Why waiver of patent rights for Covid-19 vaccines is necessary
Tuesday, June 01, 2021

Today, no one could underestimate the number of deaths and cases of Covid-19. While relying on the WHO reports, currently the confirmed cases of Covid-19 are 170 002 963 and confirmed deaths are 3 539 381. As of now, some countries are under a state of emergency, others have imposed partial or total lockdown and others have gradually relaxed restrictions after having inoculated their population. 

It is against this background that there is a growing clamour from India and South Africa for temporary intellectual property waiver on Covid-19 vaccines at the World Trade Organization (WTO). This idea is hugely supported by most of developing countries, as there’s a need for expeditious transfer of technology and availability of the raw materials to quickly increase the production of the Covid-19 vaccines and overcome the virus. 

What is the puzzling question? 

The debate on how to increase the production of Covid-19 vaccines is taking centre stage, as the world grapples with the virus. The vaccines that have been developed to combat Covid-19, providing a silver lining to the crisis are subject to patent protection under the TRIPS Agreement. The patent holders have the exclusive right to manufacture, sell, and use the vaccine or the drug for the entire term of patent protection of 20 years from the date of the filing of the patent. India and South Africa are vigorously pushing at the World Trade Organization (WTO) for a waiver of patent protections on Covid-19 vaccines but this will be contingent on the position of the US and European countries. 

One among them is Germany, which opposes the campaign to lift patent protection for Covid-19 vaccines, saying "the protection of intellectual property is a source of innovation and must remain so in the future.” On the contrast, the Biden Administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines”. 

The aim for waiver of the patent rights is to ensure that as many people in the world as possible have access to vaccine. So, prioritizing protection of patent rights could impede manufacturing ability of some countries, hence wider inaccessibility of vaccines and prolong the pandemic. The wider vaccination exercise will end the pandemic, and the challenge is to ensure that it is universalised. The task is profound due to the increasing concerns of vaccine nationalism, whereby richer countries are procuring vaccines for their population ahead of others which, in turn, could derail the goal of delivering the required vaccine doses to poorer and middle-income countries. 

What does TRIPS Agreement set out with respect to the patent rights? 

The 1995 agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is a key legal instrument that harmonises intellectual property (IP) protection by imposing binding obligations on member countries to ensure a minimum level of protection and enforcement of IP rights in their territories. As part of the World Trade Organization (WTO)’s legal regime, the TRIPS agreement also imposes the enforcement of IP rights through a compulsory and enforceable dispute settlement mechanism. The TRIPS also remains the most comprehensive multilateral agreement on intellectual property to date.

As regards the legal protection of the patent rights, for example, Article 28, paragraph 1, of TRIPS states as follows: "a patent shall confer on its owner the following exclusive rights: (a) where the subject matter of a patent is a product, to prevent third parties not having the owner’s consent from the acts of: making, using, offering for sale, selling, or importing for these purposes that product…” 

Also, Article 33 of TRIPS provides "the term of protection available shall not end before the expiration of a period of twenty years counted from the filing date”. 

To the foregoing provisions, the patent holders/owners have the right to grant permission for other countries that have manufacturing ability to manufacture COVID-19 vaccines. And such protection is for 20 years. The timeframe for protection has in fact been accommodated in national laws of all WTO member states. For example, Rwanda’s Intellectual Property Law of 2009 under Article 42 provides that "…. the patent shall lapse twenty (20) years after the filing date of the patent application”. 

Besides, paragraph 3 of the Article X of the WTO Agreement, any amendment to the TRIPS requires the TRIPS Ministerial Conference to decide by a three-fourths majority of the WTO Members that any amendment to come to effect. 

While modifying TRIPS is a bit cumbersome, it contains some flexibilities worth utilizing to waive the patent protection for the sake of saving millions of people highly susceptible to Covid-19. Article IX, paragraph 3, of the Marrakesh Agreement establishing the WTO provides that in "exceptional circumstances”, the Ministerial Conference may waive an obligation imposed on a WTO member country by the WTO Agreement or any other multilateral trade agreement. The same provision provides that such a waiver be supported by three-quarters of the members. A key hurdle relies here on whether richer nations would accept it.

In the current scenario, Covid-19 fits well in exceptional circumstances or exigency, justifying the waiver of patent rights under the TRIPS Agreement.

Fred Nkusi  is a law expert. 

The views expressed in this article are of the writer.