The primary goal of this chapter is to set the context of counterfeiting and falsification of medicines in the EU. Three legal case studies are instrumental in identifying the common issues and gaps that need to be addressed by the legal framework. The first case study, Operation Volcano, is based on the White paper written by the Medicines Agency in Italy and is based on several cases connected to one crime in Italy, involving theft of a cancer treatment drug and how that entered the legal supply chain. The second case study, Operation Singapore, is based on a court case in the UK. It concerns counterfeit and falsified medicines entering the EU from China via Belgium into the UK. The third case study, Operation Robin, hinges upon on a District court case from Sweden, which entailed sale of counterfeit medicinal products over the internet.
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