In its decisions of 15 October 2024, the Federal Supreme Court dismissed the appeals by the holder of the product authorization and upheld Swissmedic’s reclassification of the emergency contraceptives B. (30 mg tablets and 30 mg film tablets) and C. (1.5 mg tablets) from Category C to Category B under the Therapeutic Products Act (TPA). The court affirmed that these reclassifications were legally sound and aligned with Swiss public health objectives.

The reclassification stemmed from the 2019 abolition of Category C, which necessitated a reassignment of these products. The TPA, which was in force until the end of 2018, classified medicines into one of five categories based on the active ingredients they contained. There were the prescription Categories A (prescription) and B (prescription with simplified dispensing option), the non-prescription Category C (available on consultation by qualified medical professionals) and D (available on consultation), and the over-the-counter category E. Initially designated as prescription-only (Category A) in 2012, they were reclassified to Category C in 2016. The move to Category B permits non-prescription dispensing but mandates consultation by qualified medical professionals, such as doctors or pharmacists.

The appellant sought a reclassification to Category D, arguing that the safety profiles of the products justified availability without medical advice. They asserted that trained druggists could safely dispense the products. Swissmedic countered that the active ingredients posed risks of side effects and drug interactions, necessitating oversight by medical professionals.

Substantively, the court assessed whether the reclassification to Category B was justified. The court underscored that the risks associated with the active ingredients required the specialized expertise of doctors or pharmacists. It concluded that Swissmedic’s decision to assign the products to Category B was both appropriate and proportionate.

The appellant also argued that the reclassification infringed on its economic rights by limiting the marketing and distribution of the products. The court determined that these restrictions were permissible under the TPA, balancing public health objectives with commercial considerations. It emphasized that Category B offers broader access compared to Category A, as dispensing remains non-prescription but subject to professional consultation, ensuring patient safety.

For more information, see here and here.