The national concept for rare diseases in Switzerland and the role of kosek

What the national concept is

The national concept for rare diseases is the Swiss policy framework for improving care, diagnosis and information in rare diseases. The Federal Council adopted it in 2014 and implementation began in 2015. It set the direction for structures that did not exist before, notably the coordinated recognition of specialist centres.

It is a policy framework, not a legal basis for authorisation or reimbursement. Decisions about medicines continue to be taken under the Therapeutic Products Act by Swissmedic and under the Health Insurance Ordinance by the Federal Office of Public Health and the insurers.

kosek and the recognition of centres

kosek, the national coordination for rare diseases, is the body that recognises centres and reference centres at university and cantonal hospitals. Recognition gives patients and referring physicians a way to identify where expertise for a given group of diseases is concentrated, instead of relying on informal reputation.

A reference centre concentrates expertise for a group of diseases at national level, while a recognised centre provides specialist care closer to the patient. The two levels together are what makes referral in a rare disease a structured step rather than a matter of chance.

• kosek is the national coordination for rare diseases in Switzerland.
• It recognises centres and reference centres at university and cantonal hospitals.
• Recognition makes expertise identifiable for patients and referring physicians.

How large the field is

Rare diseases are individually rare and collectively common. Estimates put the share of the population affected at 7 to 8 per cent, and more than 6,000 rare diseases are known. Both figures are estimates and should be handled as such, but they explain why a national framework was considered necessary at all.

The regulatory picture is narrower than the epidemiological one. The Swissmedic list of medicinal products with orphan drug status behind this site covers 220 rare diseases as of 18/09/2026, against more than 6,000 known rare diseases. Most rare diseases have no medicine with orphan drug status in Switzerland.

The gap between the two numbers is the practical reality of rare disease care in Switzerland. For most patients the question is not which authorised orphan drug to choose, but whether any therapy exists at all and how access to it can be organised.

The patient pathway to diagnosis and care

The pathway in a rare disease usually runs through several levels of care before a diagnosis is reached. The national concept and kosek recognition are meant to shorten that route by making the specialist level findable. Patient organisations and information portals sit alongside the clinical structures at every step.

1. Initial presentation in primary or general specialist care, often with non-specific symptoms.
2. Referral to a specialist department at a cantonal or university hospital.
3. Referral to a centre or reference centre recognised by kosek for the disease group concerned.
4. Diagnostic work-up at the centre and definition of the treatment plan.
5. Continuing care shared between the centre and local providers, with reimbursement questions settled separately under the Health Insurance Ordinance.

Each handover is a point at which time is lost. That is the specific problem the recognition of centres addresses: it shortens the search for the right specialist level rather than changing what happens once the patient arrives there.

Information and representation alongside the clinical structures

Two organisations complete the picture. ProRaris, the Swiss rare disease alliance founded in 2010, represents the patient organisations. Orphanet runs a Swiss national portal with diagnoses, centres and trials, which is the practical entry point for anyone looking for information on a specific disease.

• ProRaris: the Swiss rare disease alliance, founded in 2010, representing the patient organisations.
• Orphanet Switzerland: a national portal covering diagnoses, centres and clinical trials.
• kosek: recognition of centres and reference centres at university and cantonal hospitals.

The three play different roles and none replaces the others. kosek organises the clinical structures, ProRaris carries the collective patient voice, and Orphanet makes disease-level information findable for patients, relatives and referring physicians alike.

Where the concept meets regulation and reimbursement

The national concept organises care; it does not decide on medicines. Authorisation and orphan drug status sit with Swissmedic under the Therapeutic Products Act and the TPLO, and reimbursement sits with the Federal Office of Public Health and the insurers under the Health Insurance Ordinance. The three systems intersect in the individual patient.

Reading the three systems together is therefore part of the work in a rare disease. The care structures say where a patient should be treated, the Therapeutic Products Act says what may be used, and the Health Insurance Ordinance says what is paid for, and only the last two carry an entitlement.

That separation explains a recurring frustration. A recognised centre may identify a therapy that is not authorised in Switzerland or not on the specialities list, at which point access depends on Art. 71a to 71d KVV or on individual import under Art. 49 MPLO rather than on the care structure.