Intellectual Property as the Third Dimension of GMO Regulation

Full-text available at SSRN. See link in this record.In the past, opposition to GMOs and GM crops has tended to focus on alleged dangers to human health and environmental safety. The United States, Canada, and Europe have all established regulatory frameworks whose stated aims are to ensure that GMOs and GM crops do not harm the health of their citizens or threaten the well-being of their environments. However, these jurisdictions have set up regulatory hurdles of significantly different heights. North American neighbors, the United States and Canada, have tended to regulate GMOs and GM crops with a relatively light touch that tends to ease approval for field-testing and commercial marketing. By contrast, Europe has applied much stricter regulatory standards, with the result that few GM crops have been field-tested or GM foods allowed onto the market there. A large and growing body of scientific studies into the human health and environmental safety of GMOs and GM crops has failed to find significant justification for the extreme precautionary approach adopted by Europe. Furthermore, a WTO panel decision forcefully critical of the European regulatory regime for GMOs and GM crops was recently accepted by Europe, and may herald the adoption of a new regulatory regime more accepting of GMOs and GM crops. As prospects have faded that scientific evidence will demonstrate that GMOs and GM crops pose unique threats to human health and environmental safety, a third locus of anxieties has been growing in significance: patent monopolies over new and useful GM crops. Concerns about monopoly control of GM crops are the obverse of concerns about human health and environmental safety. Where the latter rationales counsel against the easy and widespread adoption of GM crops, the former rationale would operate to ensure such easy and widespread adoption. Both the United States and Europe offer patent protection for GM plants and animals, making regulation against patent monopolies in GM crops difficult. However, Canada does not allow the patenting of GM plants and animals, thus avoiding patent monopolies in GM crops per se. Ironically, just as Europe might look to Canada for a new method of regulating GMOs and GM crops, Canada may be undergoing a transition toward allowing such inventions to be patented. Of the three loci of regulation of GMOs and GM crops, the patent system maintains the most integrity. The scientific justifications for strictly limiting GMOs and GM crops due to concerns over human health and environmental safety have yet to materialize to any significant degree. In fact, there is so little scientific evidence of unique risks of GMOs and GM crops that even invocation of a conservative precautionary principle may be unjustified. Regardless of how regulation of GMOs and GM crops changes in Canada and Europe in the future, it is likely that concerns over monopoly control will grow in significance as a rationale for regulation, while the rationales of human health and environmental safety will continue to fade in the absence of a reversal of the current trend of scientific evidence