<html><head><meta http-equiv="Content-Type" content="text/html; charset=utf-8"></head><body style="word-wrap: break-word; -webkit-nbsp-mode: space; line-break: after-white-space;" class=""><div class=""><div style="margin: 0in; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class=""><a href="https://www.fesny.org/article/the-folly-of-vaccine-monopolies/" style="color: rgb(5, 99, 193);" class="">https://www.fesny.org/article/the-folly-of-vaccine-monopolies/</a></span></div></div><div class=""><br class=""></div><div style="margin: 0in; font-size: 11pt; font-family: Calibri, sans-serif; background-color: white;" class=""><b class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class="">The Folly of Vaccine Monopolies<o:p class=""></o:p></span></b></div><div style="margin: 0in; font-size: 11pt; font-family: Calibri, sans-serif; background-color: white;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(136, 136, 136);" class=""> </span></div><div style="margin: 0in; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">By Lori Wallach<o:p class=""></o:p></span></div><div style="margin: 0in; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-family: "Times New Roman", serif; font-size: 12pt;" class="">4/28/21</span></div><div style="margin: 0in; font-size: 11pt; font-family: Calibri, sans-serif;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class=""> </span></div><p class="bodytext" style="margin-right: 0in; margin-left: 0in; font-size: 11pt; font-family: Calibri, sans-serif; background-color: white;"><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class="">As we see infection rates in India and other parts of the world skyrocketing, European Union (EU) and U.S. government officials regularly declare that the COVID-19 public health disaster and resulting economic crises will not end anywhere unless people everywhere are vaccinated. Yet the two World Trade Organization (WTO) heavyweights are blocking an initiative now supported by 100 nations that could boost access to COVID-19 vaccines, treatments and diagnostic tests worldwide. On May 5, the issue will again come to a head at the WTO. The U.S. and EU must join the rest of the world.<o:p class=""></o:p></span></p><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class="">At issue is a <a href="https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W669.pdf&Open=True" title="Internal Link" style="color: rgb(5, 99, 193);" class=""><span style="color: rgb(0, 59, 177);" class="">temporary waiver</span></a> of WTO Agreement on Trade Related Aspects of Intellectual Property (TRIPS) rules on industrial designs, undisclosed data, copyrights and patents to the extent that they undermine the “prevention, containment or treatment of Covid-19.” The TRIPS agreement requires WTO member nations to guarantee pharmaceutical corporations expansive monopoly controls. <o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class="">In the fall of 2020, the Trump administration recruited a handful of WTO members, including the EU, to join it in blocking even the start of negotiations about a waiver. The Biden administration <a href="https://mkus3lurbh3lbztg254fzode-wpengine.netdna-ssl.com/wp-content/uploads/TRIPS-Factsheet-Activist-Version-042021.pdf" title="Internal Link" style="color: rgb(5, 99, 193);" class=""><span style="color: rgb(0, 59, 177);" class="">has not yet reversed</span></a> Trump’s position.<o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class="">The pharmaceutical corporations that hold patents, copyrights and industrial design and trade secrets exclusivities control if, how much and where vaccines, tests and treatments are made and where they can be made available and at what price. Especially after governments invested our tax dollars far more than pharmaceutical corporations used their funds to develop the COVID-19 vaccines, and by one estimate gave the firms more than <a href="https://www.businesswire.com/news/home/20210110005098/en/Governments-Spent-at-Least-%E2%82%AC93bn-on-COVID-19-Vaccines-and-Therapeutics-During-the-Last-11-Months" title="Internal Link" style="color: rgb(5, 99, 193);" class=""><span style="color: rgb(0, 59, 177);" class="">$112 billion</span></a>, temporarily waiving the firms’ control seems fair.<o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class="">It also is proving to be necessary. The TRIPS-required monopoly rights have become a <a href="https://www.citizen.org/article/waiver-of-the-wtos-intellectual-property-rules-existing-trips-flexibilities-unworkable-for-scale-up-of-covid-19-medicines-production/" title="Internal Link" style="color: rgb(5, 99, 193);" class=""><span style="color: rgb(0, 59, 177);" class="">key obstacle</span></a> now thwarting worldwide access to the formulas and technology to make more vaccines and treatments. Under current projections, few people in developing countries will have access to vaccines in 2021. Poor nations will only reach herd immunity vaccination levels in <a href="https://www.eiu.com/n/85-poor-countries-will-not-have-access-to-coronavirus-vaccines/" title="Internal Link" style="color: rgb(5, 99, 193);" class=""><span style="color: rgb(0, 59, 177);" class="">2024, if ever</span></a>.<o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class="">That means the pandemic will continue to burn through a large share of the world’s population, resulting in hundreds of thousands of avoidable deaths and growing risk that a vaccine-resistant variant could slam the world back into broad shutdowns.<o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class="">To make vaccines more available in developing nations, the World Health Organization (WHO), the Global Vaccines Alliance (Gavi), and the Coalition for Epidemic Preparedness Innovations (CEPI) jointly launched the COVAX initiative. But so far COVAX has had limited success in obtaining and distributing vaccines, even as the Biden administration contributed $2 billion dollars and promised $2 billion more to match other donors. COVAX has delivered 40.2 million or <a href="https://www.theguardian.com/world/2021/apr/22/revealed-big-shortfall-in-covax-covid-vaccine-sharing-scheme" title="Internal Link" style="color: rgb(5, 99, 193);" class=""><span style="color: rgb(0, 59, 177);" class="">21% of the 187 million doses</span></a> it planned to have out by May 2021 with some large developing nations, including Pakistan and Mexico, not yet received any COVAX doses.<o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class="">Moreover, COVAX has as its goal only providing vaccines for the 20% of countries’ populations at highest risk, such as healthcare workers and people over 65. Even if it meets its full ambition of delivering 1.3 billion doses in 2021, this would not provide vaccines for the vast majority of people and not enough to establish herd immunity.<o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class="">Therefore, while programs like COVAX are important, unless production is quickly ramped up around the world to meet global demand, there simply will not be enough supply for COVAX, let alone for conferring global herd immunity. Global production in 2021 pumped out <a href="https://www.airfinity.com/insights/analysis-1" title="Internal Link" style="color: rgb(5, 99, 193);" class=""><span style="color: rgb(0, 59, 177);" class="">one billion doses as of April 13</span></a>, weeks into the second quarter.<o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class="">Yet 10-15 billion annual doses are necessary for global herd immunity. And now we are learning that <a href="https://www.cnbc.com/2021/04/15/pfizer-ceo-says-third-covid-vaccine-dose-likely-needed-within-12-months.html?__source=sharebar|twitter&par=sharebar" title="Internal Link" style="color: rgb(5, 99, 193);" class=""><span style="color: rgb(0, 59, 177);" class="">vaccines will require regular boosters</span></a>, meaning the world may well need 10-15 billion does production capacity year on year.<o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class=""> <o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><strong class=""><span style="font-size: 12pt; color: rgb(34, 34, 34);" class="">Blocking Needed Supply by Excluding Manufacturers from the South</span></strong><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class=""><o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class="">At issue is not manufacturing capacity or skills, but rather control: Big Pharma has a monopoly over vaccine knowledge and technology platforms that will determine life and death for millions of people in rich and poor countries alike and decide the fate of the global economy. These corporations stand to make a lot of money. They are focused not on global access, but on profitable markets.<o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class="">Pfizer and Moderna recently revealed COVID-19 vaccine expected revenue of <a href="https://www.cnbc.com/2021/02/02/covid-vaccine-pfizer-expects-about-15-billion-in-2021-sales-from-shots.html" title="Internal Link" style="color: rgb(5, 99, 193);" class=""><span style="color: rgb(0, 59, 177);" class="">$15 billion</span></a> and <a href="https://www.reuters.com/article/us-health-coronavirus-moderna-idUSKBN2AP1JG" title="Internal Link" style="color: rgb(5, 99, 193);" class=""><span style="color: rgb(0, 59, 177);" class="">$18.4 billion</span></a> respectively in 2021 alone. In mid-March 2021, <a href="https://www.businessinsider.com/pfizer-execs-highlight-significant-opportunity-hike-covid-vaccine-price-2021-3" title="Internal Link" style="color: rgb(5, 99, 193);" class=""><span style="color: rgb(0, 59, 177);" class="">Pfizer’s senior VP of investor relations</span></a> described how the firm planned to raise prices and profit richly in 2022 by selling vaccines annually to rich countries that can pay.<o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class="">There is no alternative to increasing vaccine production capacity to meet COVID-19 needs. Some of this capacity must be in the Global South, including to ensure speedy response to regional vaccine-resistant, more lethal or infectious variants before they become global.<o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class="">A major cause of the shortage is vaccine originators refusal to work with qualified manufacturers in Africa, Latin America, and Asia so more vaccines can be made around the world. The vaccine monopoly holders have fueled the wave of support for the waiver by more than 100 countries by effectively blocking production for markets they have no interest in supplying.<o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class="">That has been hard to decipher because pharmaceutical interests in Washington, Brussels, and Geneva are pushing a “big lie” strategy. Their claim is that a lack of manufacturing capacity, not pharmaceutical corporations’ monopoly intellectual property (IP) protections, are thwarting greater production of COVID-19 vaccines and treatments.<o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class="">A related argument, with decidedly racist overtones, is that COVID-19 vaccines are too complicated for producers in developing countries. The reality is that in every region of the world, there are multiple producers that could be greatly increasing global vaccine supplies if the technology and know-how were shared.<o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class="">Just in Africa, “Biovac and Aspen in South Africa, Institute Pasteur in Senegal, and Vacsera in Egypt could rapidly retool factories to make mRNA vaccines,” notes a group of medicine-production experts in a <a href="https://foreignpolicy.com/2021/03/01/to-democratize-vaccine-access-democratize-production/" title="Internal Link" style="color: rgb(5, 99, 193);" class=""><span style="color: rgb(0, 59, 177);" class="">recent Foreign Policy article</span></a>. The Serum Institute in India already is producing the Johnson & Johnson vaccine, but on its own cannot <a href="https://fortune.com/2021/04/20/india-covid-cases-vaccine-vaccinations-serum-institute/#:~:text=In%20February%2C%20CEO%20Adar%20Poonawalla,it%20had%20banned%20vaccine%20exports." title="Internal Link" style="color: rgb(5, 99, 193);" class=""><span style="color: rgb(0, 59, 177);" class="">make enough</span></a> to stop India’s expanding outbreak. Meanwhile, <a href="https://apnews.com/article/drug-companies-called-share-vaccine-info-22d92afbc3ea9ed519be007f8887bcf6" title="Internal Link" style="color: rgb(5, 99, 193);" class=""><span style="color: rgb(0, 59, 177);" class="">Moderna declined to partner</span></a> with a qualified Bangladeshi vaccine maker Incepta, claiming its engineers were too busy to focus beyond U.S. and EU production and Pfizer never responded to Incepta’s inquiries. Major Pakistani vaccine maker Getz <a href="https://www.washingtonpost.com/business/2021/03/20/covid-vaccine-global-shortages/" title="Internal Link" style="color: rgb(5, 99, 193);" class=""><span style="color: rgb(0, 59, 177);" class="">never received responses</span></a> to its requests. In Latin America, existing facilities in countries like Chile and Colombia have expressed interest in kickstarting vaccine production, but like qualified manufacturers in other countries have gotten no response from the vaccine originators.<o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class="">Existing and planned contract manufacturing arrangements prove facilities in developing countries certainly can produce COVID-19 vaccines. For instance, for many months, one of the few contract manufacturing partners of the vaccine originators, South African firm Aspen, <a href="https://www.citizen.org/article/webinar-us-must-lift-wto-block-on-covid-19-vaccine-technology/" title="Internal Link" style="color: rgb(5, 99, 193);" class=""><span style="color: rgb(0, 59, 177);" class="">was ordered</span></a> by Johnson & Johnson to export 91% of the vaccines it made to Europe for sale. Only 9% could be used in South Africa.<o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class=""> <o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><strong class=""><span style="font-size: 12pt; color: rgb(34, 34, 34);" class="">Gains from a TRIPS Waiver</span></strong><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class=""><o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class="">More production capacity must be created in the Global South and in developed nations. A TRIPS waiver’s quickest gains would be more production of and access to treatments and diagnostic tests. A TRIPS waiver now also will facilitate greater supplies of vaccines in several ways.<o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class="">First, it would immediately increase government leverage on originators that have refused to share vaccine technology on a more open basis. That is because it would end vaccine originators’ ability to block production.<o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class="">Rather, firms would have two choices, both of which expand access. They could choose to expand production via prompt negotiations with governments, alternative suppliers, and global initiatives like the COVID-19 Technology Pool (C-TAP), which was launched in May 2020 by the WHO in partnership with the Government of Costa Rica and 40 Member State co-sponsors.<o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class="">Or they could risk governments simply going around them and forcing technology transfers. In many nations, the regulatory authorities that approved domestic use and/or patent offices have significant information on manufacturing process and have test data that they could share with skilled teams from government agencies, local universities and pharmaceutical producers — if freed from WTO obligations to protect monopoly control of it.<o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class="">As well, waiving IP barriers would provide the legal certainty for governments and investors in developing nations to start repurposing existing pharmaceutical manufacturing and building new facilities. Already, developing country producers in every region have unused capacity to make vaccines. And new production, especially of mRNA vaccines, could be brought online relatively quickly. Because the mRNA platform does not use live cell lines, it does not require construction of new bioreactors. Lines can be set up in any “clean manufacturing” venue. A former Moderna chemistry chief said with technology transfer and know-how-sharing, any modern factory should be able to get <a href="https://apnews.com/article/drug-companies-called-share-vaccine-info-22d92afbc3ea9ed519be007f8887bcf6" title="Internal Link" style="color: rgb(5, 99, 193);" class=""><span style="color: rgb(0, 59, 177);" class="">mRNA vaccine production online in three to four months</span></a>.<o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class=""> <o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><strong class=""><span style="font-size: 12pt; color: rgb(34, 34, 34);" class="">TRIPS WAIVER 2.0</span></strong><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class=""><o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class="">Today, a new WTO TRIPS waiver is needed because the existing flexibilities were not designed for – nor do they function effectively in – a global pandemic where vaccines and other critical technologies are protected by multiple forms of IP and where production relies on complex global supply chains.<o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class="">To make antiretroviral drugs more available, in 2001 a WTO HIV/AIDS TRIPS declaration focused on compulsory licensing to deal with patent barriers. Pharmaceutical corporations hatched new strategies to protect their monopolies and now build intellectual property “thickets” of numerous patents, copyrights, industrial designs, undisclosed data, and trade secrets protections. Each would require a license.<o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class="">For instance, mRNA vaccines include 100-plus key components manufactured in over a dozen countries that may be subject to patents, in addition to copyright protections on software, algorithms, and training material used to make the drugs and on storage and use guidelines as well as undisclosed data protections covering some trade secrets, plus perhaps industrial design protections for key machinery used to mix lipids and genetic materials for mRNA vaccines. It would be nearly impossible to coordinate country-by-country, product-by-product compulsory licensing that would allow prospective producers to import the needed components, machinery and more. In contrast, a TRIPS waiver would simply clear the thorny IP thickets and related investment-chilling liabilities.<o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class="">The existing WTO flexibilities may not encompass all of the elements of IP critical to COVID-19 vaccines. Plus, countries attempting to invoke the existing TRIPS flexibilities in the past have been subject to criticisms and trade pressures from the United States and the European Union in efforts to discourage them from doing so. This makes the recent EU mantra in the WTO corridors particularly cynical. EU officials argue that the COVID-19 TRIPS waiver is not needed because countries can use compulsory licensing. Even if the U.S. and EU agreed to stop attacking countries seeking to use this tool, the reality is that the process even for patents is cumbersome and slow under any circumstance and for vaccines with complex international supply chain nearly impossible to coordinate.<o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class="">In the race against time to ensure a critical mass worldwide is vaccinated to quash outbreaks that could spawn vaccine-resistant, more deadly or infectious variants, the answer must be “Yes, And!” The TRIPS waiver is a critical step to getting more manufacturing geared up around the world.<o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class="">Efforts to expand supply through voluntary efforts have not panned out to date. C-TAP, mentioned above, was established last May, but <a href="https://www.theguardian.com/world/2021/jan/22/who-platform-for-pharmaceutical-firms-unused-since-pandemic-began" title="Internal Link" style="color: rgb(5, 99, 193);" class=""><span style="color: rgb(0, 59, 177);" class="">not a single pharmaceutical firm has donated rights</span></a> for a single COVID-19 medical technology. The waiver would remove legal and political obstacles for rich countries’ governments to compel corporations to commit technological resources and know-how to C-TAP. Adding a capacitated technology transfer<o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class="">hub and providing supports for tech transfer and absorption would expedite needed vaccines even more. The waiver is not a substitute for C-TAP. They are complementary global initiatives, both key to bolster vaccine and medicine manufacturing worldwide.<o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class=""> <o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><strong class=""><span style="font-size: 12pt; color: rgb(34, 34, 34);" class="">Public Investment for Private Profits or Public Health?</span></strong><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class=""><o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class="">In response to growing demand around the world for the TRIPS waiver, pharmaceutical interests have made the usual arguments. First, that monopoly rights and high prices are necessary to support innovation. And second, that if there is TRIPS waiver, somehow this will undermine their ability to help provide medicines for the next global health emergency.<o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class="">However, every leading COVID-19 vaccine, on the market or in final clinical trials, has benefited from <a href="https://www.businesswire.com/news/home/20210110005098/en/Governments-Spent-at-Least-%E2%82%AC93bn-on-COVID-19-Vaccines-and-Therapeutics-During-the-Last-11-Months" title="Internal Link" style="color: rgb(5, 99, 193);" class=""><span style="color: rgb(0, 59, 177);" class="">substantial public investment</span></a>. The miracle of speedy COVID-19 vaccines resulted from taxpayers providing pharmaceutical firms billions to develop and test COVID-19 vaccines and then <a href="https://www.hhs.gov/about/news/2020/07/22/us-government-engages-pfizer-produce-millions-doses-covid-19-vaccine.html" title="Internal Link" style="color: rgb(5, 99, 193);" class=""><span style="color: rgb(0, 59, 177);" class="">billions more in pre-orders</span></a>, not from pharmaceutical firms investing monopoly-gained profits. And, before that, the U.S. <a href="https://www.citizen.org/article/the-nih-vaccine/?eType=EmailBlastContent&eId=4b69c711-13b4-452f-81c9-22b1cff5412d&eType=EmailBlastContent&eId=a363f8a5-20b1-4609-bca0-72579f573204" title="Internal Link" style="color: rgb(5, 99, 193);" class=""><span style="color: rgb(0, 59, 177);" class="">National Institutes of Health</span></a> (NIH), military and other agencies invested in coronavirus research for decades.<o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class="">Indeed, the COVID-19 vaccine situation proves the opposite point that Big Pharma interests claim. This is the third time in the last 20 years that a coronavirus has made the leap from animals to humans: Severe acute respiratory syndrome (SARS) coronavirus in 2002, Middle East Respiratory Syndrome (MERS) coronavirus in 2012, and SARS-CoV-2 in 2019. Yet the patent protections of the pharmaceutical industry have yielded little investment in our pandemic preparedness.<o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class="">Why? “Because there is <a href="https://www.theguardian.com/commentisfree/2020/oct/15/peoples-vaccine-coronavirus-covid-wto" title="Internal Link" style="color: rgb(5, 99, 193);" class=""><span style="color: rgb(0, 59, 177);" class="">no real incentive to do this</span></a>, no financial incentive,” Johnson & Johnson’s chief scientific officer <a href="https://www.nytimes.com/2020/01/28/health/coronavirus-vaccine.html" title="Internal Link" style="color: rgb(5, 99, 193);" class=""><span style="color: rgb(0, 59, 177);" class="">admitted</span></a> back in January.” Firms that did not use past profits from their monopolies to prepare for the next outbreak obtained billions in public dollars to develop vaccines for this crisis. Yet under the current IP paradigm, they are given absolute control over the production and distribution of these drugs that will literally determine who lives and dies and the fate of the global economy.<o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class="">And no, a TRIPS waiver will not shipwreck Big Pharma. The market for COVID-19 vaccines is the entire world. Whether or not there is technology transfer, firms that originate a COVID-19 vaccine will make a lot of money. To start with, waiving WTO rules does not prevent governments from paying royalties or providing other compensation for research and development costs, data rights, and trade secret resources under national laws.<o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class="">In the United States, <a href="https://www.citizen.org/news/hundreds-of-prominent-us-civil-society-organizations-call-on-pres-biden-to-stop-blocking-covid-19-wto-waiver-to-boost-vaccines-treatments-worldwide/" title="Internal Link" style="color: rgb(5, 99, 193);" class=""><span style="color: rgb(0, 59, 177);" class="">hundreds of organizations</span></a> that represent the Democratic Party’s base and many <a href="https://www.sanders.senate.gov/wp-content/uploads/SenateTRIPSletter4.15.21.pdf" title="Internal Link" style="color: rgb(5, 99, 193);" class=""><span style="color: rgb(0, 59, 177);" class="">Democratic senators</span></a> and <a href="https://www.cnbc.com/2021/03/26/covid-vaccine-updates-white-house-mulls-lifting-intellectual-property-shield.html" title="Internal Link" style="color: rgb(5, 99, 193);" class=""><span style="color: rgb(0, 59, 177);" class="">House members</span></a> have called for the Biden administration to reverse Trump’s blockage of the emergency WTO COVID-19 TRIPS waiver. They are calling on the new administration to engage immediately with the rest of the world to finalize a waiver text. According to a recent poll, <a href="https://progressive.international/wire/2021-04-15-large-majority-of-us-voters-support-patent-waiver-on-covid-19-vaccines/en" title="Internal Link" style="color: rgb(5, 99, 193);" class=""><span style="color: rgb(0, 59, 177);" class="">60% of U.S. voters</span></a> support the waiver, as do <a href="https://www.ft.com/content/43fd53f5-2b82-4e41-981c-8544a6ce996b" title="Internal Link" style="color: rgb(5, 99, 193);" class=""><span style="color: rgb(0, 59, 177);" class="">170+ former heads of state and Nobel laureates</span></a> from <a href="https://peoplesvaccinealliance.medium.com/open-letter-former-heads-of-state-and-nobel-laureates-call-on-president-biden-to-waive-e0589edd5704" title="Internal Link" style="color: rgb(5, 99, 193);" class=""><span style="color: rgb(0, 59, 177);" class="">across the political spectrum</span></a>.<o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class="">With so many of the world’s nations supporting this emergency waiver, the Biden administration can also help restore America’s place in the world by siding with the majority prioritizing saving lives over pharma corporation profits. Similarly in Europe, <a href="https://www.dw.com/en/coronavirus-digest-amnesty-urges-eu-to-lift-vaccine-patents/a-57345640" title="Internal Link" style="color: rgb(5, 99, 193);" class=""><span style="color: rgb(0, 59, 177);" class="">Amnesty International called on the EU</span></a> to back the proposal to temporarily lift patent protections for COVID-19 vaccines.<o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class="">Supporting a waiver is the right thing to do in and of itself. But doing so would not just be altruistic. Ending the COVID-19 pandemic as quickly as possible is also necessary to protect the health of U.S. and European residents and <a href="https://www.citizen.org/article/waiver-of-wto-protections-for-big-pharma-will-help-u-s-economic-recovery-and-boost-u-s-employment/" title="Internal Link" style="color: rgb(5, 99, 193);" class=""><span style="color: rgb(0, 59, 177);" class="">reboot the global economy</span></a> on which so much of the U.S. and EU economies rely.<o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class=""> <o:p class=""></o:p></span></div><div style="margin: 0.625rem; font-size: 0.9375rem; font-family: Calibri, sans-serif; background-color: white; box-sizing: border-box; text-rendering: optimizeLegibility;" class=""><strong class=""><span style="font-size: 12pt; color: rgb(34, 34, 34);" class="">About the author:</span></strong><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class=""> <a href="https://www.citizen.org/about/person/lori-wallach/" title="Internal Link" style="color: rgb(5, 99, 193);" class=""><span style="color: rgb(0, 59, 177);" class="">Lori Wallach</span></a> is the director of Public Citizen’s Global Trade Watch. A 30-year veteran of congressional trade battles starting with the 1990s fight over NAFTA, she was named to the “Politico’s 50” list of thinkers, doers and visionaries transforming American politics for her leadership in the Trans-Pacific Partnership debate. She is an internationally recognized expert on trade with experience advocating in Congress and foreign parliaments, trade negotiations, courts, government agencies, the media and in the streets.<o:p class=""></o:p></span></div><div class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(34, 34, 34);" class=""><br class=""></span></div><div class="">
Arthur Stamoulis<br class="">Citizens Trade Campaign<br class="">(202) 494-8826<br class=""><br class=""><br class=""><br class="">
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