Brussels, 11 December 2002
OPINION of the European Economic and Social Committee on the Proposal for a Directive of the European Parliament and of the Council setting standards of quality and safety for the donation, procurement, testing, processing, storage, and distribution of human tissues and cells ( COM(2002) 319 final - 2002/0128 COD)
This specific directive is urgent, and the measures chosen are necessary and coherent, as reflected by the regulatory approach taken. Moreover, this trade in tissues and cells is based on fundamental principles: the anonymity of the donor, the voluntary nature of the donation, the solidarity implied, the fact that no price tag can be attached to these human body parts.
The EESC would make the same comment as the Commission: in view of extremely rapid scientific developments in these areas, provision must be made for the text to be updated regularly, to take account of proven scientific progress, while upholding the principle of coherence.
It would make sense to incorporate within the Directive a compulsory "procedural authorisation" for the preparation of a given type of product (tissue/cell), describing procedures and/or practices, by product type, for all stages, from retrieval to distribution. This authorisation would provide a guarantee of the safety and quality of transplants.
Give a clear definition of the responsibility of each of the players
Responsibility for the transfer of a product (tissue/cells) usually lies with the tissue bank. Responsibility for the health and safety of a product can, however, fall into three areas:
health establishment, site of retrieval or collection: selection of potential donor, technical and health conditions, traceability and biomonitoring; tissue bank or cell therapy unit: preparation process, microbiological tests (transmissible diseases, bacteria, etc.), biological and functional validation, traceability and biomonitoring; transplant surgeon: risk/benefit analysis in the light of the health profile of the product and the vital urgency for the patient, traceability.
Provision should be made for a Europe-wide agreement between healthcare establishments that supply and/or use tissues (likewise for cell therapy units and healthcare establishments).
The appendices are an integral part of the Directive, but there is a risk that their regular updating could be hindered for administrative reasons. For this reason, the EESC believes that Article 29 should mention the regular modification of these appendices to take account of scientific progress, and make it obligatory to update.