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

Louiza Kalokairinou(KU Leuven), Heidi Howard(Uppsala University), Santa Slokenberga(Uppsala University), Elizabeth Fisher(Robert Koch Institute), Magdalena Flatscher‐Thöni(UMIT - Private Universität für Gesundheitswissenschaften, Medizinische Informatik und Technik), Mette Hartlev(University of Copenhagen), Rachèl van Hellemondt(Leiden University Medical Center), Jonas Juškevičius(Mykolas Romeris University), J. Kapelenska-Pregowska(Nicolaus Copernicus University), Peter Kováč(University of Trnava), Luca Lovrečić(Ljubljana University Medical Centre), Herman Nys(KU Leuven), Aisling de Paor(Dublin City University), Andelka M. Phillips(Trinity College Dublin), Lukáš Prudil, Emmanuelle Rial‐Sebbag, Carlos María Romeo Casabona(University of the Basque Country), Judit Sándor(Institute for Legal Studies), Angela Schuster(University of Trento), Sirpa Soini(Helsinki University Hospital), Karl Harald Søvig(University of Bergen), D. Stoffel(Université Paris-Est Créteil), Tiina Titma(Tallinn University), Theodoros Trokanas(European University Cyprus), Pascal Borry(KU Leuven)
Journal of Community Genetics
November 18, 2017
10.1007/s12687-017-0344-2
Cited by 90Open Access
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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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