Brussels, 20 Apr 2004
A European expert group has published 25 recommendations on the ethical, legal and social implications of genetic testing. The recommendations include a call for screening for rare diseases, as well as a regulatory framework outlining when such tests should be carried out, and for what purpose the results should be used.
The recommendations will form the basis for a conference, to be held on 6 and 7 May in Brussels. The event will provide an opportunity to assess whether or not the recommendations, which are described as both a 'code of conduct' and an 'action plan', have been fully understood by the stakeholders, and whether all fields have been adequately addressed.
The deciphering of the human genome in 2001 opened the door to tailored treatment and the potential development of new drugs to treat genetic disorders. Today, a range of genetic tests has already been developed, and the possibility of genetic testing is having a significant impact on the methodologies and strategies employed in medical therapy and healthcare.
As ethical, legal and social issues accompany these new medical applications, the European Commission saw a need for 'careful reflection' and 'an appropriate strategy [...] to ensure the maximum potential of healthcare innovation.'
The expert group created by the Commission brought together representatives from the industry that produces and uses genetic tests, non-governmental organisations (NGOs), scientists and academics specialised in law, philosophy, ethics and medicine. UK MEP Eryl McNally chaired the group.
All members of the group shared the view that 'genetic testing represents progress in healthcare and an opportunity with the potential to lead to developments in preventive medicine.' They also recognised that 'there is no progress without cost and investment' and 'all progress has both positive and negative implications'.
The recommendations are listed under three headings: 'general framework'; 'implementation of genetic testing in healthcare systems'; and 'genetic testing as a research tool'.
The general recommendations include the need for a global consensus on a definition of genetic testing. The European Commission should consider taking the initiative on this topic, the paper states. Recommendations in this section also take account of the need to monitor public perceptions of genetic testing, provide clear information on the tests and all related issues, and to reinforce this effort at education with school curricula.
Under the heading 'implementation of genetic testing in healthcare systems', the expert group makes recommendations which would ensure that genetic testing is always available to patients, but that undergoing such tests is a matter of personal choice. The expert group also calls for a regulatory framework to assure standards of quality, and clear guidelines on data protection, confidentiality and privacy. Diagnostic testing for rare genetic diseases is highlighted as a 'matter of urgency', and the group therefore recommends 'an EU-level incentive system for the systematic development of genetic tests for rare diseases be created and financially supported.'
On the use of genetic testing as a research tool, the expert group is very strict. Action should be 'taken by Member States to ensure that approval by a competent review committee is obtained before research is undertaken.' The paper also suggests that the European Commission evaluates the need for harmonised standards for research involving the use of human samples, and that the Commission funds research into the ethical and social aspects of human genetic research.
Members of the expert group will present each of the recommendations at the conference, and stakeholders will be invited to respond. Speakers also include EU Research Commissioner Philippe Busquin, US ethics expert Arthur Caplan, the chair of the German Ethics Council Spiro Simitis, and representatives from NGOs and industry across Europe.
For further information on the event and the recommendations, please visit: