Last month, Eli Lilly posted a video about their serialization initiative on YouTube. It features Grant Lindman, Manager of Lilly’s Global Anti-Counterfeiting Operations, and David Colombo, Commercial Implementation Leader of Lilly’s Global Serialization Program talking about their global serialization program. It is worth a listen.
In the video they discuss Lilly’s serialization program, but I would like to extract two major points that I think are important.
“SERIALIZATION NEEDS STANDARDIZATION”
Here is how they put it in the video:
“One big obstacle is standards. In the United States, several states have passed different laws. It would be nice to have one standard—one national standard.”
“This will make it much more difficult for illegitimate product to find an entry point into the legitimate supply chain.”
“We would also like to see that federal standard line up, or be linked with, the international or global standard. We ship products around the world, and if that standard is the same, then wherever we ship our products they can be traced all the way from the manufacturer to the pharmacy.”
This is a point that we can all agree on. And we are seeing some progress being made on this front with the probable passage (sooner…or later) of a U.S. federal serialization and track & trace law (see “Waiting For The Senate To Act On A Track & Trace Bill, Again”). But the international harmonization is a little harder to produce. Fortunately, the U.S. and the E.U. are following Turkey, Brazil and Argentina in requiring, or allowing, the use of GS1 global identification and barcode standards.
The most unfortunate situation regarding global standards is in China where they have chosen to require the use of country-specific standards and approaches for serialization, barcoding, data exchange and repositories. The pharmaceutical market in China is expected to expand at a very fast rate over the next decade so this situation is very significant to drug manufacturers who have, or plan to, enter that market.
But even ignoring the standards problems in China, the U.S. FDA has their own problem with the use of global standards in the aging National Drug Code (NDC). The NDC has served us well for many years, but if the U.S. passes a nationwide serialization law, it will immediately become time to transform the NDC into something more compatible with global standards. That is, a numbering system that is closer to the approach taken in the new FDA Unique Device Identification (UDI) system (see “UDI And The Approaching End Of The NDC”).
The Lilly video doesn’t allude to any of these problems but just calling for international harmonization is enough. That’s exactly how the UDI effort started.
“THE VALUE OF SERIALIZATION IS ABOUT INSTILLING CONFIDENCE”
Almost every company is looking for the return on investment (ROI) so they can offset their serialization investments with some kind of gain. For a long time I have made the point that the biggest ROI should be viewed as simply being able to remain in business within the markets that demand serialization and traceability (see “Pharma Serialization ROI”), but that’s just the beginning.
I recently attended the Nexus ’13 event where Jason Bogroff of Blue Fin Group presented “Serialization Business Opportunities”. It was excellent analysis that took a close look at the business impact and feasibility of a bunch of different ideas for potential business benefits outside of compliance. Interestingly, they found that the opportunity with the best combination of business impact and feasibility was “market access”. That is exactly what I said. No other opportunity came close. Overall, not many opportunities were very feasible. That’s the problem.
But listen to how Eli Lilly views it.
“Lilly’s goals are to
- strengthen the security of our supply chain,
- ensure the U.S. system is based on a uniform national model with a single common standard, and,
- work toward an international harmonization of serialization requirements.”
“The value to Lilly, beyond complying with regulatory initiatives, is really about instilling confidence throughout our patient community and the healthcare providers who serve those patients.”
“We want to ensure that the patient, if they get a product that has a Lilly name on it, it is the right medicine, it is what their doctor prescribed, and is a legitimate product.”
It’s all about instilling confidence that the product in the doctor, pharmacist or patient’s hand with Lilly’s name on it is safe. For nearly 150 years, the red Eli Lilly name on the package was sufficient, but thanks to modern image capture and printing technologies, it is no longer. From now on, serialization will bolster that name. Can you put a value on that to figure into the ROI calculation?