EFPIA Recommends Drug Anticounterfeiting Measures

Brussels (May 13)-The European Federation of Pharmaceutical Industries and Associations (EFPIA), the trade association representing European pharmaceutical manufacturers, issued recommendations to the public consultation launched in March 2008 by the European Commission’s proposed drug anticounterfeiting measures. EFPIA’s proposal includes a ban on drug repackaging.

“Even one single case of counterfeit medicine is unacceptable,” said EFPIA Director General Brian Ager in an EFPIA release. “Recent seizures of counterfeit medicines in the EU have shed light on the vulnerability of the pharmaceutical supply system and on practices that undermine efforts by the industry to protect patients.”

In 2006, 2.7 million medicinal products were seized at EU customs borders, a 384% increase over 2006, according to EU statistics released by EFPIA.

Under current EU rules, products can be reboxed, relabeled, or overstickered, according to an EFPIA statement. Tablets can be removed from blisters and reconditioned. These repackaging activities can involve removing the security seal and damaging unique identification codes that ensure product traceability, according to EFPIA.

EFPIA stressed “the number one focus of the forthcoming EU legislative reform should be to ensure that the integrity of the original package is absolutely guaranteed throughout the entire supply chain, from the time it leaves the original manufacturer to the point that it reaches the end use,” according to an EFPIA prepared statement.

EFPIA is calling for requirements for tamper-evident packaging on all products, overt and covert authentication features, strengthening product identification at an individual pack level through a harmonized coding standard, banning repackaging of drugs, and increasing liabilities and criminal penalties.

EFPIA is making plans to launch a pilot for a unique barcode system that will enable the pharmacist to verify each medicine pack before dispensing it to the patient.

EFPIA also recommends involve extending good manufacturing practices (GMPs) to include good distribution practices. “While basic regulations exist to prevent traders, brokers, or agents from causing safety problems, these need to be more strictly enforced,” said EFPIA in its response. “The current system of GMP should be extended to GDP audits as well as to the entire supply chain in order to assure that measures taken with respect to product protection, packaging practices, and distribution practices are properly used and followed.”

The European Commission’s public consultation may be found

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EFPIA’s response to the public consultation may be found here.