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Compliance and enforcement


What measures are in place to enforce the laws governing medicinal products?

The Federal Agency for Therapeutic Products (Swissmedic) and the competent cantonal authorities (generally the Department of Health) are responsible for the supervision of manufacturing, distribution and marketing activities. They supervise the Swiss market in general, as well as the individuals manufacturing, distributing and marketing medicines. A specific investigation is opened if either Swissmedic or the cantonal authorities discover any violation during their supervision or if a violation is notified to them.

Swissmedic and the cantonal authorities may carry out any necessary investigation into a specific incident, and the parties involved have the obligation to cooperate fully in this investigation. In particular, Swissmedic or the cantonal authorities may take samples, demand information and essential documents and request any necessary help for this purpose. Swissmedic or, in the case of a serious and immediate threat to health, the cantonal authorities, may take all necessary administrative measures in order to remedy a breach of the applicable rules (see Article 66 of the Therapeutic Products Act).

Dishonest practices

What mechanisms are in place to combat bribery, fraud, collusion, counterfeiting and other dishonest practices in the pharmaceutical sector?

Apart from general provisions of the Criminal Code and the Cartel Act, specific criminal provisions in the Therapeutic Products Act and the Health Insurance Act apply in particular regarding bribery (see Article 86 and following of the Therapeutic Products Act and Article 92 of the Health Insurance Act). Professional codes provide for the possibility of additional measures in case their provisions have been violated (see Number 637 of the Code of Conduct of the Pharmaceutical Industry in Switzerland (Pharma Code) and Number 537 of the Code of Conduct of the Pharmaceutical Industry in Switzerland on cooperation with healthcare professional circles and patient organisations (Pharma Cooperation Code)).

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