title: Legislation on direct-to-consumer genetic testing in seven European countries.
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.
authors.affiliation: Centre for Biomedical Ethics and Law, Katholieke Universiteit Leuven, Leuven, Belgium. Pascal.Borry@med.kuleuven.be
authors.forename: Pascal
authors.initials: P
authors.lastname: Borry
authors.forename: Rachel E
authors.initials: RE
authors.lastname: van Hellemondt
authors.forename: Dominique
authors.initials: D
authors.lastname: Sprumont
authors.forename: Camilla Fittipaldi Duarte
authors.initials: CF
authors.lastname: Jales
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Rial-Sebbag
authors.forename: Tade Matthias
authors.initials: TM
authors.lastname: Spranger
authors.forename: Liam
authors.initials: L
authors.lastname: Curren
authors.forename: Jane
authors.initials: J
authors.lastname: Kaye
authors.forename: Herman
authors.initials: H
authors.lastname: Nys
authors.forename: Heidi
authors.initials: H
authors.lastname: Howard
mesh_terms: D000329:Advertising; D003256:Community Participation / Q000331:legislation & jurisprudence; D005060:Europe; D005817:Genetic Counseling / Q000941:ethics / Q000331:legislation & jurisprudence*; D020022:Genetic Predisposition to Disease / Q000235:genetics; D005820:Genetic Testing / Q000941:ethics / Q000331:legislation & jurisprudence* / Q000592:standards; D006291:Health Policy / Q000331:legislation & jurisprudence*; D006801:Humans; D007258:Informed Consent; D012307:Risk Factors