India and South Africa have submitted a proposal in the World Trade Organization (WTO) to waive intellectual property (I.P.) rights protection for the COVID-19 vaccine formula. Their proposal has been garnering much support in recent days. On 5^th May, the office of the United States (U.S.) Trade Representative announced that even the United States would be supporting this proposal and asked the pharmaceutical industry to make “sacrifices”. Keeping aside the issues related to the proposal itself and the sudden reversal of U.S. foreign policy, it is still doubtful if this proposal will go through since the WTO is an organization that functions on consensus. The United Kingdom (U.K.), European Union (E.U.), Norway, Japan, Brazil, and Switzerland have not yet supported this proposal. Although, their position on the issue might change after the American declaration, like the E.U. now showing a willingness to discuss the waiver. The European Union in the informal Trade-Related Aspects of Intellectual Property Rights (TRIPS) council meeting had mentioned that they would not take any measures which would undermine I.P. rights, but now seem to have pulled a foreign policy reversal like the U.S. As can be reasonably expected, the pharmaceutical industry has opposed the idea of an I.P. waiver to be granted for the vaccine’s formula. The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) has stated that I.P. protection is required for securing future research and is the very foundation that sustains the entire industry. They also noted that this I.P. waiver would be “counterintuitive.” The U.S. Chamber of Commerce has stated that the main aim should be assisting countries in procuring the vaccine and administering the same. It should be “reinforcing” supply chains, not “diminishing” the importance of I.P. rights, which would make it harder to develop vaccines in the case of any future pandemic. This highlights the contrary stances existing within the American administration itself. Another issue that arises is that the development of vaccines like the COVID-19 vaccine requires a large amount of capital. Multiple times this investment comes from external sources. I.P. rights assure protection of their returns on this investment. Waiving of I.P. protection will essentially waive the security of their return as well, and this will make it harder for pharmaceuticals to secure this investment the next time.

Fatal Flaw in waiver plan:

Médecins Sans Frontières (MSF) has supported the India-South Africa proposal and stated that the waiver would give “the government’s all available tools to ensure global access” for the vaccine. A fatal flaw is that this entire plan assumes that the moment I.P. rights are waived, the global community will suddenly get access to the vaccine. They assume this will function as a miracle cure to the pandemic, but it, not the silver bullet they are making it out to be. Firstly, the vaccine development process is a complicated process. The moment the I.P. rights are waived, the production is not going to increase dramatically.

An example is a statement by Moderna that the company will not enforce I.P. claims for their vaccine during the pandemic. There was no significant rise in vaccine production or distribution that could be directly connected to the statement. Using the analogy used by Silverstein that the blueprints for Elon Musk’s Space X Rockets “are not what is keeping me as an individual or my firm from making rockets. We need specialized equipment; we need trained personnel, and we need the infrastructure to support it.” But what it will definitely do, is that it will significantly disincentivize the pharmaceutical industry to conduct such critical research. The con in this case far outweighs the pro. Secondly, there are specific requirements to be complied with by a factory to produce the vaccine. Such factories are not sitting idle. As billionaire philanthropist Bill Gates had stated as well, there is no factory waiting with regulatory approval, which makes “magically safe vaccines.” Every manufacturing process must be carefully examined. The issue of safe manufacture and delivery of vaccines after the I.P. waiver stands as a significant safety issue.

What can be done?

Instead of trying to waive I.P. rights, countries should come together to reinforce supply chains and stopping export barriers. There are multiple agreements between pharmaceutical companies producing the vaccine, which has accelerated the manufacture and distribution. For example, Sanofi has an agreement to supply Pzier and BioNTech vaccines all across the European Union. Such agreements should be promoted, which protect I.P. rights of the pharmaceutical industry and at the same time benefit the global community. On a concluding note, if the I.P. waiver is brought into effect, it will set a dangerous precedent, hindering further medical research. Countries and companies should instead look into methods that do not act as barriers to further development and set the right precedents in these unprecedented times.

Ahan Gadkari