title: Which lessons can we learn from the European Union legal framework of medicines for the regulation of direct-to-consumer genetic tests?
abstract: The legal framework of the European Union (EU) for regulating access to and supply of direct-to-consumer (DTC) genetic tests is very liberal compared to the legal and regulatory framework for (internet) medicines. Nevertheless, both health related products can cause equally serious damage to the well being of individuals. In this contribution we examine whether the legal framework of the EU for the safety and responsible use of (internet) medicines could be an example for regulating access to and supply of DTC genetic tests. The EU laws governing medicines can, notwithstanding their shortcomings, serve as an example for (central) authorising the marketing of DTC genetic tests on the internal market in accordance with strict criteria regarding predictive value and clinical usefulness. Furthermore, a legal framework controlling DTC genetic tests also should introduce system supervision as well as quality criteria with respect to the information to be provided to consumers in order to enhance health protection. However, DTC genetic tests purchased through online ordering are difficult to supervise by any agency. Adequately protecting individuals against questionable testing kits calls for international vigilance and comprehensive measures by the international community. For Europe, it is important to rank the regulation of DTC genetic tests on the European regulatory agenda.
authors.affiliation: Leiden University Medical Centre, Leiden, the Netherlands.
authors.forename: Rachèl
authors.initials: R
authors.lastname: van Hellemondt
authors.forename: Aart
authors.initials: A
authors.lastname: Hendriks
authors.forename: Martijn
authors.initials: M
authors.lastname: Breuning
mesh_terms: D004345:Drug Industry / Q000331:legislation & jurisprudence*; D005062:European Union; D005820:Genetic Testing / Q000331:legislation & jurisprudence*; D006801:Humans; D020407:Internet