The number of treatments based on tissues and cells is increasing regularly, notably those offered by physicians or by institutes for aesthetic medicine. Faced with this proliferation, Swissmedic wishes to issue a reminder, via this document, that these products cannot be cosmetics and that their use is subject to certain principles and restrictions in accordance with the Transplantation Act1 and the Therapeutic Products Act (TPA)2. Under certain circumstances, in fact, it is necessary for the firms concerned to have an establishment licence granted by Swissmedic, or for the products to be authorised by Swissmedic.
Products containing tissues or cells cannot be cosmetic products in the normal sense for several reasons. The first is that the Cosmetics Ordinance (VKos / OCos)3 forbids the use of tissues or cells of human or animal origin in such products. Moreover, the Swiss Federal Ordinance on Foodstuffs and Articles of Daily Use (LGV / ODAlOUs)4 stipulates that a cosmetic is intended to enter into contact with the superficial parts of the human body. This is clearly not the case for stem cells, for example, which are applied by injection.
On the other hand, the Transplantation Act does not specifically foresee medical usage in the definition of transplant products. The message from the Federal Council to the Chambers nevertheless shows that transplantation, in all its forms, is intended to replace irreversibly damaged cells or tissues by healthy ones. It therefore also concerns aesthetic, reconstructive indications such as the reconstitution of the deep layers of skin after excessive exposure to the sun or deep wrinkles, for example.
From a legal point of view, treatments such as the injection of products based on stem cells, in examples such as that mentioned above, are in all cases subject to the Transplantation Act and, under certain conditions, to the Therapeutic Products Act, e.g. if the stem cells are subject to substantial manipulation.
Transplant products
According to the Transplantation Act, so-called "transplant products" i.e. products obtained from human or animal organs, tissues or cells which can be, or the production process for which can be, standardised (Article 3, letter d of the Transplantation Act), are governed simultaneously by the Transplantation Act and the TPA. The Transplantation Act does not, however, specify what is meant by "standardised". This concept must therefore be stated in concrete terms in order to permit firms to classify their products. Swissmedic and the Federal Office of Public Health have therefore decided to follow the European regulation 1394/2007/EC on advanced therapy medicinal products.
Tissues and cells that have been subject to substantial manipulation so that biological characteristics, physiological functions or structural properties relevant for the intended regeneration, repair or replacement are achieved are therefore classified as transplant products.
Cultivation with cell expansion, for example, is considered to be a substantial manipulation.
Following this same logic, tissues and cells that are implanted in a way that changes their function in the recipient after administration also fall within this category.
On the other hand, transplants that are only subject to manipulations such as filtering before being implanted, and whose characteristics or function are not modified once in the recipient, only fall within the area of application of the Transplantation Act. Swissmedic and the FOPH have retained, as manipulations that do not substantially modify tissues and cells, those actions listed in Annex 1 of the European Regulation cited above. The full list comprises cutting, grinding, shaping, centrifugation, soaking in antibiotic or antimicrobial solutions, sterilisation, irradiation, cell separation, concentration or purification, filtering, lyophilisation, freezing, cryopreservation, and vitrification.
Control by Swissmedic
Under these conditions, products based on tissues and cells, notably stem cells that are used in aesthetic medicine to regenerate, repair or replace cells or tissues, must be considered as transplant products. Firms that manufacture or commercialise them, including import, export or trading abroad, must obtain a Swissmedic establishment licence. The products themselves or their standardised manufacturing process must have been granted an authorisation issued by the same Agency or they may only be used within the framework of a controlled clinical trial.
As is the case for medicinal products, a product that has not been granted a market authorisation in Switzerland may be imported and used under the sole responsibility of the physician, for a defined patient, if the conditions of Article 36 of the Ordinance on Establishment Licences (ELO)5 are fulfilled.
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1RS 810.21
2RS 812.21
3RS 817.023.31 ; annex 4
4RS 817.02 ; art. 35, para. 1
5RS 812.212.1