Between 2014 and 2016, the FOPH and Swissmedic, along with the cantons, proceeded to jointly crack down on illegal sales of fresh cell preparations and corresponding treatments which were being offered by various clinics, practices and medical personnel to solvent clients mainly from Asia.
An obsolete and high-risk treatment concept
Fresh cell therapy patients are injected with preparations derived from animal organs with the aim of achieving a revitalising effect in their corresponding organs. The concept was developed in the 1930s by Swiss physician Paul Niehans. Its therapeutic effect has never been proved scientifically. The lack of therapeutic benefit is compounded by significant health risks that can range from allergic reactions, infections and autoimmune disorders to death. For that reason, medical societies as well as the WHO reject this form of therapy.
No authorisation in Switzerland
Up until 2010, fresh cell therapy preparations could be qualified in some circumstances as so-called Formula magistralis (i.e. in accordance with a doctor’s specific prescription), which meant that they were exempt from the therapeutic products legislation-mandated authorisation. Since the revision of the Therapeutic Products Act of 1 October 2010, these types of preparations, as a rule, are subject to mandatory authorisation. Neither the FOPH nor Swissmedic has ever issued an authorisation or approval in connection with fresh cell therapy. As a result of evidence hinting at an increase in such offerings, the FOPH and Swissmedic, along with the cantons, decided to get some clarity regarding the extent of the offerings, to curb the use of any inadmissible therapeutic products and to inform the providers of the legal framework conditions for these types of treatments.
During the summer of 2014, a total of 37 facilities potentially offering fresh cell or similar therapies were identified. The providers were subsequently invited to describe their offerings in detail. Additional information was requested or inspections were carried out where necessary. Fortunately, the investigation revealed that none of the facilities prepared, imported or injected their patients with preparations in the original meaning of fresh cell therapy (i.e. from living animal cells or tissues). In four cases, Swissmedic issued a ruling against the manufacturers and providers of unauthorised animal tissue preparations. Three of the rulings were challenged in the Federal Administrative Court (FAC). The FAC held one of the appeals inadmissible as deadlines were not respected, and dismissed the two others. One of these was referred to the Federal Supreme Court (as at the end of 2018).
Fourteen websites were found objectionable due to deceptive claims. Overall, the campaign succeeded in raising awareness of the current legal framework conditions within the industry and certain specialist societies.
The joint campaign by the FOPH, Swissmedic and the cantons against illegal fresh cell therapies and unauthorised fresh cell preparations was concluded by the end of June of 2016 and subsequently converted to an ongoing federal and cantonal monitoring of such offerings. Swissmedic (in charge of manufacturers and distributors of therapeutic products), the FOPH (in charge of trade with cells and tissues) and the cantonal executive agencies (in charge of enforcement) conduct risk-based monitoring of the clinics, practices and medical personnel in terms of their compliance with current legal framework conditions.
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Last modification 30.04.2019