HEALTH CARE BRIEFING: Vaccine IP Waiver Plan Redo ‘Has Legs’

By Brandon Lee

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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. Read more from Ian Lopez.

Happening on the Hill

Becerra to Testify on Biden HHS Budget: Senate Finance Chairman Ron Wyden (D-Ore.) announced that the panel will consider Biden’s fiscal 2022 Health and Human Services Department budget next Thursday. Secretary Xavier Becerra will testify. Biden requested $133.7 billion for HHS, which amounts to a 23% increase from the fiscal 2021 enacted level of $108.6 billion.

About a quarter of the $25 billion increase, $6.5 billion, would build the Advanced Research Projects Agency, a new effort under the National Institutes of Health to speed up the availability of medical innovations. The administration also wants to work on drug pricing and strengthening the Affordable Care Act. Read more from Jeannie Baumann, Jacquie Lee and Shira Stein.

E&C GOP Asks for GAO Report on Future Pandemic Origins: Republican members on the House Energy and Commerce Committee asked the Government Accountability office to assess available technology to identify and attribute microbial strains and how they formed. They also ask if policies might be needed to address research gaps to achieve this goal. The letter comes as the Biden administration doubles down on efforts to identify the origins of the coronavirus.

The Coronavirus Pandemic

U.S. to Send 25 Million Vaccine Doses Abroad: The U.S. government will send 25 million Covid-19 vaccine doses to countries across Asia, Africa and Latin America, the first time Biden’s administration has shared shots it could have used at home. Through the World Health Organization-backed Covax program, the U.S. plans to distribute an initial 6 million shots to Central and South America, 7 million to Asia including hard-hit India, and 5 million to Africa, the White House said.

The U.S. will directly send another 6 million shots to places including Mexico, South Korea, Canada, and the Palestinian territories, the administration said. Overall, the White House plans to send 75% of its total donated doses to the “Covax” program. “As the days get brighter and brighter at home, we’re focused on driving progress to help the pandemic around the globe,” White House Covid-19 response czar Jeff Zients said at a briefing. Read more from Josh Wingrove.

Global Covid-19 Shots Reach 2 Billion: Inoculations against Covid-19 reached 2 billion as the world races to control the pandemic. It took just over six months to reach the milestone, an extraordinary accomplishment precipitated by countries’ desperation to save lives and reopen their economies. Still, at the current pace, it will take nine more months to vaccinate 75% of the world population, a level that may bring about herd immunity. Read more from Lars Klemming and Janice Kew.

More Global Headlines:

What Else to Know Today

Biotechs Seek Salvation at Top Cancer Meeting: The biotech sector has shaved off over $130 billion of market value from its February peak and drugmakers at a key industry meeting are looking to reignite interest, but it won’t be easy. Usually, the American Society of Clinical Oncology’s annual get-together draws thousands of doctors, patients and industry insiders for in-person meetings. But for a second straight year, the conference will be virtual, hindering the ability of small biotechs to corner investors. Read more from Cristin Flanagan.

Drug Tracing Systems Should Be Able to Trade Data, FDA Says: Data systems used by different companies to track drugs to cut down on fake products should be able to easily exchange information with tracing mechanisms used by officials, the FDA advised in a draft advice document released yesterday. Ensuring different trade partners’ systems can trade information efficiently is among the suggestions the Food and Drug Administration made in its outline for how tracing technology should run. Read more from Jacquie Lee.

More Headlines:

Studies and Approvals:

More from the Courts:

To contact the reporter on this story: Brandon Lee in Washington at blee@bgov.com

To contact the editors responsible for this story: Zachary Sherwood at zsherwood@bgov.com; Giuseppe Macri at gmacri@bgov.com; Michaela Ross at mross@bgov.com

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