GS1 US is dedicated to expanding the adoption of GS1 Global’s standards for supply chain interaction in the U.S. market. Almost every country in the world has a GS1 “Member Organization” (M.O.) that is dedicated to the same thing within their borders. With the local M.O.’s primary focus on driving adoption, their most valuable tool is that country’s government. If they can get the government to reference GS1 standards in their laws, their work is much easier.
This isn’t unique to GS1, or course. All standards organizations know this and they all have various approaches to getting the attention of each country’s government. There is nothing wrong with this. In fact, it makes perfect sense since, unlike standards organizations themselves, countries always have very large enforcement wings.
But what happens when those governments are too big to sway easily? What if it costs too much and takes too long to get them to see the light? This is when a standards adoption organization needs to get creative. In my opinion, that’s what has led GS1 Healthcare US to create the “2015 Readiness Program”. It was out of frustration with the California State Government and with the U.S. Food and Drug Administration (FDA) and their, so far, unwillingness to create laws and regulations that mandate the use of GS1 standards. Let me explain.
THE GS1 HEALTHCARE US 2015 READINESS PROGRAM
The GS1 Healthcare US 2015 Readiness Program is a voluntary program that is open to any company that is a member of the U.S. pharmaceutical supply chain. You don’t have to be a GS1 US subscriber to participate in most of the program activities or to benefit from it. The program was conceived by GS1 U.S. about a year ago and it was kicked off in January of 2010. The program includes a series of weekly teleconferences where representatives from the member companies collaborate to document the many business processes necessary to package, distribute and dispense pharmaceuticals within the U.S. supply chain, including the many exceptions that can happen along the way. The group then figures out how to apply GS1 Electronic Product Code Information Services (EPCIS) standard in a way that GS1 Healthcare US believes would make the whole process more efficient and would hopefully increase the safety and security of the supply chain.
That is, it would do these things IF every company that participates in the U.S. pharmaceutical supply chain were to adopt the EPCIS standard in a uniform way by purchasing and deploying products based on that standard. It’s a big “IF”.
But here’s the best part about the program. As the idealized supply chain model is being developed, GS1 Healthcare US has used a third-party simulation tool to actually simulate the EPCIS data exchange that would occur in it. Participants are allowed to take home a copy of the simulation runtime environment and they can actually make some configuration changes to the model to help them study what might happen in that world under their own special circumstances. It’s pretty powerful stuff.
GS1 Healthcare US is offering two 1 ½ day workshops that are open to anyone wishing to learn about the program, learn how to use the simulation and get a copy of it for their own use. These workshops are:
October 12-13, 2010 • Hotel Kabuki • San Francisco, CA
November 10-11, 2010 • Gaylord National Resort & Convention Center • National Harbor, MD
(Co-located with HDMA Track-and-Trace Technology Seminar, my favorite serialization and ePedigree event)
You can find out more about these GS1 Healthcare US events and register by clicking here.
I’m pretty excited about it and I encourage anyone who is interested to participate in the group that is continuing the development of the simulation and/or these workshops. I’m pretty confident that GS1’s EPCIS will be used by many in the U.S. supply chain and this workshop is a great way to really understand what it can do when it is applied in a specific supply chain context. In fact, members of other supply chains might even want to take note of this excellent piece of work and consider asking GS1 US to develop one for your supply chain.
SO WHAT’S THE PROBLEM?
The problem is, I think GS1 US is crossing the line between just advocating adoption and inducing it through mis-characterization. Let’s start with the name itself: “2015 Readiness Program”. Ready for what? What happens in 2015? Oh, that’s the year that the first of multiple requirements of the California Pedigree Law goes into effect. But no one has yet figured out exactly how to apply EPCIS-only to comply with that law. In fact, even GS1 US will admit that they are not saying that use of EPCIS would make you compliant with that, or any other law, but you have to press them to hear that.
So what would you be “ready” for? Perhaps you would be ready to deal with the serialization component of the California law? Now that I would agree with. Serialization is a big part of the California law, and it’s arguably the most complex and expensive component. So, yeah, that must be it. To say nothing of compliance with the law, you could at least be “ready” for part of the pedigree law by 2015 if you made use of EPCIS to help you deal with serial numbers on drug packages and shipping containers.
But the way the program is constructed, and the solution is implemented for simulation, it results in a distributed pedigree system—one where you have to query all the previous owners of a drug to collect the various components necessary to assemble your pedigree. The implication is that you would only need to do that whenever a California State inspector shows up at your door and asks to see the pedigree for “this bottle”. The GS1 Healthcare US program doesn’t try to interpret the law to make sure the proposed solution would comply with it. That’s up to the end users.
The introductory paragraph of the GS1 Healthcare US “2015 Readiness Program Guide” starts this way:
“The 2015 Readiness Program was established by GS1 Healthcare US to help members of the U.S. pharmaceutical supply chain prepare for state drug pedigree requirements beginning in 2015 and learn how to leverage the same data stream used for regulatory compliance to realize additional business benefits.”
That implies that I should expect to be ready to comply with state drug pedigree laws if I participate, but so far, that won’t happen.
The ruse will be carried one step farther because GS1 Healthcare US has included speakers from the California Board of Pharmacy and the FDA in their workshops, giving the appearance of full support and an acknowledgement of compliance. Virginia Herold, Executive Officer of the California Board of Pharmacy will be a guest speaker at the California workshop and Connie T. Jung, RPH, senior advisor for pharmacy affairs of the FDA will speak at the Maryland workshop.
ASK THESE QUESTIONS
Those of you who will attend these workshops should ask these questions:
- Ask these guest speakers if the agency they work for would accept a distributed pedigree as compliant with their pedigree law
- Ask GS1 Healthcare US how the system being simulated will comply with the California requirement that the pedigree you receive from your supplier, and the pedigree you provide to your customer, must include all prior supply chain ownership history, including all certifications
- Will California accept that approach?
- Ask GS1 how you would include a certification that the necessary collection of events are true and correct
- Is that approach acceptable to California?
- While you’re at it, ask your legal department if they will allow you to buy drugs from a supplier who would not typically provide you with the entire pedigree as defined by California once the law goes into effect
- Will your own company accept the risk that the full pedigree data might not be available from the previous owners at the time that inspector shows up?
GS1 will tell you that these things have not yet been worked out. I say that they haven’t been worked out because GS1’s approach to pedigree using only EPCIS won’t work very well once you add the necessary steps to make it fully compliant. They are simulating the popular track and trace part of the law, but not the unpopular pedigree compliance parts. A simulation of an EPCIS pedigree system that included features necessary to fully comply with California wouldn’t be very compelling or generate as much interest as one without those “complex” features.
MY VIEW OF THE SITUATION
Serialization systems based on the GS1 EPCIS standard will very likely be valuable for pharmaceutical manufacturers who must keep track of all of the serial numbers they apply to their products—pedigree law or not. It will probably be valuable for pharmaceutical distributors to keep track of which drug packages were received and shipped and when using EPCIS. But there is no certainty that systems based on EPCIS will be justifiable for use in systems aimed at pharmacies.
The pedigree system that would result from EPCIS event exchange would require so many undefined contortions to get it to comply with California’s existing law that the industry is unlikely to accept it, especially when all you really need to do to make those systems compliant is to simply add the use of the GS1 Drug Pedigree Messaging Standard (DPMS). DPMS would give you the ability to comply with the law and EPCIS would give you the non-regulatory benefits that GS1 is simulating.
Should you attend the GS1 Healthcare US 2015 Readiness Program Workshops? Yes. Should you expect to be ready for the California Pedigree Law by 2015 as a result? No. At least not yet.