COVID-19

Continued surge of COVID-19 cases results in extended restrictions in many countries affecting trade and economic growth

The latest data from the European Centre for Disease Prevention and Control (ECDC) show the global growth in new cases and deaths accelerating in many parts of the world with resulting extensions of restrictions on activities which harms international trade and global economic growth prospects. The control of the outbreak of new cases is being complicated by new strains in the U.K., South Africa and elsewhere that are proving to be more easily spread than initial strains and rapidly spreading around the world.

Specifically, the ECDC in a report released on January 14 covering data through the first week of 2021 (assumed to be through January 6), shows the last two weeks as generating 9,487,913 new reported cases of COVID-19 — the first time, more than nine million new cases has been found in a two week period. Data on global cases to this morning (January 15) show total global cases at 93.2 million with deaths at 2 million. These are up from the 89.8 million cases through the first week of 2021 and 1.94 million deaths. The world is likely to top 100 million COVID cases by the end of January.

The United States had its worst two weeks — 3,271,355 new cases (34.48% of global new cases) and 41,116 deaths (24.07% of last week global) — and its totals since the beginning of 2020 at 22.4 million cases and 374,442 deaths (24.97% and 19.30% of global totals) dwarf its 4.3% of global population.

Many countries in Europe are continuing to struggle with new cases and deaths and hence have extended restrictions. So, for example, the United Kingdom, has had the largest number of new cases in the last two weeks(742,619) it has ever recorded and the highest number of deaths since spring in the last two weeks (10,322). The result has been continued tightening of restrictions within the United Kingdom. See, e.g., BBC, Covid-19: UK daily deaths at record high and Scotland rules tightened, January 14, 2021, https://www.bbc.com/news/uk-55652431; BBC, Covid: What are the lockdown rules across the UK?, January 13, 2021, https://www.bbc.com/news/explainers-52530518.

In Italy, following a second surge in the fall, restrictions helped lower the number of new cases and deaths but there have been upward trends in new cases in recent weeks with potential increases in deaths likely, leading to the introduction of some new restrictions. See, e.g., The Local, Italy declares three regions red zones as restrictions tighten, January 15, 2021, https://www.thelocal.it/20210115/italy-declares-three-regions-red-zones-as-restrictions-tighten.

Other countries in Europe are also seeing rising cases after drops in cases and deaths following introduction of restrictions and are often imposing or maintaining restrictions to address recent increases. See, e.g., The Local, French government extends 6pm curfew to whole country as Covid cases rise, January 14, 2021 (updated January 15), https://www.thelocal.fr/20210114/latest-french-government-to-announce-extra-restrictions-as-covid-cases-rise; France 24, France introduces tougher Covid-19 restrictions for non-EU travellers, January 15, 2021, https://www.france24.com/en/france/20210115-france-introduces-tougher-covid-19-restrictions-for-non-eu-travellers; DW, Coronavirus: German Chancellor Angela Merkel urges ‘significantly’ tougher curbs — reports, January 15, 2021, https://www.dw.com/en/coronavirus-german-chancellor-angela-merkel-urges-significantly-tougher-curbs-reports/a-56230751; El Pais, Spain reports 35,878 new coronavirus infections and 201 deaths, as third wave progresses, January 15, 2021, https://english.elpais.com/society/2021-01-15/spain-reports-35878-new-coronavirus-infections-and-201-deaths-as-third-wave-progresses.html (“Simón is taking for granted that the epidemiological curve will continue to rise for several more days, but he is hoping that the more restrictive measures that have been put in place after the Christmas holidays will put the brakes on the rhythm of infections.”).

Even in parts of Asia where there have been relatively few COVID-19 cases, recent increases have led to restrictions imposed in particular areas. See, e.g., NPR, Millions In China Under New Restrictions Amid COVID-19 Spike Near Beijing, January 9, 2021, https://www.npr.org/sections/coronavirus-live-updates/2021/01/09/955298826/millions-in-china-under-new-restrictions-amid-covid-19-spike-near-beijing; the Japan Times, Japan bars entry for new arrivals and business travelers due to new COVID-19 strains, January 14, 2021, https://www.japantimes.co.jp/news/2021/01/14/national/japan-bars-new-arrivals-business-travelers/; japan-guide.com, Travel Alerts and Disaster Updates, updated January 15, 2021, https://www.japan-guide.com/news/alerts.html (“Domestic Situation Although the virus has not spread in Japan at a rate seen in Europe and North America, infection numbers have increased considerably in recent weeks, and a state of
emergency was declared in 11 of Japan’s 47 prefectures, including in the greater Tokyo, Osaka, Nagoya and Fukuoka regions, to last until February 7.”); NPR, South Korea Tightens Restrictions During Holiday Period, December 22, 2020, https://www.npr.org/sections/coronavirus-live-updates/2020/12/22/949155094/south-korea-tightens-restrictions-during-holiday-period (“The new measures, which will be in effect through Jan. 3, follow the capital Seoul’s ban earlier in the week on private assembly of five or more people. The capital area, which accounts for more than 70% of last week’s new infections in South Korea, upped the regional alert level three times in the past month. But case numbers have yet to demonstrate a downward trend.”).

In India, where the government has worked hard to bring down the number of new cases in recent months and has had some significant success, many restrictions remain in place. See GardaWorld, India: Authorities extend domestic coronavirus disease controls through Jan. 31, 2021; international travel restrictions continue, December 29, 2020, https://www.garda.com/crisis24/news-alerts/422756/india-authorities-extend-domestic-coronavirus-disease-controls-through-jan-31-2021-international-travel-restrictions-continue-update-33.

Some governments have reduced economic recovery projections for 2021 because of the second wave of cases in the fall of 2020. See, e.g., Euronews, What does 2021 hold for jobs and businesses in Europe?, December 16, 2020, https://www.euronews.com/2020/12/16/what-does-2021-hold-for-jobs-and-businesses-in-europe (“The second wave of lockdowns devastated businesses across Europe and led the European Commission to downgrade its economic growth forecast for 2021 for the Eurozone from 6.1% down to 4.2%. It’s expected to be two years until the European economy comes close to its pre-pandemic level.”).

While other government 2021 projections show greater growth than was projected in the fall of 2020, the rebound is built on assumptions about stimulus funding, timing and effectiveness of vaccines and other elements. See, e.g., CNBC, Fed raises its economic outlook slightly, sees 4.2% growth next year and 5% unemployment rate, December 16, 2020, https://www.cnbc.com/2020/12/16/fed-raises-its-economic-outlook-slightly-sees-4point2percent-growth-next-year-and-5percent-unemployment-rate.html#:~:text=The%20Federal%20Reserve%20expects%20real,to%204.2%25%20from%204.0%25; The Conference Board, The Conference Board Economic Forecast for the US Economy, January 13, 2021, https://www.conference-board.org/research/us-forecast (“Our base case forecast yields 1Q21 real GDP growth of 2.0 percent* (annualized rate), and an annual expansion of 4.1 percent for 2021, following an annual contraction of 3.5 percent for 2020. We view this scenario as the most probable. It assumes: a) new cases of COVID-19 peak in early 1Q21 but no widespread lockdowns are implemented, b) vaccines are deployed gradually in 1Q21 but volumes accelerate into 2Q21, c) the December 2020 stimulus package is fully deployed in 1Q21 and an additional stimulus package is deployed in 2Q21, d) labor markets and consumption weaken slightly in 1Q21 but rebound in 2Q21 and 3Q21, and e) the political transition does not result in a hit to consumer or business confidence. These assumptions yield a lull in the recovery in 4Q20 and early 1Q21, but a steady acceleration of economic activity that peaks in the summer months as consumers eagerly spend on services and goods that they had forgone in 2020. In this scenario US monthly economic output returns to pre-pandemic levels in August 2021.”).

Growing concern over new strains of the COVID-19 and mounting new cases will be putting strain on many governments and keeping downward pressure on trade in services which the WTO has estimated as being down 30% globally in 2020. Travel and tourism have been decimated in 2020 and will continue to face major hurdles for at least the first half of 2021. International arrivals are down 70% for the year and more than 90% for the period since April 2020. See UNWTO, TOURISM BACK TO 1990 LEVELS AS ARRIVALS FALL BY MORE THAN 70%, 17 December 2020, https://www.unwto.org/news/tourism-back-to-1990-levels-as-arrivals-fall-by-more-than-70.

In the EU, a $2.1 trillion budget and coronavirus recovery package has been approved. See KFF, E.U. Leaders Agree To $2.1T Budget, Pandemic Recovery Fund; Main Science Research Program Receives Less Than Expected, Jul 21, 2020, https://www.kff.org/news-summary/e-u-leaders-agree-to-2-1t-budget-pandemic-recovery-fund-main-science-research-program-receives-less-than-expected/; Politico, EU leaders back deal to end budget blockade by Hungary and Poland, December 10, 2020, https://www.politico.eu/article/deal-reached-to-unblock-eu-budget-and-recovery-fund/.

In the United States, the recent $900 billion stimulus package was viewed as a temporary measure that would need to be supplemented in 2021. President-elect Biden announced on January 14, 2021 that he will be seeking a $1.9 trillion additional stimulus package to address the human costs of the pandemic, provide funding for people and businesses, strengthen efforts at vaccine distribution and vaccinations and other purposes. See, e.g., New York Times, Biden Outlines $1.9 Trillion Spending Package to Combat Virus and Downturn, January 14, 2021 (updated January 15), https://www.nytimes.com/2021/01/14/business/economy/biden-economy.html.

The stimulus packages by the EU (and member governments) and U.S. and other countries have kept demand higher than would otherwise have been possible but at the cost of significant increases in national debt which will reduce national flexibilities in later years.

In prior posts, I pointed out that the vaccine rollout, while promising, was facing a series of problems both at producers and in the ability of many governments to ramp up vaccinations. Moreover, the rapidity of the global economic rebound would depend on the speed of global vaccinations. See January 3, 2021, 2021 – how quickly will COVID-19 vaccines bring the pandemic under control?, https://currentthoughtsontrade.com/2021/01/03/2021-how-quickly-will-covid-19-vaccines-bring-the-pandemic-under-control/; January 5, 2021,  Global economic rebound in 2021 will be affected by rate of vaccinations against COVID-19 – World Bank’s January 5, 2021 release of its World Economic Prospects report, https://currentthoughtsontrade.com/2021/01/05/global-economic-rebound-in-2021-will-be-affected-by-rate-of-vaccinations-against-covid-19-world-banks-january-5-2021-release-of-its-world-economic-prospects-report/.

There is also the question of whether variants of COVID-19 will be treatable as effectively by the currently approved vaccines. See, e.g., National Geographic, Existing vaccines should work against new coronavirus variants for now, January 15, 2021, https://www.nationalgeographic.com/science/2021/01/existing-vaccines-should-work-against-new-coronavirus-variants-for-now/; VOX, How the new Covid-19 variants could pose a threat to vaccination, January 7, 2021, https://www.vox.com/22213033/covid-19-mutation-variant-vaccine-uk-south-africa.

There continue to be problems with the rate of vaccinations in many countries who have access to vaccines although all governments area working on ways to speed up the vaccination process. There are also problems in terms of the ramp up of production and the slower than expected approval of some vaccines. See, e.g., Politico, Germans vexed as coronavirus vaccine rollout lags, January 12, 2021, https://www.politico.eu/article/coronavirus-story-kiel/; Politico, France rejects criticism of EU coronavirus vaccine procurement, January 10, 2021, ; Financial Times, Pfizer to limit vaccine deliveries temporarily to Europe, January 15, 2021,https://www.ft.com/content/e8177df6-04ae-4d20-8e62-ca76589c7653?desktop=true&segmentId=d8d3e364-5197-20eb-17cf-2437841d178a; BBC News, Coronavirus: Dutch shocked to be EU vaccination stragglers, January 6, 2021, https://www.bbc.com/news/world-europe-55549656; USA Today, Tracking COVID-19 vaccine distribution by state: How many people in the US have received a shot?, January 14, 2021, https://www.usatoday.com/in-depth/graphics/2021/01/14/covid-vaccine-distribution-by-state-how-many-covid-vaccines-have-been-given-in-us-how-many-people/6599531002/ (“About 63.6% of the vaccines distributed haven’t been used yet.”).

Finally, while 49 countries have started to vaccinate their populations according to a recent article from Politico, the largest number of countries continue to wait for vaccines which will be helped when more vaccines are approved. See, e.g., Politico, Coronavirus vaccination in Europe — by the numbers, January 11, 2021, https://www.politico.eu/article/coronavirus-vaccination-europe-by-the-numbers/.

Conclusion

The COVID-19 pandemic continues to rage globally and is becoming more concerning because of faster spreading variants that are showing up around the world. Since many western countries continue to have very high numbers of new cases, hospitalizations and deaths, enormous pressure is on governments to get effective vaccines in large quantities as quickly as possible and get their populations vaccinated. Many countries with access to vaccines are having early problems in ramping up vaccinations. Some of the approved vaccinations are struggling with the production ramp up and being pressed to provide more volumes of vaccines in the absence of alternative vaccines from other producers. The main vaccines intended for broad distribution to many developing and least developed countries are either just starting to receive approvals for distribution or are still working through final trials. In a world quickly approaching 100 million reported cases and more than 2 million deaths and having suffered significant economic dislocations with services trade down an estimated 30 percent, with as many as 100 million people pushed into poverty, and 100-120 million people in the tourism sector having lost jobs, a global solution cannot occur soon enough. While 2021 will show significant improvements for many countries, the continuing challenges from COVID-19 will be with the world community for the foreseeable future.

Global economic rebound in 2021 will be affected by rate of vaccinations against COVID-19 — World Bank’s January 5, 2021 release of its World Economic Prospects report

The last forecast by the WTO for international merchandise trade for 2020 projected a decline of 9.2% for the world reflecting significant improvements in the 3rd quarter of 2020 after the sharp contraction in the second quarter. Services trade is trailing merchandise trade significantly as is reflected in the WTO ‘s December 4, 2020 press release, Electronics and automotive products lift global merchandise trade in Q3, services lag behind, https://www.wto.org/english/news_e/news20_e/stat_04dec20_e.htm. Two charts from the press release show data through the third quarter of 2020 for goods and services and are copied below.

The expected continued rebound in the fourth quarter of 2020 has likely been reduced in size by the large increase in COVID-19 cases in many countries, including the European Union, United Kingdom, the United States and some countries in Asia and reintroduction of restrictions on people in those countries, resulting in downward pressure on domestic consumption (and hence trade flows in both goods and services).

There is significant optimism about economic growth in 2021 in light of the progress on approval and production of COVID-19 vaccines. See my post from January 3, 2021, 2021 – how quickly will COVID-19 vaccines bring the pandemic under control?, https://currentthoughtsontrade.com/2021/01/03/2021-how-quickly-will-covid-19-vaccines-bring-the-pandemic-under-control/.

Today, January 5, 2021, the World Bank released its World Economic Prospects report. See World Bank, World Economic Prospects, January 2021, https://www.worldbank.org/en/publication/global-economic-prospects. The press release from the World Bank provides both an estimate for growth in 2021 for the world and for various regions of the world but also cautions that the economic rebound could be reduced significantly if there are problems with vaccinations in the developed world and various advanced developing countries. See World Bank, Global Economy to Expand by 4% in 2021; Vaccine Deployment and Investment Key to Sustaining the Recovery, January 5, 2021, https://www.worldbank.org/en/news/press-release/2021/01/05/global-economy-to-expand-by-4-percent-in-2021-vaccine-deployment-and-investment-key-to-sustaining-the-recovery. A large part of the press release is copied below (emphasis and italics in the original).

Development risks remain as economic activity, incomes likely to stay low for extended period

“WASHINGTON, Jan. 5, 2021 — The global economy is expected to expand 4% in 2021, assuming an initial COVID-19 vaccine rollout becomes widespread throughout the year. A recovery, however, will likely be subdued, unless policy makers move decisively to tame the pandemic and implement investment-enhancing reforms, the World Bank says in its January 2021 Global Economic Prospects.

“Although the global economy is growing again after a 4.3% contraction in 2020, the pandemic has caused a heavy toll of deaths and illness, plunged millions into poverty, and may depress economic activity and incomes for a prolonged period. Top near-term policy priorities are controlling the spread of COVID-19 and ensuring rapid and widespread vaccine deployment. To support economic recovery, authorities also need to facilitate a re-investment cycle aimed at sustainable growth that is less dependent on government debt.

“‘While the global economy appears to have entered a subdued recovery, policymakers face formidable challenges—in public health, debt management, budget policies, central banking and structural reforms—as they try to ensure that this still fragile global recovery gains traction and sets a foundation for robust growth,’ said World Bank Group President David Malpass. ‘To overcome the impacts of the pandemic and counter the investment headwind, there needs to be a major push to improve business environments, increase labor and product market flexibility, and strengthen transparency and governance.’

“The collapse in global economic activity in 2020 is estimated to have been slightly less severe than previously projected, mainly due to shallower contractions in advanced economies and a more robust recovery in China. In contrast, disruptions to activity in the majority of other emerging market and developing economies were more acute than expected.

“’Financial fragilities in many of these countries, as the growth shock impacts vulnerable household and business balance sheets, will also need to be addressed,’ Vice President and World Bank Group Chief Economist Carmen Reinhart said.

“The near-term outlook remains highly uncertain, and different growth outcomes are still possible, as a section of the report details. A downside scenario in which infections continue to rise and the rollout of a vaccine is delayed could limit the global expansion to 1.6% in 2021. Meanwhile, in an upside scenario with successful pandemic control and a faster vaccination process, global growth could accelerate to nearly 5 percent.

“In advanced economies, a nascent rebound stalled in the third quarter following a resurgence of infections, pointing to a slow and challenging recovery. U.S. GDP is forecast to expand 3.5% in 2021, after an estimated 3.6% contraction in 2020. In the euro area, output is anticipated to grow 3.6% this year, following a 7.4% decline in 2020. Activity in Japan, which shrank by 5.3% in the year just ended, is forecast to grow by 2.5% in 2021.

“Aggregate GDP in emerging market and developing economies, including China, is expected to grow 5% in 2021, after a contraction of 2.6% in 2020. China’s economy is expected to expand by 7.9% this year following 2% growth last year. Excluding China, emerging market and developing economies are forecast to expand 3.4% in 2021 after a contraction of 5% in 2020. Among low-income economies, activity is projected to increase 3.3% in 2021, after a contraction of 0.9% in 2020.

“Analytical sections of the latest Global Economic Prospects report examine how the pandemic has amplified risks around debt accumulation; how it could hold back growth over the long term absent concerted reform efforts; and what risks are associated with the use of asset purchase programs as a monetary policy tool in emerging market and developing economies.

“’The pandemic has greatly exacerbated debt risks in emerging market and developing economies; weak growth prospects will likely further increase debt burdens and erode borrowers’ ability to service debt,’ World Bank Acting Vice President for Equitable Growth and Financial Institutions Ayhan Kose said. ‘The global community needs to act rapidly and forcefully to make sure the recent debt accumulation does not end with a string of debt crises. The developing world cannot afford another lost decade.’

“As severe crises did in the past, the pandemic is expected to leave long lasting adverse effects on global activity. It is likely to worsen the slowdown in global growth projected over the next decade due to underinvestment, underemployment, and labor force declines in many advanced economies. If history is any guide, the global economy is heading for a decade of growth disappointments unless policy makers put in place comprehensive reforms to improve the fundamental drivers of equitable and sustainable economic growth.  

“Policymakers need to continue to sustain the recovery, gradually shifting from income support to growth-enhancing policies. In the longer run, in emerging market and developing economies, policies to improve health and education services, digital infrastructure, climate resilience, and business and governance practices will help mitigate the economic damage caused by the pandemic, reduce poverty and advance shared prosperity. In the context of weak fiscal positions and elevated debt, institutional reforms to spur organic growth are particularly important. In the past, the growth dividends from reform efforts were recognized by investors in upgrades to their long-term growth expectations and increased investment flows.

“Central banks in some emerging market and developing economies have employed asset purchase programs in response to pandemic-induced financial market pressures, in many cases for the first time. When targeted to market failures, these programs appear to have helped stabilize financial markets during the initial stages of the crisis. However, in economies where asset purchases continue to expand and are perceived to finance fiscal deficits, these programs may erode central bank operational independence, risk currency weakness that de-anchors inflation expectations, and increase worries about debt sustainability.”

Whether the economic recovery in 2021 is as robust as projected or is dramatically smaller (worst case scenario) will obviously affect trade flows of both goods and services. As can be seen from the initial roll out of vaccines in the U.S., EU, U.K., Canada and other countries, there are significant goods and services involved with the production, distribution and utilization of vaccines globally and within markets. Thus, if there are problems with vaccinating large parts of populations, that will have a direct effect on both goods shipments and on various services. There are also the indirect effects on goods and services from the likely continued restrictions on travel and tourism if the pandemic is not brought under control, something that widespread vaccinations will assist in achieving. My post yesterday reviewed some of the early challenges with vaccinations occurring in the U.S., EU and India. Additional articles are appearing which suggest a lot of work needs to be done to in fact permit rapid vaccinations of populations. See, e.g., Politico, The EU’s coronavirus vaccine blame game. Why so slow?, January 5, 2021, https://www.politico.eu/article/the-vaccination-blame-game-is-it-all-the-eus-fault/; Politico, Sluggish coronavirus vaccination rollout poses risks for Macron, January 5, 2021, https://www.politico.eu/article/coronavirus-covid19-vaccine-campaign-fail-france-president-emmanuel-macron-election/; Wall Street Journal, Covid-19 Vaccine’s Slow Rollout Could Portend More Problems, January 1, 2021, https://www.wsj.com/articles/covid-19-vaccines-slow-rollout-could-portend-more-problems-11609525711/ And this comes against the backdrop of continued surges of new cases of COVID-19 in the U.S. and many other countries which will extend restrictions into the early months of 2021 at least and hence restrict economic recovery in at least the first quarter of 2021. See, e.g., Financial Times, Covid surges as UK rolls out mass vaccination programme, January 3, 2021, https://www.ft.com/content/71140ee7-8e47-4499-9fcf-2d23d5c7d94f; New York Times, The Lull Before the Surge on Top of the Surge, January 5, 2021, https://www.nytimes.com/2021/01/05/us/california-coronavirus.html

The World Bank report identifies a host of policy issues for governments and challenges flowing from the high level of debt that has been incurred during 2020 and the downward pressures on investment flows in many countries. Many countries will have trouble implementing the appropriate policy options because of existing debt issues (particularly many developing countries) or because of political gridlock, as is apparent in the U.S. even with a new Administration due to be sworn in on January 20. See, e.g., New York Times, $900 Billion Wonʼt Carry Biden Very Far (Despite new pandemic aid, he confronts an economic crisis unlike any since he last entered office in 2009. And political headwinds have only stiffened), January 4, 2021. Indeed, as reviewed in a recent Congressional Research Service updated report on the Global Economic Effects of COVID-19 (updated as of December 23, 2020), the level of debt incurred by developed and developing countries has surged during the pandemic with the level of fiscal deficit relative to GDP reflecting declining government revenues and increased expenditures to reduce the negative effects of the pandemic. See CRS, Global Economic Effects of COVID-19, updated December 23, 2020, page 13, https://fas.org/sgp/crs/row/R46270.pdf. The figure from the report is copied below. Obviously the levels of fiscal deficit incurred in 2020 are not sustainable. They also reduce flexibilities of countries in policy actions that can be taken to speed up the recovery of the national and global economies.

Conclusion

The world needs to return to a period of sustained economic growth that is more inclusive and more equitable. The arrival of vaccines (with more expected in the first quarter of 2021) and the ramp up of production, distribution and utilization of vaccines around the world can expand economic growth both directly through the goods and services involved and indirectly through permitting countries to ease restrictions imposed to try to control the pandemic. The first few weeks of the rollout of vaccines have not been without significant problems. As reviewed in yesterday’s post, production of the vaccines that have been approved by individual nations is running behind what was anticipated, in some cases (e.g., India) significantly. While distribution has been reasonably robust in the U.S. and some other countries, there is a significant lag in getting the vaccines utilized with a wide variety of problems identified in different markets.

As the World Bank’s report today makes clear, if countries are not able to achieve significant vaccinations in 2021 the projected growth of global GDP could be cut by more than half. A global economy that is not expected to return to 2019 levels until 2022 even if 2021 growth rates are achieved will be further retarded if vaccinations lag what is needed. That will reduce trade volumes of goods and services, leave tens of millions of people around the world unemployed or underemployed, and challenge the ability to achieve UN Sustainability Goals on a host of issues including poverty, food security and many more.

President-elect Biden and his team are focused on dramatically ramping up the response in the United States, but the challenges here are significant and complicated by a divided public many of whom still doubt there is a pandemic or that it is problematic or who are opposed to vaccinations. Challenges exist in many other countries as well.

If ever there were a time for people to come together and ensure the timely vaccinations of as many people as possible as quickly as possible, it is obviously now. Whether that can be achieved is the multi-trillion dollar question.

2021 – how quickly will COVID-19 vaccines bring the pandemic under control?

News accounts report many countries starting to receive at least some doses of vaccines. In the United States, two vaccines have received emergency use authorization (“EUA”)(the Pfizer/BioNTech and the Moderna vaccines). The Pfizer/BioNTech vaccine has received approval (emergency use or other) in a number of countries (EU, Canada, United Kingdom, Bahrain) and was the first vaccine to receive an EUA from the World Health Organization. See WHO press release, WHO issues its first emergency use validation for a COVID-19 vaccine and emphasizes need for equitable global access, December 31, 2020, https://www.who.int/news/item/31-12-2020-who-issues-its-first-emergency-use-validation-for-a-covid-19-vaccine-and-emphasizes-need-for-equitable-global-access. As the WHO press releases indicates, “The WHO’s Emergency Use Listing (EUL) opens the door for countries to expedite their own regulatory approval processes to import and administer the vaccine. It also enables UNICEF and the Pan-American Health Organization to procure the vaccine for distribution to countries in need.”

AstraZeneca will likely seek emergency use authorization in the United States in January and Johnson & Johnson in February. AstraZeneca has received an emergency use authorization in the United Kingdom. It has also been given EUA by India (along with a vaccine from Bharat Biotech). See New York Times, India Approves Oxford-AstraZeneca Covid-19 Vaccine and 1 other, January 3, 2021, https://www.nytimes.com/2021/01/03/world/asia/india-covid-19-vaccine.html.

A recent Financial Times article includes a graph showing the number of citizens in various countries who have received a first vaccination shot. See Financial Times, European leaders under pressure to speed up mass vaccination, January 1, 2021, https://www.ft.com/content/c45e5d1c-a9ea-4838-824c-413236190e7e. The countries shown as having started vaccinations include China, the U.S., the U.K., Kuwait, Mexico, Canada, Chile, Russia, Argentina, Iceland, Bahrain, Oman, Israel, and fourteen of the 27 members of the EU).

Similarly an article from CGTN on January 1, 2021 shows a number of countries who are buying COVID-19 vaccines from China including Hungary and a number of others while vaccines from China are in stage 3 trials in a number of countries. CGTN, 1 January 2021, Hungary to focus on EU, Chinese coronavirus vaccine purchases, https://news.cgtn.com/news/2021-01-01/Hungary-to-focus-on-EU-Chinese-coronavirus-vaccine-purchases-WHm11NYjni/index.html. “By the end of 2020, UAE became the first country to roll out a Chinese vaccine to the public. Pakistan also announced on Thursday that they will purchase 1.2 million COVID-19 vaccine doses from China’s Sinopharm after China officially approved the vaccine for general public use. Sinovac’s CoronaVac shot, another candidate vaccine in China, has been signed up for purchase deals with Brazil, Indonesia, Turkey, Chile, and Singapore. The company is also in supply talks with Malaysia and the Philippines.”

So the good news at the beginning of 2021 is that effective vaccines are starting to be distributed. Many others are in late stages of trials, giving hope to a significant number of vaccines approved for use in the coming months. The WHO’s list of vaccines in development and their status can be found on the WHO website at this cite. https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines. How quickly approved vaccines can be produced, distributed and vaccinations given globally will determine when the pandemic will be brought under control. There are many challenges that the world faces in getting to the hoped for situation of a pandemic that is in the past.

For example, even in developed countries, governments are finding that there are significant hurdles in getting production volumes up to promised levels, and much greater challenges in going from production to distribution to vaccinations. In the United States, the Trump Administration had aimed at having 20 million vaccinations accomplished by the end of 2020. Only 13.071 million doses were distributed by the end of the year according to the US CDC and only 4.2 million vaccinations (first shot of two shots) occurred. See Center for Disease Prevention and Control, COVID-19 Vaccinations in the United States, https://covid.cdc.gov/covid-data-tracker/#vaccinations (viewed Jan. 3, 2021). President-elect Biden is talking about an aggressive program to get 100 million vaccinations (as the current vaccines require 2 shots, this means 50 million people) vaccinated in the first 100 days of his Administration (by the end of April). To achieve this objective will require cooperation from Congress in providing sufficient funding to build up the capabilities at the state and local levels. Health care infrastructure has been reduced over the last dozen years with a reduction of some 50,000 health care workers in the U.S. The huge COVID-19 case load in the United States and record hospitalizations also have health care operations across the United States overextended. So despite having sufficient vaccines on order from four companies where EUAs have been or will likely be granted in the near future to permit vaccination of all Americans by fall, there are enormous practical challenges to making the vaccinations happen in fact. And that is before the challenges of convincing portions of the population of the safety of the vaccines and the need for the vast majority of people to be vaccinated to achieve herd immunity.

Similar challenges exist in many other parts of the world as well. For example, in both the EU and India the roll out of vaccines is proceeding slower than desired. See, e.g., The Guardian, BioNTech criticises EU failure to order enough Covid vaccine, January 1, 2021, https://www.theguardian.com/world/2021/jan/01/france-to-step-up-covid-jabs-after-claims-of-bowing-to-anti-vaxxers; Politico, France under pressure to speed up coronavirus vaccine rollout, January 3, 2021, https://www.politico.eu/article/france-under-pressure-to-speed-up-coronavirus-vaccine-rollout/; New York Times, India Approves Oxford-AstraZeneca Covid-19 Vaccine and 1 other, January 3, 2021, https://www.nytimes.com/2021/01/03/world/asia/india-covid-19-vaccine.html (“The Serum Institute, an Indian drug maker that struck a deal to produce the Oxford vaccine even before its effectiveness had been proven, has managed to make only about one-tenth of the 400 million doses it had committed to manufacturing before the end of the year.”).

The WHO/GAVI/CEPI effort to get vaccines to the world on a equitable basis has much of its vaccine commitments in products still in the testing stage although roughly one billion doses can be available for a vaccine currently approved on an emergency use basis in the U.K. and India (the AstraZeneca vaccine) through COVAX agreements with AstraZeneca directly and with an Indian producer who can be asked to produce one of two potential vaccines, including the AstraZeneca one. See WHO, COVAX Announces additional deals to access promising COVID-19 vaccine candidates; plans global rollout starting Q1 2021, 18 December 2020, https://www.who.int/news/item/18-12-2020-covax-announces-additional-deals-to-access-promising-covid-19-vaccine-candidates-plans-global-rollout-starting-q1-2021.

“Geneva/Oslo, 18 December 2020

“COVAX, the global initiative to ensure rapid and equitable access to COVID-19 vaccines for all countries, regardless of income level, today announced that it had arrangements in place to access nearly two billion doses of COVID-19 vaccine candidates, on behalf of 190 participating economies. For the vast majority of these deals, COVAX has guaranteed access to a portion of the first wave of production, followed by volume scales as further supply becomes available. The arrangements announced today will enable all participating economies to have access to doses in the first half of 2021, with first deliveries anticipated to begin in the first quarter of 2021 – contingent upon regulatory approvals and countries’ readiness for delivery.

“Given these are arrangements for 2 billion doses of vaccine candidates which are still under development, COVAX will continue developing its portfolio: this will be critical to achieve its goal of securing access to 2 billion doses of safe and effective, approved vaccines that are suitable for all participants’ contexts, and available by the end of 2021. However, today’s announcements offer the clearest pathway yet to end the acute phase of the pandemic by protecting the most vulnerable populations around the world. This includes delivering at least 1.3 billion donor-funded doses of approved vaccines in 2021 to the 92 low- and middle-income economies eligible for the COVAX AMC.

“The new deals announced today include the signing of an advance purchase agreement with AstraZeneca for 170 million doses of the AstraZeneca/Oxford candidate, and a memorandum of understanding (MoU) with Johnson & Johnson for 500 million doses of the Janssen candidate, which is currently being investigated as a single dose vaccine.. These deals are in addition to existing agreements COVAX has with the Serum Institute of India (SII) for 200 million doses – with options for up to 900 million doses more – of either the AstraZeneca/Oxford or Novavax candidates, as well as a statement of intent for 200million doses of the Sanofi/GSK vaccine candidate.

“In addition to this, COVAX also has – through R&D partnership agreements – first right of refusal in 2021 to access potentially more than one billion doses (based on current estimates from the manufacturing processes under development) that will be produced, subject to technical success and regulatory approval, by candidates in the COVAX R&D Portfolio.”

* * *

“The COVAX Facility currently has 190 participating economies. This includes 98 higher-income economies and 92 low- and middle-income economies eligible to have their participation in the Facility supported via the financing mechanism known as the Gavi COVAX AMC. Of the 92 economies eligible to be supported by the COVAX AMC, 86 have now submitted detailed vaccine requests, offering the clearest picture yet on actual global demand for COVID-19 vaccines.

“In addition to gathering detailed information on participating economies’ vaccine requests, COVAX, through Gavi, UNICEF,WHO, the World Bank, and other partners has been working closely with all countries in the Facility, particularly AMC-eligible participants, to help plan and prepare for the widespread roll out of vaccines. Conditions that determine country readiness include regulatory preparedness as well as the availability of infrastructure, appropriate legal frameworks, training, and capacity, among other factors.

“’Securing access to doses of a new vaccine for both higher-income and lower-income countries, at roughly the same time and during a pandemic, is a feat the world has never achieved before – let alone at such unprecedented speed and scale,’ said Dr. Seth Berkley, CEO of Gavi, the Vaccine Alliance, which leads on procurement and delivery for COVAX. ‘COVAX has now built a platform that offers the world the prospect, for the first time, of being able to defeat the pandemic on a global basis, but the work is not done: it’s critical that both governments and industry continue to support our efforts to achieve this goal’.

Early pledges towards 2021 fundraising targets

“To achieve this ambitious goal, COVAX currently estimates it needs to raise an additional US$ 6.8 billion in 2021 – US$ 800 million for research and development, at least US$ 4.6 billion for the COVAX AMC and US$ 1.4 billion for delivery support.

“Support for the COVAX AMC will be critical to ensuring ability to pay is not a barrier to access. Thanks to the generous support of sovereign, private sector, and philanthropic donors, the AMC has met its urgent 2020 fundraising target of US$ 2 billion, but at least US$ 4.6 billion more is needed in 2021 to procure doses of successful candidates as they come through the portfolio.”

In the United States and in the EU, governments are looking to expand volumes of proven vaccines while awaiting approval of other vaccine candidates. See Pfizer press release, PFIZER AND BIONTECH TO SUPPLY THE U.S. WITH100 MILLION ADDITIONAL DOSES OF COVID-19VACCINE, December 23, 2020, https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-supply-us-100-million-additional-doses; Pfizer press release, PFIZER AND BIONTECH TO SUPPLY THEEUROPEAN UNION WITH 100 MILLIONADDITIONAL DOSES OF COMIRNATY®, December 29, 2020, https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-supply-european-union-100-million; HHS, Trump Administration purchases additional 100 million doses of COVID-19 investigational vaccine from Moderna, December 11, 2020, https://www.hhs.gov/about/news/2020/12/11/trump-administration-purchases-additional-100-million-doses-covid-19-investigational-vaccine-moderna.html.

Conclusion

The world is anxiously awaiting the resolution of the pandemic through the approval and distribution of effective vaccines on a global basis in 2021. The good news is that a number of vaccines have been approved in one or more countries and billions of doses of approved vaccines will likely be produced in 2021. The efforts of the WHO, GAVI and CEPI and the generosity of many nations, private and philanthropic organizations will mean people in nearly all countries will receive at least some significant volume of vaccines in 2021. As most vaccines require two shots, the number of people vaccinated in 2021 in an optimistic scenario is probably less than two billion. The world population at the beginning of 2021 is 7.8 billion people. Thus, 2021, even under an optimistic scenario, will not likely result in the eradication of the pandemic around the world.

Even in countries like the United States, the United Kingdom and the 27 members of the European Union where advance purchases should result in sufficient doses being available to vaccinate all eligible members of society, there are massive challenges in terms of distribution and vaccinating the numbers of people involved and educating the populations on the safety and benefits of the vaccines. Thus, even in wealthier countries it will be optimistic to achieve the desired levels of vaccination by the end of 2021.

The Director-General of the WHO in his year-end message laid out the likely situation for the world in 2021, the availability of vaccines but the continued need to be vigilant and adhere to preventive measures to control the pandemic and the need to work collectively to ensure equitable and affordable access to vaccines for all. See WHO,COVID-19: One year later – WHO, Director-General’s new year message, December 30, 2020, https://www.who.int/news/item/30-12-2020-covid-19-anniversary-and-looking-forward-to-2021 (Dr Tedros Adhanom Ghebreyesus, WHO Director-General)

“As people around the world celebrated New Year’s Eve 12 months ago, a new global threat emerged.

“Since that moment, the COVID-19 pandemic has taken so many lives and caused massive disruption to families, societies and economies all over the world.

“But it also triggered the fastest and most wide-reaching response to a global health emergency in human history.

“The hallmarks of this response have been an unparalleled mobilization of science, a search for solutions and a commitment to global solidarity.

“Acts of generosity, large and small, equipped hospitals with the tools that health workers needed to stay safe and care for their patients.

“Outpourings of kindness have helped society’s most vulnerable through troubled times.

“Vaccines, therapeutics and diagnostics have been developed and rolled out, at record speed, thanks to collaborations including the Access to COVID-19 Tools Accelerator.

“Equity is the essence of the ACT Accelerator, and its vaccine arm, COVAX, which has secured access to 2 billion doses of promising vaccine candidates.

“Vaccines offer great hope to turn the tide of the pandemic.

“But to protect the world, we must ensure that all people at risk everywhere – not just in countries who can afford vaccines –are immunized.

“To do this, COVAX needs just over 4 billion US dollars urgently to buy vaccines for low- and lower-middle income countries.

“This is the challenge we must rise to in the new year.

“My brothers and sisters, the events of 2020 have provided telling lessons, and reminders, for us all to take into 2021.

“First and foremost, 2020 has shown that governments must increase investment in public health, from funding access to COVID vaccines for all people, to making our systems better prepared to prevent and respond to the next, inevitable, pandemic.

“At the heart of this is investing in universal health coverage to make health for all a reality.

“Second, as it will take time to vaccinate everyone against COVID, we must keep adhering to tried and tested measures that keep each and all of us safe.

“This means maintaining physical distance, wearing face masks, practicing hand and respiratory hygiene, avoiding crowded indoor places and meeting people outside.

“These simple, yet effective measures will save lives and reduce the suffering that so many people encountered in 2020.

“Third, and above all, we must commit to working together in solidarity, as a global community, to promote and protect health today, and in the future.

“We have seen how divisions in politics and communities feed the virus and foment the crisis.

“But collaboration and partnership save lives and safeguard societies.

“In 2020, a health crisis of historic proportions showed us just how closely connected we all are.

“We saw how acts of kindness and care helped neighbors through times of great struggle.

“But we also witnessed how acts of malice, and misinformation, caused avoidable harm.

“Going into 2021, we have a simple, yet profound, choice to make:

“Do we ignore the lessons of 2020 and allow insular, partisan approaches, conspiracy theories and attacks on science to prevail, resulting in unnecessary suffering to people’s health and society at large?

“Or do we walk the last miles of this crisis together, helping each other along the way, from sharing vaccines fairly, to offering accurate advice, compassion and care to all who need, as one global family.

“The choice is easy.

“There is light at the end of the tunnel, and we will get there by taking the path together.

“WHO stands with you – We Are Family and we are In This Together.

“I wish you and your loved ones a peaceful, safe and healthy new year.”

We all want to have the COVID-19 pandemic in the rearview mirror as 2021 progresses. There is hope for significant progress this year. How much progress will depend on the will of governments and peoples to focus on the eradication of the pandemic and to support the dramatic ramp up of production, distribution and vaccination of the world’s people.

In last two weeks, United States adds more than three million new confirmed COVID-19 cases; world approaches nine million new cases; first vaccines start to ship in United Kingdom, Canada, Bahrain, United States and shortly in the European Union; hope for a better 2021

The European Centre for Disease Prevention and Control (ECDC) shifted from a daily report on global cases to a weekly total last week. In today’s report, the United States becomes the only country to record more than three million new cases in a two week period. ECDC, COVID-19 situation update worldwide, as of week 51 2020. It is also the only country to have recorded 2,000,000 in a two week period. The 3,087,841 new cases in weeks 50 and 51 constitute 34.73% of the global total of 8,888,940 new cases in the last two weeks and was 4.68 times the number reported in Brazil (660,079), 8.16 times the number reported in India — the two countries after the United States with the most cases. For the full 2020, the United States has accounted for 23.47% (17,844,839) of global cases (76,046,387) despite being only 4.3% of the global population.

The weekly total for the United States has been an almost uninterrupted surge in new cases for the last three months or so. Below are the data as compiled by the ECDC for weeks 37-51 for the United States. Deaths have also been climbing rapidly but at a slower rate than new cases. The U.S. accounts for 18.75% (317,670) of global deaths (1,693,858) in 2020 from COVID-19 and a higher percentage in recent weeks. Deaths for the same weeks for the U.S. are shown below. The U.S. is seeing deaths approaching 3,000/day with some days as high as 4,000+. With hospitalizations at all time highs, and surging cases and rising deaths, the U.S. is likely to surpass 400,000 deaths by January 20, 2021 when President-elect Joe Biden will be sworn in.

Number of new COVID-19 cases reported by the U.S.Week in 2020No. of deaths reported in the U.S.
             243,5582020-37  5,138               
             284,8352020-38 5,430
             310,2322020-39 5,247
             302,7992020-40 5,038
             344,6992020-41 4,977
             392,0512020-42 4,903
             481,5702020-43 5,556
             571,1972020-44 5,766
             764,2892020-45 6,576
         1,065,4102020-46 8,642
         1,209,8482020-47 10,568
         1,136,4122020-48 10,091
         1,373,6772020-49 15,437
         1,499,7562020-50 16,867
         1,588,0852020-51 18,493

The good news is the approval of the first vaccines in the U.S., approvals in a number of other countries of at least one vaccine (United Kingdom, Canada, Bahrain, European Union) and more vaccines getting close to completing their trials. See, e.g., New York Times, E.U. Approves Pfizer Vaccine, Setting Stage for High-Stakes Rollout, December 21, 2020, https://www.nytimes.com/2020/12/21/world/europe/eu-coronavirus-vaccine.html. These western vaccines are in addition to the ones produced in China and the Russia Federation that were released before all trials were completed.

However, even for countries who have lined up large volumes of vaccines through up-front contracts for delivery in December or the front half of 2021, countries who have approved one or more of the western company vaccines are still months away from having enough people vaccinated to make a significant dent in the levels of new cases or deaths without strong efforts to maintain social distancing, wear masks, minimize size of gatherings, washing hands, etc.

With mutations of the virus having appeared in the U.K. and elsewhere, it is also unclear how efficacious the early vaccines will be on the mutations. Early information on the news today, suggests at least some reduction in effectiveness is likely, which could have implications for the percentage of the population needed to be vaccinated to achieve herd immunity. Many countries are banning travel from the U.K. in an effort to prevent the spread of the mutant variation of COVID-19 identified in the U.K. which is believed to spread much more easily. See Politico, Mutant coronavirus strain: What we know so far, December 21, 2020, https://www.politico.eu/article/mutant-coronavirus-strain-what-we-know-so-far/.

While the short-term future has many challenges, many are hopeful that 2021 will see the COVID-19 pandemic being handled as vaccines are approved and produced and distributed to all peoples around the world to permit a return to greater normalcy. See Time, What Bill Gates Thinks About the State of the Fight Against COVID-19, December 22, 2020, https://time.com/5923916/bill-gates-covid-19-letter/; Bill Gates, YEAR IN REVIEW, These breakthroughs will make 2021 better than 2020, The latest on the innovations that will let us go back to normal, December 20, 2020, https://www.gatesnotes.com/About-Bill-Gates/Year-in-Review-2020.

The WTO has both been monitoring trade restrictive and liberalizing actions taken by Members relating to the pandemic and has also recently put out a paper reviewing trade policy issues that can arise as the world shifts to the production and distribution of vaccines around the world. See WTO, TRIPS, WTO paper explores role of trade policy in the rapid roll-out of COVID-19 vaccines, December 22, 2020, https://www.wto.org/english/news_e/news20_e/trip_22dec20_e.htm. The press release describes the content of the new paper as follows:

“The WTO Secretariat has published a new information note on trade-related issues for COVID-19 vaccine production, manufacturing and deployment. The note, entitled ‘Developing and delivering COVID-19
vaccines around the world,’ explores how trade policy can play its part in ensuring the rapid roll-out of vaccines against COVID-19.

“The paper goes into further detail on key topics included in two documents previously published on the WTO website: ‘Infographic: Developing & delivering COVID-19 vaccines around the world’ (https://www.wto.org/english/tratop_e/covid19_e/vaccine_infographic_e.pdf) and ‘Developing & delivering COVID-19 vaccines around the world: A checklist of issues with trade impact’
(https://www.wto.org/english/tratop_e/covid19_e/vaccine_checklist_e.pdf) .

“The new information note comprises three sections. Section A provides background information on immunization and the urgent search for vaccines against COVID-19. This section points to immunization as a key component of primary health care and highlights the ambitious national and global targets that have been set for COVID-19 vaccines. According to the World Health Organization (https://www.who.int/publications/m/item/fair-allocation-mechanism-for-covid-19-vaccines-through-the-covax-facility) and Gavi, the Vaccine Alliance (https://www.gavi.org/vaccineswork/covax-explained), two billion COVID-19 vaccine doses are to be distributed by the end of 2021, with an allocation for every country equal to 20 per cent of the population so as to cover prioritized target groups.

“Section B provides an overview of the development and delivery of vaccines in the form of an infographic listing seven steps in this process: vaccine development, domestic approval (manufacture), vaccine manufacture, domestic approval (importer), international distribution, border clearance, and domestic distribution and surveillance.

“Finally, Section C identifies where key decisions with trade impact may need to be made along the vaccine value chain and provides a non-exhaustive list of useful resources to help inform decision-making. This section includes a checklist of trade issues to consider along with the COVID-19 vaccine value chain, as well as a world map of clinical trials and partnerships on COVID-19 treatments.

“The report can be found here (https://www.wto.org/english/tratop_e/covid19_e/vaccine_report_e.pdf).”

The report is embedded below.

vaccine_report_e

Conclusion

The COVID-19 pandemic has rocked the world in 2020. Some continents have come through with relatively few cases (Africa) or have often been successful in minimizing outbreaks (significant parts of Asia, Oceania). Europe was hit hard early (March-April) and suffered a much bigger second surge in the September -November period though renewed restrictions have brought case numbers down significantly in December. The Americas has had the highest number of cases and deaths of any region. The United States has gone through a number of surges and is currently exceeding or close to exceeding medical facility capabilities in many parts of the country. So 2020 is ending in a spiraling crisis in the United States. The arrival of vaccines is welcome news for all peoples but will take considerable time to be produced and distributed both within countries with high infection rates and to the rest of the world.

The role of trade in a pandemic is largely focused on keeping markets open for the movement of medical goods and food products. While a large number of countries have introduced some export restrictions on medical goods (and some on food products), many countries have also introduced actions to speed movement of medical goods and to lower costs. While there have not been new multilateral agreements to keep markets open or liberalize trade in medical goods, there have been some efforts at cooperation and coordination by at least some countries.

While the actions taken by governments to try to control the virus led to significant contractions in trade in the second quarter of 2020, much of prior trade flows were restored in the third quarter but will likely see some reductions in the fourth with the second wave of restrictions on activities in many countries in the last month or two. Certain service sectors (travel and tourism generally; air transport, restaurants, hotels specifically) have been very hard hit by the restrictions imposed with many businesses closing, more than 100 million people unemployed or underemployed in the sector and a post-pandemic world likely to be much changed particularly in sectors like restaurants that are dominated by small business operators. Most projections don’t see a restoration of global GDP levels to those achieved in 2019 until at least 2022.

Trillions of dollars have been poured into a number of countries as stimulus to prevent the further collapse of the economies involved. Those actions have reduced the size of the downturn which still is the worst since World War II for much of the world. The size of the stimulus infusions have also greatly increased the level of debts for the countries engaged in the stimulus activities. For countries without the ability to borrow huge sums for stimulus, the contraction in GDP has often been severe with gains from the last decade being wiped out in some cases.

So the world needs 2021 to be better than 2020. How the efforts at vaccine development proceed and the level of commitment and funding for production expansion and global distribution will be major factors in whether 2021 fulfills the promise of equitable and affordable access to vaccines and therapeutics needed to get the world back to a more normal place.

As first COVID-19 vaccine starts to be shipped to the United Kingdom, Canada, Bahrain and the United States, the number of new cases reaches another record over the last fourteen days

While both Russia and China have had vaccines that they have been using within country and shipping to some other countries, the first vaccine to have gone through all testing phases and be approved by certain western countries is the BioNTech/Pfizer vaccine (Pfizer vaccine). The first shots of the Pfizer vaccine were administered in the United Kingdom last week and are being distributed to the other countries which have approved the vaccine for emergency use. In the United States, shipments are going from Pfizer’s Michigan factory today to locations around the country with first vaccinations possible for selected groups as early as tomorrow. A second vaccine from Moderna is likely to be approved in the coming week or so. Others are expected to be submitted for emergency authorization in a few weeks time. So the good news is that vaccines that are safe and efficacious have been developed in record time. The challenges now will be the ramp up of global production, distribution from plant to distribution points and further distribution to hospitals, pharmacies, doctors offices capable of handling the vaccines (particularly for the Pfizer vaccine which has to be maintained at extraordinarily low temperatures requiring special cold storage facilities to handle), adequate medical personnel and equipment to vaccinate populations, organizing populations to receive the vaccine in an order decided by government and a willingness on the part of the population to be vaccinated. In the United States, vaccines will be distributed to the states and local areas but further distribution and state efforts at fulfilling the remaining steps are handicapped by limited funds and the failure to date of the U.S. Congress and Trump Administration to agree on a supplement stimulus package that will, inter alia, ensure adequate funding for the states to ensure proper distribution and means for vaccinating their populations. There is also a need for a major communication campaign as presently only 47% of people in the U.S. indicate they will get vaccinated; 26% indicate they will not get vaccinated and 27% are unsure. The EU is hoping to get the Pfizer vaccine approved by the end of the year although is under pressure to move that time line up. Politico, December 13, 2020, Pressure mounts on EU regulator to approve coronavirus vaccine — and fast, European regulators hope that taking more time will convince the skeptics to get vaccinated, https://www.politico.eu/article/pressure-mounts-on-eu-regulator-to-approve-coronavirus-vaccine-quickly/.

Juxtaposed to the good news of vaccine approval is the continued rise in the number of new cases of COVID-19 around the world, high death rates in the U.S. and much of Europe with very challenging times facing governments until vaccine distribution and vaccinations are widespread.

This post will focus on the United States. The United States has 4.3% of the world’s population but has had one of the worst performances of any country on earth in terms of bringing the virus under control. With 16,067,031 total COVID-19 cases reported in the United States as of December 13, the United States accounts for 22.64% of the total cases in the world (70,957,979). However, during the last fourteen days, the United States 2,820,380 new cases accounted for an astounding 32.74% of global cases (8,613,822). European Centre for Disease Prevention and Control, COVID-19 situation update worldwide, as of 13 December 2020. During the last two weeks, the U.S. averaged more than 200,000 new cases each day — another first. Indeed, no other country has reported 100,000 new cases in a single day throughout the 2020 period. By contrast, the United States has reported 100,000 or more new cases on forty days, including the last 39 days in a row. The United States has now reported 200,000 or more new cases for 10 days including 9 of the last 11 days. Global cases have started to increase again, up 5.79% over the prior two week period (November 16-29). The United States saw an increase of 20.44% or an increase 478,620 over the prior two week. Indeed, the rest of the world declined slightly as the U.S. accounted for more than 100% of the global increase in the last two week. And projections are that the number of new cases will continue to rise in the United States in the coming weeks. For example, the Center for Disease Control and Prevention in the United States monitors forecasts made by various entities and reports periodically the projected number of new cases and deaths. The latest update from December 9 shows a composite projection of an increase of some 14-15% in the coming weeks. See, CDC, COVID-19 Forecasts: Cases, updated Dec. 9, 2020, https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/forecasts-cases.html. Thus, the United States will likely have the dubious distinction of recording more than 3,000,000 new cases in the next two week period.

On deaths from COVID-19, the United States has recorded 297,837 from COVID-19 or 18.35% of the world total (1,605,595). Over the last fourteen days, the United States has recorded 31,774 deaths (2,269.57/day) or 20.90% of the world total (152,064). Deaths in Europe have been very high in recent weeks following the extraordinary surge in the last two months in new cases although cases in Europe have been dropping over the last several weeks which should mean declining death totals in Europe in the coming weeks. Deaths in the United States are projected to continue rising and are already around one death every thirty seconds (indeed as deaths exceed 3,000/day some days, it is one death every 25-29 second. CDC’s recent update of various forecasts show likely increases in deaths in the U.S. in the coming weeks, some projections showing more than 3,000/day. See CDC, COVID-19 Forecasts: Deaths, updated December 9, 2020, https://www.cdc.gov/coronavirus/2019-ncov/covid-data/forecasting-us.html.

U.S. hospitalizations due to COVID-19 have now topped 100,000 and many states are near or exceeding capacity for ICU beds. On December 12, 2020, The COVID Tracking Project tallied 108,487 U.S. hospitalizations due to COVID. The image below is copied from the COVID Tracking Project webpage and shows current hospitalizations more than 60% higher than prior peaks from April and June/July. https://public.tableau.com/profile/covid.tracking.project#!/vizhome/CTPWebsiteGallery/7_USCHospitalized.

With the continued surge in new cases and increasing hospitalizations, many states are facing severe challenges. California has reimposed lock down requirements on most parts of the state. Reno, Nevada has had a huge spike in cases, requiring the city to convert a parking lot to a COVID-19 facility. Press articles show the problem is occurring in many places. See, e.g., Houston Chronicle, December 10, 2020, TMC hospitals, hit by COVID surge, exceed base ICU capacity for first time since summer, https://www.houstonchronicle.com/news/houston-texas/health/article/COVID-ICU-capacity-patients-Texas-Med-Center-news-15791754.php; Raleigh News & Observer, December 8, 2020, NC hospitals will run out of beds if current COVID trends continue, researchers say, https://www.newsobserver.com/news/local/article247691885.html.

With vaccines now starting to ship, the U.S. is predicting that some 60% of Americans will be vaccinated by the summer (described as any American who wishes to be vaccinated). Dr. Fauci has indicated that vaccinations of 70% or more will be required for herd immunity, but life may start to return to a more normal state by late summer if the government, businesses and the population work together to maximize vaccinations and continue to follow other precautions until then (mask wearing, social distancing, handwashing, small group gatherings, etc.). It will also require the Congress and the Trump Administration to get the supplement stimulus package passed and enacted into law to ensure adequate funding for the states to ensure full and timely implementation of the vaccination effort.

But despite the good news on vaccines, the challenges facing the U.S. certainly for the first two quarters of 2021 and perhaps longer, will continue to be extraordinary considering current conditions and projections through January. For the United States, it is certain to be a very dark and challenging winter and at least early Spring. The incoming Biden Administration understands the importance of a full court press to get the pandemic under control. Let’s hope that the problems prove manageable and that the carnage the American people have suffered can be drastically reduced and quickly stopped.

Council for Trade-Related Aspects of Intellectual Property Rights meeting of December 10, 2020 – no resolution on proposed waiver of TRIPS obligations to address the pandemic

On December 10th, the WTO Council for Trade-Related Aspects of Intellectual Property Rights held a meeting to consider a proposed waiver for all countries of various TRIPS Agreement obligations during the COVID-19 pandemic. I have previously looked at the proposed waiver and reactions thereto in two prior posts. See December 6, 2020, Upcoming December 11th Council for Trade-Related Aspects of Intellectual Property Rights meeting – reaction to proposed waiver from TRIPS obligations to address COVID-19, https://currentthoughtsontrade.com/2020/12/06/upcoming-december-11th-wto-council-for-trade-related-aspects-of-intellectual-property-rights-meeting-reaction-to-proposed-waiver-from-trips-obligations-to-address-covid-19/ (date of meeting incorrectly listed as December 11); November 2, 2020:  India and South Africa seek waiver from WTO intellectual property obligations to add COVID-19 – issues presented, https://currentthoughtsontrade.com/2020/11/02/india-and-south-africa-seek-waiver-from-wto-intellectual-property-obligations-to-address-covid-19-issues-presented/.

The WTO press release on the meeting indicates that Members will continue to discuss the proposal in future meetings as there was no consensus yet on the proposed waiver. See WTO press release, December 10, 2020, Members to continue discussion on proposal for temporary IP waiver in response to COVID-19, https://www.wto.org/english/news_e/news20_e/trip_10dec20_e.htm. The meeting was held to permit the Council to prepare a report to the General Council ahead of its December 16 meeting. As noted in the press release,

“As a result of the consultations, the chair proposed that the TRIPS Council provide a neutral and factual communication to the General Council reflecting the state of play of discussions and the absence of consensus on the waiver proposal in the TRIPS Council at this time. The communication would indicate that the TRIPS Council has not yet completed its consideration of the waiver request and may not be able to do so within the 90 days stipulated. Therefore, it would propose that the TRIPS Council continues its consideration of the waiver request and reports back to the General Council as stipulated in Article IX:3 of the Marrakesh Agreement.”

The next scheduled TRIPS Council meeting is scheduled for March, but the Chair indicated informal meetings may be held in January and February to work on a path forward.

The press release in its entirety is embedded below.

WTO-_-2020-News-items-Members-to-continue-discussion-on-proposal-for-temporary-IP-waiver-in-response-to-COVID-19

There remains a sharp divide between the proponents and their supporters on the one hand who argue that TRIPS obligations will hinder speedy and equitable distribution of vaccines and other materials needed for handling the pandemic and the range of Members who opposed a waiver on the basis that there hasn’t been a factual showing that TRIPS flexibilities don’t address concerns and that TRIPS provisions are not the only issue that goes to production capacity and production.

As noted in my last post, four WTO Members (Australia, Canada, Chile and Mexico) have proposed a series of questions for Members to consider and respond to in an effort to develop a factual record for what actual problems Members are having so any waiver or other action would respond to actual versus feared potential problems. There was no public indication of whether WTO Members will respond to the questions and/or otherwise cooperate in the establishment of a data base of challenges being experienced in fact by Members in addressing the pandemic.

Trade press have reported on the meeting and the continued disagreement between the two groups of Members. See, e.g., Inside U.S. Trade’s World Trade Online, December 10, 2020, WTO members to continue talks on TRIPS waiver, but no consensus in sight, https://insidetrade.com/daily-news/wto-members-continue-talks-trips-waiver-no-consensus-sight (“The U.S., the European Union and Japan, among others, oppose the waiver, insisting that intellectual property protections are necessary to spur innovation and collaboration. The U.S. on Thursday called instead for members to identify specific problems related to accessing a product and then find targeted solutions. * * * Canada on Thursday argued that the built-in flexibility of the agreement is proven to work, citing the example of Canada’s issuance, in 2017, of a compulsory license granting a Canadian company permission to use nine patents in producing an HIV drug for Rwanda.”); Washington Trade Daily, December 11, 2020, TRIPS Waiver Talks to Continue, https://files.constantcontact.com/ef5f8ffe501/25ec633d-96b4-44cd-8c0d-2eb9108795b9.pdf (pages 2-4).

Look for the proposed waiver to be a topic of continued disagreement within the TRIPS Council in 2021 until such time as there is a much clearer picture of the actual problems to which a much narrower waiver would actually be needed and effective if nonwaiver options are not available. With vaccine approvals starting and with production and distribution being ramped up in 2021, there will be materials delivered to many countries next year either through COVAX or through voluntary licensing arrangements. As noted in an earlier post, there are several billion vaccine doses capacity available through these current options.

WTO Government Procurement — proposed action by the United States to modify obligations of the central government on medicines and medical goods contained in Annex 1

On November 27, 2020, the United States filed two documents with the WTO’s Committee on Government Procurement. Each proposed modifications to Annex 1 of the U.S. schedule of commitments under the GPA dealing with central government agency/entity procurements. Proposed modification to Appendix 1 of the United States under the 1994 Agreement on Government Procurement, GPA/MOD/USA/17; Proposed modification to Appendix 1 of the United States under the Revised Agreement on Government Procurement, GPA/MOD/USA/18. As the title of the submission indicates, the U.S. proposed modifications pertain to Annex 1 commitments of the U.S. which are central government commitments only. Thus, for the 1994 Agreement, Annexes 2-5 are not in play with Annex 2 dealing with sub-central government entities being the relevant other major Annex (Annex 1: central government entities; Annex 2: sub-central government entities;
Annex 3: other entities; Annex 4: services; Annex 5: construction services). On the revised Agreement there are seven Annexes, of which only Annex 1 on center government entities is covered by the U.S. proposed modification (Annex 1: central government entities; Annex 2: sub-central government entities; Annex 3: other entities; Annex 4: goods; Annex 5: services; Annex 6: construction services; Annex 7: general notes).

While both U.S. proposed modification documents are presently restricted (and hence not available to the public), the notices constitute USTR following the requirements of Executive Order 13944 of August 6, 2020 to take steps within 30 days after the Food and Drug Administration had published its list of drugs and active pharmaceutical ingredients that are essential. See Executive Order 13944 of August 6, 2020, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Counter- measures, and Critical Inputs Are Made in the United States, 85 Fed. Reg. 49,929 – 49-934 (August 14, 2020). USTR’s obligations extend beyond the WTO and include any trade agreements with government procurement commitments. But for purposes of this post, I am focusing just on the WTO Agreement on Government Procurement (1994 and Revised). The Executive Order is embedded below but is an effort to address perceived supply chain problems and “over reliance” on imported product including active pharmaceutical ingredients (“APIs”).

FR-of-EO-13944

While the United States is a major pharmaceutical research and development country, U.S. pharmaceutical companies have moved much API production offshore as well as finished product production. China and India are the largest suppliers of APIs to the United States. With the challenges of the COVID-19 pandemic, the Trump Administration has pursued efforts to onshore manufacturing of essential medical products including through the Executive Order 13944. See, e.g., Datex, Onshoring U.S. Pharmaceutical Manufacturing:COVID-19, Congress and Puerto Rico Pharma Hub, Ideas for returning pharmaceutical manufacturing to the U.S., https://www.datexcorp.com/onshoring-u-s-pharmaceutical-manufacturing-covid-19-congress-and-puerto-rico-pharma-hub/; Fierce Pharma, June 3, 2020, U.S. seeks to onshore drug production in response to COVID-19. Is pharma even interested?, https://www.fiercepharma.com/manufacturing/pharma-pushes-back-u-s-legislation-to-bring-drug-manufacturing-stateside; Policy & Medicine, August 26, 2020, Trump Signs Executive Order Regarding Medical Supply Chain,https://www.policymed.com/2020/09/trump-signs-executive-order-regarding-medical-supply-chain.html.

While onshoring is not supported by pharmaceutical companies and has been cited as not likely cost-effective or necessary to address the current or future pandemics, to date both the Trump Administration and President-elect Biden have expressed support for at least some onshoring to ensure greater availability of medicines and materials. See, e.g., S&P Global Market Intelligence, October 15, 2020, US drug onshoring is more complex than Trump, Biden political pitches – experts, https://www.spglobal.com/marketintelligence/en/news-insights/latest-news-headlines/us-drug-onshoring-is-more-complex-than-trump-biden-political-pitches-8211-experts-60714320.

Deputy Director-General Alan Wolff in a statement to the World Economic Forum on November 12, 2020 reviewed some of the reasons for WTO Members not to put excessive reliance on onshoring and to use supply chains and strengthen them. See WTO, 12 November 2020, DDG Wolff calls for new initiatives to cut tariffs on medical supplies and equipment, https://www.wto.org/english/news_e/news20_e/ddgaw_12nov20_e.htm.

On the feasibility of localization

“Trade this year has proved to be essential to meet the world’s needs for medical supplies. National stockpiles proved inadequate. Investment was only part of the answer.

“Trade played a critical role in meeting the vastly increased demand for medical goods and medicines. WTO data show that trade in personal protective equipment (PPE) more than doubled from May 2019 to May 2020. It was a key factor in creating supply resilience, even though some shortages persist even in advanced economies.

“Purely domestic supply chains would have been unable to meet a surge in demand of the suddenness and magnitude experienced. Export controls may have exacerbated the problems, even though many have been subsequently rolled back.

“It appears that the shock persisted in policymakers’ minds in many countries, following initial calls for re-shoring manufacturing production for key products.

“Supporters of localization tend to portray it as risk-free. This is wrong. Concentrating industry at home might insulate it from turbulence elsewhere, but the domestic sources of supplies are more vulnerable to localized disruptions, such as from a hurricane or an outbreak of disease. In addition, the economics dictate that complete self-sufficiency is unworkable for any country, rich or poor.

“Deep and diversified international markets offer the most promising and cost-effective path to supply resilience. But its viability will hinge on whether countries and their citizens feel that international markets can be trusted in a crisis

On reliance on global supply chains

“Economics will be the key determinant of the resilience of international supply chain.

“If countries can be confident that they will be able to rely on international markets for imports when they need them, they will have less reason to restrict exports.

“The preliminary evidence suggests that moves to diversify supply chains have primarily seen production shift from one low-cost country to another.

“Increasingly sophisticated machines have already been diminishing the importance of labor cost arbitrage in the choice of manufacturing location.

“Productivity will be a key determinant of which firms are able to go compete internationally.

“A few years ago, the Brookings Institution looked at five key determinants of the manufacturing environment: 1) overall policies and regulations; 2) tax policy; 3) energy, transportation, and health costs; 4) workforce quality; and 5) infrastructure and innovation. It is instructive that when the study made recommendations for how to improve the manufacturing environment, at the top of their list was political and economic predictability, including open trade policies.

“On shoring and near-shoring have to obey these economic rules if they are going to play an increasing role in national choices.”

U.S. commitments in Annex 1 of the 1994 GPA and the Revised GPA

The U.S. commitments under the GPA include purchases by the Departments of Health and Human Services and of Defense. The two sets of Annex 1 obligations (1994 GPA; revised GPA) are embedded below.

GPA-1994-usa1

rev_usa1e

The Food and Drug Administration list of essential pharmaceutical and other medical products is embedded below and constitutes what is presumably being proposed for withdrawal from coverage of the GPA 1994 and revised GPA in the U.S. Annex coverage. It is a long list of products, if, as assumed, it is the FDA list that has been put forward.

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Modification of Annexes under the WTO 1994 GPA and under the WTO revised GPA

While the WTO’s Agreement on Government Procurement envisions expanded coverage over time by signatories, both the original agreement and the revised agreement provide for possible modifications of the Agreement with rebalancing of benefits for other countries or retaliation where action is taken without rebalancing. The 1994 Agreement in Article XXIV:6 provides for rectifications and modifications of commitments:

Article XXIV: Final Provisions

* * *

“6.     Rectifications or Modifications

“(a)    Rectifications, transfers of an entity from one Annex to another or, in exceptional cases, other modifications relating to Appendices I through IV shall be notified to the Committee, along with information as to the likely consequences of the change for the mutually agreed coverage provided in this Agreement. If the rectifications, transfers or other modifications are of a purely formal or minor nature, they shall become effective provided there is no objection within 30 days. In other cases, the Chairman of the Committee shall promptly convene a meeting of the Committee. The Committee shall consider the proposal and any claim for compensatory adjustments, with a view to maintaining a balance of rights and obligations and a comparable level of mutually agreed coverage provided in this Agreement prior to such notification. In the event of agreement not being reached, the matter may be pursued in accordance with the provisions contained in Article XXII.
 

“(b)    Where a Party wishes, in exercise of its rights, to withdraw an entity from Appendix I on the grounds that government control or influence over it has been effectively eliminated, that Party shall notify the Committee. Such modification shall become effective the day after the end of the following meeting of the Committee, provided that the meeting is no sooner than 30 days from the date of notification and no objection has been made. In the event of an objection, the matter may be pursued in accordance with the procedures on consultations and dispute settlement contained in Article XXII. In considering the proposed modification to Appendix I and any consequential compensatory adjustment, allowance shall be made for the market-opening effects of the removal of government control or influence.”

The revised Agreement has more detailed provisions for modifications and rectifications contained in Article XIX:

Article XIX — Modifications and Rectifications to Coverage Notification of Proposed Modification

“1. A Party shall notify the Committee of any proposed rectification, transfer of an entity from one annex to another, withdrawal of an entity or other modification of its annexes to Appendix I (any of which is hereinafter referred to as ‘modification’). The Party proposing the modification (hereinafter referred to as ‘modifying Party’) shall include in the notification:

“a. for any proposed withdrawal of an entity from its annexes to Appendix I in exercise of its rights on the grounds that government control or influence over the entity’s covered procurement has been effectively eliminated, evidence of such elimination; or

“b. for any other proposed modification, information as to the likely consequences of the change for the mutually agreed coverage provided for in this Agreement.

“Objection to Notification

“2. Any Party whose rights under this Agreement may be affected by a proposed modification notified under paragraph 1 may notify the Committee of any objection to the proposed modification. Such objections shall be made within 45 days from the date of the circulation to the Parties of the notification, and shall set out reasons for the objection.

“Consultations

“3. The modifying Party and any Party making an objection (hereinafter referred to as “objecting Party”) shall make every attempt to resolve the objection through consultations. In such consultations, the modifying and objecting Parties shall consider the proposed modification:

“a. in the case of a notification under paragraph 1(a), in accordance with any indicative criteria adopted pursuant to paragraph 8(b), indicating the effective elimination of government control or influence over an entity’s covered procurement; and

“b. in the case of a notification under paragraph 1(b), in accordance with any criteria adopted pursuant to paragraph 8(c), relating to the level of compensatory adjustments to be offered for modifications, with a view to maintaining a balance of rights and obligations and a comparable level of mutually agreed coverage provided in this Agreement.

“Revised Modification

“4. Where the modifying Party and any objecting Party resolve the objection through consultations, and the modifying Party revises its proposed modification as a result of those consultations, the modifying Party shall notify the Committee in accordance with paragraph 1,and any such revised modification shall only be effective after fulfilling the requirements of this Article.

“Implementation of Modifications

“5. A proposed modification shall become effective only where:

“a. no Party submits to the Committee a written objection to the proposed modification within 45 days from the date of circulation of the notification of the proposed modification under paragraph 1;

“b. all objecting Parties have notified the Committee that they withdraw their objections to the proposed modification; or

“c. 150 days from the date of circulation of the notification of the proposed modification under paragraph 1 have elapsed, and the modifying Party has informed the Committee in writing of its intention to implement the modification.

“Withdrawal of Substantially Equivalent Coverage

“6. Where a modification becomes effective pursuant to paragraph 5(c), any objecting Party may withdraw substantially equivalent coverage. Notwithstanding Article IV:1(b), a withdrawal pursuant to this paragraph may be implemented solely with respect to the modifying Party. Any objecting Party shall inform the Committee in writing of any such withdrawal at least 30 days before the withdrawal becomes effective. A withdrawal pursuant to this paragraph shall be consistent with any criteria relating to the level of compensatory adjustment adopted by the Committee pursuant to paragraph 8(c).

“Arbitration Procedures to Facilitate Resolution of Objections

“7. Where the Committee has adopted arbitration procedures to facilitate the resolution of objections pursuant to paragraph 8, a modifying or any objecting Party may invoke the arbitration procedures within 120 days of circulation of the notification of the proposed modification:

“a. Where no Party has invoked the arbitration procedures within the time-period:

“i. notwithstanding paragraph 5(c), the proposed modification shall become effective where 130 days from the date of circulation of the notification of the proposed modification under paragraph 1 have elapsed, and the modifying Party has informed the Committee in writing of its intention to implement the modification; and

“ii. no objecting Party may withdraw coverage pursuant to paragraph 6.

“b. Where a modifying Party or objecting Party has invoked the arbitration procedures:

“i. notwithstanding paragraph 5(c), the proposed modification shall not become effective before the completion of the arbitration procedures;

“ii. any objecting Party that intends to enforce a right to compensation, or to withdraw substantially equivalent coverage pursuant to paragraph 6, shall participate in the arbitration proceedings;

“iii. a modifying Party should comply with the results of the arbitration procedures in making any modification effective pursuant to paragraph 5(c); and

“iv. where a modifying Party does not comply with the results of the arbitration procedures in making any modification effective pursuant to paragraph 5(c), any objecting Party may withdraw substantially equivalent coverage pursuant to paragraph 6, provided that any such withdrawal is consistent with the result of the arbitration procedures.

“Committee Responsibilities

“8. The Committee shall adopt:

“a. arbitration procedures to facilitate resolution of objections under paragraph 2;

“b. indicative criteria that demonstrate the effective elimination of government control or influence over an entity’s covered procurement; and

“c. criteria for determining the level of compensatory adjustment to be offered for modifications made pursuant to paragraph 1(b) and of substantially equivalent coverage under paragraph 6.”

Likely consultations with trading partners will extend into Biden Administration

Considering the list of other GPA signatories, it is certain that a number of signatories will seek compensation from the United States or will pursue retaliation if the U.S. proposed modifications take effect. Assuming a desire by one or more signatories to seek rebalancing and/or to pursue retaliation, the timing of implementation of the modifications appear to vary based on the relevant Agreement but will almost certain extend into the Biden Administration after January 20.

Thus, while the incoming Biden Administration intends to have its focus on domestic challenges in the early part of its first term, the modification of U.S. WTO GPA commitments is another example of an important trade issue that will require focus in the early days of the new Administration.

Conclusion

During the COVID-19 pandemic there has been concern both within the Trump Administration and in the U.S. Congress about the shortages of personal protective equipment and the high reliance on offshore production of APIs and essential medicines for the treatment of patients with COVID-19 in the United States. The concern on domestic capabilities is held by both Republicans and Democrats and has been identified as an issue of importance to the incoming Biden Administration. While there is opposition from the pharmaceutical companies and certainly concerns from economists and some policy professionals about over reliance on onshoring, the United States has been taking some actions to encourage onshoring. The Executive Order 13944 addresses U.S. government procurement of essential medicines and other medical goods.

Action last week by USTR in submitting proposed modifications to its Annex 1 commitments under the 1994 GPA and the revised GPA is a necessary step to comply with WTO obligations if a change in coverage is to occur. Because of the likely actions of trading partners in the coming weeks and months, the Biden Administration, if it chooses to move forward with the Trump Administration initiative, will face an important WTO task in the early months of the new Administration to negotiate a rebalancing of commitments or face retaliation by WTO GPA partners. Similar obligations and needs will be present in FTAs that include government procurement commitments as well. This increases the importance for the Biden Administration to fill the USTR posts early as well.

Upcoming December 11th WTO Council for Trade-Related Aspects of Intellectual Property Rights meeting — reaction to proposed waiver from TRIPS obligations to address COVID-19

In my post of November 2, 2020, I reviewed a proposed waiver from many TRIPS obligations for all countries to address the COVID-19 pandemic. See November 2, 2020, India and South Africa seek waiver from WTO intellectual property obligations to add COVID-19 – issues presented, https://currentthoughtsontrade.com/2020/11/02/india-and-south-africa-seek-waiver-from-wto-intellectual-property-obligations-to-address-covid-19-issues-presented/. While originally filed by India and South Africa (IP/C/W/669), a few other countries have joined the proposal including Eswatini (IP/C/W/669/Add.1), Kenya (IP/C/W/669/Add.1), Mozambique (IP/C/W/669/Add.2) and Pakistan (IP/C/W/669/Add.3). South Africa made a supplemental filing providing what it described as “Examples of IP Issues and Barriers in COVID-19 pandemic”. Communication from South Africa, Examples of IP Issues and Barriers in COVID-19 Pandemic, IP/C/W/670, 23 November 2020. The South African communication is embedded below.

W670

My post of November 2 had raised a number of question presented by the proposed waiver:

” The proposal raises a series of questions that should be addressed to understand whether the waiver is appropriate. These questions include whether such a broad waiver request is appropriate or envisioned by Article IX:3 and 4 of the Marrakesh Agreement? Shouldn’t those requesting a waiver be required to demonstrate that the existing flexibilities within the TRIPS Agreement are inadequate to address concerns they may have? Can two Members request a waiver of obligations for all WTO Members? Can a waiver request be considered where the product scope is lacking clarity, and the uses/needs of the waiver are very broad and potentially open to differing views? To what extent is there a need for those seeking a waiver to present a factual record of actions being taken by governments, companies and international organizations to provide access to medical goods during the pandemic including to developing and least developed countries? Shouldn’t those seeking a waiver identify the extent of existing licenses by major pharmaceutical companies with them or other WTO Members for the production of vaccines or therapeutics to address COVID-19?”

The supplemental information provided by South Africa identifies various patent pending matters and identifies what it describes as restrictive actions by some companies and some patent litigation by certain companies. As such the communication provides some information of possible relevance in examining the proposed waiver. However, there is little if any information provided on most questions that seem important to an informed discussion of the proposed waiver.

On November 27, Australia, Canada, Chile and Mexico filed a communication entitled “Questions on Intellectual-Property Challenges Experienced by Members in Relation to COVID-19”. IP/C/W/671. While the entire communication is embedded below, paragraphs 3 and 4 are copied below and present a framework for the consideration of the proposed waiver and seek factual answers to a series of questions which would help understand if there are in fact any significant barriers being confronted by WTO Members in addressing the pandemic.

“3. The co-sponsors of this communication remain of the view that these important, challenging, and complex issues merit further reflection and significant consideration, in order to identify any specific and concrete IP-related challenges faced by Members in addressing COVID-19. In addition, we take note that IP rights are one part of a broad discussion informing the availability and accessibility of treatments for COVID-19. Indeed, as the Doha Declaration on the TRIPS Agreement and Public Health emphasizes, the TRIPS Agreement itself is part of the wider national and international effort to address public health problems. With respect to COVID-19, this broader response includes significant investments through procurement mechanisms like the Access to COVID-19 Tools Accelerator and the COVAX Facility and Advance Market Commitment, as well as work within the WTO and elsewhere to safeguard and protect global supply chains.

“4. The co-sponsors of this communication are actively committed to a comprehensive, global
approach that leverages the entire multilateral trading system in place to supporting the research,
development, manufacturing, and distribution of safe and effective COVID-19 diagnostics, equipment, therapeutics, and vaccines. The co-sponsors also reaffirm their support for the TRIPS Agreement, including the flexibilities it provides, and for the Doha Declaration on the TRIPS Agreement and Public Health. In this context, we invite consideration of how the existing legal framework under the TRIPS Agreement, including the flexibilities affirmed under the Doha Declaration on the TRIPS Agreement and Public Health, have operated thus far in the context of Members’ efforts to address the COVID-19 pandemic. We are also committed to fully understanding the nature and scope of any concrete IP barriers experienced by Members related to or arising from the TRIPS Agreement, and such that would constitute impediments to the fight against COVID-19. To that end, and with a view to facilitating a consensual, evidence-based approach, the co-sponsors of this communication therefore respectfully submit the following questions to Members for their consideration and response.”

The communication from Australia, Canada, Chile and Mexico then provides eight questions designed to develop a factual record of challenges faced on procurement of products, local production, compulsory licenses, as well as copyright-related challenges, industrial-designs-related challenges, and challenges from undisclosed information. The questions also include an inquiry as to “what specific legal amendments or actions would the proponents seek to enact for the prevention, containment, and treatment of COVID-19 that are not – or may not be – consistent with the TRIPS Agreement and its flexibilities?”

W671

There is a meeting of the Council for Trade-Related Aspects of Intellectual Property Rights scheduled for December 11 at the WTO. It is assumed that the only item on the agenda will be the consideration of the proposed TRIPS waiver submitted by India and South Africa and joined by four other countries. A recommendation should be forwarded to the General Council by December 31. While the proposed waiver may receive support from many WTO Members, it will be opposed by many as well as not justified and undermining the existing WTO TRIPS Agreement and built-in flexibilities. The communication from Australia, Canada, Chile and Mexico provides a possible path forward by seeking to gather factual information that would permit Members to identify what challenges actually exist and what existing tools are available for addressing the existing challenges so that the need for any waiver is limited to what is actually needed instead of being the very broad waiver proposal for all countries regardless of actual problems faced.

As United States continues to set new records in COVID-19 cases, deaths and hospitalizations, United States accounts for more than 30% of new cases in last 14 days

The United States has 4.3% of the world’s population but has had one of the worst performances of any country on earth in terms of bringing the virus under control. With 14,371,633 total COVID-19 cases reported in the United States as of December 5, the United States accounts for 21.85% of the total cases in the world (65,777,945). However, during the last fourteen days, the United States 2,457,689 new cases accounted for an astounding 30.47% of global cases (8,066,518). European Centre for Disease Prevention and Control, COVID-19 situation update worldwide, as of 5 December 2020. While global cases are now slowly declining, cases in the United States are continuing to increase. And projections are that the number of new cases will continue to rise in the United States in the coming weeks. See, e.g., CNN, December 5, 2020, As hospitals start to max out, medical workers beg officials for new Covid-19 mandates, https://us.cnn.com/2020/12/05/health/us-hospitals-covid-pandemic/index.html.

The latest WHO weekly report (though November 29) shows global cases starting to come down or plateauing with the major exception being the Americas where cases continue to increase. See WHO, COVID-19 Weekly Epidemiological Update (data up to November 29, 2020)

20201201_Weekly_Epi_Update_16

On deaths from COVID-19, the United States has recorded 278,994 from COVID-19 or 18.35% of the world total (1,520,082). Over the last fourteen days, the United States has recorded 24,583 deaths or 16.79% of the world total (146,387). Deaths in Europe have been very high in recent weeks following the extraordinary surge in the last two months in new cases although cases in Europe have been dropping over the last several weeks which should mean declining death totals in Europe in the coming weeks. Deaths in the United States are projected to continue rising and are already around one death every thirty seconds. See, e.g., CNN, November 28, 2020, US is ’rounding the corner into a calamity,’ expert says, with Covid-19 deaths projected to double soon, https://www.cnn.com/2020/11/28/health/us-coronavirus-saturday/index.html. The U.S. Center for Disease Prevention and Control (CDC) periodically provides forecasts of deaths from COVID-19 based on various forecasting models. The most recent projections were updated December 3. The four charts below are from the CDC posting. CDC, December 3, 2020, COVID-19 Projections: Death, https://www.cdc.gov/coronavirus/2019-ncov/covid-data/forecasting-us.html.

U.S. hospitalizations due to COVID-19 have now topped 100,000 and many states are near or exceeding capacity for ICU beds. On December 4, 2020, The COVID Tracking Project tallied 101,276 U.S. hospitalizations due to COVID. The image below is copied from the COVID Tracking Project webpage and shows current hospitalizations more than 50% higher than prior peaks from April and June/July. https://public.tableau.com/profile/covid.tracking.project#!/vizhome/CTPWebsiteGallery/7_USCHospitalized.

Medical personnel are stretched to the breaking point and recent news stories review the challenges at hospitals with medical staff required to reuse N-95 masks (typically reuse is of masks treated in some way) because of shortages of personal protective equipment. See, e.g., NBC Today, December 5, 2020, NBC News investigation: Nurses say reusing N95 masks feels ‘unsafe’, https://www.today.com/video/nbc-news-investigation-nurses-say-reusing-n95-masks-feels-unsafe-97174085710; NPR, December 3, 2020, ‘We’re All Tired Of This’: Health Care Workers In Seattle Prepare For Another Surge, https://www.npr.org/2020/12/03/940114449/were-all-tired-of-this-health-care-workers-in-seattle-prepare-for-another-surge. Some media reports are indicating that the fallout from COVID-19 on the U.S. medical profession may damage U.S. healthcare for decades with doctors, nurses and other medical professionals opting to withdraw from the field after the exhausting and never ending challenges with COVID-19.

The last week in the United States, COVID-19 became the largest cause of death surpassing heart disease, strokes, etc. See, e.g., CBS News, December 5, 2020, COVID-19 was the leading cause of death in the U.S. this week, report says, https://www.cbsnews.com/news/covid-19-leading-cause-of-death-united-states-this-week/.

There is, of course, the good news of the likely approval for emergency use of several vaccines in the coming weeks in the United States. And there is a projected active rollout of vaccines from later in December through the summer. But there is a long road to actually getting the vast majority of the American population vaccinated, assuming that a change in Administrations will be able to change the views of a skeptical public that the vaccines will be safe. For example, even after the very positive press about the Pfizer and Moderna vaccines, only 52% of Americans have indicated a willingness to be vaccinated for COVID-19 (although that is some improvement from earlier views). See Gallup, November 17, 2020, More Americans Now Willing to Get COVID-19 Vaccine,https://news.gallup.com/poll/325208/americans-willing-covid-vaccine.aspx.

Certainly for the first two quarters of 2020 and perhaps longer, the U.S. will be struggling to bring the case count down, take the burden off of the health care system, and reduce the number of deaths as we try to bring life back to some semblance of normal. For the United States, it is certain to be a very dark and challenging winter and at least early Spring. While the current Administration could have significantly changed the challenges for the public and our health care system by having a consistent and uniform message to have the public wear masks and do the other steps needed to reduce the spread of the virus, the Trump Administration has opted not to do that. The Biden Administration is 46 days from taking office. We are likely to suffer more than 100,000 additional deaths by then. A tragic outcome for a pandemic that should have been far more manageable.

World COVID-19 pandemic peaks on November 26 and starts to slowly recede

The most recent surge in COVID-19 cases (up from 3.57 million cases over a fourteen day period in early August to over 5 million for fourteen days on October 22 to over 8 million new cases for fourteen days on November 17), seems to have peaked on November 26 with 8,296,264 new cases over fourteen days and has been slowly receding for the last three days, down to 8,142,629 new cases during the period November 16-29. Total cases since the end of December 2019 now stand at 62,271,031 as of November 29 according to the European Centre for Disease Prevention and Control (ECDC) publication “COVID-19 situation update worldwide, as of 29 November 2020”.

The World Health Organization puts out a publication that tracks cases and deaths on a weekly basis. COVID-19 Weekly Epidemiological Update (data as of 22 November). While it breaks countries and territories into different configuarations that the ECDC, the publication shows new cases in the period November 16-22 declining 6% in Europe and in South East Asia while increasing 11% in the Americas, 5% in the Eastern Mediterranean, 15% in Africa and 9% in the Western Pacific. Because of the large spike in cases in the September – November period in many parts of the world, deaths in the November 16-22 period increased in all regions — up 10% in Europe, 15% in the Americas, 4% in South-East Asia, 10% in the Eastern Mediterranean, 30% in Africa and 1% in the Western Pacific. The latest report is embedded below.

20201124_Weekly_Epi_Update_15

The graphs in the WHO publication show by region the trajectory of new cases and deaths over time. The chart showing aggregate data show a flattening of total new cases in the last weeks of November while the number of deaths globally are sharply increasing.

The WHO Africa region peaked in the summer and has declined until the last few weeks when there has been some increase in both cases and deaths.

The Americas saw a peak in both new cases and deaths in the July period with some declines in new cases until the second half of September when the current surge started and accelerated in November. Deaths declined until early October before starting to grow again.

The Eastern Mediterranean peaked in May-June for both cases and deaths, declined through August/September and have surged to new heights with continued upward trajectory as of November 22.

The WTO European Region had an early surge of cases and deaths in the March-April period. Deaths receded sharply through August. While new cases have increased since summer, there was a massive increase in the September – end of October period in new cases and rising deaths through November.

The WHO South-East Asia region saw a huge increase in cases and deaths in the May-August period, peaking in early September and declining since then. Much of the data for the region reflect activity in India.

The Western Pacific Region has had several peaks in terms of deaths and in new cases, though the numbers are the lowest of any WHO region. The latest peak in new cases was in early August with some increase in the October-November period. Deaths last peaked in early September and have declined through November.

The United States

Turning back to the ECDC data, the United States continues to have more confirmed cases (13,246,651) than any other nation and more confirmed deaths from COVID-19 (266,063) than any other nation. The United States is also still experiencing a surge in new cases and rising deaths. October 31 was the first day that ECDC data show the U.S. recording 100,000 new cases in a single day. Since November 5, the U.S. has had more than 100,000 new cases every day up to November 29. It is the only country to record one million new cases in a week and the only country to record two million new cases in fourteen days. For the last fourteen days, the U.S. recorded 2,341,760 new cases. The U.S., which accounts for 4.3% of the global population, accounts for 21.27% of all COVID-19 cases that have been reported since December 2019 and accounted for 28.76% of new cases in the last two weeks. The rate of increase remains high for the United States — up 31.67% from the 1,778,530 new cases in the two weeks ending November 15. There are concerns that the number of new cases will continue to increase into the new year based on the high rate of infections in many parts of the country, major potential spreading events around holidays in November (Thanksgiving) and December, and limited compliance with basic requirements for limiting the spread of the virus.

The number of deaths from COVID-19 that the U.S. accounts for has declined from roughly 20% to 18.30% as of November 29. In the last two week, while the U.S. has the largest number of deaths in the two weeks, the percent of total deaths accounted for by the U.S. in the November 16-29 period was 14.65%. However, many cities, communities and even states are at or nearing the limits of the health care capacity with hospitalizations now about 90,000, limits on health care professionals with the surging cases and some challenges on personal protective equipment. Thus, models used by the government projects a continued rise in the number of deaths in the coming months.

While the first vaccine could receive emergency approval for distribution in the U.S. as early as December 10, and the U.S. could have two or three vaccines in distribution in early 2021, the United States will unfortunately likely be a major part of the continued high rate of infections and deaths well into 2021.

Europe

While Europe had faced early challenges in a number of western European countries in February-April and very high death rates in a number of countries, the second wave of cases following the relaxation of restrictions in time for summer vacations accounted for the vast majority of the incrase in new cases during the October and early November time period. In earlier posts, I showed that Europe and the U.S. accounted for nearly all of the increase from 5 million new cases in the two weeks ending October 22 to the more than 8 million new cases in the two weeks ending November 17. See November 17, 2020, New COVID-19 cases over a fourteen day period continue to soar past eight million, up from five million on October 22, https://currentthoughtsontrade.com/2020/11/17/new-covid-19-cases-over-a-fourteen-day-period-continue-to-soar-past-eight-million-up-from-five-million-on-october-22/

While some of the major countries, including France, Italy, Spain, the United Kingdom and others have seen significant reductions in the number of new cases in recent weeks from the extraordinary figures recorded in late October, early November, numbers remain very high for a number of countries including Poland, Portugal, Serbia, Croatia, Hungary, Lithuania and Luxembourg — all of whom had new cases/100,000 population in the last fourteen days that were higher than the United States.

Because deaths lag new cases by a number of weeks, it is perhaps less surprising that much of Europe had deaths/100,000 population in the last fourteen days that were higher than the United States, most at rates that were two-three times the U.S. rate. The rate for the world in total was 1.82 deaths per 100,000 population for the November 16-29 period. The U.S. was 3.38 times the global average at 6.22 deaths per 100,000 population in that two week period. The following 25 European countries exceeded the U.S. rate: France (11.76 deaths/100,000 population); Italy (16.04); Spain (8.31); United Kingdom (9.40); Armenia (12.81); Austria (13.47); Belgium (18.84); Moldova (6.50); Poland (16.65); Portugal (10.30); Romania (11.50); Serbia (7.11); Switzerland (14.98); Bulgaria (23.69); Croatia (15.92); Czechia (18.74); Greece (11.08); Hungary (16.12); Lithuania (8.12); Luxembourg (13.19); Malta (6.79); Slovenia (19.85); Bosnia and Herzegovina (20.75); Georgia (13.19); and North Macedonia (20.12).

With new restrictions in recent weeks bringing new cases down in a number of European countries, death rates should start to decline as well in the coming weeks. Challenges in terms of superspreader events in Europe include holiday travel and events and winter holidays and sports. Germany has proposed placing restrictions on the ski season to try to minimize increased cases from a sport popular across much of Europe. See DW, 26 November 2020, Coronavirus: Germany seeks EU-wide ban on ski trips, https://www.dw.com/en/coronavirus-germany-seeks-eu-wide-ban-on-ski-trips/a-55732273.

The EU has contracts with at least six pharmaceutical companies or groups for vaccines if approved. The EU and United Kingdom will start to see vaccine dosages within weeks assuming approval in their jurisdictions.

Other countries

While much of the rest of the world has not seen great increases in the number of cases that is not true for all countries. For example, Iran which had 136,753 new cases in the November 2-15 period showed 186,274 new cases in the November 16-29 period (+36.21%). Jordan, which has a total number of cases of 210,709 since the end of December has recorded 65.54% of that total in the last four weeks (68,698 new cases during November 2-15; 69,404 new cases during November 16-29). Similarly, Morocco which has a total of 349,688 cases since December 2019 has more than 37% recorded in the last four weeks (69,127 during November 2-15; 61,477 during November 16-29).

In the Americas the following countries in addition to the United States have two week totals to November 29 greater than 100,000 new cases: Argentina (108,531); Brazil (441,313); Colombia (108,609). The following countries besides the United States have more than one million cases since late December 2019: Argentina (1,413,362); Brazil (6,290,272); Colombia (1,299,613), Mexico (1,100,683). Eleven other countries have more than 100,000 cases (with Peru having 960,368). Other than the U.S., countries are facing different trend lines, many down, some showing increases (e.g., Brazil, Canada, Dominican Republic, Paraguay).

In Asia, while India continues to see declines in the number of new cases, Indonesia, Israel, Japan, Kazakhstan, Malaysia, Pakistan, Palestine, South Korea, showed increased in the most recent two weeks, some quite large. This is in addition to Iran reviewed previously.

In Africa, South Africa has the most cases and saw an increase from 23,730 new cases during November 2-15 to 35,967 during November 16-29. Morocco was reviewed above. Most other major countries in Africa saw declines in recent weeks.

Conclusion

The world in the first eleven months of 2020 has struggled to get the COVID-19 pandemic under control with several major surge periods. The global number of new cases seems to have plateaued over the last week or so at extraordinarily high levels and the death rates has been climbing after a long period where deaths appeared to be declining. It is likely that the death rate will continue to increase for the rest of 2020.

After a period during the summer and early fall where restrictions in a number of countries were being relaxed, many countries in the norther hemisphere are reimposing various restrictions in an effort to dampen the spread of the coronavirus. While trade has significantly rebounded from the sharp decline in the second quarter of 2020, services trade remains more than 30% off of 2019 levels driven by the complete collapse of international travel and tourism. Many WTO members have put forward communications on actions that could be considered to speed economic recovery. The most recent was the Ottawa Group’s communication about a possible Trade and Health Initiative. See November 27, 2020, The Ottawa Group’s November 23 communication and draft elements of a trade and health initiative, https://currentthoughtsontrade.com/2020/11/27/the-ottawa-groups-november-23-communication-and-draft-elements-of-a-trade-and-health-initiative/.

The WTO TRIPS Council has a request for a waiver from most TRIPS obligations for all WTO Members on medical goods and medicines relevant to COVID-19 on which a recommendation is supposed to be forwarded to the General Council by the end of 2020 though it is opposed by a number of major Members with pharmaceutical industries. See November 2, 2020, India and South Africa seek waiver from WTO intellectual property obligations to add COVID-19 – issues presented, https://currentthoughtsontrade.com/2020/11/02/india-and-south-africa-seek-waiver-from-wto-intellectual-property-obligations-to-address-covid-19-issues-presented/.

With vaccines very close to approval in major markets like the United States and the European Union, there will be increased focus on efforts to ensure availability of vaccines and therapeutics and diagnostics globally on equitable and affordable terms. GAVI, CEPI and the WHO have been leading this initiative with the support of many governments and private sector players. Pharmaceutical companies also have global distribution plans being pursued in addition to the above efforts.

So there hopefully is light at the end of the tunnel that the COVID-19 pandemic has imposed on the world. But vaccines without vaccinations won’t solve the pandemic’s grip. So communication and outreach globally will be critical to seeing that available vaccines are properly used. And all peoples need to be able to access the vaccines, some of which will be less available simply because of the infrastructure needs to handle the vaccines.

Trade policy options to minimize trade restrictions coupled with global cooperation and coordination should result in the world being able to rebuild in 2021 and beyond as more and more of the world is vaccinated.

Multilateral efforts to help the poorest countries deal with debt, make available trade finance and other actions continue to be a pressing need. Better plans and preparation for pandemics of the future are clearly needed. Reports suggest that many of the poorest countries have experienced loss of a decade or more of economic advancement during the pandemic. Building back greener and in a sustainable manner is critical for all.

The efforts of developed country governments and others to provide the stimulus domestically to reduce the downward spiral of the individual national economies and the global economy has been critical to limiting the damage at home and abroad. But the assumption of large amounts of debt will also pose significant challenges moving forward because of the greatly heightened national debt/GDP ratios that have developed and may restrict options for individual governments moving forward.

What is certain is that 2020 will be remembered as a year in which a virus inflicted enormous damage to the global health and to the global economy. Collectively, the level of spread has been far greater than should have been possible. Many nations were not prepared. Some, like the United States, exacerbated the problems through a lack of national government planning and messaging. Others like many in Europe, having done a good job of controlling the spread in the early months, made major mistakes as they opened up for summer vacations and didn’t deal with the problems that resulted from the reopening and experienced breathtaking surges which roughly doubled the global daily rate of new cases in five-six weeks and have led to the reimposition of a series of restrictions to try to tame the pandemic a second time. We collectively are better than the results achieved to date. The number of deaths in advanced countries is simply disgraceful.

2021 offers the opportunity for the world to come together and put COVID-19 behind us. Whether we will come to the end of 2021 and feel that this global nightmare is behind us and that there are national and global game plans to rebuild in a greener and more sustainable manner with greater opportunities for all is the question. Hopefully, the answer will be yes.

The Ottawa Group’s November 23 Communication and Draft Elements of a “Trade and Health” Initiative

On Monday, Novemer 23, Canada hosted a virtual meeting of the Ottawa Group on WTO reform. The Group includes Australia, Brazil, Canada, Chile, the European Union, Japan, Kenya, Republic of Korea, Mexico, New Zealand, Norway, Singapore and Switzerland. Deputy Director-General Alan Wolff provided comments and urged the Members to “translate their statements about reforms to global trade rules into formal proposals and concrete requests at the WTO.” WTO, 23 November 2020, DDG Wolff calls on Ottawa Group to table formal reform proposals at WTO, https://www.wto.org/english/news_e/news20_e/igo_23nov20_e.htm. DDG Wolff provided seven options for the consideration of the Ottawa Group on WTO reform, the first four of which used trade and health as one example.

“First, an observation: the game must be in play for key players to conclude that they have to join. If negotiations are not under way, there may be a substantial delay in attracting participation.

“Declarations, such as on trade and health, should be turned into formal proposals as soon as possible and should be embraced by all WTO members.

“And if some Members won’t come along or seek to delay — a joint initiative is a practical way to proceed and could then be launched as a priority. The time of testing should not be so long as to make a response to the pandemic arrive too late to be responsive to the current crisis.

“Second, Members can ask the WTO Secretariat for and receive support for evaluations of aspects of WTO reform. For example, on trade and health, Members can —

“Request the Secretariat to upgrade its COVID-19-related trade monitoring activities to collect and publish the best information available, not relying solely on notifications and verification. (This would be a more comprehensive and in-depth activity than that which takes place at present, which in itself was an upgrade from pre-COVID monitoring.)

“Request the Secretariat to work with the WHO, relevant UN agencies and other stakeholders, to highlight trade issues affecting vaccine production and availability, and to propose ways to eliminate obstacles. (This would go beyond existing activities and result in proposals put to the WTO Member- ship).

“Third, Members can

“Propose that the Director General convene a small, representative, ambassador-level group of Friends of Trade and Health to identify how the trading system has performed during the pandemic and to issue preliminary conclusions and recommendations for useful changes in approach within a short, defined timeline.

“Propose that the WTO Secretariat embark now upon the necessary supporting work without delay.

“Propose that the Director General constitute other ‘Friends’ groups to advance consideration of institutional reform and other issues of current importance, and providing possible solutions, such as with respect to the relationship to current and future WTO Agreements of the Paris Accord on Climate Change, the disciplining of fossil fuel subsidies, addressing border adjustments likely with the adoption of carbon taxes, assessing the impact on markets of subsidies and other state interventions, employing trade to reduce income inequality, making the WTO more effective for economic development within and among Member economies, improving the trading system with respect to women in trade, providing WTO support for the African Continental Free Trade Agreement, and more generally strategic foresight.

“G20 Members clearly want to enhance preparedness for future pandemics and other crises. Flexible groups with appropriate balance but able to be nimble and responsive are one way to supplement but not supplant the work of committees and joint statement initiatives (JSIs).

‘Propose that an ad hoc horizontal mechanism be created promptly in the event of crises to address — in real time — trade measures that are of concern. The mechanism, similar to trade policy reviews, but not limited to any single WTO Member’s measures, trade restrictive and trade liberalizing, should be constituted immediately for the current pandemic and economic recovery measures.

“Fourth, Members can

“Propose that the signatories of the Pharmaceutical Agreement providing for duty-free trade be updated (last done in 2010), that major nonsigna- tories join and that essential medical supplies be added to the coverage.

“Propose that the signatories of the Information Technology Agreement review and update its coverage, including adding medical equipment.

“Propose that negotiations on the Environmental Goods Agreement re-start in earnest now, with the addition of services.”

The Ottawa Group agreed to put forward a communication seeking action by WTO Members. Each of Canada and the EU (and likely other members) put out press releases. See, e.g., Government of Canada, November 23, 2020, Minister Ng hosts successful ministerial meeting of the Ottawa Group on WTO reform, https://www.canada.ca/en/global-affairs/news/2020/11/minister-ng-hosts-successful-ministerial-meeting-of-the-ottawa-group-on-wto-reform.html; European Commission, Directorate-General for Trade, 23 November 2020, Ottawa Group proposes a global Trade and Health Initiative, https://trade.ec.europa.eu/doclib/press/index.cfm?id=2215&title=Ottawa-Group-proposes-a-global-Trade-and-Health-Initiative.

The Canadian press release states in part, “As countries face a rise in COVID-19 cases, it is essential that governments minimize disruptions to trade flows in essential medical supplies. Today, members of the Ottawa Group took important steps toward a proposed WTO Trade and Health Initiative, which identifies short-term actions to strenghten supply chains and ensure the free flow of medicines and medical supplies.”

Similarly the European Commission press release stated that –

Today the Ottawa Group, a group of 13 like-minded World Trade Organisation (WTO) partners including the EU, agreed today on an initiative, calling on the WTO members to increase their cooperation and work toward enhanced global rules to facilitate trade in essential medical goods. The agreement took place as an outcome of the Ottawa Group Ministerial meeting, hosted virtually by Minister Mary Ng of Canada.

“The Ottawa Group members called for immediate actions in response to the coronavirus crisis such as exercising a restraint in using any export restrictions, implementing trade-facilitating measures in the area of customs and services, as well as improving transparency.

“They also called for further cooperation amongst members, and between the WTO and other international organisations.

“The group also encourages WTO members to refrain from imposing tariffs on essential medical goods during the crisis. Such actions are intended to strengthen the resilience of supply chains and contribute to an effective response to a public health emergency. They can serve as a basis for future permanent commitments on trade in essential medical goods.

“Commission Executive Vice President and Commissioner for Trade Valdis Dombrovskis said: ‘We are proud to promote this trade and health initiative. It aims to encourage stronger global cooperation at WTO level, by facilitating trade in healthcare products. This is critical in the current global health crisis and will also help us in future. But the Ottawa Group trade and health initiative is just the first step. Going forward, the EU will work to promote resilient global healthcare systems, as well as accessible and affordable healthcare products universally.’

“The communication will now be submitted later this week to the WTO secretariat, before being presented to the WTO General Council for discussion. It will be used to prepare the 12th Ministerial Conference of the WTO, due to be held in 2021.”

That same day, November 23, the Ottawa Group submitted to the WTO a communication entitled “COVID-19 and beyond: Trade and Health”. WT/GC/223 (24 November 2020). The document is embedded below.

223

The communication is ten paragraphs plus an Annex which is described as “Draft Elements of a ‘Trade and Health’ Initiative”. The communication reviews the social and economic impact of the COVID-19 pandemic and invites “all WTO Members to start working on a Trade and Health Initiative” referencing the Annex. Paragraph 6 of the communication summarizes the specific actions being proposed.

“6. With this objective in mind, we call on WTO Members to make their utmost efforts to prevent further disruptions in the supply chains of essential medical goods. As set out in the Annex to this Communication, we propose specific actions relating to export restrictions, trade facilitation,
technical regulations, tariffs, transparency and review, and call for the WTO to enhance its cooperation with other relevant international organizations, such as WHO, WCO, OECD as well as G20, given the context of the on-going evaluations of the global response to COVID-19. These proposed actions are not intended to be prescriptive and do not cover the universe of possible
measures that could support trade in essential medical goods. Rather, they reflect emerging best practices and should provide sufficient flexibility to be adapted to differing national circumstances.”

The Ottawa Group is hoping to get the support of all Members on a joint statement early in 2021 on a Trade and Health Initiative which could serve as a starting point for negotiations for new WTO commitments at the 12th Ministerial Conference in the summer of 2021 in Kazakhstan.

On export restrictions, the Annex calls for greater oversight of such restrictions without eliminating them outright.

On customs, services and technical regulations, the Annex calls for Members to share information and experiences on best practices in trade facilitation during a crisis (customs procedures, services (including freight, logistics, distribution and transport)) and on standards and technical requirements looking towards regulatory alignment.

On tariffs, the Annex calls on Members to “make best endeavours to temporarily remove or reduce tariffs on goods that are considered essential to fighting COVID-19 pandemic”.

On transparency and review, the Annex calls on Members to enhance transparency during the pandemic with the aim of identifying supply chain disruptions and avoiding such disruptions.

On the topic of cooperation of the WTO with other organizations, the Annex both encourages the WTO Secretariat to continue it outreach on measures related to COVID-19 and the studies developed by the Secretariat with a focus “on the causes and effects of the disruptions in the supply chains of essential goods and drawing on research of other international organizations.” The WTO Director-General is also encouraged to “intensify cooperation” with other organizations (including the G20) to improve “the analytical capacity of Members to monitor market developments in trade and production of essential medical goods.”

Finally, the Annex asks Members to review the effectiveness of the identified elements at the 12th Ministerial Conference “with a view to adopting possible commitments regarding trade in essential medical goods.”

Conclusion

There have been many communications put forward by different groups of Members at the WTO in the last eight months on actions that would make sense in terms of limiting export restraints on medical goods or avoiding such restraints on agricultural goods, about the need for effective trade facilitation measures to reduce barriers to movement of medical goods, and on other topics related to the COVID-19 pandemic.

The Ottawa Group’s communication from Monday is an effort to come up with an early possible deliverable that could garner broad WTO Member support. As a result it seeks a joint statement with agreement on the statement for early 2021. The Group also provides five draft proposals for such a joint statement. The proposals don’t eliminate existing flexibility (e.g., export restraints) but try to tighten disciplines via increased transparency. The proposals encourage development of best practices on a range of trade facilitation and regulatory alignment issues. The proposals also encourage what is obviously in most Members self-interest — reducing or eliminating tariffs on medical goods during the pandemic. The proposals also call on Members to do a better job on transparency on measure taken during the pandemic with a focus on identifying disruptions to supply chains and addressing the same in short order. Finally, while the WTO already cooperates with other organizations, the proposals point to specific areas where enhanced cooperation would be helpful.

In an organization where Members have a low level of trust in each other, a joint statement on the need for a Trade and Health Initiative such as proposed by the Ottawa Group is probably all that can be achieved in the short term. Something along the lines outlined in the Annex would indeed be a confidence builder if achieved early in 2021. The ability to review developments at the 12th Ministerial and start negotiations on trade in essential medical goods at that time will also be important if accomplished. The more ambitious options presented by DDG Wolff should be considered but realistically are unlikely to either happen or get started ahead of the 12th Ministerial.

Let’s hope that the WTO membership can come together to support the Ottawa Group proposal. The EC has indicated that the Communication will be taken up at the December General Council meeting. That will be an early opportunity to see if there is likely to broad support for the initiative.

G20 Leaders’ Declaration, 22 November 2020

The two day Leaders’ Summit of the G20, chaired in 2020 by Saudi Arabia, ended yesterday with the issuance of a Leaders’ Declaration. https://g20.org/en/media/Documents/G20%20Riyadh%20Summit%20Leaders%20Declaration_EN.pdf. The twelve page document is embedded below.

G20-Riyadh-Summit-Leaders-Declaration_EN

Yesterday, I had put up a post that looked at the WTO’s Deputy Director-General Alan Wolff’s statement to the G20 on important measures needed in the trade arena to help with responding to the global health pandemic, economic recovery and WTO reform. See November 22, 2020, DDG Wolff’s comments to G20 on immediate challenges for trade to address economic rebound from the pandemic and for WTO reform, https://currentthoughtsontrade.com/2020/11/22/ddg-wolffs-comments-to-g20-on-immediate-challenges-for-trade-to-address-economic-rebound-from-the-pandemic-and-for-wto-reform/. The activities of the G20 are far broader than simply the trade issues reviewed in yesterday’s post and much of the Declaration looks at various aspects of addressing recovery from the pandemic, including access to vaccines and therapeutics. However, on the trade agenda in particular identified by DDG Wolff, the G20 does not appear to have addressed the issue of trade finance for developing and least developed countries, did not call for creating duty free treatment for all pharmaceuticals and medical goods relevant to the COVID-19 pandemic, and while supportive of WTO reform did not provide specifics or a sense of time urgency. The Declaration contains 38 paragraphs broken in four sections. Many deal with topics that are being examined in part at the WTO (e.g., digital trade) or that may be going forward (e.g., environment, climate change). There was only one paragraph on trade and investment (para. 12) (under section “B. Building a Resilient and Long-Lasting Recovery”). The paragraph reads as follows:

“12. Trade and Investment: Supporting the multilateral trading system is now as important as ever. We strive to realize the goal of a free, fair, inclusive, non-discriminatory, transparent, predictable, and stable trade and investment environment, and to keep our markets open. We will continue to work to ensure a level playing field to foster an enabling business environment. We endorse the G20 Actions to Support World Trade and Investment in Response to COVID-19. We recognize the contribution that the Riyadh Initiative on the Future of the World Trade Organization (WTO) has made by providing an additional opportunity to discuss and reaffirm the objectives and foundational principles of the multilateral trading system as well as to demonstrate our ongoing political support for the necessary reform of the WTO, including in the lead up to the 12th WTO Ministerial Conference. We recognize the need to increase the sustainability and resilience of national, regional, and global supply chains that foster the sustainable integration of developing and least developed countries into the trading system, and share the objective of promoting inclusive economic growth including through increased participation of micro-, small-, medium-sized enterprises (MSMEs) in international trade and investment. We note that structural problems in some sectors, such as excess capacities, can cause a negative impact.”

The G20 Declaration in paragraph 3 provides a statement indicating G20 members “will spare no effort to ensure * * * affordable and equitable access for all people, consistent with members’ commitments to incentivize innovation,” to COVID-19 diagnostics, therapeutics and vaccines. The paragraph refers to the efforts of the “Access to COVID-19 Tools Accelerator (ACT-A) initiative and its COVAX facility,” and commits G20 members “to addressing the remaining global financing needs.” While obviously encouraging, the financing needs that remain are large both for vaccines and for testing and treatment. Total additional funding needs approach $40 billion. See Statement by President von der Leyen at the joint press conference with President Michel ahead of the G20 Summit, Brussels, 20 November 2020, https://ec.europa.eu/commission/presscorner/detail/en/STATEMENT_20_2170. Such contributions are voluntary and substantially exceed what has been pledged or received to date. So time will tell whether G20 countries actually fulfil the general commitment included in yesterday’s declaration.

The New York Times in an article on November 22 headlined “G20 Summit Closes With Little Progress and Big Gaps Between Trump and Allies,” describes the large number of topics where the current U.S. Administration has been at odds with many of the other G20 leaders and the resulting challenges to meaningful joint action as opposed to “general appeals for more global cooperation” and for “affordable and equitable access” to vaccines and therapeutics. New York Times, Nov. 22, 2020, G20 Summit Closes With Little Progress and Big Gaps Between Trump and Allies, ahttps://www.nytimes.com/2020/11/22/us/politics/g20-summit-trump.html. While the Trump Administration undoubtedly has contributed to the lack of greater specifics in the Declaration, there are undoubtedly strong differences among different G20 members on what commitments should be undertaken that involve G20 members specifically.

Conclusion

The G20 process has been important over the last decade or so in mobilizing the world’s leading nations to provide leadership to address global challenges. The success of the group’s efforts depends on leadership of the majors and a common understanding of the challenges at hand. There are structural challenges in the current G20 configuration with different economic models and different levels of economic development providing points of conflict as well as points of expanded understanding of global needs. The challenges have been exacerbated by the concerns of the current U.S. Administration with multilateral organizations and with whether climate change is an actual problem.

With the current internal friction points, the G20 has nonetheless put forward a largely united front in seeking to meet the challenges from the COVID-19 pandemic and economic shocks through collaboration and to seek to rebuild more sustainably and more inclusively. The lack of specifics in some areas may be better addressed under a new U.S. Administration’s participation with the expected closer ties the Biden Administration will have with at least many of the G20 members.

In the trade arena, the conflicts within the WTO are not likely to go away with a new U.S. Administration. That doesn’t mean that U.S. leadership couldn’t permit rapid movement on a number of issues that would be helpful in addressing the pandemic and the global economic recovery. But WTO reform and even singular issues like updated coverage by the Pharmaceutical Agreement or the elimination of tariffs on medical goods unfortunately are likely to take way too long to be helpful in the current pandemic. That leaves voluntary actions by countries in their own interest as the likely option most likely to provide some improved market access during the pandemic.

DDG Wolff’s comments to G20 on immediate challenges for trade to address economic rebound from the pandemic and for WTO reform

Below are Deputy Director-General Wolff’s comments to the G20 Leaders’ Summit on November 21.

“Thank you very much, Your Royal Highness, and I thank Saudi Arabia for its leadership.

“With respect to trade, there are three immediate challenges: to utilize trade to help underwrite the economic recovery, to facilitate trade in essential medical products to treat the pandemic, and to reform the institutional framework for world trade.

“First, trade finance for the developing world needs to be restored. The sum needed is very large, in the trillions of dollars. This step has been called for by business and by all the major international development banks along with the WTO. This is not just a development issue. When crops do not move and factories are idled throughout the developing world, the global recovery will be delayed for all. Close co-operation among the international financial institutions, the WTO and the large commercial banks will be needed. A trade finance initiative should be seen as an essential part of improving the outlook for economic recovery.

“Second, it is time for WTO Members to come together to agree on and implement measures to speed the supply of essential medical products worldwide to where they are needed.

“Global trade in pharmaceuticals should be duty-free under an updated Pharmaceutical Agreement.

“Medical equipment should be duty-free in an immediate update of the Information Technology Agreement.

“As new vaccines, therapeutics and diagnostics start to be rolled out, barriers at borders must be reduced, with an international understanding limiting the use of export restrictions, providing for much greater transparency and accelerating improvements in trade facilitation efforts, particularly for the poorest countries.

“Third, and last, the identification of areas of common interest achieved by the Riyadh Initiative on the Future of the WTO should result in immediate serious engagement by WTO Members in a major institutional reform effort. This would involve restoring the WTO’s deliberative and negotiating functions, providing binding dispute settlement seen as legitimate by all and providing for a strong proactive Secretariat. The WTO’s 12th Ministerial Conference next year will be an important landmark for this work. In actively engaging in the reform effort, G20 Members can contribute immeasurably to fulfilling the vision held by the founders of the multilateral trading system seven decades ago and the WTO a quarter century ago.

“Thank you.”

WTO, DDG Wolff urges G20 leaders to back WTO action to support economic rebound, pandemic response and WTO reform, 21 November 2020, https://www.wto.org/english/news_e/news20_e/ddgaw_21nov20_e.htm.

The G20 Leaders Summit is taking place virtually on November 21-22. The results of the Summit will be released later today. While a positive picture on agreed actions by the G20 will be presented, it is hard to imagine the G20 actually embracing the objectives/needs outlined by DDG Wolff.

For example, while it is likely that the G20 will lend support to a trade finance initiative to assist developing countries, the size of the initiative that is actually supported may be far less than the ambitious levels (trillions of dollars) identified as needed by Deputy Director-Wolff.

Similarly, while there is support in some quarters (e.g., the EU) for some of the trade liberalization initiatives identified in DDG Wolff’s second item, it is hard to see WTO Members being willing to reach consensus quickly on any of the three initiatives outlined. Certainly, the Pharmaceutical Agreement should be updated; how long that takes to accomplish is another issue and is unlikely to occur in a timeframe relevant to the COVID-19 pandemic. So too it is unlikely that WTO Members will quickly agree to duty free treatment of medical equipment whether under the Information Technology Agreement or otherwise, although countries needing to import such equipment have to a limited extent unilaterally reduced or eliminated duties during the pandemic. Such voluntary and temporary reductions seem the more promising short term solution. Finally, while individual countries have adopted trade facilitating/streamlining actions to speed the movement of medical goods and the WTO’s notification process has provided fair transparency of government actions, it is unlikely that there will be a quick agreement on limiting the use of export restrictions. There could be agreement on improved transparency and the WTO could work with LDCs and others to help them implement trade facilitation steps useful in speeding movement of medical goods.

On the third objective, “a major institutional reform effort,” while the G20 will undoubtedly support such action and support at least two of the three stated core planks — “restoring the WTO’s deliberative and negotiating functions, providing binding dispute settlement seen as legitimate by all” — the huge differences in objectives/concerns of many of the G20 countries makes any rapid movement towards reform in fact unlikely. For example, the United States, at least under the Trump Administration, has pushed for a fundamental rebalancing of rights and obligations in light of changed economic circumstances, pushed for a determination on whether the organization can function with very different economic systems under a set of rules designed for one type of economy, is seeking a restoration of the limited role envisioned for the WTO dispute settlement system and for panels and the Appellate Body. China has different objectives and opposes most of the U.S. priorities. The EU has very different views from the United States on the dispute settlement system. Thus, even before one looks at the broader WTO Membership, these three major Members have very different views on reform that will make efforts at reform at least time consuming (years not months). DDG Wolff includes in his list of reform efforts “providing for a strong proactive Secretariat.” This is an objective that has been stated by one or more past Directors-General, but it is unclear that there is strong Member support for a stronger Secretariat. Considering the U.S. concerns with the Appellate Body, it is hard to see them wanting a stronger Secretariat at the expense of Members. Indeed, WTO Members have frozen the WTO budget for years, and India has been seeking a reduction in budget resources for the WTO (10% cut has been proposed). The U.S. has also raised questions about Secretariat actions that appear outside of the agreed role of the Secretariat.

Conclusion

The G20 can have and has had an important role in limiting some of the more harmful actions of both G20 countries and of others in time of crisis. The G20 efforts to mobilize agreement on ways to keep markets open, limit market restrictions and support global initiatives to help smaller and more vulnerable countries has been and will continue to be important to reduce the depth of economic contraction and speed of economic rebound. And, of course, the G20 efforts go far beyond trade.

It has been important that the G20 has been open to receiving input from various organizations, including the WTO. The G20 has the ability to act fairly quickly where there is agreement among the countries. On trade, there are some major differences among G20 members not only on WTO reform but also on the need for existing WTO options for temporary export restrictions and willingness for providing greater transparency or to reach quick agreement on trade liberalization actions. Some G20 members have proposed broader WTO actions, and such actions may very well occur in the coming years although whether in time to alter the reality in the field during the COVID-19 pandemic is unlikely. Voluntary actions are obviously available in terms of reducing import restrictions including tariffs on medical goods and medicines/vaccines, and a number of countries have adopted streamlining actions to speed movement of medical goods during the pandemic.

Deputy Director-General Wolff’s statement to the G20 Leaders Summit contains important possible actions that the G20 could take or support. Some support from G20 members will almost certainly be forthcoming. Unfortunately, G20 action will not likely result in complete adoption of DDG Wolff’s proposals, nor will G20 action likely permit rapid implementation within the WTO or other organizations of DDG Wolff’s proposals. But it is useful to have a picture of a highly desirable future even if the audience for the message is unlikely to rise to the occasion for the global good.

United States becomes only country to have more than 2,000,000 new COVID-19 cases in fourteen days

The European Centre for Disease Prevention and Control (ECDC) daily report, “COVID-19 situation update worldwide, as of 19 November 2020,” shows the number of new cases in the United States surpassing two million for the fourteen days November 6 -19. The 2,043,321 new cases more than doubled the 1,019,609 new cases reported by the United States for October 19-November 1 (the first time the United States surpassed one million in a fourteen day period according to the daily reports from the ECDC). For the last fourteen days, the U.S. accounted for 24.99% of new cases recorded around the world. The 11,529,807 cases recorded by the U.S. since the end of December 2019 have been 20.45% of the world’s total cases of 56.37 million. The U.S. has just 4.3% of the world’s population.

The United States is the largest source of increases in new cases and has been that over the last month. Europe which has suffered a huge increase this fall is seeing a reduction from peak numbers for many countries.

The United States is seeing new records in terms of hospitalizations of patients with COVID-19. The COVID Tracking Project shows the U.S. having 79,410 hospitalizations on November 18, up from 28,606 on September 20 and nearly 20,000 hospitalizations more than prior peaks in July (59,677 on July 24) and April (59,773 on April 21). Some sources are projecting hospitalizations could exceed 100,000 in the coming weeks.

Deaths in the U.S. are also increasing with the COVID Project recording 1,869 on November 18. The ECDC 19 November 2020 COVID-19 situation update worldwide shows U.S. deaths due to COVID-19 as 250,537 or 18.55% of the world total up til November 19. With the spiraling number of new cases and huge increases in hospitalizations, the daily death totals are projected to continue to increase.

Many U.S. states are overwhelmed with COVID-19 hospitalizations, and there continue to be challenges for medical workers obtaining needed personal protective equipment despite increased global production and some domestic onshoring. See, e.g., NPR, November 10, 2020, COVID-19 Hospitalizations Hit Record Highs. Where Are Hospitals Reaching Capacity?, https://www.npr.org/sections/health-shots/2020/11/10/933253317/covid-19-hospitalizations-are-surging-where-are-hospitals-reaching-capacity; American Medical Association, Amid PPE shortage, AMA collaboration offers supplier for doctors, November 16, 2020,https://www.ama-assn.org/delivering-care/public-health/amid-ppe-shortage-ama-collaboration-offers-supplier-doctors.

While the news from several pharmaceutical companies about results from phase 3 vaccine tests are highly encouraging, production and distribution of the vaccines, once approved, means the U.S. will be dealing with the continuing surge of new cases for a number of months to come at least. Some forecasts predict deaths in the U.S. reaching 430,000 by the end of the first quarter of 2021. Moreover, with a change in government occurring in late January, the U.S. is suffering from a lack of coordination from the outgoing Administration with the Biden Administration as the Trump Administration has to date refused to provide access to information that is normally received by incoming Administrations. Such handicapping of an incoming Administration will have significant adverse effects on the nation’s ability to distribute vaccines once approved and otherwise permit the Biden Administration to get on top of the pandemic.

Complicating the economic and trade picture in the United States is the lack of an additional stimulus package during the growing crisis from the pandemic. Millions of Americans face serious challenges with the expiration of various relief programs, some at the end of December. Millions are at risk of eviction beginning in January. See CNN, November 18, 2020, Key pandemic relief programs are set to expire at the end of the year. No one knows what’s next, https://www.cnn.com/2020/11/18/politics/covid-relief-programs-expiring-in-december/index.html.

While before the election, the Speaker of the House Nancy Pelosi and Treasury Secretary Steven Mnuchin were discussing a possible package of around $2 trillion, the Senate was not on board with a large package, and there was no agreement on the package even between the Administration and the House. It is looking increasingly unlikely that an agreement will be reached before Joe Biden is sworn in as the next President on January 20, 2021, meaning months of delay before new legislation can be enacted. Such delay will cause significant harm to millions and millions of Americans and to the overall U.S. economy.

A large reason for the significant rebound in the third quarter from the steep drop in GDP in the second quarter in the U.S. was the broad and deep stimulus package adopted much earlier in the year. Without a new stimulus package and with surging new cases, there is the very real risk of slipping into a double dip recession. See, e.g., The Hill, November 15, 2020, Fears of double-di recession rise alongside COVID-19 cases,https://thehill.com/policy/finance/economy/525951-fears-of-double-dip-recession-rise-alongside-covid-19-cases. Indeed, with more and more states imposing at least some restrictions in an effort to slow the spread of the coronavirus, the economic rebound is certainly already slowing. The New York Fed Staff Nowcast projection of 4th quarter 2020 GDP growth has shrunk from an estimate of 7.12% on August 28 to just 2.86% projected on November 13.

The United States is not alone in facing challenges getting new stimulus measures put in place or facing a double dip recession or seeing large surges in cases during the fall. See, e.g., NPR, November 17, 2020, Hungary and Poland Block EU Budget with Pandemic Relief Funds for Hard-Hit Nations, https://www.npr.org/sections/coronavirus-live-updates/2020/11/17/935775895/hungary-and-poland-block-eu-budget-with-pandemic-relief-funds-for-hard-hit-natio; CNN Business, November 5, 2020, The UK economy heads back into recession, https://www.cnn.com/2020/11/05/economy/uk-economy-recession/index.html. Europe has already reduced its forecasted GDP growth for 2021 because of the fall resurgence in COVID-19 cases.

Conclusion

The United States continues to struggle with a pandemic that has affected all parts of the world. The U.S.’s response has been the least successful and the most costly of any nation in the world. As we head towards the end of the year, the virus continues to spiral out of control across the country with many states and local communities basically at the breaking point in terms of health care services. The President and many of his supporters have politicized basic public health steps needed to control the virus. While the Trump Administration has helped support expediting research, development and production of vaccines, the U.S. is now and will almost certainly remain the country with the worst record in terms of infections and deaths from the COVID-19 pandemic. Today’s record of more than two million new infections recorded in the last fourteen days is just one more “first” that the United States should never have achieved.

New COVID-19 cases over a fourteen day period continue to soar past eight million, up from five million on October 22

The COVID-19 pandemic continues to see an upward spiral in terms of the number of new infections although there has been a recent slowdown in new cases in Europe. Europe and the United States continue to constitute the bulk of the increase over the last 26 days as the following graph taken from the European Centre for Disease Prevention and Control’s COVID-19 situation update world wide, as of 17 November 2020 shows.

Distribution of COVID-19 cases worldwide, as of 17 November 2020

Distribution of COVID-19 cases worldwide, as of 17 November 2020


More specifically, in the last twenty-six days, the number of new COVID-19 cases globally over the last fourteen days has shot from five million to over eight million — a near sixty percent increase in a little over three and a half weeks. The total new cases identified since late December 2019 globally are now 55.15 million as of November 17.

On October 22, the European Centre for Disease Prevention and Control (ECDC) recorded the first day where the number of new COVID-19 cases over a fourteen day period globally surpassed five million (5,042,415). In just eight days, on October 30, the ECDC reports the fourteen day total shooting past six million new cases (6,093,987), an increase of 1,051,572 or 20.85% in eight days. The report for November 7 shows the total new cases in the last fourteen days crossing the seven million mark — 7,044,267 — or 15.59% over October 30 and 39.70% over October 22. And today, November 17, the ECDC report shows new cases in the last fourteen days as passing eight million (8,031,073) — 14.01% above November 7, 31.79% above October 30 and 59.27% above October 22. As reviewed in three prior posts (October 22 and October 30), the U.S. and Europe were major factors in hitting five million, six million and seven million daily cases and today’s data show them to continue to be the major causes of the continued rapid escalation in global cases. See October 22, 2020, COVID-19 new cases over last 14 days pass 5,000,000 for first time on October 22, https://currentthoughtsontrade.com/2020/10/22/covid-19-new-cases-over-last-14-days-pass-5000000-for-first-time-on-october-22/; October 30, 2020,  In last eight days, the number of global new COVID-19 cases over past fourteen days has grown from five to six million, https://currentthoughtsontrade.com/2020/10/30/in-last-eight-days-the-number-of-global-new-covid-19-cases-over-past-fourteen-days-has-grown-from-five-to-six-million/; November 7, 2020:  New COVID-19 cases over a fourteen day period continue to soar from five million on October 22 to six million on October 30 to seven million on November 7, https://currentthoughtsontrade.com/2020/11/07/new-covid-19-cases-over-a-fourteen-day-period-continue-to-soar-from-five-million-on-october-22-to-six-million-on-october-30-to-seven-million-on-november-7/

The table below shows the fourteen day totals for selected countries as of October 22, October 30, November 7 and November 17, and the change in new cases from October 22 – November 17. These twenty countries show an increase in the twenty-six days from October 22 – November 17 of 2,772,211 additional new cases while the increase from all countries was 2,988,658. So the 20 countries account for 92.76% of the total growth. In the prior periods (October 30 and November 7), the 20 countries had accounted for more than 100% of the increase in new cases. The 20 countries accounted for 2,558,802 new cases for the fourteen days ending October 22 or 50.75% of the global total at that time. For the fourteen days ending October 30, the 20 countries accounted for 3,584,674 new cases or 58.82% of the global total. For the fourteen days ending November 7, the 20 countries accounted for 4,568,491 new cases or 64.85% of the global total. And for the fourteen days ending November 17, the 20 countries accounted for 5,331,013 new cases or 66.38% of new cases. The table below shows that eight European countries — France, Spain, Belgium, Czechia, the Netherlands, Switzerland, Slovakia and Slovenia — showed significant new case reductions in the November 17 period compared to the November 7 period.

Country10-22-202010-30-202011-7-202011-17-2020Change
United States786,488966,2691,245,8761,914,2411,127,753
France303,912473,085620,778524,800220,888
United Kingdom244,954291,718315,486336,817 91,863
Spain169,394238,709282,700256,167 86,773
Italy115,708234,993377,812474,293358,585
Russia198,716227,530252,794315,975117,259
Belgium100,119171,522152,663 72,643 -27,476
Poland95,260169,302265,447338,308243,048
Czechia113,555161,058165,174114,627 1,072
Germany81,905151,137224,483255,367173,462
Netherlands103,024126,543125,163 84,442 -18,582
Ukraine76,48989,178109,792143,495 67,006
Switzerland35,26173,418107,837 93,395 58,134
Romania48,53260,55086,030114,508 65,976
Hungary18,16628,38848,845 65,890 47,724
Austria19,38735,43661,823 93,528 74,141
Bulgaria10,59220,64335,665 45,274 34,682
Slovakia18,91327,50333,177 25,447 6,534
Slovenia8,85920,02123,345 19,338 10,479
Sweden9,56817,67133,601 42,458 32,890
Total2,558,8023,584,6744,568,4915,331,0132,772,211

While the United States has the largest absolute increase in the last twenty-five days for a single country and accounted for 40.68% of the increase recorded by the twenty countries for the October 22-November 17 period, the U.S. accounted for 87.65% of the increase of the twenty countries for the November 7-November 17 period. While Europe has been the largest part of the increase in October and November, the rate of increase has slowed or declined for many European countries in the last fourteen days.

Europe led the U.S. in the dramatic increase in new cases in October and in the reintroduction of restrictions in many countries to attempt to bring the coronavirus back under control. Actions in Europe appear to be working at least in a large number of countries as the number of new cases is declining in some countries as can be seen in the table above. The United States is continuing with huge increases in new cases, in hospitalizations and is seeing a growing number of deaths. Many U.S. states are putting in place at least some restrictions to try to slow the growth of new cases and reduce the strain on the health care system. The next week or two will help understand whether the actions being taken in the U.S. are sufficient to reduce the growth in new cases.

Other parts of the world are not experiencing a second wave to the same extent as Europe or the United States, although much of the Americas remain at very high levels of new cases. Some major countries who have been seriously hit in recent months are seeing substantial reductions in new cases. India is one example — on October 22, the last 14 days showed 871,291 new cases; on October 30, for the last 14 days new cases were down to 718,383; on November 7 were down to 647,398 for the 14 days ; and for the fourteen days ending on November 1, India’s new cases were down to 606,667.

The EU and the US face problems on additional aid packages

The EU has at least a temporary crisis as Hungary and Poland have blocked adoption of the aid package that had been agreed to. See, e.g., Euronews, 16 November 2020, Hungary and Poland block EU’s COVID-19 recovery package over new rule of law drive, https://www.euronews.com/2020/11/16/hungary-and-poland-threaten-coronavirus-recovery-package.

The U.S. Congress and Administration have been unable to agree to additional stimulus funds to help the U.S. economy and citizens deal with the continued COVID-19 pandemic. The U.S. has more than 22 million Americans still out of work and with government assistance having terminated or to terminate shortly. Aid for small businesses and for sectors particularly hard hit by the pandemic is desperately needed as is funding for state and local governments and much more. While President Trump has urged Congress to pass an additional stimulus package, it is unlikely that action will be taken before the next Congress convenes and the new Administration is sworn in on January 20.

Progress on vaccine development

Two vaccines have completed phase 3 testing — one from Pfizer/BioNTech and one from Moderna — and information from the companies suggests efficacy rates of 90-94.5%. Thus, it is possible that these two vaccines will be approved for use in the coming weeks and will see large scale availability in the first half of 2021. Many other vaccines are in various phases of testing. So 2021 will hopefully see the roll out of various vaccines with significant availability around the world due to efforts of the companies and the efforts of the WHO/GAVI/CEPI to ensure availability to developing and least developed countries as well.

Conclusion

The top priority for many countries around the world remains getting the COVID-19 pandemic under control. The costs in terms of human life and serious health problems are enormous. So too the costs to the global economy from taking the steps necessary to address the pandemic are enormous.

How to address the pandemic and how to work internationally to secure a return to normalcy and a return to sustainable economic growth are the challenges for all governments and international organizations.

The fact that the number of new cases is continuing to surge globally ten and a half months after the start of global surveillance is obviously troubling and delays the return to normalcy. While some individual countries have gained control of the pandemic and others are making significant strides to reduce the number of new cases, “no one is safe until all are safe”. We have a long road to travel, and the western developed world is currently the major hot spot, struggling with the current extraordinary surge, although there are positive signs in Europe that at least many countries are slowing the spread after a very challenging September and October. We still are not in sight of a global peak although the rate of growth is slowing for the world as a whole though not for countries like the United States.

There is obviously some light at the end of the tunnel as vaccines and therapeutics get closer to public release. With more than 55 million infections recorded to date around the world and with more than 1.3 million deaths globally, the pressing question is how much worse will the situation become before the world gets back to normal with the pandemic controlled. The world is in for a challenging time til at least next summer and more realistically to the end of 2021 and the start of 2022.

COVID-19 Pandemic continues to spin out of control globally; U.S. becomes first country to record more than one million new cases in a week

Ten and a half months into the global pandemic, the world remains on a sharply upward trajectory in terms of new cases. As of November 15, the global total of new cases in the last fourteen days is just under 8 million (7,925,568) with total recorded cases since the end of December 2019 topping 54 million (54,110,061). See European Centre for Disease Prevention and Control (ECDC), COVID-19 situation update worldwide, as of 15 November 2020.

The United States accounts for 1,778,530 of the cases in the last fourteen days and became the first country to record more than one million new cases in a week — 1,043,933 for the seven days ending November 15. The 184,813 new cases recorded on November 14 is more in one day than the vast majority of countries in the world have recorded since the end of December 2019. For example 53 of 55 countries in Africa have recorded fewer cases than the U.S. did on November 14 and the other two (Morocco and South Africa) have recorded fewer cases than the U.S. recorded in the last week. Similarly 32 of 43 countries in Asia (including China) have had fewer cases over the last 10 1/2 months than the U.S. had on November 14 and of the other 11, 10 have had fewer cases in the last 10 1/2 months than the U.S. has had in the last week. In the Americas, 40 of 46 countries or territories (other than the U.S.) have had fewer cases in the last 10 1/2 months than the U.S. recorded on November 14 and three of the other six countries have had fewer cases in the last 10 1/2 months than the U.S. has recorded in the last seven days. In Europe, the other area very hard hit in the last several months, 39 of 53 countries have had fewer cases in the last 10 1/2 months than the U.S. had on November 14 and of the remaining fourteen countries, 10 have had fewer cases in the last 10 1/2 months than the U.S. has had in the last week. All countries and territories in Oceania (12 of 12) have had fewer cases in the last 10 1/2 months than the U.S. recorded on November 14. Indeed, the total cases of all of Oceania (combined) for the last 10 1/2 months are lower than the U.S. figures for just November 14.

Nearly every one of the fifty U.S. states is experiencing significant increases and a number of states are already struggling with health care facilities, personnel and supplies. U.S. hospitalizations are at a record high for patients with COVID-19 ( 69,455 on November 14; https://covidtracking.com/data/charts/us-currently-hospitalized) and are expected to go above 100,000 by the end of the year. The U.S. recorded 8,487 deaths from COVID-19 in the last week and is projected to have more than 2,000 deaths/day from COVID-19 by January. A large number of U.S. states are imposing new restrictions in an effort to halt the dramatic increase in the U.S. number of new cases. See, e.g., New York Times, November 15, 2020, Doctors Call for More Restrictions and Caution as Virus Surges, https://www.nytimes.com/live/2020/11/14/world/covid19-coronavirus-updates; CNBC, November 14, 2020, U.S. reports record Covid hospitalizations as states roll out restrictions ahead of Thanksgiving, https://www.cnbc.com/2020/11/14/us-reports-record-covid-hospitalizations-as-states-roll-out-restrictions-again.html; Bloomberg, November 13-14, 2020, World Clamps Down as Covid-19 Refuses to Cede: Virus Update, https://www.bloomberg.com/news/articles/2020-11-13/u-s-sets-record-as-states-move-to-tighten-rules-virus-update.

As the last of the articles referenced above shows, many European countries have also been imposing significant restrictions in an effort to bring the pandemic back under control. Some European countries are seeing some significant retrenchment from the extraordinary numbers recorded within recent weeks in the last week. Others are seeing a slowing of the rate of growth or a plateauing of new cases. For example, the ECDC data for France shows new cases in the week ending November 15 at 205,894 down significantly from the 384,080 new cases of the prior week. Italy’s rate of increase slowed with new cases in the last week at 242,962 compared to 223,060 the prior week. Spain saw a small decline from 143,154 new cases the week ending November 8 to 129,759 new cases during the week ending November 15.

While there has been very encouraging news on the vaccine front from Pfizer/BioNTech and with likely similar good news expected from Moderna, broad distribution in the U.S. and Europe and other developed countries is still likely months away even if started in the next month or two. The requirement for extreme cold storage and transfer of the product will make global distribution even more challenging because of extra infrastructure/equipment needs. Thus, every country has an ongoing need to take the steps necessary to bring the pandemic under control without a vaccine.

In the United States where the current Administration has focused its efforts on expediting development of new vaccines and therapeutics, the failure to provide national leadership on controlling the pandemic and the continual issuance of misinformation has unfortunately politicized much of the health care preventive efforts needed by individuals and communities. The Administration’s current refusal to recognize the results of the recent elections and failure to accord the President-elect’s team access to agencies will complicate the process of the incoming Administration being able to implement a more comprehensive and consistent response to the pandemic to assist the states. Thus, the current crisis will certainly just get worse in the coming months. Projections now are that the U.S. will suffer an additional 200,000 deaths in the next four-five months. Many of those deaths are preventable but will happen because of our inability to focus on and accept the scientific facts and known action steps to control the spread. Remarkably a recent poll suggested that a large percent of the U.S. population believes the U.S. response to COVID-19 has been well handled. Thus, a wealthy developed country with 4.3% of the global population is apparently doing well by having roughly 20% of cases and 20% of deaths.

The rebound economically of European and U.S. economies during the third quarter after the steep decline in the second quarter following largescale closures will be negatively affected by the fourth quarter surge in cases and needed renewed restrictions in both areas. Such restrictions will negatively affect not only domestic economies but global trade as well in both goods and services. Even for areas of the world where the COVID-19 pandemic has not had tremendous direct effects, there have been negative effects because of the contraction of trade in goods and services as reviewed in a recent WTO Secretariat paper. See WTO, Trade and Development, November 11, 2020, Least developed countries hit hard by trade downturn triggered by COVID-19 pandemic, https://www.wto.org/english/news_e/news20_e/devel_11nov20_e.htm; Sub-Committee on Least Developed Countries, MARKET ACCESS FOR PRODUCTS AND SERVICES OF EXPORT INTEREST TO LEAST DEVELOPED COUNTRIES
NOTE BY THE SECRETARIAT1, WT/COMTD/LDC/W/68, 23 October 2020.

The likely approach of more tailored restrictions being imposed by countries or states/provinces hopefully will mean a smaller negative economic effect from the current surge in cases. However, in the U.S., Congress and the Administration have been unable to agree to renewed stimulus measures and past stimulus packages have come to an end. There are more than 20 million Americans who have been receiving some form of unemployment assistance where assistance has or is ending. Millions of renters and home owners face potential evictions or foreclosures on homes because of non payment of rent or mortgages. The continued failure of the federal government to address these ongoing needs will depress the U.S. economy going forward and will cause major problems for millions of families — making the future months different than the U.S. economic response to the earlier surges.

The bottom line — the global challenges from the pandemic are growing and not receding.

U.S. becomes first country to exceed 100,000 new COVID-19 cases/day for a fourteen day period

As the COVID-19 pandemic continues to rage out of control in the United States and other parts of the world, the U.S. added another “first” to its sad handling of the pandemic. According to data from the European Centre for
Disease Prevention and Control, for the fourteen day period ending November 10, 2020, the United States had recorded 1,406,028 new cases in the last fourteen days — more than 100,000/day. No other country has ever recorded this level of new cases in a fourteen day period. So a brief summary of “firsts” for the United States follows — the U.S. has recorded the most deaths since the beginning of the pandemic of any country; the U.S. has recorded the most new cases since the beginning of the pandemic; the U.S. has recorded the most new cases in any given day; and now, the U.S. has recorded the most cases in a fourteen day period.

In addition, hospitalizations in the U.S. are back where they were at the initial peak in the spring (around 60,000 but still increasing) and deaths are mounting again, topping 1,000 for a number of days in a row.

In an environment in which the Trump Administration appears to be simply waiting for vaccines and therapeutics to become available but not pushing other measures, President-elect Biden announced a coronavirus task force yesterday and outlined his plan for addressing the pandemic in the U.S. after he takes office on January 20. He also asked U.S. citizens to follow the science by wearing masks, social distancing, limiting gatherings and more. The governor of Utah, faced with challenges in Utah’s hospitals issued a statewide mask mandate. With the problems facing most states continuing to escalate, it is likely that more state-level actions will occur in the coming days.

Pfizer’s announcement that preliminary results from its third round testing of its vaccine showed greater than 90% effectiveness is obviously encouraging. It is understood that Moderna’s vaccine in trial is based on a similar approach to Pfizer’s. And there are many other vaccines in stage three trials. So we are likely very close to approval of one or more vaccines with significant availability increasing as 2021 proceeds. However, the U.S., Europe and certain other parts of the world are in for a deadly fall and winter.

New COVID-19 cases over a fourteen day period continue to soar from five million on October 22 to six million on October 30 to seven million on November 7

The COVID-19 pandemic continues to spiral out of control with the vast majority of the new cases in Europe and the United States as the following graph taken from the European Centre for Disease Prevention and Control’s COVID-19 situation update world wide, as of 7 November 2020 shows.

Distribution of COVID-19 cases worldwide, as of 7 November 2020

Distribution of COVID-19 cases worldwide, as of 7 November 2020

More specifically, in the last sixteen days, the number of new COVID-19 cases globally over the last fourteen days has shot from five million to over seven million — a near forty percent increase in a little over two weeks. The total new cases identified since late December 2019 globally are just under 50 million (49.37 million) as of November 7.

On October 22, the European Centre for Disease Prevention and Control (ECDC) recorded the first day where the number of new COVID-19 cases over a fourteen day period globally surpassed five million (5,042,415). In just eight days, on October 30, the ECDC reports the fourteen day total shooting past six million new cases (6,093,987), an increase of 1,051,572 or 20.85% in eight days. Today’s report (November 7) shows the total new cases in the last fourteen days crossing the seven million mark — 7,044,267 — or 15.59% over October 30 and 39.70% over October 22. As reviewed in two prior posts (October 22 and October 30), the U.S. and Europe were major factors in hitting five million and six daily cases and today’s data show them to continue to be the major causes of the continued rapid escalation in global cases. See October 22, 2020, COVID-19 new cases over last 14 days pass 5,000,000 for first time on October 22, https://currentthoughtsontrade.com/2020/10/22/covid-19-new-cases-over-last-14-days-pass-5000000-for-first-time-on-october-22/; October 30, 2020,  In last eight days, the number of global new COVID-19 cases over past fourteen days has grown from five to six million, https://currentthoughtsontrade.com/2020/10/30/in-last-eight-days-the-number-of-global-new-covid-19-cases-over-past-fourteen-days-has-grown-from-five-to-six-million/.

The table below shows the fourteen day totals for selected countries as of October 22, October 30 and November 7 and the change in new cases from October 22 – November 7. These twenty countries show an increase in sixteen days of 2,009,689 new cases over the fourteen day periods examined or more than the global total increase of 2,001,852 new cases over the same sixteen days The 20 countries accounted for 2,558,802 new cases for the fourteen days ending October 22 or 50.75% of the global total at that time. For the fourteen days ending October 30, the 20 countries accounted for 3,584,674 new cases or 58.82% of the global total. Finally, for the fourteen days ending November 7, the 20 countries accounted for 4,568,491 new cases or 64.85% of the global total.

Country10-22-202010-30-202011-7-2020Change
United States786,488966,2691,245,876459,388
France303,912473,085620,778316,866
United Kingdom244,954291,718315,48670,532
Spain169,394238,709282,700113,306
Italy115,708234,993377,812262,104
Russia198,716227,530252,79454,078
Belgium100,119171,522152,66352,544
Poland95,260169,302265,447170,187
Czechia113,555161,058165,17451,619
Germany81,905151,137224,483142,578
Netherlands103,024126,543125,16322,139
Ukraine76,48989,178109,79233,303
Switzerland35,26173,418107,83772,576
Romania48,53260,55086,03037,498
Hungary18,16628,38848,84530,679
Austria19,38735,43661,82342,436
Bulgaria10,59220,64335,66525,073
Slovakia18,91327,50333,17714,264
Slovenia8,85920,02123,34514,486
Sweden9,56817,67133,60124,033
Total2,558,8023,584,6744,568,4912,009,689

While the United States has the largest absolute increase in the last eight days for a single country, the vast majority of the increase flows from countries within the European Union. With the exception of the United States, the rest of the countries in the chart are from Europe, most from the EU.

It is little wonder, then, that the EU, the UK and Switzerland, with dramatic growth in the number of new cases, are imposing renewed restrictions at least in many countries and facing backlash from citizens suffering COVID-19 exhaustion. See, e.g., Politico, November 1, 2020, Europe is living a coronavirus flashback plus a backlash, https://www.politico.eu/article/europe-is-living-a-coronavirus-flashback-plus-a-backlash/. While health care is handled by the individual countries within the the EU, the EU has been advocating better coordination and maintaining trade flows within the Community as countries come to grips with the current wave. See, e.g., Politico, October 30, 2020, EU leaders link arms for long fight against virus, https://www.politico.eu/article/eu-leaders-link-arms-for-long-fight-against-virus/.

In the United States, the number of new cases is spiking again, with new cases now more than 100,000/day in recent days and the fourteen day total new cases of 1,245,876 is more than 20% higher than was recorded on November 1 — the first day where a fourteen day total of new cases in teh U.S. topped one million. See November 1, 2020, United States becomes second country to have more than 1,000,000 new COVID-19 cases in fourteen days, https://currentthoughtsontrade.com/2020/11/01/united-states-becomes-second-country-to-have-more-than-1000000-new-covid-19-cases-in-fourteen-days/. With most attention in the U.S. focused on the election results, the COVID-19 situation is receiving relatively limited press attention and no change in federal government response.

Other parts of the world are not experiencing a second wave to the same extent, although much of the Americas remain at very high levels of new cases. Some major countries who have been seriously hit in recent months are seeing substantial reductions in new cases. India is the leading example — on October 22, the last 14 days showed 871,291 new cases; on October 30, for the last 14 days new cases were down to 718,383, and were down to 647,398 for the 14 days ending on November 7.

Conclusion

The top priority for many countries around the world is getting the COVID-19 pandemic under control. The costs in terms of human life and serious health problems are enormous. So too the costs to the global economy from taking the steps necessary to address the pandemic are enormous. For example, the European Union recently reduced its projected economic growth in 2021 because of the second wave of COVID-19 cases. See Politico, November 5, 2020, EU cuts economic forecast due to coronavirus wave, https://www.politico.eu/article/eu-cuts-economic-forecast-due-to-coronavirus-wave/ (2021 forecast cut from 6.1% growth to 4.2% growth).

How to address the pandemic and how to work internationally to secure a return to normalcy and a return to sustainable economic growth are the challenges for all governments and international organizations, including the WTO, WHO, IMF, World Bank and many others. Recent IMF regional economic outlooks show varied projections for economic growth for different parts of the world and major challenges for areas like Sub-Saharan Africa. See, e.g., IMF Press Release, October 22, 2020, Regional Economic Outlook, Sub-Saharan Africa, a difficult road to recovery, https://www.imf.org/en/News/Articles/2020/10/21/pr20319-sub-saharan-africa-a-difficult-road-to-recovery.

The fact that the number of new cases is continuing to surge globally ten months after the start of global surveillance is obviously troubling and delays the return to normalcy. While some individual countries have gained control of the pandemic and others are making significant strides to reduce the number of new cases, “no one is safe until all are safe”. We have a long road to travel, and the western developed world is currently the major hot spot, struggling with the current extraordinary surge. We still are not in sight of a global peak and the rest of 2020 is likely to continue to stress global capabilities.

WTO reports a 30% decline in commercial services trade in 2nd quarter of 2020 — travel challenges through September will continue to put downward pressure on commercial services trade

A press release from the WTO on October 23, 2020 was headlined “Services trade drops 30% in Q2 as COVID-19 ravages international travel.” https://www.wto.org/english/news_e/news20_e/serv_22oct20_e.htm. One of the charts in the press release shows travel down 81% in the second quarter of 2020, with transport down 31% and all other commercial services down 9%. Within other services, construction exports were down 24%; manufacturing and repair services exports were down 22%; telecommunications services exports were down 8%; insurance services exports were down 3%; financial services exports were down 1%; and computer services exports up 4%, with remaining categories of services exports down 9-14%.

The press release contained a link to monthly trade trends through August which looked at both imports and exports of merchandise and of commercial services. See WTO statistics, latest trends, https://www.wto.org/english/res_e/statis_e/latest_trends_e.htm. Commercial services were presented at an aggregate level and showed percent change for months on a year-on-year basis. For the European Union commercial services exports outside of the EU, the rate of decline from 2019 data declined 29% in May 2020, 22% in June, 21% in July and 20% in August. For the United States, exports of commercial services declined by 31% in May, 30% in June, 29% in July and 29% in August. China’s exports of commercial services went from a decline of 6% in May to a decline of 5% in June, and a !% growth in July and a 6% growth in August. The United Kingdom showed a decline of 27% in commercial exports in May, an 11% decline in June, a 9% decline in July and a 1% increase in August. India showed declines in each of the four months from May-August of 10%, 8%, 11% and 10%. Similarly, Japan showed declines each month in the four months from 24% in May, 23% in June, 35% in July and 36% in August. Korea was the last country shown and had declines each month of 30%, 24%, 27% and 26%.

Travel continues to be the major driver of the decline in commercial services into the third quarter, with the UNWTO reporting in its World Tourism Barometer (Volume 18, Issue 6, October 2020) that international arrivals declined 81% in July and 79% in August compared to year earlier figures. For the first eight months of 2020 compared to the same period in 2019, international arrivals are down 70.1%, with Asia and the Pacific down 78.8%, Europe down 67.7%, the Americas down 64.8%, Africa down 69.% nd the Middle East down 68.7. UNWTO World Tourism Barometer, Volume 18, Issue 6, October 2020, https://www.e-unwto.org/doi/epdf/10.18111/wtobarometereng.2020.18.1.6.

While travel restrictions through August had been being reduced in a number of countries, the huge increase in Europe of new COVID-19 cases in October and early November has resulted in increased restrictions in a number of European countries and will likely mean extended challenges for international travel to and from Europe, as well as cut backs in domestic travel for the remainder of 2020.

The International Air Transport Association (IATA) puts out various publications including an Air Passenger Market Analysis. The September issue shows that revenue passenger kilometers (RPKs) were down 88.8% in September 2020 for international air travel, bringing the January-September decline to 72.3%. Domestic air travel by contrast was down, but “just” 43.3% in September (51.2% for January – September). Thus, the total market (international and domestic) was down 72.8% in September and 64.7% for the first nine months of 2020. IATA, Air Passenger Market Analysis, The recovery in passenger travel slows amid elevated risks, September 2020, https://www.iata.org/en/iata-repository/publications/economic-reports/air-passenger-monthly-analysis—september-2020/.

While the travel sector encompasses far more than air travel, the challenges facing the airline industry are similar to challenges faced by other parts of the sector, although other parts of the sector are often far more fragmented (restaurants, bars, hotels, entertainment venues) and without the resources to survive the prolonged depression in demand due to the pandemic.

IATA provided a powerpoint analysis by their Chief Economist, Brian Pearce, on the 6th of October 2020, entitled “COVID-19, Outlook for airlines’ cash burn,” https://www.iata.org/en/iata-repository/publications/economic-reports/outlook-for-airlines-cash-burn/. The powerpoint reviews the steep reduction in stock prices for airlines compared to other stocks, outlines the extraordinary level of aid the industry has received from governments ($160 billion) and suppliers ($20 billion), shows the timing when government support is ending, graphs the slow recovery in passenger revenues, and explores the challenge for the airlines to downsize costs sufficiently to deal with the drastic contraction in revenues, and shows an industry cash burn (expenditures exceeding revenues) of $51 billion in the 2nd quarter of 2020 and a projected further cash burn of $77 billion in the second half of 2021. The presentation also shows that many airlines can’t sustain for long the cash burn and ends on the sobering note that airlines are not expected to turn cash positive until 2022.

Press reports show challenges for airlines in many parts of the world. See, e.g., South China Morning Post (Bloomberg article), November 3, 2020, Asia airlines seen staving off pandemic ruin for now as troubles head West, https://www.scmp.com/news/asia/article/3108066/asia-airlines-seen-staving-pandemic-ruin-now-financial-troubles-head-west; BBC, November 3, 2020, Covid threatens to ground India’s aviation industry, https://www.bbc.com/news/world-asia-india-54729074.

The U.S. has seen tens of thousands of airline employees furloughed or dismissed since October 1st as government support came to an end in September, and Congress and the Administration have not been able to agree on a further package of supports for the industry or the nation more broadly as the pandemic continues to grow in size in the U.S. The surge in new cases in the United States is also resulting in various states imposing restrictions on bars and restaurants, and the hotel and entertainment industries continue to be severely affected by declines in demand.

Similarly, much of Europe has been reimposing at least some restrictions that affect the travel sector in an effort to regain control over the pandemic.

All of the above is simply to point out that the decline in commercial services trade reported by the WTO last month for the second quarter of 2020 is likely to continue through the remainder of 2020, led by the devastating contraction of the travel sector.

India and South Africa Seek Waiver from WTO Intellectual Property Obligations to Address COVID-19 — Issues Presented

India and South Africa submitted a communication to the WTO Council for Trade-Related Aspects of Intellectual Property Rights entitled “Waiver from Certain Provisions of the TRIPS Agreement for the Prevention,
Containment and Treatment of COVID-19.” IP/C/W/699 (October 2, 2020). The document and correction are embedded below.

W669

W669C1

The waiver request was made part of the agenda of the Council for TRIPS agenda for its meeting on October 15-16. The WTO Secretariat provided a short press release on the TRIPS Council meeting. The discussion on the waiver proposal is quoted below.

“Some 40 members engaged in a substantive discussion on a proposal submitted by India and South Africa for a temporary waiver of certain TRIPS obligations they said would facilitate an appropriate response to COVID-19. The proposal suggests a waiver for all WTO members on the implementation, application and enforcement of certain provisions of the TRIPS Agreement in relation to the “prevention, containment or treatment” of COVID-19. The proponents argued this would avoid barriers to the timely access to affordable medical products including vaccines and
medicines or to scaling-up of research, development, manufacturing and supply of essential medical products.

“The waiver would cover obligations in four sections of Part II of the TRIPS Agreement (https://www.wto.org/english/docs_e/legal_e/27-trips_04_e.htm) — Section 1 on copyright and related rights, Section 4 on industrial designs, Section 5 on patents and Section 7 on the protection of undisclosed information. It would last for a specific number of years, as agreed by the General Council, and until widespread vaccination is in place globally and the majority of the world’s population is immune. Members would review the waiver annually until its termination.

“According to the proponents, an effective response to the COVID-19 pandemic requires rapid access to affordable medical products such as diagnostic kits, medical masks, other personal protective equipment and ventilators as well as vaccines and medicines. The outbreak has led to a swift increase in global demand, with many countries facing shortages, constraining the ability to effectively respond to the outbreak. As new diagnostics, therapeutics and vaccines for COVID-19 are developed, there were significant concerns about how these will be made available
promptly in sufficient quantities and at affordable prices to meet global demand.

“The proponents argued that many countries — especially developing countries — may face institutional and legal difficulties when using TRIPS flexibilities, including the special compulsory licensing mechanism provided for in Article 31bis (https://www.wto.org/english/res_e/publications_e/ai17_e/trips_art31_bis_oth.pdf), which they saw as a cumbersome process for the import and export of pharmaceutical products. Now was the time for the WTO as an organization to rise up to the collective call for defeating the pandemic. The WTO would not succeed in its efforts to rebuild the COVID-19 affected economies unless it acts now to first save those lives that are going to build these economies. It is time for members to take collective responsibility and put people’s lives before anything else, they concluded.

“While a number of developing and least developed country members welcomed the proposal as a contribution to the discussion, many were still studying it in their capitals and asked for clarification on certain points, particularly regarding its practical implementation and the possible economic and legal impact of the waiver at national level. A number of developing and developed country members opposed the waiver proposal, noting that there is no indication that intellectual property rights (IPRs) have been a genuine barrier to accessing COVID-19 related medicines and technologies.

“While acknowledging that the sustained and continued supply of such medicines and technologies is a difficult task, they observed that non-efficient and underfunded health care and procurement systems, spiking demand and lack of manufacturing capacity are much more likely to impede access to these materials. In the view of these members, solutions can be legitimately sought within the existing IP system as the TRIPS Agreement provides enough tools and sufficient policy space for members to take measures to protect public health. The suspension of IPRs,
even for a limited period of time, was not only unnecessary but it would also undermine the collaborative efforts to fight the pandemic that are already under way.

“Given this range of positions, the Council chair, Ambassador Xolelwa Mlumbi-Peter of South Africa, said that the item would remain suspended as members continue to consider the proposal. Requests for waivers concerning WTO agreements must be submitted initially to the relevant council for consideration. After 90 days, the TRIPS Council has to submit a report to the Ministerial Conference. Given that the proposal was submitted on 2 October, the 90-day time-period expires on 31 December 2020. The TRIPS Council meeting will be reconvened on the item of the waiver proposal as appropriate before that date, the chair said.”

WTO, 20 October 2020, Members discuss intellectual property response to the COVID-19 pandemic, https://www.wto.org/english/news_e/news20_e/trip_20oct20_e.htm.

Waiver provisions in the WTO

Article IX:3 and 4 of the Marrakesh Agreement Establishing the World Trde Organization deal with waivers from obligations WTO Members have assumed.

“Article IX

“Decision-Making

” * * *

“3.   In exceptional circumstances, the Ministerial Conference may decide to waive an obligation imposed on a Member by this Agreement or any of the Multilateral Trade Agreements, provided that any such decision shall be taken by three fourths of the Members unless otherwise provided for in this paragraph.

“(a)    A request for a waiver concerning this Agreement shall be submitted to the Ministerial Conference for consideration pursuant to the practice of decision-making by consensus. The Ministerial Conference shall establish a time-period, which shall not exceed 90 days, to consider the request. If consensus is not reached during the time-period, any decision to grant a waiver shall be taken by three fourths of the Members.
 

“(b)    A request for a waiver concerning the Multilateral Trade Agreements in Annexes 1A or 1B or 1C and their annexes shall be submitted initially to the Council for Trade in Goods, the Council for Trade in Services or the Council for TRIPS, respectively, for consideration during a time-period which shall not exceed 90 days. At the end of the time-period, the relevant Council shall submit a report to the Ministerial Conference.

“4.   A decision by the Ministerial Conference granting a waiver shall state the exceptional circumstances justifying the decision, the terms and conditions governing the application of the waiver, and the date on which the waiver shall terminate. Any waiver granted for a period of more than one year shall be reviewed by the Ministerial Conference not later than one year after it is granted, and thereafter annually until the waiver terminates. In each review, the Ministerial Conference shall examine whether the exceptional circumstances justifying the waiver still exist and whether the terms and conditions attached to the waiver have been met. The Ministerial Conference, on the basis of the annual review, may extend, modify or terminate the waiver.”

Some questions from the waiver proposal

The waiver proposal put forward by India and South Africa is extraordinarily broad – covering all WTO Members for a broad range of products not clearly delineated, with the waiver of a broad array of TRIPS obligations without a demonstration of the relevance of the requests for some (e.g., copyright) for a potentially lengthy period of time.

The proposal raises a series of questions that should be addressed to understand whether the waiver is appropriate. These questions include whether such a broad waiver request is appropriate or envisioned by Article IX:3 and 4 of the Marrakesh Agreement? Shouldn’t those requesting a waiver be required to demonstrate that the existing flexibilities within the TRIPS Agreement are inadequate to address concerns they may have? Can two Members request a waiver of obligations for all WTO Members? Can a waiver request be considered where the product scope is lacking clarity, and the uses/needs of the waiver are very broad and potentially open to differing views? To what extent is there a need for those seeking a waiver to present a factual record of actions being taken by governments, companies and international organizations to provide access to medical goods during the pandemic including to developing and least developed countries? Shouldn’t those seeking a waiver identify the extent of existing licenses by major pharmaceutical companies with them or other WTO Members for the production of vaccines or therapeutics to address COVID-19?

Historical usage of waivers have not been as broad as that requested by India and South Africa

Waivers are exceptional by their nature and Article IX:3 talks in terms of a waiver of some obligation for a particular Member, not the waiver of many parts of an agreement for all members. When one looks at waivers granted previously by the WTO, one sees a range of topics — many relate to time for Members to implement changes from updates of the harmonized tariff systems (for individual countries who sought the temporary waiver), some pertain to preferential arrangements between one Member and another or a group of Members and some pertain to waiver of deadlines or specific obligations for least developed countries. Two documents prepared by the WTO Secretariat show waivers granted or continuing in existence in 2019 and all waivers between 1995 AND 2015. The two documents are embedded below.

W795

W718

Thus, the present request for a waiver by India and South Africa doesn’t seem to comply with the literal terms of Article IX:3 of the Marrakesh Agreement or with the much more narrow scope of waivers typically considered. As reviewed above, the request would apply to all members, not just India and South Africa. The request also seems overly broad both in terms of products (not clearly defined), uses and provisions to be waived.

Existing flexibilities within the TRIPs Agreement

Because of the importance to all WTO Members of the health of their citizens, there has been a lot of focus and discussion within the WTO on the interface between intellectual property and public health. Under the original TRIPs Agreement and the subsequent amendment to the Agreement in 2005 that took effect as Article 31bis to the TRIPs Agreement in 2017, there is flexibility within the TRIPs Agreement for Members to deal with health emergencies including through compulsory licensing which can include the right to manufacture and export to developing and least developed countries who don’t have pharmaceutical manufacturing capabilities in-country. See TRIPs Agreement Article 31, Article 31bis and WT/L/641. The current language of Articles 31 and 31bis from the patent portion of the TRIPS Agreement are presented below.

Article 31 Other Use Without Authorization of the Right Holder

“Where the law of a Member allows for other use (7) of the subject matter of a patent without the authorization of the right holder, including use by the government or third parties authorized by the government, the following provisions shall be respected:

“(a)  authorization of such use shall be considered on its individual merits;
 

“(b)  such use may only be permitted if, prior to such use, the proposed user has made efforts to obtain authorization from the right holder on reasonable commercial terms and conditions and that such efforts have not been successful within a reasonable period of time. This requirement may be waived by a Member in the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use. In situations of national emergency or other circumstances of extreme urgency, the right holder shall, nevertheless, be notified as soon as reasonably practicable. In the case of public non-commercial use, where the government or contractor, without making a patent search, knows or has demonstrable grounds to know that a valid patent is or will be used by or for the government, the right holder shall be informed promptly;
 

“(c)  the scope and duration of such use shall be limited to the purpose for which it was authorized, and in the case of semi-conductor technology shall only be for public non-commercial use or to remedy a practice determined after judicial or administrative process to be anti-competitive;
 

“(d)  such use shall be non-exclusive;
 

“(e)  such use shall be non-assignable, except with that part of the enterprise or goodwill which enjoys such use;
 

“(f)  any such use shall be authorized predominantly for the supply of the domestic market of the Member authorizing such use;
 

 “(g)  authorization for such use shall be liable, subject to adequate protection of the legitimate interests of the persons so authorized, to be terminated if and when the circumstances which led to it cease to exist and are unlikely to recur. The competent authority shall have the authority to review, upon motivated request, the continued existence of these circumstances;
 

“(h)  the right holder shall be paid adequate remuneration in the circumstances of each case, taking into account the economic value of the authorization;
 

“(i)  the legal validity of any decision relating to the authorization of such use shall be subject to judicial review or other independent review by a distinct higher authority in that Member;
 

“(j)  any decision relating to the remuneration provided in respect of such use shall be subject to judicial review or other independent review by a distinct higher authority in that Member;
 

“(k)  Members are not obliged to apply the conditions set forth in subparagraphs (b) and (f) where such use is permitted to remedy a practice determined after judicial or administrative process to be anti-competitive. The need to correct anti-competitive practices may be taken into account in determining the amount of remuneration in such cases. Competent authorities shall have the authority to refuse termination of authorization if and when the conditions which led to such authorization are likely to recur;
 

“(l)  where such use is authorized to permit the exploitation of a patent (“the second patent”) which cannot be exploited without infringing another patent (“the first patent”), the following additional conditions shall apply:
 

“(i)  the invention claimed in the second patent shall involve an important technical advance of considerable economic significance in relation to the invention claimed in the first patent;
 

“(ii) the owner of the first patent shall be entitled to a cross-licence on reasonable terms to use the invention claimed in the second patent; and
 

“(iii)  the use authorized in respect of the first patent shall be non-assignable except with the assignment of the second patent.

Article 31bis

“1. The obligations of an exporting Member under Article 31(f) shall not apply with respect to the grant by it of a compulsory licence to the extent necessary for the purposes of production of a pharmaceutical product(s) and its export to an eligible importing Member(s) in accordance with the terms set out in paragraph 2 of the Annex to this Agreement.

“2. Where a compulsory licence is granted by an exporting Member under the system set out in this Article and the Annex to this Agreement, adequate remuneration pursuant to Article 31(h) shall be paid in that Member taking into account the economic value to the importing Member of the use that has been authorized in the exporting Member. Where a compulsory licence is granted for the same products in the eligible importing Member, the obligation of that Member under Article 31(h) shall not apply in respect of those products for which remuneration in accordance with the first sentence of this paragraph is paid in the exporting Member.

“3. With a view to harnessing economies of scale for the purposes of enhancing purchasing power for, and facilitating the local production of, pharmaceutical products: where a developing or least developed country WTO Member is a party to a regional trade agreement within the meaning of Article XXIV of the GATT 1994 and the Decision of 28 November 1979 on Differential and More Favourable Treatment Reciprocity and Fuller Participation of Developing Countries (L/4903), at least half of the current membership of which is made up of countries presently on the United Nations list of least developed countries, the obligation of that Member under Article 31(f) shall not apply to the extent necessary to enable a pharmaceutical product produced or imported under a compulsory licence in that Member to be exported to the markets of those other developing or least developed country parties to the regional trade agreement that share the health problem in question. It is understood that this will not prejudice the territorial nature of the patent rights in question.

“4. Members shall not challenge any measures taken in conformity with the provisions of this Article and the Annex to this Agreement under subparagraphs 1(b) and 1(c) of Article XXIII of GATT 1994.

“5. This Article and the Annex to this Agreement are without prejudice to the rights, obligations and flexibilities that Members have under the provisions of this Agreement other than paragraphs (f) and (h) of Article 31, including those reaffirmed by the Declaration on the TRIPS Agreement and Public Health (WT/MIN(01)/DEC/2), and to their interpretation. They are also without prejudice to the extent to which pharmaceutical products produced under a compulsory licence can be exported under the provisions of Article 31(f).”

The WTO Secretariat has a page on its website that discusses intellectual property and the public interest, https://www.wto.org/english/tratop_e/trips_e/trips_and_public_interest_e.htm, which reviews both flexibilities for Members in addressing public interest needs as well as current topics being discussed within the TRIPS Council. There also have been publications by the WTO Secretariat, WIPO and WHO on flexibilities in accessing medical technologies. See, e.g., WTO, WIPO and WHO, Promoting Access to Medical Technologies and Innovation, SECOND EDITION, https://www.wto.org/english/res_e/booksp_e/who-wipo-wto_2020_e.pdf. And on October 21, 2020 the WTO held a technical workshop on health, trade and intellectual property in addressing COVID-19. See 21 October 2020, WTO workshop on health, trade and intellectual property: an integrated approach to COVID-19; https://www.wto.org/english/news_e/news20_e/heal_21oct20_e.htm. There is a lengthy combined powerpoint presentation available from the webpage which was used in the workshop.

Thus, there can be no doubt that the WTO TRIPS Agreement provides significant flexibilities to Members to address health emergencies. The waiver proposal from India and South Africa doesn’t review any actual efforts to utilize the flexibilities but just opines that Members won’t be able to effectively utilize them. Such an approach should not be acceptable for such far reaching requests as the proposal from India and South Africa.

Ongoing efforts by governments, companies and organizations to make medical goods available to developing and least developed countries

Strangely missing from the waiver request submitted by India and South Africa is any mention of the global efforts underway to ensure access to medical goods and vaccines and therapeutics as approved.

There have been various fund raising efforts in 2020 to provide the necessary wherewithal to organizations focused on developing vaccines for global distribution or focused on the distribution of medical goods, vaccines and therapeutics globally.

CEPI and GAVI in coordination with the WHO have extensive efforts underway, including access to large manufacturing capacity for approved vaccines within the pool of vaccines being developed and included in the CEPI portfolio.

In addition, some private companies involved in manufacturing vaccines under development have licensing arrangements with certain producers for distribution to developing and least developing countries. Some companies have made access to the drawings of their medical equipment available to any company wishing to produce the equipment.

Thus, it is hard to understand a need for a broad waiver when there is considerable international cooperation and substantial vaccine capacity available for some of the vaccines in late stage testing. The WTO membership deserves to have a full compilation of developments and existing actions to facilitate access to medical supplies for developing and least developed countries. The India and South Africa waiver proposal provides none of the relevant information.

While it is not the purpose of this post to develop the full factual record, I provide below some links which supply some information on ongoing developments. See The Guardian, October 20, 2020, India at heart of global efforts to produce Covid vaccine, Country plays central role in development, manufacture, and possible distribution of potential vaccines, https://www.theguardian.com/world/2020/oct/20/india-at-heart-of-global-efforts-to-produce-covid-vaccine (“A deal has already been struck for the Serum Institute of India, based in the city of Pune, to produce 1bn doses of the the Oxford/AstraZeneca vaccine, seen as the forerunner in the vaccine race.” “Johnson and Johnson, whose Covid-19 vaccine is also in phase 3 clinical trials, has struck a deal with the Indian pharmaceutical company Biological E to produce up to 500m doses if successful.” “Bharat Biotech, a Hyderabad-based pharmaceutical company, has a deal to manufacture 1bn doses of Washington University’s intranasal vaccine, now in clinical trials, and Indian pharmaceutical giant Dr Reddy’s has a deal to do a phase 2/3 human trials in India of Russia’s controversial Sputnik vaccine and then produce 100m doses. There are also at least a dozen indigenous vaccines being developed within India. ” “Poonawalla of the Serum Institute said that ‘50% of whatever quantity we manufacture will be kept for India and the remaining will go to low- and middle-income countries.'”).

GAVI, the Vaccine Alliance, October 15, 2020, COVID-19 SITUATION REPORT #19, https://www.gavi.org/sites/default/files/covid/Gavi-COVID-19-Situation-Report-19-20201015.pdf (“COVAX is the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator, co-led by Gavi, the Coalition
for Epidemic Preparedness Innovations (CEPI) and WHO. Gavi is coordinating the development and implementation of the COVAX Facility, the global procurement mechanism of COVAX. The COVAX Facility will make investments across a broad portfolio of promising vaccine candidates (including those being supported by CEPI) to make sure at-risk investment in manufacturing happens now. Gavi is also coordinating the development and implementation of the Gavi COVAX Advance Market Commitment (AMC), the financing instrument that will support the participation of 92 low- and middle-income countries and economies in the COVAX Facility.
The goals of the COVAX Facility and AMC include:
“❖ to support the largest actively managed portfolio of vaccine candidates globally
“❖ to deliver 2 billion doses by the end of 2021
“❖ to offer a compelling return on investment by delivering COVID-19 vaccines as quickly as possible
“❖ to guarantee fair and equitable access to COVID-19 vaccines for all participants
“❖ to end the acute phase of the pandemic by the end of 2021”).

CEPI, October 21, 2020, CEPI expands global manufacturing network, reserving manufacturing capacity for more than 1billion doses of COVID-19 vaccines, https://www.gavi.org/vaccineswork/cepi-expands-global-manufacturing-network-reserving-manufacturing-capacity-over-1-billion-doses (“CEPI signs agreements with Biofabri (Spain) and GC Pharma (Republic of Korea) to reserve vaccine manufacturing capacity for more than 1 billion doses of COVID-19 vaccines designated by CEPI.
CEPI’s strategic investments in vaccine manufacturing at facilities around the world will support the COVAX goal to produce 2 billion doses of safe and effective vaccine by the end of 2021.”).

Conclusion

There is no doubt that the COVID-19 pandemic presents a global health crisis. In response to the crisis there have been activities within the WTO to minimize restrictions on the movement of medical goods and a workshop looking at the interface of trade, intellectual property and public health to help Members address internal needs. The TRIPS Agreement has various flexibilities to permit Members to address health challenges. At the same time there have been extraordinary efforts by many governments, companies and international organizations to cooperate both to develop vaccines and therapeutics but also to speed up manufacturing and work towards equitable distribution of medical goods. Leading pharmaceutical companies have already entered into licensing arrangements to provide billions of doses of vaccines when approved to developing and least developing countries. GAVI and CEPI in coordination with the WHO are working on supporting various vaccine development, securing manufacturing capacity and raising funds to permit broad distribution of vaccines and other products to countries in need and others who have contributed to the group effort.

So factually, it is hard to understand the waiver request filed by India and South Africa. Against a backdrop of how waivers have been used in the past and the lack of a demonstration that existing flexibilities won’t provide acceptable answers, the waiver proposal also is deficient in terms of legal justification. The proposal is not justified, is too broad both in terms of product coverage, Members who would be given waivers, and the range of
TRIPS provisions that would be waived for some number of years.

These are serious problems with a proposal that requires TRIPS Council action and referral to the General Council by the end of the year. Thus, the TRIPS Council should recommend against acceptance of the waiver proposal put forward by India and South Africa.