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

Journal of Community Genetics - Tập 9 - Trang 117-132 - 2017
L. Kalokairinou1, H. C. Howard2, S. Slokenberga2,3, E. Fisher4, M. Flatscher-Thöni5, M. Hartlev6, R. van Hellemondt7, J. Juškevičius8, J. Kapelenska-Pregowska9, P. Kováč10,11, L. Lovrečić12, H. Nys1, A. de Paor13, A. Phillips14, L. Prudil15, E. Rial-Sebbag16, C. M. Romeo Casabona17, J. Sándor18, A. Schuster19, S. Soini20, K. H. Søvig21, D. Stoffel22, T. Titma23,24, T. Trokanas25, P. Borry1
1Department of Public Health and Primary Care, Centre for Biomedical Law and Ethics, University of Leuven, Leuven, Belgium
2Centre for Research Ethics and Bioethics, Uppsala University, Uppsala, Sweden
3Faculty of Law, Uppsala University, Uppsala, Sweden
4Robert Koch Institute, Berlin, Germany
5Institute of Public Health, Medical Decision Making and Health Technology Assessment, UMIT - University for Health Sciences, Medical Informatics and Technology, Hall in Tirol, Austria
6Faculty of Law, University of Copenhagen, Copenhagen, Denmark
7Leiden University Medical Centre, Leiden, the Netherlands
8Faculty of Law, Mykolas Romeris University, Vilnius, Lithuania
9Faculty of Law and Administration, Nicolaus Copernicus University, Toruń, Poland
10Forensic.sk Inštitút forenzných medicínskych expertíz s.r.o, Bratislava, Slovakia
11Department of Criminal Law and Criminology, Faculty of Law, Trnava University, Trnava, Slovakia
12Clinical Institute of Medical Genetics, University Medical Centre Ljubljana, Ljubljana, Slovenia
13School of Law and Government, Dublin City University, Dublin, Ireland
14School of Law, Trinity College Dublin, University of Dublin, Dublin, Ireland
15AK PRUDIL a spol, Brno, Czech Republic
16Institut national de la santé et de la recherche médicale, Paris, France
17The University of the Basque Country, Leioa, Spain
18Faculty of Political Science, Legal Studies and Gender Studies of the Central European University, Budapest, Hungary
19Department of Legal Sciences, University of Trento, Trento, Italy
20Helsinki University Central Hospital, Helsinki, Finland.
21Faculty of Law, University of Bergen, Bergen, Norway
22University Paris-Est Créteil, Créteil, France
23School of Governance, Law and Society, Tallinn University, Tallinn, Estonia
24School of Information Technologies, Tallinn University of Technology, Tallinn, Estonia
25School of Law, European University of Cyprus, Egkomi, Cyprus

Tóm tắt

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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