Regulating direct-to-consumer advertising of genetic tests: Legitimate or not?

Abstract for poster presentation at the EMPAG 2016 conference, Barcelona 21–24 May, 2016, European Society of Human Genetics

Louiza Kalokairinou, PhD fellow of the Research Foundation Flanders (FWO),
Centre for Biomedical Ethics and Law at KU Leuven
Pascal Borry, Centre for Biomedical Ethics and Law, KU Leuven
Heidi C. Howard, Centre for Research Ethics & Bioethics (CRB), Uppsala University


During the past decade, the advertising of direct-to-consumer (DTC) genetic tests (GT) has provoked criticism over its potential adverse impact to public health. In October 2013, the European Parliament suggested in its proposal for Regulation of in vitro diagnostic medical devices that DTC advertising of GT with both direct and indirect medical purpose should be banned.

While the proposed Regulation is currently under discussion among the European institutions, this work aims to evaluate the proportionality of forbidding DTC advertising for a broad range of GT. To this end, an overview is provided of the various ways genetic tests have been advertised over the past years and the different ethical issues that have arisen from advertisements. Subsequently, this work examines the laws currently regulating the advertising of GT both at the EU and at the Member States level. Finally, the proportionality of the ban is discussed, drawing a parallel with the discussion regarding the ban on DTC advertising of prescription drugs in Europe.

As a conclusion, it is argued that it might be more proportionate to only implement a ban on DTC advertising of GT that may have a direct impact on consumers’ health, and impose rigorous rules on DTC advertising for the rest of health-related genetic tests. Such regulation should ensure that promotional claims are substantiated and the benefits, risks and limitations, as well as the target audience of GT are clearly presented.

Stay tuned for the full publication of this work in the coming months.

Download poster

Read more:

Current developments in the regulation of direct-to-consumer genetic testing in Europe, Kalokairinou L, Howard HC, Borry P, Medical Law International, advance online publication December 7, 2015.