Risks for the Pharmaceutical Supply Chain

Threats Posed by Counterfeit Medicines

Counterfeit medicines are a common threat and an international challenge to everyone involved in the pharmaceutical supply chain. The World Health Organization (WHO) estimates that in industrial countries up to seven percent of all medicines are fakes, with the figure ballooning in developing countries between 30 and 70 percent. As the profit margins in this case are even higher than those generated with drugs such as heroin or cocaine, counterfeiting syndicates with worldwide operations are increasingly involved as well. All forms of administration are affected, such as tablets, infusions, injections, ointments and solutions whether or not they require medical prescription. This puts the safety of patients at risk. Falsified medicines are spreading particularly in developing countries in Africa and Asia, and due to the growing number of internet pharmacies. The legal distribution chain is either circumvented or its complexity exploited in order to channel in products which have been falsified in terms of their identity, ingredients or origin.

Methods of Counterfeiters and Holistic Countermeasures

Fraudsters use a wide range of methods for their illegal activities. For instance, counterfeiters produce increasingly professional true-to-detail copies of medicine packs and fill them with ineffective and sometimes even harmful product imitations. In 2015, German customs investigators confiscated 150,166 counterfeit medicines worth 1.01 million euros, equating to a 26% increase compared to the year before, although only two percent of all goods are actually checked at the time they are imported. Counterfeiting affects the entire product range of the manufacturers and all forms of sale, from online  and wholesale distribution all the way to the pharmacy. Thus, effective anti-counterfeiting measures should always be based on a holistic approach regarding product and patient safety. This requires strategic security management on company level at the respective pharmaceutical manufacturer.