NEWS  The U.S. supported move will have an effect if countries simultaneously address non-IP bottlenecks among other things.

CONTEXT 

• In October 2020, India and South Africa, at the World Trade Organisation (WTO), proposed waiving Sections 1, 4, 5, and 7 of Part II of the TRIPS agreement (covering copyrights, industrial designs, patents, and undisclosed trade information) related to the prevention, containment, or treatment of COVID-19.
• In response to this proposal, the United States has finally relented and declared its support for a temporary waiver of the TRIPS agreement for COVID-19 vaccines at the WTO.

SIGNIFICANCE OF U.S. SUPPORT

• The U.S.’s support of the TRIPS waiver is a significant step forward in the global fight against the pandemic.
• Hopefully, the U.S.’s decision would cause other holdouts like Canada and the European Union to give up their opposition.

LEGAL POSSIBILITY FOR THE WAIVER

• Legally, the waiver is surely possible.
• The Article IX of the WTO Agreement allows for waiving obligations in ‘exceptional circumstances’, which the COVID-19 pandemic undoubtedly is.
• Specifically, the obligation contained in Article 31(f) of TRIPS that medicines produced under a compulsory licence are predominantly for the domestic market of that country was waived, paving the way for the export of such medicines to a country that lacked manufacturing capability.

DEVIL IN THE DETAILS

• While the U.S.’s decision is to be welcomed, the devil would be in the details.
• The countries would now negotiate on the text of the waiver at the WTO, and as per the experience of negotiating such waivers in the past, it would be too early to celebrate.

As the waiver is subject to several stringent requirements such as:

• the drugs so manufactured are to be exported to that nation only;
• the medicines should be easily identifiable through different colour, or shape;
• only the amount necessary to meet the requirements of the importing country are to be manufactured;
• the importing country has to notify the WTO’s TRIPS Council, etc,.

Given these cumbersome requirements, hardly any country, in the last 17 years, made effective use of this waiver.

CHALLENGES AHEAD

Complex process:

• The negotiations on the text of the waiver will ‘take time’ given the WTO’s consensus-based decision-making process and the complexity of the issues involved.

U.S. Narrow scope of agreement:

• While the U.S. would not like to be seen as blocking the TRIPS waiver and attracting the ire of the global community, but it would resolutely defend the interests of its pharmaceutical corporations.
• the U.S. supports waiving intellectual property (IP) protections on COVID-19 vaccines. However, India and South Africa proposed a waiver not just on vaccines but also on medicines and other therapeutics and technologies related to the treatment of COVID-19.

Technological ‘know-how’:

• While the TRIPS waiver would lift the legal restrictions on manufacturing COVID-19 vaccines, it would not solve the problem of the lack of access to technological ‘know-how’ related to manufacturing COVID-19 vaccines.
• Waiving IP protection does not impose a legal requirement on pharmaceutical companies to transfer or share technology.
• While individual countries may adopt coercive legal measures for a forced transfer of technology, it would be too draconian and counterproductive.

Nature of domestic IP regulations:

• While a TRIPS waiver would enable countries to escape WTO obligations, it will not change the nature of domestic IP regulations.

WHAT CAN BE DONE?

• The foremost stumbling block is the political will of the richer countries that house the giant pharmaceutical corporations producing COVID-19 vaccines and medicines. Hence, there is a need to invoke cooperation for humankind as a whole.
• The Medicines useful in treating COVID-19 and other therapeutics must be also included in the waiver.
• The governments would have to be proactive in negotiating and persuade pharmaceutical companies to transfer technology using various legal and policy tools including financial incentives.
• Countries should start working towards making suitable changes in their domestic legal framework to operationalise and enforce the TRIPS waiver.
• In this regard, the Indian government should immediately put in place a team of best IP lawyers who could study the various TRIPS waiver scenarios and accordingly recommend the changes to be made in the Indian legal framework.

CONCLUSION

• Notwithstanding the usefulness of the TRIPS waiver, it is not a magic pill.
• It would work well only if countries simultaneously address the non-IP bottlenecks such as technology transfer, production constraints, and other logistical challenges such as inadequacy of supply chains and unavailability of raw materials to manufacture vaccines and medicines.

Reference:

1. https://www.thehindu.com/opinion/lead/a-trips-waiver-is-useful-but-not-a-magic-pill/article34522578.ece