How IP Waivers Can Help Manage the Omicron Strain

Photo by Braňo (Unsplash)

Shannon Flynn is a Guest Writer and the Managing Editor of ReHack Magazine.

Over two years have passed since the SARS-CoV-2 virus, better known today as COVID-19, made its first appearance in the city of Wuhan, China. In those two years, the virus has circled the globe, killing more than five million people as of December 2021—a number that has climbed with the spread of the new, highly transmissible Omicron variant. Treatments and vaccines have emerged, but the challenge now lies in ensuring everyone has equal access to these measures.

The biggest challenge is getting supplies to low-income countries that need them the most— places where less than 6.3% of people are vaccinated but have high population densities that can contribute to community spread. In response, some countries are asking the World Trade Organization (WTO) to waive the intellectual property (IP) laws that cover the COVID-19 vaccines and treatments.

Is this a good idea or an enormous mistake? How can IP waivers help manage the Omicron strain?

The Risk of Omicron

We’ve made our way through most of the Greek alphabet as new COVID-19 variants emerge and either spread or vanish. Why did Omicron become a variant of concern so quickly?

Early evidence suggests Omicron may be more transmissible than previous incarnations of the virus, making it spread faster than Delta and other variants. In mid-December 2021, researchers in Hong Kong found that the Omicron variant infects and multiplies in human airways 70 times more quickly than the Delta variant. They believed those characteristics might contribute to its comparatively more efficient spread.

Studies show Omicron is between 2.7 and 3.7 times more infectious, even among vaccinated and boosted individuals. It was also thought that this variant caused milder infections. However, this may be due to the low vaccination rate in South Africa, where it was first observed. According to NPR, most South Africans have already been exposed to the COVID-19 virus and developed some level of immunity.

Both Pfizer and Moderna released statements claiming their vaccines are effective against Omicron after a third booster dose, but most boosters are available only in high-income countries. While over 60% of the global population is fully vaccinated, there isn’t much information on how many individuals received a third booster shot and from where.

Furthermore, in April 2021, the World Health Organization (WHO) stated that 87% of all administered vaccine doses went to individuals in high-income countries. The challenge is getting the vaccine to low-income countries with very low vaccination rates.

IP Protection or Waivers

What do COVID-19 and the Omicron variant have to do with intellectual property rights and waivers? In October 2020, representatives from India and South Africa presented a proposal to the WTO.

The 2020 Proposal

The 2020 proposal to the WTO waives parts of the TRIPS Agreement, a multilateral agreement covering intellectual property rights.

A part of the proposal read: “Many countries, especially developing countries, may face institutional and legal difficulties when using flexibilities available in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement).”

People have mentioned elsewhere that the TRIPS Agreement could cause cumbersome barriers to vaccine access. The 2020 proposal requested “a waiver from the implementation, application and enforcement of Sections 1, 4, 5 and 7 of Part II of the TRIPS Agreement in relation to prevention, containment or treatment of COVID-19.”

The parties behind the proposal wished for the waivers to remain active until global widespread access to the vaccine was possible.

The 2021 Revised Proposal

A revised proposal was sent to the WTO in May 2021. It includes representation from several countries beyond India and South Africa. The newer document discusses growing concerns associated with emerging variants and how they make the need for global vaccine distribution and production even more urgent. The proposal’s authors also note that the original text’s scope was too broad. The revised proposal focuses exclusively on “health products and technologies.”

The revised proposal asks for a “practical and flexible duration” regarding the waiver length. The authors request an initial term of at least three years from the decision date. After that, the General Council—the WTO’s highest decision-making body—could review whether the exceptional circumstances that originally justified the waiver were still present and if it was appropriate to set an ending date.

What Would the TRIPS Waiver Do?

TRIPS has been the subject of many discussions and opinions. However, it’s important to clarify that a waiver would not be an instant and all-encompassing solution for improving vaccine access. It will theoretically pave the way for increased production of vaccines and related health technologies in more countries.

However, it takes time and money to set up manufacturing facilities in countries with few or none. The waived intellectual property rights would let parties utilize the vaccine technology without penalties but affected nations and the people living there would not benefit immediately.

Some people also argue that waiving the IP rights could make the vaccines more expensive for everyone who needs them. That’s because there would be a larger number of parties trying to buy raw materials, driving up the associated prices.

Additionally, it takes nine to 12 months to create or increase vaccine production capacity. That’s on top of the up to $1 billion required to build the factory. Even once manufacturers get up and running, additional complications, such as new variants and the uncertainties surrounding vaccine durability, could make things more difficult for those making COVID-19 vaccines for the first time.

A potential alternative is for the international community to collectively invest in hubs for research and development (R&D) and manufacturing on each continent. The WHO is working on one for South Africa to facilitate technology transfers associated with COVID-19 vaccines.

Managing Omicron

As we move into 2022, it’s becoming increasingly apparent that COVID-19 is likely going to become endemic, similar to the influenza virus. This means that there will probably be a continuous demand for new and updated vaccines and booster shots moving forward. Getting your annual COVID-19 shot may become as common as getting your yearly flu shot.

Moderna has stated it won’t be enforcing its patent rights to its COVID-19 vaccine during the pandemic. However, that may change in a couple of years if and when the WHO declares the pandemic is over and the virus has become endemic.

As discussed earlier, waiving IP rights won’t remove all the barriers that currently prohibit worldwide vaccine production. When the virus reaches the endemic stage, it could lessen the incentive to set up the necessary facilities. Right now, Moderna and Pfizer are both working on new vaccines to combat Omicron, even though they both claim that their vaccines—with three doses—are effective against the new variant.

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