Prosecution under penal law for violations of legislation on therapeutic products is one of Swissmedic's core processes (in addition to licensing, authorisation and market monitoring).
Prosecution
Swissmedic's competence with regard to penal prosecution includes offences against legislation on therapeutic products as long as the enforcement measures fall within the area of responsibility of the Agency (see Art. 90, Therapeutic Products Act, TPA).
Violations in connection with the use and dispensing of therapeutic products are, however, the responsibility of the Cantonal prosecution authorities. For cases that fall within the competence of both Swissmedic and of the Cantons, Swissmedic may delegate its area of responsibility to the Cantonal prosecutor's office and by doing so initiate the so-called unification of proceedings.
Swissmedic may impose fines and penalties, as well as take measures (e.g. confiscations) directly, in the form of summary penalty orders and rulings. If custodial sentences come into question, it is mandatory for the sentence to be passed by a Cantonal court. Should the case come before a court, Swissmedic represents the prosecution.
The Penal Division
Swissmedic's work in the area of penal issues is carried out by the Penal Division, which is part of the Legal Affairs sector. At present, the division consists of eight investigators-in-charge. Prosecution by the Agency is handled by officials with specific training in this field. They have competences comparable to those of public prosecutors; in particular, they may carry out investigations and coercive measures such as making seizures and house searches, demanding that documents be surrendered, or having suspects arrested.
Provision of legal assistance
In the area of international crime related to therapeutic products, Swissmedic is involved in providing legal assistance to foreign authorities.
Foreign prosecution authorities may approach Switzerland when they require information for their penal proceedings. In principle, the responsibility for responding to such requests is that of the Federal Office of Justice (FOJ). The FOJ may delegate the responsibility for handling such a request to the prosecution authority competent for enforcement in that area, if the act concerned took place in Switzerland. In concrete terms, this means that the FOJ can delegate the handling of such a request for legal assistance either entirely or partially to Swissmedic if the act represents a violation of legislation on therapeutic products that falls within the area of competence of the Agency.
For further information:
Legal basis
In addition to the provisions regarding penal law in the Therapeutic Products Act (Art. 86 et. seq.), the following legal provisions are of particular relevance:
Federal Law on Administrative Criminal Law (ACL)
(www.admin.ch; available in German, French or Italian)