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Anti-Counterfeiting Advances Regionally Despite Global Impasse

This article was originally published in The Gold Sheet

Executive Summary

Counterfeits or substandard generics? Clash over definitions roils global anti-counterfeiting initiative. WHO IMPACT members divide over conflicting goals: protecting brands from counterfeits; protecting generics from being branded as counterfeits; and protecting emerging markets from substandard generics. Blowup over Dutch customs seizures. IMPACT begins to regroup as anti-counterfeiting regulatory landscape grows increasingly complex. U.S. pursues slow-tracked trace-and-trace; California e-pedigree stymied. The E.U. advances with pharmacy verification approach, registers a success with EFPIA pilot. Council of Europe works to criminalize counterfeit drugs. USP and AID minilabs would empower developing regulators. One third of antimalarials were substandard. Nigeria enables consumers to check for counterfeits by cell phone. Baxter takes layered approach. A pressing need for on-dose protection seen, but it must be covert. The day of mass serialization will arrive, but there will be no panacea.

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