The International Trade Law Review: The TRIPS Waiver and Covid-19 Vaccine Production

I Introduction

The covid-19 pandemic has led to a number of trade controversies, but one of the most contentious, as well as the most interesting from a policy perspective, has been the World Trade Organization's (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) waiver for vaccines and related medical goods. The proposal for a waiver was put forward by India and South Africa, but was seen as having little prospect of success until the Biden administration decided to support it. Even with the United States behind it, however, it faces an uphill battle. At the time of writing, the issue is unresolved, so we can tell only a partial version of the story. However, with the information we have, we describe the origins of the proposal, the key policy arguments put forward by each side and the state of the negotiations. We also suggest alternative approaches that might be more effective at achieving the goal of increased vaccine production.

II The Origins and History of The TRIPS Waiver Proposal

The inclusion of intellectual property (IP) rules in the WTO as part of the Uruguay Round was controversial as a general matter, but many of the nuances of the disagreement were not explored at the time. It was only with experience that concrete objections rose to the surface. In the area of pharmaceutical patents, developing countries, often led by India and South Africa, were the strongest critics. These issues gained prominence in relation to the production of medicines to treat HIV, resulting in a Doha Ministerial Declaration in 2001, a subsequent waiver adopted in 2003 and an amendment of the TRIPS Agreement (Article 31 bis) in 2017. Similar issues have now emerged in relation to the production of vaccines and other medical products during the covid-19 pandemic.

The formal discussion of the covid-19 IP issues at the WTO began in October 2020, when India and South Africa put forward a proposal entitled 'Waiver from Certain Provisions of the TRIPS Agreement for the Prevention, Containment and Treatment of COVID-19'.2 Noting a growing supply and demand gap for new diagnostics, therapeutics and vaccines for covid-19, and arguing that IP rights in this area could hinder the 'timely provisioning of affordable medical products',3 these two countries proposed 'a waiver from the implementation, application and enforcement of Sections 1 [copyrights and related rights], 4 [industrial design], 5 [patents] and 7 [protection of undisclosed information] of Part II of the TRIPS Agreement'.

The proposal was discussed at the WTO's TRIPS Council meeting on 16 October 2020, where South Africa formally introduced the proposal, on behalf of Eswatini, India, Kenya and South Africa. South Africa referred to the HIV crisis, the 2004 outbreak of avian influenza H5N1 and the 2009 outbreak of influenza H1N1, all of which presented difficulties for developing countries in securing access to medical supplies. Facing similar challenges now, South Africa emphasised the importance of 'rapid access to affordable medical products (to fight COVID-19)'. South Africa blamed IP, which, it said, 'sustains dominating industry's interest at the cost of lives', for 'the deep structural inequality in access to medicines globally'.4 South Africa stressed that IP rights could hinder timely provisioning of medical products and that some WTO members 'may face institutional and legal difficulties when using flexibilities' offered in the TRIPS Agreement, especially the 'requirements of Article 31bis and . . . the cumbersome and lengthy process for the import and export of pharmaceutical products'.5 Therefore, 'in order to scale up production, governments have a critical role to play'.6 To this end, South Africa called for 'global solidarity, and the unhindered global sharing of technology and know-how'.7

Along the same lines, India emphasised that 'the development of and equitable access to the tools – such as diagnostics, therapeutics, treatments, vaccines etc . . . are limited by IP barriers', which is 'evident from an array of lawsuits filed by private companies in different parts of the world for IP infringement on COVID-19 products'.8 While recognising that voluntary licensing may be more appropriate, India pointed to the fact that 'not a single IP holder has shown willingness to commit to the COVID-19 Technology Access Pool (C-TAP) and the [Access to COVID-19 Tools Accelerator] voluntary initiatives.'9 India also noted that billions of dollars of government support had been provided for developing new technologies to fight covid-19, and therefore the traditional argument for IP protection – that it rewards and stimulates innovation and invention – would not apply here.10 It also highlighted that a waiver would be limited to 'a period that this Council finds necessary to effectively handle the COVID crisis' and 'will be reviewed annually by the General Council in accordance with the provisions of Article IX (4) of the WTO Agreement'.11

China conveyed its support for 'discussions on possible waiver or other emergency measures to respond to the pandemic, which should be “targeted, proportional, transparent and temporary”, and which do not create unnecessary barriers to trade or disruption to global supply chains'.12 Sri Lanka, Nigeria, Bangladesh, Pakistan, Venezuela, Nicaragua, Mozambique, Egypt, Indonesia, Argentina, Mauritius, Mali, Honduras and the least-developed countries group represented by Chad, all showed a certain level of support for the proposal.

On the other side of the debate, the United States, with the Trump administration still in office, opposed the waiver. It believed that the goal of 'helping to ensure the swift delivery of potential COVID-19 therapeutics and vaccines around the globe' will be best achieved by 'facilitating incentives for innovation and competition to develop, test, and produce safe and effective therapeutics and vaccines for the COVID-19 response, including by respecting intellectual property rights, and supporting industry-led collaboration and voluntary knowledge sharing'.13

Along the same lines, the European Union (EU) recognised the importance of 'broad and equitable access' to vaccines for all countries, but also noted that the IP system is crucial to ensure that the extraordinary efforts that went into medical development get 'adequately incentivised and rewarded'. According to the EU, there is no evidence that IP rights have been genuine barriers here. Instead, the 'spike in demand and lack of manufacturing' are the main obstacles. As a result, the EU noted four areas that countries should instead focus on tackling: (1) rapidly developing safe and effective treatments or vaccines against covid-19; (2) increasing manufacturing capacity; (3) keeping global supply chains open; and (4) ensuring broad and equitable global distribution of treatments and vaccines once they become available.14

As an alternative to a waiver, the EU pushed for voluntary participation in the COVID-19 Tools Accelerator (ACT Accelerator) and its vaccine pillar – the COVID-19 Vaccines Global Access (COVAX) – and indicated its willingness, 'where necessary and justified', to make use of 'flexibilities provided under the TRIPS Agreement' and others, including compulsory licences under Article 31 bis, 'if all voluntary solutions fail and IP became a barrier'.15

Echoing the EU, Switzerland emphasised the 'pivotal factor' the IP system plays in innovation of pharmaceutical products including vaccines, and argued that a TRIPS waiver would undermine the ongoing research and development of covid-19-related medical products and vaccines. Similar to the EU's position, Switzerland advocated for voluntary actions and international collaborations via various means including the ACT Accelerator, with remedies and flexibilities under the TRIPS Agreement as a fallback if all voluntary efforts failed.16

Canada argued that, as the only country that has ever used Article 31 bis, it believes that the TRIPS agreement works as intended and the examples of difficulties in domestic implementation of the TRIPS Agreement that had been put forward do not necessitate a waiver.17

After the first TRIPS Council meeting on this subject, Australia, Canada, Chile and Mexico submitted a document asking a series of questions related to the 'nature and scope' of any obstacles arising from the TRIPS Agreement. In particular, they asked for specific examples of IP rights impeding covid-19-related purchases, problems with issuing compulsory licences under the TRIPS Agreement other than domestic reasons and any potential measures waiver proponents seek to enact that are not consistent with the TRIPS Agreement.18 These questions were answered to some extent in written responses submitted by South Africa, India and other waiver proponents.19

The discussion was repeated at a TRIPS Council meeting on 10 December 2020. During this meeting, the EU argued that 'many pharmaceutical companies', such as AstraZeneca and Johnson & Johnson, have stepped up to expand manufacturing.20 In this regard, it reminded other members that IP is 'a key factor' in ensuring 'vaccines to be produced in a manner that ensures their efficacy and safety'.21 It also reiterated that in case IP becomes an issue, there are flexibilities under the TRIPS Agreement, including 'fast-track procedures where no negotiations with the patent holder are required', and 'licenses for export to countries with no or insufficient manufacturing capacity'.22 With regard to problems with domestic implementations of these rules raised by some countries, the EU offered to provide technical assistance to those countries.23

The United States also pointed to 'non-exclusive voluntary licensing agreements [one country signed] with generic pharmaceutical manufacturers based in Egypt, India and Pakistan to manufacture its drug for distribution in 127 countries' as examples of measures other than a waiver that would accomplish the underlying goals here.24 With regard to a waiver, the United States, at an informal meeting held on 20 November 2020, raised questions about the proportionality, effects, scope and implementation of a waiver.25

Responding to questions regarding potential problems with using compulsory licences under the TRIPS Agreement, India reiterated that 'Article 31 compulsory licences are issued on a case-by-case, country-by-country basis' and therefore they are 'an impractical option' facing 'the need . . . to scale up supply, the need to source materials from various countries'. When discussing alternatives to a wavier, India asked the EU to identify 'plans to persuade . . . companies to “enter into transparent, non-exclusive global open licenses”' and steps to take to 'ensure full transparency and accountability in the cost of R&D and in licensing agreements'.26

South Africa noted that voluntary licensing arrangements, as some waiver opponents have pointed to, 'are often such that they may restrict access or reserve supply only for wealthy nations'.27 It also pointed out that the goals set by the ACT Accelerator, including COVAX, are far from sufficient. Specifically, the goals to 'provide 2 billion vaccine doses (for 1 billion people) to the world by the end of 2021, 245 million courses of treatment and 500 million diagnostic tests to LMICs (excluding many developing countries) in 2021 are insufficient to meet global needs of the 7.7 billion people of this world'.28

III The Public Campaign and The Surprising Shift in The US Position

As seen in Section II, the Trump administration did not have much sympathy for the waiver proposal. At the TRIPS Council meeting on 16 October 2020, the US delegate emphasised that IP has been a motivating force rather than an obstacle in combating the pandemic, and limits to manufacturing facilities, supply chain issues and possible regulatory barriers pose greater concerns than the IP system.29 In addition, without IP, 'the development and commercialization of those products would likely not happen in an effective, efficient, and timely way, if it happens at all'.30 Hence, the Trump administration only supported 'voluntary, complementary and mutually supportive' efforts to scale up covid-19 related supplies.31

The US position on a waiver did not immediately change after President Biden took office. During an April virtual WTO conference, US Trade Representative Katherine Tai did indicate a shift in tone, though, as she seemed to blame 'the market' for failing to meet global demand, and conveyed a willingness to engage in 'modifications and reforms to our trade rules [that] might be necessary'.32 She also offered strong warnings for the pharmaceutical industry.33 She noted that '[t]his is not just a challenge for governments', and '[the] challenge applies equally to the industry responsible for developing and manufacturing the vaccines'. Soon after, she met with pharmaceutical company representatives,34 unions and various interest groups35 to solicit their input, but it was not clear what impact these discussions would have.

As governments were discussing these issues at the WTO, various public health NGOs and other campaigners were pushing hard for the TRIPS waiver. With hope that the Biden administration might be more sympathetic to their views, their efforts picked up in early 2021. In February and March 2021, the NGO community redoubled its efforts,36 and Democratic members of Congress weighed in as well.37 By late March, there were reports that the White House was considering a change of position.38 The NGO campaign and the congressional interventions continued through late April and early May.39

After months of internal debates,40 on 5 May 2021 the Biden administration announced its support in principle for a waiver. While 'the Administration believes strongly in intellectual property protections', a statement from Katherine Tai said, the United States 'supports the waiver of those protections for COVID-19 vaccines' and 'will actively participate in text-based negotiations at the [WTO] needed to make that happen'.41 It was noteworthy that the statement did not commit the United States to the waiver proposal in its current form, and appeared to be more limited that what India and South Africa had requested. Nevertheless, this was a significant moment in the TRIPS waiver debate and perhaps more broadly in the US position on IP protection.

Back at the WTO, by April 2021, while the number of co-sponsors of the waiver had reached 60,42 there was still a good deal of scepticism about the waiver among various developed country governments. On 21 May 2021, perhaps in the hopes of bringing more countries on board, waiver proponents put forward a revised proposal.43 The new version, however, did not substantially change the scope of the waiver. It added a three-year time frame for the waiver, although the waiver would continue after this period unless the General Council decided to terminate it. It also added a sentence '[r]ecognizing the importance of preserving incentives for research and innovation, and that these should be balanced with the public health interest'.44 Because most of the arguments against the waiver are based on its broad scope, including the ones from the United States,45 the newer proposal may have difficulty attracting additional support.

In early June, the EU put forward several alternative proposals that it considered would increase the production and distribution of vaccines without a TRIPS waiver.46 The United States continued its support for the waiver in principle, but did not support the revised proposal, noting: 'we are still reviewing the revised proposal, [but] our initial reaction is that it is a relatively modest change. While we recognize it is not for the proponents to negotiate with themselves, it is a shared responsibility to find common ground and to respond to the issues raised by other Members, and time is of the essence.'47 In the view of the United States, 'the most expeditious pathway toward consensus would be to focus our efforts on what actions might be needed to address the supply and distribution of vaccines specifically'.

The future of the waiver is uncertain, as many differences remain between WTO Members.48 Members agreed that weekly negotiating sessions would begin on 24 June 2021, in advance of a July General Council meeting.49 But as outlined in the following sections, the waiver itself may not be as important as some of the behind-the-scenes negotiations that are taking place.

IV Is the Waiver Necessary under WTO Rules?

Moving beyond the political back and forth, it is important to understand the fundamental legal issues at play here. One criticism of the TRIPS waiver is that existing WTO rules provide sufficient flexibility for developing countries to take whatever measures they deem appropriate, and therefore a special waiver is unnecessary. In this regard, there are a number of substantive provisions that could offer a legal basis for these measures; and in terms of possible enforcement actions under WTO rules, the WTO's dispute settlement mechanism can be fairly accommodating, as it does not require withdrawal of measures that are found in violation.

Turning first to the substantive obligations, developing countries that wish to push the boundaries of TRIPS rules have a number of provisions they can invoke. For example, Article 73 of the TRIPS Agreement provides an exception for 'security'. For decades, such a defence was rarely used in disputes relating to the General Agreement on Tariffs and Trade and the WTO,50 but in recent years the United States, Russia and Saudi Arabia have all invoked it in WTO litigation in a variety of circumstances.51 If these governments can rely on the broad defence of national security, there is no reason developing countries could not do so here. Legal scholars such as Frederick Abbott and Carlos Correa have both advocated this approach.52

Dalindyebo Shabalala, another legal scholar, advocates a narrower approach, focusing on the compulsory licences that can be issued under Article 31 of the TRIPS Agreement.53 This process has not worked well in the past, but Shabalala suggests '[r]emoving the TRIPS limitations on production for export', to 'allow a country like India, at the request of a qualifying country, to issue blanket compulsory licenses covering all COVID-19 vaccine technologies, set the compensation prices and allow the vaccines to be exported to multiple countries simultaneously'.

There is also Article 30, which states that 'Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties.' Arguably, any measures taken by developing country governments to address covid-19 are 'limited' to that one disease, and given the scale of the pandemic, do not 'unreasonably' conflict with a normal exploitation of the patent or 'unreasonably' prejudice the legitimate interests of the patent owner.

And, finally, while not a formal exception, Article 8.1 sets out the following guiding principle that is sure to be cited when these issues arise: 'Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development, provided that such measures are consistent with the provisions of this Agreement.'

Thus, taking all of these provisions together, there are strong arguments that whatever actions developing countries are considering in relation to production and distribution of vaccines are actually permissible under existing WTO rules, and thus an additional waiver is not necessary. Having said that, a WTO waiver would increase the certainty surrounding actions such as compulsory licences, and could make developing country governments more willing to take these sorts of actions.

With regard to the enforceability of those rules, five points are worth noting. First, the political backlash they would receive likely means wealthy governments would not challenge the measures. Second, a full WTO dispute generally takes several years to play out, and by the time there is a final ruling in a complaint against a developing country, the pandemic may well be over and the measures withdrawn. Third, how a WTO panel would rule on the substantive issues is unclear. Fourth, because of the Appellate Body crisis, WTO dispute settlement is not functioning properly at the moment anyway. And finally, the WTO's dispute settlement rules do not require withdrawal of a measure. If they wanted to maintain the measures, developing countries could simply accept authorised retaliation by the complainant, as other respondents who did not want to implement have done.

V Is the Waiver Sufficient to Accomplish its Ultimate Goals?

In addition to questions about whether the waiver is necessary, there are also questions about whether it is sufficient. What is crucial to increasing production of vaccines is the specific know-how that the inventor has about all the different aspects of production. As law professor Sapna Kumar puts it: 'Merely having the patent in front of you that gives disclosures with regard to your new mRNA vaccine or the like, that isn't going to be enough to tell you how to immediately go and produce your own version of that vaccine. Because there's little things like manufacturing conditions – what temperature is your facility at? Small details can make a difference as to whether you're able to produce a viable vaccine. This kind of know-how is critical in terms of being able to replicate a complex biologic type of drug like a vaccine.'54

One of the strongest arguments against the waiver is that the better way to achieve the goal of more production is to do more licensing deals.55 This approach may be seen in the 'third way' advocated by WTO Director-General Ngozi Okonjo-Iweala, who has explained that WTO members 'must address issues related to technology transfer, knowhow and intellectual property'.56 As she put it: 'we need to work with manufacturers to enable them to mobilize existing capacity that is idle to manufacture. We heard from countries like Pakistan, Bangladesh, India, South Africa, and so on, Indonesia, Senegal, that there is some existing capacity that can be turned around in some months to be able to allow us to manufacture the kinds of doses we may need to go from the 5 billion doses produced in the world today to the 10.8 billion being forecast for this year to 15 billion, in particular if we need booster doses.'57

VI Would the Waiver Have Negative Effects on Future Innovation in Medicines?

Given the broader context of the IP debate at the WTO, with India, South Africa and other developing countries having long-standing concerns about the rules in this area, it is worth considering the broader impact of a TRIPS waiver on innovation. Any change to the status quo could have an impact on incentives to innovate.

Those who object to the waiver express concern about its impact on the innovation that helped create the vaccines in the first place. Former Appellate Body member Jim Bacchus explains that some waiver advocates hold the belief that all medicines should be considered 'global public goods' and that IP rights of any kind are suspect. He calls such a view 'myopic'. The 'practical reality', he says, is that 'many medicines would simply not exist if it were not for the existence of IP rights and the protections they are afforded'. The reason for granting such rights in the first place 'is that they are incentives for innovation', and '[w]ithout IP rights as incentives, there would be less new knowledge and thus less innovation.' While '[i]n the short term, undermining private IP rights may accelerate distribution of goods and services', over 'the long term, undermining private IP rights would eliminate the incentives that inspire innovation, thus preventing the discovery and development of knowledge for new goods and services that the world needs'.58

At the same time, it is worth noting that the evidentiary support for existing IP rules is sometimes weak,59 and a reconsideration based on modern empirical evidence might be in order. However, a radical change in the midst of an emergency such as the covid-19 pandemic is risky. A more practical approach to the current political and public health crisis may be to work towards a narrower waiver that can achieve a consensus,60 and put off the broader rethinking of the global IP regime until later.

VII Alternatives to the Waiver

Putting aside the waiver and the TRIPS Agreement, there are some existing voluntary alternatives that could be utilised to promote increased production and better distribution of vaccines. For example, as mentioned in Section II, there is the ACT Accelerator, which is an initiative to secure vaccine and pharmaceutical access, and the COVID-19 Technology Access Pool (C-TAP), a platform that is designed for information sharing to scale up production.

The ACT Accelerator is a multinational collaboration to raise financial support for accelerated development, production and access to innovative health tools related to covid-19, including diagnostics, therapeutics and vaccines.61 Launched in April 2020, the ACT Accelerator is designed to give all countries access to the necessary health tools to fight covid-19, while allowing them to share the cost. Participating parties to the ACT Accelerator include the World Health Organization (WHO), the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi, the Vaccine Alliance (GAVI), Unitaid, governments and private-sector organisations such as the Gates Foundation.62 The target of the ACT Accelerator is to raise US$35 billion to secure 2 billion covid-19 vaccine doses, 245 million treatments and 500 million tests.63

The ACT Accelerator has four pillars: vaccines (COVAX), diagnostics, therapeutics and health system connector. The COVAX Facility, co-led by CEPI, GAVI and the WHO, is a procurement mechanism of COVAX. By investing in a broad portfolio of vaccine candidates, the COVAX Facility pools purchasing power from participating countries to ensure their quick access to vaccines once they receive regulatory approval. The WHO is working on the allocation framework to ensure equitable distribution among participating countries.64 The COVAX Advance Market Commitment, a building block of the COVAX Facility, is a financing instrument led by GAVI, to secure vaccine access at low cost for high-risk populations in 92 lower-middle and low-income economies.65

In early June 2021, the Biden administration announced its plan to donate 80 million vaccine doses to COVAX by the end of June (the plan is in motion but with some delay), along with other plans such as 'working with U.S. manufacturers to increase vaccine production for the rest of the world, and helping more countries expand their own capacity to produce vaccines including through support for global supply chains'66 and buying 500 million doses of Pfizer's vaccine to donate to the world.67 These efforts could be seen as a short-term alternative until a waiver decision can be reached. Vaccine producers such as Pfizer, Moderna and Johnson & Johnson also committed to supply, partially through COVAX, 3.5 billion vaccine doses to middle- and low-income countries over the next two years.68

Sharing the same goal of promoting development and production and ultimately facilitating access to health products related to covid-19, C-TAP is a platform for developers of covid-19 therapeutics, diagnostics, vaccines and other health products to voluntarily share their IP, knowledge and data. Through non-exclusive voluntary licensing, C-TAP would facilitate other manufacturers to produce, obtain regulatory approval for and sell covid-19-related health products. C-TAP originated from a proposal put forward by President of Costa Rica, Carlos Alvarado Quesada, on 23 March 2020 to 'undertake an effort to pool rights to technologies that are useful for the detection, prevention, control and treatment of the COVID-19 pandemic', and was formally launched by the WHO in May 2020.69

Because C-TAP is voluntary, the WHO has no way to force any companies to participate. Despite the good intent, so far most large pharmaceutical companies including Pfizer and Moderna have shown no interest in joining C-TAP, due to concerns over losing their proprietary IP.70

On 4 June 2021, the EU put forward some 'concrete short- and medium-term solutions', which include limits on export restrictions, the use of voluntary licensing and compulsory licensing, and 'an initiative to develop vaccine production in the African continent'.71 This initiative will be carried out by the EU and EU Member States, to help develop 'investment in infrastructure and production capacities as well as skills development, supply chains management, and the necessary regulatory framework' in African countries.72 The initiative is already ongoing in some countries such as South Africa, Senegal and Rwanda, and has secured €1 billion in funding, according to the EU.73

VIII Conclusions

While the waiver has captured headlines in the public debate, the crucial issue here is transferring the production know-how from the pharmaceutical industry to developing country producers to increase production. There have already been some transfers through voluntary deals, such as to the Serum Institute of India, but more may be possible. Some companies in the developing world claim they can undertake this production,74 although the facts here are a bit unclear.75 Thus, the focus for the United States and others should arguably be on convincing the pharmaceutical industry to work with as many of these factories as possible.

Indeed, it is possible that advocates of the TRIPS waiver recognise its limited impact, and that their real goal is to increase leverage on the pharmaceutical industry to be more accommodating of licensing demands. Waiver advocates Lori Wallach and Joseph Stiglitz perhaps hinted at this in a Washington Post op-ed when they said: 'A waiver would immediately increase government leverage over vaccine makers that refuse to license the technology.'76 And US Trade Representative Katherine Tai may have been getting at the same point when she said: 'There is a lot that [the pharmaceutical industry] could do voluntarily that would obviate what we would need to do at the WTO'.77

There is also the prospect of compensating the pharmaceutical industry for the losses they will suffer from giving away their expertise. As law professor Sapna Kumar puts it: 'So let's say we come up with a mechanism to force them to turn that over. That doesn't relate just to their current COVID vaccines, right? That's strategic information that can relate to a whole slew of other drugs that they make. And I'm far from a pharmaceutical industry apologist, but even to me that seems excessive. It's a huge amount of proprietary information.'78 The pharmaceutical industry has some critics who believe it is already profiting too much from the pandemic, but in terms of coming up with a practical way forward, compensation to the industry that will lead to more production may ultimately be the most effective approach.


Footnotes

1 Simon Lester and Huan Zhu are the co-founders of China Trade Monitor.

2 Council for Trade-Related Aspects of Intellectual Property Rights. Waiver from Certain Provisions of the TRIPS Agreement for the Prevention, Containment and Treatment of COVID-19. WTO Doc. IP/C/W/669 (October 2, 2020).

3 In their proposal, India and South Africa cited the following news reports: Susan Decker and Christopher Yasiejko, 'World War II-Style Mobilization Order May Carry Risks', Bloomberg News. March 20, 2020. https://www.bloomberg.com/news/articles/2020-03-20/world-war-ii-style-production-may-carry-legal-
risks-for-patriots; Morgan Watkins, 'Kentucky Gov. Andy Beshear calls on 3M to release patent for N95 respirator amid pandemic', Louisville Courier Journal. April 3, 2020. https://www.courier-journal.com/story/news/2020/04/03/beshear-calls-3-m-release-patent-n-95-respirator-amid-pandemic/5112729002/.

4 Council for Trade-Related Aspects of Intellectual Property Rights, Minutes of Meeting for Meeting of Council for TRIPS 15-16 October and 10 December 2020, WTO Doc. IP/C/M/96/Add.1 (2 February 2021) Para. 1167.

5 ibid., Paras. 859–860.

6 ibid., Para. 1162.

7 ibid., Para. 861.

8 ibid., Para. 867.

9 ibid., Para. 869.

10 ibid., Para. 868.

11 ibid., Para. 873.

12 ibid., Para. 977.

13 ibid., Para. 1046.

14 ibid., Para. 1029.

15 ibid., Paras. 1036–1041.

16 ibid., Paras. 1050–1064.

17 ibid, Para. 1187.

18 Council for Trade-Related Aspects of Intellectual Property Rights. Questions on Intellectual-Property Challenges Experienced by Members in Relation to Covid-19, WTO Doc. IP/C/W/671 (November 27, 2020).

19 Council for Trade-Related Aspects of Intellectual Property Rights. Response to Questions on Intellectual-Property Challenges Experienced by Members in Relation to Covid-19, WTO Doc. IP/C/W/673 (January 15, 2021).

20 Council for Trade-Related Aspects of Intellectual Property Rights, Minutes of Meeting for Meeting of Council for TRIPS 15-16 October and 10 December 2020, WTO Doc. IP/C/M/96/Add.1, Para. 1275.

21 ibid., Para 1274.

22 ibid., Paras 1278–1279.

23 ibid., Para 1280.

24 ibid., Para 1321.

25 ibid., Paras. 1339–1354.

26 ibid., Para. 1425.

27 ibid., Para. 1470.

28 ibid., Para. 1479.

29 ibid., Para. 1314.

30 ibid., Para. 1362.

31 ibid., Para. 1364.

32 Office of the United States Trade Representative, 'Ambassador Katherine Tai's remarks at a WTO virtual conference on Covid-19 vaccine equity', Press Release. April 14, 2021. https://ustr.gov/about-us/policy-offices/press-office/press-releases/2021/april/ambassador-katherine-tais-remarks-wto-virtual-
conference-covid-19-vaccine-equity.

33 ibid.

34 Andrea Shalal, 'Top U.S. trade negotiator meets Pfizer, AstraZeneca execs on COVID-19 IP waiver', Reuters. April 16, 2021. https://www.reuters.com/business/healthcare-pharmaceuticals/top-
us-trade-negotiator-meets-pfizer-astrazeneca-execs-covid-19-ip-waiver-2021-04-27/.

35 Andrea Shalal, 'U.S. trade czar meets unions, companies as pressure mounts for IP waiver to boost vaccinations', Reuters. April 13, 2021. https://www.reuters.com/article/us-health-coronavirus-wto-usa/u-s-trade-czar-meets-unions-companies-as-pressure-mounts-for-ip-waiver-to-boost-vaccinations-idUSKBN2C101U.

36 '400+ US Civil Society Organizations Call on Pres. Biden to Stop Blocking COVID-19 WTO Waiver to Boost Vaccines, Treatments Worldwide', Public Citizen. February 26, 2021. https://www.citizen.org/news/hundreds-of-prominent-us-civil-society-organizations-call-on-pres-biden-to-stop-blocking-covid-19
-wto-waiver-to-boost-vaccines-treatments-worldwide/.

37 Letter from Senator Bernie Sanders to President Biden, April 15, 2021. https://www.sanders.senate.gov/wp-content/uploads/SenateTRIPSletter4.15.21.pdf.

38 Kayla Tausche and Jacob Pramuk, 'White House weighs temporarily lifting intellectual property shield on Covid-19 vaccines', CNBC. March 29, 2021. https://www.cnbc.com/2021/03/26/covid-vaccine-updates-white-house-mulls-lifting-intellectual-property-shield.html.

39 Joseph E. Stiglitz and Lori Wallach, 'Opinion: Preserving intellectual property barriers to covid-19 vaccines is morally wrong and foolish', Wall Street Journal. April 26, 2021. https://www.washingtonpost.com/opinions/2021/04/26/preserving-intellectual-property-barriers-covid-19-vaccines-is-morally-wrong-foolish; 'House Democrats push Biden to support, negotiate on IP waiver at WTO', Inside US Trade. May 4, 2021. https://insidetrade.com/daily-news/house-democrats-push-biden-support-negotiate-ip-waiver-wto.

40 Dan Diamond and Jeff Stein, 'White House is split over how to vaccinate the world', Washington Post. April 30, 2021. https://www.washingtonpost.com/health/2021/04/30/biden-administration-debates-waiving-vaccine-patents/.

41 Office of the United States Trade Representative, 'Statement from Ambassador Katherine Tai on the Covid-19 Trips Waiver', Press Release. 5 May 2021. https://ustr.gov/about-us/policy-offices/press-office/press-releases/2021/may/statement-ambassador-katherine-tai-covid-19-trips-waiver.

42 'TRIPS waiver co-sponsors to review language as White House deliberates', Inside US Trade. April 30, 2021. https://insidetrade.com/daily-news/trips-waiver-co-sponsors-review-language-white-house-deliberates.

43 IP/C/W/669/Rev.1.

44 Council for Trade-Related Aspects of Intellectual Property Rights, Waiver from Certain Provisions of the TRIPS Agreement for the Prevention, Containment and Treatment of COVID-19. WTO Doc. IP/C/W/669/Rev.1. (May 21, 2021). https://www.keionline.org/wp-content/uploads/W669Rev1.pdf.

45 ibid, Para. 1318.

46 Simon Lester, 'The EU's Counterproposal on COVID-19 Vaccines and Treatments', International Economic Law and Policy Blog. June 4, 2021. https://ielp.worldtradelaw.net/2021/06/the-eus-counterproposal-on-
covid-19-vaccines-and-treatments.html.

47 Statement by the United States – Formal Meeting at the WTO TRIPS Council. June 9, 2021. https://geneva.usmission.gov/2021/06/09/statement-by-the-united-states-formal-meeting-
at-the-wto-trips-council/.

48 Hannah Monicken, 'U.S. seeks to narrow IP waiver scope as WTO members agree to text talks', Inside US Trade. June 9, 2021. https://insidetrade.com/daily-news/us-seeks-narrow-ip-waiver-scope-wto-members-agree-text-talks.

49 Hannah Monicken, 'WTO members agree to weekly meetings to negotiate IP waiver,' Inside US Trade. June 18, 2021. https://insidetrade.com/daily-news/wto-members-agree-weekly-
meetings-negotiate-ip-waiver.

50 Roger P. Alford, 'The Self-Judging WTO Security Exception', Notre Dame Law School. 2011.
https://scholarship.law.nd.edu/law_faculty_scholarship/330/.

51 Pramila Crivelli and Mona Pinchis-Paulsen, 'Separating the political from the economic: the Russia-traffic in transit panel report', Global Governance Programme. 2021. https://cadmus.eui.eu/handle/1814/69858.

52 Frederick M. Abbott, 'The TRIPS Agreement Article 73 Security Exceptions and the COVID-19 Pandemic', FSU College of Law. August 1, 2020. https://frederickabbott.com/content/trips-agreement-
article-73-security-exceptions-and-covid-19-pandemic; Carlos Correa, 'Covid-19 Pandemic: Access to Prevention and Treatment Is a Matter of National and International Security,' South Centre. April 4, 2020. https://www.southcentre.int/wp-content/uploads/2020/04/COVID-19-Open-Letter-REV.pdf.

53 Dalindyebo Shabalala, 'How to get COVID-19 vaccines to poor countries – and still keep patent benefits for drugmakers', The Conversation. April 14, 2021. https://theconversation.com/how-to-get-covid-19-vaccines-to-poor-countries-and-still-keep-patent-benefits-for-drugmakers-158384; see also James Bacchus, 'An Unnecessary Proposal: A WTO Waiver of Intellectual Property Rights for COVID-19 Vaccines', Cato. December 16, 2020. https://www.cato.org/free-trade-bulletin/unnecessary-proposal-
wto-waiver-intellectual-property-rights-covid-19-vaccines.

54 Scott Graham, 'Should IP Rights Be Suspended for COVID Vaccines? A Q&A With University of Houston's Sapna Kumar', The National Law Journal. April 28, 2021. https://www.law.com/nationallawjournal/2021/04/28/should-ip-rights-be-suspended-for-covid-vaccines-a-qa-with-university-of-houstons-sapna-kumar/.

55 See, e.g, Editorial Board, 'How to step up vaccine supplies to poorer countries', Financial Times. May 4, 2021. https://www.ft.com/content/836845c1-e313-40b2-bdc0-61a3e244008c ('There are better alternatives. First, global pharma companies should create more partnerships among each other, and sign more licensing deals with local producers elsewhere that include providing expert support. Indeed, to fend off a Trips waiver, vaccine makers may need to show they can move faster in doing such deals. Some are happening. The Biden administration brokered a partnership for Merck to manufacture doses of the Johnson & Johnson jab; in Europe, Novartis, GSK and others are helping Germany's CureVac to produce an experimental mRNA vaccine. Including its high-profile licensing deal with the Serum Institute of India, meanwhile, AstraZeneca has contracted manufacturing capacity at 25 sites in 15 countries. The World Health Organization is trying to encourage controlled technology transfer on mRNA vaccines through regional “hubs”.')

56 Ngozi Okonjo-Iweala 'DG Okonjo-Iweala calls on WTO members to tackle vaccine inequity', WTO. May 21, 2021. https://www.wto.org/english/news_e/news21_e/dgno_21may21_e.htm.

57 Ngozi Okonjo-Iweala, 'Remarks by DG Okonjo-Iweala on the IP waiver', WTO. May 5, 2021. https://www.wto.org/english/news_e/spno_e/spno9_e.htm; Thiru, 'Incoming WTO Director-General calls for 'third way' towards scaling up manufacturing of COVID-19 vaccines', Knowledge Ecology International. February 19, 2021. https://www.keionline.org/35334; The Chair of the General Council, 'Statement of Director-General Elect Dr. Ngozi Okonjo-Iweala to the Special Session of the WTO General Council', WTO. February 13, 2021. https://www.wto.org/english/news_e/news21_e/dgno_15feb21_e.pdf.

58 James Bacchus, 'An Unnecessary Proposal: A WTO Waiver of Intellectual Property Rights for COVID-19 Vaccines', Cato. December 16, 2020. https://www.cato.org/free-trade-bulletin/unnecessary-proposal-
wto-waiver-intellectual-property-rights-covid-19-vaccines.

59 See, e.g., Simon Lester and Huan Zhu. 'Rethinking the Length of Patent Terms', American University International Law Review. Vol. 34. Iss. 4 , Article 4. (2019). https://digitalcommons.wcl.american.edu/auilr/vol34/iss4/4/.

60 Gary Winslett, 'A Compromise Moratorium,' RStreet. March 2, 2021. https://www.rstreet.org/2021/03/02/a-compromise-moratorium/.

61 Marwa Rashad, 'G20 launches initiative for health tools needed to combat the coronavirus', The Globe and Mail. April 25, 2020. https://www.theglobeandmail.com/world/article-g20-launches-initiative-for-health-tools-needed-to-combat-the-2/.

63 World Health Organization, 'Coronavirus Global Response: Access to COVID-19 Tools-Accelerator Facilitation Council holds inaugural meeting', WHO News Release. September 10, 2020. https://www.who.int/news/item/10-09-2020-coronavirus-global-response-access-to-covid-19-tools-accelerator-facilitation-council-holds-inaugural-meeting.

65 Seth Berkley, 'The Gavi COVAX AMC Explained', Gavi. February 2021. https://www.gavi.org/vaccineswork/gavi-covax-amc-explained.

66 The White House, 'FACT SHEET: Biden-Harris Administration Unveils Strategy for Global Vaccine Sharing, Announcing Allocation Plan for the First 25 Million Doses to be Shared Globally', White House Press Release. June 3, 2021. https://www.whitehouse.gov/briefing-room/statements-releases/2021/06/03/fact-sheet-biden-harris-administration-unveils-strategy-for-global-vaccine-sharing-announcing-allocation-plan-for-the-first-25-million-doses-to-be-shared-globally/.

67 Tyler Pager and Emily Rauhala, 'Biden administration to buy 500 million Pfizer coronavirus vaccine doses to donate to the world', Washington Post. June 9, 2021. https://www.washingtonpost.com/politics/biden-vaccine-donate/2021/06/09/c2744674-c934-11eb-93fa-9053a95eb9f2_story.html.

68 'Covid-19 vaccine firms pledge 3.5 billion doses for poorer nations', France 24. May 21, 2021.
https://www.france24.com/en/europe/20210521-covid-19-vaccine-firms-pledge-3-5-billion-doses-
for-poorer-nations.

69 Covid-19 Technology Access Pool, 'Operationalising the Covid-19 Technology Access Pool (C-tap)', WHO. October 27, 2020. https://cdn.who.int/media/docs/default-source/essential-medicines/intellectual-property/who-covid-19-tech-access-tool-c-tap.pdf.

70 Emily Baumgaertner, 'Vaccine companies and the U.S. government snubbed WHO initiative to scale up global manufacturing', LA Times. April 30, 2021. https://www.latimes.com/world-nation/story/2021-04-30/vaccine-companies-and-the-u-s-government-snubbed-who-initiative-to-scale-up-global-manufacturing.

71 'EU proposes TRIPS waiver alternative to address vaccine access', Inside US Trade. June 4, 2021.
https://insidetrade.com/daily-news/eu-proposes-trips-waiver-alternative-address-vaccine-access.

72 General Council, 'Urgent Trade Policy Responses to the Covid-19 Crisis,' WTO Doc. WT/GC/231. June 4, 2021. https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/WT/GC/231.pdf&Open=True.

73 ibid.

74 Maria Cheng and Lori Hinnant, 'Countries urge drug companies to share vaccine know-how', AP. March 1, 2021. https://apnews.com/article/drug-companies-called-share-vaccine-info-22d92afbc3ea9ed519be007f8887bcf6; See also, Lori Wallach, 'The Folly of Vaccine Monopolies', FESNY. April 28, 2021. https://www.fesny.org/article/the-folly-of-vaccine-monopolies/; Matthew M. Kavanagh, Mara Pillinger, Renu Singh and Katherine Ginsbach, 'To Democratize Vaccine Access, Democratize Production', Foreign Policy. March 1, 2021. https://foreignpolicy.com/2021/03/01/to-democratize-vaccine-access-
democratize-production/.

75 As former WTO Deputy-Director General Alan Wolff put it in a recent talk: 'There's a debate that is somewhat fact free at present with respect to 'is there productive capability in developing countries that is not utilized that could be utilized and that the TRIPs, trade related intellectual property, agreement is somehow preventing anyone from producing vaccine because of patents?'. That has to be explored, it has to be known.' Alan Wolff, 'The Future of the WTO', Petersen Institute for International Economics. April 29, 2021. https://www.piie.com/events/future-wto.

76 Joseph E. Stiglitz and Lori Wallach, 'Opinion: Preserving intellectual property barriers to covid-19 vaccines is morally wrong and foolish', Wall Street Journal. April 26, 2021. https://www.washingtonpost.com/opinions/2021/04/26/preserving-intellectual-property-barriers-covid-19-vaccines-is-morally-wrong-foolish/; along the same lines, writing separately Lori Wallach has argued: '[the waiver] would immediately increase government leverage on originators that have refused to share vaccine technology on a more open basis'. Lori Wallach, 'The Folly of Vaccine Monopolies', FESNY. April 28, 2021. https://www.fesny.org/article/the-folly-of-vaccine-monopolies/; See also: Ben Grossman-Cohen, https://twitter.com/BenGroCo/status/1387824000697577474; Dan Diamond and Jeff Stein, 'White House is split over how to vaccinate the world', Washington Post. April 30, 2021. https://www.washingtonpost.com/health/2021/04/30/biden-administration-debates-waiving-vaccine-patents/ ('Inside the White House, officials have wrestled with how to proceed, with some teams pushing to use the patent issue as leverage with the pharmaceutical industry to ramp up its global efforts'); and Rebecca Robbins and Peter S. Goodman, 'Pfizer Reaps Hundreds of Millions in Profits From Covid Vaccine', NY Times. May 4, 2021. https://www.nytimes.com/2021/05/04/business/pfizer-covid-vaccine-profits.html ('It could just be an incentive for companies to come forward and collaborate', Mustaqeem De Gama, councillor at the South African mission to the WTO in Geneva, said in an interview late last year ('But if left to the choice of companies, usually companies will refuse to collaborate and share what knowledge they have.').

77 Simon Lester, 'Additional Katherine Tai Exchanges on Vaccine Production/TRIPS Waiver', International Economic Law and Policy Blog. May 14, 2021. https://ielp.worldtradelaw.net/2021/05/additional-katherine-
tai-exchanges-on-vaccine-productiontrips-waiver.html ('And so I want to say there is room to have these conversations and I also want to urge industry, the manufacturers, don't be so nervous and afraid about what this means. This is actually an opportunity for them to lean in and build on the incredible work that they've done in research and development and developing these vaccines, to really also becoming part of the solution. And I've invited them to seize this opportunity for leadership, to join us. There is a lot that they could do voluntarily that would obviate what we would need to do at the WTO, but because we are not there, we have significant portions of the global economy telling us that they are in trouble, that they need access, and that they need to do something through the rules, because otherwise they're not getting any progress and their hopes and dreams and their recovery are really held back because of it.').

78 Scott Graham, 'Should IP Rights Be Suspended for COVID Vaccines? A Q&A With University of Houston's Sapna Kumar', The National Law Journal. April 28, 2021. https://www.law.com/nationallawjournal/2021/04/28/should-ip-rights-be-suspended-for-covid-vaccines-a-qa-with-university-of-houstons-sapna-kumar/.

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