Roadblocks Facing the Public Sector
- Agriculture in the developing world: Connecting innovations in plant research to downstream applications
Learning to Think Like the Private Sector. Technically, GM crops such as those suggested above could be developed now through concerted public-sector efforts. In fact, the public sector seems to be hard at work in many places doing transgenic research for the developing world (47), yet many of these projects are still in the very early stages of exploration, and one wonders whether any has a strong chance of every reaching the fields of poor farmers. It is no accident that there have been only two successful transgenic crops [Bt cotton (22) and virus-resistant papaya (32)] developed through public-sector efforts. There are plenty of public-sector scientists who can create transgenic plants in their laboratories. What has been sadly lacking in the public sector is an understanding of how to make strategic assessments of which projects can have the highest impact; how to choose the best varieties for transformation and to design the best constructs to ensure the freedom to operate and gain regulatory approval; the recognition of the need to generate very large numbers of transformants to ensure high levels of expression and the stability of the inserts and to determine the optimal promoter; and a clear plan for the stewardship, uptake, and dissemination of new varieties.
For all these issues, there could be no better mentor than the scientists of the private sector who deal with these issues on a routine basis. One way to foster such mentoring would be to engage the interest of the Private Sector Committee for CGIAR, the mission of which is to foster better interactions between private-sector science and that conducted in the CGIAR system. Such a committee might be able to arrange for private-sector consultants for any transgenic crop development projects that do not compete with private-sector interests and are undertaken by CGIAR scientists and their collaborators in national agricultural research systems around the world. But there must be a serious resolve on the part of public-sector scientists to move beyond just proof of concept with a few transgenic events, and they will also need adequate resources and infrastructure for such efforts. I would also argue that, because the approaches for many different crops are similar, it would make sense for the CGIAR centers to come together to form one serious biotechnology unit where a team of skilled and interactive scientists can work together in an environment that provides the kinds of high-throughput capabilities and ability to do easy field testing that are needed for these types of efforts.
Dealing with Intellectual Property and Regulatory Issues. With respect to freedom to operate (FTO), several new initiatives are under way to try to address these issues (48). For the benefit of African agriculture, the relatively new African Agricultural Technology Foundation has been established by Africans to help negotiate access to private-sector technologies and to assist with stewardship issues. Access to public-sector technologies should become increasingly easy to obtain due to the interest in new models for licensing of technologies by organizations like the Public Intellectual Property Resource for Agriculture and the Biological Innovation for an Open Society (BIOS) initiative of CAMBIA (49). I would urge all scientists to become familiar with the goals of Public Intellectual Property Resource for Agriculture (PIPRA) and to make sure that licensing policy for any patented invention of theirs is done to keep available rights for the use of that discovery for humanitarian purposes. Scientists should also study the strategy for the open-source licensing proposed by the BIOS initiative; as an example of how this may work, Richard Jefferson, the founder of this initiative, has agreed to make discoveries such as his recent development of an alternative to Agrobacterium-mediated transformation freely available under an open-source model in which users are free to use the technology but must keep all improvements within the public domain (49). The exciting new work on the modeling of complex interactive networks, such as that being done with Caenorhabditis elegans (50), might be an example of the type of activity that Arabidopsis gurus could take up as a highly interactive project where data are freely shared and based upon open-source concepts. Another attractive and rather obvious solution to the problem of FTO is to build the scientific capacity for transformation work within the developing country, where key patents often have not been registered, so genes can be amplified and plants transformed with limited FTO issues.
Regarding regulatory approval, so much has been written on this topic that there is little need to go over the same ground again here. Clearly, developing countries need to make their own decisions on these issues and learn from the experience of others while developing their own responsible means of regulation that takes into account and weighs benefits as well as risks. There seems now virtually no reason at all to insist on elaborate repeats of trials that have been done in vast numbers of other locations for a crop like Bt cotton, especially for countries where farmers are clamoring to grow it to remain competitive. For the developing world, the key would seem to be to find ways to make field trials responsible but as low in cost as possible; otherwise, no public-sector effort will be able to participate. One way to keep costs lower is to promote standards that are accepted not just in one country but in the entire region where growth of the crop is predicted. Another issue that has not been addressed sufficiently is the big difference between carrying out a limited field trial to test for the efficacy of a transgenic event and, depending upon the crop and the trait, more extensive trials that might be needed before final approval for release to farmers. Because it is expected that not all GM projects will yield useful products (in particular those developed by the relatively inexperienced public sector!), developing countries should find ways to allow limited efficacy trials under appropriately contained conditions that are simple in design to keep costs low but responsible in concept. Only when events are deemed worthy of further development and depending upon the crop and trait in question would it be necessary to invoke more extensive trials on a final chosen event. Bradford et al. (51) have outlined other very sensible ways good science can be combined with common sense to enhance the efficiency of regulation without compromising safety. One is to exempt selected transgenes and classes of transgenic modification from regulation where extensive data are already in place indicating they are safe. Another suggestion is to create regulatory classes in proportion to potential risk. One can offer examples relevant to the developing world. Even though cowpea and sorghum outcross with wild relatives in Africa, there would seem to be little or no risk to gene flow if the gene were one that enhanced lysine or β-carotene content, whereas introduction of herbicide tolerance might be considered a greater risk that needs some assessment. The idea of using transgenic food crops to produce pharmaceuticals involves a different class of risks and seems of dubious value when nonfood plants might just as well be used. Bradford et al. (51) also recommend eliminating the current method of “event-specific approvals.” Currently in the U.S., each independent transgenic event must be submitted for approval, although it can later be crossed into other varieties. If this practice becomes widely mandated in the developing world, it will be extremely difficult to deal with when developing GM crops like cassava and banana that, for a variety of reasons, are difficult to breed but relatively easy to transform. This type of regulation was instituted in the early days of GM crops when it was thought that position effects might show a strong influence on gene behavior, but there is little or no evidence that this has been the case. The complexity of these issues emphasizes it is essential that all regulatory agencies have some staff that understand the science involved to make sensible decisions.
Some Special Challenges. A far greater challenge may be to find responsible mechanisms for dissemination and monitoring of crops for which there is no well developed seed sector. Because there is a growing demand for hybrid maize among small farmers, hybrid GM maize already has, through private-sector seed companies, a mechanism in place for distribution and monitoring. Open-pollinated varieties of maize and other crops that outcross widely and/or where seed is saved from year to year, represent a bigger challenge, and one could argue that traits like Bt or herbicide tolerance that may transfer through outcrossing to the same non-GM crop or to wild relatives would be better restricted to hybrids that can be monitored by those who sell the seed. One can, of course, argue that non-GM crops with traits for disease, insect, and herbicide resistance have been around for years and require no regulatory approval; transfer of genes from these to wild species has posed little or no problems; and GM crops for other traits like improved nutritional quality fall into a class that poses essentially no risk to the environment. A more serious issue from a scientific perspective is that any new trait can become diluted out and lose efficacy in crops with a high degree of outcrossing and where seed is saved and reused by farmers. For vegetatively propagated crops, the use of tissue culture to provide more vigorous virus-free plantings has expanded widely for crops like banana, cassava, potato, and sweet potato. Farmers, even in Africa, are finding good value in the purchase of some of these, especially banana, suggesting that distribution of these types of GM crops might be responsibly managed through similar tissue culture operations. What is clear is that a serious analysis for each crop in each locale will be needed, and perhaps the only good news in the slowness of the public sector to develop such crops is that we still have time to create the proper roadmap for distribution and monitoring of any future crops developed.
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