Facts
The company Max Ritter distributes the medication GAVISCON, manufactured by Ferring AB in Malmö, in Switzerland. In March 1977, the boxes of 24 and 48 tablets were registered on the specialties list at prices of CHF 6.25 and CHF 11.20 respectively. In December 1978, the company requested the registration of a large box of 200 tablets at a price of CHF 42.50. The Federal Social Insurance Office (OFAS) rejected this request in July 1979, considering that the savings of only 9% compared to the 48-tablet box were too low and that the large box was therefore too expensive.Considerations
The Federal Insurance Court first examines the scope of its power of review on the issue of the cost-effectiveness of medications. It considers that Art. 12 para. 6 and Art. 23 KVG constitute a sufficient legal basis for a review of cost-effectiveness that goes beyond a simple review of abuse. The argument based on the freedom of trade and industry is not well-founded, as in the field of social health insurance, manufacturers and importers of medications cannot invoke this principle to demand the registration of their products on the specialties list.
The Federal Insurance Court then examines the validity of the OFAS guidelines on price relationships between different packaging sizes. It considers that these guidelines, which are based on empirical data, do not require a specific legal basis and that their application is not…