Legislation of direct-to-consumer genetic testing in Europe : a fragmented regulatory landscape

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http://hdl.handle.net/10138/312745

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Kalokairinou , L , Howard , H C , Slokenberga , S , Fisher , E , Flatscher-Thoeni , M , Hartlev , M , van Hellemondt , R , Juskevicius , J , Kapelenska-Pregowska , J , Kovac , P , Lovrecic , L , Nys , H , de Paor , A , Phillips , A , Prudil , L , Rial-Sebbag , E , Romeo Casabona , C M , Sandor , J , Schuster , A , Soini , S , Sovig , K H , Stoffel , D , Titma , T , Trokanas , T & Borry , P 2018 , ' Legislation of direct-to-consumer genetic testing in Europe : a fragmented regulatory landscape ' , Journal of Community Genetics , vol. 9 , no. 2 , pp. 117-132 . https://doi.org/10.1007/s12687-017-0344-2

Title: Legislation of direct-to-consumer genetic testing in Europe : a fragmented regulatory landscape
Author: Kalokairinou, L.; Howard, H. C.; Slokenberga, S.; Fisher, E.; Flatscher-Thoeni, M.; Hartlev, M.; van Hellemondt, R.; Juskevicius, J.; Kapelenska-Pregowska, J.; Kovac, P.; Lovrecic, L.; Nys, H.; de Paor, A.; Phillips, A.; Prudil, L.; Rial-Sebbag, E.; Romeo Casabona, C. M.; Sandor, J.; Schuster, A.; Soini, S.; Sovig, K. H.; Stoffel, D.; Titma, T.; Trokanas, T.; Borry, P.
Contributor: University of Helsinki, Helsinki University Hospital Area
Date: 2018-04
Language: eng
Number of pages: 16
Belongs to series: Journal of Community Genetics
ISSN: 1868-310X
URI: http://hdl.handle.net/10138/312745
Abstract: Despite the increasing availability of direct-to-c onsumer (DTC)genetic testing, it is currently unclear how such services are regulated in Europe, due to the lack of EU or national legislation specifically addressing this issue. In this article, we provide an overview of laws that could potentially impact the regulation of DTC genetic testing in 26 European countries, namely Austria, Belgium, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, the Netherlands and the United Kingdom. Emphasis is placed on provisions relating to medical supervision, genetic counselling and informed consent. Our results indicate that currently there is a wide spectrum of laws regarding genetic testing in Europe. There are countries (e.g. France and Germany) which essentially ban DTC genetic testing, while in others (e.g. Luxembourg and Poland) DTC genetic testing may only be restricted by general laws, usually regarding health care services and patients' rights.
Subject: Direct-to-consumer genetic tests
Regulation
In vitro diagnostic medical devices
Medical supervision
Genetic counselling
Informed consent
HEALTH
GENOMICS
PURPOSES
ISSUES
LEGAL
3111 Biomedicine
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