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Regulatory Focus™ > News Articles > 2 > Falsified Medicines: EC Report Finds Inconsistent Penalties Throughout the EU

Falsified Medicines: EC Report Finds Inconsistent Penalties Throughout the EU

Posted 05 February 2018 | By Michael Mezher 

Falsified Medicines: EC Report Finds Inconsistent Penalties Throughout the EU

A recent report from the European Commission (EC) finds that while all EU member states have implemented laws in line with the Falsified Medicines Directive, the penalties for breaking those laws vary widely from country to country.

"Penalties are only effective if they are well-enforced. I urge all EU countries to make sure that criminals falsifying medicines are punished," said EU Commissioner of Health and Food Safety Vytenis Andriukaitis, who urged member states to ensure that criminals caught falsifying medicines are punished.

According to the report, the maximum prison sentence for falsifying a medicine ranges from just one year in Sweden, Finland and Greece to 15 years in Austria, Slovenia and Slovakia.

The maximum fines for falsifying a medicine range from 4,300€ in Lithuania to €1 million in Spain. In the UK, there is no maximum ceiling for such fines.

Similarly, the maximum prison sentences and fines for misconduct related to active substances and excipients vary widely between member states.

Additionally, the specifics of what is criminalized varies among member states. For instance, Latvia penalizes medicine falsification that results in physical harm or death, while most member states penalize falsification itself "without the need to prove that the product is dangerous to health."

The report also notes that it is "difficult to measure the effectiveness of specific national penalties due to a lack of exhaustive data on incidents in the member states."

However, experts consulted for the report told the EC that the penalties "had at least some effect in reducing the presence of falsified medicines in the legal supply chain," but rated administrative penalties as the most effective deterrent.

But when it comes to illegal medicines sales, experts found that criminal penalties served as a more effective deterrent.

As such, the report recommends that member states introduce additional administrative and criminal penalties for falsified medicines, and calls for countries to dedicate adequate resources to enforcing those penalties.

EC, Report

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