Legislation on direct-to-consumer genetic testing in seven European countries

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 avai...

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Egile Nagusiak: Borry, P, Van Hellemondt, R, Sprumont, D, Jales, C, Rial-Sebbag, E, Spranger, T, Curren, L, Kaye, J, Nys, H, Howard, H
Formatua: Journal article
Hizkuntza:English
Argitaratua: 2012
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author Borry, P
Van Hellemondt, R
Sprumont, D
Jales, C
Rial-Sebbag, E
Spranger, T
Curren, L
Kaye, J
Nys, H
Howard, H
author_facet Borry, P
Van Hellemondt, R
Sprumont, D
Jales, C
Rial-Sebbag, E
Spranger, T
Curren, L
Kaye, J
Nys, H
Howard, H
author_sort Borry, P
collection OXFORD
description 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. © 2012 Macmillan Publishers Limited All rights reserved.
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spelling oxford-uuid:f1a126a4-197f-4c9a-b6ec-e92e7f8900632022-03-27T11:57:30ZLegislation on direct-to-consumer genetic testing in seven European countriesJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:f1a126a4-197f-4c9a-b6ec-e92e7f890063EnglishSymplectic Elements at Oxford2012Borry, PVan Hellemondt, RSprumont, DJales, CRial-Sebbag, ESpranger, TCurren, LKaye, JNys, HHoward, HAn 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. © 2012 Macmillan Publishers Limited All rights reserved.
spellingShingle Borry, P
Van Hellemondt, R
Sprumont, D
Jales, C
Rial-Sebbag, E
Spranger, T
Curren, L
Kaye, J
Nys, H
Howard, H
Legislation on direct-to-consumer genetic testing in seven European countries
title Legislation on direct-to-consumer genetic testing in seven European countries
title_full Legislation on direct-to-consumer genetic testing in seven European countries
title_fullStr Legislation on direct-to-consumer genetic testing in seven European countries
title_full_unstemmed Legislation on direct-to-consumer genetic testing in seven European countries
title_short Legislation on direct-to-consumer genetic testing in seven European countries
title_sort legislation on direct to consumer genetic testing in seven european countries
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