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emerged from the European Commission’s Framework Programme-funded project Pharma-Planta, creating a production system, approved by regulators, which can now be deployed as a flexible technology platform to produce other high-value proteins. The European Cooperation in Science and Technology Framework (COST) Action on Molecular Farming (http:// www.molecularfarming.org) has been very helpful in creating a European network to sustain and broaden the scientific basis of plant research to produce valuable molecules and to address the associated issues for clinical trials, regulatory approval and public acceptance. Main application areas within the COST Action cover proteins that may be required in large amounts (for example, monoclonal antibodies, subunit vaccines), medicines that can currently only be made in plants (for example, secretory immunoglobulin A antibodies) and medicines specifically designed for production in plants (for example, recombinant immune complexes engineered for enhanced immunological properties). Plant production systems in these areas offer various advantages in terms of scalability, cost-effectiveness, adaptability and speed. It should be noted that in some of the case studies the technology does not use whole plants as the production system. Experience with cultured plant cells successfully overcomes many of the problems associated with production (Maxmen, 2012), in particular ensuring the fidelity with which it is possible to generate complex proteins appropriately glycosylated, folded and assembled, and free of the toxins that may complicate mammalian production systems. However, although plant cell culture systems may enjoy a shorter regulatory approval pathway (under the GMO Contained Use Directive, because transgenic material in vitro is isolated from the wider environment), and such systems do provide carefully controlled conditions, the cost of the product is significant by comparison with field-grown crop products (Wilson and Roberts, 2012) 33 . Therefore, the EU may again become increasingly uncompetitive, as other countries with their faster GMO regulatory frameworks transfer production of proteins from contained cell to field-scale systems. It has been proposed that broader and more balanced legislative oversight is needed if molecular farming is to advance in Europe (Sparrow et al., 2012). Only a very small proportion of the large diversity of plant metabolites has been explored for production of novel therapeutics; there will also be many opportunities to produce small organic molecules as well as proteins. The increasing availability of high-throughput sequencing and interdisciplinary synthetic biology are transforming the discovery and production potential (De Luca et al., 2012). However, weaknesses in EU competitiveness arising from the translation from contained use to field scale may also be found to apply for those GM plant-based systems devised for other products (for example vanillin in food technology 34 ). 4.8 Appreciating the new realities and addressing policy disconnects This chapter has ranged widely in reviewing how the EU is becoming uncompetitive in the application of biotechnology-based approaches to agriculture, assessing the extent to which this is attributable to problems in devising and implementing proportionate regulatory systems. The implications for the science and technology base and public engagement, the need to respond to environmental challenges and the novel opportunities for innovation that are now coming within range, have all been emphasised. We reiterate that crop genetic improvement technologies can only be part of the solution to the sustainable intensification of agriculture but it is unwise to exclude any validated tool, as EU policy may risk doing. Recent European Commission initiatives such as the Innovation Partnership on Agricultural Productivity and Sustainability (European Commission, 2012c) enable stakeholders to work together on shared objectives, offering an opportunity to transcend the entrenched positions that have impeded EU strategic development during the last two decades. The EU has much to do. There are rapid changes in the distribution of power in agriculture worldwide and the EU has retreated from world markets, ‘… the export capabilities of the EU-27 in some key commodity sectors are predicted to decline further in the next 10 years, unless policy measures change markedly’ (Renwick et al., 2012). There is critical need to invest in R&D to find new ways to boost productivity (Renwick et al., 2012). The current EU research budget for agriculture is very small (less than 1%) compared with the CAP budget: a good case can be made to augment and coordinate this, for example through the Innovation Partnership, and to work harder to translate new knowledge to practice. Based on the analysis in this and the preceding chapters, the EASAC Working Group highlighted several inconsistencies and disconnects across the current policy 33 Because of the economies of scale-up, other current comparisons indicate that plant molecular farming can produce recombinant proteins at 0.1–10% of the cost of mammalian cell culture systems and microbial cell culture systems respectively (Chidambaram, 2011). 34 In addition to the prospects for optimising synthesis of natural products in plant systems, synthetic biology is identifying ways to engineer plant systems to generate metabolites that they would not normally do and products that do not normally exist in nature (EASAC, 2010). This is a very active area of research in some Member States, for example the UK academic network Synthetic Plant Products for Industry (http://www.sppi-net.org/index.html). 34 | June 2013 | Planting the future EASAC
landscape. Among these policy disconnects that need to be tackled are the following. • Inconsistency whereby the EU may have approved the importation of food or feed of GM crop origin but has not approved the same GM crop for cultivation within the EU. This seems illogical and there will be other consequences of this policy disconnect: as other countries adopt less stringent regulations, there will be less incentive for them to make the investments to meet EU regulatory requirements for importation and, in consequence, the EU may experience increasing difficulty in accessing certain products. • Inconsistency between the historical and current commitment to investment in plant sciences and the desire to promote a knowledge-based bioeconomy yet neglecting to use the outputs from research for agricultural innovation. • Inconsistency between the objective to reduce chemical pesticide use and the over-regulation of alternative genetic approaches to protecting crops, such that it will become increasingly difficult to protect crops from pests and diseases. • Inconsistency between the broad objectives of EU global development policy and the impact of EU GM practices on developing country decisions at a time when the EU agricultural footprint requires significant land use in developing countries to satisfy EU needs. EASAC Planting the future | June 2013 | 35
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Page 5 and 6: Contents page Forewordv Summary1 1
Page 7 and 8: Foreword The world continues to fac
Page 9 and 10: Summary Agriculture faces major cha
Page 11 and 12: 1 Introduction 1.1 Global societal
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Page 21 and 22: It has been suggested that correcti
Page 23 and 24: H. armigera, it is nearly 30 times
Page 25 and 26: or GM technology 23 . This approach
Page 27 and 28: 3 The connections between the EU an
Page 29 and 30: EU institutions) and other bodies (
Page 31 and 32: 3.3.2 What was the previous EU impa
Page 33 and 34: 4 Connecting the evidence base and
Page 35 and 36: Fagerstrom et al., 2012; Giddings e
Page 37 and 38: iotechnology in academia in Europe
Page 39 and 40: the World Trade Organization Agreem
Page 41: persist then the current complicati
Page 46 and 47: to whether surveillance and regulat
Page 49: Appendix 1 Working Group The report
Page 53 and 54: Appendix 3 Background information o
Page 55 and 56: production systems, but production
Page 57 and 58: total value of food exports (2010-1
Page 59: Appendix 4 Methodological difficult
Page 62 and 63: Other field trials are underway in
Page 65: List of abbreviations ATPS Bt CAP C
Page 68 and 69: for Global Conference on Agricultur
Page 70 and 71: EASAC (2011). Plant genetic resourc
Page 72 and 73: Gruère GP and Sun Y (2012). Measur
Page 74 and 75: Morrell PL, Buckler ES and Ross-Iba
Page 76 and 77: Smyth S and McHughen A (2008). Regu
Page 78: EASAC, the European Academies Scien

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