Ethical advisers issue opinion on human tissue banks
The European Group on Ethics in Science and New Technologies recently adopted its first opinion, on the issues relating to "human tissue banking". The Group is concerned at the ever-increasing use of human tissues, particularly for grafting purposes, and calls on the EU to develop standards for the quality and safety of human tissue use. The Group was set up in December 1997, replacing the old Group of Advisers on the Ethical Implications of Biotechnology established in 1991. With its new widened remit, the Group can deliver opinions on the request of the Commission, Council or European Parliament, as well as on its own initiative. The human tissue banking opinion was adopted on the Group's own initiative, following concern that the huge increase in the use of human tissues in the EU has not been matched by the development of legislation on the procurement, processing, storage and use of human tissues. In particular, the Group feels that under the existing system, verification of the origin of tissues is uncertain. The Group stresses that safety is an ethical imperative, and recommends the establishment of Community standards for quality and safety. In addition, it calls for the creation of a European health protection structure, in coordination with the European Agency for the Evaluation of Medicinal Products. In tandem with these proposals, the Group calls for strict controls on the activities of all tissue banks, which should require licensing throughout the EU. Such banks should in particular ensure the traceability of tissues, allowing the identification of the donor and their medical conditions where problems occur. The ethics of donations must be safeguarded according to the group, which opposes the principle of paying donors, although donors should be reimbursed for expenses related to their donation. Donors, and recipients of grafts, should remain anonymous, and they and their families are entitled to protection of their private life. In all cases, donors should give their consent prior to any donation, on the basis of national rules. Finally, the Group calls for regular studies to be undertaken, at EU level, on detailed procedures for the donation, storage and distribution of tissues. These studies should also look at the conditions for the import of tissues from third countries. The Group calls for greater transparency in the activities of tissue banks, in order to ensure the equitable distribution of tissues, on the basis of criteria relating to urgency and medical need, linked to Europe's public health objectives.