The Falsified Medicines Directive: securing the pharmaceutical supply chain ecosystem

By Dale Benton
The pharmaceutical medicine supply chain has found itself under increasing scrutiny over the past few years and this has been sparked by a number of hig...

The pharmaceutical medicine supply chain has found itself under increasing scrutiny over the past few years and this has been sparked by a number of high-profile incidents involving counterfeit drugs causing deaths across the UK, Ireland and the US.

Security and visibility are two of the biggest talking points in the modern world’s supply chain conversation and international governments, organisations and leading businesses are implementing new programmes to tackle this challenge.

One such programme is the Falsified Medicines Directive (FMD), which went live in early February. The FMD is legislation passed by the European Union Parliament, which aims to increase the security of the manufacturing and delivery of medicines across Europe and protect patients and prevent falsified medicines from entering the supply chain. Through this, manufacturers are required to place safety features on all medicines and “contribute financially to the establishment of an IT verification system that will allow the assessment of the authenticity of a medicine at the time of supply to the patient.”

Alastair Taylor, Vice President, EMEA of Systech, believes that while the FMD will strengthen the supply chain, it will also play a key role in driving what he describes as the “Grey Market”, where legal and illegal pharmaceutical supply chains meet.

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“Legitimate medications are made available through distribution channels not authorised by drug manufacturers. Largely, these medications are diverted out of the legitimate supply chain due to price point differentials and/or availability gaps in different geographies. Distribution is via quasi-legitimate e-Pharmacies on the Internet.  How this will work in the era of the FMD will be interesting to monitor,” he says.

The UK is a highly regulated market and Taylor thinks that having a popular medication available only through private-prescription use creates something of a void, one that pushes medications from their intended supply chain and into the Grey Market.

“That void highlights un-met demand.  Demand creates market opportunity.  Market opportunity causes entities to pounce,” he says. “The Grey Market retailers may or may not comply with the dispense-side requirements of the FMD. Manufacturers may never know where and when their medicines are dispensed as is required. Consumers purchasing from these quasi-legal dispensaries will never know if the medicines moved through the supply chain with the proper level of care (handling, temperature, etc).”

The key to understanding and mitigating this challenge, is education across the entire medical ecosystem. Manufacturers and individuals need to be made aware as to how imperative it is not to purchase pharmaceuticals outside of their intended supply chain. “This is quite literally a matter of life and death,” says Taylor.

Taylor advocates the use of Anti-Diversion Programs to help manufacturers keep their supply chain safer:

Anti-Diversion Program

“Pharmaceutical companies can do little about the scourge of counterfeit medications.  Putting a formal Anti-Diversion program in place is within their reach, however,” says Taylor.

 

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