Regulating the advertising of genetic tests in Europe: a balancing act. - PubMed - NCBI
J Med Genet. 2017 Jul 22. pii: jmedgenet-2017-104531. doi: 10.1136/jmedgenet-2017-104531. [Epub ahead of print]
Regulating the advertising of genetic tests in Europe: a balancing act.
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. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
KEYWORDS:
advertising; direct-to-consumer; genetic testing; in vitro diagnostic medical devices; regulation
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