Combatting counterfeit therapeutic products
Counterfeit medicines and medical devices pose a risk to public health. Switzerland relies on international cooperation and legal measures to combat the illegal trade.
Counterfeit medicines and medical devices pose significant risks to health. Counterfeit medicines may contain the wrong active ingredients, incorrect dosages or no active ingredients at all. As a result, treatment may be delayed or ineffective, and patients' health may be put at risk. In addition, contaminants or undeclared ingredients may cause adverse reactions or even poisoning.
International cooperation to combat counterfeit medicinal products
Trade in counterfeit therapeutic products is increasing worldwide. Large profits are generated with illegal trade and currently the likelihood of criminal prosecution is low, as the trade in such products across borders is often conducted online. Combating counterfeit medicines and medical devices therefore requires a coordinated international approach.
Medicrime Convention
The Council of Europe's Medicrime Convention is the first international treaty on the counterfeiting of medical products. It aims to combat the illegal trade in therapeutic products and prevent the health risks associated with counterfeit medicines and medical devices. The States Parties to the Convention, including Switzerland, undertake among other things to expand the scope of criminal offences and strengthen cooperation between the competent authorities at both the national and international levels.
Although Switzerland has an effective regulatory and control system in place, it is also affected by the illegal importation of medicinal products. According to figures published by Swissmedic, several thousand cases of illegal medicinal product imports are handled each year in cooperation with the Federal Office for Customs and Border Security (FOCBS) and other authorities. For information on 2025, see: Illegal imports of medicinal products in 2025: more consignments, new products trends and increasing shipments from the EU.
Switzerland signed the Medicrime Convention in 2011, and it entered into force on 1 January 2019. Corresponding amendments to the Therapeutic Products Act (TPA) and the Swiss Criminal Procedure Code (CrimPC) were adopted. These amendments provide the legal basis for strengthening the fight against counterfeit therapeutic products in Switzerland.
Falsified Medicines Directive FMD
In parallel with the Medicrime Convention, the European Union adopted the Falsified Medicines Directive (Directive 2011/62/EU, FMD) in 2011. The Directive introduced harmonised safety features and control mechanisms across Europe.
Commission Delegated Regulation (EU) 2016/161 sets out the detailed rules for implementing the Directive. Among other requirements, it requires prescription medicine packs to carry unique identifiers and anti-tampering devices. Unique identifiers enable each pack to be identified, while anti-tampering devices indicate whether a pack has been opened. These safety features ensure that counterfeit medicines can be identified no later than at the time they are supplied to patients. Commission Delegated Regulation (EU) 2016/161 has applied in all EU and EEA Member States since 9 February 2019.
How is the situation regulated in Switzerland?
Article 17a of the Therapeutic Products Act (TPA) and counterfeit medicinal products in Switzerland
As part of the legislative amendments accompanying the entry into force of the Medicrime Convention, Parliament introduced Article 17a into the Therapeutic Products Act (TPA). The Article regulates the placing and verification of unique identifiers and anti-tampering devices on medicinal product packaging, in line with the FMD.
Counterfeit medicines usually enter the market outside authorised supply chains. To date, no counterfeit medicines intended for the Swiss market have been detected within the legal supply chain. For this reason, Article 17a provides that the placing and verification of unique identifiers and anti-tampering devices are voluntary. However, the Article allows the Federal Council to make these safety features mandatory by ordinance if this becomes necessary (Article 17a paragraph 8 letters b and c TPA).
Ordinance implementing Article 17a of the Therapeutic Products Act (TPA)
Article 17a TPA can only enter into force once the corresponding ordinance has been adopted. A draft ordinance was published for consultation between October 2019 and February 2020 (consultation documents 2019–2020, available in German, French and Italian). At that time, the placing and verification of unique identifiers and anti-tampering devices were intended to be voluntary placing. The project was temporarily suspended in March 2020 because priority was given to managing the COVID-19 pandemic, with work resuming approximately three years later.
On 26 September 2023, Parliament adopted Motion Ettlin (22.3859), “Master Plan for the Digital Transformation of the Healthcare System: Application of legal Standards and Existing Data”. The amended item 2 of the motion called for mandatory placing and verification of unique identifiers and anti-tampering devices on the packaging of human medicinal products. The revised draft also took into account the results of the 2019–2020 consultation and the updated 2024 regulatory impact assessment. The main change compared with the original draft was the introduction of mandatory placing and verification of unique identifiers and anti-tampering devices.
The revised draft ordinance was published for consultation between May and August 2025 (consultation documents 2025, available in German, French and Italian). The proposal was rejected by the majority of stakeholders consulted. Further information is available in the consultation report.
Closure of item 2 of Motion Ettlin (22.3859)
After carefully considering all relevant factors and circumstances, the Federal Council concluded that mandatory placing and verification of unique identifiers and anti-tampering devices should not be introduced. It therefore requested Parliament to remove item 2 of Motion Ettlin (22.3859) from the agenda without implementing the requirement for mandatory unique identifiers and anti-tampering devices. This decision also reflects the currently low risk of counterfeit medicines entering the Swiss market.
On 2 September 2026, the Federal Council approved the report “Master Plan for the Digital Transformation of the Healthcare System – Use of Statutory Standards and Existing Data”, which sets out the reasons for removing item 2 of the motion from the agenda (see media release).
The proposal will now be considered by the National Council and the Council of States. If approved by both chambers, a voluntary system for the placing and verification of unique identifiers and anti-tampering devices will be introduced. This reflects the original approach adopted when Article 17a TPA was enacted and subsequently incorporated into the first draft ordinance. The introduction of mandatory safety features may be reconsidered at a later stage if circumstances change.
Further information
Index
Federal Office of Public Health FOPH
Therapeutic Products Law Section
Schwarzenburgstrasse 157
Switzerland - 3003 Bern