Sweden ∙ Pharmaceutical Advertising In Sweden: Two New Guiding Decisions By The Industry’s Self-Regulatory Bodies

Abstract

The Information Examiner Committee (‘IGN’) and the Information Practices Committee (‘NBL’) recently rendered two decisions, each shedding new light on two important pharmaceutical advertising matters in Sweden. The NBL’s decision addressed the demarcation between pharmaceutical information issued for marketing purposes on the one hand, and press releases as protected by freedom of speech on the other. In exploring the boundaries of freedom of speech, a key provision for the NBL to consider was the prohibition against marketing unauthorised medicinal products under Chapter 12, Section 1 of the Medicinal Products Act (SFS 2015:315) (‘Medicinal Products Act’). The IGN’s decision, in turn, provided some clarity on the scope of the communication on medicinal products that may legally take place between a contracting authority and a pharmaceutical company in the procurement context. This case thus mainly centred on Article 2 of the LER rules, which states that all information provided on a medicinal product must be based directly on the SmPC of that product.