The European Falsified Medicines Directive offers manufacturers the opportunity to invest in effective anti-counterfeiting measures, with the potential to implement a global standard. However, successful systems will depend on the accuracy of the code printed on the product packaging.
Counterfeit medicines pose a serious threat to public health and safety, and they remain a growing problem throughout the European Union (EU). In the last five years, over 40 million have been seized by customs at EU borders, while in 2010 alone the number seized at outer borders was 11.5 million. Just as worrying, given the huge increases in online purchases in recent years, is that the percentage of drugs ordered over the internet that turn out to be counterfeit is estimated at between 50 per cent and 80 per cent.
Part of the problem up until now has been that counterfeit medicines were previously regarded as a low priority for many governments. This was not helped by the lack of a coordinated approach, with governments acting alone and often with weak regulatory structures and inadequate penalties, which made counterfeit medicines a much safer option than narcotics for many criminals. Counterfeit medicines could be more profitable too – one recent case highlighted a two-man wholesaler in the UK that made £57.6 million in the four years prior to the arrest of the owners.
It is hardly any wonder, therefore, that the World Health Organization estimated that the counterfeit pharmaceutical market was worth $75 billion in 2010.
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