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The World Trade Organization (WTO) has been
established w.e.f. January 1, 1995 during the Uruguay Round
Ministerial Meeting held on April 15, 1994 by adoption of the
Marrakesh Declaration. WTO facilitates international trade in
goods and services and provide framework for negotiating trade
agreements and dispute resolution process among member
The Marrakesh Agreement has also established 20 separate Uruguay
Round Agreements – 16 multilateral and 4 plurilateral – which
are administered by WTO. While, the Multilateral Agreements,
including Trade Related Intellectual Property Rights (TRIPS)
Agreement, are binding on all member nations of WTO, the
Plurilateral Agreements are binding only between signatories
The TRIPS Agreement lays down minimum standards for the
regulation by member national governments of intellectual property
such as copyright, industrial designs, patents and protection of
undisclosed information or trade secrets as applied to nationals of
other WTO members and is the most comprehensive multilateral
agreement on intellectual property.
The TRIPS Agreement obliges member nations to provide patent
protection for inventions, whether a product or a process, for at
least 20 years on non-discrimination basis. The members are
required to publish laws and regulations made effective for
intellectual property protection and send such notifications to the
TRIPS Council, which will allow members to review each
other’s legislation and promote transparency of
members’ policies. The members are required to establish and
notify contact points in their administration for the purpose of
cooperation and to provide expeditious remedies to control and
deter infringements by empowering judicial authorities to provide
provisional relief for the right holder. The members are also
obligated to ensure that the enforcement procedures are fair and
equitable and not unnecessarily complicated or costly, or entail
unreasonable time limits or unwarranted delays.
The members reserve the right to refuse grant of patent rights
in order to prevent commercial exploitation of inventions. The
members may also exclude from patentability diagnostic, therapeutic
and surgical methods for the treatment of humans or animals and
other inventions to protect plant and animals.
Keeping in mind needs of the developing countries and their
public health related concerns, certain flexibilities are
incorporated in the TRIPS Agreement to implement intellectual
property rules on pro-public health and pro-access principles.
The TRIPS Agreement allows other persons to exploit a patented
product or process without the consent of the patent owner for use
of the government or third parties authorised by the government, in
case of national emergency or circumstances of extreme urgency,
provided efforts had been made to obtain authorisation from patent
holder without results.
However, such exploitation of patented product was initially
limited for supply to domestic market only, which was extended for
export to developing and least developed countries by amendment of
the TRIPS Agreement which took effect on January 23, 2017 and
replaced the 2003 waiver for members who accepted such amendment.
The members who are yet to accept the amendment have time till
December 31, 2021 to implement the amendment and for them the
waiver to the TRIPS obligation will continue to apply until a
member accepts the amendment and it takes effect for such
The flexibility of compulsory licenses1 was always
there in the TRIPS Agreement and reaffirmed in the Doha Declaration
on the TRIPS Agreement and Public Health, adopted by the WTO
Ministerial Conference on November 14, 2001, while taking
cognizance of the public health problems affecting many developing
and least developed countries. The Ministerial Conference
highlighted the member’s discretion to
circumventing patent rights for better access
to essential medicines by way of compulsory licenses, which
provides a critical tool for members seeking to balance the
interests of the public and those of the patent holders.
The Ministerial Conference stressed that the TRIPS Agreement
does not prevent members from taking measures to protect public
health and in particular to promote access to medicines for all.
Further, each member has right to grant compulsory licenses and the
freedom to determine the grounds upon which such licenses are
granted. The TRIPS Agreement does not specifically list the reasons
that might be used to justify compulsory licenses and member
nations are free to determine the grounds for granting compulsory
licenses and to determine what constitutes a national emergency. At
present, the drug patent exemption for developing and least
developed countries stands good until January 2033.
Just like HIV/AIDS was considered as national emergency in 2001
to avail flexibilities under the TRIPS Agreement, the world today
is fighting COVID-19, which is a global pandemic and nations are
struggling to develop vaccines and medicines for treatment of this
fatal disease. South Africa during the TRIPS Council meeting on
July 30, 2020, highlighted the difficulties being faced by the
developing countries in utilizing TRIPS flexibilities and lack of
domestic manufacturing capacity that make these countries dependent
on import to meet their medical needs, particularly in times of
At the TRIPS Council meeting held on October 15-16, 2020 India
and South Africa proposed, WTO to waive off implementation and
enforcement of certain provisions of the TRIPS Agreement in
relation to the prevention, containment or treatment of COVID-19
for all the member nations for term as agreed by the General
Council, and until vaccination is in place globally and majority of
the world’s population is immune. During this meeting the
Council Chair observed that the TRIPS Council will be reconvened
before mandatory deadline of 90 days expiring on December 31, 2020,
to prepare report on the waiver proposal and submit to the
Ministerial Conference for decision.
To combat COVID-19, the world needs immediate and seamless
supply of medicine and vaccine with no compromise on health
standards, safety and manufacturing capacity and that too at
reasonable prices. This raises a genuine concern for developing and
least developed countries as they have neither adequate resource
nor financial standing.
WTO has tradition of being nimble footed and standing up to
address global challenges. Keeping in view suffering of humanity
across the globe and how governments are struggling to reduce
infections and mortality, WTO needs to cut down procedural wrangles
and grant universal waiver to all member nations of the TRIPS
Agreement. Timely availability and low cost of vaccine for COVID-19
will go a long way to not only reaffirm faith of developing and
least developed nations towards global institutions like WTO in the
time of global crisis but also apply much needed balm on wounds of
humanity in these unprecedented crisis.
1 Compulsory licensing is when a government allows
someone else to produce a patented product or process
without the consent of the patent owner or plans to use
the patent-protected invention itself.
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