TY - JOUR
T1 - Legislation of direct-to-consumer genetic testing in Europe
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.
N1 - Publisher Copyright:
© 2017, The Author(s).
PY - 2018/4/1
Y1 - 2018/4/1
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
U2 - 10.1007/s12687-017-0344-2
DO - 10.1007/s12687-017-0344-2
M3 - Article
AN - SCOPUS:85044216182
SN - 1868-310X
VL - 9
SP - 117
EP - 132
JO - Journal of Community Genetics
JF - Journal of Community Genetics
IS - 2
ER -