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.

In the wake of recent regulations targeting direct-to-consumer genetic testing (DTC-GT), an increasing number of websites have emerged that offer consumers alternative means to derive health information from their DTC-GT raw data. While the ethical concerns associated with DTC-GT have been extensively discussed in the literature, the implications of third party interpretation (TPI) websites have remained largely unexplored. Here we sought to describe these services and elucidate their ethical implications in the context of the current DTC-GT debate. We reviewed five popular TPI websites that use SNP-based genomic data to report health-related information: Promethease, Interpretome, LiveWello, Codegen.eu, and Enlis Personal. We found that many of the ethical concerns previously described in DTC-GT also applied to TPI websites, including inadequate informed consent, questionable clinical validity and utility, and lack of medical supervision. However, some concerns about data usage and privacy reported in DTC-GT were less prominent in the five TPI websites we studied: none of them sold or shared user data, and 3/5 sites did not retain data in the long term. In addition, while exaggerated claims and inaccurate advertising have been frequently problematic in DTC-GT, advertising was minimal in the TPI sites we assessed, and 4/5 made no claims of health benefits. Overall, TPI adds a new dimension to the ethical debate surrounding DTC-GT, and awareness of these services will become increasingly important as personal genomics continues to expand. This study constitutes the first detailed ethical analysis of these services, and presents a starting point for further research and ethical reflection.

Direct-to-consumer (DTC) genetic tests (GT) enable consumers to access a wide range of GT, without involving a healthcare professional, promoting an increasing disassociation of genetics from the clinical context. This study explores, through semi-structured interviews, the experiences and attitudes of European clinical geneticists towards DTCGT. Our results indicate that the participants have limited experience of consultations with patients regarding such tests.In the majority of cases, the participants stated that consumers purchased tests out of curiosity and sought a general interpretation of test results by a healthcare professional. Most respondents were skeptical of the quality of these tests, especially regarding their clinical utility. The participants supported the importance of medical supervision and genetic counseling in this context. Finally, most respondents considered it their duty to accept consultations concerning DTCGT results. However, due to concerns over limited time and potential downstream costs, some participants supported that a prioritization system based on guidelines would be necessary.

Aim: Direct-to-consumer (DTC) genetic tests (GT) have created controversy regarding their risks and benefits. In view of recent regulatory developments, this article aims to explore the attitudes of European clinical geneticists toward the oversight of DTC GT. Materials & methods: Fifteen semi-structured interviews were performed with clinical geneticists based in ten European countries. The transcripts were thematically analysized in an iterative process. Results & conclusion: Respondents strongly supported quality standards for DTC GT equal to those applied within the healthcare setting. Despite participants unanimously considering the involvement of healthcare professionals to be important, mandatory medical supervision was controversial. In this regard, promoting education and truth-in-advertising was considered as being key in maintaining a balance between protecting consumers and promoting their autonomy.

work is also supported by the COST Action IS1303 "Citizen's Health through public-private Initiatives: Public health, Market and Ethical perspectives" (CHIP ME). None of these funding sources have had any involvement in the preparation of this article.The authors declare no conflict of interest. 2 AbstractA variety of health-related genetic testing is currently advertised directly to consumers. This article provides a timely overview of direct-to-consumer genetic testing (DTC GT) and salient ethical issues, as well as an analysis of the impact of the recently adopted Regulation on In Vitro Diagnostic Medical Devices (IVD) on DTC GT. DTC GT companies currently employ new testing approaches, report on wide spectrum of conditions, and target new groups of consumers. Such activities raise ethical issues including the questionable analytic and clinical validity of tests, the adequacy of informed consent, potentially misleading advertising, testing in children, research uses and commercialization of genomic data. The recently adopted IVD Regulation may limit the offers of predisposition DTC GT in the EU market.Keywords: direct-to-consumer genetic testing, genetic testing, consumer genomics, consumer genetics, informed consent, genetic counselling, IVD regulation 1 Many of the tests discussed herein involve generating the DNA sequence for much if not all of the genome, therefore it could be considered more accurate to use the term genomic. However, for the purposes of this article, we will be using the word 'genetic' referring both to genetic and genomic testing and services. DTC genetic testing and related services2 This article focuses mainly on health-related testing, excluding testing with other main purposes such as ancestry and paternity. However, it is important to note that ancestry test results may reveal health-related information to consumers, given associations between genetic ancestry and disease risks, press coverage of these relations and interest of the consumers in these issues [85]. Furthermore, the web-based interpretation services can provide health-related information on the basic of raw data received in ancestry genetic testing, which is discussed in the following sections of this article. (2015) revealed that the market of health-related DTC GT has grown significantly in the last decade reaching over 100 companies [6]. Considering that these searchers were performed in English, the total number of companies offering DTC GT may be assumed to be even larger.Importantly, not only has the number of companies grown in recent years, but their offer has expanded regarding the scope of the tests, technologies used, and the target audiences of the tests. (almost) all the DNA present in cells, whilst whole exome sequencing provides sequence of all protein coding regions of DNA; in both cases the amount of genetic information obtained is unprecedented. Once sequenced, the exome or genome can then be analysed for specific, defined purpose(s) (e.g. using targeted gene approach where only a subset of genes ...