Posted 14/09/2021 by Leah Ferris
As developing countries struggle to access COVID-19 vaccines and contend with catastrophic second and third waves of infection, the World Trade Organization (WTO) remains at an impasse in approving a waiver over intellectual property rights for COVID‑19 vaccines. While countries such as South Africa and India argue the waiver would have a profound impact on their ability to produce vaccines domestically, other countries such as Australia have questioned whether such a waiver would be effective in delivering greater numbers of vaccines. With substantial differences in the positions of the parties, it seems that despite discussions on the waiver continuing in Geneva, agreement may prove elusive in the near future.
TRIPS waiver proposal
In October 2020, India and South Africa co-authored a proposal requesting that certain obligations in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) be waived with respect to the prevention, containment or treatment of COVID-19. The TRIPS Agreement establishes minimum standards for the regulation by national governments of different forms of intellectual property rights and applies to all countries which are members of the WTO (although least-developed countries are exempt from meeting substantive TRIPS obligations generally until 1 July 2034, and pharmaceutical patent obligations until 1 January 2033).
While the proposal was initially not supported by a number of countries, including the United States, Australia and Japan, on 5 May 2021 the United States announced it would support temporarily waiving intellectual property (IP) protections for COVID-19 vaccines. This was a strong shift in domestic policy from the United States and has paved the way for other countries, including Australia, announcing that they will also engage in discussions on this issue via the TRIPS Council (the forum in which countries meet to discuss these issues).
On 21 May 2021, a number of countries (including India and South Africa) issued a revised proposal (the proposed waiver) requesting that certain obligations in the TRIPS Agreement ‘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’.
If the proposed waiver is granted, countries would not be required to provide IP protections relating to copyright, industrial designs (the appearance of a product), patents and protections of undisclosed information (for example, test data and trade secrets) with respect to any of the above listed health products and technology for an initial period of three years. This would allow for countries to domestically produce these products where they have the capacity to do so. The proposed waiver would also prevent countries from challenging the actions of other members of the WTO through the WTO’s dispute settlement system where the measures they have taken are in accordance with the waiver (though these could still be subject to other legal challenges, including by the holders of the IP rights).
However, critics of the proposed waiver have argued that it would not necessarily lead to countries being able to manufacture their own vaccines. This is due to the lack of infrastructure in certain countries, the scarcity of raw materials required to make the vaccines and the skills required to manufacture effective vaccines. Behind the border measures, such as export restrictions on vaccines and raw products, have also had impacts on supply chains and trade measures will not address broader challenges to public health infrastructure. The United States has also only committed to support a waiver of patent rights with respect to COVID-19 vaccines and it is likely that compromises will need to be made on the inclusion of other health products and technology and which IP protections the waiver will cover.
Alternative EU proposal
On 4 June 2021, the European Union (EU) submitted to the WTO General Council a communication on ‘Urgent trade policy responses to the COVID-19 crisis’, which called for limiting export restrictions, supporting the expansion of vaccine production, and facilitating the use of current compulsory licensing provisions in the TRIPS Agreement. The EU also submitted a communication to the TRIPS Council which focused on the use of the compulsory licensing provisions, including a proposal to clarify that the requirement to negotiate with the right holder of the vaccine patent does not apply in urgent situations such as a pandemic. Following the issue of these communications, the EU has drafted a declaration on the ‘TRIPS Agreement and public health in the circumstances of a pandemic’ which it is seeking to have adopted by the WTO General Council.
While this declaration is aimed at providing greater access to COVID-19 vaccines for developing countries it does not allow for manufacturers in other countries to breach IP rights in order to domestically produce vaccines.
Decision process
Currently the TRIPS Council remains engaged in ‘text-based discussions’, where countries meet in smaller groups to discuss various texts in order to develop a draft proposal to be taken to the WTO Ministerial Council (as a decision on a waiver will require consensus of the Ministerial Council or, if it were to go to a vote, a three-fourths majority in accordance with Article IX of the WTO Agreement).
Following the July meeting of the TRIPS Council, countries have agreed to continue to discuss the two proposals, but positions remain divergent. The TRIPS Council itself has stated:
While delegations remain committed to the common goal of providing timely and secure access to high-quality, safe, efficacious and affordable vaccines and medicines for all, disagreement persisted on the fundamental question of what is the appropriate and most effective way to address the shortage and inequitable access to vaccines and other COVID-related products.
Even if the waiver proposal were to go to a vote, 123 countries would be required to support the waiver and the next Ministerial Council is not scheduled till 30 November – 3 December 2021. While the next formal meeting of the TRIPS Council is scheduled for 13-14 October, the Council will meet again on 14 September to further progress discussions on a possible waiver. With the European Union, United Kingdom, Japan and others continuing to oppose the waiver it remains unclear what action, if any, the WTO Ministerial Council will take in December.
Further reading:
WTO: The TRIPS Agreement and COVID-19 (wto.org)
Johns Hopkins Bloomberg School of Public Health: WTO TRIPS Waiver for COVID-19 Vaccines (jhu.edu)
Congressional Research Service: Potential WTO TRIPS Waiver and COVID-19 (congress.gov)
European Parliament: World Trade Organization TRIPS waiver to tackle coronavirus (europarl.europa.eu)
Opinion (Ken Heydon): Getting trade policy right is key to global vaccination (The Australian Financial Review)