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

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt

Standard

Legislation of Direct-to-Consumer Genetic Testing in Europe : A Fragmented Regulatory Landscape. / Kalokairinou, Louiza; Howard, Heidi C; Slokenberga, Santa; Romeo-Casabona, Carlos María; Fischer, Eva; Flatscher-Thöni, Magdalena; Hartlev, Mette; Hellemondt, R. van; Juskevicius, J.; Kapelenska-Pregowska, J.; Kovac, P.; Lovrecic, L.; Nys, H.; de Paor, A. ; Phillips, A.; Prudil, L.; Rial-Sebbag, E.; Casabona, C.M. Romeo; Sandor, J.; Schuster, A.; Soini, S.; Søvig, K.H.; Stoffel, D.; Titma, T.; Trokanas, T.; Borry, P.

I: Journal of Community Genetics, Bind 9, Nr. 2, 2018, s. 117-132.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt

Harvard

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

APA

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

Vancouver

Kalokairinou L, Howard HC, Slokenberga S, Romeo-Casabona CM, Fischer E, Flatscher-Thöni M o.a. Legislation of Direct-to-Consumer Genetic Testing in Europe: A Fragmented Regulatory Landscape. Journal of Community Genetics. 2018;9(2):117-132. https://doi.org/10.1007/s12687-017-0344-2

Author

Kalokairinou, Louiza ; Howard, Heidi C ; Slokenberga, Santa ; Romeo-Casabona, Carlos María ; Fischer, Eva ; Flatscher-Thöni, Magdalena ; Hartlev, Mette ; Hellemondt, R. van ; Juskevicius, J. ; Kapelenska-Pregowska, J. ; Kovac, P. ; Lovrecic, L. ; Nys, H. ; de Paor, A. ; Phillips, A. ; Prudil, L. ; Rial-Sebbag, E. ; Casabona, C.M. Romeo ; Sandor, 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. I: Journal of Community Genetics. 2018 ; Bind 9, Nr. 2. s. 117-132.

Bibtex

@article{a72c0f86a2224592ba9218b1c4418bcc,
title = "Legislation of Direct-to-Consumer Genetic Testing in Europe: A Fragmented Regulatory Landscape",
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.",
keywords = "Direct-to-consumer genetic tests, Genetic counselling, In vitro diagnostic medical devices, Informed consent, Medical supervision, Regulation",
author = "Louiza Kalokairinou and Howard, {Heidi C} and Santa Slokenberga and Romeo-Casabona, {Carlos Mar{\'i}a} and Eva Fischer and Magdalena Flatscher-Th{\"o}ni and Mette Hartlev and Hellemondt, {R. van} and J. Juskevicius and J. Kapelenska-Pregowska and P. Kovac and L. Lovrecic and H. Nys and {de Paor}, A. and A. Phillips and L. Prudil and E. Rial-Sebbag and Casabona, {C.M. Romeo} and J. Sandor and A. Schuster and S. Soini and K.H. S{\o}vig and D. Stoffel and T. Titma and T. Trokanas and P. Borry",
year = "2018",
doi = "10.1007/s12687-017-0344-2",
language = "English",
volume = "9",
pages = "117--132",
journal = "Journal of Community Genetics",
issn = "1868-310X",
publisher = "Springer",
number = "2",

}

RIS

TY - JOUR

T1 - Legislation of Direct-to-Consumer Genetic Testing in Europe

T2 - A Fragmented Regulatory Landscape

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

Y1 - 2018

N2 - 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.

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.

KW - Direct-to-consumer genetic tests

KW - Genetic counselling

KW - In vitro diagnostic medical devices

KW - Informed consent

KW - Medical supervision

KW - Regulation

UR - http://www.scopus.com/inward/record.url?scp=85044216182&partnerID=8YFLogxK

UR - http://www.mendeley.com/research/legislation-directtoconsumer-genetic-testing-europe-fragmented-regulatory-landscape

U2 - 10.1007/s12687-017-0344-2

DO - 10.1007/s12687-017-0344-2

M3 - Journal article

C2 - 29150824

VL - 9

SP - 117

EP - 132

JO - Journal of Community Genetics

JF - Journal of Community Genetics

SN - 1868-310X

IS - 2

ER -

ID: 185001252