Facts
[X. AG] markets the medicinal product [Y.] , an anorectic containing the active substance phenylpropanolamine hydrochloride (PPA). The product was registered in 1998 as a generic of the original product [Z.] . As part of a group revision procedure, the Swiss Agency for Therapeutic Products Swissmedic reviewed the safety and efficacy of the product. Based on new studies showing an increased risk of intracranial bleeding with PPA-containing medicinal products, Swissmedic demanded that [X. AG] provide evidence of the long-term benefits and safety of the product. As [X. AG] was unable to provide this evidence, Swissmedic revoked the marketing authorisation for the medicinal product [Y.] .Considerations
The Federal Supreme Court confirmed the revocation of the marketing authorisation. It stated that Swissmedic was entitled under the Therapeutic Products Act to demand the submission of new evidence on the safety and efficacy of the product. The appellant was unable to demonstrate that the short-term weight loss achieved with the use of the product…