Legislation of direct-to-consumer genetic testing in Europe: a fragmented regulatory landscape
Citation:
L. Kalokairinou 1 & H. C. Howard 2 & S. Slokenberga 2,3 & E. Fisher 4 & M. Flatscher-Th?ni 5 & M. Hartlev6 & R. van Hellemondt7 & J. Ju?kevičius8 & J. Kapelenska-Pregowska9 & P. Kov?č10,11 & L. Lovrečić12 & H. Nys1 & A. de Paor13 & A. Phillips14 & L. Prudil15 & E. Rial-Sebbag16 & C. M. Romeo Casabona17 & J. S?ndor18 & A. Schuster19 & S. Soini20 & K. H. S?vig21 & D. Stoffel22 & T. Titma23,24 & T. Trokanas25 & P. Borry1, Legislation of direct-to-consumer genetic testing in Europe: a fragmented regulatory landscape, Journal of Community Genetics, 2017, 1 - 16Download Item:


Abstract:
Despite the increasing availability of direct-toconsumer
(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.
Author's Homepage:
http://people.tcd.ie/phillianDescription:
PUBLISHEDjoint author with Louiza Kalokairinou et al, ?Legislation of Direct-to-Consumer Genetic Testing in Europe: A Fragmented Regulatory Landscape? ? this has been submitted to the Journal of Community Genetics. ? This has a large number of authors because it reviewing the law in a large number of European Member States.
Author: PHILLIPS, ANDELKA
Type of material:
Journal ArticleCollections:
Series/Report no:
Journal of Community GeneticsAvailability:
Full text availableKeywords:
direct-to-consumer genetic testing, personal genomics, privacy, informed consent, data protection, medical devices, IVDSubject (TCD):
Genes & SocietyDOI:
https://doi.org/10.1007/s12687-017-0344-2Licences: