Switzerland has a long tradition of clinical research and the medical care provided at its university hospitals is outstanding. Yet the number of clinical trials performed in Switzerland has been declining for years, due to low patient numbers, decentralised and in some instances time-consuming processes involving the Ethics Committees, and slow recruitment combined with growing international competition. High costs and the multilingual nature of the country are further disadvantages for organisations working on networked research projects. They inhibit investment in the Swiss research landscape. Against this background, the framework conditions for research take on a central role.
Research in humans is indispensable in order to study the causes of diseases and develop new methods for diagnosis, therapy and prevention. New treatment methods, such as new medicines or surgical techniques, can only be used for the benefit of patients if they have first been tested for efficacy, tolerability and safety.
Before a medicinal product is authorised, its efficacy and safety must be demonstrated in clinical trials. Globally recognised legal principles exist to protect the dignity of humans in research and to safeguard the rights of the individual. The Swiss legislation governing clinical research is based largely on these standards. At the same time, the freedom of research is of central importance to progress in medicine. New findings lead to better diagnosis and therapeutic outcomes and can help to prevent diseases.
Human Research Act and constitutional provisions
The Human Research Act uniformly and comprehensively regulates research involving humans in Switzerland. The Constitution regulates fundamental aspects of information and consent to a research project and the risks and inconveniences for participants. Particular care is taken to protect individuals not capable of judgement, such as children or people with disabilities. Finally, the Constitution requires every research project to be reviewed to ensure that those participating in it are protected. The Federal Act on Research involving Human Beings (Human Research Act) specifies the article of the Constitution in more detail. It is designed to protect the dignity, identity and health of humans in research. It is also intended to create favourable framework conditions for research involving humans, help to ensure the quality of human research and ensure the transparency of human research.
In addition to the Human Research Act, other legislation governs individual aspects of research involving humans, e.g. the Therapeutic Products Act (TPA), which regulates clinical trials with medicinal products and medical devices, the Transplantation Act, and the Stem Cell Research Act (StRA). The Swiss Academy of Medical Sciences (SAMS) has additionally drawn up medical and ethical guidelines for research involving humans and for biobanks. Finally, the legislation is Switzerland is guided by the internationally recognised guidelines for Good Clinical Practice (GCP) based on the Declaration of Helsinki developed by the World Medical Association. The Swiss Pharma Cooperation Code is also based on these principles.