What’s the point of continuing a discussion on the unworkable TRIPs COVID-19 waiver proposal?

Kat friends Prashant Reddy T. and Yogesh Pai argue that continuing with WTO talks over the proposed TRIPs COVID-19 waiver is a futile and ineffective exercise in solving the problem of vaccine shortages.

As developing countries continue to struggle with a shortage of COVID vaccines, talks over the proposed TRIPs waiver, which call for a “waiver” of all IP rights related to technologies necessary for the containment, treatment or prevention of COVID-19, remain deadlocked at the WTO. There appears to be no possibility of breaking the deadlock, given the opposition from the European Union based on the claim that existing safeguards in TRIPs, such as the compulsory licensing provisions, read along with the Doha Declaration (2001), are sufficient to deal with the ongoing COVID pandemic.

In this context, it is necessary to question whether it is even worth spending more time on the TRIPs waiver when it is clear as day that the proposal will not solve the problem of continuing shortages of vaccines. To begin with, we question the proposition that IP was ever the primary barrier in meeting the global demand for vaccines. Since last year, when research into COVID vaccines began, multiple vaccine developers have voluntarily licensed their technologies to Indian companies. The Oxford-Astra Zeneca vaccine, the J&J vaccine, the Novovax vaccine and the Russian Sputnik vaccine have all been licensed to Indian companies for manufacture and distribution within India and, in some cases, for the rest of the developing world.

A fifth vaccine, developed by Indian manufacturer Bharat Biotech, has been licensed for manufacture to a government- owned company in India. Another promising subunit vaccine candidate that recently entered phase III trials is being developed by Baylor College of Medicine and Dynavax Technologies in conjunction with an Indian company called Biological E.

Simply put, there is no shortage of voluntary licensing agreements for COVID vaccines, for countries that have the capacity to manufacture vaccines. There, however, continues to be a shortage of vaccines in developing countries, presumably because of financing bottlenecks (e.g., the need for advance market commitments), poor planning (the Government of India began placing orders only in January 2021) and regulatory issues (e.g., indemnity waiver, price controls waiver, bridging trial waiver, and customs duty waiver).

The second reason we believe that the waiver is of little practical consequence is because it is widely accepted that vaccines cannot be reverse engineered and manufactured without the active co-operation of the original vaccine developer. This involves technology transfer, which in itself is contingent on the availability of highly skilled personnel and raw material. Even the Indian Government, which is one of the original sponsors of the waiver, while it was responding to domestic criticism on the non-issuance of compulsory licenses for vaccine patents, publicly accepted that vaccines cannot be reverse engineered without the co-operation of the vaccine developers.

In the context of creation of an mRNA vaccine hub in South-Africa, the WHO has acknowledged that active co-operation of the Big Pharma will be needed to quickly scale-up vaccine production. The only way to compel these companies to share such trade secrets or know how is through a governmental directive (such those issued under the Defence Procurement Act in the United States), and it is virtually certain that no Western government will force their companies to share their vaccine technology with foreign companies. At most, like the Biden administration, developed countries may ramp up domestic manufacture for the purpose of exporting excess stock to developing countries.

At this point, therefore, the only function served by advocating for a TRIPs waiver is the possibility of scoring a moral and political victory against the current system of uniform global IP norms imposed by the TRIPs Agreement. However, moral and political victories in relation to TRIPs will not bring those of us living in developing countries, like India, any closer to being fully vaccinated against COVID. Those in support of the waiver have little to say about how it will be implemented.

As citizens of a developing country, we want solutions that work to increase the production and availability of vaccines. We worry that this continuing discourse over the TRIPs waiver is distracting from identifying and solving the actual bottlenecks holding back the process of scaling up manufacture of vaccines to meet the current demand for COVID vaccines. These bottlenecks may be the lack of adequate manufacturing capacity, lack of public financing, the lack of trained personnel, or a shortage of raw material.

It also appears to us that countries, like India, are not exploiting their full manufacturing potential. For example, there is a state-of-the-art vaccine manufacturing plant in South India, which was built by the Government of India and has been lying idle for the last nine years. A recent attempt to lease it to private players failed to attract any bids for reasons that are not entirely clear.

Another problem in this regard is the choice of vaccine technology. For example, India’s domestic vaccine, manufactured by Bharat Biotech, apparently has a low yield, making it more expensive and inefficient to manufacture when compared to other vaccines. Since it requires BSL-3 facilities to manufacture and there is a shortage of BSL-3 manufacturing facilities in India, only one other plant is slated to manufacture this vaccine after the process of upgrading it to BSL-3 standards is completed. All of this could have been avoided and the manufacturing process optimized for more efficiency if better vaccination platforms had been chosen from the start.

Yet, we have hardly had a public discussion on many of these practical issues in India because the TRIPs waiver takes up a significant chunk of media attention. This works wonderfully for the Government of India because it gets to externalize the problem of vaccine shortage by blaming it on IP and foreign pharmaceutical companies.

Separate from these ‘operational issues’ is the fact that the deadlock over the TRIPs waiver is being used as an illustrative example to urge developing countries to rethink their commitment to TRIPs/WTO. It should not be forgotten that countries, like India, signed up for TRIPs only because of the promise of greater trade in sectors such as textiles, where Indian companies had a comparative cost advantage. The employment and revenue earned due to an increase in trade for countries, post the WTO Agreement, has been significant for countries like India. More employment opportunities are as important for public health as affordable medicine.

These trade-offs between IP and trade in goods/services must be kept in mind by those condemning TRIPs and WTO. The only alternative are bilateral agreements, where developing countries are unlikely to be able to collectively bargain for more favourable terms.

Picture on upper right is by Chiltepinster and is licensed under the Creative Commons Attribution-Share Alike 3.0 Unported license.