Bolivia notifies to the WTO its need to import Covid-19 vaccines using TRIPS flexibilities

Bolivia has formally notified to the WTO its need to import Covid-19 vaccines as part of its pandemic response that may be allowed using flexibilities in WTO intellectual property rules

This opens up the possibility of importing the needed vaccines from any one of around 50 countries, including India, that have put in place necessary domestic laws providing for the production and export of medicines made under compulsory licence, said an official release of the WTO on Thursday.

“Bolivia notified the WTO it needed to import 15 million doses of a vaccine under the legal system introduced in a 2017 amendment to the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). That amendment, which created Article 31bis of the TRIPS Agreement, provides an additional legal pathway for import-reliant countries to access affordable medicines, vaccines and other pharmaceutical products,” the statement pointed out.

No consent needed

Using compulsory licensing, a government allows someone else to produce a patented product or process without the consent of the patent owner to meet an emergency health crisis.

The TRIPS Agreement was amended through the Protocol of December 6, 2005 that entered into force on January 23, 2017. These provided the legal basis for WTO members to grant special compulsory licences exclusively for the production and export of affordable generic medicines to other members that cannot domestically produce the needed medicines in sufficient quantities for their patients (Article 31bis).

In February this year, Bolivia had notified to the WTO that it intended to exercise the flexibilities under the amendment.

“This is an example of a WTO member seeking to make use of available tools under the TRIPS Agreement to respond to the Covid-19 pandemic, even as members seek to expand the range of options through the TRIPS waiver proposal,” said Antony Taubman, Director of the WTO’s Intellectual Property Division. “This step provides one practical component of what could be a wider process of countries signalling urgent and unmet needs and encouraging a combined, coordinated response by international partners.”

The TRIPS flexibilities is criticised on the ground that it is too cumbersome and difficult to implement. The 2005 TRIPs amendment has been used once more than a decade back in 2007 when Canada supplied generic antiretroviral drugs to Rwanda. The process, however, took up a long time and many criticised the amendment for being overly bureaucratic, costly and complicated.

“The WTO Secretariat has been encouraged by members in the TRIPS Council to provide any necessary technical assistance to facilitate use of the system to import pharmaceutical products manufactured under compulsory licence,” the statement said.

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