June 16, 2021
Potential WTO TRIPS Waiver and COVID-19
The Coronavirus Disease 2019 (COVID-19) pandemic has
Compulsory Licenses (CLs). A government may issue a
spurred biopharmaceutical companies to conduct costly and
CL to authorize a third party to use a patented product or
risky research and development (R&D) to develop vaccines
process without the patent owner’s consent under certain
and other products to respond to COVID-19. Firms have
conditions—including first trying to get a voluntary license;
relied on intellectual property rights (IPR) to commercialize
giving adequate remuneration to the patent owner; and
these products. Governments and nonprofits have funded
using the CL mainly to supply the domestic market. These
and coordinated some of the underlying R&D. Some groups
requirements may be waived in “situations of national
have voiced concerns over the impact of IPR on affordable
emergency or other circumstances of extreme urgency….”
access to these products for low- and middle-income
The WTO has sought to address obstacles to using CLs for
countries (LMICs). An active debate is unfolding in the
members with limited domestic manufacturing capacity
World Trade Organization (WTO) on the role of IPR in the
(see Figure 1).
pandemic response. On May 5, U.S. Trade Representative
Figure 1. TRIPS Timeline: Selected Developments
Katherine Tai announced the Biden Administration’s
support for the concept of a waiver of the 1995 WTO
Agreement on Trade-Related Aspects of Intellectual
Property Rights (TRIPS) for COVID-19 vaccines, and
pledged to “actively participate in text-based negotiations at
the [WTO] to make that happen.” Many consider this
notable, given the United States’ history of advancing
stronger IPR standards globally. Members of Congress have
varying views on the issue.
Background on TRIPS Agreement
TRIPS incorporated IPR obligations into the multilateral
rules-based trading system. It requires most WTO members
to adhere to minimum standards to protect patents,
copyrights, trademarks, and other rights, and to enforce
these protections domestically. TRIPS also has certain
limitations to and flexibilities for these obligations.

The protection and enforcement of intellectual property rights
Source: CRS, based on WTO documents.
should contribute to the promotion of technological innovation
and to the transfer and dissemination of technology, to the
Essential Security Interests. A member can take measures
mutual advantage of producers and users of technological
in derogation of TRIPS if it is “necessary for the protection
knowledge and in a manner conducive to social and economic
of its essential security interests… taken in time of… other
welfare, and to a balance of rights and obligations. – TRIPS
emergency in international relations.”
Article 7 (Objectives)
TRIPS Waiver Developments
Since the agreement’s inception, some WTO members and
First proposed by India and South Africa in October 2020, a
stakeholders have debated the balance that TRIPS struck to
broad TRIPS waiver proposal drew support from many
promote innovation and other societal aims. This debate
LMICs seeking greater access to COVID-19 vaccines and
intensified during the HIV/AIDS epidemic in the 2000s
other health products. The proposal prompted skepticism
over access to anti-retroviral drugs, and more recently over
largely from a number of high-income countries concerned
access to COVID-19 treatments. Some of the relevant
about its adverse effects on innovation incentives and drug
TRIPS flexibilities are summarized below.
quality and safety. The debate grew amid worsening
Transition. Least-developed countries (LDCs) are exempt
COVID-19 outbreaks in South Asia and Latin America. On
from meeting substantive TRIPS obligations generally until
May 21, 2021, India, South Africa, and 60 other countries
July 31, 2021, and pharmaceutical patent obligations until
submitted a revised proposal. The revised proposal would
January 1, 2033. The WTO has extended the time limits on
waive the same IPR (copyrights, patents, industrial designs,
these exemptions several times in the past.
and undisclosed data), but it now specifies that the waiver
Patentability Exclusion. A government can exclude
would initially span three years and would be “in relation to
certain inventions from patentability, including if necessary
health products and technologies including diagnostics,
to protect human health or life, and if they are diagnostic,
therapeutics, vaccines, medical devices, personal protective
therapeutic, or surgical methods of treatment.
equipment, their materials or components, and their
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Potential WTO TRIPS Waiver and COVID-19
methods and means of manufacture for the prevention,
other barriers such as supply chain disruptions; lack of
treatment, or containment of COVID-19.”
manufacturing capacity, know-how, and financing; and
While the United States shifted its position to support
inadequate distribution networks and health care systems in
generally a TRIPS waiver for COVID-19 vaccines, some
many LMICs.
other high-income countries remain opposed, such as the
Some stakeholders debate whether the waiver would
European Union (EU) (though it is internally divided), the
actually help accelerate the production and deployment of
United Kingdom (UK), Switzerland, and South Korea. The
vaccines and therapeutics. The pharmaceutical industry
positions of some other countries vary and, in some cases,
claims that ongoing voluntary licensing agreements and
have shifted. The BRICS nations (Brazil, Russia, India,
technology transfer of COVID-19 treatments are sufficient
China, and South Africa) jointly voiced support for ongoing
to ensure that enough vaccines will be available globally by
consideration of a TRIPS waiver and using flexibilities
the end of 2021. Companies also doubt the ability of third-
under TRIPS. Other developments include the Asia Pacific
party manufacturers to produce the vaccines. For instance,
Economic Cooperation (APEC) group’s recent support for
if the waiver applies only to patents, a patent holder would
text-based negotiations, including on a temporary waiver.
not necessarily be under any obligation to transfer
WTO text-based negotiations are expected to commence.
technological or manufacturing knowhow, which is
The U.S. representative to the WTO has said that the United
especially critical for the mRNA vaccines. Waiver
States “has not prejudged an outcome,” and views “the
advocates counter that voluntary licenses are too costly and
most expeditious pathway toward consensus” as addressing
inefficient and, in some cases, rights-holders have been
“the supply and distribution of vaccines specifically.” On
unwilling to license their IPR to vaccine-producing
June 4, the EU submitted a proposal for a global trade
companies. For example, firms in Bangladesh, Canada, and
initiative for equitable access to COVID-19 vaccines and
Israel state they are willing and able to make the vaccine
therapeutics, relating to trade facilitation and reducing
save for the IPR. It is difficult to evaluate these claims, as
export restrictions, expanding production, and facilitating
most licensing agreements and their terms are not public.
the use of CLs under TRIPS as needed. The WTO Director-
Issues for Congress
General voiced support for members to make progress on a
Supporters may urge the Administration to negotiate a
text by July and reach agreement by the planned 12th WTO
waiver as quickly as possible and/or to advocate for a
Ministerial Conference at the end of 2021 on a “pragmatic
waiver covering specific types of IP or to cover other
framework” offering developing countries access to health
COVID-19-related products beyond vaccines. Critics may
technologies while maintaining incentives for innovation. If
press the Administration to consider alternative responses,
the WTO were to adopt a potential TRIPS waiver, it would
such as related to voluntary licensing, transfer of know-
not necessarily change WTO members’ domestic IP
how, use of existing TRIPS flexibilities, or scaling up
protections automatically. Each member would need to go
production. Various bills have been introduced to provide
through its relevant domestic procedures to decide whether
congressional input or other related requirements on any
and how to change its laws to implement the waiver.
agreement by the Administration to a waiver. Issues that
Debate
Members of Congress may examine include:
Countries and stakeholders supporting the waiver argue that
 What should the role of Congress be in any potential
the large-scale morbidity (illness) and mortality (deaths)
U.S. agreement to modify TRIPS?
caused by the pandemic and its disproportionate impact on
 Would a waiver, if adopted, actually promote greater
LMICs require a fuller response than allowed under
global production and access to COVID-19 treatments,
existing TRIPS flexibilities. They assert that the conditions
and if so, would it be in a sufficient period of time to
for invoking a CL are too lengthy, costly, and cumbersome
respond to the urgency of the crisis? Would further steps
to be a viable strategy for addressing shortfalls in domestic
be necessary to transfer know-how to develop COVID-
manufacturing. By contrast, suspending IPR obligations
19 vaccines or other products safely?
may allow countries to authorize producers to manufacture

generic COVID-19 products likely without facing the threat
How might a waiver affect U.S. industry, economic
of a WTO dispute or other negative trade consequences.
interests, and competitiveness in future innovation
U.S. advocates also argue that since the U.S. government,
including with respect to China?
with taxpayer-funded R&D, supported some COVID-19
 In terms of U.S. trade agreements, does support for a
vaccines development, the IP should be shared publicly.
waiver represent a unique position for an unprecedented
Conversely, other countries, industry, and other
pandemic, or a general shift in U.S. trade and IPR policy
stakeholders argue that IPR facilitate innovation and access
as it relates to public health tools?
to COVID-19 treatments. They point to the unprecedented

speed in the development of COVID-19 vaccines and claim
See CRS In Focus IF10033, Intellectual Property Rights
that the waiver would constrain their current production
(IPR) and International Trade, CRS In Focus IF11796,
ability and discourage future advances. Some U.S.-based
Global COVID-19 Vaccine Distribution, and CRS Legal
stakeholders also argue the waiver would cause the United
Sidebar LSB10599, The Legal Framework for Waiving
States to lose a competitive advantage to countries such as
World Trade Organization (WTO) Obligations.
China and Russia, which may reap the economic rewards of
Shayerah I. Akhtar, Specialist in International Trade and
U.S.-developed technology. They further claim little
evidence exists to show that IPR is delaying vaccine
Finance
production and distribution, which they argue is due to
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Potential WTO TRIPS Waiver and COVID-19

IF11858
Ian F. Fergusson, Specialist in International Trade and
Finance


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