India: Waiver Under The TRIPS Agreement Amid COVID-19

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 nations.

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 thereof.

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 member.

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 COVID-19 crises

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.

Footnotes

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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