A report from the European Commission (EC) has found a wide variation in penalties across the European Union (EU) for circulation of falsified medicines. The report analyzes implementation of the European Falsified Medicines Directive (FMD), which seeks to address counterfeit or falsified medicines in the EU, including the related supply chain. The FMD requires all EU countries to put in place proportionate, effective, and dissuasive penalties for those involved in the production and circulation of falsified medicines.

The EC report cited certain examples, such as inconsistency of punishment in the length of prison sentences and fines. The maximum prison sentences for the falsification of medicines range from one year (Sweden, Finland, and Greece) to 15 years (Austria, Slovenia, and Slovakia). Maximum fines range from EUR 4,300 ($5,300) (Lithuania) to EUR 1 million ($1.2 million) (Spain) and ‘unlimited’ (UK).

Additionally, the report shows that what is criminalized varies among the countries. All 28 EU member states apply criminal penalties in the form of imprisonment for the falsification of medicines. One member state (Latvia) penalizes falsification that causes physical harm or death (harm crimes) and two member states (Spain and Portugal) penalize falsification that causes a risk or danger to the health of a person or public health (concrete endangerment). Four member states (Greece, Lithuania, Romania, and Slovenia) penalize falsification that is shown to be generally dangerous, i.e. the falsified medicine contains insufficient active ingredients or harmful substances (concrete-abstract endangerment). In the remaining 21 member states, falsification per se is penalized, without the need to prove that the product is dangerous to health (abstract endangerment). For active substances, 23 member states apply criminal penalties. For excipients, 14 member states apply criminal penalties.

Vytenis Andriukaitis, EC Commissioner for Health and Food Safety, stressed the need for well-enforced punishment. “While the report published today finds measures taken by Member States to be satisfactory, penalties are only effective if they are well-enforced,” Andriukaitis said in a statement. “I urge all EU countries to make sure that criminals falsifying medicines are punished. After all, falsified medicines can kill. The EU Directive includes several other measures to help citizens steer clear of falsified medicines, notably a common EU logo which helps consumers identify legal online pharmacies that sell authentic and safe products.”

The report continues to say that measuring effectiveness of the punishments is a challenge. “It is difficult to measure the effectiveness of specific national penalties due to a lack of exhaustive data on incidents in the Member States and the inherent illegal nature of the activities.” In general, the study noted that member states should introduce both criminal penalties and administrative sanctions in order to safeguard the legal supply chain and tackle the illegal sale of falsified medicinal products.

The EC, member states, and stakeholders are working on a pan-EU authentication system for medicines, which will check the authenticity of prescription medicines before they are dispensed to patients. The system is scheduled to enter into force in February 2019.

 Source: European Commission (report) and