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 to 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.
When introduced, the finest of intentions were in play. Statistics from the World Health Organization showed that a majority of pharmaceuticals in certain developing nations were counterfeit. The internet allowed e-Pharmacies to grow, run rampant, and distribute at best “gray market” drugs and at worst lethal counterfeits all over the web. It was increasingly obvious that something needed to be done.
That answer was mass serialization; a unique, traceable number for each and every prescription drug package. A digital chain of custody that would be used to verify authenticity. It promised serial number verification at the moment of drug dispensation. This was a wonderful plan.
I need to be careful here as a blogger. Systech pioneered the first pharmaceutical serialization solutions and is now the market leader. And I work for Systech. But here’s what you need to know.
Serialization is currently a compliance solution, not an anti-counterfeiting solution.
This realization is recognized by the rest of the market—pharmaceutical manufacturers, software vendors, packaging manufacturers, CMOs and CPOs, and others the drug supply chain ecosystem. There have been numerous blogs, articles and opinion pieces saying pretty much the same thing.
What is required for a truly counterfeit-free pharmaceutical supply chain, involves several layers.
- Overt Packaging Assets
- Rich and Trusted Data Integration and Exchange
- Hyper-Scalable Authenticity Detection
Serialization – This is still a valuable first step. Unfortunately, studies like the GS1 Barcode Assessment have shown that serialized barcode quality is a continuing issue. Serialization’s data infrastructure is wonderfully equipped to store data that can be used to fight the introduction of counterfeits. Unfortunately, it doesn’t go that far. Counterfeiters can easily mimic serialized data marks on millions of packages. The data exchange and associated processes need to be stronger in order to detect fake product from legitimate.
Overt Packaging Assets – This is the most straightforward layer. Tamper evidence seals, quality outside packaging graphics, crisp blister packs, and other professional packaging assets make the product look “right”. Counterfeiters have become very good at mimicking many of these methods. However, they will never have the ability (or desire) to create the infrastructure necessary to 100 percent match overt packaging assets. Online shoppers are at the biggest risk here, as e-Pharmacies prohibit the shopper from making side-by-side comparisons.
Rich and Trusted Data Integration and Exchange – One of the underpinnings of most global serialization regulations is the notion of data exchange. Electronic records are created when huge lots of drugs are sold and moved from warehouses to distribution centers, as well as when drugs are dispensed to patients. Taking serialized information and being able to integrate it effectively throughout the distribution chain – including every level within it – is a critical component to stopping counterfeits from entering. This may go far beyond the data exchange and reporting required from the regulations. True track and trace of individual items throughout the supply chain is a necessary component, and may be more involved than just what is needed from compliance.
In the US, the Partnership for DSCSA Governance is a non-profit group looking at the 2023 requirements calling for the interoperable, electronic tracing of products at the package level. The FDA requested pilots from industry groups to develop an implementation strategy for the 2023 interoperable, package-level mandate. Systech participated in the pilot program as part of the “Optimal Solution” group.
Hyper-Scalable Authenticity Detection – Immediacy of discovery is critical in mitigating the risk of counterfeits. Immediacy of authenticity is critical in building brand and drug trust, as well as loyalty. There is no greater solution to fighting counterfeits than empowering an inspector or consumer to validate authenticity in real-time. Crowdsourcing both authenticity and counterfeit detection is the best way to protect supply chains. This means each and every serialized package needs to be authenticated as genuine and legitimate by the “crowd”.
Ultimately, global serialization initiatives are a good thing. Putting a regulatory focus on the issues surrounding counterfeiting and effective recalls is important, and will help protect people. But, the increasing awareness that serialization alone is not an anti-counterfeiting solution is perhaps even more important. Understanding the layers necessary to protect products from counterfeiting will truly strengthen and help secure the pharmaceutical supply chain.