Submitted text
(1) The Federal Council is instructed to report to parliament on the implementation of the Motion Ettlin 21.3957 “Digital Transformation in Healthcare. Catching up at last!” a concrete Present a master plan that reliably sets out and demonstrates the digitization targets in terms of time and contenthow they are to be achieved.
In the process of digitization in healthcare, the legally defined, uniform standards and existing databases are to be used and further developed, provided they are not profit-oriented or state-supervised.
The Federal Council reports annually to Parliament on the status of the digital transformation in healthcare.
2 The Federal Council is also instructed to use the SMVS data (Swiss Medicines Verification System) for the digital management of supply shortages for human medicines and to create a legal basis for this.
To ensure that the SMVS data set is always complete and reliable, the Federal Council must include in the Ordinance on Individual Identification Marks and Safety Devices on the Packaging of Medicinal Products for Human Use the affixing and verification of the Declare safety features and devices mandatory – same as in the EU.
Justification
1. the Motion Ettlin 21.3957 “Digital transformation in healthcare. Finally catching up!” was unanimously passed by the National Council and the Council of States against the will of the Federal Council. The implementation of this motion must now be tackled quickly, and Parliament should play a leading role in this.
For a unanimous will of the National Council and the Council of States is undoubtedly extremely rare. If it comes about, the motion deserves absolute priority treatment in terms of time and content. Therefore, the Federal Council is instructed to immediately present a master plan for the implementation of the digital transformation in healthcare, which is to be approved by SGK‑S and SGK‑N. In addition, annual reporting by the Federal Council to parliament on the status of implementation of the master plan is required.
2 The number and severity of drug shortages in Switzerland have been increasing for years and the situation continues to worsen. The FOPH report “Supply shortages of human medicines” calls for: “In the future, the development of a national database is desirable so that the current situation regarding drug shortages can be monitored, identified and documented, and their causes can be investigated.”
The SMVS database was created on the basis of Article 17a HMG by a non-profit association on behalf of the federal government in order to increase the security against counterfeiting of prescription drugs in Switzerland. It was paid for by the industry, it is organized as a limited liability company owned by the non-profit association, and as a particularly important advantage, it has a full connection to the European medicines database. This means that prescription drugs from Switzerland and the European market can be verified for authenticity in a fraction of a second.
With a legal basis, the data in the SMVS database can also be used to serve the FOPH, FONES and army pharmacy authorities as a reliable planning tool for anticipating, identifying and managing supply gaps. It electronically provides a daily updated overview of the number and availability of all prescription drug packages in Switzerland. Instead of going to great expense to create a new, national database without a connection to the European medicines database, it is financially and time-wise advantageous to use the data already available in the SMVS database.
The consultation on the Ordinance on Individual Identification Marks and Safety Devices on the Packaging of Medicinal Products for Human Use has been completed. The majority of the participants in the consultation were in favor of the mandatory affixing and verification of the safety features and devices – the same as in the EU. This is the only way to ensure that all prescription medicines included in the SMVS database are also on the Swiss market.
Statement of the Federal Council of 31.8.2022
1. the Federal Council supports the concern raised by the motion. In order to promote the digital transformation in healthcare, the Federal Office of Public Health (FOPH) received a mandate from the Federal Council at the beginning of May 2022 to launch a program to promote the digital transformation in healthcare. The aim is to submit a message to parliament by the end of 2023, including a corresponding commitment credit for the implementation of the program.
The Federal Council points out that only a few legally defined uniform standards exist in the healthcare sector; among other reasons, this is because the federal government has only very limited regulatory authority in the healthcare sector. One of the central points of the aforementioned program will therefore certainly be to create more binding standards.
The Federal Council is prepared to inform Parliament regularly about the status of implementation as part of the Commission’s work.
2 The Federal Council attaches great importance to a safe and orderly supply of therapeutic products in Switzerland. On February 16, 2022, it issued a FOPH report on supply shortages of human medicines in Switzerland took note of the report. It has also instructed the FOPH and the Federal Office for National Economic Supply (FONES) to examine the measures proposed in this report in greater depth and to submit a concrete implementation catalog to the Federal Council. Part of this work is also the elaboration of a concrete proposal for improvement in the anticipation, identification and management of gaps in care. The SMVS database represents a possible option here, but a comprehensive analysis is still underway.
In addition, the evaluation of the consultation on the Ordinance on Individual Identification Marks and Safety Devices on the Packaging of Medicinal Products for Human Use has not yet been completed; it had to be deprioritized due to the work on dealing with the Covid 19 pandemic. There have been various critical voices regarding the mandatory affixing and verification of the safety features and devices. Accordingly, the decision on whether to implement a mandatory or optional solution is still open.
The Federal Council is therefore of the opinion that this work should not be anticipated. A decision regarding the possible use of the SMVS database can be made after the above work has been completed.