Report issued on Trends in the Medicines' Falsification

The EU Commission must report to the European Parliament and Council on medicinal product falsification trends within five years of the Falsified Medicines Directive 2011/62/EU taking effect. This report will assess the Directive’s effectiveness in preventing counterfeit medicines from entering the legal supply chain.

Currently, a full evaluation is hindered by incomplete legislation implementation and a lack of centralized counterfeit reporting. Key points include:

- Counterfeit medicines commonly involve expensive prescription drugs and high-demand "lifestyle medicines" (e.g., Ozempic®).

- Online sales increase the risk of counterfeit distribution through illegal suppliers.

- No specific regions were identified for counterfeit origins.

- Counterfeit medicines generally remain within illegal channels.

- Data is available for identifying and tracing counterfeits.

Challenges include unconnected pharmacies, ineffective IT systems, high false alert rates, internal conflicts over data use, and inadequate standardized procedures. The Commission has urged Member States to enhance compliance and connectivity among supply chain actors. Further efforts are needed to improve measure effectiveness and safety.