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 opened the consultation process on a new federal act intended to improve the framework conditions for the healthcare of these individuals. At its meeting on 2 September 2026, the Federal Council took note of the results of the consultation process and decided to implement the legislative work in two stages.
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 framework conditions for the healthcare of people with rare diseases and to establish a basis for the sustainable funding of specific information measures.
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 people with rare diseases, 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 Swiss Confederation has only been able to provide ad hoc support. This legal basis will now be established.
Key features of the preliminary draft Federal Act
The new Federal Act on Measures to Tackle Rare Diseases intends to improve research and the healthcare situation of persons with rare diseases, as well as to support the dissemination of health-related information on rare diseases to the public. Specifically, it will establish the federal legal basis for financial assistance in the areas of healthcare delivery structures and information activities, as well as for a national rare diseases registry.
Financial assistance for the identification, designation and verification 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 Confederation may grant financial assistance for the identification and verification of specialised healthcare delivery structures. Federal financial assistance is linked to the contributions provided by the cantons and may only be granted if the cantons collectively contribute at least an equivalent amount.
Financial assistance for information and awareness activities
The preliminary draft provides for the possibility of the Swiss Confederation granting financial assistance 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 people with rare diseases 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.
Federal financial aid is only granted if the cantons make a contribution of the same amount.
National 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.
Next steps
At its meeting on 2 September 2026, the Federal Council decided to implement the legislative work in two stages.
First stage: Financial assistance for healthcare delivery structures and information activities
In a first stage, the Federal Council will submit the dispatch on the first legislative proposal to Parliament by spring 2027. The aim is to establish the basis for federal financial assistance for the identification, designation and verification of specialised healthcare delivery structures for rare diseases, as well as for information and advisory activities. In the Federal Council’s view, such financial assistance is necessary to ensure the long-term financial stability of these activities and to safeguard the Confederation’s efforts in these areas to date.
Second stage: Establishment of a registry aligned with DigiSanté
In a second stage, the Federal Department of Home Affairs (FDHA) will submit a legislative proposal for a national rare diseases registry to the Federal Council by 2030. Scheduling the legislative work in two stages will make it possible to align the work on the registry with the ongoing efforts relating to the digital transformation of the healthcare system, in particular with the DigiSanté programme. Feedback received during the consultation process showed that such alignment is necessary in order to leverage synergies, avoid duplication in the design of digital processes and infrastructures, and reduce the associated costs. It will also help to minimise the additional administrative burden on healthcare professionals subject to reporting obligations.
Further information
Index
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.
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