Legislation of Direct-to-Consumer Genetic Testing in Europe: A Fragmented Regulatory Landscape

Louiza Kalokairinou; Heidi C Howard; Santa Slokenberga; Carlos María Romeo-Casabona; Eva Fischer; Magdalena Flatscher-Thöni; Mette Hartlev; R. van Hellemondt; J. Juskevicius; J. Kapelenska-Pregowska; P. Kovac; L. Lovrecic; H. Nys; A.  de Paor; A. Phillips; L. Prudil; E. Rial-Sebbag; C.M. Romeo Casabona; J. Sandor; A. Schuster; S. Soini; K.H. Søvig; D. Stoffel; T. Titma; T. Trokanas; P. Borry

doi:10.1007/s12687-017-0344-2

Legislation of Direct-to-Consumer Genetic Testing in Europe: A Fragmented Regulatory Landscape

Louiza Kalokairinou, Heidi C Howard, Santa Slokenberga, Carlos María Romeo-Casabona, Eva Fischer, Magdalena Flatscher-Thöni, Mette Hartlev, R. van Hellemondt, J. Juskevicius, J. Kapelenska-Pregowska, P. Kovac, L. Lovrecic, H. Nys, A. de Paor, A. Phillips, L. Prudil, E. Rial-Sebbag, C.M. Romeo Casabona, J. Sandor, A. SchusterS. Soini, K.H. Søvig, D. Stoffel, T. Titma, T. Trokanas, P. Borry

WELMA - Center for Retlige Studier i Velfærd og Marked

36 Citationer (Scopus)

Abstract

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.

Originalsprog	Engelsk
Tidsskrift	Journal of Community Genetics
Vol/bind	9
Udgave nummer	2
Sider (fra-til)	117-132
Antal sider	16
ISSN	1868-310X
DOI	https://doi.org/10.1007/s12687-017-0344-2
Status	Udgivet - 2018

Emneord

Direct-to-consumer genetic tests
Genetic counselling
In vitro diagnostic medical devices
Informed consent
Medical supervision
Regulation

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10.1007/s12687-017-0344-2

s12687-017-0344-2.pdfForlagets udgivne version, 575 KBLicens: CC BY

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Kalokairinou, L., Howard, H. C., Slokenberga, S., Romeo-Casabona, C. M., Fischer, E., Flatscher-Thöni, M., Hartlev, M., Hellemondt, R. V., Juskevicius, J., Kapelenska-Pregowska, J., Kovac, P., Lovrecic, L., Nys, H., de Paor, A., Phillips, A., Prudil, L., Rial-Sebbag, E., Casabona, C. M. R., Sandor, J., ... Borry, P. (2018). Legislation of Direct-to-Consumer Genetic Testing in Europe: A Fragmented Regulatory Landscape. Journal of Community Genetics, 9(2), 117-132. https://doi.org/10.1007/s12687-017-0344-2

Kalokairinou, L, Howard, HC, Slokenberga, S, Romeo-Casabona, CM, Fischer, E, Flatscher-Thöni, M, Hartlev, M, Hellemondt, RV, Juskevicius, J, Kapelenska-Pregowska, J, Kovac, P, Lovrecic, L, Nys, H, de Paor, A, Phillips, A, Prudil, L, Rial-Sebbag, E, Casabona, CMR, Sandor, J, Schuster, A, Soini, S, Søvig, KH, 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, bind 9, nr. 2, s. 117-132. https://doi.org/10.1007/s12687-017-0344-2

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abstract = "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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AU - Kalokairinou, Louiza

AU - Howard, Heidi C

AU - Slokenberga, Santa

AU - Romeo-Casabona, Carlos María

AU - Fischer, Eva

AU - Flatscher-Thöni, Magdalena

AU - Hartlev, Mette

AU - Hellemondt, R. van

AU - Juskevicius, J.

AU - Kapelenska-Pregowska, J.

AU - Kovac, P.

AU - Lovrecic, L.

AU - Nys, H.

AU - de Paor, A.

AU - Phillips, A.

AU - Prudil, L.

AU - Rial-Sebbag, E.

AU - Casabona, C.M. Romeo

AU - Sandor, J.

AU - Schuster, A.

AU - Soini, S.

AU - Søvig, K.H.

AU - Stoffel, D.

AU - Titma, T.

AU - Trokanas, T.

AU - Borry, P.

PY - 2018

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AB - 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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KW - Genetic counselling

KW - In vitro diagnostic medical devices

KW - Informed consent

KW - Medical supervision

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JO - Journal of Community Genetics

JF - Journal of Community Genetics

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ER -

Legislation of Direct-to-Consumer Genetic Testing in Europe: A Fragmented Regulatory Landscape

Abstract

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