BRUSSELS, Belgium - European Research Commissioner Edith Cresson has confirmed that the European Union (EU) is aware of ethical implications arising from chip-bound diagnostic technology and said the commission will “closely follow its legal and ethical aspects.“
Cresson's comment came as she was responding to questions from German Euro-MP Hiltrud Breyer on the possible dangers of unregulated commercial availability in Europe of computerized gene-based diagnostic systems.
Breyer asked how the commission planned to react to a technology that “enables genetic profiles to be drawn up even without detailed knowledge of molecular genetics and without qualified medical or psychological advice“ - particularly since several large European pharmaceutical companies last year concluded agreements with Affymetrix Inc., of Santa Clara, Calif., which focuses on the use of gene-chip technology.
Cresson said the commission had no information about European companies using the technology, which, she noted, has some positive aspects, since it can be used to screen out patients who are less likely to respond to drugs, thus better targeting patients and reducing side effects.
She acknowledged that the importance of the issue had already been identified in a 1996 opinion on prenatal diagnosis from the EU's group of advisers on the ethical implications of biotechnology. The gene-chip system may be covered by the EU's forthcoming directive on in vitro diagnostic medical devices, but this will regulate only the performance required for such medical devices in view of their intended medical purpose, and will not stipulate conditions of use and possible restrictions (which will remain covered by national legislation), Cresson said. - Peter O'Donnell