In recent years the incidence of fraudulent trade in pharmaceutical products has been on the increase globally, as evidenced by counterfeiting, reimbursement irregularities, tampering and expired products. In a number of countries, such as Italy and Belgium, governments have responded to this threat by introducing mass serialisation to combat (chiefly) reimbursement irregularities. In other countries, regulatory bodies, and governments are introducing many initiatives to facilitate greater security of pharmaceutical products, appropriate reimbursement and patient safety.