By KEVIN WALKER
ALEXANDRIA, Va. — A major seed trade group has signed an industry-led agreement designed to help manage the regulatory burdens of genetically modified organisms (GMOs) once their patents expire.
This is starting to become important as more biotechnology events are approaching the point of patent expiration. Specifically, the question arises as to who will be responsible for making sure that generic events – GMOs no longer under patent protection – will continue to be registered and reregistered in the United States and elsewhere.
Many farmers who choose biotech seeds find them worth the higher price and are eagerly awaiting the expiration of patents on popular biotech traits, wrote Gregory Conko in a recent analysis for the Competitive Enterprise Institute (CEI).
The initiative, called the Generic Event Marketability and Access Agreement (GEMAA), was started Oct. 31, 2012, and took effect Nov. 15. The goal behind the new agreement is to support a smooth transition to generic status so the events can continue to be used in a way that works best for all of the stakeholders, said the American Seed Trade Assoc. (ASTA) in a written statement from last November.
ASTA is helping to push the GEMAA concept, along with the Biotechnology Industry Organization (BIO), a similar trade group. “It’s significant whenever anyone new signs the agreement,” said Kellie Boyle, a spokeswoman for ASTA. “It means we back the entire agreement, and back the concept of it. It also means we’re granted a seat at the table.”
Without being a signatory to the agreement, a given group doesn’t receive updates and other pieces of information provided to signatories, she explained. Boyle also stated the GEMAA plan had to be presented to the ASTA board for its approval before ASTA could become a signatory, and that approval didn’t happen until last month.
“We believe the agreement will promote continued innovation and competition in the seed industry, while respecting the intellectual property rights that are critical for meeting the global demand for food, feed, fiber and fuel,” said ASTA CEO Andrew LaVigne on Feb. 28.
“In becoming a signatory, we are demonstrating our support for the seamless transition of generic events when they come off patent, and providing our members with continued access to information about this process.”
So far, five BIO and ASTA member companies and agricultural biotech firms have signed the GEMAA: these are BASF Plant Science, Bayer Crop Science, Dow Agro Sciences, DuPont Pioneer and Monsanto Co.
In his analysis Conko wrote Roundup Ready soybeans and 22 other GMOs are expected to come off patent over the next 10 years; in theory, this should mean non-patent-holder companies will be able to use these inventions and help lower the cost of highly sought-after seeds.
“Unfortunately, a quirk in the way biotech crops are regulated in the United States and other countries poses several challenges that may make it difficult for breeders to develop a generic seed industry,” Conko added.
He explained GMOs have to be periodically reauthorized or reregistered, in the United States and elsewhere. These processes are expensive to comply with, he stated, but for a popular patented product the financial returns make it worthwhile.
But if the product is generic, the question of who is going to bear the cost of complying with the regulations becomes critical. And that’s what the GEMAA is attempting to address.
“When we say authorizations, what we usually mean is regulatory approvals,” said Bernice Slutzky, senior vice president for domestic and international policy at ASTA. “We have to maintain those approvals, because if we don’t have those international approvals then our exports could be impeded.”
Americans for Choice and Competition in Agriculture Executive Director Chuck Larson said GEMAA is an important first step toward assuring generic events will be able to reach the marketplace – but he pointed out what he sees as some problems with the agreement.
For example, he feels the agreement doesn’t ensure there will be sufficient sharing of regulatory data between the patent-holder and companies that might want to develop a generic product. “Thus, if a company is a bad actor who wants to effectively extend the life of its patent, it could simply deny access to regulatory data,” he said in a video statement.