The trade in counterfeit therapeutic products is increasing worldwide and poses a health threat. The Medicrime Convention and the EU Falsified Medicines Directive are two examples of the international concerted action taken in response.
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.
Counterfeit medicines and medical devices pose a major health risk. Counterfeit medicines will not always contain the correct ingredients in the correct dosages. Using them can delay recovery or even prevent it. Impurities or undeclared ingredients can have unintended side effects or even lead to poisoning.
The Medicrime Convention
In most industrialised countries with effective market surveillance systems, counterfeit medicines account for less than 1% of the medicine market (according to a WHO report which can be found under the ‘Links’ tab below). For some parts of Latin America, Southeast Asia and Africa, however, data from the WHO and the Organisation for Economic Co-operation and Development (OECD) indicates the share of counterfeit medicines to be at over 30%. Combatting the trade in counterfeit medicines and medical devices requires a coordinated international approach.
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 treaty aimed at combatting the illegal trade in therapeutic products, and is designed to prevent counterfeit medicines from endangering human health. The signatories to the Convention, which include Switzerland, undertake inter alia to expand their criminal legislation on the manufacture, marketing and trading of counterfeit therapeutic products. The Convention also lays down a framework for greater national and international collaboration among the corresponding authorities. The Medicrime Convention entered into force in January 2016.
Medicrime in Switzerland
Despite having efficient surveillance systems in place, Switzerland is also impacted by medicine imports. According to Swissmedic, an estimated 20,000 illegal consignments enter the country every year.
Switzerland signed the Medicrime Convention in October 2011, and the Convention has been in force in the country since February 2019. The resulting new legislation gives the Swiss authorities the tools they need to better combat the counterfeiting of medicines, which helps increase the safety of medicines in the country.
The Falsified Medicines Directive
A further action independent of the Medicrime Convention designed to combat medicine counterfeiting at the international level is the European Union Directive 2011/62/EU, more commonly known as the Falsified Medicines Directive or FMD, which was adopted by the EU in 2011. The Directive, which superseded the previous Directive 2001/83/EC, has laid the foundation for a series of legislative actions intended to help prevent counterfeit medicines from entering the legal supply chain.
The Falsified Medicines Directive serves as the foundation for Commission Delegated Regulation (EU) 2016/161, which requires the provision of safety features in the form of unique identifiers and anti-tampering devices on all medicinal products subject to prescription, to ensure that any counterfeit or falsified product can be identified at the latest upon its issue to the patient. While unique identifiers permit the identification and the verification of the authenticity of individual packs of medicinal products, anti-tampering devices help determine whether a medicinal packaging has already been opened or has otherwise been tampered with.
Commission Delegated Regulation (EU) 2016/161 entered into force throughout the EU on 9 February 2019.
Article 17a of the Therapeutic Products Act (nTPA)
Following the EU decision, a number of actors within the pharmaceutical industry expressed a willingness for the adoption of a similar system in Switzerland as envisaged under the FMD. For this reason, the Swiss Parliament approved the addition of a new provision – Article 17a – to the Federal Therapeutic Products Act (TPA) in parallel with the other legislative amendments resulting from Switzerland’s ratification of the Medicrime Convention. In line with the provisions of the FMD, the new nTPA Article 17a regulates the provision and verification of unique identifiers and anti-tampering devices on medicinal product packaging.
To date, no counterfeit medicines intended for the Swiss market have been found. For this and other reasons, the provision of unique identifiers and anti-tampering devices on medicinal product packaging as envisaged under nTPA Article 17a is optional in Switzerland, while it is compulsory within the EU.
The draft implementing provisions for nTPA Article 17a were subjected to a consultation phase between October 2019 and February 2020. The original draft ordinance and the associated further documentation can be found under the ‘Links’ tab below. This work was temporarily suspended due to a shift of resources required for the management of the COVID-19 pandemic. In view in particular of the subsequent referral to the Federal Council of the Ettlin Motion (22.3859) ‘Master Plan for digital transformation in the healthcare sector: application of legal standards and use of existing data’ on 26 September 2023, the demands of which include the mandatory provision of unique identifiers and anti-tampering devices on all packaging of medicines for human use (Item 2), the work on the draft ordinance for nTPA Article 17a has now resumed. A revised draft ordinance is expected to be submitted for consultation in spring 2025.
Documents
Links
Medicrime
FMD and nTPA Article 17a
Legislation
Last modification 13.02.2025
Contact
Federal Office of Public Health FOPH
Biomedicine Division
Therapeutic Products Law Section
Schwarzenburgstrasse 157
3003
Bern
Switzerland
Tel.
+41 58 463 51 54