Abstract

Counterfeit medicines are anacknowledged crisis that takespatient risk to unacceptable levels – the authors argue thatthis is but the visible part of the iceberg. Counterfeit APIs arethe much larger submerged part of the iceberg. CounterfeitAPIs are a more serious issue as it represents a threat to theintegrity of the legal supply chain of medicines, it potentiallyimpacts a much larger number of patients and European andJapanese authorities do not yet perceive it as a threat – assuch they may well remain outside the scope of proposedfalsified medicines legislation and enforcement objectives. Thepharmaceutical industry and its supply chain appear alone attaking steps to address this criminal threat.