Switzerland breaks silence on drug security label plans

Switzerland has said it plans to introduce security features for packs of medicines and medical devices that will probably be analogous to those detailed in the EU's Falsified Medicines Directive (FMD).

It has been widely anticipated since the delegated act on safety features was published last year that Switzerland would adopt a compatible system but until now the government has been quiet about its plans.

The delegated act – which applies to EU member states as well as European Economic Area (EAA) countries Norway, Iceland and Liechtenstein - introduces a requirement for prescription medicines and select over-the-counter (OTC) drugs in the EU to carry a serialised unique identifier (UI) code within a 2D datamatrix barcode, anti-tampering device on the outer packaging, and verification of the UI at the point of dispensing.

Switzerland was not obliged to follow the FMD model – although industry observers note it would make little sense to follow a different path – and is also not required to follow the same timeframe for implementation.

The country's close relationship with Leichtenstein is also a factor, as the principality has a customs and patents union with Switzerland and relies in no small part on its larger neighbour's medicines regulator Swissmedic.

The announcement by the Federal Health Office (BAG) comes on the same day that Switzerland moved ahead with plans to fully ratify the Medicrime Convention against counterfeit medicines, which entered into force on January 1, 2016.

The country signed the convention in 2011 but says it will need to make some amendments to the Therapeutic Products Act (TPA) and the Criminal Procedure Code (CrimPC) before it can complete the ratification process.

The changes – which have been forwarded to the Swiss Parliament for debate – relate to "improving the exchange of information, expanding methods of criminal investigation and clarifying the legal situation regarding the provision of therapeutic products," according to the BAG.

"The Federal Council conducted the consultation procedure on the implementation of the Medicrime Convention between 18 December 2013 and 2 April 2014," it said in a statement.

"Based on the proposal of several respondents to the consultation, the possibility of adding safety features to medicinal product packaging in Switzerland - analogous to EU Directive 2011/62/EU Falsified Medicines Directive - is currently being explored."