Brussels, 09/04/2015 (Agence Europe) - On Thursday 9 April, the European Commission adopted two sets of rules on the traceability of human tissue and cells for medical use.
As a result of progress in cellular and molecular biotechnology, transplants of tissue and cells have been constantly increasing. These new treatment prospects, however, bring about risks of the transmission of disease. In order to ensure “high quality and safety standards”, the Commission is setting in place a tracing system rapidly to identify all tissue and cells, from the donor to the recipient and vice versa, irrespective of whether the tissue and cells come from European donors or were imported from outside the EU.
The first set of rules lays down a “Single European Code”, which will provide for uniform labelling for all tissue and cells distributed within the EU, using a Commission-hosted IT platform. For instance, this will make it possible to contact all patients who have received tissue or cells from a single donor and also to identify unused tissue and cells which have to be destroyed. The Commission wants similar traceability procedures to apply to tissue and cells imported from third countries. A second raft of rules has therefore been adopted to guarantee the “same safety and quality standards”, a Commission press release states. (Jan Kordys)