BioWorld International Correspondent
BRUSSELS, Belgium - The European Parliament is returning this week to the proposed European Union rules on the use of human tissues and cells - and it is determined to tighten up the draft legislation. Member state ministers in the EU's Health Council have been urging a dilution of the original proposals, particularly in respect to ethics, and that has angered the Parliament.
Consequently, the Parliament's health and consumer affairs committee is likely this week to adopt a strongly worded text insisting on the need for caution and control. The draft up for discussion stresses that "reprogrammed differentiated cells and genetically modified tissues or cells for human therapy" pose "regulatory problems that will need to be addressed."
The text before the committee accepts that the transplantation of tissues and cells "is a strongly expanding field of medicine, offering great opportunities for the treatment of, as yet, incurable diseases," but goes on to warn that "the potential in this area is occasionally assessed too enthusiastically." It also demands that more attention should be given in the new rules to eliminate "unacceptable risks for donors and recipients."
"It is equally important for fundamental ethical principles to be observed," it adds.
It adopts a supportive attitude to some member states' reticence on new techniques - particularly the traditionally Catholic countries of southern Europe: Italy has already expressed deep reservations over the use of embryonic stem cells, for instance. The text says they should be allowed not only to ban the use of such techniques, but also to prohibit imports of cells or tissues derived via methods or from sources that offend national sensitivities.
And it seeks "for ethical reasons, and for reasons connected with the high risks of a medical nature connected with human cloning" an EU-wide ban on the use of tissues and cells of hybrids derived from germ cells or totipotent cells of human and animal origin.
The Euro-MP in charge of piloting the subject through the Parliament, Pieter Liese, is a medical doctor in Germany, who habitually takes a more moderate stance than some of his anti-industry and anti-science colleagues in the Parliament. But now he, too, is angry: Liese said the member states' dismissive attitude to ethical considerations is not just "disappointing" but also "devastating."
The draft text is, however, not entirely hostile to the idea of industrial development. Even if it remarks that there is no EU consensus as to whether - and in what circumstances - embryonic stem cells may be processed, it does clearly state that the processing of adult stem cells and of stem cells from the umbilical cord "is legal and ethically noncontroversial in all the member states." It also urges that "alternative solutions to the use of embryonic stem cells should be specifically promoted by the European Union" and that "obstacles to the processing of adult stem cells and stem cells from the umbilical cord should be removed."