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

Kalokairinou, L.; Howard, H. C.; Slokenberga, S.; Fisher, E.; Flatscher-Thöni, M.; Hartlev, M.; Van Hellemondt, R.; Juškevičius, J.; Kapelenska-Pregowska, J.; Kováč, P.; Lovrečić, L.; Nys, H.; De Paor, A.; Phillips, A.; Prudil, L.; Rial-Sebbag, E.; Romeo Casabona, Carlos María; Sándor, J.; Schuster, A.; Soini, S.; Søvig, K. H.; Stoffel, D.; Titma, T.; Trokanas, T.; Borr, P.

dc.contributor.author	Kalokairinou, L.
dc.contributor.author	Howard, H. C.
dc.contributor.author	Slokenberga, S.
dc.contributor.author	Fisher, E.
dc.contributor.author	Flatscher-Thöni, M.
dc.contributor.author	Hartlev, M.
dc.contributor.author	Van Hellemondt, R.
dc.contributor.author	Juškevičius, J.
dc.contributor.author	Kapelenska-Pregowska, J.
dc.contributor.author	Kováč, P.
dc.contributor.author	Lovrečić, L.
dc.contributor.author	Nys, H.
dc.contributor.author	De Paor, A.
dc.contributor.author	Phillips, A.
dc.contributor.author	Prudil, L.
dc.contributor.author	Rial-Sebbag, E.
dc.contributor.author	Romeo Casabona, Carlos María
dc.contributor.author	Sándor, J.
dc.contributor.author	Schuster, A.
dc.contributor.author	Soini, S.
dc.contributor.author	Søvig, K. H.
dc.contributor.author	Stoffel, D.
dc.contributor.author	Titma, T.
dc.contributor.author	Trokanas, T.
dc.contributor.author	Borr, P.
dc.date.accessioned	2018-12-14T13:59:57Z
dc.date.available	2018-12-14T13:59:57Z
dc.date.issued	2018-04
dc.identifier.citation	Journal of Community Genetics 9(2) : 117-132 (2018)	es_ES
dc.identifier.issn	1868-310X
dc.identifier.issn	1868-6001
dc.identifier.uri	http://hdl.handle.net/10810/30364
dc.description.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.	es_ES
dc.description.sponsorship	This study has not received any funding, but has benefited from interactions within the COST Action IS1303 'Citizen's Health through public-private Initiatives: Public health, Market and Ethical perspectives', supported by COST (European Cooperation in Science and Technology) (http://www.cost.eu).	es_ES
dc.language.iso	eng	es_ES
dc.publisher	Springer	es_ES
dc.rights	info:eu-repo/semantics/openAccess	es_ES
dc.rights.uri	http://creativecommons.org/licenses/by/3.0/es/	*
dc.subject	direct-to-consumer genetic tests	es_ES
dc.subject	regulation	es_ES
dc.subject	in vitro diagnostic medical devices	es_ES
dc.subject	medical supervision	es_ES
dc.subject	genetic counselling	es_ES
dc.subject	informed consent health	es_ES
dc.subject	genomics	es_ES
dc.subject	purposes	es_ES
dc.subject	issues	es_ES
dc.subject	legal	es_ES
dc.title	Legislation of direct-to-consumer genetic testing in Europe: a fragmented regulatory landscape	es_ES
dc.type	info:eu-repo/semantics/article	es_ES
dc.rights.holder	This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.	es_ES
dc.rights.holder	Atribución 3.0 España	*
dc.relation.publisherversion	https://link.springer.com/article/10.1007%2Fs12687-017-0344-2	es_ES
dc.identifier.doi	10.1007/s12687-017-0344-2
dc.departamentoes	Derecho publico	es_ES
dc.departamentoeu	Zuzenbide publikoa	es_ES

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This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

Except where otherwise noted, this item's license is described as This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.