Thursday, February 26, 2009


Charles R. Earl, M.A., ABD
CEO, Communication Connections

A recent article on this site described the attempts by the World Health Organization (WHO) to define “counterfeit” pharmaceuticals. The solution to this quandary seems rather obvious to me. Let’s start with the assumption that only flawed pharmas require definition. The “good’ ones are those that maintain compound and quality integrity and function as they were intended to do. The “bad,” on the other hand, are those that either fail to perform or cause harm because their compounds or quality were inadvertently compromised. Finally, the “ugly” are those counterfeits or adulterations that were intentionally created to cause harm to reap unwarranted profits.

So, the essence of the definitions goes to whether or not the faulty pharmaceutical was the result of intentional or unintentional action. These definitions follow the same distinctions as one would encounter when deciding between first degree murder or negligent homicide as descriptions of culpability. One is a result of malice and forethought while the other comes about because of a lack of diligence, human error or equipment malfunction. The definition of the product falls to the intention of the manufacturer or party who alters the product. Clearly, intention should be determined through the judicial process, and the appropriate remedies should be levied at sentencing.

The bottom line, however, is not the intention behind the flawed product, but rather, the detection and elimination of the “bad” and the “ugly” from the supply chain. Policing agencies and courts can deal with the apprehension and adjudication of the actors who traffic the “bad” and the “ugly.” The industry’s role is to insure that counterfeits and adulterated pharmaceuticals are detected and intercepted prior to their arriving near providers and patients. Bad and Ugly will always be around, but if members of the supply chain commit to protecting the Good from the debilitating effects of the Bad and Ugly, then the entire industry, throughout the supply chain, will prosper.

It has often been said that “the perfect shouldn’t be the enemy of the good.” That statement may have some valiance in politics, football and polka dancing, but it could be catastrophic in pharmaceuticals and health care. The good isn’t good enough. Mere perfection is the only standard.

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