At present there are no authorised medicinal products for the treatment of COVID-19 or any vaccines to prevent infections with the new coronavirus SARS-CoV-2. It is permissible to use authorised medicinal products which, in the light of initial experience abroad, might be suitable for the treatment of COVID-19 on an off-label basis – i.e. for an indication other than the approved one(s) – or in a clinical trial. Responsibility lies with the treating physicians, who are required by law to inform patients about the off-label use of the medicine concerned and to discuss the risks and side effects with them.
Use of medicinal products for indications other than those authorised
03.04.2020
As a matter of principle, doctors are free to prescribe ready-to-use medicinal products that are authorised in Switzerland or a country with a comparable control system for medicinal products (cf. Swissmedic list of countries) for the treatment of specific diseases, even if these do not feature among the authorised indications.
The deviation from the use approved by the responsible authorities as per the information for healthcare professionals may relate to the indications, uses, dosage or type of administration or to use in a specific group of patients.
Key aspects relating to the off-label use of ready-to-use medicinal products are:
- responsibility for off-label use rests with the treating physician
- as part of his/her duty of care, this doctor must inform the patient about the off-label use
- and obtain the patient’s consent.
Rechtliche Grundlagen im medizinischen Alltag. Ein Leitfaden für die Praxis.
Chapter 3.10, (“Off-Label Use”, “Unlicensed Use” und “Compassionate Use”).
Swiss Academy of Medical Sciences/Swiss Medical Association (2020)
www.samw.ch (available in German and French)
Swiss Academy of Medical Sciences/Swiss Medical Association (2020)
www.samw.ch (available in German and French)
Positionspapier 0007 V02 Empfehlungen zum Off Label Use von Arzneimitteln
(www.kantonsapotheker.ch)
(available in German and French)
(available in German and French)
If no authorised medicines are available, off-label use may be essential, e.g. in the context of new diseases, oncology, or paediatric disorders that require the use of products that are not authorised for the age group concerned. Recourse is also had to off-label use in the case of rare diseases for which – owing to the limited number of patients – no properly researched and authorised medicines are available.
Federal legislation on therapeutic products only lays down guidelines on the dispensing and use of medicinal products, leaving their precise interpretation largely to cantonal legislators. Responsibility for issues relating to off-label use, as well as supervision of the medical profession, lies with the cantons.