In 2019 the Administrative Court prohibited several companies from selling products containing CBD. The decisions were essentially based on the finding that the use of 'CBD' in the products' names amounted to a statement which presented them as having properties which treated medical conditions. Following these decisions, the Swedish Medical Products Agency seems to have widened the definition of 'medicinal products' when it prohibited two companies from selling oils which contain CBD.
In a recent case, the Patent and Market Court (PMC) elaborated on the concept of objective necessity to rebox medicinal products subject to parallel distribution in light of the implementation of the EU Falsified Medicines Regulation. The PMC's decision is a significant victory for originators, as it confirms that relabelling is still the main rule in Sweden and that reboxing remains the exception and requires evidentiary support of objective necessity by the parallel trader.
Both the Medical Products Agency and the Dental and Benefits Agency (the authority which decides on reimbursement) have long held the position that biosimilars are not interchangeable or substitutable with their reference products, which has been reiterated in different policy papers since 2007. This position has now been supported by an administrative court of appeal in a case relating to glatiramer acetate products used for the treatment of multiple sclerosis.
The Swedish system for medicinal products is generally product based. Prescriptions as such are product based (ie, by brand name or generic product name) and the indication for which the product is intended cannot be filled in anywhere by the prescriber. Off-label prescriptions are therefore not generally possible in the 'official' prescription system. However, when it comes to accessing unlicensed medicinal products, the system for licences on a named-patient basis works differently.
The Committee for the Review of Pharmaceutical Information recently confirmed the strict approach to the marketing of medicinal products in relation to pricing. The committee's findings serve as a reminder that companies should consider not only the intended purpose of offering a discount on a product, but also its actual effects. The case under review illustrates that an intended discount on a product may be considered contrary to the Ethical Rules for the Pharmaceutical Industry.