In a recent article published in Technology in Society, several academics argue that intellectual property rights—primarily the ability to obtain patents—have hindered the adoption and diffusion of agricultural biotechnology. As a way to encourage the use of agbiotech, especially in developing countries, the authors suggest that if discoveries in agricultural biotechnology were available through open source networks, developing nations would benefit much more from agricultural biotechnology.
Conspicuously absent from this analysis is any mention of the strangulation of agricultural biotechnology by unscientific, unneeded, and discriminatory regulations. Unless these debilitating regulatory burdens are removed, or at least lightened, the intellectual property framework applied to agbiotech discoveries will be irrelevant, open source or not.
The authors of the article offer three examples of genetically engineered crops currently or potentially available thanks to some attributes of open source access: virus-resistant papaya, pod borer-resistant cowpea, and vitamin A-enhanced rice (“Golden Rice”). Although all of them have benefited from open access to biotech discoveries, to be sure, all also offer cautionary tales about the irrelevance of intellectual property rights in the face of gratuitous regulatory obstacles.
Virus-Resistant Papaya – A Qualified Success
Cornell University scientists developed genetically engineered virus-resistant papayas in response to pleas for help from the Hawaiian papaya industry. Using the American land-grant university model of publicly-funded research for a “public good,” Cornell scientists were able quickly and inexpensively to develop papaya varieties resistant to the papaya ringspot virus that was ravaging Hawaii’s farms. (Scientists introduced into the papaya plant a single gene from the virus, which effectively “immunizes” it to infection.) Through agricultural extension services, they then trained Hawaiian farmers how to grow the new varieties.
Every aspect of this Cornell project—scientific, agronomic, educational, and commercial—was an unequivocal success. Within a few years, the new varieties moved from conception to farmers’ fields to supermarkets, and thereby revived a dying industry.
The Cornell papaya success story has not been replicated anywhere else. Although many national agricultural research programs and American land-grant universities possess the trained scientists and the technical skills to develop genetically engineered crops, these publicly-funded (as opposed to private-sector funded) research programs have failed to provide a single additional commercial genetically engineered crop to any farmer anywhere in the world.
There are several reasons:
—Cornell gained approval for its virus-resistant papaya in less than one year from the USDA-APHIS regulatory system, but these same regulators now take years to approve transgenic crops, and the regulatory costs (time, data, and applications) now run into tens of millions of dollars for each transgenic event. Publicly-funded institutions such as universities and research institutes are in the “business” of science but are not funded or otherwise equipped to negotiate the maze of regulatory approvals.
—Although Hawaiian farmers quickly produced quality papayas from their virus-resistant seed, they struggled to find markets for their fruit because of regulatory strictures that blocked access to export markets. For example, because of unwarranted risk-aversion, Japan’s food regulators took more than a decade to approve Hawaiian virus-resistant papaya for the Japanese market. As a result, during that time, papayas in Japan were more than 10 times more costly than in the United States. Even when Japan finally approved import of these high quality Hawaiian papayas, its regulators required labeling to identify them as genetically engineered. That stigmatizes them and scares away many potential Japanese buyers.
—In Thailand, where viruses had devastated the production of papayas (a staple food), regulators imposed a moratorium on the growing of genetically engineered virus-resistant papayas that were also developed by Cornell at the request of Thai farmers and in conjunction with local Thai scientists. As a result of this rejection of open source public goods, Thai farmers and consumers suffer the consequences of this decision—due not to intellectual property constraints but to unscientific, unneeded, and discriminatory regulation.
Research vs. Regulation
Another example in which regulatory obstacles are more influential than IP is cow peas in Africa. (Cow peas, called black-eyed peas in the United States, are an important drought-tolerant and warm-weather crop in the semi-arid tropics of Asia and Africa.) As the authors of the open source study describe, the African Agricultural Technology Foundation obtained genetic engineering technology royalty-free from agribusiness giant Monsanto. Australian and Nigerian scientists thereby obtained the genetic resources and the technological tools to develop pod borer-resistant cowpeas for West African farmers—primarily subsistence farmers.
Since 2007 African scientists have been attempting to develop pod borer-resistant cowpea varieties that are adapted to West African conditions. Although they have made significant progress and are currently conducting field trials to confirm the efficacy of the new varieties, they fear their work will be for naught unless African governments establish sensible, scientific regulatory regimes that make the commercialization of agricultural biotechnology economically feasible. The failure to create such scientifically defensible, risk-based regulation, not the constraints of intellectual property protection, is the major obstacle to African success with pod-borer resistant cowpeas.
Regulatory Delays of Golden Rice: A Moral Outrage
Rice is a food staple for hundreds of millions, especially in Asia. Although an excellent source of calories, rice lacks micro-nutrients necessary for a complete diet. In the 1980s and 1990s, German scientists Ingo Potrykus and Peter Beyer created “Golden Rice,” a collection of new rice varieties biofortified, or enriched, by the introduction of genes that enable the edible endosperm of rice to produce beta-carotene, the precursor of vitamin A. The beta-carotene is converted in the human body, as needed, to the active form of the vitamin.
The scourge of vitamin A deficiency is epidemic among poor people in tropical countries whose diets are comprised largely of rice or other carbohydrate-rich, vitamin-poor sources of calories. In developing countries, 200–300 million children of preschool age are at risk of vitamin A deficiency, which increases susceptibility to common childhood infections such as measles and diarrheal diseases; it is the single most important cause of childhood blindness in developing countries. Every year, about half a million children become blind as a result of vitamin A deficiency and 70 percent of them die within a year of losing their sight.
Golden Rice offers the potential to make contributions to human health and welfare as historic as those made by the discovery and distribution of polio vaccines. With wide use, it could save hundreds of thousands of lives a year and enhance the quality of life for millions more. But one aspect of this shining story is tarnished. Intransigent opposition by activists in Greenpeace, Friends of the Earth, and a few other radical groups has provided already risk-averse regulators the political “cover” to adopt an overly precautionary approach to the crop that has stalled approvals.
The authors of the open source article cite a technology transfer study which establishes that publicly-funded research scientists have full and free access to the genes and tools for the development of locally-adapted rice for Asian farmers and consumers. Indeed, the study shows that the intellectual property concerns had been solved by 2000. But here we are in 2012, and although it has been shown unequivocally to be safe and effective, Golden Rice is still in regulatory limbo. Far from showing simple good judgment, let alone courage, governments have placed endless regulatory obstacles in the path of the approval of Golden Rice. Asian farmers and consumers should have had access to these varieties a decade ago. The International Rice Research Institute (IRRI) now predicts its release, at the earliest, in 2013.
In the absence of access to Golden Rice and similar nutritionally enhanced foods, the world’s poor are suffering and dying unnecessarily, but not because of the failure of intellectual property. A far more critical factor is the gratuitous regulation demanded by activists and created and maintained by bureaucrats. This is a moral outrage, one to which too many people have been too blind for too long.
The bottom line is that intellectual property protection verges on the inconsequential when agricultural biotechnology regulation is, to borrow a phrase from the novelist J.K. Rowling, a “twitching pile of catastrophe.”
Henry I. Miller, MS, MD, is the Robert Wesson Fellow in Scientific Philosophy and Public Policy at the Hoover Institution. His research focuses on public policy toward science and technology encompassing a number of areas, including pharmaceutical development, genetic engineering in agriculture, models for regulatory reform, and the emergence of new viral diseases.