This is a guest post from law professor Michael Trebilcock and lawyer Dan Poliwoda:
THE TRIPS VACCINE WAIVER CONTROVERSY*
By
Michael Trebilcock
Emeritus University Professor of Law
University of Toronto
Dan Poliwoda
Lawyer, Dickinson Wright LLP
University of Toronto (J.D., 2020)
July 12, 2021
*We acknowledge the invaluable research assistance of Daniel Scarpitti, University of Toronto, Faculty of Law, 2L, in preparing these comments.
Table of Contents
III. THE PROPOSED TRIPS WAIVER.. 6
- THE CASE FOR AND AGAINST A COMPREHENSIVE TRIPS WAIVER.. 8
- REVIEWING ALTERNATIVE OR COMPLEMENTARY PROPOSALS FOR ACHIEVING COVID-19 GLOBAL HERD IMMUNITY.. 12
INTRODUCTION
This paper is motivated by the tension between international intellectual property (IP) protection and countries’ abilities to respond to public health emergencies by accessing essential medicines, a tension which has re-emerged in the context of patents, copyrights and trade secrets related to COVID-19 vaccines, diagnostics, therapeutics and other health products. More specifically, the vastly differing rate at which developed and developing countries have been able to procure COVID-19 vaccines has exposed major inequities in global vaccine access, a major concern in light of high mortality rates in developing countries and the threats posed by deadly variants to countries even with high vaccination rates.[1] In an effort to boost developing countries access to COVID-19 vaccines, it has been proposed that the World Trade Organization (WTO) grant a broad IP waiver to enable more widespread vaccine production, a proposal that has thus far been opposed by some developed WTO members, including some G7 countries.[2]
This paper proceeds as follows: section 1 introduces the TRIPS Agreement (defined below), the most comprehensive multilateral agreement on IP to date; section 2 reviews the access to essential medicines debate prior to the COVID-19 pandemic; section 3 introduces the recently proposed patent waiver regarding COVID-19 vaccines and other health products, and how WTO members have responded to it to date; section 4 considers the three main schools of thought that have emerged relating to the proposed WTO patent waiver; and section 5 considers recent policy proposals that have been advanced to address inequities in global vaccine access. Finally, we conclude with our recommendation for implementing the proposals considered in section 5. Specifically, we propose the creation of a committee (or war cabinet) formed by the heads of the four leading multilateral institutions – the International Monetary Fund (IMF), the World Bank, the World Health Organization (WHO), and the WTO – to address and implement solutions for emerging global issues as the COVID-19 pandemic continues to evolve.
I. THE TRIPS AGREEMENT
The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement or TRIPS) is a multilateral agreement that binds WTO members to maintain certain minimum standards for the protection of various forms of IP.[3] TRIPS was negotiated during the Uruguay Round (1986-1994) of the General Agreement on Tariffs and Trade (GATT), and introduced IP protections to the multilateral trading regime.[4] TRIPS is comprehensive, covering a wide range of IP – patents, trademarks and copyrights, including computer programs and databases – and mandatory enforcement procedures, remedies and dispute resolution procedures.[5]
TRIPS, as originally negotiated, contained in Article 31 a vigorously debated provision permitting compulsory licensing of IP rights subject to relatively stringent conditions. These included efforts by the proposed user to obtain authorization from the rights holder within a reasonable period of time – a requirement that may be waived by a WTO member during national emergencies or other circumstances of extreme urgency, which were undefined. Further, such use would be nonexclusive and authorized predominantly for the supply of the domestic market of the member authorizing such use, and subject to the rights holder being paid adequate remuneration in the circumstances of each case, taking into account the economic value of the authorization (again without further definition).
Prior to TRIPS, international IP protection did not factor in the multilateral trading system’s legal framework, and the GATT is mostly silent on the relationship between international trade and IP rights. As a result, IP producers were often subject to varying jurisdictional rules, largely shaped by the extent to which each jurisdiction linked trade policy to IP standards. In the United States (US), as for most developed countries,[6] trade policy and IP standards have consistently been linked, a pattern which can (at least partially) be traced back to extensive lobbying by senior management at US-based technology and pharmaceutical firms.[7] For example, since at least the 1980s, Pfizer Inc. has been involved in mobilizing other US firms and stakeholders to lobby US policymakers on the issue of international IP protection. This was largely motivated by pharmaceutical firms’ commercial considerations, i.e. stronger patent protections usually result in higher drug prices. In turn, maximizing IP privileges for producers became, and has generally continued to be, a fixture of US international trade policy priorities.[8]
II. THE ESSENTIAL MEDICINES DEBATE PRIOR TO THE COVID-19 PANDEMIC
The TRIPS Agreement has been the subject of intense criticism by some who allege that TRIPS subjects developing countries to the prices charged by pharmaceutical companies for essential medicines, practically denying the most vulnerable citizens of these countries access to potentially lifesaving drugs and preventing access to much cheaper generics (like HIV/AIDS antiretrovirals).[9] On the other side of the debate, proponents of TRIPS argue that committing WTO members to minimum IP standards resolves a collection action problem among developing countries, and they argue that in the absence of strong IP protections, pharmaceutical firms have little incentive to invest R&D resources for producing cures for diseases afflicting citizens of developing countries. They argue that TRIPS solves this problem, at least in principle, incentivizing pharmaceutical companies to address certain tropical and related diseases through the financial rewards associated with stronger IP protections.[10]
In response to concerns over access to essential medicines and TRIPS, especially in the context of the HIV/AIDS epidemic in the late 1990s, the WTO Ministerial Conference in Doha adopted the Doha Declaration on the TRIPS Agreement and Public Health (the Declaration) in 2001.[11] The Declaration reaffirmed certain flexibilities built into TRIPS which allow WTO members to circumvent patent rights for better access to essential medicines, including during public health emergencies or circumstances of extreme urgency. Specifically, the Declaration affirmed members’ rights to determine what constitutes a national emergency or circumstance of extreme urgency, and to establish their own regimes for the exhaustion of IP rights without challenge. In 2003, the WTO General Council (the Council) decided to adopt an additional set of provisions (the Decision) to ensure developing countries with insufficient pharmaceutical manufacturing capacities could make effective use of the flexibilities set out under Article 31 of the TRIPS Agreement.[12] In this respect, the Council determined that compulsory licenses could be issued to generic drug manufacturers in exporting countries and complementary compulsory licenses could also be issued by importing countries that lacked domestic manufacturing capacities.[13]
The Decision would eventually serve as the basis for a formal amendment to TRIPS Article 31 taking effect in 2017,[14] but several questions still remain regarding the most effective means for developing countries to access affordable medicines. For example, generic drug manufacturers and governments have faced challenges concluding licensing agreements in the absence of straightforward legislative steps and administrative procedures, which would help establish clear decision-making processes and responsibilities. Likewise, setting adequate compensation, as required under TRIPS Article 31(h) has never been predictable or easily administered.[15] Additionally, and of similar importance, other questions remain outstanding, including which countries qualify for parallel imports,[16] navigating the complexities of licensing agreements,[17] ensuring timeliness during public health emergencies,[18] and achieving cooperation from pharmaceutical companies who arguably have little incentive to cooperate.[19]
III. THE PROPOSED TRIPS WAIVER
On October 2, 2020, India and South Africa submitted a proposal to the WTO requesting a waiver from certain TRIPS provisions applying to COVID-19 vaccines and other health products for the “prevention, containment and treatment of COVID-19.”[20] As originally proposed, the waiver would be comprehensive, covering obligations in four sections of the TRIPS Agreement – copyright and related rights, industrial designs, patents, and protection of undisclosed information – and extend for an unspecified period of time. This comprehensive waiver proposal has subsequently been revised to clarify its scope, now applying to “health products and technologies including diagnostics, therapeutics, vaccines, medical devices, personal protective equipment, their materials or components, and their methods and means of manufacture for the prevention, treatment or containment of COVID-19.”[21] The revised proposal also clarifies the proposed waiver’s duration, namely a three-year waiver to be reviewed by the WTO General Council on an ongoing basis. Finally, and unlike the original proposal, the revised proposal reflects an explicit goal of balancing competing interests. The waiver proposal’s preamble now highlights the ongoing uncertainties regarding COVID-19, the spread of concerning variants, the “urgent need to diversify and scale-up production,” while acknowledging the importance of “preserv[ing] incentives for research and innovation, and that these should be balanced with the public health interest.”
Generally, support for the TRIPS waiver has reflected members’ stage of development. Whereas many developing countries have signed on to sponsor or support the waiver (around 100 countries total), several developed countries have opposed the waiver or favour alternative approaches to increasing global vaccine equity.[22] For example, Germany has expressed its opposition to a TRIPS waiver in any form.[23] The EU has submitted an alternative proposal to the WTO that mostly involves existing WTO mechanisms, namely “trade facilitation and disciplines on export restrictions,” “support for the expansion of production” (including through voluntary licensing agreements), and “clarifying and simplifying the use of compulsory licenses [under TRIPS] during crisis times.”[24] The US has expressed its support for text-based negotiations at the WTO over a narrower TRIPS waiver, applying specifically to COVID-19 vaccines.[25]
On June 9, 2020, the TRIPS Council decided to move to text-based negotiations of the revised proposal regarding a TRIPS waiver for COVID-19 vaccines and therapeutics.[26] At writing, the delegates to the WTO are working to prepare a draft that attempts to satisfy all of the different constituencies – waiver proponents and waiver skeptics alike – in time for the WTO General Council meeting scheduled for July 21-22.
IV. THE CASE FOR AND AGAINST A COMPREHENSIVE TRIPS WAIVER
As of the end of May 2021, poor developing countries have received less than 1% of vaccines administered. Broken down by continent, only 1.2% of the population of Africa, 4.8% of the population in Asia, and 14% of the population of South America have been vaccinated.[27] With the emergence and rapid spread of more deadly variants of the COVID-19 virus, dramatically and rapidly increasing vaccination rates globally is widely recognized as the most urgent global priority at the present time.
In this context, sharply divergent opinions have emerged as to whether IP rights in COVID-19 vaccines and their inputs are part of the solution or part of the problem in addressing this priority. One school of thought argues that IP rights are a serious impediment to dramatically expanding vaccine production capacity, especially in developing countries. Another school of thought takes the view that the relaxation or elimination of IP rights may be marginally beneficial, but that significantly more proactive and coordinated international policy initiatives are required to address this priority. A third school of thought argues that a sweeping waiver of IP rights in vaccines and their inputs is likely to have a deleterious impact on advancing this priority. We briefly review each of these three schools of thought below, drawing on prominent representatives of each school.
Prominent representatives of the first school of thought that favours a comprehensive TRIPS waiver are Joseph Stiglitz and Lori Wallach.[28] They argue that IP rights confer monopoly powers on the holders thereof, and like all monopolists they will seek to maximize profits by restricting supply and raising prices. They reject the idea that developing countries lack the manufacturing capacity or expertise to produce vaccines, noting existing agreements with the Serum Institute in India and Aspen Pharmacare in South Africa to produce vaccines in voluntary licensing or joint venture arrangements with proprietary vaccine manufacturers. They point to evidence that a number of developing countries with experience in producing other vaccines have substantial capacity to produce COVID-19 vaccines, and that proprietary vaccine manufacturers have thus far been reluctant to fully utilize this potential through voluntary licensing and joint venture arrangements. In their view, much of this potential manufacturing capacity could be deployed to COVID-19 vaccine production within a matter of months. They reject arguments that a waiver of IP rights will diminish economic incentives for the biotech sector to invest in future medical innovations, noting that even under a comprehensive TRIPS waiver they would be entitled to adequate compensation for generics derived from their proprietary products or processes and that several current proprietary vaccine manufacturers have been recipients of major public subventions. They also argue that current TRIPS flexibilities are inadequate to address the thicket of IP regulations along global supply chains, given the case-by-case nature of compulsory licensing they provide for.
We take as prominent representatives of the second school of thought Peter Hotez, Maria Elena Bottazzi and Prashant Yadav, three prominent US medical specialists, who argue that COVID-19 vaccines, especially the high-performing MRNA vaccines, entail extremely complex and sophisticated technological scientific and logistical processes, involving more than 100 components, sourced from a number of specialized input providers in a number of different countries.[29] They conclude that replicating these processes in many developing countries is not a realistic objective, at least in the near-term. They contrast these processes with the much simpler steps involved in producing HIV-AIDS antiretrovirals facilitated by the expanded TRIPS flexibilities post-2001, which allowed generic producers to enter the market for these medicines relatively quickly.[30] In the longer-term, they recommend that the international community make major investments in a select number of virus and vaccine R&D and production hubs on each major continent, although acknowledging that this does little to address urgent priorities in the near-term.[31]
The third school of thought, principally articulated by prominent representatives of the pharmaceutical industry, argue that a comprehensive TRIPS waiver would have a deleterious impact on near-term vaccine production and distribution priorities, especially because it would promote an uncoordinated scramble for critical vaccine inputs, many of which are already in short supply.[32] In addition, new manufacturing facilities in developing countries producing generic versions of proprietary COVID-19 vaccines would presumably be required to meet widely accepted standards of safety and efficacy, requiring some form of credible regulatory oversight and approval if public concerns in these respects, along with increased vaccine hesitancy, are to be minimized. Proponents of this school of thought also point out that proprietary COVID-19 vaccine manufacturers are already employing a form of tiered pricing with higher prices for vaccines in high-income countries, lower prices for middle-income countries, and lower prices again for low-income countries. They point out that even monopolists do not make money by pricing their products beyond the reach of citizens in poor countries. Indeed, the profit-maximizing strategy for a monopolist is to engage in price discrimination that reflects differential elasticities by country or customer group, and that any price above marginal cost in a given low-income market is better than selling no products at all, as long as fixed costs can be recovered in other high-income markets and these markets remain effectively segregated to preclude product arbitrage. Finally, proponents of this school of thought have expressed concerns over the effect of a comprehensive TRIPS waiver on long-term incentives for investments in medical R&D and innovation, especially for smaller highly specialized biotech companies.
In general, we find the second school of thought the most persuasive and that a comprehensive TRIPS waiver, standing alone, is likely to have only a marginal impact on near-term, urgent global priorities. Thus, we favour either suspending a vote in the WTO on the TRIPS waiver, or approving it, but then suspending it as long as measurable targets for increased output fully exploiting all potential voluntary licensing or joint ventures are met within defined timeframes. To achieve the priority of dramatically expanding vaccine output and ensuring effective deployment to most developing countries, it is becoming increasingly clear that complementary domestic capacities are required in terms of delivery and storage technology, trained healthcare workers, and credible public information campaigns to ensure substantial take-up. Thus, in the fifth section of this paper, we turn to more comprehensive policy proposals for addressing these priorities in the near-term.
V. REVIEWING ALTERNATIVE OR COMPLEMENTARY PROPOSALS FOR ACHIEVING COVID-19 GLOBAL HERD IMMUNITY
It has become a truism among policymakers that unless everyone in the world is safe from the COVID-19 virus, nobody is safe, given the ability of the virus and its variants to be transmitted rapidly across borders. For those who take the view that a sweeping waiver of IP rights, by itself, is unlikely to have any dramatic effect on achieving this goal, especially over the near term – a view that we share – it is important to explore alternative or complementary strategies.
In a thoughtful article by Raj Shah, President of the Rockefeller foundation and former head of USAID, Shah organizes the challenges that must be addressed in boosting global vaccine production and distribution into three categories: (1) supply; (2) delivery; and (3) financing. Shah also sketches proposals for addressing constraints in each of these three categories.[33] Other commentators, such as Chad Bown and Thomas Bollyky,[34] draw on Operation Warp Speed, the Trump Administration’s public-private partnership aimed at facilitating and accelerating the development of COVID-19 vaccines, proposing a globally coordinated set of initiatives designed to minimize cross-border constraints on global supply chains, and to subsidize expansions of capacities to relieve bottlenecks in these chains where necessary. They recognize that a “global coordinating body” will be needed to achieve these objectives, i.e. “an effective and transparent administrator who is in one part general contractor and one part ombudsperson” (but not further specified).
In a more recent study undertaken by the International Monetary Fund (IMF), “A Proposal to End the Covid-19 Pandemic,” Ruchir Agarwal and Gita Gopinath outline a set of detailed proposals that elaborate on Shah’s three categories of challenges.[35] Their proposals target: (1) vaccinating at least 40% of the population in all countries by the end of 2021 and at least 60% by the first half of 2022; (2) tracking and insuring against downside risks; and (3) ensuring widespread testing and tracing, maintaining adequate stocks of therapeutics, and enforcing public health measures in places where vaccine coverage is low. They estimate that their proposals’ benefits – approximately $9 trillion to the global economy – far outweigh the estimated costs of $50 billion (of which $35 billion would be paid by grants from donors and the residual by national governments potentially with the support of concessional financing from bilateral and multilateral agencies).
A recent editorial in the Economist magazine, “The West is Passing Up the Opportunity of the Century,” drawing on the IMF study, states: “imagine an investment that would earn a return of 17,900% in four years. Better yet, the initial outlay would be easily affordable. Who on earth would pass up such an opportunity?”[36] On May 31, 2021, in an op-ed published in the Washington Post, the heads of the four leading multilateral institutions – the IMF, the WHO, the World Bank, and the WTO – issued an unprecedented collective call to action, identifying key and complementary roles that each of their organizations can and should play in achieving vaccine equity and overcoming the challenges posed by the pandemic in the near term.[37]
CONCLUSION: A MULTILATERAL SOLUTION FOR ADDRESSING EMERGING CHALLENGES DURING THE COVID-19 PANDEMIC
We are persuaded that these detailed proposals, especially those advanced in the IMF study, warrant early and urgent consideration and implementation. However, the IMF study and earlier studies, such as that by Bown and Bollyky, are disappointingly thin on the institutional arrangements required for their effective implementation. For instance, the top-down, command-and-control initiatives pursued by the Trump administration during Operation Warp Speed are not readily replicated at the international level. Furthermore, coordinating the policy initiatives of the four leading multilateral institutions with overlapping but not identical membership, and with very different internal decision-making processes, poses its own challenges. For our part we see virtues in the constitution of a pandemic “war cabinet” or committee, composed of the heads of the IMF, the WHO, the World Bank, and the WTO, or their senior designates, and supported by a seconded secretariat, that over the near term would meet on a weekly basis with a checklist of issues to be addressed from week-to-week. Minutes of each meeting would be made public in the interests of transparency and accountability (with exceptions for commercially sensitive information relating to contractual and similar negotiations). Meetings of our proposed cabinet would be chaired by each of the heads of the four institutions on a rotating basis.
Given the threat posed by variants and the related concern that variants may spread more quickly than vaccination rates, time is of the essence. Implementation of well-conceived proposals, such as those advanced in the IMF study, is the critical challenge, along with institutional arrangements at the international level focused relentlessly on this challenge.
[1] See Kristalina Georgieva et al., “Here’s Our Plan to Increase Vaccine Access and End the Pandemic Faster”, Washington Post, 31 May 2021, online: <https://www.washingtonpost.com/opinions/2021/05/31/why-we-are-calling-new-commitment-vaccine-equity-defeating-pandemic/>; Raj Shah, “COVID’s Haves and Have-Nots”, Foreign Affairs, 4 June 2021, online: <https://www.foreignaffairs.com/articles/world/2021-06-04/covids-haves-and-have-nots>.
[2] Saeed Shah and Gabriele Steinhauser, “Europe Pushes Alternative to Waiving Patents on Covid-19 Vaccines,” The Wall Street Journal, 3 June 2021, online: <https://www.wsj.com/articles/europe-pushes-alternative-to-u-s-backed-covid-19-vaccine-patent-waiver-plan-11622732952?page=1>;Yuka Hayashi and Jared S. Hopkins, “U.S. Backs Waiver of Intellectual Property Protection for Covid-19 Vaccines,” The Wall Street Journal, 6 May 2021, online: <https://www.wsj.com/articles/u-s-backs-waiver-of-intellectual-property-protection-for-covid-19-vaccines-11620243518?page=2>; Ann Danauya Usher, “South Africa and India Push for COVID-19 Patents Ban,” (2020) 396 The Lancet 10265.
[3] See generally, Michael Trebilcock and Joel Trachtman, Advanced Introduction to International Trade Law, 2nd ed (Cheltenham: Edward Elgar, 2020) at chapter 12, and A. Taubman, et al., A Handbook on the WTO Trips Agreement (Cambridge: Cambridge University Press, 2012).
[4] Peter Drahos and John Braithwaite, Information Feudalism (New York: New Press, 2003) at chapter 4.
[5] TRIPS also incorporates by reference the provisions on copyright from the Berne Convention for the Protection of Literary and Artistic Works, with the exception of moral rights. It also incorporates by reference the substantive provisions of the Paris Convention for the Protection of Industrial Property.
[6] During the Uruguay Round, negotiations over TRIPS were led by the US with strong support from EU, Japan, and other developed countries.
[7] Susan K. Sell, Private Power, Public Law: The Globalization of Intellectual Property Rights (Cambridge: Cambridge University Press, 2003) at 3-4.
[8] Ibid.
[9] See Drahos and Braithwaite, Information Feudalism.
[10] See Alan O. Sykes, “TRIPS, Pharmaceuticals, Developing Countries and the Doha Solution” (2002) 3(1) Chicago Journal of International Law 47.
[11] Doha Declaration on the TRIPS Agreement and Public Health (WT/MIN(01)/DEC/2), Doha WTO Ministerial, 14 November 2001, online (pdf): <https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.pdf>.
[12] Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health (WT/L/540 and Corr.1), WTO General Council, 30 August 2003, online: <https://www.wto.org/english/tratop_e/trips_e/implem_para6_e.htm>; Amendment of the TRIPS Agreement (WT/L/641), WTO General Council, 6 December 2005, online: <https://www.wto.org/english/tratop_e/trips_e/wtl641_e.htm>.
[13] See Sisule Musungu and Cecilia Oh, “The Use of Flexibilities in TRIPS By Developing Countries: Can They Promote Access To Medicines,” 1 August 2005, online (pdf): Commission on Intellectual Property Rights, Innovation and Publish Health, World Health Organization <https://www.who.int/intellectualproperty/studies/TRIPSFLEXI.pdf?ua=1>.
[14] “An Amendment to the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS),” 2017, online: <https://www.wto.org/english/tratop_e/trips_e/tripsfacsheet_e.htm>.
[15] Musungu and Oh, “The Use of Flexibilities in TRIPS By Developing Countries.”
[16] Rojina Thapa, "Waiver Solution in Public Health and Pharmaceutical Domain under TRIPS Agreement," (2011) 16 Journal of Intellectual Property Rights 470; Carlos Correa, “Access to Drugs under TRIPS: A not so expeditious solution” (2004) 8:1 Bridges 21.
[17] Thapa, “Waiver Solution in Public Health and Pharmaceutical Domain under TRIPS Agreement.”
[18] Ibid.
[19] Vera Zolotaryova, “Are We There Yet? Taking "TRIPS" to Brazil and Expanding Access to HIV/AIDS Medication” (2008) 33:3 Brooklyn Journal of International Law 1099.
[20] Waiver from Certain Provisions of the TRIPS Agreement for the Prevention, Containment and Treatment of COVID-19 (IP/C/W/669), Council for Trade-Related Aspects of Intellectual Property Rights, 2 October 2020, online (pdf): <https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W669.pdf&Open=True>.
[21] Waiver from Certain Provisions of the TRIPS Agreement for the Prevention, Containment and Treatment of COVID-19 (IP/C/W/669/Rev.1), Council for Trade-Related Aspects of Intellectual Property Rights, 25 May 2021, online (pdf): <https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W669R1.pdf&Open=True>.
[22] Daniel Crosby et al, “Update on the Proposed TRIPS Waiver at the WTO: Where is it Headed, and What to Expect?” JD Supra, 8 June 2021, online: <https://www.jdsupra.com/legalnews/update-on-the-proposed-trips-waiver-at-8411942/>.
[23] Dharshini David, “COVID: Germany Rejects US-Backed Proposal to Waive Vaccine Patents,” BBC News, 6 May 2021, online: <https://www.bbc.com/news/world-europe-57013096>.
[24] Draft General Council Declaration on the TRIPS Agreement and Public Health in the Circumstances of a Pandemic (IP/C/W/681), Council for Trade-Related Aspects of Intellectual Property Rights, 18 June 2021, online (pdf): <https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W681.pdf&Open=True>.
[25] Statement from Ambassador Katherine Tai on the COVID-19 TRIPS Waiver,” Office of the United States Trade Representative, 5 May 2021, online: <https://ustr.gov/about-us/policy-offices/press-office/press-releases/2021/may/statement-ambassador-katherine-tai-covid-19-trips-waiver>.
[26] Andrew Green, “WTO Council Offers Hope for TRIPS Vaccine Proposal,” Devex International Development, 10 June 2021, online: <https://www.devex.com/news/wto-council-offers-hope-for-trips-vaccine-proposal-100125>.
[27] Shah, “COVID’s Haves and Have-Nots.”; As of July 11, 2021, only 1.61%, 6.09%, and 62.45% of all administered vaccines have been administered in Africa, South America, and Asia respectively. See “COVID-19 Vaccine Doses Administered by Continent,” Our World in Data, 11 July 2021, online: <https://ourworldindata.org/grapher/cumulative-covid-vaccinations-continent?stackMode=relative&country=Africa~Asia~Europe~North+America~Oceania. ~South+America>.
[28] Joseph E. Stiglitz and Lori Wallach, “Will Corporate Greed Prolong the Pandemic,” Project Syndicate, 6 May 2021, online: <https://www.project-syndicate.org/onpoint/big-pharma-blocking-wto-waiver-to-produce-more-covid-vaccines-by-joseph-e-stiglitz-and-lori-wallach-2021-05>.
[29] Peter J. Hotez, Maria Elena Bottazzi and Prashant Yadav, “Producing a Vaccine Requires More Than a Patent: Intellectual Property is Just One Piece of an Elaborate Process,” Foreign Affairs, 10 May 2021, online: <https://www.foreignaffairs.com/articles/united-states/2021-05-10/producing-vaccine-requires-more-patent>; Chad Bown & Chris Rogers, “The US Did Not Ban Exports of Vaccine Supplies. But more help is needed.”, Peterson Institute for International Economics, 7 June 2021, online: <https://www.piie.com/blogs/trade-and-investment-policy-watch/us-did-not-ban-exports-vaccine-supplies-more-help-needed>.
[30] Hotez, Bottazi and Yadav, “Producing a Vaccine Requires More Than a Patent.”; Rojina Thapa, "Waiver Solution in Public Health and Pharmaceutical Domain under TRIPS Agreement" (2011) 16 Journal of Intellectual Property Rights 470.
[31] See also, Bryan Mecurio, "WTO Waiver from Intellectual Property Protection for COVID-19 Vaccines and Treatments: A Critical Review" (Forthcoming 2021) Virginia Journal of International Law.
[32] Albert Bourla, “An Open Letter from Pfizer Chairman and CEO Albert Bourla,” Pfizer, 7 May 2021, online: <https://www.pfizer.com/news/hot-topics/an_open_letter_from_pfizer_chairman_and_ceo_albert_bourla>; Michelle McMurry-Heath, “Michelle McMurry-Heath on Maintaining IP Amid COVID-19,” The Economist, 20 April 2021, online: <https://www.economist.com/by-invitation/2021/04/20/michelle-mcmurry-heath-on-maintaining-intellectual-property-amid-covid-19>.
[33] Shah, “COVID’s Haves and Have-Nots.”
[34] Chad P. Bown and Thomas J. Bollyky, “Here’s How to Get Billions of COVID-19 Vaccine Doses to the World,” Peterson Institute for International Economics, 18 March 2021, online: <https://www.piie.com/blogs/trade-and-investment-policy-watch/heres-how-get-billions-covid-19-vaccine-doses-world>.
[35] “A Proposal to End the COVID-19 Pandemic, 1 May 2021, online (pdf): International Monetary Fund, <https://www.imf.org/-/media/Files/Publications/SDN/2021/English/SDNEA2021004.ashx>.
[36] “The West is Passing Up the Opportunity of the Century,” The Economist, 12 June 2021, online: <https://www.economist.com/leaders/2021/06/09/the-west-is-passing-up-the-opportunity-of-the-century>.
[37] Georgieva et al., “Here’s Our Plan to Increase Vaccine Access and End the Pandemic Faster.”
