New regulations in the Medicinal Products Act (SFS: 1992:859) (the “Act”) regarding the marketing of pharmaceuticals came into force in May 2006. The Swedish Medical Products Agency (the “SMPA”) has already stopped around 40 cases of undue marketing.
The new regulations in the the Act are part of the implementation of Directives 2004/24/EC, 2004/27/EC and 2004/28/EC which aim to develop the inner market for pharmaceuticals in Europe. As a result of the new regulations, the SMPA now supervises the marketing of pharmaceuticals in Sweden.
This supervision has up until last year been performed by two bodies established by the pharmaceutical industry, to which the industry as well as the SMPA reported possible violations of the marketing regulations. The SMPA could however, even prior to the new regulations, impose certain measures, such as fines, in cases of undue marketing but its authority has now been clarified and somewhat extended.
The SMPA is now given the authority to directly contact the companies and present a demand, under penalty of a fine, for the undue marketing to cease. Around 40 cases of undue marketing of pharmaceuticals have been stopped by the SMPA since the new regulations came into force in May 2006. The supervision by the two industry bodies remains in place and most cases of potential undue marketing are still examined in this way.
It remains to be seen what kind of impact the SMPA’s ability to act on its own (and its apparent willingness to do so) will have on the marketing of pharmaceutical products in Sweden.