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Confidentiality Agreements

Rubber bands can seemingly stretch and stretch and stretch. Eventually, though, the stretching stops and morphs into a stinging snap that smarts. That’s akin to confidentiality agreements between industry and land-grant universities. Used properly, they can create a symbiotic relationship beneficial to both land-grant universities and industry. When they go awry, though, they leave a sting that sours all parties.

Confidentiality agreements aren’t new or unique to agriculture. Other disciplines, such as engineering, use them. Under them, agricultural companies work with universities to jointly test products like biotech traits and pesticides. Done properly, they enable Extension and university scientists to get in on the ground floor of new technology.

“If our scientists don’t get to look at early-stage technologies, everybody loses – the public, the company, and the university,” says Nathan McKinney, assistant director of the Arkansas Agricultural Experiment Station.

Industry can benefit by obtaining the expertise and insight of third-party research. “BASF values university researcher insight and recognizes the mission of land-grant universities to evaluate agricultural products,” says Luke Bozeman, BASF group leader, field biology research and development.

There’s a hitch, though

All or some of the data is kept confidential from the public. One reason is it keeps prying eyes of competitors away. Intellectual property litigation has also risen as biotech products become more prevalent.

There’s lots of time and lots of money to protect, especially early in a product’s time line. BASF, for example, normally spends eight to 10 years bringing an active ingredient to market. To get that one, the firm normally screens 140,000 compounds. Confidentiality agreements protect this investment, while enabling university researchers to familiarize themselves with the product and to optimize them with local needs, says Bozeman.

Biotech traits have added a whole layer of complexity. “Part of the regulatory aspect is containment of that not-yet registered trait,” says Mike Johnson, who heads product evaluation and works on confidentiality agreements for Syngenta. “There is a huge liability associated with these materials getting into the food supply. The EPA and FDA both have lots of rules about how they conduct field trials to ensure that doesn’t happen.”

Later in development, continued collaboration under an agreement with universities helps to ensure best stewardship practices related to product safety, pest resistance management, and regulated trait handling, says Bozeman.

Over time, though, these agreements may mimic the tension of a stretched rubber band. “There is tension there; we have to guard the public trust,” says McKinney.

In some cases, the rubber band has snapped between industry and universities. Some weed scientists no longer do trials tied to confidentiality agreements.

“I decided it wasn’t worth it,” says Mark Loux, Ohio State University Extension weed specialist. Following are his reasons.

• No input on treatment design 

“When we look at our weed problem, the treatments a company decides upon don’t address a systems approach for serious weed problems,” he says. “We have no input on treatment design.”

In these trials, firms often focus on multiple spring and summer applications of the same compound or premix. Meanwhile, they exclude other herbicide sites of action or timings like fall applications needed for weeds like marestail, says Loux.

• Company-determined data reporting

“They basically tell us what data can be presented. Or, we get sanitized data back. That is not what we do. It goes against our mission,” Loux says.

Ford Baldwin, retired University of Arkansas Extension weed specialist and co-owner of Practical Weed Consultants, is concerned that companies have it both ways. They obtain unbiased data generated with public resources while shielding it from public view via confidentiality agreements.

“They can tell the story exactly the way it will be told,” says Baldwin. “Companies put universities and university scientists in a tough position.”

In a written policy statement, though, Monsanto says there have been times researchers have come to conclusions it didn’t agree with.

“Their conclusions have been published, and we continue to work with and supply seed for their research,” the prepared statement said.

• Time-consuming audits

University weed scientists have had to work under stewardship agreements to ensure proper handling of regulated materials . That’s understandable, says Loux.
Still, he was subject to five time-consuming audits within three weeks last year by company auditors and federal inspectors.
Other weed scientists work with them, but are selective about which ones they sign.  “There have been, on occasion, instances when we have looked at some things that are proprietary and confidential. It is not something I thought would hamper my ability to provide information to Iowa growers,” says Mike Owen, Iowa State University Extension weed specialist.

Flexibility needed
For confidentiality agreements to work, flexibility is key, says Baldwin. “You can’t draw one set of protocol for all states, all soils, and all environments,” he says. “You have to give local people the right to tailor those protocols.”

Open data sharing is also key, says McKinney. “When we sign these agreements, the primary reason is to protect the novelty and patentability of new technology,” he says. “We never agree to hold data in confidence forever.”

In agreements with the University of Arkansas, firms are given a 30- to 60-day review period.

“If they see any patentable methodology that is derived from that data, they have the right to ask us to delay publication for a short period of time while they file for patent and intellectual property protection,” McKinney says. “Companies would like to have longer windows; we would like to have shorter windows. But it’s (the 30-to-60 day review period) is the general principle we adhere to.

“We always preserve the right to publish the data,” he adds. “Favorable or unfavorable, the data that our scientists generate will be publishable and available to the public.”

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