Malaga, 08/02/2002 (Agence Europe) - Spanish Minister for Health Celia Villalobos said, on Thursday evening during the closing session of the meeting of experts on the therapeutic use of human cells and tissues, that Member States' representatives had managed to sketch out the broad lines of a future directive. Director for Health at the European Commission Fernand Sauer specified that the proposal of directive will be on the Council of Ministers' table on 26 June, for a first discussion.
On the model of the directive on blood and blood products, the future directive will be based on Article 152 of the Treaty and should guarantee a high level of quality and security for all human cells and tissue intended for transplant. It will above all cover skin, epithelial cells, the cornea, hematopoietic cells, the blood cells of the umbilical cord, bone tissue and cells, islets of Langerhans, muscles and tendons, tissue, blood vessels and cardiovascular valves. There will only be exclusion of organs, whose removal and transplant meet other criteria, mainly because of their short conservation time, and blood and blood-derived products already covered. Experts from the Member States agreed that the products derived from tissue and cells, through biotechnology, should be covered by a specific directive that the Commission should propose as soon as possible. They also recognised that the directive should establish high security and quality standards for the removal, analysis, preservation, storage and distribution of tissue and cells. The text should be presented in the form of a framework directive with annexes identifying standards to be reviewed periodically in order to take scientific progress into account. In order to guarantee respect of these norms, the future directive should foresee criteria for the approval of sampling centres and tissue and cell banks, and training standards. In order to ensure traceability, it will introduce a system of information exchange and the obligation to keep a register allowing for data to be kept for a period of 30 years. An inspection mechanism should also ensure that regular inspections are carried out.
The directive should also reaffirm a certain number of principles on confidentiality, the promotion of donations and free donations. It is a question of guaranteeing the protection of data on the origin of the samples taken and the result of analyses in particular, not only for the donor but also for the person to receive the graft, with exception being made of auto-grafts and, as far as tests are concerned, when a risk is suspected for either the receiver or for public health. Promotion of donations should be reserved for public bodies, and the donation should be free and willingly consented. Adequate donor information will also be foreseen in order to guarantee consent in full knowledge of the facts. Tissue banks should be non-profit making institutions. This provision is particularly important as commercial enterprises, often subsidiaries of American companies, have already begun to collect umbilical cord cells on the territory of certain Member States, in exchange for payment. The discussion of experts showed that there are still differences of approach on these ethical principles, but a majority tendency seems to be arising for public management of tissue and cell banks.