Legislation of direct-to-consumer genetic testing in Europe: a fragmented regulatory landscape
| Autor: | Mette Hartlev, Lukáš Prudil, R.E. van Hellemondt, M. Flatscher-Thöni, Tiina Titma, J. Kapelenska-Pregowska, C. M. Romeo Casabona, J. Juškevičius, Sirpa Soini, A. de Paor, Eva Fisher, Judit Sándor, Luca Lovrečić, Pascal Borry, Helene de Nys, Karl Harald Søvig, Andelka M. Phillips, Louiza Kalokairinou, T. Trokanas, D. Stoffel, A. Schuster, Heidi Carmen Howard, Peter Kováč, Santa Slokenberga, Emmanuelle Rial-Sebbag |
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| Přispěvatelé: | Helsinki University Hospital Area, Clinicum |
| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Medical Ethics
0301 basic medicine Economic growth medicine.medical_specialty Epidemiology Genetic counseling Legislation purposes 030105 genetics & heredity Medicinsk etik issues medical supervision 03 medical and health sciences Environmental protection Health care informed consent health genomics Medicine Data Protection Act 1998 Informed consent direct-to-consumer genetic tests Genetics (clinical) legal Genetic testing medicine.diagnostic_test business.industry Public health Public Health Environmental and Occupational Health regulation Bioethics 3. Good health Original Article HEALTH 3111 Biomedicine business genetic counselling Medical ethics in vitro diagnostic medical devices |
| Zdroj: | Addi. Archivo Digital para la Docencia y la Investigación instname Journal of Community Genetics |
| Popis: | Despite the increasing availability of direct-to-c onsumer (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. This study has not received any funding, but has benefited from interactions within the COST Action IS1303 'Citizen's Health through public-private Initiatives: Public health, Market and Ethical perspectives', supported by COST (European Cooperation in Science and Technology) (http://www.cost.eu). |
| Databáze: | OpenAIRE |
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