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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 Open the ORCID record for Khorsed Zaman [Opens in a new window]
Khorsed Zaman*
Affiliation:
Lecturer in Law, Macquarie University, Sydney, Australia Email: [email protected]
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Abstract

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.

Keywords

COVID-19intellectual property rightsTRIPS waiverWTO
Type
Articles
Information
European Journal of Risk Regulation , Volume 13 , Issue 2 , June 2022 , pp. 295 - 310
Copyright
© The Author(s), 2022. Published by Cambridge University Press

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References

1 C Quinn, “The Global Vaccine Divide Looms Large Ahead of G-7 Summit: While Most G-7 Nations Have Plenty of Vaccine Doses, Poorer Countries Still Go Without” (Foreign Policy, 9 June 2021) <https://foreignpolicy.com/2021/06/09/g7-vaccine-coronavirus-covid/> (last accessed 19 June 2021).

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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), <https://ustr.gov/about-us/policy-offices/press-office/press-releases/2021/may/statement-ambassador-katherine-tai-covid-19-trips-waiver> (last accessed 10 July 2021).

11 ibid, USTR statement.

12 H Monicken, “Tai Talks TRIPS Waiver with Allies as China Gets Behind it, GOP Balks” (Inside Health Policy, 20 May 2021) <https://insidehealthpolicy.com/daily-news/tai-talks-trips-waiver-allies-china-gets-behind-it-gop-balks> (last accessed 10 July 2021).

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15 Minutes of the Meeting: Held in the Centre William Rappard from 2 to 5 April 2001, WTO Doc IP/C/M/30 (1 June 2001) (paras 229–52) (Council for Trade-Related Aspects of Intellectual Property Rights).

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

17 ibid.

18 ibid.

19 For a brief history and background of the scenario, see SK Sell, “Intellectual Property and the Doha Development Agenda” in D Lee and R Wilkinson (eds), WTO after Hong Kong: Progress in, and Prospects for, the Doha Development Agenda (Abingdon-on-Thames, Routledge 2007) pp 57–61.

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

21 Doha WTO Ministerial 2001: TRIPS WT/MIN(01)/DEC/2, “Declaration on the TRIPS Agreement and Public Health (Adopted 14 November 2001)” (WTO, 20 November 2001) <https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm> (last accessed 19 July 2021).

22 WTO: 2017 News Item, “WTO IP Rules Amended to Ease Poor Countries’ Access to Affordable Medicines” (WTO, 23 January 2017) <https://www.wto.org/english/news_e/news17_e/trip_23jan17_e.htm> (last accessed 16 July 2021).

23 W New, “It’s Official: TRIPS Health Amendment In Effect, First Ever to a WTO Agreement” (Intellectual Property Watch, 23 January 2017) <https://www.ip-watch.org/2017/01/23/official-trips-health-amendment-effect-first-ever-wto-agreement/> (last accessed 12 July 2021).

24 TRIPS, supra, note 3, Art 66.1.

25 United Nations, “WTO Drugs Patent Waiver for LDCs Extended until 2033” (United Nations, 2021) <https://www.un.org/ldcportal/wto-drugs-patent-waiver-for-ldcs-extended-until-2033/> (last accessed 20 July 2021).

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.

31 KEI, “COVID-19 Vaccine Manufacturing Capacity” (Knowledge Ecology International, 19 February 2021) <https://www.keionline.org/covid-19-vaccine-manufacturing-capacity> (last accessed 18 July 2021).

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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.

34 UNCTAD, “COVID-19 Heightens Need for Pharmaceutical Production in Poor Countries” (UNCTAD, 27 May 2020) <https://unctad.org/news/covid-19-heightens-need-pharmaceutical-production-poor-countries> (last accessed 16 March 2021).

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).

38 United Nations, “Final Report, The United Nations Secretary-General’s High-Level Panel on Access to Medicines Report: Promoting Innovation and Access to Health Technologies” (United Nations, 14 September 2016) <http://www.unsgaccessmeds.org/final-report> (last accessed 11 July 2021).

39 Medicines Law and Policy, “TRIPS Flexibility Database” (16 February 2021) <http://tripsflexibilities.medicineslawandpolicy.org/> (last accessed 10 March 2021).

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).

46 WIPO, “Promoting Access to Medical Technologies and Innovation: Intersections between Public Health, Intellectual Property and Trade” (WTO, WIPO, 2020), 243 <https://www.wipo.int/edocs/pubdocs/en/wipo_pub_628_2020.pdf> (last accessed 19 July 2020).

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).

49 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/53 (4 December 2009).

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).

51 WTO, “Bolivia Outlines Vaccine Import Needs in Use of WTO Flexibilities to Tackle Pandemic” (WTO, 12 May 2021) <https://www.wto.org/english/news_e/news21_e/dgno_10may21_e.htm> (last accessed 12 May 2021).

52 Art 1(b), WTO Doc., Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health (Decision of 30 August 2003), WT/L/540 (2 September 2003).

53 WTO, Paragraph 1(b) (footnote 3), Annex and Appendix to the TRIPS Agreement <https://www.wto.org/english/docs_e/legal_e/31bis_trips_annex_e.htm#fnt-3> (last accessed 10 June 2021).

54 ibid.

55 R Peters and D Prabhakar, “Export Restrictions Do Not Help Fight COVID-19” (UNCTAD, 11 June 2021) <https://unctad.org/news/export-restrictions-do-not-help-fight-covid-19> (last accessed 14 June 2021).

56 J Love, “Open Letter Asking 37 WTO Members to Declare Themselves Eligible to Import Medicines Manufactured under Compulsory License in Another Country, under 31bis of TRIPS Agreement” (Knowledge Ecology International, 7 April 2020) <https://www.keionline.org/32707> (last accessed 26 December 2021).

57 European Parliament, Answer given by Executive Vice-President Dombrovskis on behalf of the European Commission, Document No. E-000463/2021 (13 April 2021) <https://www.europarl.europa.eu/doceo/document/E-9-2021-000463-ASW_EN.pdf> (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) <https://medicineslawandpolicy.org/2021/01/the-elephant-in-the-room-at-the-who-executive-board/> (last accessed 10 February 2021).

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71 WHO, “How WHO C-TAP Works?” (WHO, 27 October 2020) <https://www.who.int/initiatives/covid-19-technology-access-pool/what-is-c-tap> (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) <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> (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) <https://www.i-mak.org/wp-content/uploads/2017/10/Oxfam-VoluntaryLicensingResearchIMAKWebsite.pdf> (last accessed 15 January 2021).

76 J Lexchin, “As U.S. Buys Up Remdesivir, ‘Vaccine National-ism’ Threatens Access to COVID-19 Treatments” (The Conversation, 5 July 2020) <https://theconversation.com/as-u-s-buys-up-remdesivir-vaccine-nationalism-threatens-access-to-covid-19-treatments-141952> (last accessed 5 July 2021).

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.