warm greetings from New Zealand. President Sassoli, thank you for convening this session and for the focus on women’s empowerment and leadership during the covid crisis. To say this is a challenging time would be, of course, a monumental understatement. The world is reeling from the effects of the covid-19 pandemic.

“It has had far reaching consequences that have affected every one of us. This is a critical time for us as leaders and representatives to come together, even if it is by video in these constrained times. Covid-19 highlights how truly interdependent we all are, how reliant we are on cooperation, communication and compassion to successfully combat the virus.

“Jacinda Ardern puts people at the centre

“It highlights how important it is that we work together for a sustainable recovery that delivers for our economies and our planet. But it also puts people at the centre of our decision making. In New Zealand our approach in battling covid-19 has been one of inclusivity. The idea that everyone needs to do their bit to protect one another, especially our most vulnerable.

“I want to talk about our population as the team of five million, and we may be a small team, but one that nonetheless has proven the power and importance of the collective. And now that’s exactly what we need from the world. It’s a haunting legacy if the virus drags on around the globe. It has become clear no country is safe until every country is safe. As we move to a phase of vaccination we are not a team of five million, but we are a team of seven point eight billion

“The success of individual countries or regions means little unless we are all successful. In New Zealand‘s indigenous language Te Reo Maori, we say “we are all in this together”. But some have felt the effects of covid-19 even more acutely than others. Covid-19 has ravaged our health systems, our economies, our livelihoods. But it is also exacerbated structural inequalities that disproportionately impact women and girls.

“Women are at the forefront

“Women are at the forefront of fighting the covid crisis. Amongst the doctors, nurses, scientists, communicators, caregivers and frontline and essential workers who face the devastations and challenges of this virus every day. Along with being directly affected by the virus itself and its immediate impacts on our livelihoods, we’re also the subjects of intensified domestic violence.

“Now this is being reported as the shadow pandemic in all corners of the world. Not only by fully and meaningfully including women and girls in leadership and decision making at all levels can we ensure that our responses to the pandemic meet the needs of everyone. As prime minister of a small country on the far side of the world, I’m proud of what our team of five million in New Zealand has been able to achieve over the last year.

“We have a proud history of championing gender rights since we became the first country in the world to give all women the right to vote in 1893. I’m part of the most diverse and inclusive parliament New Zealanders have ever elected, with women making up forty eight per cent of our parliament and fifty five per cent of my party in government.

“Women hold top positions

“Women also hold the post of Governor-General, Prime Minister, Leader of the Opposition and Chief Justice, and increasingly holding senior roles in our public service and business sector. And now, for the first time and long overdue, I might add, New Zealand‘s Minister of Foreign Affairs is a woman. She is a skilled, values driven indigenous woman with a contemporary worldview.

“And yet for all of that, we have so much more to do because it doesn’t matter how many women are in leadership, so long as we have women overrepresented in job loss and low paid work and domestic violence statistics. In my mind, that is the true measure of whether we have made progress and whether we have equality.

“As we look towards the year ahead we all know it will be tough. There will be big challenges and demands made of all of us as leaders. We will be tested. We must all do more to support women lead business, including small enterprises, to be part of the covid-19 economic recovery so they can more readily experience the benefits of trade.

“The European Union and New Zealand. We are Like-Minded Partners with so many values and interests in common, we both desire the stability and freedom afforded us all by global rules and institutions, free and open markets and a world where human rights are valued and prioritised.

“As we all turn towards creating a sustainable global economic recovery, my message to you is simple. We need to stick together because we are all in this together. I wish your Parliament and all our people the very best for the challenges that lie ahead. Stay safe. Stay well.”

Conclusion

Gender equality is an issue that needs a permanent place on agendas of organizations and governments to ensure progress is made for half the world’s people. Progress has been too slow in too much of the world and discrimination or unequal treatment can be found in various forms in nearly all countries. It is unimaginable that the world has not progressed more. We can and must do better.

March 8, 2021, International Women’s Day — statements of UN Women Executive Director, heads of WTO, UNCTAD and International Trade Centre, and U.S. Executive Orders and Statement by President Biden

Today is International Women’s Day. With the pandemic still occupying center stage in global affairs, the UN effort on its Sustainable Development Goal 5 to “achieve gender equality and empower all women and girls” is in trouble. Women have been disproportionately adversely affected by the pandemic, tens millions leaving the workforce to take care of children, tens of millions losing jobs and having no safety net. Various reports have reviewed the disparities and the loss of progress towards achieving gender equality and empowering all women and girls. See, e.g., UN Women, From Insights To Action, Gender Equality in the Wake of COVID-19 (September 2020); (“The pandemic has widened gender and economic inequalities.” “COVID-19 is exposing vulnerabilities in social, political and economic systems. It is forcing a shift in priorities and funding across public and private sectors, with far-reaching effects on the well-being of women and girls. Action must be taken now to stop this backsliding.”); UN Women, SPOTLIGHT ON GENDER, COVID-19 AND THE SDGS, WILL THE PANDEMIC DERAIL HARD-WON PROGRESS ON GENDER EQUALITY?, https://www.unwomen.org/-/media/headquarters/attachments/sections/library/publications/2020/spotlight-on-gender-covid-19-and-the-sdgs-en.pdf?la=en&vs=5013.

It is against this backdrop that statements and actions today on the importance of Women to the achievement of sustainable development goals should be seen. Below are materials from the UN Women’s Executive Director, the heads of the three Geneva organizations with a trade mission or function that are headed by women, and the announced actions today by President Biden in the United States.

UN Women Executive Director Statement

The following statement was made today by the UN Women Executive Director. See International Women’s Day Statement by Phumzile Mlambo-Ngcuka, UN Women Executive Director, on International Women’s Day 2021, Change up the pace: women at the table, March 8, 2021, https://www.unwomen.org/en/news/stories/2021/3/statement-ed-phumzile-international-womens-day-2021. The statement is copied below in its entirety.

“International Women’s Day this year comes at a difficult time for the world and for gender equality, but at a perfect moment to fight for transformative action and to salute women and young people for their relentless drive for gender equality and human rights. Our focus is on women’s leadership and on ramping up representation in all the areas where decisions are made – currently mainly by men – about the issues that affect women’s lives. The universal and catastrophic lack of representation of women’s interests has gone on too long.

“As we address the extraordinary hardship that COVID-19 has brought to millions of women and girls and their communities, we also look ahead to the solid opportunities of the Generation Equality Forum and Action Coalitions to bring change.

“During the pandemic, we have seen increased violence against women and girls and lost learning for girls as school drop-out rates, care responsibilities and child marriages rise. We are seeing tens of millions more women plunge into extreme poverty, as they lose their jobs at a higher rate than men, and pay the price for a lack of digital access and skills. These and many other problems cannot be left to men alone to solve. Yet, while there are notable exceptions, in most countries there is simply not the critical mass of women in decision-making and leadership positions to ensure that these issues are tabled and dealt with effectively and this has affected the pace of change for women overall.

“There are breakthroughs to celebrate, where women have taken the helm of organizations such as the World Trade Organization, the International Monetary Fund and the European Central Bank and we look forward to more such appointments that help to change the picture of what a leader looks like. Yet this is not the norm. In2020, as a global average, women were 4.4 per cent of CEOs, occupied just 16.9 per cent of board seats, made up only 25 per cent of national parliamentarians, and just 13 per cent of peace negotiators. Only 22 countries currently have a woman as Head of State or Government and 119 have never experienced this – something that has important consequences for the aspirations of girls growing up. On the current trajectory, we won’t see gender parity in the highest office before 2150.

“This can and must change. What is needed is the political will to actively and intentionally support women’s representation. Leaders can set and meet parity targets, including through appointments for all executive positions at all levels of government, as has occurred in the few countries with gender equal cabinets. Special measures can work; where countries have put in place and enforced quotas, they have made real progress on women’s leadership, as have those that have policies to address representation. Where these measures do not exist, progress is slower or even nonexistent and easily reversed.

“No country prospers without the engagement of women. We need women’s representation that reflects all women and girls in all their diversity and abilities, and across all cultural, social, economic and political situations. This is the only way we will get real societal change that incorporates women in decision-making as equals and benefits us all.

‘This is the vision of the 2030 Agenda and the Sustainable Development Goals and the vision of the Beijing Declaration and Platform for Action. It is the vision of civil society and multitudes of young people who are already leading the way and of all those who will join us in the Generation Equality Action Coalitions. We need bold decisive action across the world to bring women into the heart of the decision-making spaces in large numbers and as full partners, so that we can make immediate progress on a greener, equitable and inclusive world.”

Video of Director-General Ngozi Okonjo-Iweala of the WTO, Acting Secretary-General Isabelle Durant of UNCTAD, and Executive Director Pamela Coke-Hamilton of the International Trade Centre

For International Women’s Day, the three heads of multilateral organizations in Geneva involved in trade put out a video entitled, International Women’s Day — Leading global trade: Three women, three organizations. The note accompanying the video states “For the first time, all three major global trade organizations have women leaders: Ngozi Okonjo-Iweala at the WTO, Isabelle Durant at UNCTAD and Pamela Coke-Hamilton at ITC. On International Women’s Day, they talk about the importance of looking at trade through a gender lens, and how trade can help tackle the challenges related to the COVID-19 pandemic.” https://www.wto.org/english/news_e/news_e.htm.

Top priorities to boost recovery outlined by the three leaders include the following. For Director-General Okonjo-Iweala, her first priority to boost economic recovery, is the health aspect. “It is absolutely a top priority for me that we should look at how to make equitable and affordable access to vaccines, therapeutics and diagnostics happen. It is unconscionable that any countries or peoples should be waiting for any of these medical products. And we know that until we tackle the health challenges, we will not be able to really get a handle on the economic challenges and return to a sustainable growth path that would spell recovery from the pandemic. So that’s a really important priority. Second is what can trade do to boost the economic recovery? How can we liberalize trade in certain sectors to make sure that supply chains stay open and work and that countries can produce more and sell more? So what can trade contribute to that? It’s a priority for me that export restrictions and prohibitions that have been put by countries during this time of the pandemic be dropped or minimized or phased out very quickly so that we can have a freer flow of goods and intermediate inputs. So those are two top priorities that I think we need to focus on to boost economic recovery.”

For Acting Secretary-General Durant, her first priority is “to ensure that our institutions contribute to making trade a real tool for recovery, especially for those countries, groups and sectors that have paid a high price due to the pandemic. My priority is that everything we provide them in terms of analysis, data, technical and intergovernmental support helps them steer their recovery towards more inclusive and greener sectors and strategies. Climate change is indeed the greatest threat to current and future generations. Countries need urgently to start planning and implementing actions to adapt their production and trade to the ruthless effects of climate change: what does this imply for better production methods; new comparative advantages; investments; diversification of their economies; and regional integration and value chains? I have the same concern for fairness in the digital revolution. How can developing countries derive the greatest benefit for their development, and become players in it, when digital technology has become the driving force of the economy? COVID has shown the importance of digital infrastructure, policies and skills. More than ever, we need the cooperation, expertise and experience of all to build the road to recovery, because we all know that countries we are far from being equal when it comes to these issues.” (English translation from French as provided in the video).

For Executive Director Pamela Coke-Hamilton, her first priorities are “empowerment and equality — empowerment by building resiliency for MSMEs through partnership; empowerment for recovery by moving towards greener trade. ITC is starting a new initiative to support MSMEs and green trade, helping MSMEs adopt more sustainable practices, pursue opportunities in the circular economy and participate in greener supply chains. Empowerment through digital inclusion by promoting greater integration of MSMEs in digital economies and facilitate digital access for all. Empowerment of women and youths. A dedicated program at ITC will lead the way to women’s economic empowerment, and we will continue to work with governments to build an eco-system of new and innovative jobs for youths. And secondly, equality. Ultimately we want to make sure that no one is left behind as we seek paths for recovery, and build resilience against future shocks. COVID-19 has loaid bare the depths of inequality still prevailing from the global economic system. We must choose to challenge the status quo, and as women we will.”

Action by President Biden

President Biden provided a statement on International Women’s Day and issued two Executive Orders. See Statement by President Biden on International Women’s Day, March 8, 2021, https://www.whitehouse.gov/briefing-room/statements-releases/2021/03/08/statement-by-president-biden-on-international-womens-day/; Executive Order on Establishment of the White House Gender Policy Council, March 8, 2021, https://www.whitehouse.gov/briefing-room/presidential-actions/2021/03/08/executive-order-on-establishment-of-the-white-house-gender-policy-council/; Executive Order on Guaranteeing an Educational Environment Free from Discrimination on the Basis of Sex, Including Sexual Orientation or Gender Identity, March 8, 2021, https://www.whitehouse.gov/briefing-room/presidential-actions/2021/03/08/executive-order-on-guaranteeing-an-educational-environment-free-from-discrimination-on-the-basis-of-sex-including-sexual-orientation-or-gender-identity/; Fact Sheet: President Biden to Sign Executive Orders Establishing the White House Gender Policy Council and Ensuring Education Free from Sexual Violence, March 8, 2021, https://www.whitehouse.gov/briefing-room/statements-releases/2021/03/08/fact-sheet-president-biden-to-sign-executive-orders-establishing-the-white-house-gender-policy-council-and-ensuring-education-free-from-sexual-violence/. The President’s statement is copied below as is the fact sheet on the two Executive Orders.

“Women’s history is American history — and world history. On International Women’s Day, we celebrate the achievements, contributions, and progress of women and girls in the United States and around the globe.
 
“My Administration is committed to honoring women by investing in their opportunity, security, and wellbeing. I was proud to issue an Executive Order today establishing the White House Gender Policy Council, to ensure that every domestic and foreign policy we pursue rests on a foundation of dignity and equity for women. My Administration is also committed to ensuring that women are represented equally at all levels of the federal government. That starts with Vice President Harris, who broke through a barrier that stood for more than two centuries. And it includes a record number of diverse women whom I’ve nominated to serve in Cabinet-level roles and appointed to senior-level positions.
 
“In our nation, as in all nations, women have fought for justice, shattered barriers, built and sustained economies, carried communities through times of crisis, and served with dignity and resolve. Too often, they have done so while being denied the freedom, full participation, and equal opportunity all women are due. Their contributions have been downplayed. Their stories have been neglected. That is why International Women’s Day is also a time for us to recommit ourselves to the cause of equity and equality for women the world over, and to shine a light on the systemic obstacles that fuel gender disparities and undermine women’s potential.
 
“Despite persistent obstacles, women are leading every day. Over the past year, women have played a critical, often outsized role in responding to the global coronavirus pandemic. They are our vaccine researchers and public health officials. They are our doctors and nurses. They are our essential workers — so many of whom are women of color — in fire stations and nursing homes, on farms and in grocery stores, in schools and in shelters.
 
“Around the world, we are seeing decades of women’s economic gains erased by this pandemic. It’s forcing millions more girls out of school, which could impact economic growth for decades to come. Incidents of violence against women in their homes and communities have spiked. And, as is so often the case, COVID-19 is hitting the poorest and most marginalized women the hardest. These global trends damage all of us, because we know that governments, economies, and communities are stronger when they include the full participation of women — no country can recover from this pandemic if it leaves half of its population behind.
 
“Elevating the status of women and girls globally is the right thing to do — it is a matter of justice, fairness, and decency, and it will lead to a better, more secure, and more prosperous world for us all.  On International Women’s Day, let us recommit to the principle that our nation, and the world, is at its best when the possibilities for all of our women and girls are limitless.”

Fact Sheet

Biden-Harris Administration establishes a government-wide focus on uplifting the rights of women and girls in the United States and around the world

“The full participation of all people – including women and girls – across all aspects of our society is essential to the economic well-being, health, and security of our nation and of the world. This is a matter of human rights, justice and fairness. It is also critically important to reducing poverty and promoting economic growth, increasing access to education, improving health outcomes, advancing political stability, and fostering democracy.

“Today, President Biden will sign two Executive Orders. The first establishes the White House Gender Policy Council to ensure that the Biden-Harris Administration advances gender equity and equal rights and opportunity for women and girls. The second directs the Department of Education (ED) to review all of its existing regulations, orders, guidance, and policies for consistency with the Administration’s policy to guarantee education free from sexual violence.

“A year into COVID-19, women are still contending with the public health crisis, an ensuing economic crisis, and on top of those challenges, a caregiving crisis. The pandemic has exacerbated barriers that have held back women, especially women of color, forcing many to leave the workforce, manage virtual schooling, and absorb additional caregiving responsibilities. Many women are also on the frontlines of the response to COVID-19 – as essential workers keeping our economy, communities and families going. As the country continues to grapple with the pandemic and reckons with the scourge of systemic racism, President Biden knows that we need a government-wide focus on uplifting the rights of women and girls in the United States and around the world, restoring America as a champion for gender equity and equality.

“Today’s actions will:

“Establish the Gender Policy Council. The first Executive Order formally establishes the Gender Policy Council within the Executive Office of the President, with a role in both domestic and foreign policy development. The Council will work in coordination with the existing policy councils to advance gender equity and equality, including by:

“Combatting systemic bias and discrimination, including sexual harassment;

“Increasing economic security and opportunity by addressing the structural barriers to women’s participation in the labor force, decreasing wage and wealth gaps, and addressing the caregiving needs of American families and supporting care workers, predominantly low-paid women of color;

“Ensuring access to comprehensive health care and preventing and responding to gender-based violence;

“Promoting equity and opportunity in education and leadership; and

“Advancing gender equality globally through diplomacy, development, trade, and defense, and by recognizing the needs and roles of women and girls in conflict prevention, peacebuilding, democratic rights-respecting governance, global health and humanitarian crises and development assistance.

“The White House Gender Policy Council will be an essential part of the Biden-Harris Administration’s plan to ensure we build a more equal and just society – by aggressively protecting the rights and unique needs of those who experience multiple and intersecting forms of discrimination, including individuals who are Black, Latina, Native, Asian American and Pacific Islander, people with disabilities, and LGBTQI+.

“The Executive Order requires the Co-Chairs of the Council to submit to the President a Government-wide strategy to address gender in policies, programs and budgets, and an annual report to measure progress on implementing the strategy. To prevent and respond to gender-based violence, wherever it occurs, there will be a Special Assistant to the President and Senior Advisor on Gender-Based Violence on the Council staff. The Executive Order also requires engagement with non-profit and community-based organizations, state and local government officials, Tribal Nations, foreign government officials and multilateral organizations.

Ensure education free from sexual violence. President Biden will sign an Executive Order that will direct the Department of Education (ED) to review all of its existing regulations, orders, guidance, and policies to ensure consistency with the Biden-Harris Administration’s policy that students be guaranteed education free from sexual violence. It also directs ED to specifically evaluate the Title IX regulation issued under the previous administration and agency action taken pursuant to that regulation, to determine whether the regulation and agency action are consistent with the policies of the Biden-Harris Administration.”

Conclusion

The WTO at its 2017 Ministerial Conference held in Buenos Aires saw a joint declaration on women and trade released. There are currently 127 WTO Members who support the declaration. There was an interim report released in 2019 and an informal working group on trade and gender working on a voluntary basis to share information and best practices in ways to increase women’s role in global trade. Such activities are a start for the WTO, but much more could be done if there was greater support by the Members. The 2020-21 selection of Dr. Ngozi Okonjo-Iweala was an important action and will likely presage change at the Secretariat. Her priorities as reviewed in today’s video address trade issues that are important to economic recovery which may facilitate greater movement towards gender equality.

The challenges women face globally during the pandemic are significantly greater than those faced by men both in terms of lost employment, withdrawal from the workforce to deal with child care and much more. The UN Sustainable Development Goal of gender equality and empowerment of all women and girls is important for many reasons. In trade, gender equality will promote growth and innovation. This is true in all societies regardless of level of economic development.

The pandemic has pushed back progress in economic development for much of the world as has been often reported and has slowed or reversed the drive for gender equality and empowerment of half the world’s population.. More focus and efforts are needed to ensure achieving the UN SDG 5 by 2030. Trade is but one aspect of the challenge.

Today’s speeches by the three leaders of multilateral organizations handling trade show some of the broader issues facing global trade to recover from the pandemic and highlight the capabilities of women leading important organizations. The UN Women’s Executive Director highlighted the deep societal challenges that continue to retard gender equality in fact in many parts of the world.

Finally, the actions by President Biden and his Administration are the types of actions needed by countries who have not achieved gender equality to date. More can and must be done by nations around the world. International Women’s Day is a reminder of the enormous global opportunities that exist if gender equality and empowerment of women and girls is achieved.

The EU’s response to challenges to its actions on COVID-19 vaccine exports

At the WTO General Council meeting held on March 1-2 this week, agenda item 9 was aimed at the European Union. The agenda item, entitled “Call to Prevent Export Restrictions on COVID-19,” was put on the agenda by Colombia, Costa Rica, Ecuador, Panama and Paraguay. I had reviewed this agenda item as one of 16 agenda items that was likely to draw a fair amount of attention. See February 26, 2021, WTO Director-General Ngozi Okonjo-Iweala’s first week on the job starts with a two day General Council meeting, https://currentthoughtsontrade.com/2021/02/26/wto-director-general-ngozi-okonjo-iwealas-first-week-on-the-job-starts-with-a-two-day-general-council-meeting/ (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 new Director-General, Ngozi Okonjo-Iweala, has stressed the importance of the WTO doing more to address the COVID-19 pandemic and help Members recover. Equitable and affordable access to vaccines is an issue of importance to the membership and stressed by the Director-General. See, e.g., 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/

While the EU Ambassador provided comments on various agenda items, agenda item 9 was obviously one of importance to the EU. See EU Statement at the General Council of 2 March 2021 on the “Call to Prevent Export Restrictions on Covid-19Vaccines,” 02 March 2021, https://eeas.europa.eu/delegations/world-trade-organization-wto/94083/eu-statement-general-council-2-march-2021-%E2%80%9Ccall-prevent-export-restrictions-covid-19-vaccines%E2%80%9D_en. EU Ambassador João Aguiar Machado provided a detailed justification for the EU actions in imposing an export licensing/authorization regime on COVID-19 vaccines claiming lack of transparency by pharmaceutical companies and the need to ensure “fair” distribution. The EU program does not affect vaccines for COVAX low- and middle-income countries nor for various neighboring countries. Of note, for countries covered by the export licensing/authorization scheme, there have been 150 export requests all of which have been granted. The statement is embedded below.

EU-Statement-at-the-General-Council-of-2-March-2021-on-the-Call-to-Prevent-Export-Restrictions-on-Covid-19-Vaccines-–-02-March-2021-European-External-Action-Service

The EU stressed that the major problem facing the world was global capacity far below global demand. The EU is working to identify production bottlenecks and to encourage producers to license their products to maximize global production and expressed a willingness to work with other WTO Members and with the Director-General. The part of the statement covering the demand/supply imbalance is copied below.

“However, the root causes of the problem lie elsewhere: the exploding global demand is well above the global production today. As long as this global industrial challenge is not met, and the world population is not vaccinated quickly enough, we will all face a risk of a continuing health emergency including new Covid-19 variants and a prolonged economic crisis.

“The European Union believes there is an important role for public authorities to play and to drive the increase of production, and to facilitate access to the vaccines and other treatments that are in need today. Cooperation must be promoted amongst the different participants along the value chains where necessary to enhance production capacities. A closer, more integrated and more strategic public-private cooperation with the industry is needed. In this spirit, the EU has set-up a Task Force for Industrial Scale-up of COVID-19 vaccines to detect and help respond to issues in real-time. In order to ramp up production, we will, amongst others, work closely with manufacturers to help monitor supply chains and address identified production bottlenecks. Since EU vaccine production is critical for global supply, the benefits of this initiative will extend beyond the EU’s borders.

“Scaling-up of production on a global level requires further actions. It will not happen without increased global collaboration with the pharmaceutical industry, which should facilitate the transfer of the right know-how and technology for the highly complex vaccine production process. We should facilitate this collaboration, while also recognising that intellectual property provides the necessary platform for it to take place. Waiving intellectual property rights would disrupt this collaboration and the transfer of know-how. In conclusion, Mr Chairman, we believe it is legitimate to engage the sector in order to ensure that all complementary production facilities across companies and continents are actively contributing to ramp up production. Companies that have tried and failed to develop a vaccine of their own, for example, should actively consider making their facilities available for the production of vaccines of successful companies. Companies with new vaccines should consider whether they have checked all options for licensing agreements to increase production. The objective should be to ensure they enter into licence agreements with companies around the world that have the necessary production capacities and could export the vaccines to any low middle-income countries without production capacities. At the same time, we should be mindful that the manufacturing campaigns for covid-19 vaccines do not crowd out the production of other life-saving vaccines and therapeutics.

“The EU, working together with other WTO Members and under the leadership of the Director-General Dr. Ngozi Okonjo-Iweala is ready to facilitate a dialogue between the vaccine developers and companies with the production facilities that are ready to step in to help out with the production of vaccines and their delivery to the countries in need. We welcome the DG’s proposal to focus on collaboration among companies to enhance licensing in order to use all the adequate manufacturing capacity, including in developing countries. The EU is ready to facilitate this dialogue and contribute to the efforts on expanding these partnerships.

“The EU remains open to a dialogue with all WTO Members on how to facilitate the collaboration with the pharmaceutical industry on the transfer of know-how and technology. In the same manner, the EU remains open to a dialogue on how to facilitate the use of the TRIPS flexibilities, should the voluntary solutions fail or not be available. The flexibilities offered by the TRIPs Agreement are absolutely legitimate tools for Members in need, as many are in the midst of this pandemic. This includes fast track compulsory licences for export to countries without manufacturing capacity. Administrative burdens should not stand in the way of manufacturing and delivering vaccines to where they are needed.

“We believe that a successful contribution of the WTO to the current pandemic will require all WTO Members to agree on actions that will not only encompass the elements enshrined in the Ottawa Group’s proposal on Trade and Health, such as export restrictions or transparency, but also address the problem of insufficient manufacturing capacity. The EU stands ready to engage in such a dialogue.”

In my post yesterday, I reviewed some of the efforts that have already occurred where pharmaceutical companies are working with other companies to expand production and availability worldwide. See 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/. But the articles referenced yesterday are just some of the collaborations going on as manufacturers with existing capacity work with companies with COVID-19 vaccines to help expand capacity and production and vaccine manufacturers work with contract producers to expand supply chain capabilities. An additional cooperation agreement was announced today in the press. In addition, some governments, including the U.S. and EU have also worked with manufacturers to ramp up production. See, e.g., Wall Street Journal, Novartis to Help Make CureVac Covid-19 Vaccine, March 4, 2021, https://www.wsj.com/articles/novartis-to-help-make-curevac-covid-19-vaccine-11614859271; Reuters, Poland strikes deal to produce Novavax COVID-19 vaccine, March 3, 2021, https://www.reuters.com/article/us-health-coronavirus-poland-mabion/poland-strikes-deal-to-produce-novavax-covid-19-vaccine-idUSKBN2AV19O (“Polish biotech firm Mabion has signed a preliminary agreement to manufacture Novavax’s COVID-19 vaccine with financial support from a state-run fund, as the government strives to accelerate its vaccination programme.”); PMLive, Novartis, Bayer announce separate agreements to bolster COVID-19 vaccine manufacturing, February 1, 2021, http://www.pmlive.com/pharma_news/novartis,_bayer_announce_separate_agreements_to_bolster_covid-19_vaccine_manufacturing_1362454#:~:text=Novartis%20and%20Bayer%20have%20announced,vaccine%20and%20CureVac’s%20vaccine%2C%20respectively.&text=Novartis%20will%20aim%20to%20begin,its%20site%20in%20Stein%2C%20Switzerland (“Novartis and Bayer have announced separate agreements to aid the manufacturing of Pfizer/BioNTech’s COVID-19 vaccine and CureVac’s vaccine, respectively.”); Pharmaceutical Technology, Pharmaceutical Technology-02-01-2021, Volume 2021
Supplement, Issue 1, Contract Service Tapped to Produce COVID-19 Vaccines, Page Number: s29-s30, https://www.pharmtech.com/view/contract-service-tapped-to-produce-covid-19-vaccines (reviewing actions by Pfizer/BioNTech, Moderna, Johnson & Johnson, AstraZeneca, Novavax). Expanding supply also requires vaccines being approved by governments for use. The EU recently announced it was beginning review of the Russian vaccine Sputnik V. See The Globe and Mail, Europe starts review of Russia’s Sputnik V vaccine to try to overcome shortages as new variants appear, March 4, 2021, https://www.theglobeandmail.com/world/article-europe-starts-review-of-russias-sputnik-v-vaccine-to-try-to-overcome/. And, of course, major producers are expanding where they are producing their vaccines using existing or new facilities. See, e.g., The Globe and Mail, Novavax publishes COVID-19 vaccine contract with Canada, March 4, 2021, https://www.theglobeandmail.com/canada/article-novavax-publishes-covid-19-vaccine-contract-with-canada/ (“American pharmaceutical company Novavax has published its vaccine agreement with Canada for 52 million doses of its COVID-19 vaccine. The company expects to eventually produce some of the vaccine in Canada.”).

Thus, a great deal is going on to expand production capacity globally. Strong intellectual property laws are critical to the developments and resource commitments being made. While many developing countries are pushing to start a process of text drafting for a TRIPS waiver at the WTO, such an effort would be counterproductive to global health needs over the longer term. Washington Trade Daily’s March 2, 2021 edition at pages 5-7 has an article entitled “Call for TRIPS Waiver Negotiations” which presents the views of largely developing countries on the desire to move to negotiating text even though there is not agreement on the proposed waiver. See Washington Trade Daily, March 2, 2021, https://files.constantcontact.com/ef5f8ffe501/ed93e180-7dee-4beb-8629-0e73d4d0ea5c.pdf.

The U.S. Chamber of Commerce released a statement on March 2nd characterizing the effort for a TRIPS waiver being promoted by India, South Africa and others as “misguided”. See U.S. Chamber, U.S. Chamber Statement on Proposed WTO IP Rights Waiver, March 2, 2021, https://www.uschamber.com/press-release/us-chamber-statement-proposed-wto-ip-rights-waiver. The statement is copied below (emphasis added to the third paragraph).

WASHINGTON, D.C. – The U.S. Chamber of Commerce’s Global Innovation Policy Center (GIPC) issued the following statement from Senior Vice President Patrick Kilbride regarding the World Trade Organization (WTO) General Council’s discussion of a proposed waiver of intellectual property (IP) commitments in the Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement. 
 
“‘Vaccine distribution is critical for ending the pandemic and reviving the global economy. The U.S. Chamber of Commerce welcomes the WTO General Council’s discussion of the role of intellectual property rights in defeating the COVID-19 pandemic. During this time, transparent and predictable intellectual property rights have formed the legal and economic basis for an unprecedented level of highly successful collaborations between government, industry, academia and NGOs. 
 
“‘The Chamber supports decisive and bold action to remove regulatory and trade barriers in order to boost the global distribution of treatments and vaccines, including support of global vaccine programs such as COVAX. Proposals to waive intellectual property rights are misguided and a distraction from the real work of reinforcing supply chains and assisting countries to procure, distribute and administer vaccines to billions of the world’s citizens. Diminishing intellectual property rights would make it more difficult to quickly develop and distribute vaccines or treatments in the future pandemics the world will face.  
 
“’The ‘3rd Way’ proposed by incoming WTO Director General Ngozi Okonjo-Iweala to encourage licensing agreements is worthy of further discussion and consistent with the ongoing success of government-industry efforts to bring an end to COVID-19 as rapidly and as safely as possible.’”

Conclusion 

While there has been a lot of concern among trading partners about the EU action in imposing export licensing of COVID-19 vaccines, to date the licensing system does not appear to have caused problems in fact in the distribution of doses ordered by the group of countries covered by the new system. Moreover, with or without government encouragement, vaccine producers have been working to expand production through arrangements with other vaccine producers, through working with contract manufacturers, and by expanding facilities and internal capacities.

There is no doubt that the COVID-19 pandemic presents a once in a century global health pandemic with demand at the beginning far outstripping supply. Governments have a role to play working with producers, suppliers, those involved in distribution and applying the vaccines to address bottlenecks, to provide encouragement and incentives to rapidly expand production and to support the efforts of the WHO, GAVI, CEPI, and UNICEF to fund the needs of COVAX. While concerns in the early days of vaccine rollout are understandable, COVAX has contracts with a number of vaccine producers and others under negotiation or awaiting approval. AstraZeneca, the first vaccine producer with a contract to supply COVAX put out a press release on March 2, 2021 which is copied in part below. See AstraZeneca, AstraZeneca advances mass global rollout of COVID-19 vaccine through COVAX, March 2, 2021, https://www.astrazeneca.com/media-centre/press-releases/2021/astrazeneca-advances-mass-global-rollout-of-covid-19-vaccine-through-covax.html.

Supply to 142 countries underway as part of the unprecedented effort to bring
broad and equitable access to the vaccine

“AstraZeneca with its partner Serum Institute of India
will be the biggest initial supplier to COVAX
 

“The first of many millions of doses of AstraZeneca’s COVID-19 vaccine have begun arriving in low and middle-income countries across the world through the multilateral COVAX initiative, the first steps in fulfilling the Company’s efforts to provide broad and equitable access to the vaccine.

“First COVAX shipments were dispatched late last week to Ghana and Cote D’Ivoire, and more are due to begin arriving this week in countries including the Philippines, Indonesia, Fiji, Mongolia and Moldova. This supply represents the first COVID-19 vaccine for many of these countries.

“Further shipments will arrive in the coming weeks with the aim of supplying a total of 142 countries with hundreds of millions of doses of the vaccine in the coming months. The majority of these doses, manufactured by AstraZeneca and its licence partner Serum Institute of India, will go to low and middle-income countries.

“Pascal Soriot, Chief Executive Officer, Astra Zeneca, said: ‘These first steps towards fulfilling our broad, equitable and no-profit emergency response to the pandemic mean millions of people, irrespective of their country’s income level, will soon be protected against this deadly virus. This is a moment of great pride for us at AstraZeneca and I am extremely grateful to our partners including Gavi, CEPI and Oxford University for their hard work and dedication in order to make this humanitarian ideal a reality for many millions of people around the world.’

“Seth Berkley, Chief Executive Officer, Gavi, said: ‘Global, equitable access to COVID-19 vaccines is only possible when the public and private sectors work together. When we launched the Gavi COVAX Advance Market Commitment in June 2020, our first Agreement was with AstraZeneca. Nine months later, the first doses are already being delivered to those that need them most. This is the beginning of COVAX’s effort to end the acute phase of the pandemic, not the end, but we can all take strength from this moment and I thank AstraZeneca and the University of Oxford for their support and partnership at every step of our journey.’

“Vaccine shipments have been allocated according to the COVAX Allocation Framework which determines volume per participating country based on a number of factors, including country readiness, national regulatory authorisations and national vaccination plans in place. The supply through COVAX follows the recent Emergency Use Listing by the World Health Organization (WHO) for active immunisation in individuals 18 years of age and older, which provides a vital and accelerated pathway to enable supply.

“AstraZeneca was the first global pharmaceutical company to join COVAX in June 2020 in line with the Company’s shared commitment to global, equitable access to vaccines.

“The vaccine can be stored, transported and handled at normal refrigerated conditions (2-8 degrees Celsius/36-46 degrees Fahrenheit) for at least six months and administered within existing healthcare settings.”

The “third way” sought by the WTO Director-General has been underway for some time and is picking up speed as vaccines start to be approved. There are an increasing number of announced agreements among producers to work together to expand production of particular vaccines. Thus, collaboration and cooperation among producers has and is occurring. Governments can help by identifying bottlenecks in all areas relevant to raw materials, intermediate products, finished vaccine doses, distribution and resources to apply the vaccines and helping to resolve the bottlenecks; by encouraging increased ramp ups of capacity and production, including through licensing.

A broad waiver of TRIPS obligations as being pursued by India, South Africa and many other developing and least developed countries is unwise, unlikely to be agreed to, and if implemented, will backfire in terms of global cooperation in getting the world’s population vaccinated and will destroy the likelihood of private sector engagement to solve future pandemics. The EU’s approach as laid out in EU Ambassador João Aguiar Machado’s statement on March 2 is likely the best course forward whether through the WTO or otherwise.