The Voltarol case

We represented GlaxoSmithKline (GSK) in proceedings against the Norwegian Medicines Agency for invalidation of an advertising prohibition for the pharmaceutical product Voltarol. The Oslo Court of Execution and Enforcement rendered an order in favour of GSK for deferred implementation of the decision, as the Court concluded that it had not been demonstrated, on the balance of probabilities, that the prerequisites for imposing such an advertising prohibition were in place. The Ministry of Health and Care Services subsequently overturned the decision of the Norwegian Medicines Agency because it had exceeded its regulatory powers and committed procedural error. The ruling is of fundamental importance in that it defines a high threshold for imposing such an advertising prohibition, whilst at the same time stipulating stringent requirements as to the administrative procedures applied by the Norwegian Medicines Agency in its monitoring of pharmaceuticals advertising.