91997E4194

WRITTEN QUESTION P-4194/97 by Hiltrud Breyer (V) to the Commission (14 January 1998)

Subject: Computer-chip genetic diagnosis

1. Is the Commission aware that, in the USA, computer-chip genetic diagnosis systems are now commercially available? These enable complex genetic information necessary for the diagnosis of genetic diseases and susceptibility to be obtained in a very short space of time, without the need for extensive laboratory facilities and with a hitherto unmatched degree of accuracy.

2. Is the Commission aware that this technology enables genetic profiles to be drawn up even without detailed knowledge of molecular genetics and without qualified medical or psychological advice?

3. Is the Commission aware that, in 1997, several large European pharmaceutical companies concluded agreements with the US company Affymetrix Inc., of Santa Clara, California, relating to the use of this technology?

4. Is the Commission aware that one of these agreements also provides for the use, for research purposes, of genetic polymorphs which are linked to sensitivity to certain chemicals in the workplace?

5. Does the Commission consider that this sensitive technology should be introduced into Europe without any rules on authorization and application or on the protection of genetic information?

6. What action is the Commission intending to take in order to prevent, in particular, genetic discrimination against certain groups of people, for instance through the use of such technology by employers or insurance companies?

Answer given by Mrs Cresson on behalf of the Commission (17 February 1998)

1. and 2. The Commission is aware of scientific publications concerning the chip-bound diagnostic system and its possible uses. It is also aware of the ethical implications arising from such device. The importance of the issue has been enhanced by the Opinion No 6 ((Doc. of 20.2.96 'Ethical aspects of PND'. )) of the group of advisers on the ethical implications of biotechnology (GAEIB) as far as the specific case of prenatal diagnosis (PND) is concerned.

3. The Commission has no information on European pharmaceutical companies which may have concluded agreements with American companies for the use of this technology.

4. This technology can be used not only to detect sensitivity to certain chemicals and therefore prevent exposing workers to risks of toxic contamination, but also to screen out patients who are less likely to respond to drugs in order better to target patients and reduce side effects.

5. and 6. Relevant diagnostic systems may be covered by the forthcoming directive relating to in vitro diagnostic medical devices. This proposal ((OJ C 87, 18.3.1997. )) is currently at the stage of first reading following the co-decision procedure. The directive will regulate the performance required for such medical devices in view of their intended medical purpose. However, it will not stipulate conditions of use and possible restrictions. These aspects remain covered by national legislation.

The Commission will, however, closely follow the legal and ethical aspects of potential genetic discrimination through its research programmes.