Legislation of direct-to-consumer genetic testing in Europe: a fragmented regulatory landscape
Year: 2017
Type: article
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.
Source: Journal of Community Genetics
Authors: L. Kalokairinou, H. C. Howard, S. Slokenberga, E. Fisher, M. Flatscher-Thöni, M. Hartlev, R. van Hellemondt, J. Juškevičius, J. Kapelenska-Pregowska, P. Kováč, L. Lovrečić, H. Nys, A. de Paor, A. Phillips, L. Prudil, E. Rial-Sebbag, C. M. Romeo Casabona, J. Sándor, A. Schuster, S. Soini, K. H. Søvig, D. Stoffel, T. Titma, T. Trokanas, P. Borry
Institutions: KU Leuven, Uppsala University, Robert Koch Institute, UMIT TIROL - Private University for Health Sciences and Health Technology, University of Copenhagen, Leiden University Medical Center, Mykolas Romeris University, Nicolaus Copernicus University, University of Trnava, Ljubljana University Medical Centre, Dublin City University, Trinity College Dublin, Inserm, University of the Basque Country, Central European University, University of Trento, Helsinki University Hospital, University of Bergen, Université Paris-Est Créteil, Tallinn University of Technology, Tallinn University, European University Cyprus
Language: English
Subfield: Issues, ethics and legal aspects
Field: Nursing
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,990
OpenAlex ID: W2553189372