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Bolivia invokes compulsory license for COVID-19 vaccines under TRIPS

Bolivia has waded into the fray over intellectual property rights at the World Trade Organization, notifying this week that it intends to import COVID-19 vaccines via a built-in compulsory license framework – a WTO-compliant pathway that has frequently triggered U.S. ire in the past.

The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights allows countries to issue compulsory licenses for additional manufacturing of otherwise patented products under certain conditions. The U.S. is historically very protective of its IP, particularly in the pharmaceutical industry, and has tried to dissuade countries from issuing compulsory licenses in that sector.


Bolivia’s notification adds a potential wrinkle to the debate over the proposed waiver of a swath of TRIPS provisions, which just last week garnered the support of the Biden administration but has not won over other mainly developed WTO members including the European Union. Some members have argued that the existing TRIPS flexibilities, including this compulsory licensing path, are sufficient to address the IP and production concerns around COVID-19 vaccines.


The U.S. has said it will “actively participate” in text-based talks on a TRIPS waiver for vaccines but has not thrown its weight behind the waiver language as-is. The waiver was first proposed by India and South Africa in October 2020. “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,” Antony Taubman, director of the WTO’s Intellectual Property Division, said in a statement on Bolivia’s notification. “This step provides one practical component of what could be a wider process of countries
signaling urgent and unmet needs and encouraging a combined, coordinated response by international partners.”

Specifically, Bolivia said it needs to import 15 million doses from a country with pharmaceutical manufacturing capabilities. WTO members in 2017 amended the TRIPS Agreement to allow developing countries that do not have their own pharmaceutical manufacturing capacity to import needed medicines from other countries under compulsory licenses. “At the moment the Member does not have manufacturing capacity in the pharmaceutical sector,” Bolivia confirmed in its notification, according to an informal translation. The country, like much of South America, is facing a “very high” level of COVID-19, according to the Centers for Disease Control and Prevention.


Bolivia has contracted with a Canadian pharmaceutical company to manufacture the Johnson & Johnson COVID19 vaccine for export pending the approval of the Canadian government, according to The Globe and Mail. Bolivia, in its notification, noted that it is likely to grant compulsory licenses as needed: “Insofar as patents have been applied for or granted for the necessary products, the Plurinational State of Bolivia intends to grant compulsory licenses, in accordance with … the TRIPS Agreement.”


The U.S. has frequently called out countries for issuing compulsory licenses that involve domestic companies. The Trump administration used particularly tough language on the subject, arguing in its 2018 Special 301 report on intellectual property rights, for example, that compulsory licenses “undermine a patent holder’s IP, reduce incentives to invest in research and development for new treatments and cures, unfairly shift the burden for funding such research and development to American patients and those in other markets that properly respect IP, and discourage the introduction of important new medicines into affected markets.”

Proponents of the waiver point to these criticisms from the U.S. – and others – as political pressure that makes it difficult for developing countries in particular to easily invoke the TRIPS Agreement flexibilities. The Trump administration had opposed the TRIPS waiver at the WTO and the Biden administration did not reverse course until last week. The U.S. support of the waiver marks a shift in its usually very staunch support of pharmaceutical IP and has the pharmaceutical industry reeling. Given this divergence from its traditional position,
how, or even if, the U.S. will respond to Bolivia’s invoking of compulsory licenses for vaccines is unclear.


The Biden administration has also received pushback domestically on its waiver announcement. Several Republican lawmakers have criticized the move, including during U.S. Trade Representative Katherine Tai’s appearances before the Senate Finance and House Ways & Means committees this week. — Hannah Monicken (hmonicken@iwpnews.com)

Contenido publicado en InsideTrade

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