WRITTEN QUESTION No. 4194/97 by Hiltrud BREYER to the Commission. Computer-chip genetic diagnosis
Date: 1998-01-14
Institutions: BREYER, European Parliament
Subjects: bio-ethics, biotechnology, electronic component, genetics, medical diagnosis, new technology

16. 6. 98

EN

Official Journal of the European Communities

C 187/137

(98/C 187/210)

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.

Is the Commission aware that this technology enables genetic profiles to be drawn up even without detailed

2.
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?

Is the Commission aware that one of these agreements also provides for the use, for research purposes, of

4.
genetic polymorphs which are linked to sensitivity to certain chemicals in the workplace?

Does the Commission consider that this sensitive technology should be introduced into Europe without any

5.
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 (1)  of  the  group  of  advisers  on  the  ethical  implications  of
biotechnology (GAEIB) as far as the specific case of prenatal diagnosis (PND) is concerned.

The Commission has no information on European pharmaceutical companies which may have concluded

3.
agreements with American companies for the use of this technology.

This  technology  can  be  used  not  only  to  detect  sensitivity  to  certain  chemicals  and  therefore  prevent
4.
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.

Relevant  diagnostic  systems  may  be  covered  by  the  forthcoming  directive  relating  to  in  vitro
5. and 6.
diagnostic medical devices. This proposal (2) 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.

(1)  Doc. of 20.2.96 (cid:145)Ethical aspects of PND(cid:146).
(2)  OJ C 87, 18.3.1997.