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“Golden Rice”, a GMO-Product for Public Good, and the Consequences of GE-Regulation

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“Golden Rice”, a GMO-Product for Public Good, and the Consequences of GE-Regulation J. Plant Biochem. Biotechnol. (October 2012) 21 (Suppl 1):S68–S75 DOI 10.1007/s13562-012-0130-5 REVIEW ARTICLE “Golden Rice”, a GMO-product for public good, and the consequences of GE-regulation Ingo Potrykus Received: 18 July 2012 /Accepted: 24 July 2012 /Published online: 14 August 2012 # Society for Plant Biochemistry and Biotechnology 2012 Abstract Compared to a non - genetically engineered (GE) DRR Directorate of Rice Research variety, the deployment of Golden Rice suffers from a delay of TNAU Tamil Nadu Agricultural University more than 10 years. The cause for this delay is GE-regulation. GE Genetically Engineered Considering the potential impact of Golden Rice on the re- GMO Genetically Modified Organisms duction in vitamin A-malnutrition, this delay is responsible for loss of numerous lives, mostly children and women. GE- regulation is also responsible for the fact that public institu- The Humanitarian Golden Rice project tions are prevented from delivering a public good GE-product with the consequence that we are faced with a de-facto mo- The following analysis is based on 10 years of experience nopoly in favour of a few potent industries. Considering the with the public good project “Humanitarian Golden Rice” forgone benefits from putative public good GE-products, GE- (www.goldenrice.org). This project from the public sector regulation can be blamed of being responsible for millions of follows the successful proof-of-concept work (Burkhardt et lives, all of them, of course, in developing countries. As there al. 1997; Ye et al. 2000; Potrykus 2001; Beyer et al. 2002; is no scientific justification for present GE-regulation and as it Al-Babili and Beyer 2005) in which GE-technology was has, so far, not prevented any harm, our society has the used to engineer the biochemical pathway for the synthesis responsibility to reconsider present regulation which is based of pro-vitamin A into the starch storing tissue of the rice on the concept of an extreme interpretation of the precaution- seed, which is consumed in the form of ‘polished rice’. ary principle. It would be justified to change regulation to a Polished “Golden Rice” contains substantial amounts of science-base and to regulate traits instead of technology. This pro-vitamin A (which the human body converts into vitamin would make regulation cheaper and faster, without compro- A). This concept of “bio-fortification” (Bouis 2007) (using mising safety. GE-technology has an unprecedented safety the potential of genetics to improve the micro-nutrient con- record and it is far more precise and predictable than any other tent of food) was applied to save eyesight and lives of the “traditional” and unregulated breeding technology. numerous vitamin A-deficient children depending on rice as their basic diet (www.goldenrice.org). As polished rice does Keywords Golden rice . Pro-vitamin A . GE-regulation . not contain any pro-vitamin A, rice-depending poor popula- Intellectual property rights tions, which cannot afford a diversified diet, suffer from vitamin A-malnutrition. “Yellow rice” (yellow indicating Abbreviations pro-vitamin A) was, therefore, on the wish-list of rice breeders IRRI International Rice Research Institute since the early 1980s, but could not be attained via traditional IARI Indian Agricultural Research Institute breeding, because of lack of appropriate variability in this trait within the rice gene pool (www.goldenrice.org). This trait I. Potrykus (*) became an option only with the advent of “genetic engineer- Emeritus Plant Sciences ETH Zürich and Chairman Humanitarian ing” (Potrykus 2003) and it is still beyond the reaches of Golden Rice Board, traditional breeding or other molecular approaches. Subse- Im Stigler 54, CH-4312 Magden, Switzerland quent to the early proof of concept work by the teams of my e-mail: [email protected] collaborator Peter Beyer and I, which produced the first J. Plant Biochem. Biotechnol. (October 2012) 21 (Suppl 1):S68–S75 S69 Golden Rice in 1999, research by the private sector (Paine et came as a surprise for the “naïve” public sector scientists, al. 2005) and traditional breeding by the public sector who followed the idealistic concept of using their scientific (www.goldenrice.org) led to substantial increases in the accu- breakthrough to fight vitamin A-malnutrition. In retrospect, mulation of pro-vitamin A in polished Golden Rice such that however, it turned out that one single problem was respon- half a cup of Golden Rice as part of the routine daily diet of sible for nearly all of the delay of 10 years. This outstanding Golden Rice instead of white rice could prevent vitamin A- problem was (and still is) the political dimension of GE and malnutrition (www.goldenrice.org). particularly its effect on GE-regulation. The rules and regu- The concept of using the potential of genetics and GE- lations established world-wide for the handling and use of technology in a public sector project to fight a severe public “transgenic plants” (genetically engineered plants, GEs) and health problem of poor societies was welcomed with much the expectations of the regulatory authorities are so demand- enthusiasm by the scientific community, the private sector, ing that even with best support it takes more than 10 years to the media, and the public, and Golden Rice featured in prepare for and to assemble all the data required for a numerous international print media, including the cover of regulatory dossier, not to mention the exorbitant costs in- TIME Magazine (Nash 2000). It provoked, however, also volved. In the following I will briefly describe the various heavy opposition by anti GE-advocates, largely as the project hurdles and their contribution to the delay of more than undermined this opposition view that GE technology was only 10 years. for industrialised farmers in industrialised countries for mul- Intellectual property rights were the first and apparently tinational profit. Rather, Golden Rice is to be provided free of “insurmountable” hurdle we were faced with. As long as any charge to growers and consumers in poor developing working for proof-of-concept, scientists can effectively ignore countries, to address one of the great public health travesties intellectual property rights. Patents do not play a role. Scien- of our time – Vitamin A Deficiency. Expectations were high tists are free to exploit the public knowledge provided by and it was generally expected that Golden Rice would be in patented inventions. We had no idea, which patents we were the fields “soon”. Based on the experience rice breeders were using for our task. The best scientific breakthrough, however, predicting, that eight backcross generations (3 years at IRRI cannot rescue a single child from vitamin A-malnutrition, if a for example, or even less in case marker-assisted breeding product is not developed on its basis. From this moment on, would be applied) would be sufficient to develop and register however, patents count. As we intended that Golden Rice Golden Rice varieties (Khush 1999, personal communica- would be handed over to the farmers free of charge, we had tion). According to these expectations Golden Rice should to organise free licenses for the IPs involved. It turned out that have reached the farmers fields by 2002. The International the number of patents was dramatic (Kovalski et al. 2002). Rice Research Institute (IRRI), Philippines and other public Free licenses, as turned out, for 70 patents belonging to 32 rice research institutions in developing countries including patent holders appeared, not only to us, like the end of our IARI, DRR, TNAU of India are working since the early idea. Under the specific circumstances of our “humanitarian” 2000 on variety development (www.goldenrice.org) . It is project (www.goldenrice.org) however, the support within a now 2012 and it will take at least until fall of 2013 before “public-private-partnership” (www.goldenrice.org),andthe the first Golden Rice varieties can be handed over to the experience and the engagement of our partner from the private farmers in the first Asian country. sector, Dr. Adrian Dubock, it was possible to solve this prob- lem within less than half a year and in such a way, that it did not delay the project for even a day (Dubock 2009). Hurdles preventing use of GE-technology for public Lack of financial support from the public domain was good projects the next hurdle. It turned out that within the public domain there was no funding beyond proof-of-concept. Financial What then were the hurdles which delayed, in comparison to support for “product development” is, probably, beyond the a comparable non GE-variety, the deployment of Golden philosophy of any academic institution. Academic institu- Rice for more than 10 years? How can we understand a tions are set up to finance basic or strategic research for 10 year delay for a case with so much public support and “scientific novelty”. Product development is considered a such high expectations of social benefits? And what can we task for the private sector. Because of that situation we were learn from this experience for the numerous other public caught in an institutional “dead end road”: Our concept was, good projects in the pipeline around the world? to use the results from our “proof- of-concept” work for a It turned out that, under the enthusiasm of the scientific public good project on the reduction of vitamin A- breakthrough, neither the scientists involved, nor the scien- deficiency, and this required to develop a “product”. There tific community, nor the media, nor the public were aware of is no question that the responsibility for public good projects the specific requirements associated with development of a are within the public sector. But the public sector does not GE-crop variety.
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