What is a rare disease?

    In Switzerland, a rare disease is defined as a life-threatening or chronically debilitating condition that affects less than 5 in 10,000 people. There are between 6,000 and 8,000 rare diseases identified worldwide, with 75% affecting children and 80% having a genetic origin. While the number of people affected by a single disease is low, is estimated that 7% of the Swiss population, i.e. more than half a million persons, lives with a rare disease.

    Swiss policy on rare diseases

    The limited number of patients per disease and the inherent challenges for research and drug development mean that special incentives are required to support the development of orphan drugs. Accordingly, various incentives such as a simplified authorization procedure and provisions for data exclusivity have been introduced over recent years in Switzerland. The Swiss policy on rare diseases has been based on the National Rare Disease Policy, adopted in 2014. The strategy defined 8 areas for actions, incl. access to diagnosis and therapy, support for patients and networking.

    Patient access to diagnosis and treatment for rare diseases in Switzerland

    In Switzerland, orphan drugs authorized by Swissmedic are reimbursed by compulsory health insurance if they are included in the Specialties List (SL) established by the Swiss Federal Office of Public Health, or FOPH (Bundesamt für Gesundheit, or BAG / Office Fédéral de la Santé Publique, or OFSP). Orphan drugs that are not included in the SL can be reimbursed via an alternative pathway, art. 71a-d of the Swiss Ordinance on Compulsory Healthcare (Verordnung über die Krankenversicherung, or KVV / Ordonnance sur l’assurance-maladie, or OAMal), if they fulfill certain criteria.

    In December 2020, the BAG published an evaluation report on this regime. The report underlines the important role played by this regime in reinforcing patient access to treatment but also highlights several shortcomings in the implementation of the KVV provisions, including the divergence in benefit assessments of treatment options by insurers (the RDAF submitted a statement on the report and the policy options to revise the regime). Based on the evaluation findings, the Swiss Federal Council decided to revise the Ordinance on Compulsory Healthcare. The revision aims to address the shortcomings identified in the evaluation report.

    Latest developments in the rare disease policy

    On 1 June 2022, the National Council of the Swiss Parliament adopted two motions to support activities in the field of rare diseases:

    • Motion 21.3978 mandating the Federal to create a legal basis to ensure the sustainable funding of measures to implement the national concept for rare diseases. The motion, adopted by both chambers, will be treated by the Federal Council,
    • Motion 22.3379 tasking the Federal Council to create a legal basis to fund information, advice and coordination activities carried out by patient organizations. The motion is under discussion within the Council of States.