Confederation and cantons take action against providers of illegal fresh cell therapy
Bern, 26.03.2015 - Swiss hospitals and private clinics have been offering 'fresh cell therapy' for some time. This is especially popular with tourists from China, Russia and the Middle East. However, the products that are used are not authorised and constitute a significant health risk. The FOPH and Swissmedic, together with the cantons, have advised all providers that they require different licences and authorisations. Charges have been brought against some individuals.
In various Swiss hospitals and private clinics, illegal fresh cell therapy that is hazardous to health has been available for some time. With such treatments the patients receive injections of cells or cell components from sheep fetuses or sheep placentas, with the assurance that this will induce a process of rejuvenation. Provision of fresh cell therapy requires authorisations from the Swiss Agency for Therapeutic Products (Swissmedic) or the Federal Office of Public Health (FOPH), according to the nature of the product. No such authorisations have so far been issued in Switzerland. On 2014, the FOPH and Swissmedic therefore worked closely together with the cantonal authorities to prepare an overview of the treatments that are currently available. All clinics, practices and medical personnel who have manufactured, imported, distributed or used such illegal products have been asked to cease these activities or apply for the appropriate licence or authorisation immediately. Swissmedic has initiated criminal proceedings against several clinics and individuals who have contravened the law.
The aim of this intervention is to prevent the illegal manufacture and use of products for fresh cell therapy in Switzerland. This should help to protect the health of medical tourists while ensuring that Switzerland only offers health services of the highest quality.
Risks of fresh cell therapy
Fresh cell therapy is a treatment that was originally developed around 1930 by Swiss doctor Paul Niehans. Live animal cells (usually from sheep fetuses or sheep placentas) are mixed with an isotonic saline solution and injected into the patient's muscles. There is now an increasing trend towards the use of frozen or dried cells, cell fragments or cell extracts - i.e. products that do not contain living cells. The aim of the treatment is primarily revitalisation and rejuvenation (anti-ageing) of the patient. However, in some cases fresh cells or fresh cell products are also advertised as treatments for migraine or chronic diseases, or as an alternative cancer therapy. The efficacy of fresh cell therapy is not scientifically proven, but its health risks have been demonstrated. It may result in allergies, abscesses at the injection site, blood poisoning or even transmission of animal pathogens.
The legal basis depends on the type of treatment: fresh cell therapy with live cells is classified as xenotransplantation, and is subject to the Transplantation Act in Switzerland. Xenotransplantation requires an authorisation from the FOPH. Issuance of an authorisation is subject to strict conditions in order to prevent the transmission of infectious agents from animals to humans. However, products that do not contain living cells are classified as medicinal products and are subject to the Federal Therapeutic Products Act (TPA). Until 2010, the cantons were able to qualify these products as 'magistral formulas'. This has not been possible since the TPA was updated in October 2010, and preparations must now be authorised by Swissmedic as medicinal products. Such authorisations are only issued if the requirements regarding quality, safety and efficacy are met. So far, no such permits or authorisations have been granted by Swissmedic or the FOPH.
 Magistral formulas are medicinal products that are exempt from authorisation, and are prepared in a public pharmacy or a hospital pharmacy according to a medical prescription for a particular person or a particular group of people.
Address for enquiries
Federal Office of Public Health, FOPH, Communications Section, email@example.com or 058 462 95 05
Swissmedic, Swiss Agency for Therapeutic Products, Media Relations, firstname.lastname@example.org or 058 462 02 76
Federal Office of Public Health