Rapid advances in medicine have made the possibility of the bionic man a probability. Procedures now exist whereby damaged human tissue can be repaired or regenerated using cell and molecular biotechnology (see Links dossier 16 Feb 2005).
Work in this area is not currently controlled at EU level and the Commission now sees the need for regulation to ensure the rapid, safe and supervised advancement of this technology. It has produced a report and draft regulation on which it invites comments from all interested parties by 20 June 2005.
The draft proposes a centralised marketing procedure, an expert committee to assess products and risk management requirements. Ethical decisions on the use of human cells will remain within member state competence but the EU level measures will be designed to respect fundamental human rights and the dignity of individuals.
