{"id":8523,"date":"2021-06-22T08:30:52","date_gmt":"2021-06-22T08:30:52","guid":{"rendered":"https:\/\/cpip.gmu.edu\/?p=8523"},"modified":"2026-02-03T20:11:18","modified_gmt":"2026-02-03T20:11:18","slug":"a-view-from-both-sides-covid-19-the-trips-waiver-ip-rights-and-how-to-increase-the-supply-of-vaccines","status":"publish","type":"post","link":"https:\/\/blogs.uakron.edu\/ualawip\/2021\/06\/22\/a-view-from-both-sides-covid-19-the-trips-waiver-ip-rights-and-how-to-increase-the-supply-of-vaccines\/","title":{"rendered":"[Archived Post] A View from Both Sides: COVID-19, the TRIPS Waiver, IP Rights, and How to Increase the Supply of Vaccines"},"content":{"rendered":"
\"scientistIssue<\/u><\/strong><\/h5>\n

The United States and other wealthy nations have access to plenty of COVID-19 vaccine doses and thus are beginning to get the pandemic under control, while less affluent countries do not have access to adequate doses and are still struggling<\/a> with rising cases. In October 2020, India and South Africa proposed<\/a> addressing this problem by waiving certain portions of the TRIPS Agreement<\/a>, the most comprehensive agreement on intellectual property (IP) aspects of international trade among the WTO\u2019s 164 member states. The waiver<\/a> cites \u201can urgent call for global solidarity, and the unhindered global sharing of technology and know-how in order that rapid responses for the handling of COVID-19 can be put in place on a real time basis.\u201d While this proposal broadly applies to any COVID-19-related technology, much of the conversation is currently focused on vaccines.<\/p>\n

The proposal would temporarily suspend patent rights covering COVID-19 vaccines and possibly also be used to compel the transfer of trade secret \u201cknow-how\u201d and \u201cshow-how.\u201d Proponents say this would allow any manufacturer to begin production\u2014boosting vaccine supply while slashing prices\u2014to end the surge of cases in less developed nations. Critics argue that the reality is more complicated: the waiver will be ineffective, even harmful, and it would have a devastating impact on our readiness for future health crises.<\/p>\n

In Support of the Waiver<\/u><\/strong><\/h5>\n

For supporters of the waiver, the answer is clear: cases are rising in many nations because they still don\u2019t have the vaccines they need. It\u2019s only reasonable to make exceptions to our ordinary system of business incentives during times of global crisis.<\/p>\n

The Biden Administration<\/strong><\/p>\n

That is essentially what U.S. Trade Representative Katherine Tai stated<\/a> when the Biden Administration announced its support for the waiver: \u201cThis is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures. The Administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines.\u201d<\/p>\n

It affects all of us<\/strong><\/p>\n

WHO Director-General Dr. Tedros Adhanom Ghebreyesus says<\/a> that the \u201cme-first approach\u201d among powerful nations \u201cis self-defeating and will lead to a protracted recovery with trade and travel continuing to suffer.\u201d Under this rationale, even purely self-interested parties should support the waiver, if only because modern commerce is so globally connected.<\/p>\n

Dropping IP barriers will facilitate greater collaboration<\/strong><\/p>\n

Many say the threat of IP litigation prevents the kind of collaboration needed to quickly ramp up production and development, and that a waiver can remove that threat. The president of M\u00e9decins Sans Fronti\u00e8res, Dr. Christos Christou, says<\/a> that \u201c[t]he waiver proposal offers all governments opportunities to take action for better collaboration in development, production and supply of COVID medical tools without being restricted by private industry\u2019s interests and actions, and crucially would give governments all available tools to ensure global access.\u201d<\/p>\n

Patents were not meant to impede emergency action<\/strong><\/p>\n

A recent editorial<\/a> in the journal Nature<\/em> argues that patents are designed to protect ordinary commercial interests, not to hinder global cooperation against a common threat: \u201cA pandemic is not a competition between companies, but a race between humanity and a virus. Instead of competing, countries and companies need to do all they can to cooperate to bring the pandemic to an end.\u201d<\/p>\n

It solves an immediate need without setting a troubling precedent<\/strong><\/p>\n

While opponents of the waiver argue that it will weaken future drug patent protection, Imron Aly and Ahmed M.T. Riaz of Schiff Hardin LLP call those concerns \u201cunfounded\u201d in their post at IPWatchdog<\/a>. Not only is the current proposal limited specifically to COVID-19, but it was also not created carelessly. Instead, it \u201chas taken substantial international efforts and official international law amendments.\u201d Aly and Riaz say this exceptional action is appropriate if it can succeed where our IP system has yet to do so: \u201cThe TRIPS waiver simply allows countries the option to suspend patent enforcement to encourage COVID-19 vaccine production, which makes sense for those countries where current investment has not resulted in vaccine access.\u201d<\/p>\n

Even if the waiver doesn\u2019t work, it might work<\/strong><\/p>\n

University of Houston Law Center Professor Sapna Kumar acknowledges<\/a> a number of functional issues with the waiver approach but notes that it may still have a positive effect on the pandemic: \u201cOverall, the greatest benefit of the Biden Administration\u2019s support for the waiver is that it signals a departure from the prior approach of punishing countries facing health crises and that it might spur pharmaceutical companies to voluntarily increase out-licensing and donations of vaccines.\u201d Her prediction was borne out by a recent pledge<\/a> to donate 2.3 billion doses by Pfizer\/BioNTech, Johnson & Johnson, and Moderna.<\/p>\n

Opposed to the Waiver<\/u><\/strong><\/h5>\n

Opponents of the waiver argue that it will not be effective because it fails to address the real problems. Further, it could actually be detrimental to quality control and supply chains in the present crisis, while quite possibly affecting how pharmaceutical companies choose to allocate investment dollars in the future.<\/p>\n

It\u2019s a long process that requires much more than a temporary waiver of licenses<\/strong><\/p>\n

Vaccines are not like other drugs. Writing for Foreign Affairs<\/em>, Peter J. Hotez, Maria Elena Bottazzi, and Prashant Yadav say<\/a> that we can\u2019t compare the current situation to similar actions on HIV treatments, and that most nations are not prepared to make use of the patented technology: \u201cProducing vaccines\u2014particularly those as technologically complex as the messenger RNA (mRNA) inoculations against COVID-19\u2014requires not only patents but an entire infrastructure that cannot be transferred overnight.\u201d The authors state that \u201c[t]he effective transfer of such complex technology requires a receiving ecosystem that can take years, sometimes decades, to build.\u201d<\/p>\n

We need another way<\/strong><\/p>\n

Professor Yogesh Pai of the National Law University Delhi says<\/a> that simply waiving trade secret protection won\u2019t automatically disclose everything a manufacturer needs to know. Accessing \u201chard tacit knowledge of manufacturing\/quality control measures for production and clinical data required for regulatory clearances\u201d could require forced technology transfer (FTT) by national governments. He recalls how detrimental such efforts were to India\u2019s economy when it tried FTT with Coca-Cola in the 1970s, prompting the company to leave the country altogether.<\/p>\n

Prof. Pai instead recommends efforts to encourage voluntary cooperation: \u201cWhere blunt legal instruments don\u2019t work, using track-1 and track-2 diplomacy to place moral coercion on western governments to nudge firms to actively engage in technology licensing may still work wonders.\u201d<\/p>\n

\u201cChina First\u201d policy?<\/strong><\/p>\n

Sixteen U.S. senators issued a sharply worded letter<\/a> to the executive branch, questioning the true motives of \u201cChina and other countries which regularly steal American intellectual property\u2014like India and South Africa,\u201d and expressing shock that an American president would go along with it: \u201cThese nations are falsely claiming that granting such a waiver would speed the development of new vaccine capacity. Nothing could be further from the truth.\u201d Instead, the senators are suggesting that the waiver is being used as a means to unfairly to acquire trade secrets that took massive resources and time to develop.<\/p>\n

Reuters reports<\/a> that \u201csome U.S. officials fear the move would allow China to leapfrog years of research and erode the U.S. advantage in biopharmaceuticals\u201d and quotes a senior U.S. official as saying that the country \u201c\u2018would want to examine the effect of a waiver on China and Russia before it went into effect to ensure that it’s fit for purpose.\u2019\u201d<\/p>\n

IP is not the Issue<\/strong><\/p>\n

A waiver on patent rights, even with the corresponding trade secrets, can only give permission to manufacture. But Eva Bishwal of Fidus Law Chambers writes<\/a> that the real problems in India \u201care state inaction, dearth of raw materials and low production capacity.\u201d<\/p>\n

According to<\/a> Patrick Kilbride of the U.S. Chamber of Commerce\u2019s Global Innovation Policy Center, and as cited<\/a> in Pharmaceutical Technology<\/em>, \u201c[p]roposals to waive intellectual property rights are misguided and a distraction from the real work of reinforcing supply chains and assisting countries to procure, distribute and administer vaccines to billions of the world\u2019s citizens.\u201d<\/p>\n

Low-quality vaccines could do more harm than good<\/strong><\/p>\n

Former USPTO Director Andrei Iancu voiced concern<\/a> recently at a World IP Day event, asking, \u201cif we waive IP rights, and exclude the original manufacturers, how are we going to control the quality of the vaccines that go into people\u2019s arms? How are we going to control for the fake vaccines? Just last week we saw fake Pfizer vaccines.\u201d And as Philip Thompson points out for IPWatchdog<\/a>, when investigators are forced to \u201cdetermine if adverse events or sub-par effectiveness originate from \u2018real\u2019 vaccines or fake doses, we should expect global production starts and stops to become much more frequent.\u201d<\/p>\n

It will discourage investment in the most critical areas<\/strong><\/p>\n

Pharmaceutical developers invest unfathomable amounts of money into bringing drugs to market. The path to success is long, expensive, and highly uncertain. But what is certain is that successful drugs can yield a profit that covers the loss from failures. Now critics are deeply worried that this waiver will skew future cost-benefit analyses against important classes of medicine. All other things being equal, a developer has a better chance at a positive return by investing in drugs that pose no risk of seizure during a global emergency. As Amanda Glassman of the Center for Global Development writes<\/a>, the waiver sends the wrong message to innovators and investors: \u201cdon\u2019t bother attacking the most important global problems; instead, throw your investment dollars at the next treatment for erectile disfunction, which will surely earn you a steady return with far less agita.\u201d The scramble amongst pharmaceutical giants to develop a vaccine was an all-out race, with good reason<\/a>, and that\u2019s exactly how it should be. If those companies believe that forfeiture is waiting at the finish line next time around, we might see fewer contestants.<\/p>\n

Even \u201cno-profit\u201d vaccine makers appear to oppose the waiver<\/strong><\/p>\n

Pfizer CEO Albert Bourla laid out<\/a> everything the company has done to combat the vaccine in an equitable manner and argued that \u201cwaiver of IP rights could only derail this progress.\u201d And while Pfizer and Moderna are selling their vaccines at a profit, Johnson & Johnson and AstraZeneca have pledged not to do so during the pandemic.<\/p>\n

However, it appears that even those companies oppose the waiver. As reported<\/a> in The Wall Street Journal, the trade group PhRMA, which represents Johnson & Johnson and AstraZeneca among many others, is \u201clobbying members of Congress to oppose the Biden administration\u2019s support for the waiver.\u201d Johnson & Johnson\u2019s Chief IP counsel Robert DeBerardine says that patent rights are responsible for the breakneck pace of development and that the drug\u2019s makers are the best-equipped people to continue the fight: \u201cWhat we’re able to do, because we have control of the IP, is to pick the best companies to help us supply the world. If you were to give everything to everybody, you may see a flood of vaccines, but you would have no idea if they’re safe and effective.\u201d<\/p>\n

Conclusion<\/u><\/strong><\/h5>\n

While we share the concerns of other organizations that effective, affordable, and accessible vaccines be made available to all persons regardless of location or wealth, we do not believe that upending longstanding U.S. patent policy for a solution that will do little if anything to increase the vaccine supply is advisable. Strong IP rights remain the best way to incentivize innovation and ultimately increase the supply of life-saving medicines. The Biden administration\u2019s unprecedented support of the proposed WTO IP waiver, while well intended, is likely to create long-term harm and unlikely to have much of an impact on global vaccine supplies. Ultimately, encouraging companies to license IP and engage in voluntary knowledge transfer, along with the sharing of excess doses that are being produced, are methods far more likely to alleviate the vaccine supply issues than waiving IP rights and would be a better path forward out of the current crisis.<\/p>\n","protected":false},"excerpt":{"rendered":"

Issue The United States and other wealthy nations have access to plenty of COVID-19 vaccine doses and thus are beginning to get the pandemic under control, while less affluent countries do not have access to adequate doses and are still struggling with rising cases. In October 2020, India and South Africa proposed addressing this problem […]<\/p>\n","protected":false},"author":3627,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[20,28],"tags":[96,104,117,129,194,203,206,275,287,337,367,526,689,693,711,732,833,916,1065,1108,1129,1134,1148,1248,1279,1374,1440,1473,1474,1487,1503,1528,1531,1551,1564,1577,1579,1581,1583],"class_list":["post-8523","post","type-post","status-publish","format-standard","hentry","category-healthcare","category-international-law","tag-ahmed-m-t-riaz","tag-albert-bourla","tag-amanda-glassman","tag-andrei-iancu","tag-biden-administration","tag-biopharmaceutical","tag-biotechnology","tag-china","tag-christos-christou","tag-copyright-2","tag-covid-19","tag-eva-bishwal","tag-imron-aly","tag-india","tag-intellectual-property","tag-ip","tag-katherine-tai","tag-maria-elena-bottazzi","tag-patent","tag-patrick-kilbride","tag-peter-j-hotez","tag-philip-thompson","tag-prashant-yadav","tag-robert-deberardine","tag-sapna-kumar","tag-south-africa","tag-tedros-adhanom-ghebreyesus","tag-trade-secret","tag-trade-secrets","tag-trips","tag-u-s-trade-representative","tag-ustr","tag-vaccine","tag-waiver","tag-who","tag-world-health-organization","tag-world-trade-organization","tag-wto","tag-yogesh-pai"],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/blogs.uakron.edu\/ualawip\/wp-json\/wp\/v2\/posts\/8523","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.uakron.edu\/ualawip\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.uakron.edu\/ualawip\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.uakron.edu\/ualawip\/wp-json\/wp\/v2\/users\/3627"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.uakron.edu\/ualawip\/wp-json\/wp\/v2\/comments?post=8523"}],"version-history":[{"count":1,"href":"https:\/\/blogs.uakron.edu\/ualawip\/wp-json\/wp\/v2\/posts\/8523\/revisions"}],"predecessor-version":[{"id":15617,"href":"https:\/\/blogs.uakron.edu\/ualawip\/wp-json\/wp\/v2\/posts\/8523\/revisions\/15617"}],"wp:attachment":[{"href":"https:\/\/blogs.uakron.edu\/ualawip\/wp-json\/wp\/v2\/media?parent=8523"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.uakron.edu\/ualawip\/wp-json\/wp\/v2\/categories?post=8523"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.uakron.edu\/ualawip\/wp-json\/wp\/v2\/tags?post=8523"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}