EFPIA plans counterfeit crackdown

pharmafile | May 20, 2009 | News story | Manufacturing and Production, Research and Development EFPIA, counterfeits 


European pharmaceutical industry association EFPIA has unveiled a new scheme to crack down on counterfeit medicines.

Beginning with a trial run in Sweden, its new coding and identification pilot will alert pharmacists if a medicine is suspect, helping to protect Europe’s citizens against the dangers from counterfeits.

David Brennan, chief executive of AstraZeneca, said the threat posed by counterfeit medicines is real and growing.

“As an industry, we are focused on patient safety and ensuring the public can have confidence in their medicines. This coding system represents a major step forward towards that goal,” he added.

EFPIA’s scheme will begin later this year in partnership with Swedish retail pharmacy chain Apoteket AB and local wholesalers Tamro and KD.

It is designed to ensure product identification from manufacture to dispensation, ensuring that the authenticity of each unit can be ascertained before it reaches the patient.

Pharmacists will check a unique identification code on each individual pack when it is dispensed to the patient. These codes are generated and applied by manufacturers using a simple 2D matrix barcode, which contains a unique serial number. The scan will reveal any duplication of data on packs and will trigger the system to alert the pharmacist to the possibility of a counterfeit product.

“We are pleased to partner with EFPIA in this project,” said director general of Apoteket AB, Stefan Carlsson. “The 2D matrix coding solution contributes not only to the improvement of patient safety with regards to counterfeiting, but also to more effective ways of managing pharmaceutical products in the pharmacies in the future.”

The new pilot is expected to last between three and four months and will be entirely financed by the pharmaceutical industry.

It will be a scaled-down version of a full EFPIA solution and aims to demonstrate that it is a practical and effective solution for manufacturers, pharmacists and patients alike, and can provide a standardised system throughout Europe.

Counterfeiting and Parallel Trade

EFPIA, along with the European Commission, have long stressed the dangers of counterfeit medicines in Europe, the detection of which they say rose by 51% between 2007/2008. Both parties say the trend compromises patient safety and also tarnishes the industry’s image.

But more controversially they have also linked counterfeit products to the legal practice of parallel trade in Europe, saying it creates conditions in which counterfeiters thrive.

The pharmaceutical industry has always grumbled about parallel trade, as its existence cuts into profits, but there is also a new attitude from European Union commissioners, who previously supported parallel trade of pharmaceuticals seeing it as embodying the ‘free movement of goods’ doctrine of the EU.

The Commission has since proposed putting a ban on re-packaging medicines to stop counterfeiters, which could indirectly stop all parallel traders, who must by law repackage drugs they export.

The proposals have since been watered down, and the European Parliament is expect to vote on the measures later this year.

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