IP waiver would ‘disrupt’ innovation, preparedness, jobs

Comments were due Friday to the USITC on the proposed expansion of the COVID IP waiver—here’s what BIO and CSBA said. Plus, it’s been a year since the USDA has required labeling for bioengineered foods—and it appears consumer choices haven’t changed much. (664 words, 3 minutes, 19 seconds)

IP waiver would ‘disrupt’ medical innovation, preparedness, jobs

BIO and the Council of State Bioscience Associations (CSBA) called on the U.S. government to reject the proposed expansion of the COVID IP waiver—here’s what we said and the next steps.

ICYMI: After agreeing to a waiver of IP protections for COVID-19 vaccines, the World Trade Organization (WTO) has been considering expanding the waiver to therapeutics and diagnostics.

What the Biden administration’s been doing: The U.S. Trade Representative (USTR) requested analysis from the U.S. International Trade Commission (USITC); stakeholder comments and requests to appear at the public hearing were due Friday.

BIO’s take: “A waiver of IP rights would significantly disrupt the existing investment and research landscape in the biotechnology sector globally—with a particularly acute impact on U.S.-based SME biotech firms,” as well as compromise U.S. life sciences leadership and pandemic preparedness, per comments filed Friday.

IP enabled the development of COVID-19 technology—and “provides a reliable legal foundation for companies to voluntarily license their IP to enhance research collaborations and provide timely, equitable global access to safe and effective therapeutics,” says BIO.

A waiver would harm future innovation—because over 60% of COVID-19 therapeutics in development have other indications, and 87% originated from small and medium-sized biotech companies.

“Ultimately, IP is essential to support our biotech companies which employ millions across the United States,” says CSBA, citing an October letter. “Waiving IP would compromise the ability for the U.S. private companies to properly respond to future pandemics and jeopardize research efforts in other related fields.”  

The next steps: USITC’s public hearing will take place March 29-30; BIO and at least half a dozen BIO and CSBA members have requested to testify in person. Stay tuned.

More Health News:

Bio.News: How biotech is addressing sources of bias in studies using real-world evidence
"The need for regulatory clarity for using this 'real-world data' and 'real-world evidence' for regulatory decision-making is reflected in recent legislative efforts. In October, the Biotechnology Innovation Organization (BIO), along with regulators, academia, and other stakeholders, came together to discuss analytical methodologies to address unmeasured confounding in real-world evidence studies."

The New York Times (Opinion): Bill Gates: ‘I worry we’re making the same mistakes again’
“We need to prepare to fight disease outbreaks just as we prepare to fight fires. If a fire is left to burn out of control, it poses a threat not only to one home but to an entire community. The same is true for infectious diseases, except on a much bigger scale,” writes Bill Gates.

What do consumers think about the ‘bioengineered’ label?

After more than a year of labeling bioengineered foods, consumer choices haven’t changed much.

ICYMI: As of January 2022, the National Bioengineered Food Disclosure Standard requires food containing genetically modified, or “bioengineered,” ingredients to be labeled to avoid a patchwork of state labeling provisions. The USDA lists 13 foods and crops requiring labeling.

What’s (not) happening: “Some experts suggest consumers aren’t noticing the labels, let alone using them to inform their purchasing decisions,” says a report from NPR.

This was predicted—by a Cornell study looking at Vermont’s labeling provision, which found “the national GMO labeling law is unlikely to have any significant additional effect on consumer behavior in the short run.”

Bioengineered ingredients are common: Almost all U.S. corn, soybeans, canola, sugar beets, and papaya are bioengineered. Read more about the prevalence and safety of GMOs at FDA's Feed Your Mind website.

Science is clear on the safety of bioengineered ingredients: The National Academies of Sciences, Engineering and Medicine notes research repeatedly confirms a 2016 study showing GMOs are safe. USDA agrees, noting FDA “studies show that GMOs do not affect you differently than non-GMO foods.”

President Biden’s Monday: Hosting a reception to celebrate Nowruz, then hosting Jason Sudeikis and the cast of Ted Lasso to discuss the importance of mental health.

What’s Happening on Capitol Hill: On Friday, Sens. Maggie Hassan (D-NH) and Todd Young (R-IN) reintroduced the bipartisan American Innovation and Jobs Act; BIO supports the bill and calls on Congress to pass it. (We’ll have more details later this week.)