Counterfeit therapeutic products and Medicrime Convention

Trade in counterfeit therapeutic products is increasing throughout the world and constitutes a danger to health. Combatting this trade calls for concerted action at the 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. A WHO report has shown that most industrialised countries have effective market surveillance that keeps the share of counterfeit medicines below the 1% mark. By contrast, this figure exceeds 30% in some countries in Latin America, Southeast Asia and Africa, according to data from the WHO and the OECD (Organisation for Economic Co-operation and Development). Despite an effective monitoring system, Switzerland too is affected by imports of illegal medicines. Some 20,000 illegal shipments are believed to arrive in Switzerland each year.

Counterfeiting and illegal sales of medicines and medical devices constitute a major threat to health. Counterfeit medicines do not always contain the correct ingredients, or else the dosages of these substances may be incorrect. Use of these medicines may delay or even prevent cure, while the presence of impurities or undeclared ingredients may trigger adverse effects or even prove toxic.

Combatting counterfeiting – Medicrime Convention

Combatting the counterfeiting of medicinal products and medical devices calls for concerted action at the 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 convention 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.

Switzerland signed the Medicrime Convention on 28 October 2011. The dispatch regarding the Convention's approval and entry into force was forwarded to the Federal Parliament on 22 February 2017, and it was adopted by both Chambers on 29 September 2017. Following deposit of the instruments of ratification on 25 October 2018, the Convention took effect in Switzerland on 1 February 2019.

Falsified Medicine Directive

In order to prevent falsified medicines from entering the legal supply chain, the European Union (EU) in 2011 adopted Directive 2011/62/EU, which is known as the Falsified Medicines Directive. 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. In line with this and in addition to the legislative changes related to the ratification of the Medicrime Convention, on 29 September 2017 the Federal Parliament also made provision within the Therapeutic Products Act for safety features to be placed to medicinal product packaging. The related implementing provisions are currently being prepared.

Last modification 10.05.2019

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Federal Office of Public Health FOPH
Division of Biomedicine
Therapeutic Products Law Section
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