<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=""><br class=""></div><div class=""><i class="">Responses to the EU’s latest attempt to derail the TRIPS waiver via Global Trade Watch and Health GAP….</i></div><div class=""><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; text-align: center; vertical-align: baseline;" class=""><span style="font-size: 14pt; font-family: "Times New Roman", serif;" class=""><br class=""></span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; text-align: center; vertical-align: baseline;" class=""><span style="font-size: 14pt; font-family: "Times New Roman", serif;" class=""> </span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; text-align: center; vertical-align: baseline;" class=""><span style="font-size: 14pt; font-family: "Times New Roman", serif;" class="">REPORTERS MEMO</span><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class=""><o:p class=""></o:p></span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class=""> </span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">FOR IMMEDIATE RELEASE: June 7, 2021 </span><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class=""><o:p class=""></o:p></span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">CONTACT: Matt Groch </span><a href="mailto:mgroch@citizen.org" target="_blank" style="color: rgb(5, 99, 193);" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">mgroch@citizen.org</span></a><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class=""> (202) 454-5111 </span><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class=""><o:p class=""></o:p></span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class=""> <o:p class=""></o:p></span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; text-align: center; vertical-align: baseline;" class=""><b class=""><span style="font-size: 15pt; font-family: "Times New Roman", serif;" class="">Increasingly Isolated, EU Struggles to Derail Global Momentum for Emergency COVID Waiver of WTO Intellectual Property Barriers, Submitting Papers in Defense of Big Pharma and Status Quo Rather Than Offering a New Proposal</span></b><span style="font-size: 15pt; font-family: "Times New Roman", serif;" class=""> <o:p class=""></o:p></span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class=""> <o:p class=""></o:p></span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; text-align: center; vertical-align: baseline;" class=""><b class=""><i class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class=""> On Eve of June 8-9 TRIPS Council Meeting,</span></i></b><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class=""> <b class=""><i class="">EU Seeks to Block U.S., Japan, China, and 100+ Nations’ Negotiations on Waiver Needed to Deliver Necessary Manufacturing Scale Up of COVID-19 Vaccines, Treatments and Diagnostic Tests</i></b> <o:p class=""></o:p></span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class=""> </span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">WASHINGTON, D.C. – Instead of unveiling alternative plans at the World Trade Organization (WTO) to boost production and availability of urgently-needed COVID-19 vaccine, treatments and tests production, the European Union revealed its intentions to block negotiations the rest of the world support to temporarily waive intellectual property (IP) barriers to end the pandemic and save lives.<o:p class=""></o:p></span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class=""> </span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">The EU’s latest move is the height of hypocrisy: </span><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">EU officials<i class=""> say</i> Covid vaccines should be a universal </span><a href="https://ec.europa.eu/commission/presscorner/detail/en/ac_20_749" style="color: rgb(5, 99, 193);" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: blue;" class="">common good</span></a><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class=""> and </span><a href="https://ec.europa.eu/commission/presscorner/detail/en/SPEECH_21_2284" style="color: rgb(5, 99, 193);" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: blue;" class="">no one is safe unless everyone is</span></a><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">, yet <i class=""><a href="http://infojustice.org/archives/43180" style="color: rgb(5, 99, 193);" class="">act</a></i> to prioritize Big Pharma demands and block the rest of the world from enacting a critical first step, the WTO IP waiver, to boost production and access.<o:p class=""></o:p></span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class=""> </span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">The increasingly isolated EU not only is blocking a waiver that the vast majority of the world’s countries deem necessary to save their people and end the pandemic. It is trying to <a href="http://infojustice.org/archives/43180" style="color: rgb(5, 99, 193);" class="">distract and delay</a> the rest of the world from moving forward. </span><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">On Friday, the EU submitted two papers at the WTO that recycle debunked, stale Big Pharma defenses of WTO rules and claim that anything but expansive IP monopolies are causing the dire global shortage of COVID vaccines, treatments and tests. The EU “plan” is to urge current vaccine makers to produce more, an approach that already has failed spectacularly and now imperils the world.<o:p class=""></o:p></span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class=""> </span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">As major economies with large pharmaceutical industries such as the United States, Japan and China and other developed nations like New Zealand have joined 100-plus developing nations supporting waiver talks, the increasingly isolated EU is expected to block waiver negotiations during the </span><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">June 8-9 meeting of the WTO’s</span><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) Council.<o:p class=""></o:p></span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class=""><o:p class=""></o:p></span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">While the vast majority of WTO members agree a temporarily waiver is necessary to remove intractable webs of patent, copyright, trade secret, industrial design and other IP barriers pharmaceutical firms have constructed to maintain monopoly control of COVID-19 vaccines and related medicines, the </span><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">EU doubled down in opposition in May 2021 after German Chancellor Angela Merkel echoed attacks from the pharmaceutical industry when the Biden-Harris administration announced U.S. support for a waiver. </span><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class=""><o:p class=""></o:p></span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class=""> </span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">The EU’s latest WTO submissions closely hew to the Big Pharma <a href="https://healthgap.org/debunking-pharmas-talking-points-on-the-trips-waiver/" style="color: rgb(5, 99, 193);" class="">talking points</a> leaked last month. They include the colonialist insinuations that developing countries<a href="https://twitter.com/PaulineMuchina/status/1400494937016311812" style="color: rgb(5, 99, 193);" class="">do not understand</a> what is in their own interest and <a href="https://twitter.com/JNkengasong/status/1397271885050699787" style="color: rgb(5, 99, 193);" class="">cannot act for themselves</a>. They assume that the press and public do not understand that the supply chain “bottlenecks” that the EU claims are the issue are in no small part <i class=""><a href="https://www.nature.com/articles/s41587-021-00912-9#Fig1" style="color: rgb(5, 99, 193);" class="">caused <span style="font-style: normal;" class="">by IP barriers</span></a></i> that limit production of COVID-19 vaccine inputs as well as finished vaccines not by “trade barriers,” as the EU claims. As Human Rights Watch recently <a href="https://www.hrw.org/news/2021/06/03/seven-reasons-eu-wrong-oppose-trips-waiver" style="color: rgb(5, 99, 193);" class="">documented</a>: “The TRIPS waiver <a href="https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W670.pdf&Open=True" style="color: rgb(5, 99, 193);" class=""><span style="color: blue;" class="">proposal sponsors</span></a> and experts at the leading science journal <a href="https://www.nature.com/articles/d41586-021-01242-1" style="color: rgb(5, 99, 193);" class=""><span style="color: blue;" class="">Nature</span></a>, <a href="https://msfaccess.org/sites/default/files/2020-12/MSF-AC_COVID_IP_TRIPSWaiverMythsRealities_Dec2020.pdf" style="color: rgb(5, 99, 193);" class=""><span style="color: blue;" class="">Médecins Sans Frontières (MSF) Access Campaign</span></a>, the <a href="https://www.twn.my/title2/intellectual_property/info.service/2021/ip210109.htm" style="color: rgb(5, 99, 193);" class=""><span style="color: blue;" class="">Third World Network</span></a>, and others have presented many other concrete examples of how enforcement of IP rules blocked, delayed, or limited production of <a href="https://www.statnews.com/pharmalot/2020/03/27/roche-covid19-coronavirus-netherlands/" style="color: rgb(5, 99, 193);" class=""><span style="color: blue;" class="">chemical reagents</span></a> for Covid-19 <a href="https://www.spotlightnsp.co.za/2020/05/05/covid-19-behind-sas-shortages-of-test-materials/" style="color: rgb(5, 99, 193);" class=""><span style="color: blue;" class="">tests</span></a>, <a href="https://www.techtimes.com/articles/248121/20200317/maker-ventilator-valves-threatens-sue-volunteers-using-3d-printed-coronavirus.htm" style="color: rgb(5, 99, 193);" class=""><span style="color: blue;" class="">ventilator valves</span></a>, Covid-19 <a href="https://www.citizen.org/news/remdesivir-should-be-in-the-public-domain-gileads-licensing-deal-picks-winners-and-losers/" style="color: rgb(5, 99, 193);" class=""><span style="color: blue;" class="">treatments</span></a>, and elements of <a href="https://www.fiercepharma.com/pharma/pfizer-biontech-regeneron-sued-for-infringement-allele-s-patent-their-covid-19-products" style="color: rgb(5, 99, 193);" class=""><span style="color: blue;" class="">Covid-19 vaccines</span></a>. IP constraints have not only led to vaccine shortages but have also led to shortages of key raw materials like <a href="https://mattstoller.substack.com/p/why-are-there-shortages-of-plastic" style="color: rgb(5, 99, 193);" class=""><span style="color: blue;" class="">bioreactor bags</span></a> and filters.”</span><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class=""><o:p class=""></o:p></span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class=""> </span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">They pretend that manufacturing shortfalls are not caused by IP barriers even as a few firms holding vaccine monopolies have <a href="https://mkus3lurbh3lbztg254fzode-wpengine.netdna-ssl.com/wp-content/uploads/TRIPS-waiver_Facts-vs-Common-Myths042621.pdf" style="color: rgb(5, 99, 193);" class="">refused to license technology to world class drug producers</a> worldwide.</span><span style="font-size: 14pt; font-family: "Times New Roman", serif;" class=""><o:p class=""></o:p></span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; text-align: center; vertical-align: baseline;" class=""><span style="font-size: 14pt; font-family: "Times New Roman", serif;" class=""> </span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">Despite the <a href="https://mkus3lurbh3lbztg254fzode-wpengine.netdna-ssl.com/wp-content/uploads/TRIPS-waiver_Existing-TRIPS-Flexibilities-Unworkable-for-Scale-Up-of-Covid-19-Medicines-Production-.pdf" style="color: rgb(5, 99, 193);" class="">overwhelming evidence to</a> the contrary, the EU paper reviews</span><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class=""> </span><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/" style="color: rgb(5, 99, 193);" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">existing WTO TRIPS “flexibilities</span></a><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">” and argues these are sufficient.<o:p class=""></o:p></span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class=""> </span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline;" class=""><img align="left" hspace="12" alt="figure1" v:shapes="Picture_x0020_1" apple-inline="yes" id="42F304DF-216D-4BAE-8677-2A4415789426" src="cid:image004.jpg@01D75ACE.302171E0" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">It’s an absurd claim on its face. Countries worldwide support a waiver because, contrary to the claims of Big Pharma and the EU, the </span><span lang="EN" style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">existing WTO “flexibilities” for HIV/AIDS treatments that were reaffirmed in the 2001 Doha Declaration after hard campaigning are obviously <u class="">insufficient</u> in the </span><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">COVID</span><span lang="EN" style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">-19 context. </span><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class=""> First, because COVID vaccines have complex global supply chains </span><span lang="EN" style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">that rely on numerous inputs subject to patents, and other forms of IP monopoly that are cross-licensed and produced in multiple countries</span><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">, the existing flexibilities that are focused on compulsory patent licensing are widely recognized to be unworkable for quickly boosting COVID-19 vaccine production.<o:p class=""></o:p></span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class=""> </span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline;" class=""><a href="https://www.nature.com/articles/s41587-021-00912-9#Fig1" style="color: rgb(5, 99, 193);" class=""><img border="0" align="left" hspace="12" vspace="5" alt="Nature" v:shapes="_x0000_s1027" apple-inline="yes" id="1AF2BFE7-0DF4-47DD-BFBA-BF1F38DC485C" src="cid:image006.png@01D75ACE.302171E0" class=""></a><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">Even leaving aside other IP restrictions, pharmaceutical firms have made sure that webs of patent claims underpin and restrict the marketing of many vaccines, as exposed in a </span><a href="https://www.nature.com/articles/s41587-021-00912-9#Fig1" target="_blank" style="color: rgb(5, 99, 193);" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: windowtext;" class="">recent Nature article</span></a><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class=""> that exposes the complex patent and licensing deals for mRNA vaccines and their underlying technologies. This intricated web of patents, licenses and sublicenses eviscerates the UE papers’ claims that somehow existing compulsory licensing flexibilities suffice to ramp up production. <o:p class=""></o:p></span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline;" class=""><span lang="EN" style="font-size: 12pt; font-family: "Times New Roman", serif;" class=""> </span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">Second, </span><span lang="EN" style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">technology has developed rapidly since 2001 and pharmaceutical firms have created IP “thickets,” adding layers of additional copyright, industrial design and other exclusivities that extend beyond the patent barriers that were the focus of the 2001 flexibilities. </span><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class=""> Copyright protections on software, algorithms and training materials 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 are among the innumerable IP barriers thwarting production by non-originator firms. None of these IP barriers are addressed by the EU plan communication to supposedly boost production and availability of COVID-19 vaccines. <o:p class=""></o:p></span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline;" class=""><span lang="EN" style="font-size: 12pt; font-family: "Times New Roman", serif;" class=""> </span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">In order to manufacture a COVID-19 mRNA vaccine using compulsory licensing, the relevant producer would have to seek licenses for <i class="">each</i> IP-protected commodity in its country of origin and for export, which would require the compulsory licensing cooperation of the exporting country and input producer. It would likewise have to seek a compulsory license allowing for import of each such component and allowing for production of the vaccine. These multiple cases of component-by-component and country-by-country licenses result in timing and coordination complexities that are virtually insurmountable </span><span lang="EN" style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">even if the existing WTO flexibilities were determined to cover all of the different forms of IP exclusivities involved.</span><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class=""> Even for medicines not subject to such complicated supply chains, successfully obtaining a compulsory license requires a time-consuming and administratively burdensome process.<o:p class=""></o:p></span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class=""> </span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">The EU touting compulsory licensing as the way forward is even more cynical given decades of developing countries’ attempts to use compulsory licensing being viciously attacked with trade threats and more by rich countries, including the EU and its member nations. In the midst of COVID-19 pandemic, pharmaceutical firms continue to pressure countries over the use of compulsory licensing. </span><a href="https://makemedicinesaffordable.org/gilead-sues-russia-private-company-challenges-a-countrys-right-to-protect-public-health/" target="_blank" style="color: rgb(5, 99, 193);" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: windowtext;" class="">Gilead sued Russia</span></a><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class=""> for issuing a compulsory license on remdesivir. The Pharmaceutical Research and Manufacturers Association (PhRMA), the Biotechnology Innovation Organization (BIO) and the U.S. Chamber of Commerce </span><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/" target="_blank" style="color: rgb(5, 99, 193);" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif; color: windowtext;" class="">tried to recruit the U.S. government</span></a><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">to threaten countries that have used or planned to use compulsory licenses to incentivize domestic manufacturing of COVID-19 vaccines and treatments. <o:p class=""></o:p></span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class=""> <o:p class=""></o:p></span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline;" class=""><b class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">The EU communications does not address any solution to overcome these problems. In contrast, a TRIPS waiver would simply clear the thorny IP thickets, the related investment-chilling liabilities and threats of trade sanctions. <o:p class=""></o:p></span></b></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class=""> <o:p class=""></o:p></span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">The EU papers were only novel in the seeming ignorance that what is labeled as reforms in fact are terms that have been in place since the 2001 WTO Declaration on the TRIPS Agreement and Public health: <o:p class=""></o:p></span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class=""> </span></div><div style="margin: 0in 0in 0in 4.5pt; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; text-indent: 0in; vertical-align: baseline;" class=""><span style="font-size: 10pt; font-family: Symbol;" class="">·<span style="font-stretch: normal; font-size: 7pt; line-height: normal; font-family: "Times New Roman";" class=""> </span></span><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">The EU purports that the use of the compulsory licensing system can be eased by formal clarification that COVID qualifies as a national emergency so countries are not subject to requirements to negotiate with patent holders when issuing compulsory licenses. Beyond the absurdity that the WTO must clarify that COVID has caused national emergencies, under existing WTO rules countries self-declare emergencies, and emergencies are not the only basis for waiving the negotiate-first rule. Public non-commercial use is also included, like when governments provide vaccines to their populations. <o:p class=""></o:p></span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class=""> </span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; text-indent: 0in; vertical-align: baseline;" class=""><span style="font-size: 10pt; font-family: Symbol;" class="">·<span style="font-stretch: normal; font-size: 7pt; line-height: normal; font-family: "Times New Roman";" class=""> </span></span><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">The EU purports to clarify that WTO Members can set patent holder remuneration under a compulsory license at the price charged by the manufacturer of the vaccine or therapeutic. Yet the TRIPS Agreement already makes that clear. And, the problem with compulsory licensing of COVID vaccines is not related to compensation, but that compulsory licensing is not a workable solution in this context.<o:p class=""></o:p></span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class=""> </span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; text-indent: 0in; vertical-align: baseline;" class=""><span style="font-size: 10pt; font-family: Symbol;" class="">·<span style="font-stretch: normal; font-size: 7pt; line-height: normal; font-family: "Times New Roman";" class=""> </span></span><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">The EU papers restate as a new reform another </span><a href="https://www.wto.org/english/tratop_e/trips_e/art31bis_modelnotifs3_e.htm" style="color: rgb(5, 99, 193);" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">existing TRIPS rule</span></a><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">: That when countries export medicines made under a compulsory licensing to countries with no or insufficient pharmaceutical manufacturing capacity, the exporting country can provide a single notification that lists all the importing countries to which vaccines or therapeutics would be supplied. Yup, that’s been the case for many years…<o:p class=""></o:p></span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class=""> </span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">Given the EU is increasing alone against the world in service of Pharma, the latest EU WTO papers that restate existing WTO rules as if they are innovations and recycle old Big Pharma claims that have been so thoroughly debunked are surprisingly lame.<o:p class=""></o:p></span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline;" class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class=""> </span></div><div style="margin: 0in; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; vertical-align: baseline;" class=""><b class=""><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">Instead of obstructing the world’s progress towards the massive increase in COVID vaccines and medicines needed to save lives and end the COVID pandemic, the EU should just say <i class="">nein</i> to Germany’s deadly, self-defeating position and join the community of nations in favor of the WTO TRIPS waiver.<o:p class=""></o:p></span></b></div><p class="MsoNormal" align="center" style="margin: 0in 0in 8pt; line-height: normal; font-size: 11pt; font-family: Calibri, sans-serif; text-align: center; vertical-align: baseline;"><span style="font-size: 12pt; font-family: "Times New Roman", serif;" class="">###<o:p class=""></o:p></span></p><p class="MsoNormal" style="margin: 0in 0in 8pt; line-height: 15.399999618530273px; font-size: 11pt; font-family: Calibri, sans-serif;"><o:p class=""> =====</o:p></p><div class=""><br class=""></div></div><div class=""><div style="margin: 0in; font-size: 12pt; font-family: "Times New Roman", serif; text-align: center;" class=""><b class="">Disinformation, Diversion, and Delay:</b><o:p class=""></o:p></div><div style="margin: 0in; font-size: 12pt; font-family: "Times New Roman", serif; text-align: center;" class=""><b class="">The Real Text of the European Union’s Communication to the WTO TRIPS Council – Urgent Trade Policy Responses to the COVID-19 Crisis</b><o:p class=""></o:p></div><div style="margin: 0in; font-size: 12pt; font-family: "Times New Roman", serif; text-align: center;" class="">Professor Brook K. Baker, Senior Policy Analyst Health GAP<o:p class=""></o:p></div><div style="margin: 0in; font-size: 12pt; font-family: "Times New Roman", serif; text-align: center;" class="">June 5, 20221<o:p class=""></o:p></div><div style="margin: 0in; font-size: 12pt; font-family: "Times New Roman", serif; text-align: center;" class=""> <o:p class=""></o:p></div><div style="margin: 0in; font-size: 12pt; font-family: "Times New Roman", serif;" class="">If the European Union’s Communication to the TRIPS Council – Urgent Policy Responses to the COVID-19 Crisis has no real substance, then it is fair to conclude that its true purpose is disinformation, diversion, and delay. The Communication purports to address clarifications needed to make existing TRIPS flexibilities more operational for countries that might need to issue compulsory licenses to access COVID-19 vaccines and therapeutics. However, the proposed clarifications have no substance beyond what is already well established in the text of Articles 31 and 31bis of the TRIPS Agreement and of the Doha Declaration on the TRIPS Agreement and Public Health. When a powerful group of nations, like the E.U., offers a set of “pseudo” proposals with no substance, we can look beyond the façade to see that their real intention is to misinform decision-makers, the press, and the public and to divert attention from the proposal by India, South Africa and 61 other countries to the WTO to waive intellectual property protections on COVID-19 health products and technologies for at least three years. (Adopting this substantive waiver would mean that countries experiencing grossly inequitable access to vaccines, medicines, diagnostic, personal protective equipment, and other medical supplies could act on their own behalf to find alternative producers to ameliorate shortages, excessively high prices, and stockpiling by rich countries.) In addition to muddying the water and diverting attention, the E.U. is also hoping that its empty-package compulsory licensing proposals will delay text-based negotiations of a waiver agreement so long that implementing the waiver would be economically impractical for alternative producers and countries. Just as the existing 8-month delay in responding to the October waiver proposal has coincided with at least a million extra COVID-19 death, continued prevarication by the E.U. will leave many millions more in its former colonies waiting in line to die.<o:p class=""></o:p></div><div style="margin: 0in; font-size: 12pt; font-family: "Times New Roman", serif;" class=""> <o:p class=""></o:p></div><div style="margin: 0in; font-size: 12pt; font-family: "Times New Roman", serif;" class="">The Table below presents the relevant existing text of the TRIPS Agreement and the Doha Declaration, the pseudo-proposals on compulsory licensing clarifications put forth by the E.U. to the TRIPS Council, and critical commentary on the illusory impacts of what the E.U. has proposed.<o:p class=""></o:p></div><div style="margin: 0in; font-size: 12pt; font-family: "Times New Roman", serif;" class=""><b class=""> </b><o:p class=""></o:p></div><table class="MsoNormalTable" border="0" cellspacing="0" cellpadding="0" style="border-collapse: collapse;"><tbody class=""><tr class=""><td width="208" valign="top" style="width: 155.8pt; border: 1pt solid windowtext; padding: 0in 5.4pt;" class=""><div style="margin: 0in; font-size: 12pt; font-family: "Times New Roman", serif;" class=""><b class=""><span style="font-size: 11.5pt;" class="">TRIPS Agreement Article 31 and 31<i class="">bis</i> and Doha Declaration on the TRIPS Agreement and Public Health</span></b><o:p class=""></o:p></div></td><td width="208" valign="top" style="width: 155.85pt; border-top-width: 1pt; border-right-width: 1pt; border-bottom-width: 1pt; border-style: solid solid solid none; border-top-color: windowtext; border-right-color: windowtext; border-bottom-color: windowtext; padding: 0in 5.4pt;" class=""><div style="margin: 0in; font-size: 12pt; font-family: "Times New Roman", serif;" class=""><b class=""><span style="font-size: 11.5pt;" class="">EU [Pseudo] Proposal to the TRIPS Council on Clarification of Compulsory Licensing rules</span></b><o:p class=""></o:p></div></td><td width="208" valign="top" style="width: 155.85pt; border-top-width: 1pt; border-right-width: 1pt; border-bottom-width: 1pt; border-style: solid solid solid none; border-top-color: windowtext; border-right-color: windowtext; border-bottom-color: windowtext; padding: 0in 5.4pt;" class=""><div style="margin: 0in; font-size: 12pt; font-family: "Times New Roman", serif;" class=""><b class=""><span style="font-size: 11.5pt;" class="">Critical Comments</span></b><o:p class=""></o:p></div></td></tr><tr class=""><td width="208" valign="top" style="width: 155.8pt; border-right-width: 1pt; border-bottom-width: 1pt; border-left-width: 1pt; border-style: none solid solid; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; padding: 0in 5.4pt;" class=""><p style="margin-right: 0in; margin-bottom: 7.5pt; margin-left: 0in;" class=""><span style="font-size: 10.5pt; font-family: "Museo Sans 300", serif;" class="">Doha ¶4: “We agree that the TRIPS Agreement does not and should not prevent members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO members' right to protect public health and, in particular, to promote access to medicines for all.</span><o:p class=""></o:p></p><p style="margin-right: 0in; margin-bottom: 7.5pt; margin-left: 0in; box-sizing: border-box;" class=""><span style="font-size: 10.5pt; font-family: "Museo Sans 300", serif;" class="">In this connection, we reaffirm the right of WTO members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose.”</span><o:p class=""></o:p></p><div style="margin: 0in; font-size: 12pt; font-family: "Times New Roman", serif;" class=""><span style="font-size: 11.5pt;" class=""> </span><o:p class=""></o:p></div></td><td width="208" valign="top" style="width: 155.85pt; border-style: none solid solid none; border-bottom-width: 1pt; border-bottom-color: windowtext; border-right-width: 1pt; border-right-color: windowtext; padding: 0in 5.4pt;" class=""><div style="margin: 0in; font-size: 12pt; font-family: "Times New Roman", serif;" class=""><span style="font-size: 11.5pt;" class="">¶10: “The discussions in the Council for TRIPS since the start of the COVID-19 pandemic have identified aspects related to the use of compulsory licensing that, in the view of a number of WTO Members, limit the use of this tool. In order to address these aspects, provide more legal certainty and enhance the effectiveness of the system, the EU considers that all WTO Members should be ready to agree on the following:</span><o:p class=""></o:p></div><div style="margin: 0in; font-size: 12pt; font-family: "Times New Roman", serif;" class=""><span style="font-size: 11.5pt;" class="">(a) The pandemic is a circumstance of national emergency and therefore the requirement to negotiate with the right holder may be waived;</span><o:p class=""></o:p></div><div style="margin: 0in; font-size: 12pt; font-family: "Times New Roman", serif;" class=""><span style="font-size: 11.5pt;" class="">(b) To support manufacturers ready to produce vaccines or therapeutics at affordable prices, especially for low- and middle-income countries, on the basis of a compulsory licence, the remuneration for patent holders should reflect such affordable prices; and </span><o:p class=""></o:p></div><div style="margin: 0in; font-size: 12pt; font-family: "Times New Roman", serif;" class=""><span style="font-size: 11.5pt;" class="">(c) The compulsory licence could cover any exports destined to countries that lack manufacturing capacity, including via the COVAX facility.</span><o:p class=""></o:p></div></td><td width="208" valign="top" style="width: 155.85pt; border-style: none solid solid none; border-bottom-width: 1pt; border-bottom-color: windowtext; border-right-width: 1pt; border-right-color: windowtext; padding: 0in 5.4pt;" class=""><ul type="disc" style="margin-bottom: 0in; margin-top: 0in;" class=""><li class="MsoListParagraphCxSpFirst" style="margin: 0in 0in 0in -0.25in; font-size: 12pt; font-family: "Times New Roman", serif;"><span style="font-size: 11.5pt;" class="">The EU underplays the concerns that waiver proponents and other expert commentators have advanced concerning the limited effectiveness of existing TRIPS flexibilities.</span><o:p class=""></o:p></li><li class="MsoListParagraphCxSpMiddle" style="margin: 0in 0in 0in -0.25in; font-size: 12pt; font-family: "Times New Roman", serif;"><span style="font-size: 11.5pt;" class="">Critics have pointed to the massive problems of coordination and cooperation in issuing compulsory licenses in multiple territories that must export patent protected components, intermediate products, and final formulations. </span><o:p class=""></o:p></li><li class="MsoListParagraphCxSpMiddle" style="margin: 0in 0in 0in -0.25in; font-size: 12pt; font-family: "Times New Roman", serif;"><span style="font-size: 11.5pt;" class="">These complexities are doubled with the need to issue coordinated import licenses as well. </span><o:p class=""></o:p></li><li class="MsoListParagraphCxSpMiddle" style="margin: 0in 0in 0in -0.25in; font-size: 12pt; font-family: "Times New Roman", serif;"><span style="font-size: 11.5pt;" class="">Moreover, the clarification will not be self-effectuating, countries, many of which have not previously adopted Article 31<i class="">bis</i> provisions domestically would have to do so. </span><o:p class=""></o:p></li><li class="MsoListParagraphCxSpLast" style="margin: 0in 0in 0in -0.25in; font-size: 12pt; font-family: "Times New Roman", serif;"><span style="font-size: 11.5pt;" class="">Finally, TRIPS compulsory license provisions only deal with patent rights and do not address the confidential information, trade secret, regulatory data, and biologic resource protections that act as barriers to alternative producers of vaccines, biologics, and other COVID-19 health technologies, nor associated copyright and industrial design protections. </span><o:p class=""></o:p></li></ul></td></tr><tr class=""><td width="208" valign="top" style="width: 155.8pt; border-right-width: 1pt; border-bottom-width: 1pt; border-left-width: 1pt; border-style: none solid solid; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; padding: 0in 5.4pt;" class=""><div style="margin: 0in; font-size: 12pt; font-family: "Times New Roman", serif;" class=""><span style="font-size: 11.5pt;" class="">Doha </span><span style="font-size: 10.5pt; font-family: "Museo Sans 300", serif;" class="">¶</span><span style="font-size: 11.5pt;" class="">5(c): </span><span style="font-size: 10pt; font-family: "Trebuchet MS", sans-serif;" class="">Each member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency.</span><o:p class=""></o:p></div><div style="margin: 0in; font-size: 12pt; font-family: "Times New Roman", serif;" class=""><span style="font-size: 11.5pt;" class=""> </span><o:p class=""></o:p></div></td><td width="208" valign="top" style="width: 155.85pt; border-style: none solid solid none; border-bottom-width: 1pt; border-bottom-color: windowtext; border-right-width: 1pt; border-right-color: windowtext; padding: 0in 5.4pt;" class=""><div style="margin: 0in; font-size: 12pt; font-family: "Times New Roman", serif;" class=""><span style="font-size: 11.5pt;" class="">¶10: “The EU proposes to clarify that the circumstances of a pandemic fulfil the requirement of a national emergency and therefore the requirement to demonstrate the efforts to negotiate for a certain period of time can be waived.”</span><o:p class=""></o:p></div></td><td width="208" valign="top" style="width: 155.85pt; border-style: none solid solid none; border-bottom-width: 1pt; border-bottom-color: windowtext; border-right-width: 1pt; border-right-color: windowtext; padding: 0in 5.4pt;" class=""><div style="margin: 0in; font-size: 12pt; font-family: "Times New Roman", serif;" class=""><span style="font-size: 11.5pt;" class="">EU proposes nothing that is not already exquisitely clear – countries have absolute sovereign discretion to determine what constitutes emergencies or matters of extreme urgency; epidemics are clearly intended to be covered; COVID-19 is both an emergency and global pandemic, even worse than an epidemic; and thus the EU clarification is worthless.</span><o:p class=""></o:p></div></td></tr><tr class=""><td width="208" valign="top" style="width: 155.8pt; border-right-width: 1pt; border-bottom-width: 1pt; border-left-width: 1pt; border-style: none solid solid; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; padding: 0in 5.4pt;" class=""><div style="margin: 0in; font-size: 12pt; font-family: "Times New Roman", serif;" class=""><span style="font-size: 11.5pt;" class="">TRIPS §31(b) makes it clear that the requirement that the proposed user of a compulsory license make efforts “to obtain authorization from the rightholder for a reasonable period of time on commercially reasonable terms” is waived in the case of “a national emergency or other matter of extreme urgency or in cases of public, non-commercial use.” Article 31(k) states further that prior negotiations for a voluntary license are not required for compulsory licenses addressing competition abuses.</span><o:p class=""></o:p></div></td><td width="208" valign="top" style="width: 155.85pt; border-style: none solid solid none; border-bottom-width: 1pt; border-bottom-color: windowtext; border-right-width: 1pt; border-right-color: windowtext; padding: 0in 5.4pt;" class=""><div style="margin: 0in; font-size: 12pt; font-family: "Times New Roman", serif;" class=""><span style="font-size: 11.5pt;" class="">¶10: “Therefore, the EU proposes to clarify that the waiving of the requirement to negotiate with the right holder applies also in the circumstances of Article 31bis.”</span><o:p class=""></o:p></div></td><td width="208" valign="top" style="width: 155.85pt; border-style: none solid solid none; border-bottom-width: 1pt; border-bottom-color: windowtext; border-right-width: 1pt; border-right-color: windowtext; padding: 0in 5.4pt;" class=""><div style="margin: 0in; font-size: 12pt; font-family: "Times New Roman", serif;" class=""><span style="font-size: 11.5pt;" class="">The waiver of requirements to negotiate before issuing a compulsory license found in Article 31(b) and (f) already fully apply to Article 31 bis licenses. No one has ever suggested that Article 31 bis licenses addressing emergencies or government use needs would require prior negotiation. Once again, the EU clarification is worthless.</span><o:p class=""></o:p></div></td></tr><tr class=""><td width="208" valign="top" style="width: 155.8pt; border-right-width: 1pt; border-bottom-width: 1pt; border-left-width: 1pt; border-style: none solid solid; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; padding: 0in 5.4pt;" class=""><div style="margin: 0in; font-size: 12pt; font-family: "Times New Roman", serif;" class=""><span style="font-size: 11.5pt;" class="">TRIPS §31</span><span style="font-size: 10.5pt; font-family: "Museo Sans 300", serif; background-color: white;" class="">(h): “the right holder shall be paid adequate remuneration in the circumstances of each case, taking into account the economic value of the authorization;</span> …”<o:p class=""></o:p></div><div style="margin: 0in; font-size: 12pt; font-family: "Times New Roman", serif;" class=""><span style="font-size: 11.5pt;" class=""> </span><o:p class=""></o:p></div></td><td width="208" valign="top" style="width: 155.85pt; border-style: none solid solid none; border-bottom-width: 1pt; border-bottom-color: windowtext; border-right-width: 1pt; border-right-color: windowtext; padding: 0in 5.4pt;" class=""><div style="margin: 0in; font-size: 12pt; font-family: "Times New Roman", serif;" class=""><span style="font-size: 11.5pt;" class="">¶12: The EU proposes to clarify that in the circumstances of a pandemic, WTO Members can set the remuneration to the right holder at a level that reflects the price charged by the manufacturer of the vaccine or therapeutic under a compulsory licence. This would support production and supplies of vaccines and therapeutics at affordable prices to low and middle-income countries.</span><o:p class=""></o:p></div></td><td width="208" valign="top" style="width: 155.85pt; border-style: none solid solid none; border-bottom-width: 1pt; border-bottom-color: windowtext; border-right-width: 1pt; border-right-color: windowtext; padding: 0in 5.4pt;" class=""><div style="margin: 0in; font-size: 12pt; font-family: "Times New Roman", serif;" class=""><span style="font-size: 11.5pt;" class="">The TRIPS Agreement already only requires adequate remuneration appropriate to the circumstances taking into account the economic value of the authorized CL. Adequate remuneration for issued compulsory licenses in the past have always been single digit royalties based on the generic price of the licensed medicine. Actual rates have varied from a fraction of 1% to 7.5%. The EU remuneration proposal offers nothing of value.</span><o:p class=""></o:p></div></td></tr><tr class=""><td width="208" valign="top" style="width: 155.8pt; border-right-width: 1pt; border-bottom-width: 1pt; border-left-width: 1pt; border-style: none solid solid; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; padding: 0in 5.4pt;" class=""><div style="margin: 0in; font-size: 12pt; font-family: "Times New Roman", serif;" class=""><span style="font-size: 11.5pt;" class="">TRIPS §31<i class="">bis</i>2</span><span style="font-size: 10.5pt; font-family: "Museo Sans 300", serif; background-color: white;" class="">(c) the exporting Member shall notify</span><sup id="fntext-8" class=""><span style="font-size: 8pt; font-family: "Museo Sans 300", serif;" class=""><a href="https://www.wto.org/english/docs_e/legal_e/31bis_trips_annex_e.htm#fnt-8" style="color: rgb(5, 99, 193);" class=""><span style="color: rgb(0, 174, 255);" class="">(8)</span></a></span></sup><span class="apple-converted-space"><span style="font-size: 10.5pt; font-family: "Museo Sans 300", serif; background-color: white;" class=""> the Council for TRIPS of the grant of the licence, including the conditions attached to it.</span></span><sup id="fntext-9" class=""><span style="font-size: 8pt; font-family: "Museo Sans 300", serif;" class=""><a href="https://www.wto.org/english/docs_e/legal_e/31bis_trips_annex_e.htm#fnt-9" style="color: rgb(5, 99, 193);" class=""><span style="color: rgb(0, 174, 255);" class="">(9)</span></a></span></sup><span class="apple-converted-space"><span style="font-size: 10.5pt; font-family: "Museo Sans 300", serif; background-color: white;" class=""> The information provided shall include the name and address of the licensee, the product<b class="">(s)</b> for which the licence has been granted, the quantity(ies) for which it has been granted, the country<b class="">(ies)</b> to which the product<b class="">(s)</b>is (are) to be supplied and the duration of the licence. </span></span><o:p class=""></o:p></div><div style="margin: 0in; font-size: 12pt; font-family: "Times New Roman", serif;" class=""><span class="apple-converted-space"><span style="font-size: 11.5pt;" class=""> </span></span><o:p class=""></o:p></div></td><td width="208" valign="top" style="width: 155.85pt; border-style: none solid solid none; border-bottom-width: 1pt; border-bottom-color: windowtext; border-right-width: 1pt; border-right-color: windowtext; padding: 0in 5.4pt;" class=""><div style="margin: 0in; font-size: 12pt; font-family: "Times New Roman", serif;" class=""><span style="font-size: 11.5pt;" class="">¶12: “The EU proposes that in the circumstances of a pandemic, the WTO Members agree that the exporting Member may provide in one single notification a list of all countries to which vaccines and therapeutics are to be supplied directly or through the COVAX Facility.”</span><o:p class=""></o:p></div></td><td width="208" valign="top" style="width: 155.85pt; border-style: none solid solid none; border-bottom-width: 1pt; border-bottom-color: windowtext; border-right-width: 1pt; border-right-color: windowtext; padding: 0in 5.4pt;" class=""><div style="margin: 0in; font-size: 12pt; font-family: "Times New Roman", serif;" class=""><span style="font-size: 11.5pt;" class="">Article 31bis already allows notification relating to multiple products and multiple countries. Nothing in the existing text suggests that exporting countries cannot already rely on a single notification document. Note, however, that the EU has not proposed a waiver of the requirement to specify quantities, which means, new needs would still require new notices. As with all its other CL clarifications, the EU’s third clarification is worthless.</span><o:p class=""></o:p></div></td></tr></tbody></table><div style="margin: 0in; font-size: 12pt; font-family: "Times New Roman", serif;" class=""><span style="font-size: 11.5pt; color: white;" class=""> </span><o:p class=""></o:p></div><div style="margin: 0in; font-size: 12pt; font-family: "Times New Roman", serif;" class=""><b class="">Conclusion:</b><o:p class=""></o:p></div><div style="margin: 0in; font-size: 12pt; font-family: "Times New Roman", serif;" class=""> <o:p class=""></o:p></div><div style="margin: 0in; font-size: 12pt; font-family: "Times New Roman", serif;" class=""><span style="font-size: 11.5pt;" class="">The E.U. proposal is meaningless and insulting. Its true purpose is obscuration and postponement of the proposed TRIPS waiver. The best evidence of this intention is found in the E.U.’s <i class="">Questions and Answers: EU Communications to the WTO – EU proposes a strong multilateral trade response to the COVID-19 pandemic</i>:</span><o:p class=""></o:p></div><p class="p1" style="margin-right: 0in; margin-left: 0.5in; font-size: 12pt; font-family: "Times New Roman", serif; margin-bottom: 0in;"><span style="font-size: 11.5pt;" class="">[W]e want to maintain the levels of [IP] protection required for investment in innovation, so we can fight against new strains of COVID-19 and any future disease.<span class="apple-converted-space"> </span><b class="">The EU does not consider that the broad waiver proposed by a number of WTO members is the right response to the pandemic. We are arguing for a different and more targeted approach</b>. …</span><o:p class=""></o:p></p><p class="p1" style="margin-right: 0in; margin-left: 0.5in; font-size: 12pt; font-family: "Times New Roman", serif; margin-bottom: 0in;"><span style="font-size: 11.5pt;" class=""> </span><o:p class=""></o:p></p><div style="margin: 0in; font-size: 12pt; font-family: "Times New Roman", serif;" class=""><span style="font-size: 11.5pt;" class="">Once again, even in describing the waiver, the E.U. misinterprets its probable impacts: </span><o:p class=""></o:p></div><p class="p1" style="margin-right: 0in; margin-left: 0.5in; font-size: 12pt; font-family: "Times New Roman", serif; margin-bottom: 0in;"><b class=""><span style="font-size: 11.5pt;" class="">Waiving IP rights: All relevant rights are waived, i.e. the protection granted by patents, copyright or other IP rights ceases to exist for the duration of the waiver. The vaccine developer is not remunerated and has no role or information on the product. The absence of interaction between the vaccine developer and the producers makes the transfer of know-how unlikely</span></b><span style="font-size: 11.5pt;" class="">.</span><o:p class=""></o:p></p><div style="margin: 0in; font-size: 12pt; font-family: "Times New Roman", serif;" class=""> The revised waiver test does not discount remuneration and in fact says that incentives for innovation are important. Countries would clearly be free to provide remuneration after taking into account past public and charitable investments in the subject product. If the IP rightholders were truly interested in having some role with respect to out-licenses, they could join the WHO COVID-19 Technology Access Pool, which will only grant out-licenses to qualified licensees who can meet stringent quality and equitable distribution requirements. Likewise, the suggestion that transfer of know-how would be unlikely is directly contrary to what the waiver would permit. It would permit countries to require rightholders to transfer their confidential information, trade-secrets, and manufacturing know-how, as is routinely done is the industry’s regular co-manufacturing and contract manufacturing agreements.<o:p class=""></o:p></div><div style="margin: 0in; font-size: 12pt; font-family: "Times New Roman", serif;" class=""> <o:p class=""></o:p></div><div style="margin: 0in; font-size: 12pt; font-family: "Times New Roman", serif;" class=""><span style="font-size: 11.5pt;" class="">The best response would be to ignore it so that countries could move on to the serious task of adopting an effective waiver of IP rules at the WTO, implementing them domestically, and forcing Pharma to the bargaining table to extract new open licenses and technology transfer to speed access to lifesaving COVID-19 vaccines, therapies, tests, and personal equipment. The E.U. needs a rap on the knuckles to get back to the real business of addressing the abomination of vaccine apartheid.</span><o:p class=""></o:p></div><p class="MsoNormal" style="margin: 0in; font-size: 12pt; font-family: "Times New Roman", serif;"><span style="font-size: 11pt; font-family: Calibri, sans-serif;" class=""> </span></p></div><div class=""><br class=""></div><br class=""><div class="">
Arthur Stamoulis<br class="">Citizens Trade Campaign<br class="">(202) 494-8826<br class=""><br class=""><br class=""><br class="">
</div>
<br class=""></body></html>