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June 16, 2021
Potential WTO TRIPS Waiver and COVID-19
The Coronavirus Disease 2019 (COVID-19) pandemic has
spurred biopharmaceutical companies to conduct costly and
risky research and development (R&D) to develop vaccines
and other products to respond to COVID-19. Firms have
relied on intellectual property rights (IPR) to commercialize
these products. Governments and nonprofits have funded
and coordinated some of the underlying R&D. Some groups
have voiced concerns over the impact of IPR on affordable
access to these products for low- and middle-income
countries (LMICs). An active debate is unfolding in the
World Trade Organization (WTO) on the role of IPR in the
pandemic response. On May 5, U.S. Trade Representative
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.
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mutual ndvnntnue of hrndurer and ucerc of terhnnlnuiral
knowledge and in a manner rnnducive to .social and economic
welfare and to a halance of rights and obligations. - TRIPS
Article 7 (Objectives)
Since the agreement's inception, some WTO members and
stakeholders have debated the balance that TRIPS struck to
promote innovation and other societal aims. This debate
intensified during the HIV/AIDS epidemic in the 2000s
over access to anti-retroviral drugs, and more recently over
access to COVID-19 treatments. Some of the relevant
TRIPS flexibilities are summarized below.
Transition. Least-developed countries (LDCs) are exempt
from meeting substantive TRIPS obligations generally until
July 31, 2021, and pharmaceutical patent obligations until
January 1, 2033. The WTO has extended the time limits on
these exemptions several times in the past.
Patentability Exclusion. A government can exclude
certain inventions from patentability, including if necessary
to protect human health or life, and if they are diagnostic,
therapeutic, or surgical methods of treatment.
Compulsory Licenses (CLs). A government may issue a
CL to authorize a third party to use a patented product or
process without the patent owner's consent under certain
conditions-including first trying to get a voluntary license;
giving adequate remuneration to the patent owner; and
using the CL mainly to supply the domestic market. These
requirements may be waived in situations of national
emergency or other circumstances of extreme urgency....
The WTO has sought to address obstacles to using CLs for
members with limited domestic manufacturing capacity
(see Figure 1).
Figure I. TRIPS Timeline: Selected Developments
. 1995 The WTO TRIPS Agreement enters into force.
2001 WTO members adopt the Doha Declaration on the
TRIPS Agreement and Public Health that affirms countries
are free to decide what constitutes a national emergency
or other circumstance of extreme urgency for CLs.
2003 WTO members adopt a decision to implement the
, Doha Declaration to waive certain CL requirements to
allow governments to issue CLs to produce pharmaceuti-
cal products and export them to eligible importing
members that cannot produce them domestically.
2005 WTO members approve the CL waiver.
2007-O9After notifying the WTO, Canada and Rwanda
use the TRIPS amendment CL waiver fora Canadian
company to make and export an AIDS therapy drug to
Rwanda-the first and only use of the flexibility to date.
* 2021 Bolivia notifies the WTO of its need to use the TRIPS
amendment CL waiverto import COVID-19 vaccines.
Source: CRS, based on WTO documents.
Essential Security Interests. A member can take measures
in derogation of TRIPS if it is necessary for the protection
of its essential security interests ... taken in time of... other
emergency in international relations.
TRIPS Waiver Developments
First proposed by India and South Africa in October 2020, a
broad TRIPS waiver proposal drew support from many
LMICs seeking greater access to COVID-19 vaccines and
other health products. The proposal prompted skepticism
largely from a number of high-income countries concerned
about its adverse effects on innovation incentives and drug
quality and safety. The debate grew amid worsening
COVID-19 outbreaks in South Asia and Latin America. On
May 21, 2021, India, South Africa, and 60 other countries
submitted a revised proposal. The revised proposal would
waive the same IPR (copyrights, patents, industrial designs,
and undisclosed data), but it now specifies that the waiver
would initially span three years and would be in relation to
health products and technologies including diagnostics,
therapeutics, vaccines, medical devices, personal protective
equipment, their materials or components, and their
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