Combatting counterfeit therapeutic products

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 the report by the World Health Organization (WHO), Substandard and falsified medical products). 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 over 30%. Combating the trade in counterfeit medicines and medical devices requires a coordinated international approach.

The Council of Europe's Medicrime Convention is the first international treaty on the counterfeiting of medical products and similar crimes involving threats to public health. It aims to combat the illegal trade in therapeutic products and 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 since February 2019. The resulting new legislation, passed at the same time, 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. Further information is available on the Medicrime Convention page of the Swissmedic website.

The Falsified Medicines Directive FMD

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. This Directive laid the foundation for a series of legislative actions intended to help prevent counterfeit medicines from entering the legal supply chain.

Delegated Regulation (EU) 2016/161 supplements Directive 2011/62/EU by providing detailed, tangible implementing provisions and requirements. These inclulde the provision of unique identifiers and anti-tampering devices on all medicinal products subject to prescription. Thus, 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 and applies to all EU and EEA states.

Article 17a of the Therapeutic Products Act (nTPA)

The Swiss Parliament approved the addition of a new Article 17a to the Federal Therapeutic Products Act (TPA; Art. 17a nTPA) 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 Article regulates the provision and verification of unique identifiers and anti-tampering devices on medicinal product packaging.

Counterfeit medicines are notably marketed outside official distribution channels. To date, no counterfeit medicines intended for the Swiss market have been found in legal supply chains. For this reason in particular, the provision of unique identifiers and anti-tampering devices on medicinal product packaging as envisaged under nTPA Article 17a is optional in Switzerland. By contrast, it is compulsory within the EU for prescription-only medicinal products. However, the Federal Council has the option of introducing a mandatory requirement in the ordinance (Art. 17a para. 8 let. b and c nTPA).

Ordinance on Article 17a nTPA

The legal implementation of Article 17a nTPA requires corresponding implementing legislation. The draft of the new ordinance was subjected to a consultation phase between October 2019 and February 2020 (Documents on the 2019–2020 consultation). At the time, an optional provision and verification of unique identifiers and anti-tampering devices was intended. The project was temporarily suspended due to a shift of resources required for the management of the COVID-19 pandemic.

Following the referral of the Ettlin Motion (22.3859) "Master Plan for digital transformation in the healthcare sector: application of legal standards and use of existing data" to the Federal Council on 26 September 2023, which includes a requirement for the mandatory provision of unique identifiers and anti-tampering devices on the packaging of certain medicines for human use (Item 2, as amended by the National Council), work on the draft ordinance under Article 17a nTPA resumed in early 2024. The work on the updated ordinance took account not only of the requirements of Item 2 of the Ettlin Motion 22.3859, but also the results of the first consultation phase in 2019/2020 and the updated regulatory impact analysis. The main difference between the current and first drafts is that the provision and review of unique identifiers and anti-tampering devices are now mandatory on all prescription-only medicinal products.

The Department submitted the revised draft ordinance for consultation on 6 May 2025. Consultation will continue until 27 August 2025. The consultation documents can be found on this page under "Documents" or on the website of the Federal Chancellery (available in German, French and Italian).