Rare diseases legislation

Rare diseases present a major challenge to those affected and to the Swiss health system. On 12 September 2025 the Federal Council put a new federal act out for consultation, which is intended to improve the conditions for the implementation of measures to tackle rare diseases.

Background

In referring the two motions 21.3978 ‘For long-term financing of public health projects in the National Rare Disease Policy’ and 22.3379 ‘Strengthening and funding the patient organisations in the area of rare diseases’, the Federal Assembly mandated the Federal Council to improve the conditions for measures to tackle rare diseases, and to establish a basis for the sustainable financing of efforts to collect, process and disseminate health information.

Both motions were prompted by the Federal Council report on the legal basis to ensure rare disease care from 2021. The report showed that implementation of the National Rare Diseases Policy formulated in 2014 was reaching its limits in terms of the establishment of specialised care delivery structures and in terms of information and guidance provided by patient organisations to sufferers, family members and professionals. One of the reasons is the approach taken up until now whereby each actor provides the necessary funding for the implementation activities they undertake. The absence of a legal basis means that to date the federal government has only been able to provide ad hoc support. This legal basis will now be established.

Key features of the preliminary draft Federal Act on Measures to Tackle Rare Diseases

The new Federal Act on Measures to Tackle Rare Diseases will improve the conditions for the implementation of measures to tackle rare diseases and establish a basis for the sustainable financing of efforts to collect, process and disseminate health information. The preliminary draft of the new federal act provides for the following:

Rare diseases registry

The preliminary draft provides that the federal government will in future have the task of maintaining a rare disease registry, or delegating this task to a third party. The registry will provide basic information and evidence about the spread and evolution of the diseases in Switzerland, and support research in the area of rare diseases.

In this context, the legislation sets out a duty for medical professionals and healthcare institutions to report new diagnoses to the registry. Patients or their authorised representatives will have the right to opt out so that their data is not included in the registry.

There are also plans for the federal government to set up and operate a data coordination office for rare diseases. This will make it easier to reuse already collected data for research purposes and to evaluate diagnosis and treatment quality. Data privacy will be guaranteed at all times.

Financial support for the establishment, recognition and inspection of specialised care delivery structures

Specialised care delivery structures are necessary for better and more structured care for people with rare diseases. They include, for example, cross-diagnosis centres for rare diseases, reference centres and care networks.

Various structures are available to patients. The cross-diagnosis centres for rare diseases are contact points for people with symptoms but who are undiagnosed. Patients with a diagnosis will receive disease-specific care at reference centres and their networks.

These structures allow efficient collaboration between the stakeholders involved and help ensure that patients are able to access the most qualified professional as directly as possible.

The preliminary draft provides that the federal government can grant financial support for the establishment and recognition of specialised care structures. As the regulation of healthcare for people with a rare disease is the responsibility of the cantons – unless the federal government issues any other provisions – federal financial support is tied to cantonal contributions and can only be granted if the cantons at least match the contributions from the federal government.

Financial support for information and awareness activities

The preliminary draft provides for the possibility of the federal government granting financial support for information and awareness activities and for the organisation and running of training and continuing education on rare diseases. This is intended to empower patient organisations in particular as through their activities they help sufferers navigate the health system and help improve the health literacy of patients and their family members. In addition, patient organisations often pool all the available empirical knowledge from patients and can combine this with the expertise of care providers.

Financial aid can also be granted to support self-help groups. Federal financial aid is only granted if the cantons make a contribution of the same amount.

Next steps

The consultation is set to run until 12 December 2025.

Opinions can be recorded electronically during the consultation period, if possible via the new Consultations platform.

If you are unable to use this tool, you can write your opinion in the form of a document (preferably in Word) and upload it to the Consultations platform under ‘Stellungnahmen’, or email it to the following addresses:
tarife-grundlagen@bag.admin.ch and gever@bag.admin.ch

The consultation documents can also be obtained via the Federal Chancellery: Laufende Vernehmlassungen (ongoing consultations).

Further information

Further topics

Rare diseases

Although rare diseases may be individually rare, they are collectively common. In Switzerland, over half a million people are affected by a rare disease.

Rare diseases in Switzerland and the national policy

A series of practical measures was implemented between 2014 and 2019 as part of the National Rare Disease Policy with the aim of improving care for people living with rare diseases throughout the course of their illness.

Rare diseases: useful information for patients and their families

Not only are the individual diseases rare, but there is little specialist knowledge about them. In order to improve care, efforts are now being made to pool expertise and share information more effectively.