Intellectual Property Rights the Regulatory Process and Scientific Innovation

Much has been written and discussed about the way in which intellectual property rights legislation and patents has distorted research objectives, raised product prices, slowed the exchange of scientific findings and genetic materials, and otherwise negatively impacted research results reaching the consumer in a timely and economical manner. Each of these concerns has some validity. It is also true, however, that insuring exclusive control over — or exploitation of — for innovators and developers of their innovation has led to much larger investments in research and development directed at marketable products. Without these investments, many profit-enhancing, risk-avoidance products that are now in farmers' fields or in the research pipeline would not have been developed.

However, a much more dangerous barrier to the delivery of new science is now coming to the forefront. During the early to mid-1990s, regulation of GMOs in the United States was relatively streamlined and not strongly focused on the process of transgenic transformation per se. Rather, it focused on the effect that a particular trait, such as insect resistance or herbicide tolerance, might have on consumers or the environment. But starting in the late 1990s, the regulatory process moved ever more toward review of the transformation process itself. Originally, large multinational companies welcomed the increasing complexity of regulation, both to protect themselves and to serve as a type of screening mechanism to control smaller, perhaps less rigorous, research initiatives. The cost of regulation would serve as a sort of nontariff barrier to all but the very strong. Thus, when nine U.S. professional agricultural science societies (which encompassed 80,000 members) attempted in Congress in the late 1990s to oppose a much more elaborate — and costly — GMO regulation and certification process, the private sector broke ranks and supported the new legislation. This has led to a serious situation of overregulation of GMO products — and many would argue — spurious regulation.

Today, the documentation required by regulators for any single GMO "event" is likely to cost upward of US $1 million. This high cost becomes a barrier to all but the largest research organizations — and the most profitable GMO traits. It prevents smaller research laboratories from bringing products to market, as well as most public sector research efforts. Effectively, the regulations have created a large and growing divide between the R&D functions, with publicly funded organizations focusing on the "R" for an array of useful traits, but with little hope to engage actively in the "D" function of bringing research findings to fruition in the marketplace. This regulatory barrier has already been encountered with the so-called pro-Vitamin A "golden rice," and it is likely to affect most GMO research in orphan crops and the new work to expand micronutrient biofortification. A return to more reasonable regulations — based on the effect of the trait and not the transformation process itself — is urgently needed before the regulatory institutional structure becomes so formidable that changing it becomes almost an insurmountable quest.

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