Legislation of direct-to-consumer genetic testing in Europe: a fragmented regulatory landscape
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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-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
This article is part of the Topical Collection on Citizen’s Health through public-private Initiatives: Public health, Market and Ethical perspectives. * L. Kalokairinou [email protected]
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Clinical Institute of Medical Genetics, University Medical Centre Ljubljana, Ljubljana, Slovenia
1
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School of Law and Government, Dublin City University, Dublin, Ireland
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School of Law, Trinity College Dublin, University of Dublin, Dublin, Ireland
Department of Public Health and Primary Care, Centre for Biomedical Law and Ethics, University of Leuven, Kapucijnenvoer 35, Box 7001, 3000 Leuven, Belgium
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Centre for Research Ethics and Bioethics, Uppsala University, Uppsala, Sweden
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AK PRUDIL a spol, Brno, Czech Republic
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Faculty of Law, Uppsala University, Uppsala, Sweden
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Institut national de la santé et de la recherche médicale, Paris, France
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Robert Koch-Institute, Berlin, Germany
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The University of the Basque Country, Leioa, Spain
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Institute of Public Health, Medical Decision Making and Health Technology Assessment, UMIT - University for Health Sciences, Medical Informatics and Technology, Hall in Tirol, Austria
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Faculty of Political Science, Legal Studies and Gender Studies of the Central European University, Budapest, Hungary
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Department of Legal Sciences, University of Trento, Trento, Italy
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