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Today we use more medicines than ever before. The total worldwide market for pharmaceuticals is estimated at over $770 billion and this number is set to increase. Yet, while much focus has been placed on how to pay for the growth in demand for medicines, little attention has been paid to what may amount to an equally serious problem: ensuring their safety for patients.

Complex and interlinked supply chains now mean that the process of testing, manufacturing and marketing a new medicine spreads across different countries (for example from India to the US or the EU and vice versa). However, the globalisation of pharmaceutical markets and production has also increased the spread and prevalence of unsafe medicines, be they counterfeit or substandard. Counterfeit medicines are defined by the WHO as being ‘deliberately and fraudulently mislabelled with respect to identity and/or source’. Substandard pharmaceuticals, on the other hand, are those which have been legitimately manufactured and, more often than not, approved for market and sale by a national or regional Drug Regulatory Authority (DRA) but which nevertheless do not meet the required quality or safety requirements.

The Stockholm Network has previously highlighted the serious effects of counterfeit medicines. We now aim to demonstrate how substandard drugs are a real and growing threat to public health in both the developed and developing world. As substandard drugs have often been approved by a regulator, we need to examine where existing drug regulations have gone wrong and how they can be changed. In this public workshop our expert panel highlighted the problem that substandard drugs present to public health and the Stockholm Network presented the findings of our new report into the issue.