Towards governance of human tissue engineered technologies in Europe: Framing the case for a new regulatory regime

The development of human tissue engineered technologies, located in the context of wider debates around the governance of biotechnology, raises important issues. This paper explores these issues by examining theoretical approaches to the regulation of risk, the limits of technical risk assessment and implications of scientific uncertainty in this area. We consider broader social concerns and how these shape contemporary debates relating to the sourcing and use of human tissue-engineered technologies. We examine the emergence of a new regulatory 'regime' in Europe and the social shaping of a regulatory space between medicinal products, medical devices and biologics where these innovative products may be situated. Reporting on recent policy initiatives and a survey of regulatory authorities in Europe, we analyse the ways in which public trust in these technologies may be engendered, providing insight into public participation in policy debate and relations between industry and the regulatory state at national and European levels. © 2005 Elsevier Inc. All rights reserved