Direct-to-consumer (DTC) genetic tests (GT) have provoked criticism over their potential adverse impact on public health. The European Parliament called for a ban on DTC advertising of GT during the debate for the adoption of a European Regulation on in vitro diagnostic medical devices. This proposal, however, was not ultimately retained in the final text. Instead, the regulation includes an article prohibiting misleading claims for this kind of advertising. These two different approaches raise questions about the optimal degree of regulation. Herein, we provide an overview of the ways GT have been advertised and related ethical issues. Subsequently, the laws regulating the advertising of GT at the European Union and national level are examined. Finally, recent regulatory developments are discussed.
- genetic testing
- in vitro diagnostic medical devices
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Contributors All authors contributed to the conception and design of the work, including the basic outline of the topics to be addressed, and gave final approval for the manuscript to be published. LK performed the bulk of data gathering and interpretation with PB and HCH providing critical comments and guidance. LK drafted the initial manuscript and worked iteratively with HCH to develop the final manuscript and conducted the legal analysis.
Funding This work was supported by a doctoral fellowship from the Research Foundation Flanders (FWO). Part of this work has also been supported by the Swedish Foundation for Humanities and Social Science under grant M13-0260:1), the Biobanking and Molecular Resource Infrastructure of Sweden (BBMRI.se) and the BBMRI-ERIC, and the CHIP ME COST Action IS1303.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.