European Parliament adopts human tissue directive 17/12/03. By the Public Health Genetics Unit The European Directive 'setting standards of quality and safety for the donation, procurement, testing, processing, storage, distribution and preservation of human tissues and cells' is nearing the end of its progress through the EU’s decision-making process.

As reported in March and June 2003, the draft Directive had been subject to attempts by some members of the Parliament to use it to ban embryonic stem-cell research and tissue transplants involving material derived from embryonic stem cells. This ban, had it succeeded, would have been binding on all member states. However the Council of Ministers and the Parliament have now reached agreement on a text that excludes these contentious provisions; the amended text was adopted by the Parliament on 16 December and is expected to be approved by the Council.

The UK is likely to adopt the legislation early in 2004 and it would come into force in 2005.

The Council did accept some of Parliament’s amendments to the Directive, including a ban on direct payment for tissue donations (apart from reasonable compensation for expenses and inconvenience), and adoption of traceability requirements that will mean records will have to be kept for at least 30 years after clinical use of the tissue. Tissue recipients will not be told the identity of the donor, though member states can relax this requirement in the case of donated gametes.

All establishments involved in cell or tissue therapy will be placed on a register and will have to show that they adhere to strict criteria for quality control, professional training and record-keeping.

Article courtesy of the Public Health Genetics Unit .

Image credit: Yorgos Nikas