Governance of Human Tissue Engineered Products in Europe –
the case for a new regulatory body
Julie Kent1, Alex Faulkner2, Ingrid Geesink2, David FitzPatrick3
1.
School of Sociology, Faculty of Humanities, Languages and Social Science, University of West of England,
Coldharbour Lane, Bristol, England, BS16 1QY (address for correspondence).
2.
School of Social Sciences, Cardiff University, Cardiff, Wales.
3.
School of Biomechanical Engineering, University College Dublin, Dublin, Ireland.
In Europe we are witnessing the emergence of innovative healthcare products for tissue
repair and regeneration. These ‘hybrid’ or combination products are at the borderline of
existing regulation of medical devices, medicinal products and biologics. Debate across
Europe centres on the need for new policies and new regulatory processes and
institutions to regulate these products. Some commentators see regulation as facilitating
more effective technology transfer and as promoting greater investment in research and
development. It has been suggested that in the absence of agreed regulatory controls
populations in Europe may be denied the potential benefits of this new ‘regenerative
medicine’ (EUCOMED 1999, WTEC 2002). At the same time concerns have been
expressed about the safety of these products and the adequacy of existing risk
management approaches.
This paper explores this debate and the political process that is shaping regulatory policy
in this area. As part of an ongoing research project an initial survey of EU competent
authorities is presented to illustrate the convergence and divergence between states in
regulatory policy. We investigate the development of consensus at the EU level, national
legislation and differences in the approval and post market surveillance of these
products. Nation states have statutory responsibilities for the regulation of
pharmaceuticals and medical devices under the terms of European directives but it has
been argued that there is ‘a regulatory vacuum’ around these newer ‘hybrid’ products.
Our research explores the engagement of a number of constituencies or ‘stakeholders’
in the process of standard setting, policy decision making and the development of new
legal statutes at the EU level. These include, to varying degrees, scientists, regulators,
manufacturers, clinicians and consumers. We examine the ways in which these
constituencies participate in the organisation of this regulatory space (Hancher & Moran
1989) and the relationships between regulatory agencies, the manufacturers,
professional and scientific bodies and consumer groups.
The recent work of the EU Commission in conducting an open consultation on ‘the need
for a community legal framework on “human tissue engineered products”’, and the
drafting of a new directive on human tissues and cells is described. We consider the
proposal by the Scientific Committee on Medicinal Products and Medical Devices for the
establishment of a new Tissue Engineering Regulatory Body and the responses of
national agencies. In addition the industry position, represented by EUCOMED, is
outlined. In order to examine the relationships between the different constituencies in
more detail our research focuses on the application of tissue engineering to produce skin
systems for wound repair, cartilage and bone regeneration and vascular prostheses. At
present the technology ‘outpaces’ the regulations and some healthcare products are
already in use while others are at earlier stages of clinical testing and development.
Scientific and technical advice highlights issues relating to biological safety, cell sourcing
and contamination, storage and tracking of tissues amongst others. A new code of
practice in the UK (Medical Devices Agency 2002) emphasises a reliance on quality
assurance systems of manufacturers for risk assessment and protection of public health.
Formal regulatory guidance is expected to take several more years but our analysis of
such quasi and proto-regulatory activity will contribute to the understanding of risk and
governance in this area of healthcare innovation. We draw on existing understandings of
the Europeanisation of regulation in pharmaceuticals (Abraham & Lewis 2000) and
medical devices (Kent & Faulkner 2002). We also consider the extent to which organised
consumer groups are able to participate in this policy debate, notions of democratic
governance and the importance of policy networks.
References:
Abraham, J. & Lewis (2000) Regulating Medicines in Europe, Routledge.
EUCOMED (1999) Industry Position on Human Tissue Product Regulation, at
http://www.eucomed.be.htm
Hancher, L & Moran, M. (1989) Organizing regulatory space, in Baldwin, R., Scott, C. &
Hood, C. A Reader on Regulation, Oxford University Press.
Kent, J. & Faulkner, A. (2002) Regulating human implant technologies in Europe:
understanding the new era in medical device regulation Health, Risk & Society, vol 4, no
2, 189-210.
Medical Devices Agency (2002) A Code of Practice for the Production of Human-derived
Therapeutic Products, Department of Health, UK.
World Technology Evaluation Center WTEC (2002) Panel Report on Tissue Engineering
Research at http://www.wtec.org.htm.