Trade in counterfeit therapeutic products, increasing throughout the world, constitutes a danger to health. The Medicrime Convention and the European FMD are two examples of the concerted action being taken at international level.
The trade in counterfeit therapeutic products is increasing throughout the world. Considerable profits can be earned in this illegal trade and yet the risk of penalties is minimal, as resellers often operate beyond national borders through the internet. Counterfeit medicines and medical devices constitute a major threat to health. Counterfeit medicines do not always contain the correct components, or else the dosages of these substances may be incorrect. Taking them may delay or even prevent cure, while the presence of impurities or undeclared ingredients may trigger adverse effects or even prove toxic.
Most industrialised countries have effective market surveillance that keeps the share of counterfeit medicines below one per cent of total market volume (see WHO report under Links below). By contrast, according to WHO and OECD data, this figure exceeds 30 per cent in some countries in Latin America, Southeast Asia and Africa. Combatting the trade in counterfeit medicines and other falsified medical products requires therefore concerted action at international level.
The Medicrime Convention (Council of Europe Convention on the Counterfeiting of Medical Products and Similar Crimes involving Threats to Public Health) is the first international agreement aimed at halting the illegal trade in therapeutic products and at preventing counterfeit therapeutic products from endangering people’s health. The parties to the Convention undertake in particular to prosecute any acts linked to the manufacture or marketing of counterfeit therapeutic products or to the trade in such products. The Convention also provides for national and international cooperation between the competent authorities. It came into force on 1 January 2016.
Medicrime in Switzerland
Despite an effective monitoring system, Switzerland too is affected by imports of illegal medicines. Some 20,000 illegal shipments are believed to arrive in this country each year (estimate by Swissmedic).
Switzerland signed the Medicrime Convention in 2011, which came into effect in Switzerland in February 2019.
These changes to the law equip Switzerland with the instruments necessary to step up the fight against counterfeit medicines and to increase the safety of medicines in our country.
Falsified Medicines Directive
A further international measure taken against the trade in falsified medicines – independent from Medicrime – is the European Falsified Medicines Directive (FMD, 2011/62/EU), adopted by the European Union (EU) in 2011. This aims to prevent counterfeit medicines entering the legal supply chain.
This Directive makes provision inter alia for safety features on the packs of medicinal products that are subject to prescription, making it possible to detect falsified medicines at the time they are given to the patient at the latest.
These safety features fall into two categories. The first makes it possible to verify that medicines are authentic and to identify individual boxes (unique identifier), the second to detect whether packages have been opened (anti-tampering device).
The delegated regulation that specifies the implementation details of the FMD entered into force in the EU on 9 February 2019.
New article in TPA: 17a
Following the introduction of the FMD in the EU, some voices in the pharmaceutical industry called for a similar system in Switzerland. Parliament therefore added a clause (Article 17a) to the Therapeutic Products Act (TPA) as legislative amendments linked to the ratification of the Medicrime Convention were being made. This clause regulates the application and verification of safety features on medicinal products packaging, similar to those of the FMD.
So far, no counterfeit medicines destined for the Swiss market have been identified. Also for this reason, the system of safety features on packaging is optional in Switzerland, unlike in the EU.
The implementing provisions relating to Article 17a TPA are currently being drawn up. The draft ordinance and all associated documents can be accessed under Links. The new article will apply from the same date as the related ordinance.
Convention Médicrime : Rapport sur les résultats de la procédure de consultation relative à l'approbation et à la mise en œuvre (PDF, 460 kB, 22.02.2017)in French, German and Italian
FMD and art. 17a TPA
Text of article 17a TPA – Arrêté fédérale du 29 septembre 2017 (Medicrime) (available in French, German and Italian)
Last modification 24.02.2023
Federal Office of Public Health FOPH
Division of Biomedicine
Therapeutic Products Law Section
Tel. +41 58 463 51 54