The story so far: Breaking with a long-held position, the U.S. Trade Representative, Katherine Tai, announced that the Biden administration would support waiving trade-related aspects of intellectual property rights (TRIPS) for the production of COVID-19 vaccines . The news was welcomed by liberal activists and some global leaders, given that the United States was until now a major World Trade Organization (WTO) member blocking such a proposal, framed by India and South Africa . The proposal, if passed by the WTO with the support of the European Union (EU), could dramatically alter how pharmaceutical companies worldwide access proprietary trade know-how for the production of leading vaccines. However, questions remain regarding whether the easing of TRIPS rules for COVID-19 vaccines will lead to a greater supply of efficacious vaccines in countries where they are the most needed, or if less circuitous options to boost supply are more relevant in the present scenario.
What is the argument in favour of relaxing TRIPS rules?
The broader context for emergency action aimed at rapidly increasing vaccine availability across the world is the sharp surge in COVID-19 cases in India and Brazil. Global concern also stems from the risk that the Indian variant, believed to be driving a second wave of devastating intensity in the country, could potentially fuel second or third waves across the world, causing a setback to the progress made in controlling transmission across the U.S. and EU. Additionally, the Brazil and South African variants still pose a threat in some pockets. Across many affected nations, vaccine availability has emerged as a bottleneck impeding progress.
In this context, a fierce debate has been underway, pitting global-vaccine-access advocates against vaccine developers and pharmaceutical firms that rely on patented technology, usually of a highly specialised nature, to produce vaccines. The latest step by the U.S. to declare its support for TRIPS waivers for such vaccines stems from the promise Joe Biden made during his election campaign, to “absolutely positively” commit to sharing vaccine technology if elected.
Can a waiver resolve the vaccine shortage?
This is a complex question to which there is, so far, no clear answer. On the one hand, it is undeniable that intellectual property rights are a part of the problem of worldwide vaccine shortages — the logic of a wider production base globally leading to an exponential increase in vaccine production is undeniable. However, several caveats remain.
First, there may be serious issues associated with manufacturing vaccines, for example, with those based on messenger RNA (mRNA) technology, if there is just an easing of the associated intellectual property rights rules but no further support to generic pharmaceutical firms in countries such as India and South Africa. This is because a “tech transfer” is also needed for the latter to actually commence production, especially for mRNA vaccines, including the ones produced by Moderna and Pfizer along with BioNTech. To illustrate, Pfizer has pointed out that its vaccine requires the use of 280 components from 86 suppliers and highly specialised manufacturing equipment.
Second, there is a strong likelihood that it will take a considerable amount of time, even several years, for generic producers’ plants to become operational at optimal capacity. This raises the question of whether today’s vaccines would even be relevant at that point in time, especially if new variants prove resistant to vaccine formulations currently available.
Finally, there is the classic counter-argument to calls for patent relaxations, that such policies could discourage pharmaceutical companies from investing in producing next-generation vaccines. Though many, including Mr. Biden, have argued that humanitarian need trumps the profit motive during a pandemic, the decision to waive all TRIPS rules should be preceded by a rigorous analysis of the effects such a policy would have on the biotechnology sector and global supply chains for its products.
What actions are likely?
No significant steps forward will be possible until other major member nations of the WTO sign on, including the EU. The speed of potential action will also be dampened by the fact that in parallel to the waivers, a transfer of personnel, raw materials and equipment to developing nations will be necessary.
However, there is another possibility: Mr. Biden may either intend to release more of the existing U.S. vaccine stockpile to other countries to meet emergency needs and seek the cooperation of pharmaceutical companies in that mission, or he may be using the threat of the TRIPS waivers to nudge U.S. vaccine producers to ramp up their production and donate more doses to countries like India and Brazil.
Either way, it would be unwise for countries like India to rely on this initiative for an increase in vaccine supply.