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Stem cell compromise

Euro Parliament adopts tissue and cell law without a ban use of cloned cells

December 17, 2003
Stephen Pincock
The Scientist Inc

The European Parliament has voted in new legislation covering the safety and quality of human tissues and cells for medical use, rejecting proposals to forbid the clinical application of cells generated by cell nuclear replacement.

The directive sets safety and quality standards for tissues and cells used clinically, but does not cover their research use.

David Byrne, Health and Consumer Protection commissioner, welcomed the move. “Soon we will have comprehensive European legislation to guarantee the safety and quality of human tissues and cells,” he said in a statement. “This is good news for patients throughout the European Union.”

The European Parliament and Council had earlier agreed on a package of compromise amendments regarding the donation, procurement, testing, processing, preservation, storage, and distribution of human tissues and cells.

“Regarding cloned human embryos, it was agreed that existing legislation in the member states should remain into force,” according to an official parliament statement. “This directive does not interfere with these states' decisions concerning the use or non-use of any specific type of human cells, including germ cells and embryonic stem cells.”

The final deal is a compromise, replacing an earlier amendment that had demanded that cloned human embryos and human–animal hybrid embryos produced by cloning or other procedures should be excluded as sources of material for transplantation.

This could not be accepted by the council, made up of ministers from member states, so the parliament accepted another less stringent amendment that was adopted with 503 votes in favor, 42 against, and 12 abstentions.

Simon Festing, from the UK's Association of Medical Research Charities, expressed relief that the compromise was passed.

“The tissues and cells directive never had anything to do with trying to regulate stem cell research… but it was in effect hijacked by pro-life groups in the European Union,” he told The Scientist. “That threat essentially evaporated in the days leading up to the vote.”

The directive will take force after being ratified by the council. Considering that the compromise directive was agreed on by the council, parliament, and commission, “everything we understand is that it should sail through,” Festing said.

The compromise deal was also applauded by Britain's BioIndustry Association (BIA), the group that represents British bioscience companies.

“Research using embryos created by CNR [cell nuclear replacement] is permitted in the UK, and it is critical that this work continues under proper regulation where it is allowed by national legislation,” said Aisling Burnand, BIA chief executive, in a statement. “The principle of subsidiarity on this issue is essential, and the BIA welcomes the parliament's resounding support.”

Other issues in the bill included an agreement that member states should try to ensure voluntary and unpaid donations of tissues and cells. The directive also calls for tissue establishments to keep the data needed to trace tissues at all stages for a minimum of 30 years after clinical use.

The parliament also supported amendments that permit public and private sector tissue banks to operate alongside each other under the same set of rules. A spokesman for the UK Biobank told The Scientist: “At this point, we are looking into the implications of the directive for the project.”

Copyright © 2003, The Scientist Inc.