Abstract:
Commercial and academic activities in the production of pharmaceuticals or other substances of industrial interests from genetically modified plants, i.e. molecular farming, have so far centred in the USA and Canada. Recent increases in EU activities and the proximity to market stage of the first plant-made pharmaceuticals, some of which from EU based companies, represent a call to action for EU regulators. Drawing on the North American debate on molecular farming it will be argued that both the rationale of and the risk issues associated with molecular farming will differ significantly from those of first generation GM crops. Based on these differences, the suitability of the existing regulatory framework, which essentially was developed in response to the arrival of insecticide and herbicide tolerant crops for food and feed use, is discussed. Possible options for adapting the already complex EU regulatory system to cater for molecular farming are examined. It will be argued that the policy challenges posed will inevitably spark a broader public debate. As an issue for debate, molecular farming is located at two crossroads: of the risk debate on agricultural biotechnology and the sustainability debate on renewables and greening of industry and of red and green biotechnology. Complex scientific, technical and legal issues, new issues at stake and a new pattern of actors are likely to give EU regulators a difficult time.