History and Past Activities
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History and Past Activities |
ESA Conference: Ageing Societies, New Sociology
September 23-26, 2003 in Murcia, Spain
Two streams of sessions of the
Research Network 18: Sociology of Science and Technology (SSTNET)
Convenors:
Raymund Werle: Max Planck Institute for the Study of Societies, Köln, Germany (werle@mpi-fg-koeln.mpg.de)
Marja Häyrinen Alestalo: Dept. of Sociology, University of Helsinki, Finland (marja.alestalo@helsinki.fi)
Luísa Oliveira: DINÂMIA/ISCTE, Lisboa, Portugal (luisa.oliveira@iscte.pt)
Maarten Mentzel: 38 Johan de Wittstraat, 2334 AR Leiden, The Netherlands (m.a.mentzel@planet.nl)
First Stream: Governing Science and Technology in the Era of Globalization
Wednesday Sept. 24
14.30 - 16.30 session 3 (Campus de La Merced)
Chair: Maarten Mentzel
3.4. Author(s): Geesink, Ingrid/Kent, Julie/Faulkner, Alex/FitzPatrick, David
Institution: Cardiff University/ University of the West of England/ University College Dublin
Professional Category:
City: Cardiff/ Dublin
Country: United Kingdom/ Ireland
E-mail: geesinki@cardiff.ac.uk
THE GLOBALISATION OF RISK AND HUMAN TISSUE ENGINEERED PRODUCTS
A range of innovative healthcare products for tissue repair and regeneration are being developed. The market for human tissue engineered products (HTEPs) is expanding globally. To promote trade and extend the European market is a priority for industry. The implications for public health and consumer protection are the focus of current regulatory activity in the UK and Europe. In Europe, these ‘hybrid’ or combination products are however at the borderline of existing regulation of medical devices, medicinal products and biologics, creating a ‘regulatory vacuum’. New EU legislation is expected soon. At present there is national variation in policy, leading to confusion and uncertainty.
Focusing on product application-areas in differing stages of development (skin, bone & cartilage and vascular disease) this paper discusses the risk discourses around the use of human tissue in the manufacturing of these products and the new questions this raises about the regulation and management of risk. Recent debate has highlighted ethical and social concerns around the sourcing, storage, import and export of human body parts. This paper draws on existing understandings of the Europeanisation of regulation in pharmaceuticals, medical devices and the literature on biotechnology governance to analyse the construction of risk related to HTEPs. It presents preliminary interview data from a research project that investigates relations between industry, regulators, policy makers, scientists, clinicians and consumers. We examine the ways in which each of these groups construct risk and how this is shaping regulation in this area.
Sociology of Science and Technology NETwork - last update: April 2006