title: A critical assessment of the directive on tissue engineering of the European union.
abstract: The development of tissue engineering in Europe suffers from the absence of a coherent regulatory framework. Therefore, the European Commission has drafted a directive to regulate all tissue-engineered products in a comprehensive yet flexible framework. This article analyzes the directive from an ethical viewpoint. We argue that there are shortcomings to the proposal because of disjunctures at various regulatory levels and because responsibilities of several authorities have not been clearly established. The conscious decision to exclude ethically sensitive issues from the regulation will contribute to a continued complex regulatory environment for tissue-engineered products in Europe. We suggest that, from the start, ethical issues must be considered as an integral part of the regulation of tissue-engineered products. We propose the development of a multistage regulatory framework that makes provision for the diversity of tissue-engineered products, whereby the hybrid character and the ethical sensitivity of these products are fully taken into account. We equally suggest that the general public remain involved in regulatory issues concerning tissue-engineered products.
authors.affiliation: Faculty of Medicine, Centre for Biomedical Ethics and Law, Catholic University of Leuven, Leuven, Belgium. Helena.Trommelmans@med.kuleuven.be
authors.forename: Leen
authors.initials: L
authors.lastname: Trommelmans
authors.forename: Joseph
authors.initials: J
authors.lastname: Selling
authors.forename: Kris
authors.initials: K
authors.lastname: Dierickx
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence*; D005062:European Union; D033161:Government Regulation; D017410:Practice Guidelines as Topic; D023822:Tissue Engineering / Q000941:ethics* / Q000331:legislation & jurisprudence*