The Cost of Orphan Drugs: the Swiss Perspective

Switzerland is lagging behind European developments in the field of rare diseases. In 2014, the Federal Council adopted the National Concept for Rare Diseases and instructed the Federal Office of Public Health (FOPH) to develop an implementation plan. The FOPH then drew up a plan for the implementation of the 19 measures together with the stakeholders concerned. This also includes an improvement in the reimbursement of costs for orphan drugs. The original plan was to complete implementation by 31 December 2017. However, the definition of the process for designating reference centers/supply networks has been delayed by 2 years. Many measures of the concept depend on these designations and could not be completed. Like EU law, Swiss law also recognizes orphan drug status. The Swiss Agency for Therapeutic Products (Swissmedic) maintains a publicly accessible list of all medicinal products with orphan drug status. The reimbursement of the costs of orphan drugs by the basic health insurance funds is problematic. Although Swissmedic decides on the granting of orphan drug status and on the authorization of medicinal products, the FOPH is responsible for pricing and for deciding on their eligibility for reimbursement. In such cases, health insurers have a great deal of leeway when it comes to reimbursing costs, which can lead to considerable (legal) uncertainty for patients affected.