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Vaccine IP Waiver Plan Redo ‘Has Legs’ but Devil’s in the Detail

June 4, 2021, 9:35 AM

A revised proposal to waive international intellectual property protections on Covid-19 vaccines shows good faith from developing countries seeking to ramp up immunization efforts, but it may not be enough to persuade holdout nations to come on board, legal and policy observers say.

Egypt, Mongolia, and Pakistan are among the countries that submitted revisions to address concerns that the plan before the World Trade Organization was “too broad.” The revised text clarifies that the waiver only pertains to “Covid-19 prevention, treatment and containment” and would be in effect for “at least 3 years.”

The revisions show “the waiver has legs rather than being a moonshot proposal,” said Daniel Takash, a policy fellow at the Niskanen Center. They provide “the breathing room for many countries to negotiate,” he said.

But critics say that although it’s a step in the right direction, the updated proposal still leaves the door open to the use of companies’ Covid-19 vaccine-related patents, trade secrets, and other rights for non-pandemic purposes—a possibility that threatens product safety and quality.

The Biden administration threw its weight behind an IP enforcement waiver in May as part of a broader effort to facilitate the sharing of vaccine doses with countries in need. U.S. endorsement tips the scale in favor of a waiver, but all 164 WTO members would need to sign on for a plan to get off the ground.

The countries behind the waiver are “saying, we know there’s a lot of discussion, and we’re hearing it,” said Jaci McDole, senior policy analyst at the Information Technology and Innovation Foundation.

‘Makes Some Things Worse’

Waiving IP rights is a contentious topic in the drug industry.

Vaccine manufacturers like Pfizer credit IP as the foundation for rapid vaccine creation and global distribution, while Senate Republicans characterize an IP waiver as a giveaway to countries like China who want to steal American inventive know-how.

Authors of the revised proposal position it as a means to “progress to text-based discussions” drafted with criticisms in mind. But the revision “makes some things worse,” said Andrei Iancu, former director of the U.S. Patent and Trademark Office under Donald Trump.

In Iancu’s view, a major issue is that the waiver would last for at least three years, after which the WTO general counsel would review whether to terminate it.

The halt to IP enforcement “could go on indefinitely” Iancu said, “unless there is unanimous consensus to lift the waiver.” The WTO generally reaches decisions by consensus.

Critics of the initial waiver were worried that overseas companies could use patents and trade secrets to develop products not related to the pandemic. The revised version specifies a waiver would apply to “health products and technologies” for Covid-19 efforts, including medical devices, personal protective equipment, and diagnostics.

The revised version attempts to narrow the scope of a waiver, but the text still “makes clear the intent is to apply it to a much broader scope of technology than just vaccines,” Iancu said.

‘Limiting the Loophole’

Revised or not, another issue with an IP waiver is enforcement.

Critics say enforcement is done at the country level, meaning nations would be responsible for stopping use of IP on things like masks and ventilators for purposes other than Covid-19. The waiver also leaves it up to international regulatory agencies and the public to determine whether copied versions of major vaccines like those from Pfizer Inc. or Moderna Inc. are effective and safe.

“The devil is still in the details. The problem is, how do you enforce this?” said Matthew Howell, an IP lawyer at Alston & Bird.

“I don’t know if there is a perfect solution once you let the IP genie out of the bottle,” he said. “You’re really hoping these individual countries who stand to benefit the most from the IP waiver are in good faith still trying to enforce IP generally and limiting the loophole to Covid-type things.”

Getting the Ball Moving

Some legal and policy experts say the revised proposal signals the international community is serious about hammering out a plan to drop IP enforcement for pandemic purposes.

The U.S. so far has given enough doses to cover about 46% percent of its population, according to Bloomberg’s vaccine tracker. Other affluent countries are reaching relatively high numbers—the U.K. has given enough doses for nearly 49% of its population and Germany clocked in at 30%.

Developing nations are in a different camp. India and South Africa—the countries behind the initial waiver—have given enough doses for 8% and 1.2% of their populations, respectively.

Proponents of a waiver say dropping IP enforcement, along with increased manufacturing capabilities, could help address vaccine inequity. And the revised proposal shows that countries are willing to work together to make it happen.

“This is an attempt at really pushing for consensus in advance of the next meetings to get the waiver knocked out,” Howell said. “I would expect to see another revision coming out of the meetings when everyone sits down together.”

To contact the reporter on this story: Ian Lopez in Washington at ilopez@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloombergindustry.com; Alexis Kramer at akramer@bloomberglaw.com

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