ESRC Institute for Innovation Generation INNOGEN, The University of Edinburgh, Old Surgeons Hall, High School Yards, Edinburgh, EH1 1LZ, UK.
Transgenic Res. 2013 Aug;22(4):681-95. doi: 10.1007/s11248-013-9724-5. Epub 2013 Jun 19.
Scientific advances in methods of producing genetically modified (GM) animals continue, yet few such animals have reached commercial production. Existing regulations designed for early techniques of genetic modification pose formidable barriers to commercial applications. Radically improved techniques for producing GM animals invite a re-examination of current regulatory regimes. We critically examine current GM animal regulations, with a particular focus on the European Union, through a framework that recognises the importance of interactions among regulatory regimes, innovation outcomes and industry sectors. The current focus on the regulation of risk is necessary but is unable to discriminate among applications and tends to close down broad areas of application rather than facilitate innovation and positive industry interactions. Furthermore, the fields of innovative animal biosciences appear to lack networks of organisations with co-ordinated future oriented actions. Such networks could drive coherent programmes of innovation towards particular visions and contribute actively to the development of regulatory systems for GM animals. The analysis presented makes the case for regulatory consideration of each animal bioscience related innovation on the basis of the nature of the product itself and not the process by which it was developed.
科学技术在生产转基因动物方面的进展不断，但此类动物很少进入商业生产。现有的旨在适应早期遗传修饰技术的法规为商业应用带来了巨大的障碍。在生产转基因动物方面的技术取得了突破性进展，这促使人们重新审视当前的监管制度。我们通过一个认识到监管制度、创新成果和行业部门之间相互作用的重要性的框架，对当前的转基因动物监管法规进行了批判性的审查，重点是欧盟。目前对风险监管的关注是必要的，但无法区分各种应用，往往会关闭广泛的应用领域，而不是促进创新和积极的行业互动。此外，创新动物生物技术领域似乎缺乏具有协调未来导向行动的组织网络。此类网络可以推动针对特定愿景的创新计划，并为转基因动物的监管系统的发展做出积极贡献。所提出的分析表明，应根据产品本身的性质而不是开发产品的过程来对与动物生物技术相关的每一项创新进行监管考虑。
