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

Despite the increasing availability of direct-to-consumer (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...

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Autores principales: 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, C. M., Sándor, J., Schuster, A., Soini, S., Søvig, K. H., Stoffel, D., Titma, T., Trokanas, T., Borry, P.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5849704/
https://www.ncbi.nlm.nih.gov/pubmed/29150824
http://dx.doi.org/10.1007/s12687-017-0344-2
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author 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, C. M.
Sándor, J.
Schuster, A.
Soini, S.
Søvig, K. H.
Stoffel, D.
Titma, T.
Trokanas, T.
Borry, P.
author_facet 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, C. M.
Sándor, J.
Schuster, A.
Soini, S.
Søvig, K. H.
Stoffel, D.
Titma, T.
Trokanas, T.
Borry, P.
author_sort Kalokairinou, L.
collection PubMed
description Despite the increasing availability of direct-to-consumer (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.
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spelling pubmed-58497042018-03-21 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, C. M. Sándor, J. Schuster, A. Soini, S. Søvig, K. H. Stoffel, D. Titma, T. Trokanas, T. Borry, P. J Community Genet Original Article Despite the increasing availability of direct-to-consumer (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. Springer Berlin Heidelberg 2017-11-18 2018-04 /pmc/articles/PMC5849704/ /pubmed/29150824 http://dx.doi.org/10.1007/s12687-017-0344-2 Text en © The Author(s) 2017 Open Access 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.
spellingShingle Original Article
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, C. M.
Sándor, J.
Schuster, A.
Soini, S.
Søvig, K. H.
Stoffel, D.
Titma, T.
Trokanas, T.
Borry, P.
Legislation of direct-to-consumer genetic testing in Europe: a fragmented regulatory landscape
title Legislation of direct-to-consumer genetic testing in Europe: a fragmented regulatory landscape
title_full Legislation of direct-to-consumer genetic testing in Europe: a fragmented regulatory landscape
title_fullStr Legislation of direct-to-consumer genetic testing in Europe: a fragmented regulatory landscape
title_full_unstemmed Legislation of direct-to-consumer genetic testing in Europe: a fragmented regulatory landscape
title_short Legislation of direct-to-consumer genetic testing in Europe: a fragmented regulatory landscape
title_sort legislation of direct-to-consumer genetic testing in europe: a fragmented regulatory landscape
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5849704/
https://www.ncbi.nlm.nih.gov/pubmed/29150824
http://dx.doi.org/10.1007/s12687-017-0344-2
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