Last week I attended the Enforcement Committee meeting of the California Board of Pharmacy. The value of attending these meetings is hard to extract. It helps to have a solid knowledge of the language of the pedigree law, understanding of the standards and technology being considered to meet it, and the history of how we got where we are today. Even with all that on your side it takes a lot of concentration during the meeting and after it is over to put it all into perspective and find the value.
I will provide you with my thoughts on what went on at the meeting in a future essay, after they post the video of the event. I was there live but I want to provide the video time of the points that I reference so you can go right to them and see if you agree with my conclusions. Hopefully it will be posted by the Board of Pharmacy by the end of this week.
SOLUTION VENDORS PRESENT TO THE BOARD
One of the more amusing things that often happen at these meetings is when vendors make presentations that aren’t pertinent to the California law. For example, at this meeting we heard from Hewlett Packard about a drug authentication service they provide in small countries in Africa. I know that often when solution providers present to the Board they are really using the “opportunity” as an excuse to actually talk to the supply chain members who are in the audience (who are looking at their backs), but in this case, the service HP presented would have absolutely no applicability to meeting the California pedigree law. In response to the presentation by Abbott Labs, McKesson, the VA and GHX about their pilot, which had been made earlier, they seemed to be saying, “Look! We can operate an online database too!”. But the authentication service HP runs in Africa is a far cry from what is needed to meet the California law (see my essay, “Illegitimate Drugs In The U.S. Supply Chain: Needle In A Haystack”), so what’s the point?
In a joint presentation, representatives from Intelleflex, Verify Brand and Rehrig Pacific explained their RFID-based returnable container track & trace solution that they think would be great for use in the pharmaceutical supply chain. Maybe I missed something, but I couldn’t figure out why the Board needed to know about it. Maybe on individual company could use their system to track containers along with their contents while they are within their control, but it just doesn’t really seem to work as an overall industry solution to the California requirements.
What these two presentations—and many others just like them through the past—are missing is that the solution the industry needs cannot be based on a single proprietary database or service. That will be especially true if/when a U.S. nationwide pedigree or track & trace regulations is passed. What is needed is a standards-based approach that will enable competition in all the software and services that model defines.
WHY THE GHX SERVICE IS DIFFERENT
The GHX service looks like a proprietary service too on first glance, but as I understand it, it implements the GS1 EPCIS standard Capture and Query interfaces with a security layer, an additional value-added reporting interface and some expanded capture capabilities for enterprises that want to capture events directly from readers. The point was to create the first service that would eventually be one of multiple competing services that implement an EPCIS-based semi-centralized Network Centric ePedigree (NCeP) system. Of course, when you are the first implementer of a semi-centralized NCeP you instead look more like the fully centralized model, which it more like the government-run repositories in Italy, Turkey and Brazil (see my essay “The Viability of Global Track & Trace Models” for more on the differences between centralized and semi-centralized models).
But from what I understand, GHX fully expects other companies to offer compatible but competing services in a semi-centralized model. Apparently they believe they can compete and still be profitable. So now what they need is one or more competitors to help work out the details of an interoperable system. And the right place to do that is in the GS1 GSMP Pedigree Security, Choreography and Checking Service (PSCCS) work group which is right now working on the security, communications choreography and pedigree checks of just such a model. In fact, that work group still needs more participation from supply chain members as well. Contact John Ryu of GS1 if you would like more information about the group or to sign up.
BUT EVEN THE GHX SERVICE PROBABLY ISN’T USABLE FOR CALIFORNIA
I’ll have more to say about this in my future essay about last week’s meeting, but right now it doesn’t appear to me that the GHX service is usable directly for compliance with the current California pedigree law because it is based on the GS1 EPCIS standard alone (see my essays “Why GS1 EPCIS Alone Won’t Work For California Pedigree, Part 1” and “…Part 2” for an explanation). Others may disagree.
So doesn’t that tear down my argument that the GHX service is more important to meeting the California pedigree law than services like the one that HP runs in Africa? Perhaps, but I think it is much more likely to be usable in the U.S. in the future than the HP service—either to meet a slightly modified California law or a likely future federal nationwide pedigree system. At least it warrants more attention than it is getting from potential competitors.
Stay tuned for more on last week’s meeting.