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The Waiver of Certain Intellectual Property Rights Provisions of the TRIPS for the Prevention, Containment and Treatment of COVID-19: A Review of the Proposal under WTO Jurisprudence

Published online by Cambridge University Press:  05 January 2022

Khorsed Zaman*
Lecturer in Law, Macquarie University, Sydney, Australia Email:


This article is a critical legal analysis of the proposed TRIPS waiver under World Trade Organization (WTO) law. It reviews the existing TRIPS flexibilities and the “August 2003 TRIPS waiver”, highlighting the obstacles to achieving the goals of these legal instruments. It demonstrates that numerous critical TRIPS flexibilities, notably TRIPS Article 31bis, are ineffective, prompting some countries to submit a new waiver proposal to the WTO. It highlights several WTO rules that are also quite ambiguous. This paper argues that a WTO clarification might be an alternative to the new TRIPS waiver proposal if it is ultimately rejected due to a lack of consensus among WTO members. Finally, this article emphasises the importance of adopting a balanced approach that may simplify complicated TRIPS rules, decrease the risk of trade-based retaliation and improve collaboration in knowledge transfer and scaling up the manufacture of and access to lifesaving vaccines, pharmaceuticals and healthcare equipment.

© The Author(s), 2022. Published by Cambridge University Press

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3 WTO Agreement on Trade-Related Aspects Intellectual Property Rights (TRIPS), 15 April 1995, 33 I.L.M 81 (1994). The Legal Texts: The Results of the Uruguay Round of Multilateral Trade Negotiations 321 (1999), as amended on 23 January 2017.

4 The Waiver from Certain Provisions of the TRIPS Agreement for the Prevention, Containment and Treatment of COVID-19: Communication from India and South Africa, WTO DOC. IP/C/W/669 (2 October 2020).

5 ibid, paras 12 and 13.

6 Revised Waiver Proposal, WTO Doc. IP/C/W/669/Rev.1 (25 May 2021).

7 ibid. Revised Proposal, paras 2 and 5.

8 Operative Paragraph 1, Revised Waiver Proposal. IP/C/W/669/Rev.1.

9 ibid, para 4.

10 The original proposal includes all technologies for COVID-19 detection, prevention, treatment and response, but the US statement simply supports waiving IPRs in COVID-19 vaccines. See “Statement from Ambassador Katherine Tai on the COVID-19 TRIPS Waiver” (USTR, 5 May 2021), <> (last accessed 10 July 2021).

11 ibid, USTR statement.

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14 B Baschuk, “EU’s Trade Response to Pandemic Stops Short of Vaccine IP Waiver” (Bloomberg, 3 June 2021) <>; K Cullinan, “G20 Leaders Promise to Share More Vaccines While EU Digs in Against TRIPS Waiver” (Health Policy Watch, 21 May 2021) <>; European Commission, “Opening Statement by Executive Vice-President Valdis Dombrovskis at the European Parliament Plenary Debate on the Global COVID-19 Challenge” (European Commission, 19 May 2021) <> (all last accessed 10 July 2021).

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16 D Gervais, The TRIPS Agreement: Drafting History and Analysis (London, Sweet and Maxwell 2003) pp 32–43.

17 ibid.

18 ibid.

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20 Ministerial Declaration, WTO Doc WT/MIN(01)/DEC/1 (20 November 2001) (para 17) (Ministerial Conference, Fourth Session, Doha, 9–14 December 2001).

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24 TRIPS, supra, note 3, Art 66.1.

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26 For multiple national and international perspectives on compulsory licensing, see, in general, RM Hilty and K-C Liu (eds), Compulsory Licensing: Practical Experiences and Ways Forward (Berlin, Springer-Verlag 2015); CM Correa, “Guide for the Granting of Compulsory Licenses and Government Use of Pharmaceutical Patents” (South Centre Research Paper No. 107) (April 2020).

27 FM Abbot, “Parallel Trade in Pharmaceuticals: Trade Therapy for Market Distortions” in I Calboli and E Lee (eds), Research Handbook on Intellectual Property Exhaustion and Parallel Imports (Cheltenham, Edward Elgar 2016) pp 145–67.

28 S Frankel and D Gervais, “International Intellectual Property Rules and Parallel Imports” in I Calboli and E Lee (eds), Research Handbook on Intellectual Property Exhaustion and Parallel Imports (Cheltenham, Edward Elgar 2016) pp 85–105.

29 TRIPS, supra, note 3, Arts 31(b) and 73(b)(iii).

30 J Bacchus, “An Unnecessary Proposal: A WTO Waiver of Intellectual Property Rights for COVID-19 Vaccines (CATO Institute: Free Trade Bulletin Number 78, 16 December 2020); B Mercurio, “WTO Waiver from Intellectual Property Protection for COVID-19 Vaccines and Treatments: A Critical Review” (2021) 62 Virginia Journal of International Law Online 10–31.

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33 F Abbott, “The TRIPS Agreement Article 73 Security Exceptions and the COVID-19 Pandemic”, Global South Research Paper 116 (South Centre, August 2020), 22.

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35 Doha Declaration on the TRIPS Agreement and Public Health, supra, note 21.

36 ibid.

37 WTO, “Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health”, WTO Doc. WT/L/540 (2 September 2003) (Decision of 30 August 2003).

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40 As per Arts 31 and 32 of the Vienna Convention on the Law of Treaties (VCLT), 1969 (23 May 1969) (Effective from 27 January 1980) United Nations, Treaty Series, vol 1155, p 331.

41 ICTSD, TRIPS Council: Debate over Effectiveness of System for Access to Medicine (Vol 14, No 38, 3 November 2010).

42 Canada was the first country to export the first shipment of generic drugs to Rwanda in 2008. See ICTSD, “First Generic Drugs En Route to Africa under 5 Year Old WTO Deal” (2008) 12(31) Bridges Weekly Trade News Digest.

43 ICTSD, “Lamy: Review Mechanism Can Improve Access to Medicine in Developing Countries” (2008) 12(42) Bridges Weekly Trade News Digest.

44 Medicines Law and Policy, supra, note 39.

45 Notification under Paragraph 2(a) of the Decision of 30 August 2003 on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, WTO DOC. IP/N/9/RWA/1 (19 July 2007).

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47 ibid.

48 Council for Trade-Related Aspects of Intellectual Property Rights, Notification under Paragraph 2(c) of the Decision of 30 August 2003 on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, WTO Doc. IP/N/10/CAN/1 (8 October 2007).

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50 Council for Trade-Related Aspects of Intellectual Property Rights, Annual Review of the Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health: Report to the General Council, WTO Doc. IP/C/57 (10 December 2010).

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54 ibid.

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57 European Parliament, Answer given by Executive Vice-President Dombrovskis on behalf of the European Commission, Document No. E-000463/2021 (13 April 2021) <> (last accessed 14 May 2021).

58 Sell, supra, note 19.

59 TRIPS Art 73 also provides another ground to issue compulsory license.

60 Abbott, supra, note 33.

61 Arts 31 and 32, Vienna Convention on the Law of Treaties, 1969, supra, note 40.

62 Russia – Measures Concerning Traffic in Transit, Panel Report (5 April 2019), WTO Doc. WT/DS512/R, paras 7.27–7.149.

63 Saudi Arabia – Measures Concerning the Protection of Intellectual Property Right, Panel Report (16 June 2020) WTO Doc. WT/DS567/R.

64 Saudi Arabia–Qatar IPRs dispute, paras 7.241–7.243.

65 ibid, paras 7.242, 7.252, 7.271, 7.285 and 7.293.

66 Supra, notes 13 and 14; E ‘t Hoen, “The Elephant in the Room at the WHO Executive Board” (Medicine Law and Policy, 22 January 2021) <> (last accessed 10 February 2021).

67 E Bonadio and F Fontanelli, “Push for COVID-19 Vaccine Patent Waiver Isn’t a Panacea: But It Could Nudge Companies to Share” (The Conversation, 13 May 2021) <> (last accessed 12 October 2021).

68 KHN, “Can Pfizer and Moderna End the Pandemic by Sharing Their Vaccine Designs? It’s Not that Simple” (KHN, 15 February 2021) <> (last accessed 30 November 2021).

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70 J Kollewe, “From Pfizer to Moderna: Who’s Making Billions from Covid-19 Vaccines?” (The Guardian, 6 March 2021) <> (last accessed 30 November 2021).

71 WHO, “How WHO C-TAP Works?” (WHO, 27 October 2020) <> (last accessed 30 November 2021).

72 Los Angeles Times, “Vaccine Companies and the U.S. Government Snubbed WHO Initiative to Scale Up Global Manufacturing” (Los Angeles Times, 30 April, 2021) <> (last accessed 1 December 2021).

73 GB Dinwoodie and RC Dreyfuss, “Designing a Global Intellectual Property System Responsive to Change: The WTO, WIPO and Beyond” NYU School of Law, Public Law Research Paper No. 09-63 (2009); H Ullrich, J Drexl, M Lamping and RM Hilty (eds), TRIPS Plus 20: From Trade Rules to Market Principles (Berlin, Springer-Verlag 2016) p 302.

74 Panel Report, Canada – Patent Protection of Pharmaceutical Products, WT/DS114/R, adopted 7 April 2000, paras 7.23–7.26; Appellate Body Reports, Australia – Certain Measures Concerning Trademarks, Geographical Indications and Other Plain Packaging Requirements Applicable to Tobacco Products and Packaging, WT/DS435 - 441/AB/R, adopted on 29 June 2020, paras 6.625, 6.626 and 6.658. If such a balance is maintained, it will not undermine the “research, development and innovation” as claimed by some authors (eg Mercurio, supra, note 30, pp 16, 17).

75 T Amin, “Voluntary Licensing Practices in the Pharmaceutical Sector: An Acceptable Solution to Improving Access to Affordable Medicines?” (Oxfam, 8 February 2007) <> (last accessed 15 January 2021).

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77 C Deere, The Implementation Game: The TRIPS Agreement and the Global Politics of Intellectual Property Reform in Developing Countries (Oxford, Oxford University Press 2009) pp 303–20.

78 Bonadio and Fontanelli, supra, note 67.