While the entire world is in the grips of the ongoing COVID-19 pandemic, 62 co-sponsor countries including India, South Africa, and Indonesia have recently given a revised draft proposal for waiving the Intellectual Property (“IP”) rights of COVID vaccines to the TRIPS Council of the World Trade Organisation (“WTO”), seeking a patent waiver for manufacturing various COVID-19 medical props including vaccines.
India and South Africa had floated the idea of overriding patent rules and argued that such a waiver should last until the majority of the world’s population has developed herd immunity and the pandemic is declared over. The importance of this proposal was rooted way back in October 2020, on the grounds that it would lift barriers and allow countries to regionally manufacture and address the situation of COVID-19. However, the United States of America has supported limiting such waiver to the IP rights of the vaccines.
Provisions governing the waiver under Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS”)
Pursuant to Article IX of the Marrakesh Agreement, the Ministerial Conference of WTO is permitted to grant waivers in cases of “extraordinary circumstances.” Initially, the WTO members are required to submit waiver requests to the relevant WTO body for further considerations.
It is pertinent to note that under Article 31(f) of the TRIPS agreement, a compulsory license issued for a product by a country is permitted for limited use and is restricted to that country only. A compulsory license can be defined as a regulatory tool that is used by governments to produce and process patented products without the prior permission of the patent holder. Generally, compulsory licenses are only considered in special circumstances, such as in national emergencies and health crises. The issue of granting the license has always been debatable since developing countries support the idea due to the lack of availability and affordability of medicines, and the ones opposing it believe that it would make innovation more difficult for pharmaceutical industries.
Under Article 12 of the International Covenant on Economic, Social and Cultural Rights, the member states are under an obligation to give the right to health foremost importance, which includes the provision of essential drugs and health care facilities. On the other hand, the Committee on Covenant on Economic, Social and Cultural Rights has cleared the air around intellectual property rights by stating that there are temporary measures that can be revoked.
Moreover, the international community has been entrusted with the responsibility to contain transmissible diseases and has justified the extraterritorial application of the right to health in instances of transmissible diseases. Therefore, the entire legal framework paves the way for the TRIPS waiver proposal, which should be abided by other member countries to ensure that they are fulfilling their obligations to save other countries from transboundary impairment.
Can waiving vaccine IP rights help in battling the COVID-19 pandemic?
The main objective behind coming up with such a proposal is to permit countries to manufacture their own versions of vaccines and scale up production. Countries like India and South Africa believe that it is necessary to win the race against time with a mutating virus. It has been projected that companies will scale up massively by the end of 2021, but the proponents of the waiver are of the opinion that production needs to happen speedily, especially in light of boosters or new vaccines, to tackle a mutating virus.
The proponents are contending for a temporary suspension from the WTO of certain patent rules enshrined in the TRIPS agreement. To put it another way, supporters say that a patent waiver would help overcome certain legal barriers that have been preventing them from producing their own vaccines. They further argue that waiver could be an initial step towards distributing vaccines more equally as 80% of all vaccines have gone into the arms of rich and middle-income countries.
Supporters of the waiver also argue that more manufacturers in more countries could drive prices down as prices are constantly rising and are set to rise even further in 2022, which would make it essentially unpayable for poorer countries. Therefore, it would not be wrong to say that the purpose of the waiver is to ensure that countries worldwide are able to increase production and generate enough supply to meet the rapidly increasing demand.
On the other side, opposition to the idea of waiver remains strong, and countries like Japan and Brazil are among those which are rejecting the proposal as they believe that the WTO waiver would not address the current issue. Instead, it would damage the incentive of various pharmaceutical companies around the world that will now choose to restrain themselves from contributing to further research and inventing such life-saving drugs in the future.
European Union’s (“EU”) alternative proposal to IP Waiver
The EU’s alternative proposal has reignited the debate on whether the IP waiver would expand the global vaccine crisis in the market. The Brussels-headquartered organization has proposed to ease supply chains and its treatments to increase cross-border access of the vaccines. The EU argues that patent waiver is not the solution; the war against COVID can be triumphed by improving cooperation between countries. The proposal of the organization, which has the backing of the UK, supports the form of subsidies that may be guaranteed by high-income countries to low and middle-level income countries.
The EU has therefore proposed to ease up the export limitations, and in case the cooperative approach fails, a Compulsory License under Article 31 of TRIPS could be used as a tool to increase the outreach of the vaccines.
Furthermore, the EU seems to be right in its approach because even if the IP waiver is granted, the problem of accessibility cannot be tackled. The bigger problems associated with such waiver are technology transfer, training of staff, and processing of raw materials in a scientific environment, which could become a tedious task for low and middle-income countries owing to infrastructural deficiencies. The IP waiver can lead to significant risks at nascent stages of development of the vaccines because once the patent is waived, the liability of private entities ceases to exist, and therefore any mishap can lead to global ramifications.
The supporting countries emphasize TRIPS waiver for preventing and treating COVID-19. However, the supporting, as well as opposing, sides agree that a patent waiver would not be a silver bullet since the production and distribution of vaccines involve challenges ranging from complexities of supply chains to shortages of raw materials, and the need to meet high production standards.
The countries which are advocating the IP waiver must ensure proper infrastructural requirements, adequate mode of technology transfer, and the capability to generate vaccines at a large scale. We need to understand that waiving IP rights is not the solution; rather it can give birth to a catena of problems in the future.
Anshika Gubrele and Subodh Asthana are law students at Bharati Vidyapeeth (Deemed to be University) New Law College, Pune and Hidayatullah National Law University, Raipur, in India, respectively.
Suggested citation: Anshika Gubrele and Subodh Asthana, Conundrum on TRIPS IP Waiver: Assuring COVID Jabs for the Masses, JURIST – Student Commentary, July 1, 2021, https://www.jurist.org/commentary/2021/07/gubrele-asthana-covid-trips-ip-waiver/.
This article was prepared for publication by Viraj Aditya, a JURIST staff editor. Please direct any questions or comments to him at commentary@jurist.org
