Why patent waiver for Covid‐19 vaccines and pharmaceuticals?

• Published date: 01 July 2023
• Author: Mrityunjay Kumar,Nalin Bharti
• Date: 01 July 2023
• DOI: http://doi.org/10.1111/jwip.12269

Received: 13 May 2022

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Accepted: 11 March 2023

DOI: 10.1111/jwip.12269

ORIGINAL ARTICLE

Why patent waiver for Covid‐19 vaccines

and pharmaceuticals?

Mrityunjay Kumar |Nalin Bharti

Department of Humanities and Social

Sciences, Indian Institute of Technology

Patna, Patna, Bihar, India

Correspondence

Nalin Bharti, Department of Humanities and

Social Sciences, Indian Institute of Technology

Patna, Patna, Bihar 801106, India.

Email: nalinbharti@iitp.ac.in and

nalinbharti@gmail.com

Abstract

Patent protection emerged as one of the most challenging

barriers to the access to medicines, medical equipment, and

vaccines as well for the treatment and containment of

Covid‐19 when it became a pandemic. The severe scarcity of

vaccines and pharmaceutical products were weakening the

fight against Covid‐19, and endeavor to contain the recur-

rence of pandemic waves while mutation of the

SARS‐CoV‐2 was also on the full swing. Therefore, India

and South Africa jointly proposed for patent waiver at WTO

in October 2020 to effectively deal with the short‐supply of

medicines, medical equipment, vaccines and high price

concern related to these products. After 20 months of

consultation and negotiations with major stakeholders, the

WTO came up with decision on patent waiver in 12th

Ministerial Conference (12th MC). The time taken to reach to

the decision in the pandemic situation and the narrow scope

of the decision is a serious concern for the entire world to

deal effectively with Covid‐19 and its variants. This paper

attempts to analyse the patent waiver in the context of the

agreement on Trade Related Aspects of Intellectual Property

Rights (TRIPS). It discusses patent barriers, alternative

measures and needs for equitable access to vaccines and

pharmaceuticals amidst the pandemic. Paper applies the

qualitative methodology of research main ly content analysis

method in the framework of contextualisation, decontextua-

lisation, and recontextualisation. Results show that suspend-

ing certain provisions of theTRIPS required for the production

J World Intellect Prop. 2023;26:195–226. wileyonlinelibrary.com/journal/jwip © 2023 John Wiley & Sons Ltd.

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of vaccines and medicines would prove a crucial tool for

economies to return to its pre‐Covid‐19 era. Paper concludes

that, patent waiver can be one of the most important tool to

fight the Covid‐19 (as WHO has not yet declared the end of

pandemic) and will pave the way to deal with any such

unknown future pandemic effectively.

KEYWORDS

access, Covid‐19, medicines, patent waiver, TRIPS, vaccines

1|INTRODUCTION

The outbreak of the Covid‐19 pandemic is about to complete 3 years but the number of cumulative cases of

infection and the number of total deaths is still increasing at a substantial rate. Globally, there were 647.97 million

confirmed Covid‐19 cases including 6.814 million cases of deaths by 30 January, 2023

1

. Every week, on average

10,000 people die of Covid‐19 worldwide whereas countries like Japan, Brazil, Republic of Korea, United States,

Germany, France, and China are still reporting Covid‐19 infections in lakhs every week. The fresh wave of infection

in China during November–December 2022, is worrisome for everyone as experts of the disease predicted that in

the next few months about one million people could die in China alone due to Covid‐19

2

.

In many countries, Covid‐19 vaccination rate and the proportion of population which have been fully

vaccinated is far lower than the rich countries. The United Nations analysis found that by March 2022, out of

10 billion doses administered worldwide, only 1% have been administered in low‐income countries (LICs) which

shows a link with the widening poverty gap in these countries.

3

As per the data published in June 2022 out of 194

member countries of WHO only 58 countries reached the 70% target of vaccination coverage that was set in 2021

and as of first week of December 2022, only 28.89% people have been vaccinated at least one dose in LICs while in

high‐income countries (HICs) this number was 72.82%.

4,5

By the end of January 2023, just about 23% population of

the low income countries have been fully vaccinated with the primary series of vaccination

6

.

The world has experienced a mismatch between the large number of Covid‐19 infection and the availability of

required medicines, medical equipment and vaccines to combat the health crises. At this juncture, a very relevant

question is—what causes supply‐bottleneck of medicines and vaccines at the first place? The obvious answer is that

there are very few firms that produce patent‐protected Covid‐19 vaccines or pharmaceuticals and the patent rights

over their product allow them to restrict others from manufacturing and selling their patent‐protected products

until the patent expires.

7

Such patent holder firms exercise monopoly power and controls over the amount of

output to be produced and the price of their products.

8

Given the life‐saving nature of vaccines and

pharmaceuticals, the TRIPS agreement—to which patent is one of the categories of Intellectual property rights

(IPRs)—has relaxed certain provisions, best termed as TRIPS flexibilities, under the circumstances of public health

concern. Unfortunately, in the time of this pandemic too, IPR protection is controlling the global access to Covid‐19

vaccines and medicines.

9

According to Ranjan

10

the flexibilities allowed in theTRIPS agreement are not sufficient in

eliminating the supply crisis of vaccines and pharmaceuticals. Thus, the existing situation of IPR protection and the

resulting vaccines and pharmaceuticals access scenario compelled India and South Africa to submit a proposal to

the TRIPS Council of WTO to waive certain provisions of the TRIPS agreement temporarily to increase the

production of vaccines and pharmaceuticals currently under patent‐protection which cannot be otherwise

produced and supplied to match the high demand at present necessary to contain and control the pandemic.

11

Further, the concern has been raised in the revised draft of the patent waiver proposal in the TRIPS council, that any

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measures taken in conformity with the waiver proposal shall not be challenged by any member.

12

Moreover, the

patent waiver proposal has been supported by more than hundreds of countries, NGOs, civil societies, other

prominent personalities of the world, and most importantly the WHO.

13

Although, WHO can only influence the

demand side mechanism of the vaccines and pharmaceutical products, the supply‐side mechanisms are regulated

and controlled by WTO through its TRIPS agreement. In theTRIPS council of WTO, even after various rounds of

consultation on patent waiver proposal, member countries could not reached to any consensus before 12th

Ministerial Conference (12th MC) held in June, 2022. Thus, IPRs continued to control the manufacturing and supply

of Covid‐19 related IPs embodied vaccines, therapeutics and diagnostics over this period.

This paper focuses on why the patent waiver is crucial to contain and control the pandemic and the alleged

complexities before the proposal. It has discussed the potential of alternatives to patent waiver proposal in

mitigating vaccines and pharmaceuticals crisis and the need for solidarity and cooperation among world

organisations, countries, and communities in support of patent waiver and thereby fight against the present

pandemic effectively. Further, the experience of patent waiver granted and executed during this pandemic would

help to design the policy for prompt and accelerated production and distribution of pharmaceuticals and vaccines

developed for the unknown pathogen once identified to be future pandemic.

2|METHODOLOGY

This paper is based on the content analysis method taking three steps of contextualisation,

14

decontextualisation,

15

and recontextualisation

16

.

Contextualisation was required to understand the linkages between patent and issues related to

pharmaceuticals access that are continue to exist since the pre‐Covid‐19 period with the segregated documents

such as theTRIPS Agreement, Marrakesh Agreement and International Health Regulations along with cases related

to TRIPS and pharmaceuticals under the dispute settlement body (DSB).

Decontextualising was adopted to explore the challenges of scarcity of medicines and vaccines in the

exceptional Covid‐19 crisis. This includes discussions that start with the Covid‐19 infection and deaths reported in

three geographical regions of the global‐south, then the drugs candidates suggested by WHO, thereafter the global

access to Covid‐19 vaccines and the initiatives of WHO such as Covid‐19 Technology Access Pool (C‐TAP) and

COVAX along with vaccines donations by rich countries to secure equitable access to vaccines which are followed

by the discussion on patent waiver campaign that has culminated from the terrific situation of Covid‐19 vaccines

and pharmaceuticals access during the initial pandemic waves.

Taking the above facts into account and considering the continuing mutation of the virus and the slow pace of

negotiation on IP waiver at the WTO, recontextualisation is performed as the third steps—to explore following

points: why does patent waiver matter from the global socioeconomic perspective, the fundamental differences in

the vaccines and pharmaceutical manufacturing technology and protection under TRIPS framework, and the

resulting impediments to the working of the patent waiver. Recontextualising the discussion on the status of the

voluntary licensing, and compulsory licensing in this pandemic time along with the discussion on public funding

aspects of innovation and IP protection/waiver was a crucial details to reaching out the conclusion of this paper.

3|CONTEXTUALISING PRE‐COVID‐19 SITUATIONS FOR VACCINES

AND PHARMACEUTICALS

Access to affordable medicines has always been a matter of grave concern for poor people. A pre‐COVID

publication of the WHO found that two billion people around the world face challenges with pharmaceutical

accessibility.

17

One of the prime reasons for emergence of such situation is that, the patented or proprietary

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