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Law360 (June 4, 2021, 6:58 PM EDT ) The European Union on Friday handed over a proposal aimed at boosting global distribution of COVID-19 vaccines by easing regulatory hurdles, but it stopped short of calling on countries to suspend intellectual property protections on the vaccines.
Less than a month after the Biden administration announced its support of a temporary waiver on intellectual property protections for the life-saving doses, the EU proffered a plan that instead calls for expanding production of the shots, phasing out export restrictions and using the existing flexibilities provided within the World Trade Organization's intellectual property rules.
"In reality, the main problem at this moment relates to the lack of sufficient manufacturing capacity to rapidly produce the required quantities," European Commissioner for Trade Valdis Dombrovskis said in a statement. "The objective must be to ensure that any available and adequate manufacturing capacity anywhere in the world is used for COVID-19 vaccines production."
The proposal calls on members to ensure that vaccine and treatment products can cross borders freely, to avoid disruptions to global supply chains and to not restrict supplies to COVID-19 Vaccines Global Access, the WTO body designed to provide vaccines to poorer countries.
The plan also suggested expanding production by increasing manufacturing capacity in Africa and by encouraging vaccine producers to make pledges to increase supplies to vulnerable developing countries.
However, it makes no mention of an effort to lift IP rights for vaccines, led by India and South Africa, in an attempt to speed up worldwide vaccination rates.
The EU proposal instead voiced support for compulsory licensing, in which a government grants a limited license to create vaccines without the patent holder's consent when companies will not agree to voluntarily license the technology.
Compulsory licenses for patents are already authorized under the WTO's Agreement on Trade-Related Aspects of Intellectual Property Rights, or TRIPS, and have been used during previous public health emergencies, including to boost production of AIDS and HIV drugs.
For public health advocates, the proposal is notable less for its contents and more for what remains unsaid.
"I think the most concerning thing is not the content of this communication, but what it tries to achieve," Burcu Kilic, a director at Public Citizen, told Law360. "It aims to disrupt the discussion because now with the U.S. support of a waiver we've made progress."
Kilic added that the EU's focus on compulsory licenses as an option for countries simply rehashes conversations the TRIPS Council has been having for months.
Critics of the waiver have argued that the move will impede speedy vaccine distribution and weaken IP rights.
"For months, vaccine producers have been scaling up production exponentially and sharing intellectual property with manufacturers via licenses to boost global capacity," Myron Brilliant, executive vice president and head of international affairs at the U.S. Chamber of Commerce, said in a statement Thursday in response to reports of ramped up vaccine distribution.
"These collaborations — rather than the risky move to circumvent them via IP waivers — will be key to vaccinating billions worldwide," he said.
The Biden administration's about-face in early May supporting the waiver put pressure on other nations that remained opposed.
Supported by more than 100 other WTO members, the waiver would suspend four provisions of the 1995 TRIPS agreement that require members to enact laws protecting intellectual property. The waiver would be in force for three years, targeting "health products and technologies."
The proposal will be presented to the WTO in early June, as will a potential waiver, where its 164 members must reach a consensus before a decision can be made. The U.K., Japan and other nations have also opposed the COVID-19 vaccine waiver.
--Additional reporting by Britain Eakin, Ryan Davis and Alex Lawson. Editing by Regan Estes.
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