New EU legislation sets common standards for human cells and tissues

Brussels, 04 Mar 2004

After 18 months debate, the Council of Ministers has adopted a directive on common standards for the medical use of human cells and tissues, leaving ethical matters up to national governments.

The rules cover the donation of eggs, sperm and other tissue, but do not apply to blood or organ donations. Blood is covered by a different EU legislation while organs fall under the responsibility of Member States.

'This is positive news for hundreds of thousands of patients in Europe,' declared Health and Consumer Protection Commissioner David Byrne. 'Patients can now be sure that human tissues and cells derived from donations in another Member State nonetheless carry the same guarantees as those in their own country.'

Rules governing the use of stem cells harvested from human embryos will continue to come under the control of individual governments. Countries such as Italy, Spain and Ireland oppose stem cell technology as it often uses aborted embryos.

Concerned that payment would encourage trade in body parts, the same countries requested that under the new legislation, donors will not be paid for cells and tissues although they can claim expenses and loss of earnings.

Member states will have two years to implement the Directive.

Europe's biotechnology industry has welcomed the adoption of the Directive. Erwan Gicquel from Europabio, the European Association for Bioindustries, stated: 'It's a first step to ensure quality and safety in getting human cells or tissues for whatever its (end)-use.'

CORDIS RTD-NEWS / © European Communities