Is clampdown on Swiss stem cell therapies justified?

In Switzerland, an increasing number of organizations have been offering stem cell therapies for the treatment of a broad range of diseases and conditions including neuro-degenerative diseases, strokes and traumatic brain injuries, diabetes, heart diseases and generic aging conditions. The respective treatments have been used particularly by individuals from Asia, Russia and the Middle East. Last year, Swiss authorities again took action to specify and enforce the legal requirements applicable to stem cell therapies and similar treatments.

Two papers

In 2012, Swissmedic, the Swiss surveillance authority for therapeutic products, issued its first paper on the use of human tissues and cells in the field of aesthetic medicine (Swissmedic Journal, 09/2012).

Swissmedic stated in the paper that products containing human tissues or cells cannot be qualified as cosmetics. Rather, they constitute transplants and are, therefore, subject to the Federal Transplantation Act. If such transplants are turned into products which, or the production process of which, can be standardised, then the transplants must be qualified as “transplant products”. As such, they fall not only under the Transplantation Act, but also the federal Therapeutic Products Act (TPA). The regulation under the TPA is more restrictive than under the Transplantation Act and, among other things, requires stem cell therapies to go through extensive marketing authorization proceedings involving clinical trials.