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Gene Therapy Legislation in Switzerland

The competent Authority for clinical gene therapy trials in Switzerland is the Swiss Agency for Therapeutic Products (Swissmedic). The agency ensures that only high-quality, safe and effective medicines and medical devices are placed on the market in Switzerland according to the Swiss Law on Therapeutic Products. A single application for a gene therapy clinical trial is submitted to Swissmedic and circulated to different agencies, including the Swiss Expert Committee for Biosafety (SECB), the Federal Office of Public Health (FOPH) and, in case of an in vivo gene therapy clinical trial to the Federal Office for the Environment (FOEN). In parallel the application is submitted to the Ethics Committee.

A limited number of gene therapy clinical trials have been conducted in Switzerland. The Ordinance on Clinical Trials with Therapeutic Products describes the specific information that is required to obtain a consent for a clinical gene therapy trial. The positive opinion of all involved parties is required for Swissmedic to issue a Decision within 90 days after submission of the application.

(Last reviewed by the Competent Authority: 17 June 2011)