As Switzerland is not a member of the European Union, it is not obliged to implement European legislation into national legislation. Instead, different laws and regulations of the Federal Council and the Agency Council are to be applied when dealing with drugs and medical devices. With regard to clinical research, this article deals with the most important legal bases in Switzerland.
The Swiss Federal Act on Medicinal Products and Medical Devices came into effect on 01.01.2002. It is also referred to as the Therapeutic Products Act (TPA) and concerns drugs (human and veterinary drugs) as well as medical devices. In addition to the general-purpose TPA, the Federal Act on Research involving Human Beings (Human Research Act, HRA) is of significant importance for clinical trials. Other essential regulations are the Ordinance on Clinical Trials in Human Research (Clinical Trials Ordinance, ClinO) and – for observational studies – the Ordinance on Human Research with the Exception of Clinical Trials (Human Research Ordinance, HRO).
For additional information regarding all legal bases, please refer to the website of the Swiss Agency for Therapeutic Products:
In Switzerland, clinical trials with drugs and medical devices are subject to the ClinO. In a simplified scheme, clinical trials with drugs are classified into the categories A, B and C. For more information, please refer to the ClinO (Art. 19).
|– authorised in Switzerland||x||x|
|– administered as specified in the Summary of Product Characteristics||x|
For medical device trials, there is the classification into the categories A and C. Please refer to ClinO (Art. 20) for more information.
|– bearing the CE mark||x|
|– applied in accordance with the operating instructions||x|
|– with an application ban in Switzerland||x|
In Switzerland, clinical trials with drugs and medical devices of category A must be approved by the responsible Cantonal Ethics Committee before being conducted. In addition to the approval by the Cantonal Ethics Committee, clinical trials with drugs and medical devices in categories B and C require additional authorisation from Swissmedic.
In accordance with the HRO (Art. 6), research projects are defined as observational studies, in which “biological material is sampled or health-related personal data is collected from a person”. In accordance with the HRO (Art. 7) these trials are classified into the categories A and B:
|Study-related measures with||A||B|
|– minimal risks and strains||x|
|– more than minimal risks and strains||x|
It should be noted that the aforementioned “risks and strains” do not refer to the actual treatment but exclusively to additional study-related measures. Research projects that are subject to the HRO only need to be approved by the responsible Cantonal Ethics Committee before commencing.