Inside the COVID-19 TRIPS Waiver: Ongoing Discussions on possible extension to Diagnostics and Therapeutics

Inside the COVID-19 TRIPS Waiver: Ongoing Discussions on possible extension to Diagnostics and Therapeutics.

The global response to the COVID-19 pandemic has necessitated unprecedented actions across various sectors, including international trade and intellectual property rights. Central to these discussions is the proposed waiver from certain provisions under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement (TRIPS Waiver), which has sparked a significant debate among World Trade Organization (WTO) members. Initially introduced by India and South Africa in October 2020, the TRIPS waiver aimed to temporarily suspend the application of some intellectual property rules under the assumption that it would ensure broader access to COVID-19 vaccines, treatments, and other essential medical technologies. This article intends to briefly update readers on the main developments related to this interesting topic.

• The TRIPS Waiver was originally proposed by India and South Africa on 2 October 2020 with a draft text[1] intended to suspend the application of Sections 1, 4, 5 and 7 of Part II of the TRIPS Agreement or to enforce said sections in relation to the prevention, containment or treatment of COVID-19.
• Several formal and informal meetings took place among WTO members within the TRIPS Council to discuss the matter in order to try to reach consensus, which is the mechanism used by the WTO to make decisions for this type of issues.
• On 12 May 2021, AIPPI issued a first position paper[2] basically opposing the proposed waiver and emphasizing that intellectual property rights had been crucial in developing COVID-19 vaccines and therapeutics. AIPPI stated that waiving IP rights could negatively impact long-term innovation and urged the WTO to find a balanced approach that addresses public health needs while preserving IP rights. The paper also highlighted existing TRIPS flexibilities that countries could use to address public health issues.
• An outcome of the WTO discussions was the “Ministerial Decision on the TRIPS Agreement” adopted by the 12th WTO Ministerial Conference on 17 June 2022[3]. While the Decision was limited in scope with respect to the original waiver proposal, it contained provisions for eligible WTO members to allow the authorization of the use of subject matter of patents required for the production and supply of COVID-19 vaccines without the consent of the right holders to the extent necessary to address the COVID-19 pandemic, subject to a series of further restrictions. Additionally, the decision established a six-month deadline for members to decide on the possible extension of the waiver to cover the production and supply of COVID-19 diagnostics and therapeutics.
• On 12 September 2022, AIPPI released another position paper[4] raising concerns on the implications of the Ministerial Decision and the possible extension of the waiver to cover the production and supply of COVID-19 diagnostics and therapeutics.
• Discussions on the extension are ongoing, with the deadline being indefinitely extended[5] due to persistent disagreement on the fundamental question of whether a waiver is the appropriate and most effective way to address the shortage and inequitable distribution of and access to vaccines and other COVID-related products. A report on the discussion was published by the WTO TRIPS Council on 13 February 2024[6] summarising that delegations have exchanged views, asked questions, and provided responses, clarifications, and information, including through new submissions, without being able to reach consensus. Up to date, no evidence was found of a country notifying the TRIPS Council of a measure related to the implementation of the Ministerial Decision under point 5 of the same[7].

Through its TRIPS Committee, AIPPI remains actively engaged in monitoring the ongoing developments of this critical and complex issue. By staying informed, AIPPI ensures that it can swiftly address emerging challenges related to the protection of intellectual property rights in the evolving global landscape.

[1] https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W669.pdf&Open=True

[2] https://www.wto.org/english/tratop_e/covid19_e/aippi_pos_paper_may21_e.pdf

[3] https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/WT/MIN22/30.pdf&Open=True

[4] https://aippi.org/wp-content/uploads/2021/05/AIPPI-Position-Paper-on-WTO-Waiver_12May2021.pdf

[5] https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/95.pdf&Open=True

[6] https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/100.pdf&Open=True

[7] Point 5 indicates “For purposes of transparency, as soon as possible after the adoption of the measure, an eligible Member shall communicate to the Council for TRIPS any measure related to the implementation of this Decision, including the granting of an authorization”. With the following explanatory note “The information provided shall include the name and address of the authorized entity, the product(s) for which the authorization has been granted and the duration of the authorization. The quantity(ies) for which the authorization has been granted and the country(ies) to which the product(s) is(are) to be supplied shall be notified as soon as possible after the information is available”.