After nearly 18 months of negotiations, there has finally been some progress with regard to the request to waive certain provisions of the TRIPS Agreement in response to the COVID-19 pandemic. It was in October 2020, during the meeting of the WTO’s TRIPS Council, that India and South Africa initially tabled this waiver request. A revised proposal was subsequently submitted in May 2021.
Following intensive quadrilateral negotiations between South Africa, India, the United States and the European Union on 15 March 2022, a compromise agreement was tentatively reached that will now be presented to other WTO members for their consideration and possible adoption.[1] It will be interesting to see what benefits this is going to reap, as some have argued that there is likely to be little practical impact from any waiver of IP rights.[2]
The compromise draft text has drawn criticism from both those who support and oppose the waiver request.[3] The proponents of the waiver request find the compromise draft text disappointing. They argue that it is a very limited and narrow agreement. It only covers vaccines, and it limits “eligible members” to developing countries.[4] On the other hand, opponents of the waiver maintain the view that the compromise draft is a solution in search of a problem.[5] However, it remains to be seen if this compromise draft text would constitute the basis of any final waiver that may be adopted by the TRIPS Council.
Essentially, the May 2021 revised proposal sought a waiver of TRIPS obligations relating to the application and enforcement of copyright, patent rights, industrial designs, and the protection of undisclosed information.[6] These obligations were to be waived ‘in relation 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.’ According to the revised proposal, the waiver should be in place for at least 3 years.[7]
However, the provisions of the compromise draft text are far from the demands contained in the revised waiver proposal. According to Oke, one could convincingly argue that the text is probably closer to the positions of both the EU and the US in this regard.[8] The compromise text merely provides some concessions regarding the rules governing compulsory licensing contained in Article 31 of the TRIPS Agreement, and its scope is limited to the production and supply of COVID-19 vaccines for now at least. This is basically in line with the position of the EU and the US on the waiver request. Although initially opposed to the waiver request, the US eventually expressed its support for the waiver proposal in May 2021. This support was, however, strictly limited to the production of vaccines.[9] In June 2021, the EU subsequently tabled its own counterproposal at the TRIPS Council, which essentially revolved around clarifying the rules relating to compulsory licensing in Articles 31 and 31bis of the TRIPS Agreement.[10] Nevertheless, when compared with the permanent waiver codified in Article 31bis of the Agreement, one could say that the provisions of the compromise draft text are not as cumbersome and complex as the provisions contained in Article 31bis.[11]
The aspects of the draft text that may be considered as gains for proponents of the waiver request include paragraph 2 of the text which allows that :
“…an eligible Member may authorize the use of patented subject matter under Article 31 without the right holder’s consent through any instrument available in the law of the Member such as executive orders, emergency decrees, government use authorizations, and judicial or administrative orders, whether or not a Member has a compulsory license regime in place…”
According to the text, the ” law of a Member” referred to in Article 31 is not limited to legislative acts such as those laying down rules on compulsory licensing. It also includes other acts, such as executive orders, emergency decrees, and judicial or administrative orders.[12]
Although the scope of the compromise text is currently limited to the production of vaccines, Oke argues that paragraph 3(c) of the compromise text is an implied admission of the practical difficulties associated with the use of Article 31bis of the TRIPS Agreement. [13] Paragraph 3(c) is a crucial departure from the strictures codified in Article 31bis, which was, ironically, originally intended to address the problems associated with Article 31(f), especially for countries with no or insufficient domestic manufacturing capacity.[14] It permits an eligible member to ‘waive the requirement of Article 31(f) that authorised use under Article 31 be predominantly to supply its domestic market’. Paragraph 3(c) further provides that an eligible member ‘may allow any proportion of the authorised use to be exported to eligible Members and to supply international or regional joint initiatives that aim to ensure the equitable access of eligible Members to the COVID-19 vaccine covered by the authorisation.’[15]
Paragraph 6 addresses the question regarding the duration of the compromise waiver. However, as can be read from the text, there is no consensus in this regard. The text refers to both 3 and 5 years. “An eligible Member may apply the provisions of this Decision until [3][5] years from the date of this Decision…”. Could this be a suggestion that the waiver could be in force for at least 3 years? It is certainly effective to clarify this in the text of the compromise waiver. Paragraph 6 goes on to state that ‘the General Council may extend such a period taking into consideration the exceptional circumstances of the COVID-19 pandemic. The General Council also has authority to review annually the operation of this Decision’.[16]
Before outlining some of the gains from the outcome of the quadrilateral negotiations, I highlighted some of the reasons why the proponents of the waiver are disappointed with the draft compromise text. First of all, the compromise text only covers the compulsory licensing of patents. This is not satisfactory as the waiver proposal requests for the waiver of obligations relating to copyright, patents, industrial designs, and the protection of undisclosed information. The scope of the compromise text is also limited to the production and supply of COVID-19 vaccines.
As indicated above, the definition of an ‘eligible Member’ in the compromise waiver text is another area of concern. The compromise waiver text defines, in a footnote, an ‘eligible Member’ as ‘any developing country Member that exported less than 10 % of world exports of COVID-19 vaccine doses in 2021.’[17] As noted by Oke, “this automatically excludes developed countries from the scope of the compromise waiver. It further narrows down the number of developing countries that can effectively use the waiver to export vaccines to other developing countries”.[18] This limited scope is likely to face more challenges as the compromise agreement is presented to other WTO members.
Having said the above, one may question the use of negotiations that are open to only four WTO members to deal with an issue that is affecting the entire international community? I guess the answer will lie in the reaction of the other WTO members to the compromise waiver text as it is presented. At this point, whether or not the compromise waiver text would also constitute the basis of any final waiver decision is still subject to debate. As has been said elsewhere, it will be up to the remaining WTO members to decide whether this is a promising or a compromising text.
[1] E.K Oke, “The TRIPS Waiver Compromise Draft Text: A Preliminary Assessment” 18 March 2022 [Accessed 30 March 2022] Available online at: https://www.afronomicslaw.org/category/analysis/trips-waiver-compromise-draft-text-preliminary-assessment.
[2] G. Quinn, “COVID IP Waiver Attempts are Becoming Harder to Justify” [accessed 30 March 2022] Available online at https://www.ipwatchdog.com/2021/10/20/covid-ip-waiver-attempts-becoming-harder-justify/id=138993/.
[3] E. MacDermott, “Latest WTO Waiver Compromise Text Targets COVID Vaccine Patents, Draws Criticism from Both Sides” [Accessed 30 March 2022] Available online at https://www.ipwatchdog.com/2022/03/16/latest-wto-waiver-compromise-text-targets-covid-vaccine-patents-draws-criticism-sides/id=147576/.
[4] J. Love, “QUAD’s tentative agreement on TRIPS and COVID 19” [Accessed 30 March 2022] Available online at https://www.keionline.org/37544.
[5] E.K Oke, “The TRIPS Waiver Compromise Draft Text: A Preliminary Assessment” 18 March 2022 [Accessed 30 March 2022].
[6] Ibid.
[7] Ibid.
[8] Ibid.
[9]Statement from Ambassador Katherine Tai on the Covid-19 Trips Waiver: https://ustr.gov/about-us/policy-offices/press-office/press-releases/2021/may/statement-ambassador-katherine-tai-covid-19-trips-waiver.
[10] E.K Oke, “The TRIPS Waiver Compromise Draft Text: A Preliminary Assessment” 18 March 2022 [Accessed 30 March 2022].
[11] Ibid.
[12] TRIPS COVID-19 solution (the outcome of the quadrilateral discussions at the end of last week, to be presented to WTO Members).
[13] E.K Oke, “The TRIPS Waiver Compromise Draft Text: A Preliminary Assessment” 18 March 2022 [Accessed 30 March 2022].
[14] Ibid. See also TRIPS COVID-19 solution (the outcome of the quadrilateral discussions at the end of last week, to be presented to WTO Members).
[15] TRIPS COVID-19 solution (the outcome of the quadrilateral discussions at the end of last week, to be presented to WTO Members). para 3(c).
[16] TRIPS COVID-19 solution (the outcome of the quadrilateral discussions at the end of last week, to be presented to WTO Members). para 6.
[17] TRIPS COVID-19 solution (the outcome of the quadrilateral discussions at the end of last week, to be presented to WTO Members). Footnote 1.
[18] E.K Oke, “The TRIPS Waiver Compromise Draft Text: A Preliminary Assessment” 18 March 2022 [Accessed 30 March 2022].