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Volume 3, Issue 16
September 30, 2004



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Remmele Engineering Inc., Automation Div.
a provider of custom-built automated packaging lines for turnkey integrated systems

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a leading manufacturer of high-quality thermal-transfer ribbons


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Pharmaceutical companies can no longer ignore the threat of counterfeit drugs—but are they investing enough time, manpower, and money into brand protection?

Best Practices LLC recently conducted a survey through its Business Excellence Board to determine how top pharmaceutical companies implement resources and staff to protect against counterfeit products. Ten companies participated in the study: 3M Pharmaceuticals; Abbott Laboratories; Aventis; Merck & Co.; Merck, Sharp & Dohme Ltd. (affiliate); Ortho Biotech; Pfizer (affiliate); Pfizer (affiliate); Proctor & Gamble; and Solvay Pharmaceuticals. 

The study, Safeguarding Against Counterfeit Products: Developing the Pharmaceutical Brand Security Function, found that most companies have a council or task force assigned to brand security, or they split the function between departments. However, only a few companies have a permanent department whose primary role is to protect their brand. Dan Egbert, senior research associate for Best Practices, notes that the formation of a permanent department is more of an “emerging trend” at this point, and companies are just starting to explore the idea of forming a working group. The study found that, on average, these companies have a staff of about five full-time-equivalent employees dedicated to brand security. Two of the companies have brand security staffs greater than 10, and—as might be expected—those companies did more than most of the other companies that had smaller staffs.

In terms of budget, the benchmark average was less than $500,000 a year. “Most companies are staking out what they’re trying to accomplish with these organizations,” says Egbert, “so they haven’t put big money into it yet.” Two of the companies had a budget greater than $1 million a year, and one had a budget of $3 million to $5 million a year.

In terms of functional responsibilities, the brand security groups with the largest staffs were able to accomplish all of the following: report potential counterfeit incidents to FDA or other regulatory authorities, monitor the supply chain for counterfeits, manage external communications on counterfeit drugs, collect and track data for product complaints, manage litigation, and develop authentication technology. What was surprising, says Egbert, is that two of the organizations with staffs of three people were able to accomplish all of those functions. The study did not yield enough data to say whether those companies are more effective at accomplishing all of those functions with a smaller budget, or if they are “overstretched.”

In terms of early warning activities, the most important and most common activity cited was getting feedback from the sales people who interact with physicians. Only one company monitored returned goods. The most common first-response activity was reporting incidents to FDA. In fact, in terms of communication and outreach, all of the companies communicated with FDA.

Considering the billions of dollars lost annually due to counterfeit drugs, the budgets and staffs allotted to protecting these companies’ products may, on the whole, seem smaller than one would expect. But the good news is that all of these companies are taking steps to address this problem—and all are communicating with FDA. As companies continue to create programs aimed at identifying potential threats to their products and devising ways to protect them against counterfeiters, we can only hope that packaging employees are involved to the same extent as sales, manufacturing, distribution, legal, and security personnel. According to Egbert, one of the survey respondents stated that his company was focusing on the packaging department as an important source of expertise. If your company’s brand protection team isn’t working closely with packaging, it may have a hurdle to overcome in terms of understanding all the elements that go into brand protection.

Kassandra Kania

 
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