Future of Generic Biotech Crops in Doubt

WASHINGTON, D.C., September 25, 2012 – The Competitive Enterprise Institute released a new study today finding that regulatory policy could inhibit the development of a generic market for biotech seeds once patents on those varieties expires.

Over the next decade, the patents on nearly two dozen of the most popular biotech crop traits will expire, and farmers in the U.S. and abroad are eager to get access to low-cost, generic versions of those seeds. But most biotech crop traits must be reapproved every three to five years, and the process requires applicants to have access to confidential business information held by the original product developers. This establishes a potentially impassable roadblock to the future of affordable, generic biotech products.

In “Is There a Future for Generic Biotech Crops?CEI Senior Fellow Gregory Conko explains why the re-approval process does nothing to protect consumer or environmental safety, and he proposes eliminating the requirement in the U.S. and in important export markets abroad. “Maintaining product approvals in all the relevant markets around the world is an expensive and time-consuming process for the sellers of biotech crop seeds,” says Conko. “So the re-approval requirement will only serve to protect brand-name biotech companies against would-be generic competitors.”

Trade associations representing seed breeders and the biotechnology industry are now negotiating a contractual agreement through which generic breeders can pay biotech crop developers for needed regulatory data. “This agreement will be a helpful first step in creating a viable generic seed industry,” Conko acknowledges. “But it is merely a bandage that masks a deeper regulatory problem. Without fundamental reform, regulators will be forcing farmers to pay much higher prices for generic biotech seeds.”

“There is little doubt that American agriculture has benefited tremendously from the introduction of crop biotechnology. And more than 15 million farmers in 28 countries have found that biotech seeds help to raise yields, deliver important environmental benefits, and increase per-acre profitability,” Conko writes. “But while producers and consumers reap tremendous benefits from the expiration of patents in nearly every other industry, the same will not be true of biotech crops if regulatory impediments are not cleared from the path forward.”

>> Read Gregory Conko’s full study: “Is There a Future for Generic Biotech Products? Regulatory Reform Is Needed for a Viable Post-Patent Industry