Pricing of Medicinal Products

In the Republic of Slovenia, the pricing of medicinal products is regulated by the Medicinal Products Act (Uradni list RS [Official Gazette of the Republic of Slovenia], No. 17/14) and falls within the competence of the Public Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (hereinafter: JAZMP), while their financing from public revenues is regulated by the Health Care and Health Insurance Act and falls within the competence of the Health Insurance Institute of Slovenia (hereinafter: ZZZS). Both acts are compliante with EU Directive 98/105/EEC. That directive regulates only the fundamental procedural parameters, while the choice of pricing model and pricing policy-making rests with the Republic of Slovenia.

JAZMP is the national authority competent for the pricing of medicinal products for human use that are financed from public revenues. The procedures for medicinal product pricing are based on provisions of the Medicinal Products Act and the Rules on the Pricing of Medicinal Products for Human Use (Uradni list RS, No. 32/15, 15/16, 19/18 and 11/19). The regulations lay down in detail the criteria and procedures for the determining, amending and publication of regulated prices of medicinal products.

In accordance with EU recommendations, pricing regulation in Slovenia applies only to those medicinal products that are financed from public revenues. Like the majority of other countries, Slovenia has introduced an external price referencing. The model takes into account the prices of medicinal products in Germany, Austria and France. The determined regulated price is the highest price, allowed for marketing of a medicinal product. The Medicinal Products Act enables medicinal product providers, payers and buyers to negotiate prices that are below the determined regulated price.