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

L. Kalokairinou; H. C. Howard; S. Slokenberga; E. Fisher; M. Flatscher-Thöni; M. Hartlev; R. van Hellemondt; J. Juškevičius; J. Kapelenska-Pregowska; P. Kováč; L. Lovrečić; H. Nys; A. de Paor; A. Phillips; L. Prudil; E. Rial-Sebbag; C. M. Romeo Casabona; J. Sándor; 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

L. Kalokairinou^*
, H. C. Howard
, S. Slokenberga
, E. Fisher
, M. Flatscher-Thöni
, M. Hartlev
, R. van Hellemondt
, J. Juškevičius
, J. Kapelenska-Pregowska
, P. Kováč
, L. Lovrečić
, H. Nys
, A. de Paor
, A. Phillips
, L. Prudil
, E. Rial-Sebbag
, C. M. Romeo Casabona
, J. Sándor
, A. Schuster
, S. Soini

K. H. Søvig, D. Stoffel, T. Titma, T. Trokanas, P. Borry

^*Corresponding author for this work

KU Leuven
Uppsala University
Robert Koch-Institut
Private University for Health Sciences, Medical Informatics and Technology
University of Copenhagen
Leiden University
Mykolas Romeris University
Nicolaus Copernicus University in Toruń
Forensic.sk Inštitút forenzných medicínskych expertíz s.r.o
University of Trnava
University Medical Centre Ljubljana
Dublin City University
Trinity College Dublin
AK Prudil a spol.
Institut national de la santé et de la recherche médicale
University of the Basque Country
University of Trento
Helsinki University Central Hospital
University of Bergen
Universite Paris XII
Tallinn University of Technology
Tallinn University
European University Cyprus

Research output: Contribution to journal › Article › peer-review

Abstract (may include machine translation)

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.

Original language	English
Pages (from-to)	117-132
Number of pages	16
Journal	Journal of Community Genetics
Volume	9
Issue number	2
DOIs	https://doi.org/10.1007/s12687-017-0344-2
State	Published - 1 Apr 2018

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

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

Access to Document

10.1007/s12687-017-0344-2License: CC BY

Sandor-Judit4_2018Publisher version, 575 KBLicense: CC BY

Cite this

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., ... 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

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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{\textquoteright} rights.",

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Kalokairinou, L, Howard, HC, 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, CM, Sándor, 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, vol. 9, no. 2, pp. 117-132. https://doi.org/10.1007/s12687-017-0344-2

TY - JOUR

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T2 - a fragmented regulatory landscape

AU - Kalokairinou, L.

AU - Howard, H. C.

AU - Slokenberga, S.

AU - Fisher, E.

AU - Flatscher-Thöni, M.

AU - Hartlev, M.

AU - van Hellemondt, R.

AU - Juškevičius, J.

AU - Kapelenska-Pregowska, J.

AU - Kováč, P.

AU - Lovrečić, L.

AU - Nys, H.

AU - de Paor, A.

AU - Phillips, A.

AU - Prudil, L.

AU - Rial-Sebbag, E.

AU - Romeo Casabona, C. M.

AU - Sándor, J.

AU - Schuster, A.

AU - Soini, S.

AU - Søvig, K. H.

AU - Stoffel, D.

AU - Titma, T.

AU - Trokanas, T.

AU - Borry, P.

PY - 2018/4/1

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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.

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KW - In vitro diagnostic medical devices

KW - Informed consent

KW - Medical supervision

KW - Regulation

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ER -

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

Abstract (may include machine translation)

UN SDGs

Keywords

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