What Your Data Can Tell You About Illicit Trade Risk

One of the objections I sometimes hear when discussing counterfeiting and diversion challenges with pharmaceutical manufacturers, particularly smaller ones, is that they just don’t know enough about the problem. They may suspect they have a problem and/or they may have seen some evidence of a problem, but they feel they lack sufficient data or knowledge to take concrete steps to address it—beyond doing the minimum required by law, of course, such as serialization. This knowledge gap may also lead them to conclude that even if a problem exists, the risk is likely to be low, and additional investment in product integrity is not warranted.

My response to this challenge is always that you probably know more than you think—you just need to know where to look. And, as for the risk, it may be greater than you perceive it to be—for your patients, your reputation, and your business. My best advice is to take proactive steps to gather the available data, which will enable you to better understand the issue and make an informed decision about what illicit trade risk management should entail for your business.

How do you know more than you think? Because your existing internal data and business intelligence, when viewed through a product integrity lens, can provide a trove of relevant and useful information. Digging into this data can begin to shed light on the issue and provide actionable insights. Your colleagues working in the commercial, quality, and supply chain areas may also be able to provide valuable information to help you begin to formulate a clearer picture of the risk. Consider the data sources in the below table and what they can tell you about illicit trade risk (click to enlarge).

Knowing where to look and what the data can potentially reveal is, of course, just the first step on your data-driven journey to becoming better informed about illicit trade risk. Armed with a list of the relevant data sets and the questions you’re trying to answer with the data, that’s when you invite your data and analytics team to the table. They’ll need to understand the problem you’re trying to solve, then prepare the data and apply the appropriate analytical tools and techniques, such as machine learning, natural language processing, statistical analysis, and AI techniques, to obtain answers and actionable insights that will inform your decision-making.

The global threat of illicit trade continues to grow every year. If you wait to take additional preventive measures until a counterfeit product turns up online or in your legitimate supply chain, then it’s probably too late. It’s a lot more challenging to be in a reactive mode, trying to address patient safety and customer concerns, versus taking proactive steps now to conduct a rigorous assessment, followed by an informed leadership decision about what level of risk is acceptable and implementing a program that meets your objectives. It’s a risk you can’t afford to ignore.

About the Author

Sean O’Hearen is Founder and Principal Consultant at 1st Line Partners.