Pharmaceutical serialization has been looked upon as a panacea for the rampant global issue of counterfeiting. Now that enforcement data has become available on the US Drug Supply Chain Security Act (DSCSA) and EU Falsified Medicines Directive (FMD), it’s time analyze the results. Has serialization put an end to counterfeiting?
Spoiler alert. According to the EU IP Office, pharmaceutical counterfeiting has not slowed down, but is a growing threat.
Liquid Gold. That's how Interpol has described organized crime's view of vaccine demand. The more in demand a product is, the more it will be counterfeited. We can count on an absolute tidal wave of COVID vaccine and treatment counterfeiting to flood the markets now that the vaccine is available.
Crowdsourcing your counterfeit detection gives you an army of real-time field inspectors. The underlying tech is also your key to more connected customers.
Updated Sept 24 2020.
As of September 24, 2020 Class I medical devices needed to meet the FDA’s Unique Device Identification Final Rule. However, that date was postponed by the FDA in July with the publication of a new Policy Guideline document. That means the FDA will not begin enforcing the UDA Final Rule on these devices until September 24, 2022. By this new date,
Serialization was introduced by governments as a mechanism to protect the pharmaceutical supply chain over 10 years ago. Major serialization mandates in the US, EU and other regions are now live. Now is a good time to reflect back on this massive undertaking and review some “lessons learned”. We say this because serialization isn’t “over” in pharma.
Crime has no moral code. If you have a high-demand product, people will likely counterfeit it. Itcomes as no surprise that during this time of pandemic, counterfeiters are targeting everythingfrom hand sanitizer to test kits. (In 2020 I blogged about counterfeit COVID test kits and counterfeit COVID vaccines.)
I have written and spoken about global counterfeiting issues many times. Pretty much in every single one, I’ve said something like “if you have a successful product, it will be counterfeited.” Illicit counterfeit rings have infiltrated pharmaceuticals, consumer goods, cosmetics, fragrances, automobile parts, aircraft parts, clothing, footwear, wine, spirits and more. The riches and rewards from producing and distributing counterfeit products in most cases far outweigh the penalties of...
The fight against counterfeiting and diversion is at a crossroad. Never has there been such a loss of revenue due to these global supply chain threats and it’s only getting worse. Companies are spending over $105 billion annually to combat these issues, yet this “gray market” of products is projected to surpass $2.8 trillion globally by 2022… That’s a 100% increase over ten years!
Near the end of 2019, there were rumors that the Russian Federation would extend its regulatory deadlines for pharmaceutical serialization and traceability past its initial January 1, 2020 deadline, which called for full serialization using Russian Crypto Codes and government reporting...
Change is afoot, we are entering a new phase of activity within the pharmaceutical sector. The next stage of patient protection is starting to take shape across the industry, and it is a case of going back to the future. Though, no DeLorean, TARDIS or even a hot tub time machine are needed to make this change, we are not going to have hover boards or give cousin Chuck Berry a new sound. Instead of fighting Daleks we are going to wage war on counterfeiters and grey marketeers.