Overview of the Selection of Strategic Authentication and Tracing Programmes 9

There is a wide range of pharmaceutical product threats, including counterfeit and substandard products. Consumer products, including pharmaceuticals, must be protected from fraudsters and criminals (the term ‘fraudster’ is used as a descriptive, formal term for this specific type of criminal and their activity [1–3]). The goal is not to see how many infringers can be caught: the goal is to reduce the prevalence of counterfeit product in the first place – to reduce the vulnerability and determine which countermeasures also increase our probability of finding new or evolving threats. To be most efficient and effective, the countermeasures must be strategic, holistic, interdisciplinary, all-encompassing and proactive rather than single-discipline, narrow, reactive and tactical. This chapter is based on experience and expertise gained through engagements and research projects with industry brand owners and security suppliers, government enforcement and prosecution agencies, as well as a wide range of associations and academic thought leaders. The approach is extremely interdisciplinary and grounded in the behavioural sciences and criminology with a focus on reducing fraud opportunity in the first place. Anti-counterfeit strategy is within the broader ‘brand protection’ concept, which is under the even broader concept of ‘product protection’. Product protection includes a wide range of concepts that focus on consumer or patient safety. The broader concepts often include: tamper resistance, child resistance, universal design/seniorfriendly, cargo theft, shoplifting, return fraud, warranty fraud, expiration date monitoring and management, and support of more effective recalls.