The (Original) TRIPS Waiver: The Key to Fulfilling the Right to Health in the Global South

AMISOM Public Information, A medical officer serving under the African Union Mission in Somalia (AMISOM) prepares to administer the COVID-19 vaccine at the launch of the COVID-19 vaccination campaign in Mogadishu, Somalia on 17 May 2021, Mokhtar Mohamed, Creative Commons.

As we move deeper into this new decade, the international community is confronted by crises that require imminent collective action in our interconnected world. COVID-19 may be one of the most devastating pandemics of our generation but it is unlikely to be the last.

How has the international community responded to this global crisis and what does this portend about future crises? The COVID-19 pandemic is far from over. At the time of writing, there have been approximately 500 million recorded cases of COVID-19 and 6.2 million recorded deaths worldwide, and counting.

Several months into the pandemic, scientific and technological innovation (funded in large part by State governments) has provided several vaccines to mitigate the impact of COVID-19 and reduce mortality. Research on effective treatments continues, yielding positive results. However, existing geopolitical fault lines in the international distribution of wealth have led to a concentration of vaccines and health technologies in the global North with the global South lacking access.

This is a result of a scramble by the global North to purchase doses early on, some countries purchasing enough to vaccinate their population several times over; concentration of production capacity in the hands of a few pharmaceutical companies in the global North; COVAX experiencing vaccine donation shortages; export controls over essential raw materials; lack of technology transfer and data disclosure; underutilisation of the WHO COVID-19 Technology Access Pool; “bureaucratic, uncertain and/or time-consuming” barriers faced in domestically issuing individual compulsory licences; and most recently, the administering of booster doses across entire populations in the global North, further delaying first and second doses in the global South, amongst other things.

The global South is thus hit harder by the pandemic: both epidemiologically and economically. At the time of writing, only 15% of the adult population on the African continent has been fully vaccinated. The emergence of new variants of concern, like Omicron which was sequenced by South African scientists in late 2021, led to knee-jerk reactions – particularly from the global North, imposing travel bans and creating further unpredictability. To end the pandemic, and reduce the risk of further variants of concern emerging, the WHO has called for universal vaccination and access to health technologies.

There are many pressing problems relating to universal vaccination, such as vaccine hesitancy, misinformation, corruption and mismanagement of vaccine rollout, low levels of public trust, amongst other things, that require States to take action. In this short piece, however, I focus on the importance of India and South Africa’s original proposed waiver of certain aspects of the TRIPS Agreement that would enable States to give full effect to their human rights obligations and therefore work towards ending the pandemic in solidarity with other States. 

I juxtapose the original proposal with the recent “leaked” compromise text. It is not my argument that the TRIPS Waiver will miraculously entail 100% vaccination – rather, I argue that it removes some of the more intractable barriers confronting resource-constrained States, in particular, facilitating an increase in production and therefore access to vaccines and other health technologies.

“The Waiver remains a crucial step to ending the pandemic and its disproportionate effects on African countries and the global South.”

States parties to the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) undertake intellectual property obligations to create and regulate copyright, trademarks, patents, industrial design, and trade secrets within their jurisdictions as well as provide for redress where unauthorised uses take place. Further, since the TRIPS Agreement forms part of the World Trade Organisation’s (WTO) common undertaking, States subject themselves to the WTO Dispute Settlement System (DSS) for the resolution of any disputes regarding its interpretation, and to the Trade Policy Review Mechanism for the monitoring of domestic actions taken in furtherance of the Agreement. 

States parties to the International Covenant on Economic, Social and Cultural Rights (ICESCR) undertake international human rights obligations to realise the rights to health, participating in and accessing the benefits of science and technology, and the right to social security in a manner that is equal and does not discriminate against any member of society. States parties also undertake obligations of cooperation and assistance. 

The ICESCR and the TRIPS Agreement have 142 States parties in common. They also have near-universal application, with 73% of UN members party to both. Of the States that have opposed the TRIPS Waiver, the UK, as well as Germany, Norway and Switzerland among several other EU member States are party to both treaties and undertake concurrent obligations.

The Vienna Convention on the Law of Treaties (VCLT) provides that all treaties, irrespective of subject matter, must be interpreted according to its Articles 31 and 32. Along with the text, surrounding context and object and purpose, Article 31 provides for other relevant rules of international law to be taken into account. The VCLT thus recognises the principle of systemic integration – although States undertake competing overlapping obligations, international law is a single system and these obligations must be interpreted harmoniously.

Evidence from State practice and the literature demonstrates that the current interpretation of the above obligations, grounding the ICESCR obligations in TRIPS “flexibilities” to facilitate access to health technologies, has failed. However, even if it is contended that recent WTO DSS jurisprudence provides a route through which both sets of treaty obligations (those under the TRIPS Agreement and the ICESCR) can be harmonised at the interpretation stage, the institutional framework and normative environment of these obligations play a big role in constraining the actual domestic application of such an interpretation. 

For one, the WTO DSS has exclusive compulsory jurisdiction. Any dispute regarding the application and interpretation of the TRIPS Agreement is likely to be decided by the DSS. The DSS is empowered to issue rulings and recommendations if it finds that the particular provision of the TRIPS Agreement is not adequately fulfilled. If these rulings and recommendations are not implemented within a “reasonable time” the DSS is empowered to issue sanctions against the defaulting State. Although the VCLT requires that all interpreters take into account other relevant rules of international law, there has been a raging debate regarding the extent to which the DSS may consider other international law outside the covered agreements. 

For African countries and other countries in the global South whose resource-constrained economies have already been devastated by the COVID-19 pandemic, the threat of sanctions for not adopting a strict textual interpretation of the TRIPS Agreement is real. Bearing in mind the complex intellectual property thickets surrounding mRNA technology, as well as other health technologies such as ventilator designs, States are likely to steer away from using “flexibilities” to give effect to their human rights obligations. That is indeed what has happened, and where we are today. 

The proposed TRIPS Waiver thus calls for a waiver not only of the IP provisions set out above but also of the enforcement provisions. This would enable resource-constrained States in Africa to take meaningful steps to fulfil their human rights obligations by domestically manufacturing ventilator valves, for instance, as well as scaling up manufacturing capacity for vaccines without fear of sanctions. A Waiver that includes all these aspects remains urgent in order to move towards ending the pandemic. The Chair of the General Council and Director General of the WTO, despite postponing the WTO Ministerial Conference due to Omicron, committed to arriving at a “mutually agreeable draft” by the end of February 2022. 

On 11 March 2022, Geneva Health Files reported on “the beginnings of a potential compromise” on the Waiver. The “leaked” text of the compromise was published online. This compromise was reported to have been struck by the “Quad” – India, South Africa, the USA and the EU. This text has been described as “crumbs” in comparison to the original proposal made by India and South Africa. It focuses solely on patents as a barrier to scaling up vaccine production without considering copyright, industrial design and trade secrets as barriers. 

The compromise text excludes other health technologies, essential research, and cutting edge therapeutics that are crucial to ending the pandemic. It also excludes other forms of IP, and crucially excludes the waiver of the enforcement provisions. This maintains status quo where States remain reluctant to use “flexibilities” and the threat of sanctions remains ever present, further underrealising the human rights of the most vulnerable. 

Moreover, in its focus on patents, the compromise text locates its solution almost entirely in the realm of compulsory licences, despite well-documented concerns regarding its inadequacy and bureaucratic and cumbersome operation, especially to respond to a pandemic. The compromise indeed provides for a limited waiver of the domestic market requirement in issuing compulsory licences. However, it places a geographical limitation that limits the triggering of this requirement possibly excluding countries like Brazil and China. It also includes additional measures that are not presently required by the TRIPS Agreement, making it onerous to utilise – the very opposite of the original proposal.

The compromise text is not final. It is being negotiated upon and requires the other WTO Members to consider their position in the coming weeks leading up to the rescheduled WTO Ministerial Conference. The Waiver remains a crucial step to ending the pandemic and its disproportionate effects on African countries and the global South.

Author’s note: This blog post is an updated version of a piece written for the South African Branch of International Law Bulletin (February 2022). It is part of an argument developed in a working paper titled ‘A human right to the COVID-19 TRIPS Waiver? Confronting the fragmentation of international law during the global pandemic’ presented at the American Society for International Law Mid Year Meeting, October 2021. It draws on the author’s PhD thesis: Sanya Samtani, ‘The Right of Access to Educational Materials and Copyright: International and Domestic Law’ (University of Oxford, 2021) as well as a co-authored expert opinion: Sanya Samtani, Tim Fish Hodgson, et al ‘Human Rights Obligations of States to not impede the Proposed COVID-19 TRIPS Waiver’ (International Commission of Jurists, November 2021), endorsed by over 140 international experts.