BioWorld International Correspondent

BRUSSELS, Belgium - The European Union is on the brink of deciding on new controls on therapies derived from human tissues and cells, explicitly including starting materials for tissue- and cell-derived manufactured products.

The consequence will be additional regulation for many biotechnology companies in Europe, and for the tissue banks and distribution channels on which many of them rely. The proposal will, the EU acknowledges, have implications for the tissue-engineering products industry.

The European Commission today is launching its proposal for a directive "setting standards of quality and safety for the donation, procurement, testing, processing, storage and distribution of human tissues and cells." The 60-page proposal prescribes measures ranging from data protection to tissue-bank licensing, and from donor selection to staff training and the importation of tissues into the EU.

Its justification is that "each year in Europe, hundreds of thousands of patients undergo some form of therapeutic treatment based on the use of tissues and cells of human origin," going beyond traditional transplants and implants, "as the basis for services or products derived through biotechnology." The advances in biotechnology, it points out, have resulted in cultured allogeneic cells, engineered structural tissues and constituent parts of medical devices, and "in order to increase public confidence," and since "they can transmit diseases," it is "essential that EU provisions should ensure their quality and safety."

Many EU member states have adopted national legislation to control the ethical aspects of donor protection, but "many have yet to agree upon rules covering quality, safety or the use of tissues and cells." Specific rules for the authorization and inspection of tissue procurement and banking activities are lacking in the majority, the Commission said. The Commission suggests, for instance, that member states should "encourage nonprofit tissue banks, without introducing a strict legal obligation."

The new rules are not intended to apply where tissues and cells are to be used for other purposes than direct transplantation, such as for production of antitumoral vaccines or "therapies where the objective is not to recover a function by transplanting equivalent cells or tissues." But the currently excluded areas remain under review, it said. "These new therapeutic approaches require different, and very specific, processing standards, which cannot be established now since the associated risks are still under investigation."

The Commission proposal ducks the ethical issues that continue to plague EU discussion of rules on sensitive aspects of biotechnology. It notes that "germ cells, fetal cells/tissues and embryonic stem cells pose particular ethical concerns," but since "there is no consensus among member states upon which basic harmonized decisions at EU level can be taken with regard to their use or prohibition," the EU will not attempt at present to regulate that aspect, or to require any member state to go further than it has already agreed in its use of such products. "This proposal does not interfere with decisions made by member states concerning the use or non-use of any specific type of human cells, including germ cells and embryonic stem cells." Instead, the Commission said its proposed new rules will apply only if a particular application of those cells is accepted in a member state.