title: Novel GM animal technologies and their governance.
abstract: 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.
authors.affiliation: ESRC Institute for Innovation Generation INNOGEN, The University of Edinburgh, Old Surgeons Hall, High School Yards, Edinburgh, EH1 1LZ, UK. ann.bruce@ed.ac.uk
authors.forename: Ann
authors.initials: A
authors.lastname: Bruce
authors.forename: David
authors.initials: D
authors.lastname: Castle
authors.forename: Corrina
authors.initials: C
authors.lastname: Gibbs
authors.forename: Joyce
authors.initials: J
authors.lastname: Tait
authors.forename: C Bruce A
authors.initials: CB
authors.lastname: Whitelaw
mesh_terms: D000818:Animals; D030801:Animals, Genetically Modified; D001709:Biotechnology / Q000639:trends*; D004345:Drug Industry; D004467:Economics; D005062:European Union; D012106:Research