EU homes in on track and trace rules

The European Union is embarking on a track and trace system to try to foil counterfeiters, which when implemented in 2014, will include unique identifiers on each individual package of drugs. The process will be closely watched in the U.S. where a similar system could end up in the pending FDA reauthorization legislation.

A host of associations representing drug wholesalers and distributors and led by the European Association of Pharmaceutical Full-line Wholesalers (GIRP), have given their tacit approval to a memorandum of understanding, according to a story in New Europe. The document lays out possible "legal, practical and technical aspects" of the European Medicines Verification System (EMVS). It will be the jumping off point for debate among the European Commission and the drug handlers as its final points are worked out, New Europe reports.

That includes what the unique identifier will be and how it will be tracked. GIRP has said it must be a 2-D matrix barcode for companies handling drugs to be able to meet the law's regulations.

The U.S. is not as far along in acceptance as the EU. The House and Senate versions of the FDA reauthorization bill both include language that would set up more stringent tracking of drugs but details have yet to be set. The FDA wants a nationwide program that includes and tracks identifiers on individual containers. The industry would put unique serial numbers on individual drug packages but require scanning drugs only in lots when they get to distributors. They have argued that to expect individual tracking from truck to warehouse to distributor to pharmacies is unworkable, at least for now.

But as more counterfeit drugs get discovered here and in Europe, the pressure is on politicians, and by extension Big Pharma, to try to ferret out the fakes. Just last week the FDA warned that counterfeit versions of the Adderall, the ADHD drug made by Teva Pharmaceutical Industries ($TEVA) had surfaced here. That follows the discovery that counterfeits of Roche's ($RHHBY) cancer drug Avastin were sold to more than four dozen physician practices throughout the U.S. But given the global nature of the industry, finding a system that works not only in a country or a region, but across the world, is going to be difficult and ultimately quite expensive.

- read the New Europe story

Related Articles:
Fake Adderall surfaces as Congress turns attention to track and track
FDA, industry differ on level of track and trace needed in U.S.

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