Report on Trends in the Falsification of Medicines

The EU Commission is obliged to submit a report to the European Parliament and the Council on the latest trends in the falsification of medicinal products within five years of the Falsified Medicines Directive 2011/62/EU coming into force. The report should also include an assessment of whether the Directive is effective in preventing falsified medicines from entering the legal supply chain.

As the EU legislation has not yet been fully implemented in all countries and counterfeiting cases are not reported centrally at EU level, a complete and reliable assessment of the Directive is currently not possible. Nevertheless, some important points have been emphasized:

• The categories of medicines that are most frequently counterfeited are expensive prescription medicines and high-demand products such as "lifestyle medicines" (e.g., Ozempic®).
• Widespread access to online sales increases the risk that counterfeit medicines could be distributed via illegal suppliers. 
• The Report did not identify any specific regions of origin or distribution for falsified medicines.
• It is more difficult to introduce illegal medicines into the legal supply chain, so that illegal medicines remain in the illegal supply chain.
• Data is available for investigators to recognize suspicious packs and trace counterfeits.

Still Incomplete Implementation & Lack of Standard Procedures

The currently incomplete implementation of the measures makes it difficult to assess their effectiveness. There are five main reasons for this:

• Many pharmacies are still not connected to the EU system
• Some of the pharmacies that are connected to the system may not yet be using the IT system effectively
• Some IT systems developed at national level still trigger a level of false alerts that is too high
• The governance of the system by the responsible organizations representing supply chain operators has sometimes led to internal conflicts on the use of the information contained in the EMVS 
• The lack of standard procedures to qualify cases as confirmed cases of falsification and the lack of centralized files reporting all EU cases make comparisons and trend analysis particularly difficult

The Commission has therefore called on the Member States to fulfil their obligations and ensure that all actors in the supply chain comply with them. The need to increase the number of actors connected to the repository system (pharmacies, wholesalers, etc.) is particularly emphasised.

Despite some progress, further efforts are required to fully realize the effectiveness of the measures and increase safety in the supply of medicinal products. More information is available in the Report from the Commission to the European Parliament and the Council on trends in the falsification of medicinal products and measures.