Counterfeit medicines are an acknowledged crisis that takes patient risk to unacceptable levels – the authors argue that this is but the visible part of the iceberg. Counterfeit APIs are the much larger submerged part of the iceberg. Counterfeit APIs are a more serious issue as it represents a threat to the integrity of the legal supply chain of medicines, it potentially impacts a much larger number of patients and European and Japanese authorities do not yet perceive it as a threat – as such they may well remain outside the scope of proposed falsified medicines legislation and enforcement objectives. The pharmaceutical industry and its supply chain appear alone at taking steps to address this criminal threat.

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