Legislation of direct-to-consumer genetic testing in Europe: a fragmented regulatory landscape
Open accessAbstract
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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The direct-to-consumer testing market has expanded, is variably controlled by country-specific regulations, and is moving toward models with direct access to ordering physicians and genetic counselors.
“One consequence of these difficulties has been an expanding direct-to-consumer testing market, variably controlled by country-specific regulations150, which is moving beyond a focus on ancestry and personal traits, towards models in which individuals have direct access to ordering physicians and genetic counselors151.”
From A brief history of human disease genetics (2020) · cites this paper as [150]
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- Authors
- Kalokairinou, L., Howard, H. C., Slokenberga, S., Fisher, E., Flatscher-Thöni, M., Hartlev, M., van Hellemondt, R., Juškevičius, J., Kapelenska-Pregowska, J., Kováč, P., Lovrečić, L., Nys, H., de Paor, A., Phillips, A., Prudil, L., Rial-Sebbag, E., Romeo Casabona, C. M., Sándor, J., Schuster, A., Soini, S., Søvig, K. H., Stoffel, D., Titma, T., Trokanas, T., & Borry, P.
- Affiliations
- KU Leuven (BE)
- Uppsala University (SE)
- Robert Koch Institute (DE)
- University of Copenhagen (DK)
- Mykolas Romeris University (LT)
- University of Trnava (SK)
- Ljubljana University Medical Centre (SI)
- Trinity College Dublin (IE)
- University of Trento (IT)
- Helsinki University Hospital (FI)
- University of Bergen (NO)
- Université Paris-Est Créteil (FR)
- Tallinn University of Technology (EE)
- European University Cyprus (CY)
- Corresponding author
- Kalokairinou, L.
- ORCID
- Venue
- Journal of Community Genetics
- Published
- 2017-11-18
- Volume
- 9
- Issue
- 2
- Pages
- 117-132
- ISSN
- 1868-310X (ISSN-L)
- 1868-6001
- PMC
- PMC5849704
- OpenAlex
- W2553189372
- Cited by
- 93
- References
- 34
- Citations by year
- 2026: 4 · 2025: 4 · 2024: 15 · 2023: 6 · 2022: 13 · 2021: 18 · 2020: 20 · 2019: 11 · 2018: 2
- FWCI
- 6.68
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Locations
- Journal of Community Genetics (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Arrow@dit (Dublin Institute of Technology) (submittedVersion, cc-by)
- Lirias (submittedVersion, cc-by)
- KTH Publication Database DiVA (KTH Royal Institute of Technology) (submittedVersion, other-oa)
- Publication server of the Robert Koch Institute (Robert Kock Institute) (submittedVersion)
- Communities in ADDI (Universidad del Pais Vasco) (submittedVersion, other-oa)
- Communities in ADDI (University of the Basque Country) (submittedVersion, other-oa)
- LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (submittedVersion, cc-by)
- Työväentutkimus Vuosikirja (submittedVersion)
- Hispana (submittedVersion, cc-by)
- Open Research (Auckland University of Technology) (submittedVersion, cc-by)
- Lund University Publications (Lund University) (submittedVersion)
- Open Research (Auckland University of Technology) (submittedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (submittedVersion)
- Trinity's Access to Research Output (TARA) (Trinity College Dublin) (submittedVersion)
- Topics
- Health Sciences › Medicine › Physiology › Biomedical Ethics and Regulation
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Medical and Health Sciences Research
- Health Sciences › Health Professions › Health Information Management › Healthcare Regulation
- Keywords
- direct-to-consumer genetic testing, genetic testing regulation, health care legislation, genetic counseling, informed consent, medical supervision, patient rights, EU health law
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