Brussels, 04 Jun 2003
EU health ministers have reached a political agreement on the proposed directive setting quality and safety standards for the donation, procurement, testing, storage and distribution of human tissues and cells.
During the Health Council's meeting on 2 June, ministers rejected amendments made to the proposal by the MEPs in April, prohibiting research on human cloning for reproductive purposes and research designed to create human embryos solely for research purposes or to supply stem cells.
Instead, ministers agreed that the proposal's provisions should only be applicable to 'those cells and tissues that are applied to the human body in clinical trials. Tissues and cells used for other research purposes, i.e. in vitro research or in animal models, are not covered by the proposed Directive.'
In an effort to calm fears among some delegations regarding the ethical implications of the directive, the Presidency noted that the provisions made at EU level will not prevent Member States from maintaining and introducing more stringent protective measures '[...] as long as they comply with the provisions of the Treaty establishing the European Communities.'
This would allow, in particular, Member States to introduce requirements for voluntary unpaid donation of tissues and cells, as well as to prohibit the donation, procurement, testing, processing, preservation, storage, distribution and use of tissues and cells from specific sources, such as embryonic origin, claimed the Presidency.
However, despite such reassurances, the German delegation stated that it was still unable to lift its parliamentary scrutiny reservation at this stage. The common position will be formally adopted at a forthcoming Council meeting, after which it will be forwarded to the European Parliament for a second reading. To read the directive proposal, please visit the following web address: http://europa.eu.int/eur-lex/en/com/pdf/ 2002/com2002_0319en01.pdf