THE TRIPS WAIVER PART 1: THE ORIGINAL PROPOSAL
In this series of articles, CIPIT examines the TRIPS1 Waiver and access to health. The series will discuss the content of the waiver as originally proposed, the revisions of the proposal, the arguments posed in support and against the waiver, and finally the implications of the adopted waiver.
Just over 61% of the global population had received a full dose of the COVID-19 vaccine by mid-June 2022.2 In Kenya, it was reported that 31% of the adult population has been vaccinated, and the Ministry of Health has a target of vaccinating 100% of the adult population and 50% of the teenage population by the end of 2022.3 According to the World Health Organisation (WHO), 15% of Africa’s adult population have been vaccinated, with only Mauritius and Seychelles having surpassed the targeted 70% vaccination coverage.4 These vaccination numbers are important as the number of COVID-19 reported cases have once again been on the rise powered by the so-called sixth wave.5 One of the limitations to vaccination in the African region is the lack of access to vaccines. It is argued that Intellectual Property (IP) laws such as patents on the development of medical products have contributed to this lack of access in low and middle-income countries.6
The growing initiative to implement “systematic changes to how intellectual property law incentivises technologies” is not novel.7 The COVID-19 pandemic is perceived to be an example of the “disjuncture in law, policy and practise” in relation to “a right to health and international trade agreements”, specifically when assessing conflicts between IP laws and public health agendas.8 The pandemic is argued to have exposed the “problematic relationship between intellectual property law and global health”.9 It has been contended that the Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS) is a hurdle to “vaccine and medicine affordability” within developing and least developed countries.10 TRIPS is a “hard law” instrument that is “enforceable and binding” as it permits patent rights for pharmaceutical products for a period of 20 years, any violations to the above would lead to trade sanctions.11
Appreciating the “global inequalities that the pandemic further exacerbated”,12 India and South Africa presented an “unprecedented proposal” to the TRIPS Council at the WTO, urging for a “temporary waiver” to assist with mitigating the global pandemic.13 The TRIPS waiver seeks to suspend certain provisions of TRIPS for the prevention, containment, and treatment of COVID-19. This four-part series will firstly highlight the proposals within the various versions of the TRIPS Waiver. We will thereafter discuss the arguments by supporters and those raised by the opposers of the Waiver. Finally, we will discuss the implications on access to health, post-waiver.
THE ORIGINAL PROPOSAL
On the 2nd of October 2020 South Africa and India submitted to the TRIPS Council a draft decision text14 (Original Waiver), for the waiver from the implementation, application and enforcement of copyright, industrial designs, patents, and protection of undisclosed information for the prevention, containment, and treatment of COVID-19.15 This is a reflection of the TRIPS Waiver dismantling the different layers of property rights that are found within inventions.16 The Waiver, however, excludes the protection of performers, producers of sound recordings and broadcasting organisations under TRIPS provisions.17 The suspension would also not directly affect trademarks, geographical indications, plant variety protection, and the layout designs of integrated circuits.18
The duration of the Waiver, under this proposal, was to last until widespread vaccination and global immunity was achieved by the majority of the worlds’ population. In order to ensure flexibility, the Waiver was reflective of open-ended language regarding the period in which it would operate as it opted “for [X] years”.19 The Waiver would be reviewed by the General Council at least one year from the date granted and annually thereafter until its termination. An immunity provision was included to combat WTO challenges that would arise from the “measures taken in conformity with the provisions of the Waiver”.20 However, we appreciate that this proposal was drafted in 2020, when there was no vaccine in place. This Waiver was not limited to the protection of vaccines but included “health products and technologies like test kits, masks, medicines, vaccines, components of ventilators like valves, control mechanism and the algorithms and CAD [Computer-Aided Design] utilised in their manufacturing.”21
The justification behind this Waiver proposal was that an effective response to the COVID-19 pandemic requires rapid access to affordable medical products. It is therefore intended to encourage and permit unhindered global sharing of technology and know-how for a rapid COVID-19 response.
The Waiver proposers indicated that there had been reports of IP rights hindering the provision of medical products to patients, and other reports of countries that amended their laws to expedite the procedure of issuing compulsory IP licenses for the access of medical products.22 The proposers further specified that the need for the Waiver was due to the institutional and legal difficulties that would be met by countries with insufficient or lacking manufacturing capacity, especially developing countries, as Article 31bis of TRIPS “requires a cumbersome and lengthy process for the import and export of pharmaceutical companies”.23
The TRIPS Waiver fell in line with the global health diplomacy agenda of expediting the development of medicines, vaccines and diagnostics for the prevention, containment, and treatment of the COVID-19.24 It is worth noting that, at the time of this proposal, developing states were not only concerned with the lack of affordable access to the required vaccines, as their fear extended to the forecasted competition with developed states for the products.25 This is evident with reports that emerged from the TRIPS Council deliberations; where it was reported that the European Commission only paid USD 3.50 per shot for a dose of the vaccine (manufactured in India) in comparison with South Africa that paid USD 5.25 and Uganda paying USD 8.50 per shot.26
1 Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS)
2 Coronavirus Disease (COVID-19) : Vaccines <https://www.google.com/search?q=Global+Covid+19+Vaccine+uptake&rlz=1C1CHBF_en-GBGB770GB770&oq=Global+Covid+19+Vaccine+uptake+&aqs=chrome..69i57j0i546.22784j0j7&sourceid=chrome&ie=UTF-8#colocmid=/m/019rg5&coasync=0> last accessed on 21st June 2022.
3 ‘Ministry launches accelerated COVID-19 Vaccination campaign following re-emergence of cases’, June 3, 2022 <https://www.health.go.ke/ministry-launches-accelerated-covid-19-vaccination-campaign-following-re-emergence-of-cases>/> last accessed 16th June 2022.
4 ‘Africa’s COVID-19 Vaccine uptake increases by 15%’, 17 March 2022 <https://www.afro.who.int/news/africas-covid-19-vaccine-uptake-increases-15> last accessed 16th June 2022.
5 ‘Africa CDC Says Kenya Experiencing Sixth Wave of Covid 19’, June 17, 2022
<https://www.citizen.digital/news/africa-cdc-says-kenya-experiencing-sixth-wave-of-covid-19-n300314 > last accessed 14th July 2022.
6 ‘Open Letter to TRIPS Council Members: Remove Barriers to Access for Critical COVID-19 Supplies’
< https://www.bu.edu/gdp/2020/11/18/open-letter-to-trips-council-members/> last accessed 21st June 2022.
7 Thambisetty S, McMahon A, McDonagh L, Yoon Kang H & Datfield G, The TRIPS Intellectual Property Waiver Proposal: Creating the Right Incentives in Patent Law and Politics to end the COVID 19 Pandemic  LSE Law Society and Economy Working Papers 06/2021,4.
8 ‘Report of the United Nations Secretary General’s High-Level Panel on Access to Medicines: Promoting innovation and access to health technologies (September 2016)’
< http://www.unsgaccessmeds.org/final-report/> last accessed 8th June 2022.
9 Thambisetty (n7).
10 Chittu VK, Singh B, Kaur J, Jakovljevic M, COVID-19 Vaccine, TRIPS and Global Health Diplomacy: India’s Role at the WTO  BioMed Res Int.
13 Yu K P, A Critical Approach of the COVID-19 TRIPS Waiver  Texas A&M University School of Law Legal Studies Research Paper,21.
14 Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS Council), ‘Waiver from Certain Provisions of the TRIPS Agreement for the Prevention, Containment and treatment of COVID-19: Communication from India and South Africa’ (2nd October 2020) IP/C/W/669.
15 Trade-Related Aspects of Intellectual Property Rights Agreement, Part II, Sections 1, 4, 5, and 7.
16 Thambisetty (n7) 16.
17 TRIPS Agreement, Article 14.
18 TRIPS Waiver (n14) para 1 and para 2.
20 ibid..para 5.
21 TRIPS Council, Minutes of Meeting Held in the Centre William Rappord on 15-16 October and 10 December 2020 (16th February 2021) IP/C/M/96/ADD.1
22 ‘Kentucky Government. Andy Besher Calls on 3M to release patent for N95 respirator amid pandemic’, 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/ > last accessed 16th June 2022.
23 TRIPS Agreement.
25 Yu K P(n13)2.
26 TRIPS Council, Minutes of Meeting Held in the Centre William Rappord on 10-11 March 2021(30th July 2021) IP/C/M/98/Add:1,30, para 284.