The Swiss Federal Council has decided not to introduce mandatory safety features on medicinal product packaging for the time being. Following a consultation on implementing legislation, it intends to maintain Switzerland’s existing voluntary approach and has asked Parliament to dismiss the relevant part of Motion Ettlin (22.3859), which called for mandatory safety features.

Safety features can include unique identifiers in the form of 2D Data Matrix codes, allowing individual packs to be identified, as well as anti-tampering devices indicating whether packaging has been opened or manipulated. Unlike in the EU, Swiss therapeutic products law currently does not require such features to be applied and verified. However, the Federal Council retains the power to make them mandatory if necessary.

According to its press release, the Federal Council had examined a mandatory system at Parliament’s request and submitted corresponding implementing provisions for consultation. According to the Federal Council, most affected stakeholders were critical of the proposal, requested extensive exemptions or rejected a mandatory regime altogether. Concerns included additional administrative burdens and costs as well as potential risks to the security of medicines supply.

The Federal Council has therefore decided to retain a voluntary regime at ordinance level. It notes that counterfeit medicines intended for the Swiss market have so far not been detected in legal distribution channels and are primarily encountered outside official supply chains.

A mandatory system could nevertheless be reconsidered in the future should the risk of counterfeit medicines entering Switzerland’s legal supply chain increase.