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Legislation of direct-to-consumer genetic testing in Europe: a fragmented regulatory landscape
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.ORCID iD: 0000-0001-6149-5498
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2017 (English)In: J Community GenetArticle in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
2017.
Keywords [en]
Direct-to-consumer genetic tests, Genetic counselling, In vitro diagnostic medical devices, Informed consent, Medical supervision, Regulation
National Category
Medical and Health Sciences
Research subject
Bioethics
Identifiers
URN: urn:nbn:se:uu:diva-342729ISBN: 1868-310X (Print) 1868-310X (Linking) OAI: oai:DiVA.org:uu-342729DiVA, id: diva2:1186598
Note

Kalokairinou, L Howard, H C Slokenberga, S Fisher, E Flatscher-Thoni, M Hartlev, M van Hellemondt, R Juskevicius, J Kapelenska-Pregowska, J Kovac, P Lovrecic, L Nys, H de Paor, A Phillips, A Prudil, L Rial-Sebbag, E Romeo Casabona, C M Sandor, J Schuster, A Soini, S Sovig, K H Stoffel, D Titma, T Trokanas, T Borry, P eng Germany 2017/11/19 06:00 J Community Genet. 2017 Nov 18. pii: 10.1007/s12687-017-0344-2. doi: 10.1007/s12687-017-0344-2.

Available from: 2018-02-28 Created: 2018-02-28 Last updated: 2018-02-28

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http://www.ncbi.nlm.nih.gov/pubmed/29150824

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