NCPA - National Center for Policy Analysis

Is There a Future for Generic Biotech Crops?

October 4, 2012

In medicine, when patents on a drug expire, there is intense competition to create generic versions, resulting in lower prices. The theory should be the same for biotech crops that farmers use, but regulations make it a very complex process that ends up costly to farmers, says Gregory Conko, a senior fellow at the Competitive Enterprise Institute.

  • When intellectual property rights on biotech plants expire, generic breeders have to ensure that growers and end users have permission to sell the seeds and grow and sell the crop.
  • Furthermore, most biotech seed products need to be periodically reapproved for sale.
  • However, this requires access to proprietary testing data held by the original developers of the approved product, not the generic producers.
  • Moreover, entire bulk shipments of a crop can be rejected by an import country on the grounds that the product has not been reapproved.
  • Disruptions in shipments can have negative economic effects that ripple through the food supply chain.
  • Consequently, those that buy or sell biotech seeds will have heightened costs that could eliminate any gains made from producing biotech crops or their generic counterparts.

On top of the clear problems with the regulation, there is a consensus that they aren't necessary. There has been agreement by plant scientists for the past 30 years that biotech plants pose no new or unique threats compared to conventional breeding methods. Similarly, several scientific bodies such as the U.S. National Academies of Science and the UN's Food and Agriculture Organization agree that there is no basis for the regulation.

Adding to the cost and complexity is that reapproving requires that the regulators get the original safety data. However, this does not make sense because the regulators already had to approve a biotech plant market approval in the first place, meaning regulatory scientists already examined the original data.

Despite the lack of political support, policymakers should seek to eliminate the regulations. However, in the interim, the biotechnology industry has begun cooperating under what is known as the "Accord Agreement." Essentially, developers will maintain registrations for their products after patents expire so that generic breeders are able to share the needed data with regulatory agencies.

Source: Gregory Conko, "Is There a Future for Generic Biotech Crops," Competitive Enterprise Institute, September 25, 2012.


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