Title: Legislation on direct-to-consumer genetic testing in seven European countries
Authors: Borry, Pascal ×
van Hellemondt, Rachel E
Sprumont, Dominique
Jales, Camilla Fittipaldi Duarte
Rial-Sebbag, Emmanuelle
Spranger, Tade Matthias
Curren, Liam
Kaye, Jane
Nys, Herman
Howard, Heidi #
Issue Date: Jul-2012
Publisher: Karger
Series Title: European Journal of Human Genetics vol:20 issue:7 pages:715-721
Article number: 10.1038/ejhg.2011.278
Abstract: An increasing number of private companies are now offering direct-to-consumer (DTC) genetic testing services. Although a lot of attention has been devoted to the regulatory framework of DTC genetic testing services in the USA, only limited information about the regulatory framework in Europe is available. We will report on the situation with regard to the national legislation on DTC genetic testing in seven European countries (Belgium, the Netherlands, Switzerland, Portugal, France, Germany, the United Kingdom). The paper will address whether these countries have legislation that specifically address the issue of DTC genetic testing or have relevant laws that is pertinent to the regulatory control of these services in their countries. The findings show that France, Germany, Portugal and Switzerland have specific legislation that defines that genetic tests can only be carried out by a medical doctor after the provision of sufficient information concerning the nature, meaning and consequences of the genetic test and after the consent of the person concerned. In the Netherlands, some DTC genetic tests could fall under legislation that provides the Minister the right to refuse to provide a license to operate if a test is scientifically unsound, not in accordance with the professional medical practice standards or if the expected benefit is not in balance with the (potential) health risks. Belgium and the United Kingdom allow the provision of DTC genetic tests.European Journal of Human Genetics advance online publication, 25 January 2012; doi:10.1038/ejhg.2011.278.
ISSN: 1018-4813
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Interfaculty Centre for Biomedial Ethics and Law
× corresponding author
# (joint) last author

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