“Medicrime” is the umbrella term used by Swissmedic for all national and international activities to combat medicinal product-related crime. These activities are intended to ensure that all medicinal products and medical devices marketed in Switzerland are safe and legal, and to combat national and international trafficking in therapeutic products. In pursuit of this goal, Swissmedic partners closely with other enforcement agencies, including Swiss customs, police and cantonal Medicines Inspectorates.
It is forbidden in Switzerland to trade in, use and sell illegal therapeutic products, particularly on the Internet. Criminal proceedings are instituted if necessary.
Swissmedic is Switzerland’s national single point of contact (SPOC). The Agency works with Swiss customs and cantonal authorities to monitor imports of medicinal products by companies, professional users and private citizens.
Swissmedic exchanges information on the source of illegal medicinal products with international partner authorities in a bid to curb manufacturing and trafficking.
The Medicrime Convention is the Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health.
Switzerland is fully committed to the Medicrime Convention, which was drawn up by the Council of Europe as the first international legal instrument to curb trafficking in medicinal products. The signatory states, of which Switzerland is one, are committed to expanding the range of offences associated with the production, offering for supply and trafficking in counterfeit therapeutic products. It is estimated that some 20,000 illegal consignments of medicinal products arrive in Switzerland annually.
Signatory states to the Convention regard the following activities as criminal offences:
- Manufacturing counterfeit medicinal products
- Supplying, offering to supply or trafficking in counterfeit medical products
- Falsifying documents
- Producing and supplying medicinal products without authorisation and placing medicines on the market that do not comply with industry standards
Switzerland signed the Convention in 2011 and ratified it on 1 January 2019. By adding this additional instrument to its armoury, it stepped up its efforts to combat counterfeit therapeutic products at national and international level.
Single point of contact (SPOC) for counterfeit medicinal products in Switzerland
In accordance with the Medicrime Convention, and following the entry into force of the revised TPA on 1 January 2019, Swissmedic became the national single point of contact (SPOC) under Art. 69 para. 4 of the new legislation.
Swissmedic has been developing and fulfilling the role of SPOC for many years. The revised legislation now puts this role on a legal footing. Collaboration with the points of contact at the Directorate FOCBS, Federal Office of Police (fedpol) and other stakeholders is being established on an ongoing basis.
In addition to its national duties, Swissmedic’s role as SPOC extends to international cooperation in prevention and other administrative activities, such as exchanging reports on specific cases and working in various international committees and working groups.
The international committees (include link to other page listing organisations) have set up, and are continuously updating, networks of international contacts (lists of European and global SPOCs). This facilitates rapid communication when dangerous counterfeits or other forms of trafficking come to light.
International product warnings – product databases
As Switzerland’s SPOC for illegal medicinal products, Swissmedic is responsible for ensuring access to international information about counterfeits and other illicit products. Swissmedic receives reports on illegal products from international authorities, reviews them and initiates corrective action as necessary or passes them on to the competent units.
Swissmedic was instrumental in helping set up the European Know-X product database, access to which is restricted to authorities’ points of contact.
Know-X contains product-specific information on counterfeit medicinal products, such as results of analytical testing, steps taken, the authorities involved and the risk to health posed by a particular product.
The information in the database comes from a variety of sources, including OMCLs, health authorities, regulatory authorities, supervisory authorities for medical devices, customs and the police. It is intended to assist the competent authorities in making decisions on managing and preventing risks.
Global information sharing
Swissmedic is also networked with the SF Medical Products Group. This group is affiliated to the WHO and is the receiving point for reports of counterfeit medicinal products from around the world. It compiles these reports in a database. If there is a particular risk to health and international relevance, it issues and publishes product alerts.