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

Kalokairinou L1, Howard HC2, Slokenberga S2,3, Fisher E4, Flatscher-Thöni M5, Hartlev M6, van Hellemondt R7, Juškevičius J8, Kapelenska-Pregowska J9, Kováč P10,11, Lovrečić L12, Nys H13, de Paor A14, Phillips A15, Prudil L16, Rial-Sebbag E17, Romeo Casabona CM18, Sándor J19, Schuster A20, Soini S21, Søvig KH22, Stoffel D23, Titma T24,25, Trokanas T26, Borry P13.

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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.