Monday, June 7, 2010

CSSP Working Paper: "How law makes technoscience: The shaping of expectations, actors and accountabilities in regenerative medicine in Europe"

CSSP Electronic Working Paper Series on S&T Policy and Innovation Studies

The CSSP Electronic Working Paper Series (EWPS) is intended to explore and debate themes in science, technology and innovation studies. While drawing into active dialogue of leading scholars and practitioners who share similar concerns, this effort will reflect the academic priorities of the CSSP.

Working Paper No. CSSPEWPS 1

How law makes technoscience: The shaping of expectations, actors and accountabilities in regenerative medicine in Europe

by

Alex Faulkner (King's College London)

March 2010


Abstract: The paper undertakes a textual analysis of the Advanced Therapy Medicinal Products (ATMP) Regulation which passed into law in the European Union (EU) in 2007, using the analytic concept of performativity. The ATMP document is significant for the development of regenerative medicine in the EU and globally. Drawing on concepts from socio-legal studies, innovation studies and science & technology studies, the text is discourse-analysed with a focus on: scientific-industry structure; production and technology; expectation and vision; rights and responsibilities; and actors - regulatory actors, participants in regenerative medicine production, and the public. The analysis shows a tension between standardisation and imprecision in the conceptual scaffolding of the legislative text, and reveals a number of 'elephants in the room' - including the concept of regenerative medicine itself. The reasons for the imprecision and conspicuous absences are discussed. Such texts combine material significant to key concerns of recent theorising of innovative technologies, such as technology expectations, sector-building and the stabilisation of technology. Referring to philosopher John Austin's well-known work on 'how to do things with words', Austin's concept of the 'conventional consequences' of a performative text is referred to in order to argue that legislative texts are a special class of document which should be accorded a more prominent place in studies of the governance and emergence of new scientific-technological zones and sectors.

Biographical Notes: Dr Alex Faulkner is Senior Research Fellow at the Centre for Biomedicine & Society (CBAS), Kings College London. He is a sociologist of medicine and technology, and has been researching the developing regulatory regimes for tissue engineering in the EU, supported by the UK's Economic and Social Research Council. In 2009 he received a substantial grant from the UK's National Institute of Health Research (NIHR) to investigate the different pathways that device technologies take into the healthcare system. He has published over 30 scholarly articles in peer-reviewed journals. His recent book is: 'Medical Technology into Healthcare and Society: a sociology of devices, innovation and governance' (Palgrave Macmillan, 2009). Other current interests are in theories of governance of emerging biomedical sectors in the global context, and the interface of sport and regenerative medicine.