Editorial: New eu Rules for In Vitro Diagnostic Genetic Tests, a First Step in the Right Direction

摘要

1. Introduction: The provision of direct-to-consumer in vitro diagnostic genetics tests over the internet is a lucrative business. Gene Watch uk has long exposed companies making misleading claims about genetic test results. The claims were possible because the eu legislative regime of the Medical Device Directives did not require proof either of analytical validity or of clinical utility. Yet, these are pre-requisites of all genetic tests before their implementation into clinical routine. In its 2002 Resolution on the Commission Communication on Life Sciences and Biotechnology, the European Parliament (ep) already called on the Commission to draft a Regulation for the introduction of a standard for genetic tests (Resolution, para. 51). The reason for this was that these services lie outside the scope of Council Regulation (eec) 2309/93, laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and of Directive 98/79/EC on in vitro diagnostic medical devices, which applies only to products to be marketed.