Author:

Keywords:

tissue engineering, regenerative medicine, ethics, Europe, guidelines

Abstract:

This European Ethical-Legal Paper provides an overview of the ethical issues related to tissue engineering (TE). In the first chapter we give a short description of TE as a new medical technology. In a second chapter we provide an overview of the relevant European regulatory and ethical frameworks and the fundamental ethical principles they put forward for biomedical research and therapy, including the development and use of HTEPs. We have restricted our survey of the ethical and legal documents to documents issued by the European Union, the Council of Europe and the European Group on Ethics. Guidance and regulations are also being developed outside the EU. These documents provide useful information, but we have opted not to include them in this paper. In a third chapter we concentrate on four approaches to the ethical evaluation of TE and HTEPs and investigate the ethical questions that each of these four fields raises with respect to TE and HTEPs. These fields are: (1) the anthropological perspective, (2) social and economic concerns, (3) HTEPs and TE as examples of regenerative medicine and (4) the development of specific HTEPs. We have chosen this approach in order to make the discussion more transparent, although we are aware that these four fields influence each other, and that this methodology has some limitations. We are also aware that TE is rapidly developing and that many of the ethical concerns can not yet be fully envisioned.