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To address the severe disparity in the global distribution of COVID-19 vaccines where wealthier countries now hold the lion's share of available supply, intellectual property rights must be waived. Over 1.3 billion doses had been provided globally by the end of April 2021, but just 0.2% of vaccines had been administered in low-income nations. Africa continues to have the lowest immunisation rates of any continent. Less than 15% of its people have received all recommended vaccinations as of March 2022. A person who has taken two doses or just one of a single-dose vaccine is said to be “fully vaccinated”. Low-income countries tend to have GNI (Gross National Income) per person less than $1,045, while high-income nations have GNIs above $12,696 per person.

The proposed intellectual property waiver

The "patent waiver" is a proposal to suspend for three years certain provisions of the Trade-Related Aspects of Intellectual Property (TRIPS) Agreement. TRIPS requires certain member countries, including the United States, to provide certain minimum intellectual property protections. While this proposal is commonly referred to as a "patent waiver," it also includes provisions for copyright, industrial designs, and ‘undisclosed information’.

A waiver of intellectual property rights on certain items required in response to COVID-19 has garnered popularity within the international community during 2021 as one form of a potential solution to vaccine scarcity. This initiative was formally launched in October 2020 by South Africa and India, who asked the World Trade Organisation to start the process of waiving intellectual property rights on products used in the "prevention, containment, or treatment of COVID-19." As of right now, the TRIPS Agreement's codified international intellectual property laws do not permit a temporary suspension of the enforcement of intellectual property rights. 

Legal confidence that nations offering compulsory licences for COVID-19 products or technology would not be in breach of international intellectual property law would be the practical result of the passage of a waiver. The TRIPS Agreement mandates the granting and enforcement of patents for eligible technology, which include many parts of vaccines and other medical devices required to identify, treat, and prevent COVID-19. Legally speaking, these licences would allow third parties to utilise patented technology even when the rightsholder has not granted authorisation for particular uses, and the nations providing these licences would not be viewed as breaking the TRIPS Agreement.

Director-General Okonjo-Iweala hails breakthrough on TRIPS COVID-19 solution

Dr Ngozi Okonjo-Iweala, the director-general of the World Trade Organisation, warmly welcomed the agreement reached by four WTO Members to waive the agreement on trade-related intellectual property in order to produce vaccinations against the COVID-19 pandemic.      

She emphasised that although the agreement reached by the European Union, India, South Africa, and the United States is a crucial component of any final agreement, not all the specifics have been worked out and that internal domestic deliberations within the four nations are still ongoing. She also emphasised that work must start right away to expand the discussions to include all 164 WTO members.

“In the WTO we decide by consensus, and this has not yet been achieved. My team and I have been working hard for the past three months and we are ready to roll up our sleeves again to work together with the TRIPS Council Chair Ambassador, Lansana Gberie (Sierra Leone) to bring about a full agreement as quickly as possible. We are grateful to the four Members for the difficult work they have undertaken so far,” said Dr. Okonjo-Iweala.

Who backs the waiver?

The proposal from South Africa and India had received formal support by May 2021.

The majority of the 62 WTO members are LDCs from the global south.

Kenya, Indonesia, and Pakistan were among those who backed the initiative.

More than 100 countries are said to support the principle of a waiver (the WTO has 164 members). 

In April 2021, President Biden reversed his predecessor's decision to support a vaccine waiver in principle. He argued in late 2021 that the emergence of the Omicron variant highlighted the need for increased vaccine production globally. However, the G7 as a whole has not supported a waiver. 

At the G7 summit in June 2021, its members stated that they would "engage constructively with discussions at the WTO. "The G7 consists of the United Kingdom, the United States, France, Germany, Italy, the European Union, Japan, and Canada. 

Proponents argument

Proponents of the waiver argue that Big Pharma's monopoly on vaccine development is unjust, given that the majority of COVID-19 vaccines are funded by taxpayers. The government has funded at least 97 percent of the AstraZeneca-Oxford vaccine research, while Moderna, Janssen, and BioNTech – the German company with which Pfizer developed its vaccine; have all received significant government funding. 

According to the Indian/South African proposal in October 2020, property rights such as patents, industrial designs, trademarks, and the protection of undisclosed information obstruct timely access to affordable vaccines and medicines needed to combat COVID-19. Thus, they propose that the waiver be granted indefinitely, with an ongoing review until it expires, as they advocate for unrestricted global sharing of technology and technical expertise. They also claim that the waiver will compel pharmaceutical companies with patents to increase the supply of their drugs.

Opponent’s argument: Big Pharma’s perspective

One of the counterarguments is that the waiver cannot help generic manufacturers (or patients) because it does not address certain LMICs' lack of manufacturing capability and fragile healthcare systems. Furthermore, they claim that it is unable to alleviate raw material scarcity or the steep learning curve of manufacturing processes. To put this in context, the technology used to make the Pfizer mRNA vaccine was developed recently and with groundbreaking technical expertise; as a result, no pharmaceutical company can easily replicate it. 

Big Pharma claims that the constraint is not only intellectual property rights but also the underlying processes surrounding the protected technology. Vaccine manufacturing is said to be difficult. Based on insights from non-specialist AstraZeneca's manufacturing problems, while Big Pharma maintained that suspending patents alone would not result in more shots, another critic suggested that the proposal was unnecessary. While these claims differ in their perspectives, the main concern is how this will affect COVID-19 containment in low- and middle-income countries and how quickly vaccines will be available there.

Compromise reached on COVID-19 vaccine intellectual property rights waiver

According to a document obtained by POLITICO, the EU, South Africa, India, and the United States have reached an agreement on a waiver of intellectual property rights for coronavirus products.

Supporters of a waiver argue that it would have resulted in a significant increase in coronavirus products produced during the pandemic, potentially saving many lives. It would have effectively allowed manufacturers to replicate coronavirus vaccines, tests, and diagnostics without fear of infringing on pharmaceutical companies' patents. Coronavirus vaccines were in short supply until the end of last year, with many poorer countries, particularly in Africa, having almost no access to them. According to the compromise, which currently only applies to vaccines, developing countries that exported less than 10% of the world's coronavirus vaccine doses in 2021 would be able to use a patented coronavirus vaccine without the consent of the patent owner. The solution is said to be much broader than compulsory licensing, an alternative proposal that would allow countries to increase vaccine production through means such as executive orders.

The new text could signal the start of a resolution to the World Trade Organisation debate that has been deadlocked since October 2019, but it still requires agreement from EU member countries as well as other WTO members:

A waiver of intellectual property rights for coronavirus products was first proposed by India and South Africa, and it eventually received widespread support. However, it was met with strong opposition from several WTO members, including the EU and the United Kingdom.

Adam Hodge, the United States Trade Representative confirmed in an online statement that the "difficult and protracted process has resulted in a compromise outcome" on intellectual property, which he said would offer "the most promising path toward achieving a concrete and meaningful outcome."

Hodge went on to say that "no text agreement has been reached, and we are in the process of consulting on the outcome."

Although the breakthrough appears to be significant, advocates for greater global access to effective COVID treatments were disappointed that the compromise only applies to vaccines.

The fact that the waiver was limited to vaccines was "appalling," according to James Love, director of Knowledge Ecology International. 

Shailly Gupta of Doctors Without Borders was equally critical, tweeting: "What about therapeutics that are or will be needed for those who will continue to fall sick due to #COVID19 in low and middle-income countries.”

Love added that countries already have the freedom to allow non-voluntary use of patents "even without prior negotiation with patent owners in cases of emergency or pandemic," and he criticised the restriction on certain WTO members, claiming that it protects "American and European vaccine manufacturers from competition from developing country suppliers."

Conclusion