Federal Council approves report in response to a postulate on the monitoring of drug safety

During its session on 13 June 2025, the Federal Council approved the report in fulfilment of postulate 20.3456 of the National Council Social Security and Health Committee (SSHC-N) dated 14 May 2020. The report, "Adverse drug reactions. Greater safety and better legal protection", shows that the Swiss system for monitoring drug safety is working and that risk minimisation measures are promptly implemented. Most of the suggestions for improvement listed in the report have already been implemented.

The system for monitoring drug safety (pharmacovigilance) is working in Switzerland – this was the conclusion of the report in fulfilment of postulate 20.3456 of the National Council Social Security and Health Committee (SSHC-N), which was approved by the Federal Council in its session on 13 June 2025. The report highlights the spontaneous reporting system for monitoring adverse drug reactions and issues of legal protection when patients have been harmed by such adverse reactions to medicines. At the same time, the report shows how the official monitoring of medicinal product risks can be further improved.

The report is based on an external review by Dr. Axel Thiele, an internationally renowned expert in drug safety. This report confirms that – despite its limited resources compared to other countries – Swissmedic fulfils its legal mandate and promptly implements risk minimisation measures. During an audit in 2023, the Swiss Federal Audit Office (SFAO) also confirmed that Swissmedic has a functioning and effective monitoring system in the area of drug safety.

Most of the recommendations for further development already implemented

The report recommends specific improvements, for example in relation to individual processes or for closer alignment with international standards. It also proposes targeted amendments to the Therapeutic Products Ordinance (TPO).The competent authorities have already implemented most of these recommendations.

No legal basis for legal protection

The report also addresses the question concerning the extent to which the Federal Social Insurance Office (FSIO) is able to grant legal protection for patients who have suffered adverse reactions and corresponding harm after taking the epilepsy medicine Depakine. Legal protection could, for example, consist of the appointment of a lawyer or the payment of court and legal fees. The report concluded that no legal basis currently exists for this option.