Anticounterfeiting Initiatives on Criminal Penalties and Serialization Advance in the US and Europe

Lawmakers in the US and Europe are moving forward with initiatives to significantly increase criminal and monetary penalties for the manufacture and distribution of counterfeit drugs and to create an internationally-harmonized serialization system.

In late December, 2010, the Council of Europe (CoE) adopted a “Medicrime Convention,” that includes criminal penalties for counterfeiting medicines, marketing medicines without authorization, being non-compliant with conformity requirements for medical devices or falsifying related documents.  The convention is voluntary and is open for signature by any national authority, including non-EU member states.

In the US, the “Counterfeit Drug Penalty Enhancement Act,” introduced with bipartisan sponsorship into both chambers of Congress in late November, would increase the maximum prison sentence and maximum fines for both individuals and firms manufacturing or trafficking in counterfeit medicines.

The US legislation proposes to increase the maximum prison sentence for counterfeiting medicines to 20 years for individual first-time offenders, and to increase the maximum fine that can be imposed on them to $4M. Repeat offenders would be liable for fines up to $8M.  Firms found guilty of trafficking could be fined $10M for a first offense and $20M for repeat offenses.

Criminal penalties for counterfeiting in Europe’s Medicrime Convention support legislation adopted by the European Commission (EC) in late May that will significantly strengthen the EU’s ability to detect falsified medicines and prevent their entry into the legitimate supply chain by adding new requirements in four main areas: ● safety features ● supply chain and good distribution practices (GDPs) ● active substances, and ● Internet sales (IPQ “In the News” May 31, 2011).

Also supporting the falsified medicines legislation in the EU is a mass serialization initiative taking place under the auspices of the European Directorate for the Quality of Medicines & Healthcare (EDQM), known as “eTACT.” The aim of the initiative is to harmonize traceability systems from manufacturers to patients across Europe with the use standards such as GS1.

GS1’s globally harmonized serial number approach continues to gain traction as pharmaceutical manufacturers seek to navigate the complicated maze of international regulatory requirements and comply with their looming deadlines (IPQ “In the News,” April 19, 2011).

At the APIC/CEFIC European API conference in Munich, Germany, in mid-November, EDQM Certification Division Head Helene Bruguera provided an insider’s look at the Medicrime Convention and eTACT.  She commented that the combination of the two will make “significant contributions to the fight against counterfeiting.”

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