Medicinal product safety

Patient safety has always been the top priority both for the legislator and for the research-based pharmaceutical industry. In Switzerland, Swissmedic, the Swiss Agency for Therapeutic Products, is responsible for the safety of therapeutic products and enforcement of the Therapeutic Products Act (TPA). The Therapeutic Products Act requires anyone who handles medicinal products to adopt all the measures commensurate with the state of science and technology to ensure that the health of humans and animals is not endangered.

Safety in official channels

Companies that manufacture or distribute medicinal products in Switzerland (including import, wholesale, export and foreign trade activities) require an establishment licence from Swissmedic. An establishment licence is issued by Swissmedic following a successful inspection. Switzerland is the only country that requires a licence to be held for trade in medicinal products outside the country. The regulations governing the trade in medicinal products are even stricter within the country. As a result, according to Swissmedic, counterfeit medicines have never been found in the official distribution channels.

The Therapeutic Products Act authorises Swissmedic to confiscate, impound or destroy therapeutic products that are harmful to health or not compliant with the law. Furthermore, Swissmedic can forbid and prosecute the sale, distribution, import, export and trade in such products in other countries. Nowadays, it is a punishable offence to endanger people’s health by failing to take the necessary care when handling medicinal products, and to manufacture, place on the market, prescribe, import, export or trade outside Switzerland in medicinal products without an authorisation or a licence.

Measures for greater safety of medicines

The revised Therapeutic Products Act that came into force at the start of 2019 brings about further improvements to the safety of medicines. The enforcement authorities are no longer required to prove that the health of patients could be endangered if they suspect that a medicine is counterfeit. This is almost impossible to prove. In many cases the patients are unknown, or doctors are required to maintain medical confidentiality. Today the potential endangerment of health is a punishable offence.

There is unfortunately no absolute protection against counterfeit medicines and misuse. Because of the potentially serious health implications, a major effort is made both internationally and in Switzerland to prevent the manufacture and distribution of unsafe or counterfeit medicines. A package of measures and precautions is ultimately in place with the aim of ensuring the safety of medicines in Switzerland. These include the authorisation of medicinal products by Swissmedic and the fight against counterfeiting.