Regulatory policy as innovation: Constructing rules of engagement for a technological zone of tissue engineering in the European Union

This paper addresses the question of the part that regulation plays in processes of innovation in sectors of technology. The politico-economic phenomenon of ‘Europe’ is partly constituted by regulatory regime-building, and new technologies are one of the major sites of regime-building. A constructionist social theory perspective shows that study of the conflictual processes of regulatory policymaking affords insights into the formation of the rules of engagement that constitute technology domains. Adopting the concept of emergent ‘technological zone’ in preference to industrial ‘sector’ or technoscientific network, the paper presents, using empirical research, a detailed account of the case of the debate and development of regulatory policy for therapeutic tissue engineering in the European Union's policy institutions and stakeholder networks. It describes how the jurisdiction of an emergent zone has been formed through such negotiations, providing a counter-example to the common view that regulation ‘lags behind’ innovation. The analysis takes account particularly of the part played by the malleability of the definition of the material technology itself in such constructive governance processes, and it also suggests various consequences for the array of producers of the technology, for market structuring and for the innovation pathways taken by tissue engineering technology. Concluding, the paper argues that there is conceptual advance to be made by bringing together constructionist social theory with innovation studies approaches that highlight the part played by non-firm, public institutions in shaping innovation ecologies.