Good Day BIO: How the IP waiver harms SMEs – plus, takeaways from BIO's patient summit

Every member of the Council of State Bioscience Associations (CSBA) joined a letter expressing concerns about expanding the COVID IP waiver, and Mexico’s Deputy Ag Minister confirmed the corn ban is happening. Plus, three takeaways from Day 1 of the Patient and Health Advocacy Summit and how to follow the conversations today. (894 words, 4 minutes, 28 seconds)

How to follow BIO’s Patient & Health Advocacy Summit:

• Join the conversation in real-time at @IAmBiotech.
• Bookmark Bio.News for news and analysis from the sessions.
• Watch this space—we’ll have a Day 2 recap on Monday!

What we’re watching today: The event will close with election insights and predictions from David Wasserman of The Cook Political Report and NBC News. Catch up on yesterday’s coverage.

Expanding COVID IP waiver would harm SMEs across America, says CSBA

Every member of the Council of State Bioscience Associations (CSBA) signed a letter to President Biden expressing serious concerns with the proposed expansion of IP protections for COVID technology.

Catch up: In June, the WTO agreed to waive IP protections for COVID-19 vaccines, a decision supported by the Biden administration. The WTO is now considering expanding the waiver to include COVID-19 therapeutics and diagnostics.

This would have “serious consequences…for small and medium enterprises (SMEs)—most of which have yet to bring a product to the market,” says the letter.

Here’s why: “Of the over 350 therapeutics being developed in the United States, 86%—totaling 307 therapeutics—originated from SME biotech firms spanning over 28 states,” they write. “For SME biotech firms, the expansion of a TRIPS waiver to therapeutics creates significant market risk for the commercialization of their products for indications unrelated to COVID-19.”

And there’s just no justification: “Manufacturers are supplying therapeutics at a rate that outpaces demand. Biotech antiviral manufacturers have entered into dozens of voluntary licensing agreements with companies in South America, Africa, and Asia to manufacture generic antivirals and distribute these products to countries throughout the developing world.”

What’s the alternative? “Strengthening health systems infrastructure, addressing vaccine hesitancy, and supporting more robust COVID-19 testing and therapeutic procurement initiatives are examples of some initiatives that can have a meaningful impact,” they said.

Every state biotech association signed the letter—“a sign of just how significant the issue of the TRIPS waiver is for our innovators across the country,” said David Lachmann, BIO’s Senior Director of Federal Government Relations. “The response of every state biotech association demonstrates the seriousness of the threat.”

Mexico set to halve U.S. corn imports with ban

Mexico’s Deputy Agriculture Minister Victor Suarez tells Reuters that the corn ban is happening, with Mexico “on track to halve its U.S. imports of yellow corn…when the ban comes into effect in 2024.”

Will they or won’t they? Despite questions about whether or not Mexico’s ban would go into effect as planned, Suarez’s remarks are “the strongest indication yet” the ban will hit U.S. corn.

Meanwhile, Mexico has been rejecting biotech traits. Mexican regulator Cofepris has been “quietly ruling on GMO traits,” rejecting 14 traits in corn, soybean, cotton, and canola seeds since late 2021, reports Agri-Pulse—though details “are scant because Mexico has not published the results.”

Why it matters: Mexico imports around 17 million tons of U.S. corn per year, and as much as 20% is for human consumption, we’ve reported. According to USDA, roughly 90% of U.S. corn is genetically modified, so a ban would have a huge impact on U.S. farmers.

This would hurt Mexico’s food security, found a recent report by World Perspectives Inc. (supported by BIO). Under the ban, Mexico will pay $4.4 billion more for corn imports over the next 10 years, with prices of tortillas rising 30% in the first year of the ban alone.

And a ban would hurt both economies: “This translates to the loss of 138,000 jobs and a likely $4.3 billion reduction in Mexico’s GDP. In the U.S., economic output declines by $16.5 billion and GDP shrinks by $7.95 billion,” wrote BIO’s Lynne Finnerty for Bio.News.

The next steps: BIO has been calling for a dispute settlement case since we testified before the Senate Finance Committee last year. A U.S. Trade Representative (USTR) spokesperson told Agri-Pulse “all options are on the table,” though they remain engaged with Mexican counterparts, and several officials, including the nominee for Chief Agricultural Negotiator Doug McKalip, have indicated that this is a priority.

What we learned on Day 1 of the Patient and Health Advocacy Summit

It’s all about patient-centric leadership.

1. Patient stories are vital to drug R&D.
“Patient stories, in terms of the patient journey, help drug developers really understand what is important to patients, and therefore what kind of things we should be evaluating in clinical trials,” said BIO’s interim CEO Rachel King.

“Talking about science in the abstract does not tell our story,” she said. “What tells our story is when we can talk about the specific benefits of what scientific innovation has achieved and that means sharing the stories about our patients.” 

2. Build trust.
Consensus is needed for coalitions to be successful, speakers agreed during a panel on best practices for coalitions.

“If your voice is cohesive, if you do have a consensus position on something, that’s just going to be more effective on the Hill,” said Michele Guadalupe, Associate Director of Advocacy and Access for the National Eczema Association.

But to build consensus, you need to build trust, said Quardricos Driskell, Vice President of Policy and Government Affairs for the Autoimmune Association, who explained how he reaches out to every coalition stakeholder to solicit ideas.

“It’s also understanding past history and it’s getting people on board excited and empowered,” he noted.

3. Success on the Hill is about relationships.
With the midterm elections coming up and a new Congress on the horizon, congressional advocacy is top of mind—but what should advocacy and fly-ins look like in 2023 and beyond? Two panels explored this topic, and we spoke to a few of the experts one-on-one to get their insights on best practices.

A few tips: build relationships, make advocacy meetings accessible, plan the structure and format of your meetings, and above all, tell patients’ stories.

President Biden’s Friday: Heading to Philadelphia to give remarks with Vice President Harris at a Pennsylvania Democratic Party reception.   

What’s Happening on Capitol Hill: Recess.