Your move, China

China's confirmed it will indeed sign the trade deal with the United States, but TBD if the country will move to loosen its onerous biotech approval process, reports Agri-Pulse—a move that would be a promising development for American biotech.

The details: China’s Ministry of Agriculture & Rural Affairs announced the approval of “biosafety certificates” for 203 new genetically engineered biotech seed traits for domestic planting and import, including 192 developed in China and two (a soybean and a papaya) developed in the United States, reported AgriCensus in December. 

This could be big. China’s long had an “onerous and time-consuming process” for biotech approvals, explains Agri-Pulse, which the USDA’s Foreign Agricultural Service said last year seems to be “evolving into a more onerous, less science-based system”—but the certificates and the trade deal signal change could be on the horizon.

But: “While these developments appear to be progress, it’s still early and there’s no guarantee the biosafety certificates will translate into approval for commercialization.”

Why it matters: “For U.S. biotech companies and the farmers who want to plant the latest seed technology, China has long been a major obstacle. Chinese approval is effectively a requirement for any crop that is sold internationally, but the country’s opaque approval system adds years to the acceptance process. That translates into billions of dollars in losses for biotech seed companies that don’t want to commercially release new products until China signs off on them,” explains Agri-Pulse.

It’s promising news—but hang tight. “There’s a lot to be seen yet and the process still needs to play out,” says Matt O’Mara, BIO’s vice president of international affairs. “You’ve got to start somewhere, and maybe we’re getting there.”

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Yesterday, more than 200 individuals representing 150 companies, investors, and academics announced a commitment to patients to “act with the highest integrity and corporate responsibility” in a letter published in STAT.

The specifics: “Price increases… must be reasonable and guided by the need for uninterrupted patient access,” stated those who signed the letter. They’ll also work to “find ways to limit or eliminate copays and deductibles for all patients,” “support generic and biosimilar approvals of safe and effective medicines after legitimate patent and regulatory protections expire,” and “invest only in novel therapies that address unmet patient needs.”

What they’re saying: “If you look at the public perception of the biopharmaceutical industry over the 20 years that I've been involved, it is really bad, and frankly tragic, and it doesn't reflect the great work that we're doing,” said John Crowley, CEO of BIO member Amicus Therapeutics and one of the co-authors of the letter. 

BIO’s take: While BIO did not originate or participate in the effort, which was driven by individual CEOs, points in the letter reflect the passion and ideals embodied by leaders of the hundreds of biotech companies that make up BIO’s membership, and many of the underlying principles are expressed in and consistent with BIO’s Value Principles and advocacy. 

Jim’s Judgment: “We continue to stand firmly beside those working to ensure patients have access to the medicines they need today and tomorrow, at prices they can afford,” says BIO CEO Jim Greenwood. “We are proud that so many of our science and business leaders in the biotechnology field chose to sign a statement in support of patients, even though the statement was developed separate from and independent of BIO.”

More Health Care News: 

STAT (Opinion): Antibiotics need a special place in the drug pricing debate
Congress should create “targeted economic incentives to invest in discovery and development of these medicines. This isn’t about whether pharmaceutical companies charge too much for antibiotics; it’s about whether there will be any effective drugs available for them to sell."