Tissue-engineered products: Potential future socio-economic impacts of a new European regulatory framework

Potential chances and risks of tissue-engineering

Tissue engineering is a multidisciplinary, emerging biotechnology sector. It promises to change medical practice profoundly, regenerating diseased tissues and organs instead of just repairing them. However, the growth of tissue engineering markets in Europe is hampered – among other factors – by the present regulatory situation: neither medicinal products regulation nor medical device regulation can be unanimously applied to human tissue engineered products. As a result, the regulatory framework applied differs widely across the European Union. The European Commission is currently seeking to prepare legislation which will harmonise the authorisation procedures for the placing on the market of human tissue-engineered products.

At the same time, the European Commission aims at improving the quality and coherence of the policy development process by subjecting all major regulatory initiatives to an impact assessment. The European Commission commissioned its Joint Research Centre Institute for Prospective Technological Studies (IPTS, Seville, Spain) in collaboration with the Fraunhofer Institute for Systems and Innovation Research to carry out the impact assessment of the planned regulation for human tissue-engineered products. The purpose was to analyse systematically the likely impacts of the planned regulation, thus providing information for decisions how to shape the planned regulation.


Duration: 01. Feb. 2004 – 31. July 2004

Funding: European Commission DG Enterprise and Industries/DG Joint Research Centre – Institute for Prospective Technological Studies (IPTS), Sevilla, Spain

Coordination: Bärbel Hüsing at Fraunhofer ISI

Publication: Bock, A.-K.; Rodriguez-Cerezo, E.; Hüsing, B.; Bührlen, B.; Nusser, M. (2005): Human tissue-engineered products: Potential socio-economic impacts of a new European regulatory framework for authorisation, supervision and vigilance. Technical Report EUR 21838 EN. Online: ftp://ftp.jrc.es/pub/EURdoc/eur21838en.pdf