Submitted text
In response to the Motion 18.4203 informed that the conditions are in place to make as much patient data as possible available to human research in Switzerland in a structured and anonymized form.
Research based on patient data is very important for our country in several ways: for research in universities and industry on the one hand, and for our national economy on the other. Compared to various other countries that have already made such data available, Switzerland is lagging behind.
To this end, the following questions:
1. do the companies of the Swiss pharmaceutical industry and the universities know the procedure for obtaining such data?
2. are such data already usable for interested Swiss companies and universities?
3. when will all preliminary work be completed so that research can be carried out domestically by companies and universities on the basis of such data?
Answer of the Federal Council from 29.5.19
The goal of the national funding initiative “Swiss Personalized Health Network“ (SPHN) is to establish a nationally coordinated data infrastructure and thus create the conditions to enable the exchange of clinical data necessary for research. In addition to questions of access to these data, the focus is particularly on the harmonization of local and regional information systems as well as data interoperability at the national level. The As a result, patient data remains with the hospitals and is made available to research directly from there via a decentrally organized infrastructure..
1. the Swiss universities as well as the university hospitals are involved in the SPHN initiative as key stakeholders and are informed about the ongoing SPHN activities through their representatives in the steering committee. In 2017, discussions were held with all five university hospitals Performance agreements completed in order to Establishment of compatible clinical data management systems (with CHF 3 million per hospital). In addition, two calls for proposals were issued in 2017 and 2018 to test the development of the data infrastructure on the basis of pathology-specific projects, among others. In principle, companies can participate in such projects as partners of universities (however, commercial use of the data is excluded).
The goal of the first, current phase (2017−2020) is to build a secure IT infrastructurewhich enables these research institutions to make health-related personal data (primarily clinical data), which are particularly worthy of protection, accessible for research under correspondingly high security and data protection standards. In addition, the requirements of the Human Research Act (HRA; SR 810.30) must be complied with so that the right to informational self-determination of the patients from whom the data originate is safeguarded.
2 In principle, such clinical data can already be used for research projects at Swiss universities, if these have been released by the patients for the research (“informed consent”). Furthermore, a contractual agreement between the academic research institutions and the hospitals is required, as well as a Approval of the competent ethics committee for the respective research project. In case of a regulated collaboration with the respective hospitals – e.g. in the context of contract research with participation of industry as sponsor or in collaboration projects – this is also possible, outside the SPHN, for Swiss companies.
3. the Setting up the IT infrastructurewhich connects the university hospitals and the research institutions, is to be Completed by the end of 2020 be. By this time, the first central services and uniform standards for data linkage should also have been established. The development of uniform specifications throughout Switzerland for the consent of patients to the further use of their health data for research should also be completed by then. Furthermore, it is important to note that the provision of clinical data in high quality and by means of uniform semantics is a long-term process that will extend beyond 2020. The goal of the second phase 2021 – 2024 is to consolidate the research infrastructure with clinical data nationally and to integrate other important data sets, such as the cohort studies or the data of the biobank platform.