05.08.2024
Swissmedic has made an initial assessment of the Sarco suicide capsule according to therapeutic products legislation. Based on the publicly available information, the Agency for Therapeutic Products does not categorise the capsule as a therapeutic product.
Various enquiries from private individuals, the media and authorities over recent weeks have shown that there is considerable interest in the Sarco suicide capsule.
Swissmedic has therefore qualified the device according to the regulations and therapeutic product legislation and has concluded that its purpose fundamentally contradicts the medical purpose of a therapeutic product.
The primary objective of the Therapeutic Products Act is to protect the health of humans and animals, which is why only high-quality, safe and effective therapeutic products (medicinal products and medical devices) may be placed on the market.
Not a medicinal product
The nitrogen gas used in the capsule is not a medicinal product. The element of a medicinal product that is intended to have a particular pharmacological effect in a patient’s body is classified as its active substance.
By contrast, according to the function published by the provider, the nitrogen used in the suicide capsule serves only to change the composition of the air in the closed capsule: it displaces the oxygen, resulting in the suffocation of the person wishing to die.
Not a medical device
Medical devices are also differentiated from other devices on the basis of their medical purpose, as this purpose (diagnosis, prevention, treatment and alleviation of disease or injuries) is the key requirement for qualification and classification as a medical device.
The general safety and performance requirements for such devices are intended to guarantee that they ensure a high level of health protection and do not endanger the clinical condition and safety of patients.
A device that is used solely for suicide contradicts the medical purpose under therapeutic products legislation and cannot be classified as a medical device.
In view of the unresolved question regarding what legislation applies to this new device, further regulatory clarifications on the qualification and legitimation of the device from a legal, health policy and ethical perspective would appear to be advisable, along with a broad-based public discussion.
Information on the regulation of medical devices
The media is also incorrectly reporting that medical devices are authorised by Swissmedic.
In both Switzerland and Europe, medical devices are not authorised by a regulatory authority. Consequently, Swissmedic is not involved in any market access process.
Medical device suppliers determine the requirements of their devices themselves and can place them on the market within Europe under their own responsibility based on conformity assessment procedures.
Accordingly, under therapeutic products legislation, Swissmedic’s focus in the area of medical devices is on surveillance.
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