T.B. Binz¹

¹Federal Office of Public Health

The Federal Law on Human Genetic Testing and the Ordinance on Human Genetic Testing (OHGT) have entered into force as of april 1st, 2007. These regulations provide the legal framework for the protection of human dignity and personality with regards to genetic data, to the prevention of abuses, to the prescription and performance of genetic testing and to the ensurance of a high quality of genetic testing. The presentation will focus on the requirements for laboratories seeking federal licence (i.e. authorization) for genetic testing and the authorization process in particular. Specifically, laboratories conducting cytogenetic and molecular genetic tests on humans as well as human genetic screening have to comply with, among others, the following requirements (according to the OHGT): i) the appropriate qualification of the head of the laboratory, ii) the appropriate qualification of laboratory staff , iii) the compliance of the laboratory with state-of-the-art of science and technology iv) quality assurance, and v) the submission of a concept for human genetic screenings to the Federal Office of Public Health (FOPH). Applications for authorization are filed to the FOPH. The scope of the licence depends on the qualification of the laboratory head (FAMH-title for specialization). According to this qualification, specific tests are admitted as listed in the Ordinance to the OHGT of the Federal Department of Home Affairs. The presentation will also include informations about the obligations of laboratories, exemptions from authorization and the status of the current authorization process.