The Governance of Risk and Human Tissue Engineered Products
ABSTRACT
BSA Risk & Society Study Group
Conference 8 – 9 September 2003, University of Plymouth
Proposal for paper in session on Governance of Risk
Word count abstract: 300
- Ingrid Geesink
Cardiff University School of Social Sciences
Glamorgan Building
King Edward VII Avenue
Cardiff, CF10 3WT
Wales, United Kingdom
Tel +44 (0)29 208 75184
- Julie Kent, University of the West of England
- Alex Faulkner, Cardiff University
- David FitzPatrick, University College Dublin
The Governance of Risk and Human Tissue Engineered Products
A range of innovative healthcare products for tissue repair and regeneration are currently 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, thus creating a ‘regulatory vacuum’. New EU legislation is expected soon. At present there is national variation in policy, leading to confusion and uncertainty.
Some suggest that in the absence of agreed regulatory controls, populations in Europe may be denied the potential benefits of this new ‘regenerative medicine’ and industries will continue their innovation in other countries. At the same time concerns have been expressed about the safety of these products and the adequacy of existing risk management approaches.
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 tissue engineering products. 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.