Current issues in the regulation of human tissue-engineering products in the European Union.
Tissue engineering (TE) is an emerging technology that combines expertise in life sciences, clinical medicine, and engineering. Current challenges in TE include anticipating and streamlining appropriate regulation with product development. Consequently this study has focused on views of developers, companies, and regulators on biological risks of TE products, aspects of commercial applications, and patentability. Most concerns about TE products focus on risk of cancer formation, infection risk, and rejection risk. Thus, at the present time, product developers should follow guidelines for medicinal products, in order to address product safety at an adequate level. According to the data of the present study, cell and biomaterial products, manipulated cells, and scaffolds appear to be the primary interest for commercial product development. In contrast, producing services were not considered as interesting. Constraints are also imposed by patentability, which stipulates demands for technical performance and highlights ethical issues, which are difficult to address.
Heinonen
Maarit
M
Laboratory of Biochemistry and Microbiology, Helsinki University of Technology, Espoo, Finland. maarit.k.heinonen@helsinki.fi
Oila
Outi
O
Nordström
Katrina
K
D001672:Biocompatible Materials / Q000592:standards; D002986:Clinical Trials as Topic; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence / Q000592:standards; D005062:European Union; D006801:Humans; D013673:Technology Assessment, Biomedical; D023822:Tissue Engineering / Q000941:ethics / Q000331:legislation & jurisprudence / Q000639:trends
D001672:Biocompatible Materials