ORIGINAL ARTICLE
Legislation of direct-to-consumer genetic testing in Europe:
a fragmented regulatory landscape
L. Kalokairinou
1
&
H. C. Howard
2
&
S. Slokenberga
2,3
&
E. Fisher
4
&
M. Flatscher-Thöni
5
&
M. Hartlev
6
&
R. van Hellemondt
7
&
J. Juškevičius
8
&
J. Kapelenska-Pregowska
9
&
P. Kováč
10,11
&
L. Lovrečić
12
&
H. Nys
1
&
A. de Paor
13
&
A. Phillips
14
&
L. Prudil
15
&
E. Rial-Sebbag
16
&
C. M. Romeo Casabona
17
&
J. Sándor
18
&
A. Schuster
19
&
S. Soini
20
&
K. H. Søvig
21
&
D. Stoffel
22
&
T. Titma
23,24
&
T. Trokanas
25
&
P. Borry
1
Received: 15 February 2017 /Accepted: 6 November 2017 /Published online: 18 November 2017
#
The Author(s) 2017. This article is an open access publication
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 su-
pervision, genetic counselling and informed consent. Our
results indicate that currently there is a wide spectrum of
laws regarding genetic testing in Europe. There are coun-
tries (e.g. France and Germany) which essentially ban
DTC genetic testing, while in others (e.g. Luxembourg
This article is part of the Topical Collection on Citizen’s Health through
public-private Initiatives: Public health, Market and Ethical perspectives.
* L. Kalokairinou
louiza.kalokairinou@med.kuleuven.be
1
Department of Public Health and Primary Care, Centre for
Biomedical Law and Ethics, University of Leuven, Kapucijnenvoer
35, Box 7001, 3000 Leuven, Belgium
2
Centre for Research Ethics and Bioethics, Uppsala University,
Uppsala, Sweden
3
Faculty of Law, Uppsala University, Uppsala, Sweden
4
Robert Koch-Institute, Berlin, Germany
5
Institute of Public Health, Medical Decision Making and Health
Technology Assessment, UMIT - University for Health Sciences,
Medical Informatics and Technology, Hall in Tirol, Austria
6
Faculty of Law, University of Copenhagen, Copenhagen, Denmark
7
Leiden University Medical Centre, Leiden, the Netherlands
8
Faculty of Law, Mykolas Romeris University, Vilnius, Lithuania
9
Faculty of Law and Administration, Nicolaus Copernicus University,
Toruń, Poland
10
Forensic.sk Inštitút forenzných medicínskych expertíz s.r.o,
Bratislava, Slovakia
11
Department of Criminal Law and Criminology, Faculty of Law,
Trnava University, Trnava, Slovakia
12
Clinical Institute of Medical Genetics, University Medical Centre
Ljubljana, Ljubljana, Slovenia
13
School of Law and Government, Dublin City University,
Dublin, Ireland
14
School of Law, Trinity College Dublin, University of Dublin,
Dublin, Ireland
15
AK PRUDIL a spol, Brno, Czech Republic
16
Institut national de la santé et de la recherche médicale, Paris, France
17
The University of the Basque Country, Leioa, Spain
18
Faculty of Political Science, Legal Studies and Gender Studies of the
Central European University, Budapest, Hungary
19
Department of Legal Sciences, University of Trento, Trento, Italy
20
Helsinki University Central Hospital, Helsinki, Finland
21
Faculty of law, University of Bergen, Bergen, Norway
22
University Paris-Est Créteil, Créteil, France
23
School of Governance, Law and Society, Tallinn University,
Tallinn, Estonia
24
School of Information Technologies, Tallinn University of
Technology, Tallinn, Estonia
25
School of Law, European University of Cyprus, Egkomi, Cyprus
J Community Genet (2018) 9:117–132
https://doi.org/10.1007/s12687-017-0344-2
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