![handle is hein.crs/govegah0001 and id is 1 raw text is: Potential WTO TRIPS Waiver and COVID-19
The Coronavirus Disease 2019 (COVID-19) pandemic has
spurred biopharmaceuticalcompanies to conductcostly and
risky research and development (R&D) to develop vaccines
and otherproducts to respond to COVID-19. Firms have
relied on intellectual property rights (IPR) to commercialize
these products. Governments and nonprofits have funded
and coordinatedsome ofthe 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). On May 5, 2021, the Biden
Administration announcedits support for the concept of a
waiver of parts of the World Trade Organization (WTO)
Agreement on Trade-Related Aspects of Intellectual
Property Rights (TRIPS) for COVID-19 vaccines, and
pledged to actively participate in text-basednegotiations at
the [WTO] to make that happen. Many consider this
notable, giventheUnited States' history ofadvancing IPR
standards globally. Members of Congress are divided on the
is sue. An active debateis underway in the WTO on the role
of IPR and trade policy in the pandemic response.
Background on WTO TRIPS Agreement
TRIPS, which entered into force in 1995, incorporated IPR
obligations into the multilateral rules -based trading system.
It requires most WTO members to adhere to minimum rules
and disciplines on patents, copyrights, trademarks, and
otherrights, and to enforce these commitments
domestically. It also has certain limitations to and
flexibilities for these obligations. Long-standing debates
over the balance in TRIPS to promote innovation and other
societal aims has intensified over access to COVID-19
vaccines and other treatments. Select relev ant TRIPS
flexibilities are summarized below.
Transition. Least-developed countries (LDCs) are exempt
frommeeting most substantive TRIPS obligations generally
until July 1, 2034, and meeting pharmaceutical patent and
clinical trial data protection obligations until January 1,
2033. The time limits on these exemptions have been
extended severaltimes using WTO waiver authority.
Patentability Exclusion. A government can exclude
certain inventions frompatentability, including if necessary
to protect human health or life, or 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. These conditions include requiring the proposed
userto first seekalicense on commercialterms; giving
adequate remuneration to the patent owner; and using the
CL mainly to supply the domestic market. These
requirements may be waived in situations ofnational
emergency or other circumstances ofextreme urgency....
The WTO has sought to address obstacles to CLuse by
poorer members (see text box).
Additional Compulsory Licensing Flexibility
In 2003, WTO members adopted a decision to waive the TRIPS
obligation generally limiting members' CL use to supply
pharmaceutical products to their domestic markets. The waiver
allowed members to export pharmaceutical products made under
CLs to least-developed and other eligible countries that cannot
make these products themselves, subject to certain requirements.
In 2005, members formally amended TRIPSto make thewaiver
permanent. The amendment entered into force in 20 1 7,following
its ratification by two-thirds of WTO members (the United
States accepted in 2005). The WTO has periodically extended
the deadline to ratify the waiver, most recently to December 31,
2021. For members who have not accepted the amendment, the
waiver continues to apply. The first and only use of this additional
CL flexibility was in 2007-2009 (until potential recent
developments), for a Canadian company to make and export an
AIDS therapy drugto Rwanda. In 2021, Bolivia notified the WTO
of its need to use the flexibility to import COVID-19 vaccines.
Debate over the effectiveness of this mechanism persists.
Essential SecurityInterests. A WTO member can take
measures in derogationof TRIPS if it is necessary for the
protection of its es sential security interests... taken in time
of... other emergency in international relations.
T RIPS Waver Developments
In October 2020, India and South Africa proposed a waiver
of certain TRIPS obligations (copyrights, patents, industrial
designs, andundisclosed information) in relation to
prevention, containment ortreatmentofCOVID-19. The
specific time period for the waiver would be determined
during negotiations among WTO members ; India and South
Africa proposedto extend the period untilwidespread
vaccination exists. The propo sal drew support frommany
LMICs seeking greater access to COVID-19 vaccines and
other health products, but it prompted skepticis m, largely
from a number ofhigh-income countries, due to concerns
about its scope, duration, and possible adverse effects on
innovation incentives and drug quality and safety.
In May 2021, India, South Africa, and 60other mainly
lower-income countries submitteda revised proposal in
hopes of garnering more support. As revised, the proposal
would waive the same IPR obligations as originally
proposed, but by contrast, it would limit the waiver to cover
initially a period of three years, and apply in relation to
health products and technologies, including diagnostics,
therapeutics, vaccines, medicaldevices, personalprotective
equipment, their materials or components, and their
methods and means of manufacture for the prevention,
treatment, or containment of COVID-19.
Updated September 13,2021](ViewImageLocal?handle=hein.crs/govegah0001&div=1&collection=&method=preview&ext=.png&size=3)
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