Regulating the advertising of genetic tests in Europe: a balancing act. Issue 10 (22nd July 2017)

• Record Type: Journal Article
• Authors: Kalokairinou, Louiza; Borry, Pascal; Howard, Heidi Carmen
• Is Part Of: Journal of medical genetics. Volume 54:Issue 10(2017)
• Page Start: 651
• Page End: 656
• Publication Date: 2017-07-22
• Subjects: direct-to-consumer -- genetic testing -- advertising -- regulation -- in vitro diagnostic medical devices; Medical genetics -- Periodicals; 616.042
• DOI: 10.1136/jmedgenet-2017-104531
• Languages: English
• ISSNs: 1468-6244

Abstract

Abstract : 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.