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IPA Special

Time Is Appropriate Now For WTO Waiver On Existing Patent Laws

By Sachin Sathyarajan

The Omicron variant, declared as a “variant of concern” by the World Health Organization (WHO) has alarmed the global community, who thought the worst was over. The emergence of the variant had led to the postponement of the twelfth Ministerial conference (MC12) of the World Trade Organization (WTO). The MC12 was to consider the historic proposal by South Africa and India for waiving intellectual property rights (IP) to ensure global access to COVID-19 health technologies.

The Omicron variant was identified first in South Africa on November 24 and it is feared to spread faster than early variants of the SARS-CoV-2. It is quite a coincidence that the dangerous new variant was first sequenced and reported by the same country which initiated the solution of IP waiver to facilitate local manufacturing capacity in the Global South. The emergence and international spread of the new variant is a clear signal that achieving high vaccination within one’s national borders alone will not be enough.

At present, a total of 24 countries including nations with high domestic vaccination rates such as the US, Canada, Australia, Japan, the UK and several EU members have confirmed cases of the variant. The variant reportedly shows an unusual 30 mutations of the spike protein and its capacity to cause havoc is yet to be seen. The Dutch authorities have confirmed that the variant was already present in the country for at least a week before the flights arrived from South Africa. The German and Belgian authorities have confirmed that the Omicron variant was confirmed in people who had no contact or travel connection with southern Africa.

As a response to WHO’s announcement, more than 50 countries have introduced “knee-jerk” travel restrictions and most of them have singled out southern African countries. For instance, the EU had placed restrictions on Namibia, Zimbabwe, Botswana, Lesotho and Eswatini. The US had added Malawi and Mozambique to this list of African countries with a travel ban. Notably, the US did not ban the EU, Israel, Australia or any other non-African country. The Indian government has opted out of resuming international flights from December 15, while the first cases of Omicron were reported in India on December 3.

The UN Secretary-General has stated that the people of Africa should not be penalised for identifying and sharing crucial science and health information. The fact that the cases in the Netherlands predate the South African alert to the WHO means that the western powers have been unfairly penalising South Africa’s scientific initiative. There were also efforts to rebuke the Omicron as the “South African variant” by certain sections of the western media, which is an insult to the efforts of the brilliant scientists who spotted, sequenced, and reported it for the benefit of the world.

Only South Africa, Botswana and Nigeria have reported active Omicron cases in Africa and several nearby African countries with no Omicron variant have been subjected to travel bans. The South African President has claimed that there is no scientific basis for the travel bans and added that southern Africa is the victim of unfair discrimination. According to him, the travel bans will damage the economies of affected countries and undermine the ability to recover from the pandemic. Are the Africans responsible for the emergence of the new variant or is the international community to blame? Even if we assume for the moment that the new variant emerged from Africa, it is because of the lack of global cooperation in making vaccines available and affordable for the continent.

The WHO chief Tedros Ghebreyesus had tweeted on November 29 that the Omicron variant reflects the “threat of prolonged vaccine injustice”. The WHO chief warned that the longer we take to deliver vaccine equity, the more we allow the virus to circulate, mutate and become potentially more dangerous. The low vaccine coverage in poor countries increases the risk of new variants by allowing higher community transmission and high viral replication which facilitates mutation. As vaccination rates rise, the only virus strains that can infect people will be variants that partially escape the protection given by vaccines.

The fact remains that Africa was neglected from the global vaccine supply while the booster shot program had begun in the rest of the world. The WHO had already called the booster shots a “scandal” with six times more booster shots administered globally than primary doses in low-income countries.

While the UK and the US have administered 168.3 and 135.1 doses per 100 people, South Africa has only administered 42 doses per 100 people. The President of France, Emmanuel Macron made it clear that a third dose would be required to revalidate the national health pass. Germany had expanded the booster program to all adults. 15% of the UK population has already received a booster shot while only 9% of people in Africa have had their first dose.

The COVAX initiative, the global program co-led by the WHO for manufacturing and distributing Covid-19 vaccines, has struggled to secure enough vaccine doses. The aim of the COVAX to deliver 2 billion doses by the end of the year, was not met and roughly 575 million doses have actually been delivered. The pre-purchase agreements meant that half of the first 7.5 billion vaccine doses were purchased by high-income countries.

With countries such as the US, the UK, France, Germany etc. already administering the third round of vaccine shots or booster shots, only 7% of Africans have been fully vaccinated. High-risk groups in several African nations, including frontline health workers, have still not gotten their first dose. As the pharmaceutical companies continue to profiteer from the vaccine market, it is important to conclude that distributive justice and vaccine equity is still a distant dream.

Considering the grave situation of vaccine inequity, South Africa and India came up with the “TRIPS waiver” proposal at the World Trade Organization in October 2020. The Trade Related Aspects of Intellectual Property Rights or TRIPS is the agreement which has created common minimum standards of protection of IP for all the members of the WTO.

The WTO rules have been contested since its inception by developing countries and public health advocates that they impede access to medicines. The last time there was a TRIPS waiver was during the height of the HIV-AIDS pandemic, in the beginning of the millennium. The only requirement for a waiver under the WTO Agreement is the existence of “exceptional circumstances”.

The TRIPS waiver proposal, currently supported by more than 100 countries, called for a temporary waiver on IP such as patents, copyrights, trade secrets and industrial designs outlined in sections 1, 4, 5 and 7 of the Part II of the TRIPS agreement. In terms of vaccines, waiving patents in itself is not enough for generic manufacturers to start manufacturing because access to critical know-how protected as trade secrets is required. The proponents of the waiver did not limit the proposal to vaccines alone but included other critical COVID-19 health technologies such as therapeutics, medical equipment and diagnostic kits.

The opposition by the EU, the UK, Switzerland and Japan has stalled the progress of the negotiations for over a year. The waiver proposal quickly captured the interest of civil society and the media, while other industrialised nations gradually started extending support. The WTO in earlier meetings had already considered the South Africa-India proposal and the alternative proposal by the EU.

The talks are a litmus test for the WTO itself, which has not reached a multilateral agreement since 2015. In the middle of a raging pandemic and a year of intense negotiations, the trade representatives were not able to agree upon a modest set of measures at the WTO. The hopes for a TRIPS waiver was already waning before the MC12, but minds can be receptive to change with the fresh challenges brought forward by a novel variant. The Omicron variant has shown that even from a self-interest point of view, the Global North cannot be safe until everyone in the world is vaccinated.

In evolutionary biology, the punctuated equilibrium theory proposes that most of the evolutionary changes happen in rare and rapid events. The punctuated equilibrium in social theory considers that most social systems exist in extended periods of stability and are punctuated by sudden shifts leading to radical change. This pandemic is a moment in history where a dramatic shift can replace the inertia and the slow pace of policy processes at intergovernmental organisations. If we choose the TRIPS waiver and global solidarity at this juncture, we are not just defeating coronavirus. We will be restoring trust in international legal processes in dealing with future crises that will challenge humankind.

The original TRIPS agreement is not set in stone, as it was a highly political process and an outcome of its time. The developing world did not have the negotiating leverage and nations were arm twisted to accept the terms of the TRIPS agreement. Compared to compromises in textiles and agriculture, intellectual property was less of a priority for the Global South in the late 80s and early 90s. The US which owns much of the IP related to vaccines was once a notorious IP pirate and benefitted from copying technology for hundreds of years.

Much of the developing world is composed of decolonised nations, having relatively shorter transition periods to build domestic technology prowess by learning from foreign works. The erstwhile power imbalances are still protected by the maximalist rules of TRIPS. However, there is still hope that decisions that take years of deliberation in normal times, can happen in weeks during a crisis. Until now, public health was considered a barrier to free trade. The new variant presents an opportunity to steer clear of business-as-usual and opt for an economic regime that prioritizes global health needs. (IPA Service)

Courtesy: The Leaflet

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