The Falsified Medicines Directive: How to secure your supply chain.

With new EU-wide legislation being introduced to protect patients from falsified medicines, how can the existing supply chain adapt and thrive in this new, safer environment? Falsified medicines, and supply chain security in general, are a global issue gaining great political and consumer attention.1 Although no formal study has been carried out on a global scale, it is known that the issue affects both developing and developed nations, across the entire spectrum of available drugs.2 According to the World Health Organisation, a variety of factors contribute to the problem. These include high drug prices, demand in excess of supply and, critically, a lack of appropriately enforced legislation. The rise in illegal online retail of pharmaceuticals has greatly augmented the threat of falsified medicines from outside of the legal supply chain,3 though they may also reach patients via the legal supply chain.4 When properly formulated and enforced, government legislation helps keep people safe in the realest terms. Consider Scotland’s recent lowering of the drink-driving limit, which resulted in an early 30% drop in the number of drivers found over the limit.5 Mandatory fitting and use of seatbelts in cars have saved untold thousands of lives across Europe and electrical safety laws have reduced accidents and injuries in homes and workplaces. When you consider that, in 2009, France’s inability to efficiently recall the diabetes drug, Mediator (Benfluorex; Servier Laboratories, Surenes, France) resulted in as many as 2,000 deaths,6 the same principles must apply to the pharmaceutical industry.