“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 problem 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. There were numerous problems which support – and has no expertise in - product development, S70 J. Plant Biochem. Biotechnol. (October 2012) 21 (Suppl 1):S68–S75 and expects that the private sector takes care of product How GE-regulation delayed GE-variety deployment development. This concept works for cases, where the pri- by 10 years vate sector has an interest and can expect a financial return for the investment required. Humanitarian projects do not The only and dramatic bottleneck was, and is, GE- offer a chance for such a return. Therefore, the private sector regulation. As there was no experience in the public domain cannot afford to develop such a product. So, again this with deregulation of a GMO-product, we followed advice looked like the end of our concept of a “Humanitarian from the private sector with appropriate expertise. Regula- Golden Rice”? tion affects a GE-product long before the collection of data The only way out was to find some mutual interest for a regulatory dossier starts, and much longer before a which could encourage the private sector to support the complete dossier can be handed in to national authorities for humanitarian project. As we had patented our invention, the actual process of deregulation. The actual process of we could accept a proposal by the private sector regulatory clearance, once a dossier is in line with the (Zeneca, now Syngenta) to grant to them the rights for regulatory requirements, can be relatively fast. Which are commercial exploitation of our invention in return for then the practical GE-stumbling blocks which interfere with rights to additional necessary technology from Syngenta the development of a product long before regulatory author- and defined support for clearly and precisely defined ities work on the regulatory clearance? humanitarian exploitation. This concept worked out (www.goldenrice.org). The rights for our invention were Deletion of selectable marker (2 years) transferred to Zeneca/Syngenta. We licensed back, to- gether with other necessary technology and defined GE-technology requires use of selectable marker genes, support, the rights for “humanitarian use”, agreed a which allow the selection from amongst millions of cells “sublicense agreement” to be used as the basis for the few ones which have integrated the novel genes of collaboration with numerous partner institutions on the interest. Regulatory authorities prefer, under public scrutiny, basis of a “sub-sub-license agreement”. We benefited that antibiotic selectable marker genes are deleted. This is from this “public-private partnership” by substantial in- technically possible, but takes a lot of time and effort to do kind support, solution of the patent problems, and re- so. This has to be done despite the fact, that there is a wealth ceived very valuable donations for the humanitarian of scientific literature documenting that the antibiotic mark- project from work done by Syngenta while working er genes in use have no effect on consumer and environ- towards the development of a commercial Golden Rice mental safety (Ramessar et al. 2007). product. Much to our regret, the company stopped the commercial project because the chance for a financial Screening for streamlined integration (2 years) return at the level of the investment was too low. We learned the hard way, what it means to develop a Regulatory authorities do not accept complicated integration product and what it means to manage such a task patterns of the “transgenes”. The argument is, that this can effectively. Nothing from these activities was holding have unexpected and unforeseeable consequences. As inte- back the development of a Golden Rice product. Finan- gration of genes is a random event, the only way to achieve cial support was received from philanthropic and other clean integration is, to repeat the experiment so often until visionary organisations such as The Rockefeller Foun- such an event has been found. This requires endless dation, USAID, and the Syngenta Foundation. But no repetitions of the same experiment. Use of Agrobacterium- support was available from any public European or any mediated transformation is helpful, but does not guarantee for UN institution. Thanks to the existence of altruistic clean integration. This request is maintained for GE crops organisations “lack of financial support” was not a despite the fact that any “traditional” standard breeding pro- factor blocking the development of our product. cess leads to uncontrolled integration as well, especially if There were further disturbing factors such as the negative prior mutagenesis by radiation or chemical means is involved. political climate around GE-technology (Sinha 2009), anti Such random mutagenesis goes unregulated if no new genes GE-activists (Taverne 2005), the negative attitude of devel- have been introduced from other organisms. opmental aid organisations to GE crops, which all had strong negative effects on possible governmental support Screening for regulatory clean events (2 years) and especially on putative support from UN-organisations, even those having a specific mandate to reduce vitamin A- “Regulatory clean” events are DNA integration events, malnutrition, who did not even reply to written invitations to which combine all features which make them unproblematic engage in some way. But all this did not slow down Golden for regulatory authorities under all molecular genetic Rice development. aspects. The gene cassette for one transgene is integrated J. Plant Biochem. Biotechnol. (October 2012) 21 (Suppl 1):S68–S75 S71 in an ideal and perfect manner: a) one copy only, b) no house. This means that tests can begin on small plots only alterations of the construct, c) no read-through on both sides after 18 months – according to the regulatory requirement. possible, d) no disturbance of existing reading frames, e) no Whether permission is given, has however, also a political activation or inactivation of neighbouring genes or expres- component. We waited until late 2008 for the first permission signals, f) no activation of possible mobile elements, g) sion for the first small scale field plot in a developing stable expression at the predicted level and under the pre- country. Fortunately, we did initial field tests in Louisiana, dicted conditions. Such “ideal” events are rarities. To find USA, in 2004 where granting of the permission did not even them requires not only hundred-fold repetitions of the same require half a year. Variety development, however, means experiment with regulatory clean constructs and technology, “breeding”; breeding depends upon large numbers of off- but also sequencing for all candidate events not only of the spring; large numbers are possible only in the field. Breed- construct but also of the adjacent host DNA, which by itself ing also requires response to the natural environment to is not as problematic as the discovery of such an event explore response to the natural stress conditions. Neither amongst thousands. We were in the fortunate situation that the necessary numbers nor the environmental conditions Syngenta was screening for them with an enormous effort can be achieved under artificial conditions. This most severe during their, later abandoned, “commercial” Golden Rice impediment of normal, efficient breeding is the automatic phase and was donating the material to the humanitarian consequence of regulation. It does not matter that nobody project under the terms of the original license. All final has ever come up with a hypothetical scenario arguing for Golden Rice varieties are based on such “regulatory clean” any hypothetical environmental risk from Golden Rice. events. Every GE case has to follow all rules and regulations, independently of whether there is any putative risk or not. Trans-boundary movement of seeds (2 years) Again, we lost far more than 2 years to ideology-based regulation! Golden Rice is, of course, an international breeding exer- cise. Rice breeders within the Golden Rice network Requirement for “lead-event” selection (3–4 years) (www.goldenrice.org) in the different countries develop, using traditional and marker-assisted breeding, agronomi- Preparing a regulatory dossier for a single transgenic event cally improved, locally optimised Golden Rice varieties on is so demanding and expensive that it is totally impossible to the basis of the most popular varieties of their countries. deregulate several independent transgenic events. This This requires free exchange of breeding seed material be- forces any GE product developer to base all variety devel- tween countries. The conditions set up by the Cartagena opment on one single transgenic event. To be able to select protocol (Gruere and Rosegrant 2008) make exchange of the single event and then invest all resources in it requires transgenic seed so complicated, that it took more than collection of numerous data from many events. To collect 2 years to transfer e.g. breeding seed from The Philippines these data without extended work in the field is impossible. to Vietnam; and one year from USA to India, during which Event selection can come only after permission for field time 30 politically loaded questions were asked in the Indian experiments (see above for the problems!). Different varie- Parliament. These Cartagena conditions are enforced de- ties developed from a single transgenic event can be deregu- spite, common sense suggesting it is extremely difficult to lated on the basis of the same regulatory dossier, if they are construct a hypothetical risk from seed transfer between two derived by traditional breeding. Therefore, all Golden Rice breeding stations in different countries, especially for Gold- varieties are derived from one single transgenic event more en Rice. Incidentally, free movement of cereal seed between than half a decade ago and all subsequent steps are the result different countries seed breeding systems was absolutely at of traditional plant breeding in the different partner institu- the heart of the success of the green revolution of the 1960s tions in the different countries. We definitely would prefer to and 1970s in introducing new genes to countries, increasing have varieties based on different events. But the conditions biodiversity, and increasing food productivity and reducing for deregulation leave no choice. malnutrition. Requirements for the regulatory dossier (4 years) Obligatory sequence from growth chamber to greenhouse to screen-house to field (2 years) I will not describe all the hundreds of expensive studies in molecular genetics, biochemistry, nutrition, protein identity, Permission for work in the field is given, if at all, only after -digestibility, -immunogenicity, gene expression, anti- intensive testing and data collection in (a) a contained nutrients, and agronomy required, at publication level qual- growth chamber, (b) followed by the same in a contained ity, for the final regulatory dossier. These requirements keep glasshouse, (c) followed by the same in a contained screen- an entire team of specialists busy for at least 4 years. Part of S72 J. Plant Biochem. Biotechnol. (October 2012) 21 (Suppl 1):S68–S75 the studies can already be done during the course of The World Bank’s benchmark cost of saving one development, but an essential part has to be done with ‘disability-adjusted life year’,valuedat$620– $1,860 the final variety to be released. This also means that by the Bank, is $200. The actual costs for the, so far, 10 years of expensive experimentation has to be per- most effective, traditional intervention – the free distri- formed with no guarantee, that at the end everything bution of vitamin A-capsules - is between $ 134 and $ will be in accordance with the regulatory requirements. 559. Golden Rice is expected to do the same thing for Not to be in line with the regulatory requirements does, only $3. And this $3 cost would include all money however, not mean, to constitute a realistic risk. It just spent in 10 years of proof-of-concept work, plus all means no permission for release. money spent on product development and deregulation and variety registration and social marketing. These Deregulation procedure unprecedentedly low costs are the consequence of the fact that there are no recurrent costs, once a variety has Once a complete regulatory dossier, especially one based on been released. This is the major reason why this inter- a regulatory clean event, has been assembled, the actual vention based on “biofortification” is highly sustain- procedure for regulatory clearance has a fair chance to take able as well as cheap. less than a year. Therefore, it is neither the regulatory Once cleared for adoption by the national authorities, authorities, nor the final regulatory process which has to seeds of agronomically optimised and locally adapted Gold- be blamed for delaying registration of GE varieties. It is the en Rice varieties will be provided to the farmers by public rules and regulations for the use of transgenic plants them- seed distribution units or by licensed seed multiplications selves, and, of course, the political attitude enforcing its units, free of charge for the trait and within the framework of “extreme precautionary application”. the humanitarian project. The farmer will be free without any restrictions to grow, harvest, sell, consume and store Golden rice including to use part of the harvest for the next The putative impact of Golden Rice sowing and to pass seeds on to neighbours. The rice farmers will continue to use their traditional farming practices and The definite impact of Golden Rice will be studied in they will not require any additional input in form of agro- epidemiological studies following release to the farmers chemicals or fertiliser. The costs of production will be the and consumption by vitamin A-deficient and rice- same as for any other variety of rice The yield of Golden depending populations. Because of regulation this will not Rice varieties is at least as good as of other popular non-GE be possible before 2013 onwards. Socio-economic ex-ante varieties and there is no off-taste which would discourage studies allow, however, to get an educated estimate already consumers from eating Golden Rice. The only difference is now. Since solid data about human bioconversion and bio- the yellow colour. Initial but in depth social marketing availability of pro-vitamin A from Golden Rice have been research has shown that households have no problem with generated (Tang et al. 2009; Sommer 2009), the predictions the colour when they understand it is associated with good can be relatively precise. There have also been a series of nutrition. economic ex-ante studies with Golden Rice in different countries. In the following paragraph I refer to the detailed study on the putative impact of Golden Rice in India, Lessons learned from the Humanitarian Golden Rice published by the team of Professor Matin Qaim, Göttingen project in Nature Biotechnology (Stein et al. 2006). The annual burden of vitamin A-deficiency in India is From the long years of work with the development of the characterized by the loss of 71, 600 lives or 23,28,000 first public sector GE-product we can derive a series of “DALYs”. (A DALY is a technical term used by economists lessons which apply to any further public sector GE project. to quantify, and allow comparison between, the impact of These lessons are, probably, new to most colleagues in interventions and refers to a standardised Disability Adjust- academia, and to the public sector, in general. As they have, ed Life Year.). The potential annual impact of Golden Rice however, far-reaching consequences for all those projects in is presented in two scenarios, a “pessimistic” and an “opti- the public domain, financed with the vision of contributing mistic” one. Three years after this publication we know that to the solution of altruistic problems (much of basic science the optimistic scenario is a realistic one. According to these in plant molecular biology and biotechnology is financed scenarios Golden Rice could save up to 40,000 lives per with this argument in mind) those financing and working on year, or in DALYs, up to 13,82,000 healthy life years such problems should at least be aware of what stands annually. The lives saved would represent 95 % of those between a pleasing, academic proof-of-concept result and rice-dependent poor in danger of losing eyesight and life. the practical impact it claims to achieve. J. Plant Biochem. Biotechnol. (October 2012) 21 (Suppl 1):S68–S75 S73

Negative attitudes to GE crops high-iron-, high zinc-, high protein- rice, and exactly the same in cassava, banana, and sorghum, which have the potential to The European negative attitude to GE has a very strong save millions of lives per year. All these projects suffer from the negative effect on governments and civil society in devel- same consequences of regulation, increasing the number of oping countries. The negative attitude is prevalent within lives lost to the tens of millions per year. And there are several NGOs, a small part of the public, much of the media, drought-, salt-, flooding-,virus, bacterial- fungal-, insect-, many development aid organizations, and most European nematode-resistance, projects too, not only with the major governments. This effect is exacerbated by the financial crops but also with staple crops important for food security in support of European governments to NGO groups paid to developing countries, and there is improved exploitation of lobby against GE crops. This effect is exacerbated by the natural resources which all could substantially contribute to financial support by European NGOs to NGOs in develop- food security (Cohen 2005; McGloughlin 2010;Morandini ing countries. 2010), if GE-regulation did not prevent public good GE- product development. Numerous other public projects e.g. Regulatory process improved food security, including many from developing country laboratories and with orphan crops, have – under these Justification for present regulation is based on the notion conditions – no chance to make it to the market place. The that the technology leads to “unpredictable and uncontrolled GE-potential is, therefore, blocked for public good projects. modifications of the genome”. This argument ignores the The often raised complaint (especially by the GE-opposition) fact that all traditional breeding has been and is doing that GE technology has been exploited for industrial projects exactly the same (Baudo et al. 2006; Shewry et al. 2007; only, has its only cause in the GE-regulatory system, and Batista et al. 2008; Herman et al. 2009; Potrykus 2010). In politicisation of this useful technology. the entire history of GMO technology development and application there is not a single documented case of harm, The social cost of over regulation which could be used to argue for maintenance of the present regulatory situation (Bradford et al. 2005; Potrykus and According to the ex-ante study above (Tang et al. Klaus 2010). There is no scientific justification for present 2009), Golden Rice could save in India alone ca. 40, regulation. 000 lives per year. The social costs as the consequence of GE regulation, calculated only for the case of Golden The financial and time cost implications of excessive Rice, India and the delay of deployment of 10 years, regulation would add up to a loss of about 4,00.000 lives. How- ever, there are further countries with vitamin A- The costs for the development of a GE-variety are currently deficiency problems and rice-dependent poor popula- so immense, due to politics, not science, that it is difficult to tions such as The Philippines, Bangladesh, India, Viet- identify a product which offers a fair chance for financial nam, Indonesia, China, etc. for which Golden Rice is return of the investment for non-industrial crops. In addi- under development (www.goldenrice.org). Delay of de- tion, GE-regulation delays delivery of GE-based products ployment raises the social costs of regulation to a loss for about 10 years, compared to non-GE varieties and car- of lives far beyond one million. A conservative estimate ries a huge financial penalty. of the social costs of all those blocked public good Time and costs for delivery of a GE-product to the market projects indicated above and considering just the are, therefore, so immense that neither public institutions, 10 years of delay, amounts to astronomic losses of nor any small- or medium-sized enterprise can afford the hundreds of millions of lives. And this is not everything investment in funds and/or personnel. with regards to social costs, because the great majority of the public good projects will not just be delayed; Impact on food security of unscientific regulation they will never make it to the marketplace, thus adding further lives lost. In addition to the unacceptable and Food security for developing countries requires, however, astronomic social costs, there are also enormous eco- besides the best of traditional agriculture, also the best of nomic losses which cannot be recovered because the novel technologies. GE-regulation excludes a very potent loss of lives and healthy life years (DALYs) are irre- and promising technology. There is, in addition to Golden versible. A World Bank study (Anderson et al. 2005) Rice , excellent progress within the Bill & Melinda Gates calculates the yearly economic loss of GDP due to lack Foundation funded biofortification projects within Grand of adoption of “Golden Rice technology” to ca. $ 15.6 Challenges in Global Health No.9 (www.grandchallenges.org/ billion in Asia alone, with at most $300 m of exports ImproveNutrition/Challenges/NutrientPlants) with regards to to Europe at risk. S74 J. Plant Biochem. Biotechnol. (October 2012) 21 (Suppl 1):S68–S75

The role & limitations of the public sector risk as compared to non-transgenic plants derived from traditional plant breeding (Morris 2007) it is difficult to The public sector, not the private one, is responsible for understand, that our society continues with the practice of public good, altruistic, and humanitarian projects. The pub- extreme precautionary regulation exclusively of those plants lic sector has competence for proof-of-concept work, but is which have been produced with the most precise and pre- totally incompetent and unwilling to deliver public good dictable technique of genetic modification and which have GE-products from its own successful research. The public the safest track record compared to any other technology sector, therefore, depends upon partnership with the private (Ensering 2008). “Regulation must be revolutionized” sector for the exploitation of its achievements in science and (Potrykus 2010). technology. In contrast to the private sector, academic personnel survive on publications. All work necessary for Acknowledgement This paper is an edited and updated version of a product development and for deregulation does not offer previous publication: Ingo Potrykus (2010) Lessons from the the slightest chance for publication. New ways of recognis- “Humanitarian Golden Rice” project: regulation prevents development ing merit need to be developed to address this shortcoming of public good genetically engineered crop products. New Biotechnology – which impedes academic involvement in pro-poor product 27, 466 472. I am grateful to Dr. Adrian Dubock for the English editing of the manuscript. development.

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