Counterfeit drugs?

Jamie Love has a very thoughtful post on the use and misuse of the term “counterfeit” when applied to drugs, calling both the NYT and The Lancet to account. Legally, the term “counterfeit” describes a product that violates trademark law – the package says Merck, but Merck had nothing to do with it.

The industry profits by confusing true counterfeiting with many other drug safety problems. Some of these drugs have the proper active ingredients, but may violate law only in a technical sense (parallel importation of safe and effective drugs from Canada); some are made by global companies, but have quality problems either in manufacturing or the supply chain; others violate domestic drug regulatory law by importing foreign drugs never approved locally; and some are chalk powder (or worse), created by criminals to pass off as the real thing.  The WHO has noticed this problem, and distinguishes between “spurious/falsely-labelled/falsified/counterfeit medical products.”

As I wrote back in 2006 (free registration), this matters because the government responses are very different:

Poor quality drugsStronger drug regulatory laws and enforcement, including inspection of manufacturing & supply chain pedigree
Parallel importation from abroadRegulate the process (certified foreign pharmacies); or lower the US price of drugs to consumers (Part D)
Selling unapproved drugsEnforce drug regulatory laws
Criminal violations of trademark laws on a commercial scaleEnforce trademark laws

Jamie also describes (at the bottom of his article) the extensive public process on the issue at the WHO over the last few years, leading to an Executive Board resolution (EB130.R13) and a global process starting in Buenos Aires in November 2012.


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